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Tolerance of iopromide in angiography: a multicenter study.

This prospective multicenter study analyzes the image quality and incidence of undesirable side effects in 2543 film and 1133 intravenous digital subtraction angiographic (DSA) examinations with iopromide. It can be shown that the frequency of undesired side effects in both methods is twice as high in patients at risk as in patients without special risk factors. The most frequent side effects are gastrointestinal and, in cerebral angiography, of a central nervous system nature. The image quality for 99% of the film angiographies was good or better. It could be demonstrated for the DSA that a higher iodine concentration of 370 mg I/ml tends to result in a reduction of the image quality with an increased rate of side effects.

Adolescent

Long-term suppression with oral acyclovir of recurrent herpes simplex virus infections in otherwise healthy patients. A European multicenter study.

In a multicenter study, the efficacy of oral acyclovir 800 mg daily in preventing the development of recurrent herpes simplex virus lesions in 379 patients was assessed. Medication given in two or four divided doses daily for one year was highly effective and well tolerated. A high therapeutic index of acyclovir was maintained throughout the period of study.

Acyclovir

Optimal felodipine dose when combined with metoprolol in arterial hypertension: a Swedish multicenter study within primary health care. Swedish General Practitioner Felodipine Study Group.

In a multicenter study comprising 23 Swedish primary health care centers, felodipine extended-release (ER) tablets in doses of 5, 10, and 20 mg were compared double-blind with placebo when given in addition to metoprolol controlled-release (CR) tablets 100 mg. All medication was given once daily in the morning. Altogether, 251 hypertensive patients with a diastolic blood pressure greater than 95 mm Hg after 4 weeks of treatment with placebo in combination with metoprolol CR 100 mg were randomized to four parallel groups. After 4 weeks of treatment, there were significantly greater reductions in blood pressure with all doses of felodipine ER than with placebo, both 2 and 24 h after intake of the tablets. Twelve patients were withdrawn because of adverse reactions. Of these, one patient was taking placebo, one 5 mg of felodipine ER, four 10 mg of felodipine ER, and six patients 20 mg of felodipine ER. When combined with metoprolol, 5 mg of felodipine ER seemed to be less effective than higher doses, but was very well tolerated. Adding 10 mg of felodipine ER to the basal metoprolol appeared to be optimal if both the effect and adverse reactions were taken into consideration.

Adult

Transcutaneous PCO2 and PO2: a multicenter study of accuracy.

A multicenter study used 756 samples from 251 patients in 12 institutions to compare arterial (PaO2, PaCO2) with transcutaneous (PsO2, PsCO2) oxygen and carbon dioxide tensions, measured usually at 44 degrees C. Of these samples, 336 were obtained from 116 neonates, 27 from 25 children with cystic fibrosis, and 140 from 40 patients under general anesthesia. Ninety-one patients were between 4 weeks and 18 years of age, 32 were between 18 and 60 years, and 12 were over 60. The ratio of transcutaneous to arterial P(s/a)CO2 was 1.01 +/- 0.11 with PaCO2 less than 30 mm Hg, increasing to 1.04 +/- 0.08 at PaCO2 greater than 40 mm Hg. Mean bias and its standard deviation (PsCO2 - PaCO2) were + 1.3 +/- 3.9 mm Hg in the entire group, + 1.8 +/- 4.2 mm Hg in neonates (NS). Bias was + 0.2 +/- 2.7 mm Hg when PaCO2 was less than 30 mm Hg (N = 175, NS), 1.0 +/- 3.4 with 30 less than PaCO2 less than 40 (n = 329, p less than 0.001), and + 2.04 +/- 4.00 mm Hg with 40 less than PaCO2 less than 70 (n = 229, p less than 0.001). These data suggest that, using transcutaneous PCO2 monitors with inbuilt temperature correction of 4.5%/degrees C, the skin metabolic offset should be set to 6 mm Hg. The linear regression was PsCO2 = 1.052(PaCO2) - 0.56, Sy.x = 3.92, R = 0.929 (n = 756); and PsCO2 = 1.09(PaCO2) - 1.57, Sy.x = 4.17, R = 0.928 in neonates (n = 336).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent

Cefprozil versus cefaclor in the treatment of mild to moderate skin and skin-structure infections. The Cefprozil Multicenter Study Group.

