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PubMed1987

Sucralfate versus cimetidine in reflux esophagitis. A single-blind multicenter study.

A single-blind randomized multicenter study was performed in 42 patients with endoscopically documented reflux esophagitis. Patients were randomly given 400 mg cimetidine q.i.d. or a suspension of 1 g sucralfate q.i.d. for a period of 8 weeks. Forty patients were evaluated after 8 weeks. Symptomatic improvement was good and was comparable in both groups. We saw side-effects in only three patients, two on sucralfate and one on cimetidine, and these did not necessitate withdrawal from the study. Endoscopy showed improvement of esophagitis in 53% and healing in 31% of patients after sucralfate treatment. With cimetidine, improvement was seen in 67% and healing in 14%. One patient on cimetidine developed a stricture during treatment. We conclude that treatment with sucralfate improves symptoms and lessens severity of reflux esophagitis and that the results with sucralfate appear to be comparable to those obtained with cimetidine. Sucralfate is a valid alternative to H2-receptor antagonist therapy.

Adult↗
PubMed1984

Naftidrofuryl in chronic arterial disease. Results of a controlled multicenter study.

In a double blind, randomized multicenter study naftidrofuryl, a vasoactive substance, was compared with placebo in the treatment of 104 patients with chronic arterial occlusive disease. After a run-in period of four weeks the patients received either naftidrofuryl (600 mg daily) or placebo over 12 weeks. The pain-free and the total walking distances improved significantly in both groups. However, the difference in the improvement of the pain-free walking distance was significant (p less than 0.02) in favour of naftidrofuryl. There also was a difference in the improvement of the total walking distance in favour of naftidrofuryl which was not significant. The results indicate that naftidrofuryl has a beneficial effect on the symptoms and lengthens the painfree walking distance in patients with arterial occlusive disease.

Adult↗
PubMed1987

The treatment of angina pectoris with nitroglycerin plasters. A multicenter study involving 6,986 patients.

A multicenter study was carried out in order to evaluate the efficacy and tolerability of 2 doses of a nitroglycerin transdermal system (TTS-NG 5 mg/24 h and TTS-NG 10 mg/24 h) on a large population of patients affected by angina pectoris. Nine hundred and seventy three cardiologists enrolled a total of 6,986 patients, 4,290 males and 2,696 females, mean age 61.7 years (range 26-95), 3,283 with effort-angina, 2,062 with mixed angina and 1,641 with angina at rest. Patients whose angina was not satisfactorily controlled by their previous therapy, were given TTS-NG 5 for 1 week in the morning, while continuing their antianginal treatment, with the exception of nitrates which were gradually withdrawn. At the end of this period, patients who responded to the treatment continued taking the same dose for a further 6 weeks, while poor responders were given a double dose of the study medication over the same period. Six thousand two hundred and sixty patients (90%) completed the study. TTS-NG 5 proved to be effective in 2,091 patients (33%) with a reduction in weekly anginal attacks after only 1 week of treatment (from 5.8 +/- 2.9 to 2.4 +/- 2.3). This reduction improved in the following 2 weeks (from 2.4 +/- 2.3 to 1.2 +/- 1.6) and subsequently remained virtually unchanged. Four thousand one hundred and sixty-nine patients (67%), whose angina was not sufficiently controlled by TTS-NG 5 (from 5.0 +/- 2.4 to 4.3 +/- 2.8), received double the dose at the end of the first week. TTS-NG 10 brought about a reduction in weekly anginal symptoms during the 2nd and the 3rd week (from 4.3 +/- 2.8 to 2.0 +/- 2.2), with a further decrease during the following 2 weeks (from 2.0 +/- 2.2 to 1.1 +/- 1.7). The reduction in anginal attacks was of the same extent both during the day and the night, thus suggesting that the drug is effective throughout 24 hours. A similar pattern was observed in the reduction of the number of anginal attacks weighted by their severity, the severity of attacks weighted by their number and the number of trinitrine pills taken. Tolerability was good in the majority of cases. In conclusion, this study confirms the efficacy of TTS-NG in the treatment of angina pectoris, thus supporting some recently published data obtained by using more standardized protocols and rigorous evaluation criteria.

