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PubMed1989

Risk behaviors for HIV-1 infection in Italian drug users: report from a multicenter study. First Drug User Multicenter Study Group.

In June 1987, a cross-sectional study was carried out on drug users attending public centers for drug dependency in Italy. Observed proportions of HIV seropositives among the 1,363 subjects from 34 public centers in 11 regions included in the study varied widely, with an overall seropositivity rate of 37%. Sharing syringes/needles, already used by other intravenous drug users, for preparing and injecting drugs represented independent risk factors for HIV-1 infection, while sexual lifestyle did not. Risk of infection increased with frequency of sharing equipment for preparing and for injecting drugs. Modification of risk behaviors in drug use was reported more frequently than in sexual lifestyle; both were significantly associated with knowledge of being seropositive for HIV-1 infection.

Acquired Immunodeficiency Syndrome↗
PubMed1989

An open multicenter long-term treatment evaluation of Sinemet CR. Sinemet CR Multicenter Study Group.

The safety and efficacy of Sinemet CR were studied in an open-label, 52-week trial. The study was completed by 156 mildly to moderately ill Parkinson's patients (primarily Hoehn and Yahr stage II to III) at 10 sites. Patients had their treatment optimized on standard Sinemet prior to beginning Sinemet CR treatment. Following titration, there was a median reduction in dosing frequency of 25% (from 4.1 to 3.2 doses/day) relative to the standard Sinemet baseline. Total daily levodopa dosage increased from 623 to 808 mg/day (+33%), a factor consistent with the lower bioavailability of the controlled-release formulation. Mean efficacy scores on the New York University Parkinson's Disease Scale decreased from 7.4 at the end of baseline to 5.8 at 12 weeks, a decline of 20%. The scores remained at this level throughout 52 weeks of treatment. At the end of 1 year of treatment, 60% of patients rated themselves as improved, while physicians rated 64% of the patients as improved. Adverse experiences were similar to those reported by patients taking standard levodopa preparations. Two thirds of the reported adverse experiences occurred within the 1st 3 months of Sinemet CR therapy, indicating that increased length of exposure to Sinemet CR was not associated with an increasing incidence of adverse experiences.

Aged↗
PubMed1993

A multicenter trial for resuscitation of injured patients with 7.5% sodium chloride. The effect of added dextran 70. The Multicenter Group for the Study of Hypertonic Saline in Trauma Patients.

OBJECTIVE: To evaluate the use of 250 mL of a 7.5% sodium chloride solution, both with and without added dextran 70, for the prehospital resuscitation of hypotensive trauma patients. DESIGN: Double-blind randomized trial. SETTING: Six trauma systems served by helicopter transport. PATIENTS: Injured patients with systolic blood pressures less than 90 mm Hg at any time in the field or during helicopter transport. INTERVENTIONS: Infusion of study solution, in the field or during transport, followed by conventional isotonic solutions as needed. Solutions studied in four cohorts were as follows: (1) lactated Ringer's; (2) 7.5% sodium chloride (hypertonic saline); (3) 7.5% sodium chloride combined with 6% dextran 70; and (4) 7.5% sodium chloride combined with 12% dextran 70. MAIN OUTCOME MEASURES: Blood pressure response; survival to time of hospital discharge among the treatment groups; and survival compared with that predicted by norms from the Major Trauma Outcome Study (MTOS). RESULTS: The mean (+/- SD) change in systolic blood pressure on arrival in the emergency department was significantly higher in the hypertonic saline solution group than that in the lactated Ringer's solution group (34 +/- 46 vs 11 +/- 49 mm Hg, P < .03). Overall survival in the four treatment groups was 49%, 60%, 56%, and 45% (not statistically significant). Survival in the hypertonic saline solution group, however, was significantly higher than that predicted by the MTOS norms (60% vs 48%, P < .001). Survival to hospital discharge in patients with baseline Glasgow Coma Scale scores of 8 or less was correlated with treatment group (P < .05 by logistic regression and P < .01 by Cox proportional-hazards analysis; with survival in the hypertonic saline solution group [34%] vs lactated Ringer's solution group [12%]). CONCLUSIONS: Prehospital infusion of 250 mL of 7.5% sodium chloride is associated with an increase in blood pressure and an increase in survival to hospital discharge compared with survival predicted by the MTOS norms. Patients with low baseline Glasgow Coma Scale scores seem to benefit the most from 7.5% sodium chloride resuscitation. Hypertonic saline solution without added dextran 70 is as effective as the more expensive solutions that contain dextran 70.