In a multicenter study, 598 patients with skin or skin-structure infections were randomly assigned to receive 500 mg of cefprozil once daily (or 20 mg/kg once daily) or 250 mg of cefaclor three times daily (or 20 mg/kg daily in three equal doses) for 5 to 10 days. Treatment was evaluated in 212 cefprozil-treated patients and in 210 cefaclor-treated patients. The patients were aged 2 to 99 years (mean, 28 years) and their primary diagnoses were impetigo (in 99 patients), pyoderma (in 98), superficial abscess (in 70), and cellulitis (in 64). A satisfactory clinical response was found in 93% of the cefprozil-treated patients and in 92% of the cefaclor-treated patients, the pathogens were eradicated in 91% and 89%, and overall treatment was rated effective in 87% of both groups. Adverse clinical events were reported by 5% of the patients in both groups; one cefprozil-treated patient and three cefaclor-treated patients withdrew from treatment because of adverse events. It is concluded that cefprozil administered once daily is as effective and safe as cefaclor administered three times daily in the treatment of mild to moderate skin and skin-structure infections.

Abscess

[Lisuride for the prevention of migraine. Results of a multicenter study].

In an open multicenter study involving 420 patients lisuride proved to be an effective and well-tolerated migraine prophylactic. In 61.4% of the patients the frequency of migraine attacks was reduced by more than 50% during the 3 month treatment period; the severity and duration of remaining attacks were markedly reduced. In the overall assessment, the effect was regarded as good to excellent in 69.7% of the patients and tolerance was good to excellent in 94.2%. The most common side effects were nausea (4.0%), vertigo (3.1%), drowsiness (1.4%). Prognostic criteria for the response to lisuride could not be identified.

Adult

[Perforated sigmoiditis. Experiences with 805 cases. A multicenter study].

This was a multicenter study corresponding to 40 services. For each patient, a card containing 90 questions was filled out. At the same time we sent a personal survey card with 11 criteria questions. Our cases corresponded to 805 patients, 457 males and 348 females. The highest frequency was between 50-80 years. The therapeutic methods most often used were: drainage plus Hartmann, 37.1%; drainage plus colostomy, 24.9%; resection and anastomosis without colostomy, 12.45%, and with colostomy, 5.11%; drainage plus exteriorization, 5.98%, and conservative, 4.6%. We studied the morbimortality correlation according to different anatomoclinical groups and techniques used. The results were nonsignificant for mortality and statistically significant for evisceration, eventration, diffuse peritonitis, upper gastrointestinal bleeding, anastomotic dehiscence and type of anastomosis, manual or instrumental.

Adult

[Tolerance and effectiveness of transdermal nitroglycerin in angina pectoris. A multicenter study. Adesitrin Italian Study Group].

A multicenter open study was carried out in order to evaluate the tolerability and antianginal efficacy of the nitroglycerin "multilayer transdermal system". Forty eight cardiologic centers enrolled 506 outpatients (123 females and 383 males), mean age: 61 +/- 8 (SD) years, with effort angina (43%), angina at rest (17%) and mixed angina (40%), not well controlled by their previous antianginal therapy (greater than or equal to 2 anginal attacks a weeks). The duration of the treatment with 5 or 10 mg/die was 10 weeks with a control every 2 weeks. At the end of the study, the weekly frequency of anginal attacks was reduced by 88%, and 60% of the patients were free from anginal attacks. In 117 patients, studied by ergometer test, the exercise time increased by 31% (p less than 0.001) and the ST depression decreased by 63% (p less than 0.001). The treatment was interrupted in 9.1% of the patients: in 4.55% for unwanted effects (headache and/or local intolerance) and in 4.55% for other reasons. The same unwanted effects, but of mild or moderate severity, were observed in 18.4% of the patients, most of them during the first 2 weeks of the treatment. In conclusion, the "multilayer system" for delivering transdermal nitroglycerin showed a good clinical and ergometer efficacy and was well tolerated and accepted by the anginal patients in study.