Administration, Cutaneous↗
PubMed1993

German multicenter studies on plateletpheresis from healthy donors. German Hemapheresis Study Group.

It is reported on two German Multicenter Plateletpheresis Studies with the Fresenius AS 104 cell separator accompanied by a Multicenter Counting Study. 15 centers participated, a total of 1884 separations were evaluated. It could be shown that multicenter studies help to give a more objective opinion about a cell separator and the separation protocol used if it is possible to improve the counting methods and to eliminate individual center effects by an accompanying Multicenter Counting Study. The AS 104 proved to be a good cell separator for platelet collection regarding platelet yields (3.1 x 11" from 3.5 I citrated blood), separation efficiency (about 45%), yield prediction (SD = not equal to 15%) and leukocyte contamination (median WBC 47 x 10(6)).

Blood Donors↗
PubMed1994

A multicenter study on HLA and autoimmunity in Japanese patients with early-onset insulin-dependent diabetes mellitus (IDDM): the JDS Study.

The Japan Diabetes Society (JDS) conducted a multicenter study on HLA and autoimmunity in Japanese patients with early-onset insulin-dependent diabetes mellitus (IDDM). HLA, immunoglobulin heavy-chain complex (Gm), properdin factor B (BF), and glyoxalase of erythrocytes (GLO) were typed, and organ-specific autoantibodies including islet cell antibodies (ICA) were assayed in 159 IDDM patients and their relatives and in 258 healthy Japanese subjects. The HLA-DRw9 phenotype and HLA-Bw61/DRw9 haplotype were significantly increased among the patients with autoantibodies other than ICA, whereas the DR4 phenotype and Bw54/DR4 haplotype were significantly increased in those without the autoantibodies. The DR4 phenotype was significantly increased in the patients with autoimmune thyroid diseases. The relative risk of the HLA-DRw9/DR4 genotype was highest among all DR genotypes. The Gm phenotype of g and gft were significantly increased in the patients with the autoantibodies. The BF-F phenotype was significantly decreased in the patients either with or without the autoantibodies. There was no association of GLO types with IDDM. The prevalence of ICA among IDDM patients was decreased with duration of IDDM. No significant association was found between the prevalence of ICA and sex, age at onset, or HLA type. On the other hand, the prevalence of the autoantibodies was not significantly changed with duration of the disease, and was significantly higher in females than in males.

Adolescent↗
PubMed1986

The Norwegian multicenter study.

The largest multicenter, double-blind trial comparing piroxicam with naproxen in the treatment of osteoarthritis has recently been conducted in Norway. More than 2,000 patients were enrolled in the 12-week study. Both drugs showed similar efficacy, and serious gastrointestinal side effects occurred in less than 1 percent of the patients taking either agent. These findings are similar to results with other nonsteroidal anti-inflammatory drugs. This study indicates that in the treatment of osteoarthritis, piroxicam is as effective as naproxen and poses no greater risk of serious gastrointestinal side effects.

Adult↗
PubMed1991

[Multicenter study with a large number of patients for the validation of pharmacokinetic and clinical findings from controlled studies with small patient cohorts].

