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PubMed1989

Comparative multicenter studies with TRUE Test and Finn Chambers in eight Swedish hospitals. TRUE Test Study Group.

A multicenter study with the TRUE Test standard panel and the same allergens in petrolatum applied with the Finn Chamber technique indicated 167 positive reactions with both test methods. Thirty-eight positive reactions were indicated with TRUE Test alone and 28 positive reactions were indicated with the Finn Chamber method only. Irritant reactions were equally frequent with both tests. Quality, as scored by surface distribution and adherence of the tape, tended to be slightly better with TRUE Test. Less than 50% of the positive test results were predicted by history, whereas more than 75% of them had past or present relevance.

Allergens↗
PubMed1989

Clinical experience with ciprofloxacin: analysis of a multicenter study.

In a multicenter study of 36 patients treated with ciprofloxacin (mean daily dosage, 986 mg per day; mean duration of treatment, 10.8 days) for a variety of infections, 32 were microbiologically proven. Of these, bacteriologic cure and/or improvement resulted in 100% of cases. For all 36 infections clinical cure and/or improvement resulted in 97.1% of cases. A total of 13 infections were classified as chronic. Overall there were six adverse reactions reported in 4/36 (11.1%) patients. Five were considered related definitely to ciprofloxacin therapy, one was not. Therapy with ciprofloxacin was discontinued in two patients (5.5%). Two patients elected to continue ciprofloxacin therapy despite mild side effects.

Adolescent↗
PubMed1989

Clinical experience with ciprofloxacin: analysis of a multicenter study.

In a multicenter study of 90 patients treated with ciprofloxacin (mean daily dosage, 936 mg per day; mean duration of treatment, 9.7 days) for a variety of infections, 42 were microbiologically proven. For one case the outcome of therapy was unknown. Of the 41 reported outcomes bacteriologic cure resulted in 92.7%, improvement in 7.3% of cases. Clinical cure equaled 88.4%, while improvement was 9.3%. Failure was reported in 2.3% of cases. A total of 14 infections were classified as chronic. Overall, there were 9/90 (10%) adverse reactions. Six were classified as definitely related to therapy. Therapy with ciprofloxacin was discontinued in four (4.4%) patients because of adverse effects.

Adolescent↗
PubMed1989

Clinical experience with ciprofloxacin: analysis of a multicenter study.

In a multicenter study of 128 patients treated with ciprofloxacin (mean daily dosage, 982 mg per day; mean duration of treatment, 8.9 days) for a variety of infections, 48 were microbiologically proven. Of these, bacteriologic cure and/or improvement resulted in 93% of cases. For all 128 infections clinical cure and/or improvement resulted in 93.8% of cases. Twenty-nine (23.8%) of all infections were classified as chronic. Overall, there were 3/128 (2.3%) adverse reactions (ADRs); one case each of diarrhea, malaise, and nausea/vomiting. None were related definitely to ciprofloxacin therapy. Therapy with ciprofloxacin was discontinued in two (1.6%) of 128 patients because of adverse gastrointestinal (GI) effects. One patient elected to continue ciprofloxacin therapy despite mild GI side effects.

Adolescent↗
PubMed1988

Cefoxitin for one day vs. ampicillin and metronidazole for three days in elective colorectal surgery. A prospective, randomized, multicenter study.

In a multicenter study the prophylactic efficacy of two antibiotic regimens was tested against postoperative septic complications following elective colorectal surgery. The study was conducted in a prospective block-randomized design. Patients were preoperatively allocated to either ampicillin, 1 gm, four times daily, and metronidazole, 0.5 gm, three times daily, for 72 hours, or to cefoxitin, 2 gm, given three times in a period of 10 hours. Both regimens were initiated immediately before surgery. Forty-five patients were withdrawn from the study after randomization. Three hundred fifty two patients (175 receiving ampicillin and metronidazole and 177 receiving cefoxitin) completed the study and were followed for one month postoperatively. The frequency of septic and nonseptic complications was not statistically significant different between the two regimens. About one third of all septic complications appeared more than two weeks after surgery. It is concluded that short-term treatment with cefoxitin is at least as efficient as a three-day treatment with ampicillin and metronidazole.

Aged↗
PubMed1990

[Tolerance to Triatec in monotherapy and in combination with Lasilix in a French multicenter study].

