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The Karnofsky Scale of Performance Status (KPS) is a measure of health status that is widely used for HIV-infected persons, although few studies have documented its reliability and validity for HIV. We developed a modified KPS in an attempt to make it more appropriate for use in HIV-infected persons and evaluated its inter-rater reliability in a multicenter study. Patients (N = 657) were recruited from five hospitals in three Italian cities; responses were scored using the modified scale by three different raters in each hospital: one experienced physician, one young physician, and one nurse. Kendall's correlation test showed a strong inter-rater agreement for the total of observations: 0.82 between the two physicians, 0.77 between the experienced physician and the nurse, and 0.76 between the young physician and the nurse. The analysis of variance showed a strong effect of the stage of the disease on the KPS score. The specific hospital had little effect, whereas the effect of the type of rater disappeared when the nurse was excluded from the analysis. This modified scale demonstrated a good reliability, although training of raters could help to eliminate differences among raters and among hospitals.

Non-Hodgkin's lymphoma (NHL) is one of the most common malignancies in patients infected with human immunodeficiency virus (HIV): it occurs 25-60 times more frequently in HIV-infected patients than in the general population. This neoplasm in acquired immunodeficiency syndrome (AIDS) patients is a highly aggressive tumour with a poor prognosis and tends to develop in extranodal sites, such as the central nervous system, digestive tract and bone marrow. NHL involving the paranasal sinuses is rare in HIV-infected patients, and is likely to be confused clinically and radiographically with sinusitis; moreover, its optimal treatment is currently uncertain. We present a case of NHL involving the left maxillary sinus in a patient with AIDS. The patient was treated with systemic chemotherapy (low dose-CHOP), but the malignancy did not respond. Subsequently, he was treated with local maxillary sinus irradiation which resulted in partial regression of the neoplasm and in decrease of local symptoms.

The tuberculin reaction following the intradermal injection of PPD appears 48-72 hours after injection. The positivity is shown by an > 5 mm area of induration of the skin. Tuberculin reaction is an invaluable instrument of epidemiologic investigation. Clinically, the value of tuberculin test, though remarkable, is limited by the fact that its positivity is not necessarily a sign of active tuberculosis. The three control strategies of tuberculosis are: prompt identification and correct management of cases, vaccination, prophylaxis. The latter, that in most cases is performed with isoniazid (300 mg/daily for 12 months) is indicated in the following situations: subjects with > 5 mm tuberculin test; recent contacts with patients with infective tuberculosis; chest X-ray indicative for old fibrotic lesions, HIV infection; subjects with > 10 mm tuberculin test: HIV-negative drug-addicts; clinical conditions at high risk for tuberculosis (e.g. silicosis, hematologic malignancy, iatrogenic immunosuppression).

Objective: This study was intended to present evidence for the reliability and validity of an Italian version of the MOS-HIV Health Survey and to identify important disease-related factors associated with health-related quality of life (HRQoL) in people with nonadvanced HIV., Design: In this cross-sectional study, HRQoL was measured using an Italian version of the MOS-HIV Health Survey questionnaire in 213 HIV-infected people without previous opportunistic infections or neoplasms attending an outpatient clinic in a university hospital. Distribution of scores, reliability, and validity were calculated, and presence and frequency of HIV-related symptoms were recorded and transformed into a score. The relation of HRQoL values to sociodemographic, epidemiologic, and clinical data was assessed., Results: The level of internal consistency of the Italian version of the MOS-HIV Health Survey was high (Cronbach's alpha, 0.80-0.93), and items demonstrated acceptable discrimination across scales. At linear regression analysis, all domains of HRQoL correlated with symptom score (r2 range, 0.07-0.41), but only the pain and physical-functioning scores showed a significant correlation with CD4 cell count. A weighted sum of single domains of HRQoL, TOTQoL, is also strongly correlated with symptom score (r2 = 0.57; p < .0001) but not with CD4 cell count (r2 = 0.01; p = .1). Using multivariate analysis, only symptom score (p < .0001) and total number of daily pills (p = .03) showed significant association with HRQoL. The same results were observed when analysis was performed only on people with CD4 levels <200/microl., Conclusions: This study presents the first evidence for the reliability and validity of a HRQoL instrument in Italian for people with HIV. Results also suggest a strong impact of symptoms on all measured dimensions of health status. The number of pills required to be taken daily is the only other significant factor associated with a lower HRQoL, whereas no relations were found with CD4 cell count or Karnofsky performance status values. To improve HRQoL in persons with nonadvanced HIV disease, symptom control could be a crucial element of medical treatment.