In 94 surgeries a total of 682 patients were included into a multicenter study. Serum theophylline concentrations were monitored in patients with obstructive pulmonary diseases, that were treated with theophylline dosages as recommended in the Euphylong professional information or as adjusted after a theophylline serum level control. Peak-flow rates and theophylline tolerance as stated by the patients were also monitored and documented. 72% of the patients already received theophylline in the past. The increase of the mean daily dosage of theophylline to 750 mg administered as a single dose in the evening raised the concentration of serum theophylline in average from 8.7 +/- 5.0 mg/l to 12.2 +/- 4.1 mg/l. No increase of the portion of patients with serum concentrations above 20 mg/l was observed. The patients additional bronchodilatory medication remained unchanged during the study. As a consequence of the improved theophylline medication morning and evening peak-flow rates increased in average from 272 +/- 99 l/min to 315 +/- 109 l/min and 278 +/- 101 l/min to 318 +/- 107 l/min, respectively. After a temporary increase during the first week of treatment the frequency of side effects decreased below the one stated at the starting point of the study. Out of 106 patients, that did not finish the study, 44 (= 6.5%) dropped out because of side effects. The overall assessment of effectiveness and tolerance of Euphylong by physicians and patients was good to very good. Herein the single dosage per day was well accepted by most of the patients. The results of the presented multicenter study with Euphylong therefore confirm the pharmacokinetic and clinical data gained from single center studies with small patient numbers hitherto.

Adolescent↗
PubMed1988

[Defibrotide in the prevention of deep venous thrombosis in general surgery. Preliminary results of a multicenter study].

In an open multicenter comparative study aimed at the evaluation of the efficacy of defibrotide in the prophylaxis of postsurgical deep vein thromboses (DVT) an ad interim evaluation has been made on 2626 patients thus far enrolled. 1323 had received defibrotide (200 mg q.i.d. by IV route from day -1 to day +7th postoperative), 941 calcium heparin (5000 IU b.i.d. or t.i.d. by SC route from day 0 to day +7 postoperative) and 362 other treatments (antiaggregating agents, placebo or no therapy). This group has not been included in the final evaluation, due to its limited size. The diagnosis of DVT or pulmonary embolism (PE) was made according to clinical routinary criteria. The incidence of DTV has been 15/1323 (1.13%) in the defibrotide group and 21/941 (2.23%) in the heparin group (chi-square, p = 0.056) while the cases of suspected or ascertained PE have been respectively 3/1323 (0.22%) and 10/941 (1.06%) (p = 0.02). The incidence of adverse effects with defibrotide was less than 1%; occasional cases of increased serum transaminase levels were seen with heparin. These preliminary results supports the effectiveness of defibrotide in the prevention of post-surgery DVT, its effects being similar or more prominent than those of calcium heparin, currently regarded as the standard medication.

Adult↗
PubMed1992

Combination of ramipril and hydrochlorothiazide in the treatment of mild to moderate hypertension: Part 1--A double-blind, comparative, multicenter study in nonresponders to ramipril monotherapy.

In a parallel-group multicenter study, the efficacy and safety of combination therapy with ramipril 5 mg plus hydrochlorothiazide 25 mg were compared double-blind with those of 5 mg and 10 mg ramipril monotherapy in patients with mild to moderate hypertension who had not responded adequately to ramipril 5 mg alone. Patients were initially treated single-blind for 1 week with ramipril 2.5 mg and 3 weeks with ramipril 5 mg. Of 240 patients enrolled, 165 were subsequently classed as nonresponders (diastolic blood pressure > 90 mmHg) and were randomized to one of the three double-blind treatments for a further 4 weeks. In the double-blind phase, the mean reductions in supine systolic and diastolic blood pressures at end point were significantly greater in the 5 mg plus 25 mg combination group (11.6/10.6 mmHg) than in the groups receiving ramipril 5 mg (6.2/5.9 mmHg; both p < 0.01) and ramipril 10 mg (7.4/7.1 mmHg; both p < 0.05). The proportion of responders at end point was also higher for combination therapy (72%) than for monotherapy (48% for ramipril 5 mg and 62% for ramipril 10 mg). All three treatments were well tolerated. Analysis of laboratory values revealed no clinically important changes.

Adult↗
PubMed1982

Metoprolol eyedrops 3%, a short-term comparison with pilocarpine and a five-month follow-up study. (Multicenter).

