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AIM: To study the effect of topical dorzolamide 2% on macular thickness reduction in diabetic cystoid macular edema (CME). METHODS: This was a prospective, non-randomized, open study including eyes with diabetic macular edema (DME). All eyes received topical dorzolamide 2% three times daily for one month. Changes in best-corrected visual acuity (BCVA), and central macular thickness (CMT) by optical coherence tomography) were evaluated at 1wk, 1, and 3mo post-treatment. RESULTS: Ninety-three eyes (84 patients) were included. Mean±SD (logMAR) BCVA improved significantly from 1.08±0.26 pretreatment to 0.66±0.24 at 1mo and 0.87±0.26 at 3mo post-treatment (P

Dopamine supersensitivity psychosis (DSP) in patients with schizophrenia is induced by treatment with a high dosage of antipsychotics for a long time period, and it is characterized by unstable psychotic symptoms. The upregulation of dopamine D2 receptor (DRD2) provoked by antipsychotics underlies DSP. Aripiprazole does not cause an excessive blockade of DRD2 and is less likely to upregulate DRD2 by aripiprazole's dopamine partial agonistic profile. Aripiprazole; however, has a potential risk of inducing severe rebound psychosis in patients who have already developed dopamine supersensitivity. Recently, an animal model study suggested that aripiprazole could attenuate established dopamine supersensitivity. The present study was conducted to examine whether very slowly switching to aripiprazole could help patients with schizophrenia with dopamine supersensitivity while avoiding rebound psychosis. This study was a single-armed and open-labeled study in which patients were observed over a period of 2 years. Only 11 patients were ultimately recruited. Five patients were successfully switched to a sufficient dose of aripiprazole and completed the study protocol. These five patients did not present with severe DSP over the study period, but only one patient showed a large improvement in psychopathology. Five patients dropped out of the study, and one of these five showed a severe worsening of psychosis. The present study indicated that the introduction of aripiprazole in patients with DSP was difficult, but suggested that aripiprazole could contribute to attaining a stable state in psychosis if it was applied with careful observation.

The treatment of small intestinal overgrowth (SIBO) varies according to the center. The present study aimed to evaluate the efficacy of COLIGENTA, an association of colimycin and gentamycin, on SIBO symptomatology and breath test normalization PATIENTS AND METHODS: In this prospective cross-sectional open study, 150 patients with functional bowel disorders and SIBO diagnosed by lactulose hydrogen breath test (LHBT) underwent COLIGENTA oral treatment. A new HLBT was performed 4 weeks after the first HLBT.The patients were mainly female (74%), with a mean age of 47.4 ± 16.2 years and a body mass index of 26.2 ± 5.9 kg/m². After treatment, a decrease of expired hydrogen concentration (P0.001) was found in the entire population. Improvement of gastrointestinal symptoms was found in 129 patients (86%), while the breath test's normalization was found in 62 patients (42%). Logistic regression showed that normalization of bowel symptoms was not associated with demographics, clinical, or hydrogen breath concentration. In contrast, normalization of LHBT was associated with an increase of breath hydrogen concentration at time 100 min during the first test (P = 0.003; OR=1.072; 95%CI= [1.023-1.123]).The present study shows that 10-days of COLIGENTA treatment has a high SIBO clinical improvement rate and can be used as the first or second treatment line.

Background:Tocilizumab (TCZ) has shown promising results in the treatment of inflammatory ocular disease, especially in uveitis (1-3). Graves orbitopathy (GO) is the most common complication of Graves’ disease (GD). Conventional immunosuppressive drugs are not always effective or well tolerated. TCZ may be useful in the treatment of GO.Objectives:To assess the efficacy of TCZ in corticoid-resistant GO.Methods:Multicenter open study of corticoid-resistant GO. We measured clinical activity using the clinical activity score (CAS). CAS evaluates 10 different ocular items, ranging from 0 (no symptoms) to 10. We defined remission as the presence of CAS ≤ 3.Results:We studied 48 (95 eyes) patients (TABLE). Besides oral corticosteroids, they had received iv Methylprednisolone (n=43), methimazole (n=20), selenium (n=11) or radioactive iodine (n=5). According to the classification of severity (EUGOGO group), before of TCZ onset our patients had severe (n=19) or moderate (n=29) disease. TCZ was used in monotherapy (n=45) or combined with methotrexate (n=2) or azathioprine (n=1) at a dose of 8 mg/kg/iv/4 weeks (n=43) or 162 mg/sc/week (n=5). TCZ yielded rapid and maintained improvement and most patients achieved remission (FIGURE).TABLE:Number of patients/eyes affected, n/n48/96Age, mean (SD), years50.96 (11.78)Sex, men/women, n/n (%)10/38 (20.8 / 79.2)Regimen of TCZ therapyMonotherapy/combined treatment, n (%)45/3 (93.8/6.2)• AZA1 (2.1)• MTX2 (4.2)TCZ dosage, n (%)• 8 mg/kg/iv/4 weeks43 (89.6)• 162 mg/sc/week5 (10.4)Follow-up on TCZ therapy, mean (SD), months16.05±2.06• Remission, n (%)72 (75.8)• Discontinuation treatment, n (%)29 (60.4) • Remission25 (86.2) • Inefficacy4 (13.8) • Side effects0FIGURE:After a mean follow-up of 16.1±2.1 months, most patients experienced ocular improvement, with TCZ withdrawal in 29 cases due to remission (n=25) or inefficacy (n=4). Only 5 relevant adverse events were observed (neutropenia, external otitis, otitis media, costal osteitis and gingival hyperplasia). None of these events resulted in discontinuation of the treatment.Conclusion:TCZ appears to be an effective and safe treatment in corticoid-resistant GO.References:[1] Santos-Gómez M, et al. Clin Exp Rheumatol 2016; 34 Suppl 102(6):34-40[2] Calvo-Río V, et al. Clin Exp Rheumatol. 2014; 32 (4 Suppl 84): S54-7[3] Vegas-Revenga N et al. Am J Ophthalmol. 2019 Apr; 200:85-94.Disclosure of Interests:Lara Sanchez-Bilbao Grant/research support from: Pfizer, David Martinez-Lopez: None declared, Belén Atienza-Mateo: None declared, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Janssen and Celgene, Speakers bureau: Pfizer and Lilly, Vanesa Calvo-Río Grant/research support from: Abbvie, Lilly, UCB, MSD, Cellgene, Speakers bureau: Abbvie, Lilly, UCB, MSD, Cellgene, Rosalía Demetrio-Pablo: None declared, Monica Calderón-Goercke: None declared, D. Prieto-Peña: None declared, Iñigo González-Mazón: None declared, Elia Valls-Pascual Grant/research support from: Roche, Novartis, and AbbVie, Speakers bureau: AbbVie, Lilly, Pfizer, MSD, Novartis, Janssen, Bristol Myers Squibb, UCB Pharma, Beatriz Valls-Espinosa: None declared, Olga Maiz-Alonso: None declared, Ana Blanco Speakers bureau: Abbvie, Ignacio Torre-Salaberri: None declared, Verónica Rodriguez-Mendez: None declared, Ángel García-Aparicio: None declared, Raúl Veroz González: None declared, Vega Jovani: None declared, Diana Peiteado Grant/research support from: AbbVie, Lilly, MSD, and Roche, Speakers bureau: AbbVie, Roche, and MSD, Santos Castañeda: None declared, Margarita Sánchez-Orgaz: None declared, Eva Tomero Muriel: None declared, Francisco J. Toyos Sáenz de Miera: None declared, Valvanera Pinillos: None declared, Elena Aurrecoechea: None declared, Ángel Mora: None declared, Arantxa Conesa: None declared, Manuel Fernández: None declared, J. Antonio Troyano: None declared, Marcelino Revenga: None declared, J. Luis Hernández: None declared, Miguel A González-Gay Grant/research support from: Pfizer, Abbvie, MSD, Speakers bureau: Pfizer, Abbvie, MSD, Ricardo Blanco Grant/research support from: AbbVie, MSD, and Roche, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD

Background A rapid antidepressant effect of ketamine has repeatedly been documented in the literature, and identifying clinical features associated with a better response to this treatment is currently an essential question. Considering the relationship between rumination and depression and the need to identify potential predictors of response to ketamine, we analyzed the effect of a single injection of ketamine 0.5 mg/kg on rumination in treatment-resistant depressive (TRD) patients and explored whether baseline ruminative style and early improvements of rumination would predict a greater antidepressant effect of ketamine. Methods Ten TRD outpatients who participated in a 4-week open study on the antidepressant effect of ketamine also completed the Ruminative Response Scale the day before, the day after, and a week after ketamine administration. Results We found that in our patients, a single rapid 1-minute intravenous injection of ketamine 0.5 mg/kg was efficacious in reducing rumination, but neither severity of rumination at baseline nor early improvements of rumination after ketamine injection predicted antidepressant response. Conclusions Our preliminary data suggest that a single injection of ketamine 0.5 mg/kg can be efficacious in reducing rumination in TRD patients but rumination does not seem to be a useful clinical predictor of response to ketamine. Larger studies are necessary to confirm these results.

Contains fulltext : 219893.pdf (Publisher’s version ) (Closed access) BACKGROUND: Treatment of venous thromboembolism in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. The aim of our study was to compare the efficacy and safety of rivaroxaban versus standard anticoagulants in children with venous thromboembolism. METHODS: In a multicentre, parallel-group, open-label, randomised study, children (aged 0-17 years) attending 107 paediatric hospitals in 28 countries with documented acute venous thromboembolism who had started heparinisation were assigned (2:1) to bodyweight-adjusted rivaroxaban (tablets or suspension) in a 20-mg equivalent dose or standard anticoagulants (heparin or switched to vitamin K antagonist). Randomisation was stratified by age and venous thromboembolism site. The main treatment period was 3 months (1 month in children /=1 dose), were centrally assessed by investigators who were unaware of treatment assignment. Repeat imaging was obtained at the end of the main treatment period and compared with baseline imaging tests. This trial is registered with ClinicalTrials.gov, number NCT02234843 and has been completed. FINDINGS: From Nov 14, 2014, to Sept 28, 2018, 500 (96%) of the 520 children screened for eligibility were enrolled. After a median follow-up of 91 days (IQR 87-95) in children who had a study treatment period of 3 months (n=463) and 31 days (IQR 29-35) in children who had a study treatment period of 1 month (n=37), symptomatic recurrent venous thromboembolism occurred in four (1%) of 335 children receiving rivaroxaban and five (3%) of 165 receiving standard anticoagulants (hazard ratio [HR] 0.40, 95% CI 0.11-1.41). Repeat imaging showed an improved effect of rivaroxaban on thrombotic burden as compared with standard anticoagulants (p=0.012). Major or clinically relevant non-major bleeding in participants who received >/=1 dose occurred in ten (3%) of 329 children (all non-major) receiving rivaroxaban and in three (2%) of 162 children (two major and one non-major) receiving standard anticoagulants (HR 1.58, 95% CI 0.51-6.27). Absolute and relative efficacy and safety estimates of rivaroxaban versus standard anticoagulation estimates were similar to those in rivaroxaban studies in adults. There were no treatment-related deaths. INTERPRETATION: In children with acute venous thromboembolism, treatment with rivaroxaban resulted in a similarly low recurrence risk and reduced thrombotic burden without increased bleeding, as compared with standard anticoagulants. FUNDING: Bayer AG and Janssen Research & Development. 01 januari 2020

To evaluate criteria driving retreatment with ranibizumab in Italian patients with myopic choroidal neovascularization (mCNV). OLIMPIC was a 12-month, phase IIIb, open-label study. Patients with active mCNV were treated with ranibizumab 0.5 mg according to the European label. The study assessed local criteria in Italy driving retreatment decisions with ranibizumab; and the efficacy, safety, and tolerability of ranibizumab. The mean (standard deviation [SD]) age of treated patients (N = 200) was 61.8 (12.7) years; range 22–85 years. The multivariate regression model indicated that presence of active leakage (odds ratio [OR] 95% confidence interval [CI]: 11.30 [1.03–124.14]), presence of intraretinal fluid (OR [95%CI]: 28.21 [1.55–513.73]), and an improvement in best-corrected visual acuity (BCVA) from baseline

Introduction Children with Attention Deficit Hyperactivity Disorder can present Auditory Processing (AP) Disorder. Objective The study examined the AP in ADHD children compared with non-ADHD children, and before and after 3 and 6 months of methylphenidate (MPH) treatment in ADHD children. Methods Drug-naive children diagnosed with ADHD combined subtype aging between 7 and 11 years, coming from public and private outpatient service or public and private school, and age-gender-matched non-ADHD children, participated in an open, non-randomized study from February 2013 to December 2013. They were submitted to a behavioral battery of AP tests comprising Speech with white Noise, Dichotic Digits (DD), and Pitch Pattern Sequence (PPS) and were compared with non-ADHD children. They were followed for 3 and 6 months of MPH treatment (0.5 mg/kg/day). Results ADHD children presented larger number of errors in DD (p

Background/Aims: Previous reports highlighted the potential interest of cetuximab alone or in combination with chemotherapy in locally advanced or metastatic cutaneous squamous cell carcinomas (cSCC) care. Material and Methods: To further evaluate the efficiency and safety of cetuximab in advanced cSCC, a single-center retrospective study including all patients treated with cetuximab alone or combined with carboplatin for locally advanced or metastatic cSCC was conducted in a tertiary referral center. The primary end point was the overall response rate (ORR) after 2 cycles of treatment. Secondary end points were best overall disease control rate (DCR), overall survival (OS), best response duration, progression-free survival (PFS), and toxicity profile. Results: Of the 14 enrolled patients, no complete response was obtained after 2 cycles of treatment, but 3 partial responses and 6 stable diseases were observed. ORR and DCR were 21.4 and 64.3%, respectively. Median OS and PFS were 9.25 and 2.65 months, respectively. Median PFS was longer with combined treatment compared with cetuximab monotherapy (9.03 vs. 3.55 months). The safety profile was acceptable with a trend toward a relationship between acne-like rash and longer response (median PFS 5.2 vs. 2.2 months). Discussion/Conclusion: In all series including ours, disease control is usually rapidly obtained with cetuximab alone or combined with conventional chemotherapy, although with a minority of partial responses and no complete response. However, this control is of short duration in most cases. The safety profile is acceptable. A randomized phase III trial is warranted to better assess the benefit/risk ratio.