We investigated the prevalence and intensity of symptoms and the use of drugs for symptom control among all HIV-infected patients reporting to the outpatient clinics or wards of 15 clinical centres in central Italy, recording clinical and epidemiological data on three consecutive days. A total of 1128 patients were observed and tabulated. Their most frequent symptoms were asthenia (65%), anorexia (34%), cough (32%), pain (29%), and fever (29%). Opioid analgesics were used in 3% of these patients and non-opioid analgesics in 13%. A large majority of HIV-infected patients presented with symptoms regardless of the stage of their disease. Pain was present in fewer than one third of patients but nonetheless seemed to be undertreated. Pain was more frequent and more intense among intravenous drug users. Based on our study, a greater effort to control symptoms in HIV patients seems to be warranted.

The purpose of this study is to retrospectively review the clinical, radiographic and laboratory characteristics, the therapy and evolution of sinusitis in HIV-infected patients hospitalized between January 1, 1985 and July 31, 1994. We have observed 65 cases of sinusitis in 58 HIV-infected patients (77.6% classified as group C). Forty-five of 65 cases (69.2%) showed radiographic evidence of acute sinusitis; the remaining 20 cases (30.8%) showed chronic sinusitis. In 61 cases (93.8%) there were symptoms related to sinusitis. In 61 sinusitis cases antibiotics were administered. Although the majority of patients responded at least partially to antibiotic therapy, a complete resolution of clinical and radiographic signs was observed in only 47.4% of acute sinusitis cases. No resolution was observed in chronic sinusitis after treatment stop. Sinusitis appears to occur quite frequently in HIV-infected patients, is often related to non-specific symptoms, may be recurrent and is commonly refractory to treatment.

According to the guidelines of the "Third international workshop conference on GDM", we have examined 2000 pregnant women. The glucose challenge test (GCT) was positive in 408 cases (20.4%) and negative in 1592 (79.6%). The OGTT (Carpenter and Coustan's criteria) was performed in 647 pregnant women. GDM and IGGT prevalence was of 6.25% and 5.5% respectively and normal glucose tolerance (NGT) 88.25%. The GCT effectiveness for GDM and IGGT diagnosis is: sensibility 75.1%, specificity 44%, positive predictive value 46.4% and negative predictive value 74%. GDM and IGGT compared with NGT women were significantly older (p < 0.05) and prepregnancy BMI was higher (p < 0.01); the prevalence of previous macrosomia (p < 0.01), previous gestational diabetes (p < 0.01) and family history for diabetes mellitus (p < 0.05) was greater in GDM and IGCT. The prevalence of preterm delivery was higher in both GDM and IGCT (GDM 12.5% and IGGT 15.4% vs NGT 6%; p < 0.01), as well as the prevalence of cesarean sections (GDM 31.6% vs IGGT 23.5% and NGT 20.3%; p < 0.02), and the occurrence of macrosomia (GDM 27.6%, IGGT 16.6% and NGT 16.2%). In addition a higher prevalence (p < 0.01) of hyperbilirubinaemia, hypoglycemia and hypertrophy cardiomyopathy was observed in newborns from GDM women. Our data show that: GCT has a good specificity for GDM diagnosis, prevalence of GDM in our population is about 6%, GDM is still correlated to an elevated maternal and neonatal morbility.