Adolescent↗
PubMed1995

Multicenter evaluation of a new commercial assay for detection of immunoglobulin M antibodies to Toxoplasma gondii. Multicenter Study Group.

A new commercial assay for detection of IgM-specific antibodies to Toxoplasma gondii (IMx Toxo IgM, Abbott, USA), based on microparticle enzyme immunoassay technology, was evaluated at 15 clinical sites in Europe and the USA. Performance characteristics were established by testing clinical specimens collected randomly from pregnant women, blood donors, individuals with suspected Toxoplasma gondii infection and individuals confirmed HIV positive. Reference testing was performed using Toxo-M EIA (Abbott). Specimens evaluated at European sites yielding discordant results between the new assay and the reference EIA were further tested with an immunosorbent agglutination assay; at sites in the USA, discordant results were resolved using Platelia Toxo IgM (Sanofi, France) and Vidas Toxo IgM (bioMérieux, France) assays. In addition, matched plasma and serum, heat-treated and non-heat-treated specimens, and fresh and frozen specimens were evaluated at the USA sites. At European sites the new commercial assay had a sensitivity of 95.6% (196/205), a specificity of 99.8% (3,137/3,143) and an agreement of 99.6% (3,333/3,348) following resolution of discordant results; sensitivity in the USA was 97.4% (184/189), specificity was 99.8% (1,204/1,207) and agreement was 99.4% (1,388/1,396) following resolution. The new IMx Toxo IgM is a sensitive and specific assay for measurement of IgM antibodies to Toxoplasma gondii in human serum and plasma.

Animals↗
PubMed2006

A prospective, randomized multicenter trial of the empirical addition of antifungal therapy for febrile neutropenic cancer patients: results of the Paul Ehrlich Society for Chemotherapy (PEG) Multicenter Trial II.

BACKGROUND: The aim of the study was to compare the efficacy of empirical antifungals in combination with broad spectrum antibiotics with that of antibiotics alone in high risk febrile neutropenic cancer patients not responding to initial antibacterial therapy. PATIENTS AND METHODS: A prospective, randomized controlled trial was conducted at 22 cancer centers in Germany. Patients with fever of unknown origin were randomized to either piperacillin (Pip) plus an aminoglycoside (AMG) (arm A) or a third generation cephalosporin (Ceph) plus AMG (arm B). Patients not responding after 4-6 days were randomized to either imipenem (Imi) plus glycopeptide (GLP) (arm C), or Imi/GLP plus amphotericin B deoxycholate (AmB) plus 5-flucytosine (5-FC) (arm D), or Imi/GLP plus fluconazole (Fluco) (arm E). A successful outcome was defined as resolution of fever. RESULTS: In arm A, 192 of 373 patients (51.5%) responded as compared to 176 of 344 patients (51.2%) in arm B. The response rates of 155 patients randomized for further empirical treatment were 55.6%, 77.8% and 62.5% in arm C, D and E, respectively. The difference between arm C and D was of borderline statistical significance (p = 0.06) after correction for multiple testing. CONCLUSION: In neutropenic cancer patients with persistent fever the combination of antibiotics with AmB/5-FC is superior to salvage antibacterial therapy alone. There is no difference in efficacy between Pip and third generation Ceph given as initial empirical therapy in combination with an AMG.

Adolescent↗
PubMed1995

Intravenous sotalol for the termination of supraventricular tachycardia and atrial fibrillation and flutter: a multicenter, randomized, double-blind, placebo-controlled study. Sotalol Multicenter Study Group.

