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Background Evaluating COVID-19 vaccine coverage and risk factors is useful to develop public health strategies against COVID-19 pandemic. In the framework of two studies commissioned by the European Centre for Disease Prevention and Control (ECDC) and coordinated by Epiconcept, France, we reported findings about incidence and seroprevalence among healthcare workers (HCWs) enrolled from three Italian hospitals. Methods From July 2021 to date, the AOUP “G. Rodolico-San Marco” (Catania), the San Gerardo Hospital (Monza) and the Policlinico Gemelli (Rome) participated in the ECDC study to measure COVID-19 vaccine effectiveness. Catania and Rome also participated to the ECDC study of nosocomial transmission. HCWs were asked to complete a weekly questionnaire to report changes in health status and professional/personal exposures. At recruitment, a nasopharyngeal swab for RT-PCR and a blood sample for serology test were collected. Moreover, HCWs were followed-up with a weekly or bimonthly nasopharyngeal or saliva swabs. Blood samples were collected every one or two months. Results A total of 226 HCWs was enrolled from Catania, 330 from Rome and 132 from Monza in the COVID-19 vaccine effectiveness study. As of February 2022, PCR tests performed were 2270 in Catania, 5475 in Rome and 891 in Monza sites. Moreover, the serological tests performed were 845 in Catania, 760 in Rome and 395 in Monza sites. A total of 6 SARS-CoV-2 infections were identified in Catania, 34 in Rome and 4 in Monza sites. Interestingly, the study of nosocomial transmission reported the highest incidence rate in Catania (4 per 10,000 person-day), while 0.7 per 10,000 person-day in Rome. During the study period seroprevalence declined by 17% among HWCs enrolled in Catania. Conclusions Our findings revealed low number of COVID-19 infections, with high COVID-19 vaccine coverage among HCWs. However, further analyses are needed to provide more robust estimates of vaccine effectiveness. Key messages

The outbreak of Coronavirus disease 2019 (COVID-19) made imperative the use of protective devices as a source control tool. As there is no definite antiviral treatment and effective vaccine, the only efficient means of protecting and mitigating infectious contagion has been the use of personal protective equipment, especially by healthcare workers. However, masks affect the humidification process of inhaled air, possibly leading to a basal inflammatory state of the upper airways.This is a single-center observational study conducted at the University Hospital of Catania from April 1, 2020, to June 31, 2020.We analyzed the role of protective masks on the elimination of upper airways complaints in healthcare workers of the University Hospital of Catania. We evaluated 277 subjects through a self-administered 17 item questionnaire based on respiratory, work performance and health-related quality of life domains.A higher prevalence of nasal and ocular symptoms, perceived reduced work performance, difficulty in concentrating, and sleep disorders were found. After two weeks adhering to a list of good practices that we recommended, significant reversibility of the symptoms investigated and work performance enhancement were observed.Despite clinical complaints related to personal protective equipment, effective amelioration through usage rules is easily obtained. Given the essential use of protective masks, healthcare workers have to adhere to appropriate work and safety prevention rules.

Background Hyaluronidases are commonly employed in aesthetic medicine to reverse the effects of the injected hyaluronic acid filler, eliminating nodules, correcting the injection of excessive quantities of filler, or reducing the odds of ischemic complications, although toxicity studies and clear guidelines are lacking in the literature. The objective of this study was to evaluate effects of hyaluronidases on skin and soft tissue viability.