A study protocol to record prospectively, frequency and intensity of symptoms in terminally ill AIDS patients was developed. Other information included mode of transmission, active intravenous drug use, regular visits of family/friends to the ward, the use of symptom-control drugs, and death without family or partner. The study population was selected from patients admitted to the wards or followed in the Clinic or Day Center of the Department of Infectious Diseases of the Catholic University, Rome. Inclusion criteria were diagnosis of AIDS prior to 12 months and advanced stage AIDS (defined with standardized criteria). To standardize the analysis of data, the terminal phase was considered to start 3 months before death (T1). From January 1, 1993 to December 12, 1993, 266 patients (208 males, 58 females) were enrolled. By June 30, 1995 168 patients had died and were considered for analysis. The most frequent symptoms at T1 were anorexia (63.1%), fatigue (60.1%), pain (60.1%), fever (47.6%), and cough (37.5%). At the end week (T6) the most frequent symptoms were fever (81.5%), fatigue (70.2%), dyspnea (68.1%), and pain (58.9%). In two-thirds of the patients, symptom-control drugs were used, most frequently nonopioid analgesics (39.9% at T1 and 56.5% at T6) and antipyretics (38.7% at T1 and 53.6% at T6). Opioid analgesics were used in 19% of patients at T1 and in 28.6% at T6. Almost one-third of the patients (29.2%) died alone without having family, their partner, or a friend near. Considering the high frequency of treatable symptoms in terminally ill AIDS patients, the use of palliative therapy should be emphasized. Flexibility and patient-directed care should be used in deciding care plans to avoid overhospitalization and promote alternative care.

Affinity of Z1046 for dopamine receptor subtypes, its ability to modulate D1- and D5-mediated AC stimulation and D1-induced cAMP accumulation were evaluated. On D1-like receptors Z1046 and fenoldopam (fen) showed a similar high affinity, being more potent than DP-5,6-ADTN and 5,6-ADTN. For the D2-like receptors, the affinity rank orders were: D2: Z1046 > or = DP-5,6-ADTN > fen = 5,6-ADTN; D3: Z1046 > DP-5,6-ADTN > fen = 5,6-ADTN; D4: Z1046 = DP-5,6-ADTN > fen = 5,6-ADTN. In AC studies the rank order was: Z1046 = fen > DP-5,6-ADTN > 5,6-ADTN. Z1046 was more efficient than fen in stimulating cAMP accumulation. These results make Z1046 an innovative agent combining D1-like and D2-like activities.

We have characterized the endothelin-converting enzyme (ECE)-like activity involved in big endothelin (ET)-1-induced contraction in rabbit saphenous artery (RSA). Big ET-1 30 nM caused a contraction that was independent of the vascular endothelium. Phosphoramidon and the neutral endopeptidase (NEP) inhibitors thiorphan and candoxatrilat blocked the vasoconstriction caused by big ET-1 in endothelium-denuded RSA. Candoxatrilat (IC50 17 nM) and thiorphan (IC50 2.5 nM), were 5- to 30-fold more potent than phosphoramidon (IC50 83 nM). Other protease inhibitors were inactive. In cultured endothelial cells the ET-1 release was inhibited only by phosphoramidon (IC50 16 microM) but at a concentration 200-fold that required an endothelium-denuded RSA. In conclusion, we can speculate that the big ET-1 contraction in RSA is mediated by an ECE, probably present on smooth muscle cells, which is susceptible to NEP inhibitors and is different from the ECE on endothelial cells.