Sotalol is an antiarrhythmic agent with combined beta-blocking and class III antiarrhythmic properties. This study was designed to assess the safety and efficacy of sotalol in terminating supraventricular tachycardia (SVT), atrial fibrillation (AFib), and atrial flutter (AFl). Ninety-three patients with spontaneous or induced SVT (n = 45) or AF (AFib or AFl; n = 48) with a ventricular rate of > or = 120 beats/min were studied. In the first phase, the double-blind phase, patients were randomly assigned to receive placebo or intravenous (i.v.) sotalol, 1.0 or 1.5 mg/kg. If SVT or AF did not convert to sinus rhythm or if the ventricular rate did not slow to < 100 beats/min within 30 minutes, patients then entered the second phase, the open-label phase, which also lasted 30 minutes, and were given 1.5 mg/kg iv sotalol. In the SVT group, during the double-blind phase conversion to sinus rhythm occurred in 2 (14%) of 14 of patients who received placebo, 10 (67%) of 15 who received sotalol, 1.0 mg/kg (p < 0.05 vs placebo), and 10 (67%) of 15 who received 1.5 mg/kg sotalol (p < 0.05 vs placebo); during the open-label phase, 1.5 mg/kg i.v. sotalol converted 7 (41%) of 17 of patients. In the AF group, during the double-blind phase conversion to sinus rhythm occurred in 2 (14%) of 14 of patients who received placebo, 2 (11%) of 18 who received 1.0 mg/kg sotalol (p not significant [NS] vs placebo), and 2 (13%) of 16 who received 1.5 mg/kg sotalol (p = NS vs placebo); in these groups, a > 20% reduction of ventricular rate without conversion to sinus rhythm occurred in 0 (0%) of 14, 13 (72%) of 18 (p < 0.05 vs placebo), and 12 (75%) of 16 of patients (p < 0.05 vs placebo), respectively; during the open-label phase, 1.5 mg/kg i.v. sotalol converted 7 (30%) of 23 of patients. The most common adverse events were hypotension and dyspnea. During the double-blind phase they occurred in 10% of patients who received placebo, 9% of those who received 1.0 mg/kg i.v. sotalol (p = NS vs placebo), and 10% of those who received 1.5 mg/kg i.v. sotalol (p = NS vs placebo). Most of these events were mild to moderate, but all were transient and clinically manageable.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1992

Multicenter trial of automated nitroprusside infusion for postoperative hypertension. Titrator Multicenter Study Group.

Hypertension is common after a cardiac operation and may result in postoperative hemorrhagic and other complications. Most often this problem has been treated using manually controlled doses of intravenous sodium nitroprusside. To evaluate the clinical impact of an automated closed-loop administration system on patients after cardiotomy, a prospective trial was conducted at nine clinical centers. Patients with hypertension were managed by either manual nitroprusside titration (n = 532) or a closed-loop automated titration system (n = 557). Patient groups were not significantly different in age, weight, or height. Moreover, the types of surgical procedures were comparable: primary coronary artery bypass grafting, 59.2% and 58.9%, manual group versus automated group; repeat coronary artery bypass grafting, 10.5% and 8.6%, respectively; valve procedures, 11.3% and 15.1%, respectively; and other cardiac procedures, 19.0% and 17.4%, respectively (all p = not significant). The automated group showed a significant reduction in the number of hypertensive episodes per patient (1.8 +/- 0.2 versus 0.6 +/- 0.07; p = 0.0001. At the same time, the number of hypotensive episodes per patient was reduced with automated closed-loop titration (0.40 +/- 0.05 versus 0.30 +/- 0.03; p = 0.02). Chest tube drainage (866 +/- 37 mL versus 693 +/- 23 mL [mean +/- standard error of the mean]; p = 0.0001), percentage of patients receiving transfusion (40.0% versus 33.0%; p = 0.02), and total amount transfused (2.4 +/- 0.12 units versus 2.0 +/- 0.10 units; p = 0.0003) were all reduced significantly by the use of an automated titration system.(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Transfusion↗
PubMedDate not supplied

A multicenter, randomized, double-blind comparison of roxatidine with ranitidine in the treatment of patients with uncomplicated benign gastric ulcer disease. The Multicenter Roxatidine Cooperative Study Group.