In a multicenter study in general practice, the tolerability and safety of ramipril alone and in combination with a low dose of furosemide were assessed in moderate hypertension. After a placebo run-in period involving 770 patients, 661 were included in the active treatment period and received ramipril alone (2.5-5 mg/day). After 6 weeks, the nonresponders entered in a double-blind period and they received daily ramipril 10 mg or ramipril 5 mg in combination with furosemide 20 mg. In this hypertensive population, the adverse events more commonly reported were headache, cough, dizziness, asthenia, cramps diarrhea and nausea, but not all these events were related to ramipril. There was seemingly a relation between cough prevalence and rampiril dosage; an increased incidence was also observed during the outbreaks of flu-syndrome in our country. 38 patients discontinued the active treatment due to non-serious adverse events, mainly cough, dizziness or diarrhea. No serious adverse drug reaction was observed. Laboratory data (blood cells count, electrolytes, serum creatinine, fasting blood glucose, apolipoproteins AI and B) remained most commonly unaffected. In moderate hypertension in general practice, this study confirms that ramipril is well tolerated, especially with regard to the class effects of the angiotensin converting enzyme inhibitors.

Adult↗
PubMed1990

Clinical experience with ciprofloxacin: analysis of a multicenter study.

In a multicenter study of 132 patients treated with ciprofloxacin for a variety of infections, 35 were microbiologically proven. Of these, bacteriologic cure equaled 85.7%, while improvement equaled 11.4%; failure was 2.9%. Clinical cure equaled 65.8%, while improvement was 26.3%. Failure was reported for 7.9% of cases. A total of 46 (35.9%) infections were classified as chronic. Overall, six of the 132 patients had adverse reactions. Two were related definitely to ciprofloxacin therapy. Therapy with ciprofloxacin was discontinued in two (1.5%) patients because of adverse effects.

Adolescent↗
PubMedDate not supplied

Efficacy of two comparative antibiotic regimens in the treatment of serious intra-abdominal infections: results of a multicenter study.

A multicenter, open-label randomized trial was conducted to evaluate the efficacy and tolerability of monotherapy with imipenem-cilastatin (I-C) compared with combination therapy with clindamycin and an aminoglycoside (C+A) for treatment of 117 patients with serious intra-abdominal infections. Fifty-three patients (45%) received I-C and 64 patients (55%) received C+A. The overall clinical success rate was 96.2% for the I-C patients and 92.2% for the C+A patients. Clinical failure rates were 3.8% and 7.8%, respectively (P = NS). Eradication or suppression of pathogens was observed in 81.8% and 82.2% of patients, respectively. Uniform bacteriologic response was observed among all infection subgroups. Fourteen of 145 patients experienced adverse symptoms, including six of 66 (9.1%) monotherapy patients and eight of 79 (10.1%) combination-therapy patients (P = NS). The results of this study demonstrate that I-C monotherapy was as effective as C+A combination therapy for the treatment of serious intra-abdominal infections, regardless of the site or severity of infection or the clinical status of the patient. Both regimens also were found to be comparable in tolerability.

Abdomen↗
PubMed1992

[Comparative effects of angiotensin converting enzyme inhibitors and calcium inhibitors related to baseline ambulatory blood pressure. A French multicenter study].

OBJECTIVE: This multicenter study was aimed at determining whether the baseline ambulatory blood pressure (BP) level does influence the efficacy of angiotensin-converting enzyme inhibitors (CEI) and that of calcium antagonists (CA) to the same degree. METHODS: The BP recordings of 236 patients with mild to moderate hypertension were reviewed: these subjects previously entered clinical trials comprising a mean 2-week placebo period and a mean 6-week active treatment phase (CEI = 115, CA = 121). The 24-hour baseline ambulatory BP was considered as high when greater than 139/87 mmHg, according to Staessen's meta-analysis. RESULTS: In the patients with an high baseline ambulatory BP, CEI and CA have had roughly a similar effect (reduction in systolic = 9.5 +/- 7.8% vs 7.7 +/- 6.3%, NS; reduction in diastolic = 9.8 +/- 8.6% vs 8.3 +/- 5.8%, NS). Conversely, the patients with a baseline ambulatory BP level lower than or equal to 139/87 mmHg experienced a greater reduction in ambulatory BP with CEI than with CA (systolic = 7.9 +/- 7.0% vs 0.6 +/- 6.7%, p = 0.0001; diastolic: 5.0 +/- 7.4% vs 1.9 +/- 7.6%, p = 0.040). Finally, further analysis found the threshold of drug efficacy to be 120/80 and 135/85 mmHg in CEI and CA patients respectively. CONCLUSIONS: 1) CEI are more effective than CA in patients with a low ambulatory BP only. 2) The risk of a visceral hypoperfusion seems however to be limited, since CEI do not reduce diastolic ambulatory BP further, when its baseline level is lower than 80 mmHg.

Adult↗
PubMed1991

[The treatment of humeral shaft fractures. Results of a prospective AO multicenter study].