A comparative study comprising 30 patients with glaucoma and 11 ocular hypertensives showed that pilocarpine 2%-4% and metoprolol 3% lowered the intraocular pressure to the same extent over a 4-week period. The magnitude of effect corresponded to 29.0% of the untreated pressure level in the pilocarpine group and to 31.9% in the metoprolol group. No statistically significant difference in the pressure lowering effect was found between glaucoma and ocular hypertension. Sufficient control of the intraocular pressure could not be achieved in approximately 35% of the patients with metoprolol single therapy and a tendency towards fading efficiency of metoprolol was noted, but no significant tachyphylaxis appeared during a 5-month follow-up period. Local irritation was the predominant side-effect of metoprolol treatment. Objective adverse reactions recorded were transient, epithelial keratopathy (3 patients) and exanthema (1 patient). Deterioration of a pre-existing visual field defect was observed in one case.

Adult↗
PubMed1995

New directions in dietary studies and heart disease: the National Heart, Lung and Blood Institute sponsored Multicenter Study of Diet Effects on Lipoproteins and Thrombogenic Activity.

The National Heart, Blood and Lung Institute-sponsored DELTA study is the first collaborative, multicenter diet study to utilize standardized protocols to feed specific diets to study participants. In the first study, the investigators are focusing on the effects of reducing dietary saturated fat on plasma lipids, lipoproteins, and thrombogenic activity. Future studies will attempt to address important diet/public health questions dealing with high carbohydrate vs. high monounsaturated fat diets, and the cholesterol raising activity of specific saturated fatty acids. Moreover, DELTA will be an invaluable model for other multicenter diet studies.

Adult↗
PubMed1989

The Tertatolol International Multicenter Study (T.I.M.S.). Predicting factors of an efficient therapy.

The Tertatolol International Multicenter Study (T.I.M.S.) was aimed at assessing the efficacy and tolerability of 5 mg tertatolol (T) once daily over a one year period and at finding, among the clinical variables before treatment, parameters predicting a successful single beta-blocking therapy. The study was carried out in 230 patients (96 men, 134 women, mean age +/- standard error of the mean: (51.5 +/- 0.7 years) suffering from uncomplicated mild to moderate hypertension. After a one-month placebo run-in period (M0-M1) and a one-month double-blind placebo-controlled period (M1-M2), 213 patients entered and 166 completed the one-year open period (M2-M14). A diuretic (D) was added if blood pressure (BP) was inadequately controlled with the single therapy. After one year, 88.5% of patients were controlled (sitting diastolic BP less than or equal to 90 mm Hg): 56.3% on single therapy (T) and 32.2% on dual therapy (T + D), respectively. Statistical analysis performed on the controlled subjects showed that patients who were controlled with T alone had an initially lower standing diastolic BP and a higher standing heart rate, were younger and had a lower sitting systolic BP than those controlled with T + D. Using such discriminant parameters which are predictors, 83.5% patients (single therapy group) and 49% patients (dual therapy group) were classified in the therapeutic group to which they really belonged. This study confirms the antihypertensive efficacy of tertatolol, and highlights relevant parameters for a successful single beta-blocker therapy in clinical practice.

Adrenergic beta-Antagonists↗
PubMed1994

Value of immunologic testing in stroke patients. A prospective multicenter study.

BACKGROUND AND PURPOSE: The aims of this prospective and multicenter study were to determine the frequency of anticardiolipin and antinuclear antibodies in an unselected ischemic and hemorrhagic stroke population and to evaluate the clinical significance of these autoantibodies. METHODS: Over a 1-year period, we collected plasma from 481 consecutive patients with ischemic or hemorrhagic stroke attending four different hospitals. Blood (10 mL) was drawn from each subject into a citrated glass tube. Plasma was obtained immediately by centrifugation and was stored at -70 degrees C until use. Concentrations of IgM and IgG anticardiolipin antibodies were measured at room temperature in normal (not heat-treated) plasma by standardized enzyme-linked immunosorbent assay. All sera were treated by indirect immunofluorescence on mouse liver and kidney sections for antinuclear antibodies. RESULTS: A total of 481 patients (325 men, 156 women) 16 to 90 years in age (mean age, 61 years) were studied. Anticardiolipin antibodies were present in 5 of 481 (1.04%) patients. One patient was IgG positive and four patients were IgM positive. Of 481 patients, 35 (7.2%) were positive for antinuclear antibodies. Anti-DNA antibodies were not demonstrable in any patient. CONCLUSIONS: The frequency of anticardiolipin antibodies in a heterogeneous stroke population is possibly lower than reported. The routine screening of anticardiolipin and antinuclear antibodies in a stroke population is of questionable value.