Roxatidine (150 mg, 312 patients) was compared with ranitidine (300 mg, 308 patients) in a randomized, double-blind, parallel-group, 6-week therapeutic study for the treatment of patients with uncomplicated, benign gastric ulcer disease. The study end points (verified by using endoscopy results) were fully healed ulcers at 4 or 6 weeks. The results of roxatidine therapy were comparable to those of ranitidine therapy: healing rates of 52% and 54% at week 4 and 77% and 76% at week 6 were recorded for roxatidine and ranitidine, respectively. The drugs produced comparable reductions in ulcer diameters and decreases in abdominal pain. Adverse events associated with both roxatidine (27%) and ranitidine (28%) were headache, diarrhea, and dizziness; rash was associated in 6 of 8 cases and in only 1 case with roxatidine. In this trial, roxatidine 150 mg once daily was as efficacious and safe as ranitidine 300 mg once daily for treatment of patients with uncomplicated, benign gastric ulcer disease.

Adult↗
PubMed1992

Cyclosporine in psoriasis: a multicenter dose-finding study in severe plaque psoriasis. The German Multicenter Study.

Interim results of a randomized, controlled, dose-finding study conducted in 24 dermatology centers on 217 patients with severe chronic plaque psoriasis (entry psoriasis area and severity index of at least 15) are presented. Patients were first treated with cyclosporine either 1.25 or 2.5 mg/kg/day (Sandimmune); in case of inadequate response the dosage was increased to a maximum of 5 mg/kg/day. Cyclosporine was given for 12 to 36 weeks. Treatment was classified as "successful" if the psoriasis area and severity index was reduced to 25% or less of the baseline value or below 8. At the end of the treatment period 18% of patients had improved their psoriasis area and severity index "successfully" with the initial dose of 1.25 mg/kg/day. "Successful" improvement with the initial dose of 2.5 mg/kg/day was achieved in 56% of the cases. In the 1.25 mg group, 44 patients had to increase their dose to 2.5 mg/kg/day and 31 patients to 5 mg/kg/day. In 29 patients whose dosages were started at 2.5 mg/kg/day the dosage was subsequently increased to 5 mg/kg/day. Although 1.25 mg/kg/day proved to be effective in some cases, 2.5 mg/kg/day of cyclosporine is the optimal starting dose. Adverse events were observed in 10% of the patients taking 1.25 mg/kg/day, in 20% taking 2.5 mg/kg/day, and in 32% taking 5 mg/kg/day. The most common were gastrointestinal complaints, followed by the common cold and other viral infections. An increase of serum creatinine level above 130 mumols/L occurred in five patients who could continue therapy after reducing the dose.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1995

Effect of high dose angiotensin-converting enzyme inhibition on restenosis: final results of the MARCATOR Study, a multicenter, double-blind, placebo-controlled trial of cilazapril. The Multicenter American Research Trial With Cilazapril After Angioplasty to Prevent Transluminal Coronary Obstruction and Restenosis (MARCATOR) Study Group.

OBJECTIVES: We conducted a randomized, double-blind, placebo-controlled trial to assess the effect of low and high dose angiotensin-converting enzyme inhibition with cilazapril on angiographic restenosis prevention after percutaneous transluminal coronary angioplasty. BACKGROUND: Angiotensin-converting enzyme inhibitors possess antiproliferative effects in animal models of vascular injury. However, a recent clinical trial using low dose cilazapril, a long-acting angiotensin-converting enzyme inhibitor, failed to prevent restenosis. METHODS: Patients received either cilazapril (1 or 2.5 mg in the evening after successful coronary angioplasty, then 1, 5 or 10 mg twice daily for 6 months) or matched placebo. All patients received aspirin for 6 months. Coronary angiograms before and after angioplasty and at 6-month follow-up were quantitatively analyzed. In addition, the clinical, procedural and angiographic factors associated with restenosis were determined with the use of stepwise logistic analysis. RESULTS: A total of 1,436 patients with a successful coronary angioplasty were recruited. As assessed by an intention-to-treat analysis, the mean difference in minimal coronary lumen diameter (mean +/- 1 SD) between the postangioplasty and follow-up angiogram at 6 months (primary end point) was -0.35 +/- 0.51 for the placebo group and -0.37 +/- 0.52, -0.45 +/- 0.52 and -0.412 +/- 0.53, respectively, for the 1-, 5- and 10-mg twice daily cilazapril groups (p = NS). Clinical events during follow-up did not differ among the four study groups. Multivariate analysis revealed only six variables as independent predictors of the loss of minimal lumen diameter: duration of angina < 6 months, history of myocardial infarction, minimal lumen diameter before and after angioplasty as well as a proximal lesion location and reference diameters. Traditional risk factors for atherosclerosis did not relate to restenosis. CONCLUSIONS: Long-term angiotensin-converting enzyme inhibition with cilazapril in high as well as low dosages does not prevent restenosis and does not favorably influence the overall clinical and angiographic outcome after coronary angioplasty. Few factors are predictive of restenosis.