SIM 6080 is a new calcium antagonist, structurally related to diphenylalkylamines, which combines transmembrane and intracellular calcium antagonist activities. In the present study we investigated the effect of SIM 6080 on atherogenesis in cholesterol-fed rabbits. Subcutaneous administration of the compound at 0.33, 1, and 3 mg kg-1/bid for 60 days neither affected plasma lipids nor blood pressure. However at 1 and 3 mg kg-1/bid SIM 6080 reduced in a dose-dependent manner both the area of the aorta covered by plaques and aortic cholesterol content. Determination of SIM 6080 plasma and aortic content indicated that the compound could concentrate up to 10 times in the arterial tissue. In vitro studies demonstrated that at concentrations similar to those observed in the aorta this compound may stimulate rabbit beta VLDL catabolism by smooth muscle cells in an homologous system suggesting that the up-regulation of LDL-receptors in the aorta may contribute to the antiatherosclerotic properties of SIM 6080.

The authors describe a case of invasive nasosinusal aspergillosis in an immunocompetent patient. After a careful bibliographic review, they emphasize that in the present case the diagnosis was made by means of fungal culture as the clinical picture, imaging techniques and histopathological findings were aspecific. The pathogenetic agent resulted Aspergillus tamarii which belongs to the Aspergillus flavus group and is one of the most unusual agents in literature. The treatment of choice, in the invasive form, is surgery that should be as radical as possible followed by a medical therapy. In the present case, after two-phase radical surgery on all the paranasal sinuses, medical treatment with traconazole was employed with excellent local results at a follow-up of one year.

We have investigated the in vitro effect of the new calcium antagonist SIM 6080 on proliferation of rat aortic smooth muscle cells and on LDL receptor-mediated catabolism in human fibroblasts. Verapamil was used as the reference compound. SIM 6080 inhibited the proliferation of rat aortic myocytes in concentrations ranging between 1 and 20 microM. The inhibition, evaluated as cell number and nuclear incorporation of [3H]thymidine, was dose and time dependent; the cell doubling time increased with drug concentrations up to 69 h versus 20 h for controls. Similar results on both LDL pathway and smooth muscle cell proliferation were achieved with verapamil, but higher concentrations were needed. The specific uptake and degradation of 125I-LDL was evaluated in human fibroblasts after 48 h incubation with SIM 6080 (1-10 microM). The compound dose dependently enhanced the receptor-mediated 125I-LDL uptake, with a fourfold increase as a maximal effect (10 microM); LDL degradation was less sensitive to the drug. The present results provide evidence that the new calcium antagonist SIM 6080 interferes in vitro with processes involved in atherogenesis.

We assayed digoxin-like immunoreactivity in the serum of 19 healthy neonates (blood sample from umbilical cord), not receiving digoxin therapy, using a solid-phase radioimmunological method. In addition, urinary concentrations of a digoxin-like immunoreactive substance (DLIS) were assayed throughout the first 10 weeks of extrauterine life in 50 healthy infants. The mean (+/- SD) serum DLIS concentration obtained was 211 +/- 60 ng/l digoxin equivalents (d.e.) while, in the urinary samples of the first day of life, the mean concentration was 818 +/- 560 ng/l d.e. (n = 20). These DLIS values in infants were higher (about 5- to 10-fold) than those previously observed in adults. In addition, urinary DLIS values were very high in the first week of life and fell quite rapidly in the next weeks of life. We used serum and urine pools from neonates for gel filtration experiments using a Sephadex G 25 column. In the urine sample we found some immunoreactive peaks eluted at the end and after the region of salts, while the chromatographic profiles of the serum pool showed only a major peak eluted with the peak of proteins. After boiling, the same serum pool showed an elution pattern characterized by a smaller immunoreactive peak eluted with that of proteins and by other peaks similar to those observed for the urine sample. Our study demonstrated that a substance or more substances which cross-react with digoxin-specific antibodies are present in blood and urine of healthy infants. In addition, our chromatographic studies indicate that DLIS is probably a low molecular weight substance(s) which circulate(s) in blood bound to a higher molecular weight molecule.