Objective: To assess efficacy and safety of inert cellulose powder (ICP) in the treatment of mild seasonal allergic rhinitis (SAR). Methods: An observational, non-randomized, open study including 74 examinees suffering from mild SAR was conducted. The study subjects were divided in two groups, Group 1 (G1) and Group 2 (G2). The study subjects from G1 were treated 10 days with oral cetirizine and ICP, while the study subjects from G2 were treated 10 days only with oral cetirizine. The treatment outcomes were evaluated after five and 10 days by self-assessment of the symptoms on a five-point scale. Results: In both groups improvement of the symptoms five and 10 days after the treatment was registered. There was significantly higher prevalence of the G1 study subjects in the point 4 (“major relief, casual sneezing”) five days after beginning of the treatment (43.2% vs. 18.9%; P

Infantile hemangiomas, occurring at birth or during the first weeks of life, are benign vascular tumors with an initial proliferative phase and a later involutional phase. The massive proliferation on the key regions and unpredicted regression may threaten life. Thus, early management of infantile hemangiomas is necessary for affected infancies. Recent studies showed that propranolol for infantile hemangiomas had high efficacy for disappearance or reduction of infantile hemangiomas. However, a most recent study demonstrated existence of propranolol-resistant infantile hemangiomas. Therefore, we retrospectively evaluated efficacy of established early pulsed dye laser treatment for infantile hemangiomas in the 50 Japanese infancies which were applied in the period from 2000 to 2005, because our series included from the plaque subtype to the more proliferative tumor subtype. High efficacy in both subtypes suggests that early pulsed dye laser treatment can still be included as the first option for the mixed type of infantile hemangiomas and that pulsed dye laser treatment may be useful as the second line for the propranolol-resistant mixed type of infantile hemangiomas.

Currently, therapy for interstitial lung disease in patients with systemic sclerosis is unsatisfactory. A prospective open label study was conducted in a North Indian tertiary Institute to assess the efficacy of intermittent pulse cyclophosphamide (CYC) and high-dose prednisolone in systemic sclerosis (SSc)-related interstitial lung disease (ILD).Consecutive patients with SSc and ILD, diagnosed on spirometry, carbon monoxide diffusing capacity (DLCO) and high-resolution computed tomography (HRCT) scan were treated. Pulmonary function tests were carried out at baseline and after 6 months. Patients received oral prednisolone 1 mg/kg body weight initially, with tapering to a dose of 7.5 mg/day was reached. Monthly CYC pulses were given for 6 months followed by 3-monthly maintenance pulses. CYC was discontinued in patients with declining pulmonary function, adverse effects or static disease after 6 months.Average disease duration of 36 patients was 59.78 +/- 63.22 months. Seven patients improved (forced vital capacity [FVC] increase 10% or DLCO increase 15%), five deteriorated (FVC decline 10% or DLCO decline 15%) and 24 had stable disease. Thus, 31 out of 36 patients either improved or had static lung disease. Mean FVC (% of predicted) improved by 4.16% over 6 months (P = 0.069). Mean DLCO (% of predicted) improved by 5.66% (P = 0.27). Average % of predicted DLCO at baseline was 39%.High-dose prednisolone with pulse CYC can either improve or stabilize lung functions in patients with severe systemic sclerosis lung disease irrespective of presence of ground glass appearance on HRCT.

A multicentre, group comparative open study was carried out on 68 patients to compare the effects of 2% sodium cromoglycate eyedrops and an oral antihistamine, terfenadine, on acute symptoms of seasonal allergic conjunctivitis. The study was continued for one week after the onset of acute symptoms. Both medications were equally efficient in reducing symptoms during the first hour of observation. During the one-week follow-up both medications reduced symptoms to a low level, and both medications were equally effective for allergic symptoms, except that terfenadine was more effective in reducing the watering of eyes.

In adult neutropenic patients with hematological malignancies, we explored imipenem-cilastatin as empirical antibiotic therapy in a dose of 500 mg four times daily. Changing to second-line treatment was only resorted to if clinical deterioration, new infections or recurrence of fever occurred. A clinically or microbiologically documented infection was apparent in 115 of 150 episodes studied (76.7%). Imipenem-cilastatin was successful in 70.7% of all episodes and in 67.8% of all proven infections. Modification was necessary and successful in 22.0% of all episodes. 11 patients died while still febrile, 6 of them by infection (4%) and 5 because of progressive disease (3.3%). Imipenem-cilastatin is safe initial therapy in neutropenic febrile patients.

Objectives - To test new electronic equipment, TREMOR, for quantitative registration of rest tremor and kinetic tremor of the extremities. Patients and methods - The tremor intensity of rest tremor and kinetic tremor was studied in 14 multiple sclerosis (MS) patients. Clonazepam was used in an open study in 11 MS patients to evaluate the sensitivity of TREMOR, compared to the clinical observations. Results - We found no diurnal variations in tremor. Five patients discontinued the trial because of side effects due to clonazepam. Clonazepam significantly reduced clinically rest tremor in all 6 patients and clinically kinetic tremor in 5 patients. Tested by TREMOR all patients showed significant reduction in rest tremor and kinetic tremor. Correlation between electronic assessment of kinetic tremor, clinical score and Peg board test were good. Conclusion - TREMOR was found useful for assessment of the severity of tremor in patients with kinetic tremor and thereby avoid intra- and interobserver variation.