Angioplasty, Balloon, Coronary↗
PubMed1994

Lessons learned from data logging in a multicenter clinical trial using a late-generation implantable cardioverter-defibrillator. The Guardian ATP 4210 Multicenter Investigators Group.

OBJECTIVES: This study examined patterns of implantable cardioverter-defibrillator use as documented by data logging. BACKGROUND: Implantable cardioverter-defibrillators are accepted therapy for malignant ventricular tachyarrhythmias; however, relatively little is known about their patterns of use. Incorporation of data-storage capacities into these devices provides insight into long-term defibrillator function. METHODS: Stored data-logging information was retrieved from 401 implanted cardioverter-defibrillators in 393 patients over an average of 303 days of follow-up. RESULTS: A total of 91,443 detections were recorded in 299 patients. One hundred-six patients (26%) had detections due to supraventricular tachycardias, electrical noise or other causes, resulting in inappropriate therapy delivery to 92 patients (23%). Two hundred eighty-one patients recorded 66,276 episodes of ventricular tachycardia or ventricular fibrillation. Of these, 74.4% episodes terminated spontaneously without any delivered therapy, 22.1% terminated after antitachycardia pacing, and 1.7% terminated after shock therapy. Antitachycardia pacing was activated without formal testing in 47% of all patients receiving this therapy and was successful in 96% of all episodes receiving this therapy. Acceleration of tachycardia to shock therapy occurred in 1.3% of all episodes and in 30.5% of patients receiving antitachycardia pacing. Thirty-four patients (8.7%) died during follow-up. Mortality was associated with patient age, heart failure functional class at implantation and frequency of shocks received during follow-up (all p < or = 0.05). CONCLUSIONS: Most ventricular tachyarrhythmia detections by this noncommitted implantable cardioverter-defibrillator resolve spontaneously, whereas the majority receiving therapy can be treated with antitachycardia pacing. Mortality after implantable cardioverter-defibrillator implantation is associated with age, heart failure class and frequency of shocks received during follow-up. Data-logging capabilities provide valuable insights into the patterns of defibrillator use.

Algorithms↗
PubMed2000

Prophylactic implantable cardioverter defibrillator trials: MUSTT, MADIT, and beyond. Multicenter Unsustained Tachycardia Trial. Multicenter Automatic Defibrillator Implantation Trial.

MUSTT and MADIT have clearly shown the survival benefit of an implantable cardioverter defibrillator (ICD) in patients with previous myocardial infarction, left ventricular ejection fraction < or = 0.40, and nonsustained ventricular tachycardia (VT), and who have had sustained VT induced at electrophysiology study. Progress in primary prevention of sudden cardiac death (SCD) depends on a concerted effort by clinicians to identify and appropriately treat MUSTT/MADIT-type patients; further research to more precisely define patient subgroups at risk for SCD and the willingness of industry to develop a lower priced ICD for prophylactic use are needed.

Clinical Trials as Topic↗
PubMedDate not supplied

Multicenter clinical trial for evaluating methylprednisolone pulse treatment of idiopathic optic neuritis in Japan. Optic Neuritis Treatment Trial Multicenter Cooperative Research Group (ONMRG).

BACKGROUND: A randomized, controlled clinical trial was conducted in 1991 to compare an intravenous megadose of methylprednisolone with a control drug (mecobalamin) for treating acute idiopathic optic neuritis. CASES: Sixty-six cases from 22 clinical centers throughout Japan were examined to evaluate the treatment on visual function parameters, such as visual acuity, visual field, color vision, contrast sensitivity, and critical flicker frequency. OBSERVATIONS: The methylprednisolone pulse treatment group showed faster recovery of visual function, particularly the visual acuity at 1 week (P<.05), Humphrey field analyzer mean deviation at 3 weeks (P<.05), and color vision at 1 week (P<.05). Recovery of contrast sensitivity at several different spatial frequencies was significant in the pulse treatment group at 1 (P<.01), 2 (P<.05), and 4 weeks (P<.05) after the start of treatment. Visual function test results at 12 weeks and 1 year were essentially the same in the two treatment groups. Side effects appeared more frequently in the pulse treatment group than in the control (P<.05). CONCLUSIONS: Pulse treatment does not appear effective for idiopathic optic neuritis even though visual function in the pulse treatment group of this trial recovered more quickly during the initial phase compared to the controls. More effective and specific treatment should be established for optic neuritis.

