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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

Cardiovascular complications of estrogen therapy for nondisseminated prostatic carcinoma. A preliminary report from a randomized multicenter study.

In a prospective multicenter study, 244 men with highly or moderately differentiated prostatic cancer in stage I, II or III (VACURG) were consecutively randomized to three groups of treatment: Group A (77 patients) received polyestradiol phosphate (Estradurin, Leo) 80 mg i.m. every fourth week + ethinyl estradiol (Etivex, Leo) 150 micrograms daily, group B (72 patients) estramustine phosphate (Estracyt, Leo) 280 mg twice daily, and group C (76 patients) no therapy. Only men without current or previous other malignancy and without cardiovascular disease were admitted to the study. After 4 1/2 years 125 of the 244 patients had left the study, 9 because of cancer progression (stage IV, VACURG). The most serious complications were cardiovascular, including ischemic heart disease, cardiac decompensation, cerebral ischemia and venous thromboembolism, which occurred in 24 patients from group A and 9 from group B as compared to only one patient in group C. The subgroup superficial or deep venous thrombosis comprised 11 group A and 2 group B patients. Estrogens (E + e) offered as palliative treatment to patients with non-generalized prostatic carcinoma is burdened with a high incidence of serious cardiovascular complications.

Aged

Left ventricular dysfunction after acute myocardial infarction: results of a prospective multicenter study.

In a multicenter prospective study of 866 patients who survived the coronary care unit phase of an acute myocardial infarction, variables reflecting left ventricular function were examined to assess their impact on 2 year survival. Single variables that reflected left ventricular dysfunction before infarction and in the acute and recovery phases were, respectively, history of prior myocardial infarction, rales in the coronary care unit dichotomized at greater than bibasilar and predischarge radionuclide ejection fraction dichotomized at less than 0.40. When combined in a stepwise fashion, patients lacking these three risk characteristics had a 2 year 4.2% mortality rate, whereas patients possessing all three characteristics had a 45% mortality rate. Rales in the coronary care unit and predischarge ejection fraction act independently, and each contributes to mortality. Fifty-two patients with advanced rales but an ejection fraction of 0.40 or greater had a 21% mortality rate. Similarly, 208 patients with few rales but an ejection fraction of less than 0.40 had a 15% mortality rate. These data suggest that the mortality risk imposed by those factors that assess permanent left ventricular damage is independent of and additive to the mortality risk contributed by dynamic, acute phase dysfunction. These data fit the hypothesis that acute phase dysfunction is, in part, due to transient ischemia that, on reversal, can restore function toward normal. The results suggest 1) that assessment of left ventricular function during the acute and recovery phases of myocardial infarction is necessary to define prognostic characteristics of an individual patient, and 2) that of particular importance is the identification of patients whose postinfarction course is consistent with reversible ischemia.

Cardiac Output

Angiographically assessed coronary arterial patency and reocclusion in patients with acute myocardial infarction treated with anistreplase: results of the anistreplase reocclusion multicenter study (ARMS).

In this open multicenter study, 156 patients with acute myocardial infarction received 30 U of anistreplase intravenously over 5 minutes within 4 hours of the onset of chest pain. The patency of the infarct-related vessel was determined by coronary angiography 90 minutes after anistreplase treatment, and also 24 hours after treatment, in patients with a patent infarct-related vessel at 90 minutes, to assess the reocclusion rate. The investigators categorized the infarct-related vessel as patent or occluded, and 2 independent cardiologists graded the infarct-related vessel according to the Thrombolysis in Myocardial Infarction (TIMI) perfusion criteria. At the 90-minute assessment, 106 of 145 evaluable patients (73%) had patent infarct-related vessels, and 39 of 145 (27%) had occluded infarct-related vessels. Of the 139 independently assessed patients, 98 (71%) had TIMI grades 2 or 3 and 41 (29%) had TIMI grades 0 or 1. At the 24-hour assessment, 98 of 102 patients (96%) had a patent infarct-related vessel, and reocclusion had occurred in 4 of 102 patients (4%). Of the 94 independently assessed patients 90 (96%) had TIMI grades 2 or 3, and 4 (4%) had TIMI grades 0 or 1. The reliability of noninvasive parameters as indicators of achieved patency of the infarct-related vessel was estimated by means of correlation with patency assessed by coronary angiography. A significant correlation of 0.62 was found. The patency rate of 71 to 73% after use of anistreplase in patients with acute myocardial infarction corresponds with findings in earlier studies. The low reocclusion rate of 4% after use of anistreplase probably reflects the prolonged action of anistreplase.