The incidence of type 1 diabetes in childhood is increasing by 3 % per year, placing growing demands on healthcare professionals and medical expenditures. Aim of this study wars to assess the organization of care to children with diabetes in Italy.During 2012 a structured questionnaire was sent to all of the members of Italian Society of Paediatric Endocrinology and Diabetology (ISPED). Questions examined organizational structure of Centers, personnel dedicated to the care of children with diabetes, number of subjects followed, local legal legislation supporting centres.A total of 68 centers taking care to 15,563 children and adolescents with diabetes under 18 years of age were identified with a prevalence of 1.4 per 1,000 people. A wide variation in the organizational background was also reported. Fourty-four centers were organized as outpatient departments, 17 as simple units, 5 as complex units and 2 as simple departmental structures. Most centers had a multidisciplinary team. Ten out of twenty Italian regions had introduced supportive regional legislation, but it was fully applied only in six of them.Great differences between regions were found in organizational structures, staffing levels and supportive legislation. The national legislation on diabetes was broadly implemented throughout the country regions. Further efforts are needed to improve standards and consistency of pediatric diabetes care in Italy.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are represented by rare but life-threatening cutaneous adverse reactions to different drugs. Previous studies have found that in a Han Chinese population from Taiwan and other Asian Countries, a strong genetic association between HLA-class I alleles (B*15:02, B*58:01) and SJS and TEN was induced by carbamazepine and allopurinol, respectively. To identify genetic markers that covered the MHC region, we carried out a case-control association enrolling 20 Caucasian patients with SJS/TEN. Our patient series included 10 cases related to paracetamol, 7 to allopurinol and 3 to different drugs (plaquenil, itraconazol, nabumetone). Healthy controls were represented by 115 Caucasian bone marrow or stem cell donors. The HLA-A*, B*, C*, DRB1*, DQB1*, DQA1* and DPB1* genotyping were determined. The frequencies of HLA-A*33:03 as well as C*03:02 and C*08:01 were significantly higher in SJS/TEN patient subgroup showing allopurinol drug-induced severe cutaneous adverse reactions (SCAR) as compared to controls (28.6% vs 0%, P=0.00002, Pc=0.0011; 28.6% vs 0%, P=0.00002, Pc=0.001; 28.6% vs 0%, P=0.00002, Pc=0.001, respectively). In the same subgroup the frequencies of B*58:01, DRB1*15:02 and DRB1*13:02 alleles, although considerably higher than in control group (42.8% vs 5.2%, P=0.003; 28.6% vs 1.7%, P=0.005; 28.6% vs 3.5%, P=0.037, respectively), appeared no more statistically different after P correction (Pc=0.248; Pc=0.29; Pc=1.00, respectively). In addition, in 10 of the 20 SJS/TEN patient subgroup with paracetamol-induced SCAR no statistically significant association with HLA alleles could be found. However, in the same SJS/TEN patient subgroup showing allopurinol drug-induced SCAR, haplotype analysis indicated that B*58:01, DRB1*13:02 and DRB1*15:02 alleles, that in a single allele analysis lost statistical significance after P correction, may still confer susceptibility, because the B*58:01-DRB1*13:02 and DRB1*15:02-DQB1*05:02 are positively associated with the disease (14.2% vs 0.43%, P= 0.00001, Pc=0.00028; 14.2% vs 0.43%, P=0.00001, Pc=0.00028, respectively). Our results show that in contrast to SCAR-related to paracetamol, where HLA alleles do not appear to be involved, HLA molecules behave as a strong risk factor for SCAR-related to allopurinol even when a limited number of patients are considered.

This is the final report of a large, controlled, multicenter Italian study on immuno- and chemotherapy in adult patients with burns affecting 20 to 95% of total body surface area (mean 35%). The antibiotic treatment of burn patients consisted of topical silver sulfadiazine, short-term antimicrobial chemoprophylaxis with pefloxacin (800 mg i.v. qd) for the first 4 days and polychemotherapy with teicoplanin (800 mg i.v. qd) together with netilmicin (300 mg i.m. qd) in one or more cycles of 5-12 days. At random, half of the patients received thymostimulin, 70 mg i.m. qd for the first month and every other day thereafter. The analysis at completion of 634 valid cases showed that when the results are stratified by means of the Roi risk index, 396 of the 530 patients who contracted wound infection (84%) after chemoprophylaxis were in the first three categories and a mean of 95% survived. Of the remaining 134 patients (Roi index 4-5) only 50% survived. There was no difference in survival of the immunotherapy group in comparison with the parallel group without thymostimulin. The short-term antimicrobial prophylaxis prevented wound infection in only 104 of 634 patients (16%) and they were at low risk (84% Roi index 1). Of the bacterial pathogens involved in septic complications Staphylococcus aureus and Pseudomonas aeruginosa were prevalent (86%): eradication was achieved in 43% of patients and clinical cure or improvement were seen with combination chemotherapy in 64% of all patients, mainly with only one treatment cycle. This value increased to 79% for the 395 protocol-complying patients and went down to 20% in the 135 non-compliers. The total survival of complier and non-complier patients was 447 of the 530 valid patients (84%). The overall mortality of the 634 evaluable patients was 13.1%, ranging from less than 2% to 68%. Burn mortality was directly proportional to the percentage of burned body surface area, to increasing age and other variables of the Roi index, a 50% mortality being associated with a 72.5% total body surface area burned. Normoergic burn patients had a mortality rate of 9.1% versus 35.7% in anergic patients.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are represented by rare but life-threatening cutaneous adverse reactions to different drugs. Previous studies have found that in a Han Chinese population from Taiwan and other Asian Countries, a strong genetic association between HLA-class I alleles (B*15:02, B*58:01) and SJS and TEN was induced by carbamazepine and allopurinol, respectively. To identify genetic markers that covered the MHC region, we carried out a case-control association enrolling 20 Caucasian patients with SJS/TEN. Our patient series included 10 cases related to paracetamol, 7 to allopurinol and 3 to different drugs (plaquenil, itraconazol, nabumetone). Healthy controls were represented by 115 Caucasian bone marrow or stem cell donors. The HLA-A*, B*, C*, DRB1*, DQB1*, DQA1* and DPB1* genotyping were determined. The frequencies of HLA-A*33:03 as well as C*03:02 and C*08:01 were significantly higher in SJS/TEN patient subgroup showing allopurinol drug-induced severe cutaneous adverse reactions (SCAR) as compared to controls (28.6% vs 0%, P=0.00002, Pc=0.0011; 28.6% vs 0%, P=0.00002, Pc=0.001; 28.6% vs 0%, P=0.00002, Pc=0.001, respectively). In the same subgroup the frequencies of B*58:01, DRB1*15:02 and DRB1*13:02 alleles, although considerably higher than in control group (42.8% vs 5.2%, P=0.003; 28.6% vs 1.7%, P=0.005; 28.6% vs 3.5%, P=0.037, respectively), appeared no more statistically different after P correction (Pc=0.248; Pc=0.29; Pc=1.00, respectively). In addition, in 10 of the 20 SJS/TEN patient subgroup with paracetamol-induced SCAR no statistically significant association with HLA alleles could be found. However, in the same SJS/TEN patient subgroup showing allopurinol drug-induced SCAR, haplotype analysis indicated that B*58:01, DRB1*13:02 and DRB1*15:02 alleles, that in a single allele analysis lost statistical significance after P correction, may still confer susceptibility, because the B*58:01-DRB1*13:02 and DRB1*15:02-DQB1*05:02 are positively associated with the disease (14.2% vs 0.43%, P= 0.00001, Pc=0.00028; 14.2% vs 0.43%, P=0.00001, Pc=0.00028, respectively). Our results show that in contrast to SCAR-related to paracetamol, where HLA alleles do not appear to be involved, HLA molecules behave as a strong risk factor for SCAR-related to allopurinol even when a limited number of patients are considered.

This paper presents guidelines for the safe outpatient practice of aesthetic surgery. These guidelines have been prepared by the Lombard Association of Plastic Surgery for Outpatients (ALChiPlA), an association confined to board certified plastic surgeons and holders of official authorizations issued by the Lombard ASL to perform outpatient surgery. The cornerstone of these guidelines is the health and safety of patients, who are turning to this type of surgery in ever increasing numbers. This is the first and thus far the only attempt of its kind and its value is increased by the fact that it has been prepared by specialists who have been carrying out this type of surgery in outpatient situations for years.

A comparative double-blind study of paroxetine and amitriptyline in the treatment of depressed hospital outpatients was undertaken at 15 centres in Italy. Three hundred and nine patients of either sex were admitted to the study. The starting dose of paroxetine was 20 mg daily and of amitriptyline 75 mg daily in divided doses; at week 3 these doses could be increased at the investigators' discretion. Efficacy was measured on the Hamilton Depression Rating Scale and on Clinical Global Impression. Both treatment groups showed significant improvement at week 6 with no significant between-group differences. Significantly fewer patients receiving paroxetine reported adverse events compared with those on amitriptyline (44% vs 62%; p < 0.01 in favour of paroxetine).

The effectiveness of t,t-muconic acid (t,t-MA) has been investigated as indicator of benzene exposure in workers of an oil refinery. 196 blue collar workers that operate in the field and 25 white collar workers who work in administration have been studied. Workers had not chronic diseases; all workers resulted fit to work. The environmental monitoring, effected with personal and fixed samplers (141 samplings), has shown that benzene air levels were lower than 170 mcg/m3. Biological monitoring was performed with measurements of blood benzene, urinary t,t-MA and urinary phenols. Each worker has been questioned regarding smoking habit, consumption of food containing sorbic acid and non-occupational exposure to benzene. Values of biological index were: t,t-MA 88 +/- 94.1 mcg/g cr, phenols 17.7 +/- 2.9 mg/g cr, blood benzene 25.4 +/- 4.3 ng/l. No significant differences were found between blue and white collars respect t,t-MA, phenols, blood benzene, non-occupational exposure to benzene, smoking habit, consumption of food containing sorbic acid. A meaningful correlation was found between the t,t-MA and the ingestion of the number of foods containing sorbic acid (r = 0.87). The results confirm that the t,t-MA seems incapable to distinguish occupationally exposed workers, at low levels of benzene exposure, from unexposed.

Back disorders are a major health problem in many occupations. Physical loads at work, such as manual materials handling frequent bending and twisting, lifting, and forceful movements, have been identified as possible risk factors for low back pain (LBP). Aim of the present study was to evaluate the rehabilitative treatment in the chronic lumbago.

Vibration exposure of the hand-arm system is associated with an increased risk of upper-limb vascular, neurological and musculoskeletal lesions, or hand-arm vibration syndrome (HAVS). The prevalence of occupational HAVS and upper-limb disorders was studied among 278 Forestry Service workers in Sicily and Calabria. Subjects who used chain-saws (18 weeks/year) had a greater prevalence of peripheral sensory-neural disturbances (28%), upper-limb musculoskeletal disorders (33%) and carpal tunnel syndrome (19%) compared with 260 manual workers from the same Corps not exposed to hand-transmitted vibration. Raynaud's phenomenon was comparable in exposed and control subjects (5.3% vs. 4.7%.) Upper-limb neuropathies were significantly associated with energy-equivalent frequency-weighted acceleration; exposure duration; and cumulative vibration dose (m2/s4h). The variable "years of work with vibrating tools" was strongly associated with peripheral neuropathies; carpal tunnel syndrome; and upper-limb musculotendinous syndromes. Data suggest that in Sicily and Calabria, where the climate is milder than in other areas of Italy, forestry work with hand-held vibrating tools does not entail a greater prevalence of peripheral vascular disorders (Raynaud's phenomenon), while the prevalence of occupational upper-limb neurological and musculoskeletal disorders, in which combined ergonomic and mechanical risk factors have a large pathogenic role, is significantly increased.

We previously showed that apoptosis in the lungs of sheep exposed to fluoro-edenite fibres is induced via the receptor pathway. The present study was performed to gain further insights into the mechanisms of activation of programmed cell death induced by the fibres. Fluoro-edenite fibres are similar in size and morphology to some amphibolic asbestos fibres. They have been found in benmoreitic lavas, in the local stone quarry, in building materials and in road paving at Biancavilla, a town in eastern Sicily (Italy), where epidemiological surveys revealed a cluster of mortality from pleural mesothelioma. Inhalation of asbestos fibres can cause chronic inflammation and carcinogenesis. Since fluoro-edenite has been shown to activate the apoptotic process, we set out to characterise the expression of apoptosis-regulating proteins in fluoroedenite- exposed lung disease and sought to determine if apoptosis results from fluoro-edenite exposure. Lung tissue from apparently healthy sheep habitually grazing near Biancavilla was processed for immunohistochemical localisation of bcl-2 and bax. Results showed epithelial and interstitial bax overexpression, especially in cells directly in contact with the fibres, and negative bcl-2 immunoexpression. TUNEL-positive cells were detected in alveoli and connective tissue. The integrity of alveolar epithelium and alveolar apoptosis are critical determinants in the pathways that initiate fibrogenesis in the lung and fibroblastic foci are usually found close to abnormal or denuded alveolar epithelium. Our results are consistent with the hypothesis that apoptosis is an important mechanism for removing cells with irreparable fluoro-edenite-induced genetic changes that predispose them to a neoplastic evolution.

Objective: A large retrospective analysis was performed to assess the outcomes of burns and chronic ulcers treated with collagenase in an outpatient setting. No cost comparison was performed. Method: Of 979 patients entered into the analysis, 647 had burns affecting ≤15% body surface area (BSA) and 332 had chronic ulcers of various aetiologies. All were treated with collagenase-based ointments once daily (Noruxol or Iruxol, Smith & Nephew). Treatment was continued until complete healing was achieved. Results: In burns patients the overall average healing time was 17.9 days in the paediatric population and 23.6 days in adults. Burn depth and presence of eschar were the main factors affecting healing probability. The chronic ulcers were predominantly of diabetic, venous and mixed aetiology. Average healing time was 15.4 weeks, with ulcers of mixed aetiology showing the shortest average healing time (9.2 weeks). There was a positive correlation between wound area and healing time. The topical application of collagenase-based ointments was well tolerated by patients and caregivers. Conclusion: This large retrospective analysis shows that collagenase treatments in outpatient clinics are effective and well accepted in patients with burns affecting ≤15% BSA or with chronic ulcers of various aetiologies. Implementation of collagenase treatments in outpatient clinics has the potential to improve wound healing and may also decrease the cost of wound care. Declaration of interest: The statistical evaluation was supported by Smith & Nephew. All materials were hospital acquired and the authors have no conflict of interest.

Hand injuries exceed 20% of all occupational injuries. This article reviews the history of 237 hand injuries mostly occurred in craftsmen and farmers. The results allow us to make some considerations on the role of occupational physician in their prevention.

Epidemiological studies revealed an unusually high incidence of malignant pleural mesothelioma in Biancavilla, a town in eastern Sicily located in a volcanic area. In the absence of occupational risk factors connected with asbestos inhalation, a nearby stone quarry, which has long been providing most of the local building materials (e.g. plaster), was suspected to be the source of mineral fibres. These fibres had never been studied before and were identified as fluoro-edenite.To investigate the ability of the fluoro-edenite fibres present in mineral dusts and house plaster to release hydroxyl radicals in vitro.After fibre characterisation and the determination of particulate specific surface, the ability of quarry rock dust and house plaster dust to generate hydroxyl radicals was measured in vitro using the deoxyribose degradation assay. Treatment with 1,3-dimethyl-2-thiourea (DMTU), a hydroxyl radical scavenger, or deferoxamine (DFX), an iron chelator, was performed to confirm hydroxyl radical production and study the role of iron. Crocidolite (UICC) was used as positive control.The rocks were found to contain fibrous amphiboles, identified as fluoro-edenite, which are chemically similar to tremolite. All samples generated hydroxyl radicals, with rocks yielding consistently higher values than plaster. Treatment of the dusts with DMTU or DFX significantly reduced hydroxyl radical production by both samples. The type of biological reactivity observed with these fluoro-edenite fibres resembled that of asbestos fibres.The hydroxyl radicals generated by asbestos fibres have long been known to mediate inflammatory fibrosis of the lung and DNA damage that may ultimately result in lung carcinoma and mesothelioma.

Rhizarthrosis of the hand secondary to job-related static-dynamic stress is a rare occupational condition characterised by secondary osteoarthrosis.We report 5 clinical cases of female ironers employed in small-scale laundries, who after more than 10 years on the job developed pain in the right thumb. Disease onset may have been favoured by the continuous functional stress exerted on the joint.Clinical examination, hand X-rays and ultrasonography of the trapezio-metacarpal joint led to the diagnosis of rhizarthrosis. The electromyographic and biomechanical analysis of work tasks was conducted by simulating normal ironing activity.Patient history and electromyographic and biomechanical data showed a close causal relationship between age, job and diagnosis.In the case of workers over 50 years of age whose jobs have the characteristics described here, Finkelstein's test should be performed on occasion of occupational health surveillance to screen for the arising of the disease.

Isocyanates, particularly Toluene Diisocyanate (TDI), have been the most common cause of occupational asthma for decades. Fifty workers with a diagnosis of isocyanate-induced asthma were followed up for a mean period of 8.4 years. Pulmonary function testing for FVC and FEV1, allergological tests, nonspecific bronchial challenge to methacholine and specific bronchial challenge to isocyanates were performed at the time of diagnosis and during follow-up. Data on symptoms and drug response were rated on a scale. Patients were subdivided into two groups based on persistence of (A; 13 patients) or removal from (B; 37 patients) isocyanate exposure. There were no significant differences in any characteristic between the two groups at the time of diagnosis. At follow-up, group B subjects showed significant improvement in symptoms, consequent reduction in use of medications and increase in PD20. None worsened, sixteen (43.3%) remained stable, twelve (32.4%) improved and nine (24.3%) became asymptomatic. The latter subjects were generally younger, they had shorter duration of symptoms and exposure to the agents, and longer removal from exposure, although none of these differences was significant. In 67% of cases they had an immediate reaction to TDI challenge. By contrast, the condition of group A patients deteriorated significantly during the follow-up period in terms of symptoms, pulmonary function parameters, PD20 and use of medications. Overall, seven subjects (53.8%) worsened during follow-up and none improved. Group B subjects were further divided into subgroups B1 and B2 based on duration of removal from exposure: B110 years, B2or = 10 years. There were no significant differences between the two subgroups, even though PD20 was higher in B2. The present study confirms that early diagnosis and immediate removal from exposure are crucial, though not always sufficient, for a favourable evolution of the disease.

Cystic lymphangioma is a rare benign tumor that occurs more often in children with different localizations. Abdominal localization and its development may produce symptoms and clinical features of acute abdomen leading to problems in the differential diagnosis. The Authors report a rare case of pancreatic lymphangioma in a nine years old child resolved by surgical treatment. A review of the literature concerning problems of diagnosis and treatment is also presented.

We assessed the safety and therapeutic efficacy of bromperidol decanoate in a six-month open trial on 21 patients (13 males and 8 females), mean age 41.3 years, who were no longer in the acute phase and were being treated as outpatients. The recommended initial dosage was 150 mg bromperidol (one 3 ml ampoule), and this did not in fact have to be increased during the trial. The scores for psychotic symptom rating scales (SAPS, SANS, BPRS, HAM-D and social adaptation scale) were analysed by analysis of variance, which indicated that bromperidol decanoate was effective on almost all parameters. Adverse reactions were reported for 14.3% of the patients, indicating that the drug was very well tolerated; only three patients complained of a total of seven adverse events. In conclusion, bromperidol decanoate was effective in the treatment of residual schizophrenia, with significant differences between before and after treatment ratings for symptoms. The drug was well tolerated, only one patient dropping out on account of adverse reactions.

A possible method of reducing the delay in antidepressant response is to use S-adenosyl-L-methionine (SAMe), a naturally occurring compound that appears to have a rapid onset of effect in the treatment of depression. In this open, multicenter study, 195 patients were given 400 mg of SAMe, administered parenterally, for 15 days. Depressive symptoms remitted after both 7 and 15 days of treatment with SAMe, and no serious adverse events were reported. Further studies with a double-blind design are needed to confirm this preliminary indication that SAMe is a relatively safe and fast-acting antidepressant.

Three hundred in- and outpatients suffering from depressive disorder, as diagnosed using DSM-III criteria were treated for 6 weeks under double-blind conditions in a multicenter controlled study of tianeptine vs. amitriptyline. Both groups presented steady improvement of depressive syndrome from day 7 up to the end of the treatment, as shown by all evaluation scales: HDRS, SAD, CGI. Furthermore, anxiety linked to the depressive syndrome decreased equally in both groups, as shown by the HARS measurements. In addition to the improvement of mood, the tianeptine-treated patients presented less somatic complaints and side effects when compared to the reference antidepressant. These results confirm previous findings that tianeptine is an effective antidepressant with a lower side effect profile than amitriptyline.

Rubidium (atomic number 37, atomic weight 85.47), discovered in 1861 by Kirchof and Bunsen, is an alkali metal belonging to the same periodic series as sodium, potassium, cesium, and lithium (Meltzer et al. 1969). It is widespread in nature, being present in the earth’s crust and in vegetable and animal organisms. There are also physiological traces of rubidium in man (Rutigliano et al. 1980).

A comparative double-blind study of paroxetine and amitriptyline in the treatment of depressed hospital outpatients was undertaken at 15 centres in Italy. Three hundred and nine patients of either sex were admitted to the study. The starting dose of paroxetine was 20 mg daily and of amitriptyline 75 mg daily in divided doses; at week 3 these doses could be increased at the investigators' discretion. Efficacy was measured on the Hamilton Depression Rating Scale and on Clinical Global Impression. Both treatment groups showed significant improvement at week 6 with no significant between-group differences. Significantly fewer patients receiving paroxetine reported adverse events compared with those on amitriptyline (44% vs 62%; p0.01 in favour of paroxetine).