Adolescent↗
PubMedDate not supplied

Baseline features of idiopathic optic neuritis as determined by a multicenter treatment trial in Japan. Optic Neuritis Treatment Trial Multicenter Cooperative Research Group (ONMRG).

BACKGROUND: An optic neuritis treatment trial was conducted at 30 clinical centers in Japan using the same protocol. Patient participation was based on: age range of 14-55 years; acute symptoms indicative of unilateral optic neuritis of unknown or demyelinating origin; visual symptoms of 14-day duration or less; relative afferent pupillary defect in affected eye; and normal or swollen optic disc of affected eye. CASES: Initially, 102 patients qualified for participation; baseline data were obtained for analysis from 70 of these patients. Demographic characteristics of Japanese patients with optic neuritis were clarified and compared with those in a US study. OBSERVATIONS: The incidence of ocular or periocular pain and the presence of periventricular plaques were noted to be lower, and the incidence of disc swelling higher, in the Japanese patients, suggesting racial differences in the characteristics of the disease. Such differences may possibly be related to the lower incidence of multiple sclerosis in Japanese patients. The results of visual function tests were virtually the same in both studies. The nonaffected eyes of more than half the patients showed abnormal mean deviation in Humphrey field analysis, as also noted in the US study. CONCLUSIONS: The baseline clinical features of optic neuritis in the Japanese patients have been defined. Some racial differences in the characteristics of the disease may exist.

Adolescent↗
PubMed1996

A placebo-controlled multicenter study of auranofin in the treatment of patients with corticosteroid-dependent asthma. Auranofin Multicenter Drug Trial.

BACKGROUND: Previous clinical studies have demonstrated that injectable gold salts and the oral gold compound, auranofin, possess significant steroid-sparing effects in the treatment of asthma. OBJECTIVES: The objectives of this investigation were to determine whether auranofin could reduce oral corticosteroid requirements and to evaluate the safety of auranofin in the treatment of chronic corticosteroid-dependent asthma. METHODS: Patients with asthma were eligible if they required at least 10 mg of prednisone per day for control and prevention of asthma exacerbations. Two hundred seventy-nine patients with chronic corticosteroid-dependent asthma (requiring > or = 10 mg/day) were randomized to receive auranofin, 3 mg twice daily, or placebo during an 8-month clinical trial, which was divided into three phases including: a 4-week baseline period (phase I), a 6-month double-blind treatment and steroid reduction period (phase II), and a 4-week posttreatment observation period during which steroid and auranofin doses or placebo doses were maintained at levels achieved by the end of phase II (phase III). The primary efficacy variable was "therapeutic success" or reduction of daily corticosteroid use by 50% or more. RESULTS: The proportion of patients in the auranofin group achieving therapeutic success (41%) was significantly higher than that in the placebo group (27%) (p = 0.01). This effect was greatest in patients requiring 10 to 19 mg of oral prednisone per day at baseline (p < 0.001). In all treated patients, including those who did and did not complete the trial, significant reduction (> or = 50% of baseline) in oral corticosteroid dosage was achieved in the auranofin group (60%) compared with the placebo group (32%) (p < 0.001). There were no significant differences between treatment groups in symptoms, concomitant medication use, or lung function. Mean serum total IgE levels decreased significantly from baseline in the auranofin group (-44.63 IU/ml) compared with the placebo group (p = 0.001). Gastrointestinal and cutaneous adverse events were greater in the auranofin group. CONCLUSIONS: Auranofin demonstrated a steroid-sparing effect without concomitant worsening of symptoms or lung function and appeared to be more effective in patients dependent on 10 to 19 mg of prednisone per day. Therefore this study has demonstrated that auranofin is useful as a steroid-sparing agent in the treatment of chronic corticosteroid-dependent asthma.