Adult

[An epidemiogenetic study of typical retinitis pigmentosa in Japan--a preliminary report of nationwide, multicenter study].

We performed a nationwide, multicenter study of typical retinitis pigmentosa with reference to the inheritance patterns of the disease. A total of 253 probands were registered during two months of 1989, and an analysis of the parental consanguinity of 182 probands with the method of inbreeding coefficient enabled us to estimate the relative prevalence of genetic types; autosomal recessive trait: 47.6%; autosomal dominant trait: 17.3%; sporadic cases: 34.6%. A comparison of the results with previous studies has indicated a decrease in the prevalence of the autosomal recessive trait and an increase in the sporadic cases, as would be expected from the decrease in consanguineous marriages and offsprings in the past few decades in Japan. X-linked retinitis pigmentosa was rarely identified, but precise evaluation of its frequency needs further investigation.

Adolescent

Angiographic assessment of patency and reocclusion: preliminary results of the Dutch APSAC Reocclusion Multicenter Study (ARMS).

The main objective of the ARMS (APSAC Reocclusion Multicenter Study) trial was to obtain patency and reocclusion data. In an open multicenter study, a total of 156 patients were treated with 30 U of anistreplase or anisoylated plasminogen streptokinase activator complex (APSAC) within 4 h after onset of pain. Patency of the infarct-related vessel was assessed by coronary angiography performed 90 minutes after anistreplase administration. In those patients with a patent infarct-related vessel at 90 min, repeat coronary angiography was performed at 24 h to assess the reocclusion rate. Two independent cardiologists evaluated the angiograms and scored the coronary artery perfusion of the infarct-related vessel. The preliminary data of the first 148 patients indicate that the patency rate at 90 min was 73-75% and the reocclusion rate at 24 h was 4%. This patency rate corresponds with previous studies. The low reocclusion rate is noteworthy and probably reflects the prolonged action of anistreplase.

Acute Disease

Distributed data analysis in a multicenter study: the CARDIA Study.

Unlike distributed data entry, which is used in many large epidemiologic studies and multicenter clinical trials, distributed data analysis is a relatively new concept. This paper reports on the usefulness of such a system in the Coronary Artery Risk Development in Young Adults (CARDIA) Study. CARDIA distributes the entire examination dataset to participating centers soon after completion of each round of data collection. The process was designed to encourage more numerous, diverse, and rapid publications, and to allow for more efficient use of the manpower and expertise in centers. Responsibilities of the coordinating center have changed from a conventional coordinating center but remain substantial due to the need for collating, monitoring, verifying, and documenting the distributed data analysis (DDA) system. DDA is successful from the standpoint of implementation and operation--21 manuscripts representing work analyzed at six participating centers had been submitted for publication within 3.5 years of the completion of the baseline examination.

Adolescent

Quality control in antimicrobial disk susceptibility testing: a Belgian multicenter study.

A Belgian multicenter trial was conducted to evaluate problems encountered with quality control results of antimicrobial disk susceptibility testing and to compare the performance of BBL disks and Rosco tablets. Over a period of four weeks 18 laboratories daily tested three reference strains against eight antibiotics. A standardised method was used by all participants. For all results together 10.4% and 7.3% of the measurements with BBL disks and Rosco tablets, respectively, were outside the recommended range. Major problems were observed for some specific strain-antibiotic combinations. Standard deviations were similar for both systems; their precision was comparable. The results suggest that cooperation between manufacturers and some reference laboratories could be improved in order to establish optimal quality control limits.

Anti-Bacterial Agents

Conference on insulin pump therapy in diabetes. Multicenter study of effect on microvascular disease. The Central Biochemistry Laboratory in the Multicenter Kroc Study. Problems and proposals.