Administration, Cutaneous

[Iohexol in studies of the spinal canal. Multicenter study].

The author presents the results of a multicentric study of Iohexol in investigation of the spinal canal undertaken at the request of Winthrop Laboratories in 32 Radiological departments. The study involved 329 adults of both sexes. It confirmed the excellent quality of results obtained with this preparation in the literature and its excellent tolerance. On the basis of these results Iohexol may be considered to be definitely one of the best currently available preparations for investigation of the spinal canal.

Female

Use of external shock-wave lithotripsy and adjuvant ursodiol for treatment of radiolucent gallstones. A national multicenter study.

A prospective multicenter trial was performed to evaluate the use of external shockwave lithotripsy (ESL) and adjuvant medical therapy for the treatment of gallstones. A Medstone STS lithotripter was used together with ursodiol. Two hundred twenty-three patients were treated under general anesthesia (75%) or with intravenous analgesia (25%). Initial treatments were on an inpatient basis, but as centers gained experience, outpatient treatments became more common. Stone fragmentation and clearance were greatest in patients with solitary gallstones less than 2 cm in diameter. In this group of patients, stone fragmentation occurred in 97% of patients, and the cumulative stone-free rates at three and six months were 54% and 90%, respectively. These results indicate that fragmentation of gallstones can be achieved by a dry shock-wave lithotripter and that stone clearance is induced more rapidly by external shock-wave lithotripsy and adjuvant ursodiol therapy than by ursodiol therapy alone.

Adult

[Whole-body MRT studies--the results of the "Multicenter study on the evaluation of magnetic resonance tomography"].

In a nation-wide multicentre study, the use of MRI was examined in its clinical context and in relation to other imaging methods and as a routine examination. It was found that examinations of the brain and spine were predominant. MRI is accurate for certain problems affecting the extremities, the pelvis and the liver. The findings also show that there are still technical limitations. A high degree of accuracy can only be obtained if there is adequate information concerning individual problems. Technical limitations include the frequent appearance of artifacts. In its present state, MRI can only supply additional information, concerning the trunk only, in certain situations. The study also outlines the development of MRI and the role of other conventional diagnostic procedures.

Evaluation Studies as Topic

Sultamicillin versus amoxicillin in the treatment of tonsillitis and pharyngitis: a European multicenter study.

In this multicenter open, comparative study, 135 patients were treated with sultamicillin (67 subjects; 500 mg every 12 h) or amoxicillin (68 subjects; 500 mg every 8 h) for 10 d. Of the pathogens isolated pre-treatment, 24 of 29 (including 4 of 6 resistant strains) in the sultamicillin group were eradicated at the end of treatment, as were 17 of 22 in the amoxicillin group. At follow-up, the figures were 17 of 25 and 16 of 19, respectively. Clinical success was achieved in 55 of 55 sultamicillin and 40 of 43 amoxicillin patients at the end of treatment, and in 40 of 42 and 29 of 31, respectively, at follow-up. Overall success was recorded in 20 of 25 and 15 of 23 sultamicillin, and 14 of 19 and 13 of 17 amoxicillin patients at the two assessments. Side effects were reported for 21 sultamicillin patients, 1 of whom withdrew because of diarrhea, and 15 amoxicillin patients, 4 of whom withdrew because of rash. One sultamicillin and 4 amoxicillin patients developed minor abnormalities in laboratory safety parameters.

Adolescent

Clinical experience with ciprofloxacin: analysis of a multicenter study.