Administration, Oral↗
PubMed2000

Does HIV-infection influence the response of chronic hepatitis C to interferon treatment? A French multicenter prospective study. French Multicenter Study Group.

BACKGROUND/AIM: The aim of this prospective study was to compare the response to alfa-interferon treatment of chronic hepatitis C in two groups of patients: coinfected with human immunodeficiency virus (HIV) (G I) or not (G II). METHODS: One hundred and fifty-three patients with chronic hepatitis C had been enrolled in 30 French liver units or infectious diseases units between May 1992 and January 1995 (G I: 76, G II: 77) to receive alfa-2a interferon: 3 MU thrice weekly for 6 months. RESULTS: One hundred and twenty-seven patients (G I: 63, G II: 64) fulfilled all criteria for analysis. The two groups were comparable for all demographic data, while significantly more severe biological and histological (p=0.001) parameters attested to more serious hepatitis among HIV-HCV coinfected patients. HCV viremia was higher among HIV-coinfected patients (p=0.0169), while genotype repartition was identical among the two groups (more than 52% of genotype 1, more than 31% of genotype 3). ALT normalization was, respectively, (G I/G II) obtained in 17.46%/26.56% (not significant) of patients at the end of treatment and in 11.11%/12.5% (not significant) of patients after 6 months of follow-up. In a multivariate analysis, GGT level before therapy (relative risk 2.1, confidence interval 1.1-5.8) and body surface area (relative risk 1.9, confidence interval 1.1-3.7) were the variables independently associated with the response to alfa-interferon treatment (higher GGT and more elevated body surface area were associated with a risk of non-response). CONCLUSION: In our study HIV infection did not affect the alfa-interferon treatment response of chronic hepatitis C, and response could be achieved among HIV-coinfected patients. Present therapeutic anti-HCV schedules need to be proposed to HIV-HCV coinfected patients before severe immunosuppression occurs. On the other hand, more severe biological and histological parameters were observed among HIV-HCV coinfected patients, which suggests a need to study whether HIV infection is associated with a worsening course of chronic hepatitis C.

Adult↗
PubMed1992

Long-term multicenter experience with a second-generation implantable pacemaker-defibrillator in patients with malignant ventricular tachyarrhythmias. The Guardian Multicenter Investigators Group.

A second-generation implantable pacemaker-cardioverter-defibrillator was evaluated in 200 patients with sustained ventricular tachycardia, ventricular fibrillation or prior cardiac arrest. The device permits demand ventricular pacing for bradyarrhythmias and for long QT interval or tachycardia suppression, uses programmable (3 to 30 J) energy shocks for conversion of ventricular tachycardia and ventricular fibrillation and is used with conventional pacing and defibrillation leads. Ventricular tachycardia/fibrillation recognition is based on the ventricular electrogram rate and requires reconfirmation before shock delivery. Two hundred patients (mean age 62 years, mean left ventricular ejection fraction 36%) were enrolled and followed up for 0 to 23 months (mean 12). Epicardial lead system implantation was performed with use of an anterolateral thoracotomy (38%), median sternotomy (26%) and subxiphoid (20%) or subcostal (16%) approach. Perioperative mortality rate was 5.5% (all nonarrhythmic deaths). Implant defibrillation threshold ranged from 3 to 30 J (mean 15), with initial programmed shock energy ranging from 3 to 30 J (mean 22). Ventricular tachycardia/fibrillation sensing threshold ranged from 0.7 to 1.8 mV (median 1) and the tachycardia detection interval from 288 to 416 ms (median 320). Reprogramming of implant variables was necessary for reliable electrographic sensing (54 patients), programmed shock therapy (61 patients) and tachycardia detection rate (63 patients). Device activation for potential shock delivery occurred in 111 patients (55.5%) with actual shock delivery after ventricular tachycardia/fibrillation reconfirmation in 66 patients (33%). During follow-up study, there was a 1% arrhythmia mortality rate, 6.5% cardiac mortality rate and 10.5% total mortality rate. This study demonstrates that the programmable implantable pacemaker-cardioverter-defibrillator is effective in preventing arrhythmic death, yet reduces patient exposure to repeated shock therapy. Reprogramming is usually necessary during follow-up for optimal function.

Adolescent↗