This prospective multicenter study conducted by the German section of the AO International analyzes 302 fractures of the humeral shaft, 170 (56%) of which were operated upon and 132 (44%), treated conservatively. Among those operated upon, 3.5% developed infections and 10% showed paresis of the radial nerve. In contrast, the only complication in the group treated conservatively was pseudarthrosis, in 1 case. However, further analysis revealed that complications were distributed unequally among the centers and the most complications were reported from only a few hospitals. We were able to contact 173 (57%) patients for follow-up. Results of operative and conservative treatment were compared for similar fractures. Both techniques resulted in predominantly good to excellent results. The somewhat inferior results in the group operated upon were explained by the higher percentage of associated local injuries and concomitant injuries to other organs. The results of this study were compared with those of other recent studies, and recommendations were established for the operative and conservative treatment of fractures of the humeral shaft.

Adolescent↗
PubMed1990

[Wound healing with Iruxol. Results of a multicenter study].

In a multicenter study, a total of 100 wounds in 94 patients were treated with Iruxol ointment over a period of 3 weeks. The ointment was applied to the wound surface once or twice daily. The target parameters, wound debridement, granulation and epithelialization were assessed qualitatively. The area of the ulcers was determined quantitatively and approximately. In wounds considered to be uncomplicated, the results were clearly better than in so-called problem wounds, in which the blood supply obviously played a considerable role in the healing process. Postoperatively the wounds shrank by only two-thirds, while the area of problem wounds, i.e. "skin ulcerations", was reduced by only about 46%. On the whole Iruxol ointment was well tolerated. However, in two out of 32 patients with leg ulcers treatment had to be terminated due to contact dermatitis.

Chloramphenicol↗
PubMed1992

Major histocompatibility complex haplotypes and complement C4 alleles in systemic lupus erythematosus. Results of a multicenter study.

In a multicenter study more than 300 central European systemic lupus erythematosus (SLE) patients were examined for HLA-B, HLA-DR, and complement C4 phenotypes. For 174 SLE patients MHC haplotypes were determined by family segregation analysis, and for 155 patients C4 gene deletions were determined by TaqI restriction fragment length polymorphism. Two haplotypes, B8-C4AQ0-C4B1-DR3 and B7-C4A3-C4B1-DR2, were identified as risk factors for SLE. These findings were confirmed by applying the haplotype frequency difference (HFD) method, which uses nontransmitted haplotypes from the family study as internal controls. Furthermore, only HLA-DR2, but not DR3, B7, or B8, was significantly increased in SLE patients independently of the two risk haplotypes. C4A gene deletions, but not silent C4AQ0 alleles, were increased in SLE patients and neither C4BQ0 alleles nor C4B gene deletions were increased. The observed frequencies of homozygosity and heterozygosity for the two haplotypes and the frequencies of homozygotes for C4AQ0 and C4A deletions did not differ from the expected values, indicating that the risk for SLE is conveyed by single allele effects. In conclusion, there are two MHC-linked susceptibility factors for Caucasian SLE patients carried by the haplotypes B7-DR2 and B8-DR3. The results argue against C4Q0 alleles being the decisive factors increasing susceptibility to SLE.

Alleles↗
PubMedDate not supplied

[Risk of occupational exposure to hepatitis B virus in Venezuelan health workers. Multicenter study].

In a multicenter study, 970 serum samples were collected from venezuelan health workers. Presence of HBV serological markers (HBsAg, antiHBs and total anticore) were screened by microELISA. Two-hundred and forty-seven samples (27%) showed at least one positive marker, being the most frequently found the antisurface antibody which was present in different working areas, including those considered at the low exposure level (medicine 24.7%). The proportion of antisurface positive samples also was significantly higher in the group with more than 10 years of service compared to the prevalence showed by the group with less than 5 years (19.1 vs 12.8%). Groups considered to be at low risk, contrary to the expected results, showed a similar or higher prevalence compared to the groups classified as continues or frequent exposure (17.7 vs 8.6%). Our findings suggest a permanent HBV load circulation at the venezuelan hospitals environment.

Biomarkers↗
PubMed1989

Intravenous prostaglandin E1 versus pentoxifylline therapy in chronic arterial occlusive disease--a controlled randomised multicenter study.

In a controlled multicenter study 70 patients with chronic arterial occlusive disease stage IV according to Fontaine's classification were randomised to treatment with prostaglandin E1 (PGE1) or pentoxifylline (PX), administered over 4 weeks. Parameters of effectiveness were the reduction of analgesics, the relief of rest pain according to an analogue scale, the improvement of the ulceration according to an ulcer score and the healing of necrotic area. The results show that both forms of treatment produced a significant reduction in analgesic consumption and rest pain. Moreover in both groups a significant reduction of the ulcer score and healing of the necrotic area were observed. Side effects occurred in six patients of the PGE1-group and in ten patients of the PX-group, which required premature discontinuation of treatment in four patients of the PX-group. The study also demonstrated that PGE1 is more effective in the treatment of severe arterial occlusive disease than PX. With respect to the analgesic consumption, the reduction of ulcer score and the healing of necrotic area a significant difference was found in favour of PGE1. In accordance the six months follow-up examinations showed a marked deterioration in the PX-group opposed to the PGE1-group. The intravenous application of PGE1 over a period of 4 weeks in patients with severe arterial occlusive disease seems to be an effective therapeutical principle.

Aged↗
PubMed1989

Preliminary report of cardiac study: cross-sectional multicenter study on dietary factors of cardiovascular diseases. CARDIAC Study Group.

The International cooperative 'Cardiovascular Diseases and Alimentary Comparison Study' (CARDIAC Study) was designed to study the relationship of dietary factors to blood pressure (BP) and other major cardiovascular diseases (CVD) in widely different populations of both industrialized and developing countries. The primary aim of the research was to test specific hypotheses linking the intake of certain dietary constituents, e.g., sodium (Na), potassium (K), calcium (Ca) and protein, to BP ('Core' Study); in some centers the relationship between dietary factors and mortality from CVD was also examined ('Complete' Study). The final aim of this multicenter research was to contribute to the scientific information base required to guide the formulation of dietary goals for the primary prevention of major CVD. Forty centers in 20 countries are now participating in the CARDIAC Study. From each population 100 males and 100 females aged 50-54 years were selected randomly for BP measurement by an automated system, 24-hour urine collection by aliquot cups, blood sampling etc. according to CARDIAC protocol; and all samples were analyzed by the WHO Collaborating Center (Izumo) by standardized methods. Although studies are now in progress, surveys in China, Tanzania, USSR and Japan suggest the importance of Na and protein intakes, and all data so far obtained of systolic and diastolic BP, urinary Na and K excretions, serum cholesterol levels, etc. show wide distribution in different populations, so that dietary factors of CVD will be analyzed in more detail when the analyses of total samples are completed.

Blood Pressure↗
PubMed1992

Treatment with growth hormone-releasing hormone (GHRH) 1-44 in children with idiopathic growth hormone deficiency: a randomized double-blind dose-effect study. The GHRH European Multicenter Study (GEMS) Group.

One hundred and eleven pre-pubertal children (70 boys, 41 girls, aged 2.5 to 14.3 years) with growth failure (height 2 SD below the mean for chronological age (CA) and height velocity (HV) below the 10th percentile for bone age) due to idiopathic growth hormone deficiency (peak plasma GH < 20 mUI/1 to two standard provocative tests) were treated with GHRH 1-44 NH2. Patient stratification in two classes was performed according to body weight; in each class, patients were randomly allocated to one of seven GHRH doses, from 30 to 300 micrograms/day. GHRH was injected subcutaneously, every evening, for six months in a double-blind fashion. No relationship was found between the absolute or incremental HV during treatment and the dose (range from 1.3-23.1 micrograms/kg/day) of GHRH. However, HV (cm/year) increased from 3.8 +/- 0.1 (mean +/- SEM) before treatment to 6 +/- 0.2 during six months treatment and 47 patients (42%) increased their HV up to at least the mean normal HV for bone age (catch-up growth). Low titer antibodies to GHRH were found in 19 patients (17.1%) at six months; no adverse effect was observed. Our results suggest that patients showing catch-up growth were older, had a height closer to the mean for chronological age and a slower pre-treatment height velocity. Failure to demonstrate a relationship between GHRH dose and changes in growth velocity might be explained by the combination of a placebo effect, insufficient frequency of GHRH administration and heterogeneity of the population.

Adolescent↗
PubMed1990

Survival in cystic fibrosis: preliminary report from an Italian multicenter study.

An Italian multicenter study has been carried out in order to obtain data on survival and prognostic factors in CF. We report data from four CF Centers: Milan, Neaples, Cagliari, Rome, Anagraphic data, mode of presentation and of diagnosis were collected, using CFDB database, from 536 CF pts. 39 pts had meconium ileus (7.3%); 269 (50%) were diagnosed before 12 months of age. 27 pts were lost to follow-up (5%); and 65 pts died (12%). Statistical analysis was performed by Kaplan-Meier survival curves compared by Logrank test.

Adolescent↗