Adolescent↗
PubMed1988

Surfactant replacement therapy for severe neonatal respiratory distress syndrome: an international randomized clinical trial. Collaborative European Multicenter Study Group.

In a randomized multicenter trial, involving the collaboration of eight European neonatal intensive care units, the efficacy of replacement therapy with a new surfactant preparation (Curosurf) was tested in 146 patients with severe neonatal respiratory distress syndrome. Criteria for entry included birth weight 700 to 2,000 g, age when treated two to 15 hours, and requirement of artificial ventilation with FiO2 greater than or equal to 0.6. The babies were treated with a single large dose of surfactant (200 mg/kg) at a median age of nine hours (range two to 15 hours). Average FiO2 before treatment was the same (0.80) for both surfactant-treated patients and control patients. Babies receiving surfactant showed, within five minutes, a dramatic improvement of oxygenation as reflected by a nearly threefold increase of the PaO2/FiO2 ratio. Six hours after randomization, the PaO2/FiO2 ratio still showed a 98% improvement in surfactant-treated patients compared with controls (P less than .001), and statistically significant differences in favor of the treated babies persisted until 48 hours after randomization, when surviving control infants began to recover. Treatment with surfactant decreased neonatal (less than or equal to 28 days) mortality from 51% to 31% (P less than .05). Compared with control babies, the surfactant-treated group also had a decreased incidence of pulmonary interstitial emphysema (23% v 39%; P less than .05) and pneumothorax (18% v 35%; P less than .05). The percentage of survivors without bronchopulmonary dysplasia in the treated group was more than twice that of the control group (55% v 26%; P less than .001).(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗
PubMed1989

[A double-blind comparative study of intracoronary administration of GE-0943 and urokinase: multicenter study].

Coronary thrombolysis with plasminogen proactivator, GE-0943, was undertaken in patients with acute myocardial infarction and compared with urokinase. Fifty patients were given 6000 units of GE-0943 intracoronary and the totally occluded infarct-related arteries were recanalized in 92.0%. Fifty-four patients who were given 3000 units of GE-0943 intracoronary demonstrated a recanalization rate of 68.2%, while intracoronary administration of urokinase in 54 patients showed a recanalization rate of 70.4%. There was only one patient with hemorrhagic complication among GE-0943 3000-units group, none among GE-0943 6000-units group, and 5 among urokinase group. Thus, intracoronary administration of GE-0943 is very effective and safe with a dose up to 6000 units.

Adult↗
PubMed1993

A multicenter study of typical retinitis pigmentosa in Japan.

A nationwide, multicenter study of typical retinitis pigmentosa was carried out in collaboration with 13 university hospitals throughout Japan. A total of 253 patients, 122 males and 131 females, with a wide range of ages (mean 48 years), were registered during a two-month period in 1989. Determination of inheritance pattern revealed 30.2% autosomal recessive cases, 15.4% autosomal dominant, 0.5% X-linked, and 48.9% simplex, indicating a relative decrease in autosomal recessive cases and a relative increase in simplex cases in recent decades. The age at onset, initial symptom, and visual functions including visual acuity, visual field and electroretinogram showed a marked interindividual variability, but statistical analysis demonstrated that visual defects progressed with increasing age and disease duration. A correlation between the phenotypic variation and the genetic type was observed. This survey of retinitis pigmentosa in Japan provides information for counseling and rehabilitation of patients and encourages basic and clinical research of this genetic disease.

Adolescent↗
PubMed1991

Italian Multicenter Study on Very Low Birth Weight Babies.