The authors report a multicenter study of 19 patients treated with ciprofloxacin (mean daily dosage, 972 mg per day; mean duration of treatment, 8.5 days) for a variety of infections, ten microbiologically proven. Of these, bacteriologic cure equaled 70%, and improvement 30%. Overall, clinical cure equaled 73.7%, while improvement was 15.8%. No infections were classified as chronic. One adverse reaction was noted; a case of severe vomiting classified as related definitely to ciprofloxacin therapy. The patient discontinued therapy.

Adolescent

Efficacy of nifedipine gastrointestinal therapeutic system in combination with beta blockers in the management of exertional angina. A multicenter study of 54 patients.

This multicenter study assessed the efficacy of a new formulation of nifedipine in 54 patients with stable angina pectoris receiving beta-blocker therapy. This once-daily preparation of nifedipine was administered in double-blind fashion in doses of 30, 60, and 90 mg. All patients experienced pain-limited exercise at placebo baseline treadmill testing. Eight hours post-dose exercise testing resulted in a significant increase in time to onset of angina for all three dose levels of nifedipine but not for placebo. Exercise testing 24 hours after dosing showed significant improvement in time to angina and total exercise time for patients receiving 60-mg and 90-mg doses but not for the 30-mg or placebo categories. These preliminary results suggest that this new formulation of nifedipine is beneficial when added to stable doses of a beta blocker in patients in whom angina is still exhibited during exercise testing.

Adrenergic beta-Antagonists

The prognosis of transient global amnesia. Results of a multicenter study.

In a Danish multicenter study, 74 patients 20 to 75 years of age (mean age, 58.8 years) with transient global amnesia (TGA) without accompanying major neurological signs were studied. Over a follow-up period ranging from seven to 210 months (mean, 66.6 months) the observed rates of death and cerebrovascular morbidity were similar to those expected in the Danish population, matched for age and sex. Sixteen patients (22%) had further TGAs occurring one month to nine years after the original episode; the mean annual recurrence rate was 4.7%. We concluded that TGA without associated major neurological deficits is a benign clinical phenomenon, probably caused by a functional cerebral disturbance unrelated to cerebrovascular disease in general. Furthermore, the observed temporal pattern of recurrence suggests that, although TGA is in principle a recurrent disorder, the annual risk of recurrence is so low that most of the elderly patients are likely to experience only one attack.

Adult

Intravenous immunoglobulin (i.v. IgG) for previously treated acute or for chronic idiopathic thrombocytopenic purpura (ITP) in childhood: a prospective multicenter study.

In a prospective multicenter study 42 thrombocytopenic (less than 30 X 10(9) platelets/l) children with chronic idiopathic thrombocytopenic purpura (ITP) or with acute ITP, dependent on or refractory to corticosteroids, were given 0.4 g i.v. IgG/kg body weight/day on 5 consecutive days and thereafter once a week if the platelet count fell to less than 20 X 10(9)/l or if the patient bled. After the initial 5 days of i.v. IgG the platelets rose within a mean of 7-8 days to greater than 30 X 10(9)/l in all and to greater than 150 X 10(9)/l in 33 of 42 patients (79%). After a mean observation time of 26.6 months 26 of 42 patients (62%) showed a satisfactory long-term effect, i.e. no need for treatment for at least 6 months without bleeding and with no platelet counts below 20 X 10(9)/l. No difference in response rate was found between children with chronic and those with previously treated acute ITP. These results indicate that i.v. IgG could be used to control emergency situations, e.g. to stop bleeding or to prepare a patient for surgery. I.v. IgG also represents a good alternative to treatment modalities, such as splenectomy and/or the administration of cytostatic immunosuppressants with potentially serious side effects. In addition to the expected transient rise in serum IgG levels, i.v. IgG induced a more prolonged elevation of serum IgM. Platelet associated IgG, elevated before therapy, was correlated with the clinical long-term outcome.

Acute Disease