The advantages of a multicenter trial can easily be lost if results from individual centers cannot be safely combined for statistical analysis. One objective of the Kroc Study was to develop methods that would allow valid amalgamation of results from laboratories at the six clinical centers and a central biochemical laboratory at the University of Newcastle upon Tyne. Responsibilities of the local laboratories, in addition to measurement of plasma glucose, creatinine, and glycosylated hemoglobin, were to obtain and prepare samples for measurement of plasma glucose, glycosylated hemoglobin, and serum lipids at the central laboratory, of C-peptide at the University of Chicago, and to collect and prepare samples for measurement of urinary albumin excretion at Guy's Hospital. The central laboratory was additionally to provide a system to ensure the comparability of plasma glucose determinations between and within centers, and to advise on common procedures for sample handling. Major problems were encountered with sample labeling, dispatch, and transport to the central laboratory. Although central determinations of plasma glucose and serum lipids were still possible in transported specimens, central assay of glycosylated hemoglobin proved inaccurate and useless. Compliance with the plasma glucose quality control program was variable among centers. Although the difference between the centers recording the highest and lowest values was 24.6% of the mean estimate of plasma glucose level, correlation between local and central plasma glucose determinations was good (r = 0.99, see pages 22-26).(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Glucose

[The recurrence of duodenal ulcer in patients undergoing treatment with ranitidine and placebo. A multicenter study].

This randomised, double-blind multicenter study was conducted in order to evaluate the long-term effect (one year) of 150 mg ranitidine vs placebo in 51 patients with healed duodenal ulcer. Seventeen patients had ulcer recurrence at the end of follow-up, one among the 24 patients that received ranitidine and 16 among the 27 patients that received placebo (p = 0.00009). No side effects was detected. Our results support the usefulness of a one-year maintenance therapy with 150 mg ranitidine.

Adult

Endoscopic release of the carpal tunnel: a randomized prospective multicenter study.

A 10-center randomized prospective multicenter study of endoscopic release of the carpal tunnel was carried out. Surgery was performed with a new device for transecting the transverse carpal ligament while control hands were treated with conventional open surgery. There were 122 patients in the study; 25 had carpal tunnel surgery on both hands and 97 had surgery on one hand. Of the surgical procedures, 65 were in the control group and 82 were in the device group. The endoscopic device was coupled to a fiberoptic light and a video camera. A trigger-activated blade was used to incise the transverse carpal ligament. After surgery, the best predictors of return to work and to activities of daily living were strength and tenderness variables. For patients in the device group with one affected hand, the median time for return to work was 21 1/2 days less than that for the control group. Two patients treated with the endoscopic device required reoperation by open surgical decompression; only one of these had incomplete release with the device. Two patients in the device group experienced transient ulnar neurapraxia.

Activities of Daily Living

[Clinical and prognostic significance of echocardiographic parameters in dilated cardiomyopathy: a prospective study on 225 patients. The Italian Multicenter Study of Cardiomyopathies Group].

To assess the prognostic role of echocardiographic indexes and their relation to clinical conditions, 225 patients with dilated cardiomyopathy were studied prospectively. All cases had a normal coronary angiogram and non specific endomyocardial biopsy findings. 163 men (72.4%) and 62 women (27.6%), mean age 41.5 +/- 12.3 (range 8-61), were studied. Clinical, electrocardiographic and echocardiographic parameters, normalized for body surface area, were tested according to NYHA class and presence of segmental or diffuse wall motion abnormalities. One hundred-four patients were in NYHA class I-IIa, 94 were in class IIb-III and 27 were in class IV. Left ventricular end systolic diameter index, right ventricular end diastolic diameter index, left atrial diameter index, left ventricular fractional shortening and ejection fraction, and radius to wall thickness ratio were significantly more impaired in patients with more severe symptoms. Twenty-eight patients (13%) showed segmental wall motion abnormalities and had smaller left ventricular end systolic and left atrial diameter index and higher left ventricular fractional shortening and ejection fraction. During a mean follow up of 23 +/- 15 months (range 1-67 months), 25 patients (11.1%) died from cardiac causes and 16 (7.1%) underwent heart transplant because of refractory heart failure. Prognostic evaluation was performed separately for cardiovascular mortality alone and for cardiac events (cardiovascular mortality and heart transplantation). At Cox multivariate analysis only right ventricular end diastolic diameter index (p < 0.005) predicted cardiovascular mortality, while left atrial diameter index (p < 0.001), right ventricular end diastolic diameter index (p < 0.01) and left ventricular ejection fraction (p < 0.05) were significant independent predictors of cardiac events.

Adolescent

Comparison of different schedules of cytostatic intravesical instillations in patients with superficial bladder carcinoma: final evaluation of a prospective multicenter study with 419 patients.