1. To investigate endogenous cardiac glycoside-like compounds in plasma and their ability to inhibit the sodium pump, digoxin-like immunoreactivity [digoxin-like immunoreactive substance(s), DLIS] and 86Rb uptake by erythrocytes were measured in plasma extracts from normal adults, hypertensive adults and neonates. 2. DLIS levels in neonate plasma extracts were significantly higher than those found for normotensive or hypertensive adults. No difference was observed between normotensive and hypertensive subjects. DLIS was significantly increased when boiled plasma was extracted. 3. Extracts of boiled neonate and adult plasma inhibited 86Rb uptake. Instead, when boiling was omitted, no detectable inhibition was found in extracts of plasma from normotensive or hypertensive adult subjects. When present, the inhibition resulted from a depression of the ouabain-sensitive (sodium-pump-mediated) component, and, for the boiled neonate plasma only, also of the ouabain-resistant component. When the data from the different groups were pooled, a statistically significant inverse relationship between DLIS and erythrocyte 86Rb uptake was observed. Furthermore, in a subgroup of samples in which determinations were made before and after boiling in the same samples, an inverse correlation was found between changes in DLIS and changes in ouabain-sensitive (but not ouabain-resistant) 86Rb uptake. 4. Plasma extracts incubated with albumin at a physiological concentration significantly decreased (by approximately 20%) the inhibition of 86Rb uptake observed. 5. These findings support the existence of one or more endogenous compounds which both bind to antidigoxin antibodies and inhibit transmembrane cation transport. Part of this inhibition may, however, not involve the sodium pump. Furthermore, this chemically unidentified substance(s) may be bound to plasma proteins which partly reduce its action in vivo.

Elevated levels of a group of substances with digoxin-like immunoreactivity (DLIS) are present in biological fluids of newborns. These endogenous substances could also have the biological properties of cardiac glycosides, such as natriuretic and vasoconstrictor activity. Therefore, DLIS could be involved in electrolyte and volume regulation in infants. We measured DLIS, electrolyte (Na+, K+, Cl-) and creatinine concentrations in 157 urine samples collected from full-term and preterm infants, with the aim to establish if a correlation exists between the urinary DLIS levels and the respective values of these electrolytes. Significant and positive correlations were found between the urinary concentrations of DLIS and electrolytes. In addition, electrolyte values correlated significantly between themselves. DLIS, K+ and Cl- values correlated positively with urinary creatinine concentrations (n = 142). A significant multiple correlation was found among DLIS concentrations and creatinine and Cl- values. We also studied the DLIS concentrations in serum samples collected at birth in peripheral blood of the mothers and in umbilical cord and gastric aspirate of 5 full-term infants. We observed that DLIS values in newborns are significantly higher than the respective values of the mothers. In conclusion, our data do not demonstrate a clear relationship between DLIS and electrolyte concentrations in urine samples of newborns. Further investigations are necessary to elucidate the biochemical and physiological properties of DLIS.

The pharmacokinetics of clofoctol [(tetramethyl-1,1,3,3,butyl)-4-(dichloro-2,4-benzyl)-2-hydroxy-1-benzene ] was investigated in six healthy newborns and compared with the kinetic parameters of the drug in six healthy adults. The concentration of the drug in plasma was measured by means of an original sensitive HPLC technique. In both neonates and adults treated rectally with clofoctol, the plasmatic peak occurred at the 30th min, although the maximal peak of adults was significantly lower. Kel and T1/2 exhibited a similar pattern, whereas the AUC was about 5 times higher in newborns. The present findings suggest that clofoctol is well absorbed rectally. The higher plasmatic levels of clofoctol in neonates may result from their lower degree of hepatic metabolic activity.

The influence of tetracycline and cotrimoxazole on polymorphonuclear leukocyte (PMNL) chemiluminescence and adherence to nylon was investigated in vivo on healthy volunteers. A significant impairment of chemiluminescence and (although not statistically significant) an inhibitory effect on adherence to nylon was observed in subjects receiving tetracycline. Cotrimoxazole did not appear to have a significant influence on PMNL function.