This is an open study, with 5 years follow-up, of 502 smokers who received treatment according to their degree of physical nicotine dependence. Those least dependent (BCG) were not given nicotine replacement therapy (NRT), while those with the highest level of dependence (NRTG) used nicotine patches during a 12-week period. A total of 267 subjects completed a 5-year period of followup; 123 were from the BCG and 144 from the NRTG. The abstinence was greater for those who used NRT than for those in the BCG: 29.9% as opposed to 24.4%, for intermittent abstinence (OR 0.93; CI 95 %: 0.53–1.62), and 20.1% as opposed to 15.4% for continual abstinence (OR 1.41; IC 95 %: 0.75–2.66). The 74.4% of subjects who achieved 5 years of abstinence and belonged to the NRTG had correctly completed the pharmacological therapy and 25.6% had not done so. Of those who were not able to achieve nonsmoking status at 5 years, 37.6% had correctly completed the therapy and 62.4% had not done so (p < .05). At the 5-year follow-up 20.1% of subjects who used NRT for 3 months remained abstinent, while only 15.4% of those without patches remained abstinent. Those patients who were more likely to achieve abstinence were those who were older and who were male.

In a prospective open study 21 patients with upper abdominal complaints and chronic active gastritis as well as endoscopically proven erosions were treated with bismuth subsalicylate (4 X 30 ml/day, corresponding to 4 X 314 mg Bi3+) for three weeks. In 20 patients (95%) Campylobacter pylori (CP) was found in at least two of three examinations (culture, CLO quick-test, special histology). After the treatment 17 of 21 patients (81%) were CP negative, and the clinical symptoms had gradually disappeared. The histologically demonstrated degree of activity had regressed significantly after the three-week treatment; in 90% of patients the inflammatory process had completely abated. These results demonstrate that bismuth subsalicylate is highly effective in the acute treatment of CP-associated chronic erosive gastritis.

Twenty participants undergoing elective cataract surgery received 1% voriconazole eye drops (1 drop per eye) either 20, 40, 60, or 80 min before surgery. Median voriconazole concentrations of 1.9 to 3.2 mg/liter in aqueous humor samples were attained over the first 80 min, which were higher than in vitro MIC 90 values for typical fungi that cause keratitis.

Background: Several lines of evidence suggest that clozapine is more effective than both first- and second-generation antipsychotic drugs in treatment-resistant schizophrenia (TRS). However, clinicians appear to be hesitant to prescribe this drug. It would therefore be extremely valuable if predictors of response to clozapine could be identified. The aim of this study was to evaluate the predictive factors of clinical responses to clozapine in a group of Turkish patients with TRS. Methods: This was a 16-week uncontrolled open study carried out among 97 TRS patients (80 males and 17 females; DSM-IV diagnosis). All patients fulfilled the criteria for refractory schizophrenia according to the UK guidelines for the National Institute of Clinical Excellence (NICE). After all previous antipsychotic medications had run their course, the patients were started on clozapine according to a standardized titration and dosage schedule. Psychopathology was evaluated before the initiation of clozapine therapy and once every 4 weeks using the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment for Positive Symptoms, and the Scale for the Assessment of Negative Symptoms. Results: Of the TRS patients on clozapine, 55.7% achieved a clinical response, defined as at least a 20% decrease in BPRS. We observed a favorable effect of clozapine on both positive and negative symptoms. Logistic regression analysis showed that a good clozapine response was more likely when schizophrenia began at a later age, when negative symptoms were severe, and when patients had an early response at 4 weeks. Conclusion: A combination of demographic, baseline clinical, and acute treatment response variables may accurately predict response to clozapine in TRS. Priority should be given to initiating clozapine at the earliest phase of TRS, especially for patients with evident negative symptoms. © 2007 Elsevier Inc. All rights reserved.

ACTFAST-2 was designed to match the starting dose of a statin to the baseline low density lipoprotein-cholesterol (LDL-C) value, to allow high-risk European subjects to achieve LDL-C targets within 12 weeks with the initial dose or one up-titration.This was a 12-week, prospective, open-label trial that enrolled 610 high-risk subjects from 8 European countries. Subjects with LDL-C2.6 mmol/L (100 mg/dL), butor = 5.7 mmol/L (or = 220 mg/dL) were assigned a starting dose of atorvastatin (10, 20, 40, 80 mg/day) according to LDL-C level and status of statin use at baseline (either statin-free or statin-treated), with a single up-titration at 6 weeks if needed.At 12 weeks, 68.0% of subjects overall, including 73.5% of statin-free and 60.5% of statin-treated subjects, achieved LDL-C target (2.6 mmol/L (100 mg/dL). The total cholesterol/high density lipoprotein-cholesterol (TC/HDL-C) ratio target was achieved by 75.2% of subjects overall, including 78.1% of statin-free and 71.2% of statin-treated subjects. In the statin-free group, LDL-C decreased by a mean of 42%. In the statin-treated group, atorvastatin led to an additional 31% reduction in LDL-C over the statin used at baseline. Mean decreases in TC/HDL-C ratio were 30% and 20% in the statin-free and statin-treated groups, respectively. The incidence of AST/ALT greater than 3 times of upper limit of normal range in all patients was 0.8% and no rhabdomyolysis was reported.This study confirms that use of a flexible starting dose of atorvastatin allows the large majority of high-risk subjects to achieve their LDL-C target safely within 12 weeks with an initial dose or just a single up-titration.

SUMMARY Fifty Helicobacter pylori- (H. pylori) positive patients entered an open study and were assigned to one of four treatment regimens comprising: pivampicillin (500 mg b.d.) for 2 weeks tripotassium dicitrato bismuthate (tablet or liquid form) for one month. The 14C-urea breath test was used to evaluate clearance (negative at the end of treatment) and eradication (negative at 1 month posttreatment) of H. pylori. Clearance rates were 20% (2/10) after pivampicillin alone, 86% (12/14) after tripotassium dicitrato bismuthate tablets (240 mg b.d.) plus pivampicillin, 67% (6/9) after tripotassium dicitrato bismuthate tablets (120 mg q.d.s.) plus pivampicillin, and 100% (13/13) after tripotassium dicitrato bismuthate liquid (120 mg in 5 ml q.d.s.) plus pivampicillin. The eradication rates were 0% (0/10), 13% (2/15), 0% (0/11) and 54% (7/13), respectively. Combination of the results from the 2 tripotassium dicitrato bismuthate tablet/pivampicillin groups gave an eradication rate of 7.7% (2/26) which was significantly lower than the 53.9% (7/13) obtained with tripotassium dicitrato bismuthate liquid/pivampicillin (P < 0.02). In conclusion, a liquid tripotassium dicitrato bismuthate pivampicillin combination may be of special use in the treatment of H. pylori-positive patients when triple therapy is contraindicated (e.g. patient sensitivity/allergy to metronidazole) or when the H. pylori isolate is resistant to metronidazole.

Summary Objectives To compare the efficacy and tolerability of dihydroartemisinin–piperaquine (DHA–PQP) with that of a 3-day regimen of mefloquine and artesunate (MAS3) for the treatment of uncomplicated falciparum malaria in Cambodia. Method Randomized open-label non-inferiority study over 64 days. Results Four hundred and sixty-four patients were included in the study. The polymerase chain reaction genotyping-adjusted cure rates on day 63 were 97.5% (95% confidence interval, CI, 93.8–99.3) for DHA–PQP and 97.5% (95% CI, 93.8–99.3) for MAS3, P = 1. There were no serious adverse events, but significantly more episodes of vomiting (P = 0.03), dizziness (P = 0.002), palpitations (P = 0.04), and sleep disorders (P = 0.03) reported in the MAS3 treatment group, consistent with the side-effect profile of mefloquine. Conclusions DHA–PQP was as efficacious as MAS3, but much better tolerated, making it more appropriate for use in a routine programme setting. This highly efficacious, safe and more affordable fixed-dose combination could become the treatment of choice for Plasmodium falciparum malaria in Cambodia. Objectifs Comparer l'efficacite et la tolerance du dihydroartemisinine-piperaquine (DHA–PQP) a celles d'un regime a base de mefloquine de trois jours (MAS3) pour le traitement de la malaria falciparum non compliquee au Cambodge. Methode Etude Randomisee ouverte de non inferiorite sur 64 jours. Resultats 464 patients ont ete inclus dans l’etude. Les taux guerison au jour 63 ajustes par les resultats du genotypage par la reaction en chaine de la polymerase etaient de 97,5% (IC95%: 93.8–99.3) pour le DHA–PQP et de 97,5% (IC95%: 93,8–99,3) pour le MAS3, P = 1. Il n'y avait aucun effet adverse serieux, mais de facon significative, des episodes de vomissement (P = 0,03), des vertiges (P = 0,002), des palpitations (P = 0,04), et des troubles de sommeil (P = 0.03) ont ete rapportes dans le groupe du traitement au MAS3, ce qui etait consistant avec les profiles d'effets secondaires du mefloquine. Conclusion le DHA–PQP etait aussi efficace que le MAS3, mais bien mieux tolere, le rendant ainsi plus approprie pour l'usage en routine dans le cadre d'un programme. Cette combinaison a dose fixe de grande efficacite, sure et plus accessible pourrait devenir le traitement de choix pour la malaria aPlasmodium falciparum au Cambodge. Objetivos Comparar la eficacia y la tolerabilidad de la dihidroartemisinina-piperaquina (DHA–PQP) con la de un regimen de 3 dias de mefloquina (MAS3), para el tratamiento de la malaria no complicada por falciparum en Cambodia Metodo Estudio aleatorizado, abierto, de no-inferioridad, durante 64 dias. Resultados Se incluyeron 464 pacientes en el estudio. Las tasas de curacion en el dia 63, ajustadas por genotipaje mediante PCR, fueron del 97.5% (95% IC: 93.8–99.3) para DHA–PQP y del 97.5% (95%IC: 93.8–99.3) para MAS3, P = 1. No se observaron eventos adversos serios, pero si se reporto un numero significativo de episodios de vomitos (P = 0.03), mareos (P = 0.002), palpitaciones (P = 0.04), y desordenes del sue,no (P = 0.03) entre el grupo de tratamiento con MAS3, algo consistente con el perfil de efectos secundarios de la mefloquina. Conclusiones La DHA–PQP fue tan eficaz como la MAS3, ademas de ser mejor tolerada, siendo mas apropiada para el uso dentro del marco de un programa de rutina. Esta combinacion de dosis fija, altamente eficaz, segura y mas asequible, podria convertirse en el tratamiento de eleccion para malaria por Plasmodium falciparum en Cambodia.

This study evaluated whether or not augmentation with aripiprzazole is beneficial and tolerable to patients with an inadequate response to antidepressants (ADs). Thirteen patients with nonpsychotic major depression, who had failed to respond to an adequate trial of at least one AD, were prescribed aripiprazole (dose, 5-30 mg) for 8 weeks. The dose of their preexisting ADs was not changed. The treatment response was defined as the mean changes in the scores of the Hamilton Depression Rating Scale (HAM-D) from the baseline to the end of treatment. Eleven (84.6%) patients returned for at least one follow-up visit, and 7 (53.8%) patients completed the study. The HAM-D and Clinical Global Impression-Severity (CGI-S) scores decreased significantly from the baseline to the end of treatment by 53.8% and 56.0%, respectively (Z = -2.937, P =.003; Z = -2.961, P =.003). Seven (63.6%) patients showed a > or = 50% reduction in the HAM-D score at the end of treatment. Three (27.3%) patients met the remission criteria at the end of treatment. There were no serious side effects. Despite the high dropout rate in this open study, aripiprazole appears to be reasonably effective and tolerated as an augmentation strategy in conjunction with conventional ADs treatment in patients with an inadequate AD response. These results highlight the potential benefits of aripiprazole for these patients. However, adequately powered, randomized, controlled trials are needed to confirm these results.

The aim of the study was to evaluate the adherence of patients to treatment with new fixed in one blister combinations of enalapril and indapamide. 115 patients participated in the study. In conclusion, analysis revealed high efficacy of studied combinations, which can be partly explained by high compliance of patients.

Objective The aim of this study was to compare the efficacy and tolerability of reboxetine in the treatment of major depressive disorder (MDD) and MDD with anxiety features to venlafaxine XR. Method Patients with MDD, aging 18 between 65 years, were randomly allocated to two groups receiving either open-label venlafaxine XR capsules (n = 50) or reboxetine tablets (n = 43). Subjects were administered Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Scale (HAM-A) at baseline and 2, 4, 7, 10 weeks after the baseline visit. Results Response rates to antidepressant treatment were significantly higher in the venlafaxine XR group at 10th week. When patients having anxious depression were analysed separately; response rate for anxiety of reboxetine group was significantly higher at 7th week only. Mean number of side effects were significantly higher in reboxetine group. Only one subject in each group was dropped out due to side effect. Conclusion We may suggest that reboxetine is as effective and tolerable as venlafaxine XR in the treatment of MDD and MDD with anxiety features, and it may be considered a treatment option to venlafaxine XR. Copyright © 2006 John Wiley & Sons, Ltd.

Background.—Subcutaneous (SQ) sumatriptan 6 mg is effective in the treatment of acute cluster headache attacks. However, patients sometimes benefit from a dose less than 6 mg. Objective.—Therefore, we designed a prospective open study to evaluate how many patients benefit from a dose less than 6 mg SQ sumatriptan. Methods.—We enrolled 81 consecutive patients with cluster headache and recorded their use of SQ sumatriptan and oxygen. Patients regularly using SQ sumatriptan 6 mg were advised to treat attacks with doses less than 6 mg and with oxygen. Efficacy and side effects of the different treatment options (6 mg, 3 mg, 2 mg, and oxygen) were evaluated. Results.—As a result, 74% of the patients using SQ sumatriptan 3 mg showed efficacy and 89% reported efficacy after 2 mg. Seventy-nine percent reported side effects after the use of SQ sumatriptan 6 mg (29% severe side effects). After the use of 2 mg SQ sumatriptan, only 50% of the patients reported side effects, none of these were classified as severe. Patients' preference was 41% for 6 mg sumatriptan, 28% for doses less than 6 mg, and 31% for oxygen. Conclusions.—We conclude that sumatriptan in doses less than 6 mg can be effective in the acute treatment of cluster headache attacks. We suggest that patients should have experience in their individual efficacy of sumatriptan doses less than 6 mg.