The Italian Multicenter Study on Very Low Birth Weight babies (IMS-VLBW) is the first collaborative investigation performed in Italy on the health status of newborns weighing less than 1500 g at birth. Eight Neonatal Intensive Care Units (NICUs) participated in the study: Cagliari, Napoli, Padova, Palermo, Roma, Sassari, Trieste, Udine. Data were analyzed in the Laboratorio di Epidemiologia e Biostatistica of the Istituto Superiore di Sanità. The objectives of the study were established in the following: a) to collect accurate descriptive data on neonatal morbidity, mortality and long term outcome of VLBW babies admitted to NICUs; b) to analyze the risk factors of unfavourable outcome (death or handicap) and to analyze, with respect to outcome, the relationships between risk factors, neonatal diseases and therapeutical procedures; c) to test the feasibility of a multicenter follow-up programme based on the use in all participating Centers of the same diagnostic criteria (the results of follow-up will be presented in a forthcoming paper). In the years 1987 and 1988, 634 newborns weighing 500-1499 g at birth were enrolled in the study. In-hospital mortality for the whole group was 33.1% (65.1% in the 500-999 g birth weight class and 19.2% in the 1000-1499 g class). Mortality was not different for inborn vs outborn babies. A high incidence of unfavourable perinatal conditions was observed in these babies, namely birth asphyxia, sub-optimal care during transport, poor clinical conditions on arrival to the NICU. Neonatal diseases, like respiratory distress syndrome and peri-intra ventricular hemorrhage were also frequent and severe. A logistic regression analysis of pre-admission risk factors of in-hospital death identified eight statistically significant variables: birth weight; gestational age; sex; antenatal steroid stimulation of lung maturity; first minute Apgar score; absence of spontaneous respiration, body temperature and pH on arrival to the NICU. Using the equation derived from the logistic regression analysis a theoretical mortality rate, predicted on the basis of the local incidence of pre-admission risk factors, was calculated for each Center. In no case the predicted mortality was statistically different from the observed one, suggesting that in our study differences in observed mortality rates from one Center to another are largely influenced by pre-admission risk factors.

Apgar Score↗
PubMed1995

The impact of cocaine and marijuana use on low birth weight and preterm birth: a multicenter study.

OBJECTIVE: Our aim was to evaluate prospectively the effects of cocaine and marijuana use on pregnancy outcomes. STUDY DESIGN: A prospective multicenter cohort study was conducted at seven university-based prenatal clinics in the United States from 1984 to 1989. The cohort described herein consisted of a multiethnic population of 7470 pregnant women. Information on the use of drugs was obtained from personal interviews at entry to the study and assays of serum obtained during pregnancy. Pregnancy outcome data (low birth weight [< 2500 gm], preterm birth [< 37 weeks' gestation], and abruptio placentae) were obtained with a standardized study protocol. RESULTS: A total of 2.3% of the women used cocaine and 11.0% used marijuana during pregnancy. Cocaine use was not associated with having a low-birth-weight infant (adjusted odds ratio 0.7, 95% confidence interval 0.4 to 1.3) or a preterm birth (1.3, 0.9 to 2.0). There was no association between short-term exposure to cocaine and preterm delivery (1.1, 0.3 to 4.0). However, cocaine use was strongly associated with abruptio placentae (adjusted odds ratio 4.2, 1.9 to 9.5). Marijuana use was not associated with low birth weight (1.1, 0.9 to 1.5), preterm delivery (1.1, 0.8 to 1.3) or abruptio placentae (1.3, 0.6 to 2.8). By comparison, 35% of the women smoked cigarettes during pregnancy, and cigarette smoking was positively associated with low birth weight (1.5, 1.2 to 1.8). CONCLUSIONS: In this population of women receiving prenatal care, cocaine use was uncommon and was not related to most adverse birth outcomes. Marijuana use was relatively common and was not related to adverse pregnancy outcomes. Tobacco is still the most commonly abused drug during pregnancy, 15% of all cases of low birth weight in this study could have been prevented if women did not smoke cigarettes during pregnancy.

Abruptio Placentae↗