The influence of ofloxacin and pefloxacin on human myelopoiesis in vitro was investigated. Drug concentrations varied from 0.5 to 50 micrograms/ml, and the effect on granulomonocyte precursors was evaluated on cell cultures in agar. Our results indicate that ofloxacin and pefloxacin do not induce inhibition of myelopoiesis.

ELISA has been used for the detection of IgG antibodies against PPD in 48 patients with pulmonary tuberculosis, in 10 individuals with previously treated tuberculosis and clinically recovered, in 22 PPD skin-test positive healthy volunteers and in 48 blood donors with unknown PPD skin-test. Positivity was obtained in 29 patients (83%) with active tuberculosis, in one patient (10%) with clinical recovery, in none of the healthy controls. This technique may have a potential diagnostic relevance in evaluating patients with suspected pulmonary tuberculosis.

The authors assess the sensitivity and specificity of the antibody-coated bacteria assay for the localization of urinary tract infections. The results are compared with those obtained from cultures of urine samples taken from the upper tract either by ureteral catheterization or by direct puncture of the renal pelvis. In upper urinary tract infections the research of total immunoglobulins has proven positive in 71.4% of the cases; of the IgA class in 71.4%; of the IgG class in 57.1%; of the IgM class in 28.6% and of the secretory component of IgA in 60% of the patients. In case of lower urinary tract infections the research of total immunoglobulins was positive in 25% of the cases: that of the IgA class in 8.3%; of the IgG in 25%; of the IgM in 25% and of the secretory component of IgA in 22.2% of patients.

The influence of two fluoroquinolone derivatives, ofloxacin and pefloxacin, on lymphocyte immunoglobulin secretion and on polymorphonuclear leucocyte superoxide anion production was assessed. Pharmacological concentrations did not influence the studied functions, while suprapharmacological concentrations decreased immunoglobulin production.

Reported are the results of a study on the incidence of nosocomial surgical infections in ten wards of the university hospital A. Gemelli, Rome. One thousand, five hundred five patients were studied and the overall incidence of surgical infections was 8.7%. Factors that influenced infection rates included age, immunosuppressive diseases, and immunosuppressive therapy. We assessed the inutility of antibiotic prophylaxis in clean operations and its usefulness in clean operations with insertion of prostheses or other devices. The importance of the duration of preoperative hospitalization and of the length of the operation were also noted. The most frequent etiological agents proved to be Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coli. The average hospital stay for patients with surgical infection was more than double that of patients with no infection (25.7 days v 11.7 days).

The results of a study on the incidence of nosocomial infections in a 1800 bed University hospital are reported. The study, carried out over a 9 months period, included: continuous microbiological surveillance, and a clinical and epidemiological survey. On the basis of the microbiological data collected and analyzed by a computer data system, developed and employed for the control of nosocomial infections, a weekly bed-to-bed survey was carried out by the staff of the Institute of Infectious Diseases. Among 2777 suspected nosocomial infections, as revealed by microbiological monitoring, 701 were confirmed after the bed-to-bed survey. The nosocomial infection rate was 6.75 per 100 discharges. It was higher in the surgical than in the medical wards (7.3 and 6 per 100 discharges, respectively). Nosocomial urinary tract infections were the most frequent (74.2%). The urinary infection rate was higher in the surgical than in the medical wards (5.3 and 4.6 per 100 discharges, respectively). Escherichia coli (19.4%), Pseudomonas aeruginosa (19.3%), Proteus spp. (18.4%) were the pathogens most frequently associated with nosocomial infections. They were followed by Klebsiella pneumoniae (7.8%) and Staphylococcus aureus (6.5%) in frequency. Among the risk factors, involved in nosocomial infections, the importance of catheterization was confirmed: among our patients with nosocomial urinary tract infections, 73.4% and 79.5%--in the medical and surgical wards, respectively--underwent urological instrumentation, mainly catheterization. An analogous and more detailed study is now in progress and will be extended in the next years.