Background. Almost 20% of patients with active Crohn's disease are refractory to conventional therapy. Infliximab is a treatment of proven efficacy in this group of patients and it is not clear which variables predict a good response. Aims. To evaluate the role of infliximab looking at the predictors of response in a large series of patients with Crohn's disease. Patients and methods. Five hundred and seventy-three patients with luminal refractory Crohn's disease (Crohn's Disease Activity Index (CDAI) > 220–400) (312 patients) or with fistulising disease (190 patients) or both of them (71 patients) were treated with a dose of 5 mg/kg in 12 Italian referral centres. The primary endpoints of the study were clinical response and clinical remission for luminal refractory and fistulising disease. We evaluated at univariable and multivariable analysis the following variables: number of infusions, sex, age at diagnosis, smoking habit, site of disease, previous surgery, extraintestinal manifestations and concomitant therapies, and type of fistulas. Results. Patients with luminal refractory disease: 322 patients (84.1%) had a clinical response and 228 (59.5%) reached clinical remission. Patients with fistulising disease: 187 patients (72%) had a reduction of 50% of the number of fistulas and in 107 (41%) a total closure of fistulas was observed. For luminal disease, single infusion (OR 0.49, 95% CI 0.28–0.86) and previous surgery (OR 0.53, 95% CI 0.30–0.93) predicted a worse response for fistulising disease. Other fistulas responded worse than perianal fistulas (OR 0.57, 95% CI 0.303–1.097). Conclusion. In Crohn's disease infliximab is effective in luminal refractory and in fistulising disease. A single infusion and previous surgery predicted a worse response in luminal disease whereas perianal fistulas predicted a better response than other type of fistulas.

The authors conducted an open study of levetiracetam as add-on therapy in nine patients with well-defined progressive myoclonic epilepsies and refractory myoclonus. Myoclonus was evaluated semiquantitatively (territory, intensity, daily living activities). Five patients had improvement of their myoclonus score. Levetiracetam may benefit myoclonus in progressive myoclonic epilepsy.

OBJECTIVE: To review the literature regarding the efficacy of stimulants to treat attention-deficit-hyperactivity disorder (ADHD) in adults. DATA SOURCES: The relevant pharmaceutical manufacturers were contacted, and searches of MEDLINE (1966–December 2002) and the reference sections of each article obtained were performed using the key search terms: adult ADHD, stimulants, methylphenidate, amphetamines, and pemoline. STUDY SELECTION AND DATA EXTRACTION: All English-language original studies identified from the data sources were evaluated and all information deemed relevant was included in the review. DATA SYNTHESIS: Studies involving methylphenidate, amphetamines, and pemoline were identified. There was evidence for the efficacy of amphetamines from 5 studies (4 controlled, 1 open). Methylphenidate data from 6 controlled trials were conflicting. Three studies indicated efficacy; 2 studies failed to show efficacy, possibly due to methodologic reasons; and the results from 1 study were conflicting. The limited data from 1 controlled and 1 open study indicated that pemoline may be less effective than methylphenidate and amphetamines. CONCLUSIONS: While the current limited data indicate that stimulants may be effective in adult ADHD, more data are required to confirm long-term efficacy

Purpose: To assess the effects of patient-controlled methylphenidate for cancer-related fatigue. Patients and Methods: In this prospective open study, 31 patients with advanced cancer and fatigue who scored ≥ 4 on a scale of 0 to 10 received methylphenidate 5 mg by mouth every 2 hours as needed for 7 days (maximum, 20 mg/d). Multiple symptoms were assessed daily; the primary end point, fatigue, was measured using the 0 to 10 scale, and the Functional Assessment for Chronic Illness Therapy–Fatigue (FACIT-F) was performed at baseline, day 7, and day 28. Results: The following mean (± standard deviation) scores for 30 assessable patients improved significantly between baseline and day 7: fatigue (0 to 10 scale), 7.2 ± 1.6 v 3.0 ± 1.9 (P < .001); overall well-being (0 to 10 scale), 4.5 ± 2.2 v 2.8 ± 2.1 (P < .001); fatigue (FACIT-F) subscore, 17.5 ± 11.3 v 34.7 ± 10.0 (P < .001); functional well-being, 14.4 ± 5.9 v 18.3 ± 6.6 (P < .001); and physical well-being, 13.5 ± 6.4 v 21.4 ± 5.0 (P < .001). Anxiety, appetite, pain, nausea, depression, and drowsiness all improved significantly (P < .05). All patients took afternoon or evening doses, and 28 patients (93%) took three or more doses daily. All patients chose to continue taking methylphenidate after 7 days of treatment. No serious side effects were reported. Conclusion: These preliminary results suggest that patient-controlled methylphenidate administration rapidly improved fatigue and other symptoms. Randomized controlled trials are justified.

To the Editor:We read with interest the paper by Ning et al. entitled ‘‘Switchingfrom entecavir to PegIFN alfa-2a in patients with HBeAg-positivechronic hepatitis B: A randomised open-label trial (OSST trial)’’ inthe latest issue of the Journal of Hepatology [1]. The authors con-ducted a randomized open study (randomization: 1:1; peginter-feron alfa-2a 180

Hemocue leuco+diff and DBS are two recent technological advances that can beneficially affect clozapine treatment in the near future. 1. Hemocue Leuco+diff is a new point of care instrument that provides both a total white blood cel count as that of the five most common types of leucytes (neutrophils, lymphocytes, monocytes, eosinophils and basophils). In an open study in 70 patients on clozapine maintenance treatment, 39 clinical and 31 out-patients, the tolerability and the (dis-), advantages of the two methods of blood sampling, venous versus point-of care, were compared. In four consecutive monthly measurements, the method of blood sampling alternated monthly from point-of-care to venous and the other way around, from venous sampling to point-of-care. In those patients who indicated a preference, point of care method was preferred because it is less burdensome (no travelling involved, no waiting time) and immediate access to the results. 2. The dried blood spot (DBS) is a method of measurement of drug plasma levels in a drop of dried blood on standardized paper card. DBS has been validated for antibiotic therapy of fungal infections and the treatment of tuberculosis. In a study of 15 outpatients on clozapine maintenance therapy we studied the non-inferiority of clozapine monitoring with DBS compared with venous blood sampling. We will present the first results and the possible implications of the outcome for clinical practice.

Introduction Open studies suggest that mirtazapine has efficacy in panic disorder treatment. We designed an open study that evaluates changes induced by mirtazapine compared with paroxetine in panic disorder. Methodology Patients 18-65 years old consecutively referred to a psychiatry liaison service with panic disorder (DSM-IV criteria) were offered either mirtazapine or paroxetine treatment. Results There were statistically significant reductions from baseline to week 3 and from week 3 to 8 for mirtazapine and paroxetine groups for: number of panic attacks, Beck Anxiety or Depression Inventory (BAI, BDI) Clinical Global Impresion (CGI) of panic disorder severity and CGI of panic disorder response (these variables were evaluated by the patient, the clinician or a blind evaluator). Responders at week 3 (BAI decrease of 50%) were 83% for the mirtazapine group and 84% for the paroxetine group. Responders at week 8 (number of panic attacks equal to 0) were 77% for the mirtazapine group and 73% for the paroxetine group Statistically significant differences between mirtazapine and paroxetine were found for number of panic attacks at weeks 3 and 8 and BAI at week 3, suggesting a faster response for mirtazapine. Responders at week 8 maintained a no recurrence figure of 95% at follow-up 6 months later. Panic disorder either with or without comorbid depression improved in both groups of treatment. Discussion Our study supports the hypothesis that mirtazapine has efficacy in the treatment of panic disorder either with or without comorbid depression.

OBJECTIVE The aim of this open study was to assess the efficacy and safety of the serotonin-noradrenaline reuptake-inhibiting antidepressant, milnacipran, for the treatment of generalised anxiety disorder. METHODS Twelve patients, treated with milnacipran at doses from 30 to 150 mg/day for 8 weeks, were evaluated at baseline and after 1, 2, 3, 4, 6 and 8 weeks of treatment using the Hamilton Anxiety Rating (HAM-A) scale and a self-rating visual analogue scale. RESULTS Two patients dropped out early in the trial because of adverse effects. The 10 patients who completed the trial showed a marked improvement in anxiety symptoms with HAM-A scores being reduced from 21.6±6.5 (mean±SD) to 1.5±1.8 after 8 weeks. All of the patients who completed the 8 weeks of treatment had a reduction of at least 70% in their HAM-A score. Adverse effects, principally nausea, were mild and occurred early in the study, regressing as the study progressed. CONCLUSION These results suggest that milnacipran is effective and well tolerated in patients suffering from generalised anxiety disorder. A full-scale double-blind placebo trial is clearly warranted.

Objective To determine whether goserelin (ZoladexTM; AstraZeneca, London, UK), plus surgery offers advantages over surgery alone in the management of ovarian endometriomas. Design Prospective, multicentre, randomized, open-label, parallel-group study. Interventions Following preoperative aspiration of endometriomas, they were sized by ultrasound, a diagnosis of endometriosis confirmed by laparoscopy and its severity assessed. Patients were stratified according to endometrioma size and randomly allocated to one of two groups: group 1 (G1; n = 21) received a monthly (every 28 days) subcutaneous injection of goserelin 3.6 mg for 3 months (12 weeks); group 2 (G2; n = 27) received no treatment. At 3 months, the size of endometriomas was reassessed in both groups before definitive excision. Both groups were reassessed at 6 months postsurgery. Main outcome measures Change in size of the largest endometrioma from entry to just prior to excision. Results The mean change in endometrioma size was −2.29 cm in G1 and −1.29 cm in G2. The resulting (adjusted) mean difference of −1.25 cm was statistically significant in favour of G1 (P = 0.036, 95% CI −2.42 to −0.08 cm). Very difficult surgery was reported in four (22%) patients in G1 and 10 (46%) patients in G2. Mean duration of surgery was 74.2 min in G1 and 86.4 min in G2. There was a trend towards a greater reduction in mean Additive Diameter of Implants (ADI) score at 6 months postsurgery in G1 compared with G2 (−65.9 vs. −56.6). Both groups were comparable in terms of the number of complete excisions of their endometrial cysts at surgery, blood loss at surgery, Revised American Fertility Society (R-AFS) scores and pelvic symptoms. Goserelin was well tolerated. Conclusions Laparoscopic aspiration of endometriomas followed by a monthly goserelin 3.6 mg depot for 3 months compared with laparoscopic aspiration alone results in significantly smaller endometriomas at 3 months and a trend towards a greater reduction in ADI score.

Sixty patients with moderate and severe burns were randomly assigned to receive topical silver sulfadiazine (SSD) alone (n=30) or SSD combined with cerium nitrate (SSD-CN) (n=30). There were four deaths in the SSD group and one in the SSD-CN group; more patients with higher risk severity survived in the SSD-CN group. Wound infection did not differ significantly between the groups. The rate of re-epithelialization of partial thickness burns was faster by 8 days in the SSD-CN group. The relatively dry shell-like eschar of the SSD-CN-treated burn allowed planned excisions with immediate autologous grafting and the tissue beneath was ready to accept grafting 11 days earlier than in the SSD group (p=0.03). This resulted in a significantly shorter hospital stay for those in the SSD-CN group than in the SSD group (23.3 vs. 30.7 days; p=0.03) with consequent cost savings. A higher incidence of transient stinging pain was reported with application of SSD-CN, but this was effectively managed with analgesics where necessary. The results of this study confirm the greater efficacy of SSD-CN in the treatment of burns patients.

A mirror study design monitored the progress of five patients with a diagnosis of borderline personality disorder in a maximum-security hospital who were treated with clozapine. Patients showed a marked reduction in their requirement for nursing observations. This study adds to the evidence that clozapine may be an effective treatment for patients with this disorder.

Aim. To analyse factors hampering the achievement of compensation of carbohydrate metabolism in patients with type 2 diabetes mellitus treated for3 months with diabeton MB at a daily dose of 90-120 mg under real practical conditions. Materials and methods. This open study included 70 patients with type 2 diabetes mellitus given gliclazide MB-based hypoglycemic therapy(90-120 mg/day); their HbA 1c level was measured before and 3 months after the onset of therapy. Results. The treatment resulted in a significant decrease of the HbA 1c level especially pronounced in patients capable of following the rational therapeuticstrategy. At the closing visit, each patient was prescribed a pathogenetically sound regime of combined hypoglycemic therapy. Conclusion. Poor efficacy of hypoglycemic treatment in real clinical practice is attributable to frequent prescription of monotherapy, untimely onsetof insulin administration, its correction and intensification to meet changing requirements

Dermatoses affecting the skin around stoma sites are common and difficult to treat. We have investigated the effectiveness of topical sucralfate in the management of peristomal dermatoses in adults using an open study design. Apart from forming a physical barrier to further irritation, sucralfate binds to basic fibroblast growth factor preventing its degradation and thereby promotes healing. In eight out of nine patients with faecal or urine erosions, daily, topical sucralfate treatment was associated with healing within 4 weeks. There was limited or no response to treatment in a further nine patients with traumatic ulcers, excoriated dermatitis or pyoderma gangrenosum. Topical sucralfate represents a safe, inexpensive and effective therapeutic intervention, particularly for those patients with high output or short stomas where repeated stoma leakage may be unavoidable.

Background Atopic dermatitis is a severe chronic skin disease often deteriorated by the presence of microorganisms and often responds well to treatment with potent corticosteroids. However, the long-term use of potent topical corticosteroids are accompanied by side-effects such as skin atrophy. Objective To study the effect and safety of prophylactic treatment with mometasone furoate fatty cream (contains hexylene glycol) for 6 months in patients with atopic dermatitis. Results Sixty-one of 68 (90%) patients were still free of their disease after 6 months of twice weekly treatment and only one showed possible treatment related signs of skin atrophy. The number of Staphylococcus aureus and Pityrosporum ovale were significantly reduced in cleared patients. Conclusions Mometasone furoate fatty cream is effective and safe both for treatment and as a prophylaxis in patients with atopic dermatitis.

Objective: Efficacy of tender point [TeP] injections in fibromyalgia syndrome [FMS] has not been well described in the literature. The goal of our study was to determine the extent of benefit from such injections in this syndrome in the usual clinical practice setting.Methods: Tender points at most symptomatic sites of forty-one patients with FMS, 40 females and one male, were injected with a mixture of 1/2 ml 1% lidocaine and 1/4 ml intralesional triamcinolone diacetate suspension, and prospectively followed for a mean period of 66 [range 14–240] weeks. All patients were asked to maintain a diary to record the duration of pain relief from injections. They continued their usual therapies.Results: On an average, 3.97 injections per visit were performed. Mean duration of pain relief per injection site was 13.1±9.4 weeks, excluding a single outlier patient. Only one patient failed to obtain any relief at any injected site. There were no side-effects with the exception of a brief postinjection flare in one pa...

In an observational study, we prospectively evaluated the efficacy and safety of remifentanil in 205 parturients. Remifentanil was administered as a continuous infusion. The initial infusion of 0.025 microg x kg(-1) x min(-1) was increased in a stepwise manner to a maximum dose of 0.15 microg x kg(-1) x min(-1). Maternal pain, other maternal and fetal variables, side effects, and satisfaction were recorded. The mean (+/-sd) visual analog score before the start of the infusion was 9.4 +/- 1.2 cm and decreased to 5.1 +/- 0.4 cm after 5 min and 3.6 +/- 1.5 cm after 30 min. The maternal side effects were minimal and no fetal or neonatal side effects were noted.

Background/Aims: Itraconazole is active against most human fungal pathogens and has been conventionally used in the treatment of tinea corporis/ cruris at a dosage of 100 mg once daily for 15 days. Recently, a new regimen of 200 mg daily for 7 days has been shown to be equally effective, but there are no reports of the use of this new regimen in the Taiwanese population.Methods: In this open study, 17 patients with recalcitrant superficial mycoses were given 200 mg/day itraconazole for 7 days. All of them completed the treatment and 11 patients returned for follow-up 4 weeks after the treatment.Results: Cure or marked improvement at the end of the 7-day treatment period was noted in 10 of 17 patients (59%) while partial improvement was noted in 7 of 17 (41%). Four weeks after completion of the treatment, 9 of 11 (82%) remained cured or markedly improved, 1 of 11 (9%) was partially improved, and 1 of 11 (9%) had relapsed. These findings were consistent with the grading of each clinical symptom of infection...

An open study was conducted to evaluate the safety of bevacizumab, anti-vascular endothelial growth factor antibody, in patients with neuromyelitis optica developing signs of relapse.

In this open 4-month pilot study on the efficacy of fluoxetine treatment of social phobia, 26 of our 32 patients (81%) showed moderate or marked alleviation of symptoms. The treatment response seen on various self- and observer-rated scales emerged within 8 weeks and remained stable until the end of the study. The treatment was well tolerated; the commonest adverse events during the study were headache and sedation at the beginning of the study. Despite the limitations of an open study, our results suggest that fluoxetine is efficacious in the treatment of social phobia.

In an open study design, 50 opioid-dependent subjects (DSM-IV: 304.0) were investigated in a gradual detoxification treatment with buprenorphine. The study was performed at the drug addiction outpatient clinic of the Department of General Psychiatry at the University of Vienna. Subjects had to contact the outpatient clinic on a daily basis and buprenorphine was administered according to their clinical status. Withdrawal symptoms were evaluated by applying the WANG scale. Urine samples were screened for drug toxicology to exclude additional consumption. In this investigation buprenorphine was applied sublingually in a free dosage scheme aimed at completing detoxification treatment within 10 days by reducing buprenorphine on a daily basis. A mean daily dosage of 2.3 mg buprenorphine was required by patients on day 1 of the treatment period. The highest mean daily buprenorphine dosage was given on day 2, followed by a daily reduction over the study period. The result of this open study design revealed that a gradual daily reduction of buprenorphine might be a successful alternative outpatient detoxification treatment in opioid-dependent subjects. Compliance was 70%, the reported and evaluated withdrawal symptoms during the study period were moderate.

Introduction. Among atypical antipsychotics, none has been linked to torsade de pointes. In the present study, the electrocardiographic changes induced by olanzapine have been compared with risperidone. Method and Materials. 268 patients were entered into an open study for random assignment to olanzapine or risperidone. ECG was taken at baseline and at the end of the treatment. The parameters that had been assessed included Q-T interval (corrected = Q-Tc) and other related parameters. Correction of the observed Q-T interval was done according to Frederica’s formula (QTcF). Results. While 14.86% and 25% of the cases in the olanzapine group showed prolongation and shortening of QTcF, respectively, comparable changes in the risperidone group were restricted to its prolongation (32.5%). Comparison of means between baseline QTcF of risperidone group versus its posttreatment measurement showed a significant increment (P=0.02). Also, the quantity of cases with shortening of QTcF in the olanzapine group was significantly more than its opposite (P=0.02). Conclusion. Comparable propensity of olanzapine and risperidone for induction of electrocardiographic changes demands adequate cautiousness by clinicians, particularly with respect to shortening of Q-T interval, which was mainly noticeable in the olanzapine group.

In an open study we have investigated the efficacy of 20 ml of 0.75% ropivacaine (7.5 mg ml-1) to provide extradural anaesthesia for elective Caesarean section. Plasma concentrations (total and free) were estimated in the mother and neonate. Anaesthesia was effective and safe. Plasma concentrations of ropivacaine in the mother and neonate were within safe limits and consistent with previous studies. Two mothers received accidental i.v. injections of ropivacaine 75 mg and 150 mg, respectively, without serious adverse effects.