Forty schizophrenic inpatients, on constant low-dosage maintenance therapy with haloperidol, entered a superimposed, double-blind, placebo-controlled clinical trial with supidimide 2 x 200 mg per day. The double-blind phase lasted 5 days and was preceded and followed by single-blind base line and washout periods, respectively, during which all patients received matching placebos. The therapeutic effects were evaluated by BPRS, NOSIE, a post-sleep questionnaire, and, in a subgroup of patients, by objective monitoring of movements during sleep. Supidimide substantially relieved sleep disturbances, as demonstrated by subjective (p less than 0.05; n = 20) and objective (p less than 0.1; n = 3) measurements. In addition, the following drug-related effects (p less than 0.05 versus base line and placebo) on daytime behaviour were observed: a decrease in "somatic concern" (BPRS), items related to agitation (BPRS), "irritability" and "manifest psychosis" (NOSIE), and a slight increase in "retardation" (NOSIE). No adverse effects attributable to supidimide were detected. It is concluded that supidimide exerts beneficial effects on day-time behaviour and sleep in agitated schizophrenic patients undergoing low-dosage maintenance neuroleptic therapy.

Unlike conventional antidepressants, rolipram stimulates both the presynaptic as well as the postsynaptic component of monoaminergic transmission. Several double-blind comparative trials are on the way to assess the clinical efficacy and safety of this novel compound. The present study was a randomized double-blind double-dummy comparison with imipramine in inpatients with major, "minor" and atypical depressions (DSM III). Results show no relevant differences between rolipram and imipramine regarding efficacy and safety.

The incidence of pregnancy with IUD in situ varies from 1 to 3.8%. Apparently IUD failure is often due to abnormalities of the uterine cavity, or to a disproportion between the size of the uterine cavity and the size of the IUD. This article reports on the case of a woman, pregnant with a Gravigard in situ, who delivered at term a perfectly healthy 3500 g baby. The IUD, whose strings were invisible, had not been removed, and was found embedded in placental tissue at delivery. When IUD failure occurs it is necessary to ascertain whether the device is still in situ; ultrasound is the best suited tool even if not always accurate. When the IUD strings are visible and the woman intends to continue the pregnancy, a phsyician should try very gently to remove the device; should the removal prove difficult, it would be better to leave the device within the uterine cavity. A review of the published literature shows that 48 to 56% of women pregnant with IUD in situ will spontaneously abort, that risk of early delivery is 10%, and that risk of ectopic pregnancy is about 3.4%, higher with a Progestasert device. Doctor should regularly examine the patient for septic conditions. Risk of neonatal malformation is extremely low; the possible influence of the copper component of many IUDs on the development of the fetus is still not clear.

A new benzodiazepine, chlordesmethyldiazepam, was administered at a dose of 6 mg/day to 27 patients (18 neurotics and 9 psychotics) with the common symptom of anxiety. The study period was limited to eight days for the whole group, although the drug has been given to some patients for 38 days. Changes in global scores in neurotic patients were determined by administering the Wittenborn and Hamilton rating scales. In psychotic patients the same rating scales were used in addition to the BPRS. A multistimulator was used to evaluate the performance recording complex reaction times (CRT). The statistical evaluation of results shows a highly significant amelioration of all the studied parameters except for reaction times in the psychotic group.

The Authors report a double-blind study to compare mianserin and chlorimipramine efficacy in the treatment of two groups of 30 depressed patients. The trial confirms that mianserin has an antidepressant effect similar to that of chlorimipramine with fewer side effects. During the study some subjects were tested by Electrodermic Response to acoustic stimuli, comparing the results with the responses of patients treated with chlorimipramine. Furthermore, the plasmatic beta-endorphin level in 10 subjects treated with mianserin was compared with values found in basic conditions. The significant decrease of the plasmatic beta-endorphin level after treatment with mianserin suggests that the drug may act as an antidepressant, by varying the endorphinergic cerebral activity.

An account of the aetiology, pathogenesis, anatomical and pathological picture, progression and complications of spontaneous biliodigestive fistula is flowed by a description of its clinical picture and diagnostic problems. Reference is also made to 7 patients subjected to emergency surgery and 10 electively operated. Diagnosis is ensured by careful review of the history, radiological examination of the abdomen in blank, and assessment of the digestive apparatus with an opaque meal and clyster. Little assistance is provided by the objective data and radiological examination of the bile ducts.

To speak of persons in psychiatry, only really makes sense if we restore to the word its etymological sense as used by the Latins: a mask.