In a prospective multicenter study we compared the value of various protocols of mitomycin C and doxorubicin instillation for the prevention of recurrent tumors in patients whose superficial bladder tumors (stages TA and T1) had been removed by transurethral resection. The 3-year and short-term instillation protocols were compared to each other and to a combination of 2 protocols. Evaluation after a mean followup of 28 months confirmed the value of cytostatic bladder instillation in preventing recurrence and progression of tumor in patients with superficial bladder carcinoma. There was no significant difference between the results of long-term and short-term prophylaxis; their combination achieved the best results. Doxorubicin and mitomycin yielded similar results; mitomycin was better tolerated.

Administration, Intravesical

Arthroscopic drainage in septic arthritides of the knee: a multicenter study.

The results are presented of a multicenter study, conducted by questionnaire, of 46 cases of septic arthritis of the knee treated by arthroscopic drainage. This series consisted of 28 male and 16 female patients. Two patients had bilateral arthritides. The average follow-up period was 7.1 months. There were 11 cases of hematogenous arthritides, 15 arthritides secondary to puncture and infiltration, and 20 postoperative arthritides. There were 29 positive cultures (63%). After thorough articular lavage (average, 7 L) and prolonged antibiotic therapy (average 2 months) there were 36 bacteriological cures (78.3%), five failures (10.9%) due to persistent articular sepsis, and five recurrences of the infection (10.9%) after an initial remission. Five infectious flare-ups recovered secondarily, four recovered after repeated arthroscopy and one recovered after synovial centesis. The rate of cure after this second therapeutic attempt was 89.2%. Different parameters were used in evaluating the quality of the results: the etiology of the arthritis, the causal germ, and the delay prior to arthroscopy. Arthroscopic drainage is a method that has proved effective, with minimal morbidity, in attempts to cure septic arthritis of the knee, particularly in cases of hematogenous arthritis. This method could also be effective in total arthroplasties of septic knees.

Adolescent

Treatment of angina pectoris with isosorbide-5-mononitrate. A multicenter study in general practice.

In this multicenter study 191 practitioners treated 532 patients with coronary artery disease and chronic stable angina pectoris by isosorbide-5-mononitrate (IS-5-MN), 20 mg 2-3 times daily. At the end of this period the frequency of anginal attacks was reduced by 83% and nitroglycerin consumption by 85.7% (p less than 0.0001). 40.1% of the patients categorized this treatment as very good, 28.6% as excellent and 23% as good. Serious adverse effects were observed in 2% of the patients and 6.4% of the patients discontinued treatment during the study because of inefficacy, infarction, death, or adverse effects. At the end of the study 90.2% of the patients were still on IS-5-MN. In conclusion, IS-5-MN is an effective treatment for patients with chronic stable angina pectoris. It is well tolerated, with minimal side effects.

Aged

[Results of the West German multicenter study "Urological traumatology"].

The West German Multicenter Study on Urological Traumatology ran from April 1984 to December 1986. During this time, 19 departments of urology evenly scattered over the Federal Republic of Germany including Berlin (West) recorded and evaluated the data pertaining to a total of 385 patients (83% male, 17% female) with urogenital trauma. The distribution of the different mechanisms of injury demonstrates that 41% were due to traffic accidents; 13% each to accidents during sports and work; 8% to sexual activities; and 6% to violence. The trauma was slight in 40% of the cases, moderate in 21%, and severe in 39%. Of a total of 427 urogenital injuries, 27% were combined with intra-abdominal and 24% with pelvic injuries. Renal injuries were recorded in 51%, ruptures accounting for 49% of these and contusions for 48%. Hilar lesions were observed in 7%, with complete destruction of the organ occurred in 6% of these cases. In all, 76% of these traumas were treated conservatively, while 8% each required surgical reconstruction and nephrectomy. Traumatic lesions of the urinary bladder, urethra, penis, and scrotum including the testes and accessory organs were recorded in about 10% each. Macrohematuria was seen with 73% of renal, 83% of urinary bladder, and 73% or urethral injuries. Microhematuria occurred with 24%, 9%, and 13% of all cases, while no hematuria was ascertained in 3%, 5%, and 13% of renal, bladder and urethral traumas, respectively. The injury-related sensitivity of the different imaging methods was calculated at 95% for cystograms, 91% for retrograde urethrograms, and 83% for angiograms.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent