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Peritonitis occurrence in a multicenter study of icodextrin and glucose in CAPD. MIDAS Study Group. Multicenter Investigation of Icodextrin in Ambulatory Dialysis.

OBJECTIVE: To compare peritonitis occurrence and outcome in a large U.K. study Multicentre Investigation of Icodextrin in Ambulatory Dialysis (MIDAS). DESIGN: Prospective, randomized, controlled 6-month comparison of icodextrin with glucose for the long dwell in continuous ambulatory peritoneal dialysis (CAPD) patients. SETTING: Eleven CAPD units in U.K. teaching hospital. PATIENTS: A total of 209 patients established on CAPD for at least 3 months (103 control, 106 icodextrin). Twenty-three control (C) and 22 icodextrin (I) patients experienced peritonitis during the study. INTERVENTION: Patients who had peritonitis remained on treatment (unless CAPD was withdrawn, temporarily or permanently). MAIN OUTCOME MEASURES: The main outcome measures were the rate of peritonitis and duration of CAPD treatment prestudy; the rate of peritonitis episodes and their outcome during study; the effect of peritonitis on laboratory variables, serum icodextrin metabolites, and ultrafiltration efficacy. RESULTS: Prestudy: Nine (39%) of C but 14 (64%) of I patients had suffered previous peritonitis episode(s), with overall rates of 0.58 and 0.78 episodes per patient-year, respectively. DURING STUDY: There were 31 C episodes and 35 I episodes, with overall rates of 0.76 and 0.93 per patient-year, respectively. The increase in the C and I groups was 31% and 19%, respectively. Serum osmolality and sodium levels were unaffected by peritonitis, and there was no increase in serum icodextrin metabolites during peritonitis. Overnight ultrafiltration volume during peritonitis (mean +/- SD) declined slightly from 218 +/- 354 mL to 185 +/- 299 mL (NS) in the control group, but increased in the icodextrin group from 570 +/- 146 mL to 723 +/- 218 mL (p < 0.01). CONCLUSIONS: Using icodextrin for the long dwell in CAPD does not increase the rate of peritonitis, nor does it alter the outcome of peritonitis. Peritonitis does not affect uptake of icodextrin from the peritoneum.

Chlorides↗

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↗

The Erasme study: a multicenter study on the safety and technical results of the Palmaz stent used for the treatment of atherosclerotic ostial renal artery stenosis.

PURPOSE: To assess, in a multicenter setting, safety, technical results, and restenosis rate of the Palmaz stent for treatment of atherosclerotic ostial renal artery stenosis. METHODS: Ten centers enrolled 106 patients (120 treated renal artery stenoses) in the study. Patient selection was based on unsuccessful percutaneous transluminal renal angioplasty (residual stenosis >/= 20%) performed for treatment of ostial stenosis >/= 50%, in patients with hypertension and/or impaired renal function. Safety was assessed by means of the complication rate, and technical results by the number of successful stent placements and occurrence of restenosis (>50%) at intraarterial angiographic follow-up. RESULTS: Stent placement was successful (n = 112) or partially successful (n = 5) in 117 (98%) arteries. Complications occurred in 19 procedures; seven were of serious clinical significance. Angiographic follow-up was performed in 89 of 117 (76%) cases, at a mean of 8 months (range 2. 5-18 months). Fifteen stents (16.9%) showed restenosis (at a mean of 8.5 months), of which 10 were successfully redilated. CONCLUSION: Renal artery stenting has a high technical success rate, a complication rate comparable to percutaneous transluminal renal angioplasty, and a low rate of restenosis at 8 months angiographic follow-up.

Aged↗

Relapse-preventing effect and safety of sulfasalazine and olsalazine in patients with ulcerative colitis in remission: a prospective, double-blind, randomized multicenter study. The Ulcerative Colitis Multicenter Study Group.

Forty-nine patients with ulcerative colitis in remission were entered into a prospective, double-blind, multicenter trial comparing the relapse-preventing effect and safety of 4 g sulfasalazine and 2 g olsalazine daily during 48 wk. Of the 46 evaluable patients, 23 were assigned to sulfasalazine and 23 to olsalazine. Seven of 23 patients (30.4%) relapsed on sulfasalazine and six of 23 patients (26.1%) on olsalazine (95% confidence interval of the difference -22.0% to 30.3%). The relapse-free survival curves did not differ significantly at any time during the trial period. In both treatment groups, three patients dropped out because of adverse effects. Four patients on sulfasalazine and six patients on olsalazine experienced minor adverse effects. One patient on sulfasalazine had mild leukopenia, and four patients on sulfasalazine and one patient on olsalazine had decreased levels of haptoglobin. Thus, sulfasalazine and olsalazine are equally effective in maintaining remission of ulcerative colitis and are accompanied by a similar incidence of adverse effects.

Adolescent↗

Atrial fibrillation following coronary artery bypass graft surgery: predictors, outcomes, and resource utilization. MultiCenter Study of Perioperative Ischemia Research Group.

OBJECTIVE: To determine the incidence, predictors, and cost of atrial fibrillation and flutter (AFIB) following coronary artery bypass graft (CABG) surgery. DESIGN: Prospective observational study (MultiCenter Study of Perioperative Ischemia). SETTING: Twenty-four university-affiliated hospitals in the United States from 1991 to 1993. SUBJECTS: A total of 2417 patients undergoing CABG with or without concurrent valvular surgery selected using a systematic sampling interval. MEASUREMENTS: Detailed preoperative, intraoperative, and postoperative data collected on standardized reporting forms. RESULTS: The overall incidence of postoperative AFIB was 27 percent. Independent predictors of postoperative AFIB included advanced age (odds ratio [OR], 1.24 per 5-year increase; 95 percent confidence interval [CI], 1.18-1.31); male sex (OR, 1.41; 95 percent CI, 1.09-1.81); a history of AFIB (OR, 2.28; 95 percent CI, 1.74-3.00); a history of congestive heart failure (OR, 1.31; 95 percent CI, 1.04-1.64); and a precardiopulmonary bypass heart rate of more than 100 beats per minute (OR, 1.59; 95 percent CI, 1.00-2.55). Surgical practices such as pulmonary vein venting (OR, 1.44; 95 percent CI, 1.13-1.83); bicaval venous cannulation (OR, 1.40; 95 percent CI, 1.04-1.89); postoperative atrial pacing (OR, 1.27; 95 percent CI, 1.00-1.62); and longer cross-clamp times (OR, 1.06 per 15 minutes; 95 percent CI, 1.00-1.11) also were identified as independent predictors of postoperative AFIB. Patients with postoperative AFIB remained an average of 13 hours longer in the intensive care unit and 2.0 days longer in the ward when compared with patients without AFIB. CONCLUSION: Postoperative AFIB is common after CABG surgery and has a significant effect on both intensive care unit and overall hospital length of stay. In addition to expected demographic factors, certain surgical practices increase the risk of postoperative AFIB. Randomized controlled trials are necessary to determine if modification of these surgical practices, especially in patients at high risk, would decrease the incidence of postoperative AFIB.

Age Factors↗

Efficacy and safety of enalapril versus extended-release nifedipine for the treatment of mild-to-moderate essential hypertension: a multicenter 22-week study. Multicenter Cooperative Study Group.

The antihypertensive effects and tolerability of single daily doses of enalapril and extended-release nifedipine (nifedipine-ER) were compared in an open-label, randomized, parallel-group, 22-week treatment study involving 230 men and women (mean age, 55 years). Following a 3-week washout period, mean +/- SD blood pressure levels were 153 +/- 17/99 +/- 4 mmHg in the enalapril group (n = 117) and 157 +/- 17/100 +/- 5 mmHg in the nifedipine-ER group (n = 113). Beginning at 5 mg once daily for enalapril and 30 mg once daily for nifedipine-ER, the dosage was titrated every 4 weeks for 16 weeks, up to a maximum of 40 mg for enalapril and 120 mg for nifedipine-ER. The treatment goal (satisfactory response) was to lower trough sitting diastolic blood pressure to < 90 mmHg or by at least 10 mmHg to a level of < 100 mmHg. At a mean daily dose of 16 mg of enalapril and 57 mg of nifedipine-ER, more than three quarters of each treatment group achieved a satisfactory response. The mean reductions in trough sitting blood pressure levels at the end of 22 weeks of treatment were 15/11 mmHg for enalapril and 21/13 mmHg for nifedipine-ER. The difference between treatments was significant only for the change in systolic blood pressure (P < 0.05). However, enalapril was better tolerated than nifedipine-ER. The numbers of patients with adverse experiences and withdrawals from the study because of an adverse experience were significantly lower for enalapril than for nifedipine-ER (P < 0.05). The incidence of abnormal laboratory findings was small and considered of no clinical importance in either group. These data suggest that enalapril and nifedipine-ER had approximately equal efficacy as once-daily antihypertensive treatments, but enalapril was better tolerated.

Delayed-Action Preparations↗

Adverse reactions of low osmolality contrast media during cardiac angiography: a prospective randomized multicenter study.

A multicenter study was performed to determine the incidence of adverse reactions to two contrast media with similar low osmolality during cardiac angiography. The study was of a randomized double-blind design comparing ioxaglate (an ionic dimer) and iopamidol (a nonionic compound) and included 500 patients; 250 patients received ioxaglate and 250 iopamidol. There were 58 adverse reactions attributed to the contrast media in the ioxaglate group and 29 in the iopamidol group (p less than 0.001). Chest pain occurred in 11 patients in the ioxaglate group compared with 5 in the iopamidol group (p = 0.123). Nausea or vomiting was present in 20 and 2 patients, respectively (p less than 0.0003). Allergic adverse reactions, such as bronchospasm, urticaria and itching, occurred in 15 of the ioxaglate group and only 1 of the patients receiving iopamidol (p less than 0.0007). Fifty-two patients in the ioxaglate group had a known allergic history (not to contrast medium) or asthma, whereas 77 receiving iopamidol had a similar history. Seven of the 52 ioxaglate-treated patients developed an allergic adverse reaction compared with none of the 77 in the iopamidol group (p = 0.001). Of 41 patients receiving ioxaglate who were premedicated with diphenhydramine, 4 had an allergic adverse event. In the iopamidol group 45 patients received similar premedication and none had an allergic adverse reaction (p less than 0.03). Thus, this multicenter study shows that adverse reactions occur more often with ioxaglate than with iopamidol and that patients with an allergic history have a greater risk with ioxaglate therapy compared with iopamidol.

Adult↗

Efficacy and tolerability of the long-acting somatostatin analog lanreotide in acromegaly. A 12-month multicenter study of 58 acromegalic patients. French Multicenter Study Group on Lanreotide in Acromegaly.

OBJECTIVE: To determine the effects of the new somatostatin analogue, lanreotide, in its prolonged released form (PR), in patients with acromegaly. DESIGN: Prospective open multicenter non comparative study. SETTING: Thirty-three university-affiliated medical centers. PATIENTS: One hundred sixteen acromegalic patients with active disease, of whom 58 patients complied with the protocol and completed the 12-month period treatment. INTERVENTION: Lanreotide PR treatment was started at a dose of 30 mg intramuscularly every 14 days. If integrated mean plasma GH levels were not below 5 micrograms/L and/or IGF-I levels were not normalized after one month of treatment, injections were given every 10 days. The duration of the study was 12 months. RESULTS: After one month of treatment mean plasma GH and IGF-I levels had fallen from 10.7 +/- 11.1 micrograms/L (mean +/- SD; range, 2.6-74.8 micrograms/L; median, 7 micrograms/L) and 718 +/- 270 micrograms/L (range 338-1440 micrograms/L; median, 645 micrograms/L), respectively, to 7.8 +/- 10.1 micrograms/L and 575 +/- 252 micrograms/L, respectively. Thirty patients (22%) had plasma GH levels below 2.5 micrograms/L, and 8 patients (16%) had age-adjusted normal plasma IGF-I levels. At the sixth month of treatment mean plasma GH levels of 2.5 micrograms/L or less, and normal plasma IGF-I levels were observed in 33%, and 33% of patients, respectively. At the twelvth month of treatment, these percentages were 41%, and 41%, respectively. The interval between two injections was shortened (one injection every 10 days) in 8 of the 58 patients (13%) at the second month of treatment, and at the end of the study, 70% of patients required 3 injections per month. The most frequent adverse event elicited by enquiry was transient diarrhea (76% of patients), followed by abdominal pain (62%) and pain at the injection site (59%). Based on the analysis of a subgroup of 46 patients who had at least a measurement of fecal fat content after day 0 of the study, a non significant increase (from 4.2 +/- 3.4 to 5.1 +/- 4.3 g/24 h, p = 0.3) in mean steatorrhea was observed during treatment. Before treatment, steatorrhea was present in 9 (19%) patients. During the study, 15 additional patients (32%) developed persistent steatorrhea, and there was a transient increase in fecal fat content above 6 g/24 h in another 11 patients. After exclusion of the 7 patients (12%) with gallstones at enrollment, new gall-stones were diagnosed in 6 out of 50 patients (12%) during the study. CONCLUSION: Two or three monthly injections of lanreotide PR decreased GH concentration to less than 2.5 micrograms/L and normalized IGF-I levels in 41% of patients treated during 12 months. The good tolerability of this treatment, and the reduction in the frequency of injections, plus the sustained drug serum concentrations, confirm the usefulness of this new somatostatin analog formulation.

Academic Medical Centers↗

Chest radiographic data acquisition and quality assurance in multicenter studies.

BACKGROUND: Multicenter studies rely on data derived from different institutions. Forms can be designed to standardize the reporting process allowing reliable comparison of data. OBJECTIVE: The purpose of the report is to provide a standardized method, developed as a part of a multicenter study of vertically transmitted HIV, for assessing chest radiographic results. MATERIALS AND METHODS: Eight hundred and five infants and children were studied at five centers; 3057 chest radiographs were scored. Data were entered using a forced-choice, graded response for 12 findings. Quality assurance measures and inter-rater agreement statistics are reported. RESULTS: The form used for reporting chest radiographic results is presented. Inter-rater agreement was moderate to high for most findings, with the best correlation reported for the presence of bronchovascular markings and/or reticular densities addressed as a composite question (kappa = 0.71). The presence of nodular densities (kappa = 0.56) and parenchymal consolidation (kappa = 0.57) had moderate agreement. Agreement for lung volume was low. CONCLUSION: The current tool, developed for use in the pediatric population, is applicable to any study involving the assessment of pediatric chest radiographs for a large population, whether at one or many centers.

Child↗

Design of the multicenter study of hydroxyurea in sickle cell anemia. Investigators of the Multicenter Study of Hydroxyurea.

The Multicenter Study of Hydroxyurea in Sickle Cell Anemia is a randomized double-blind placebo-controlled trial to test whether hydroxyurea can reduce the rate of painful crises in adult patients who have at least three painful crises per year. The sample size of 299 patients yields at least 90% power to detect a 50% or greater reduction in crisis rate. Dosage starts at 15 mg/kg/day and is titrated to the patient's maximum tolerated dose up to 35 mg/kg/day. Placebo dosage is titrated in similar fashion to maintain blinding. Attempts are made to ascertain medical contacts for at least 2 years after study entry. The Core Laboratory, Treatment Distribution Center, and Data Coordinating Center collaborate to provide standardized monitoring for toxicity and dose adjustments. The Core Laboratory also reduces the possibility of inadvertent unmasking of treatment assignment during review of hematologic data in clinical centers. An independent Crisis Review Committee classifies clinical events to assure that outcome evaluations are standardized and unbiased by knowledge of treatment assignments. The Data and Safety Monitoring Board assures scientific integrity of the study, as well as the safety and ethical treatment of study patients. We expect the study to determine whether or not treatment with hydroxyurea can offer significant clinical benefit to patients with the most common hereditary disorder among African-Americans in the United States.

Adult↗

Low dose interferon-alpha2b combined with PUVA is an effective treatment of early stage mycosis fungoides: results of a multicenter study. Cutaneous-T Cell Lymphoma Multicenter Study Group.

BACKGROUND AND OBJECTIVE: The early stages of mycosis fungoides (MF) can be treated but not cured by photochemotherapy (PUVA) alone; some recent studies of the effect of a combination of human interferon-alpha (IFN(alpha)) and PUVA reported a high degree of response. The aim of our study was to evaluate the activity of a low dose of IFN-alpha2b combined with PUVA. DESIGN AND METHODS: Twenty-five patients were included: 16 men and 9 women aged between 23-80 years; 19 patients ahd stage I and 6 stage II disease. In the induction phase, the dose of IFNalpha was gradually raised over 6-8 weeks to the target dose of 18 MU/week; in the maintenance phase, the combination with PUVA allowed IFNalpha to be reduced to a maximum dose of 6 MU/week; in this way the cumulative administration of IFNalpha and PUVA was considerably lower than in similar combination protocols. Treatment success was analyzed in terms of freedom from treatment failure (FFTF). RESULTS: After the induction phase 9/25 patients (36%) achieved complete remission (CR) and 15/25 (56%) achieved partial remission (PR). One to five months from the beginning of the maintenance phase, a CR was recorded in 19/25 patients (76%) and a PR in 5/25 patients (20%) accounting for an overall response rate of 96%. The median of FFTF was not reached; probability of FFTF was 82% at 12 months and 62% at 24 months. Disease free survival projected to 48 months was 75%. INTERPRETATION AND CONCLUSIONS: Even with low doses of IFNalpha plus PUVA it is possible to achieve excellent clinical responses,many of which are long-lasting, in patients with early MF.

Adult↗

European Captopril Radionuclide Test Multicenter Study. Preliminary results. Inspective renographic analysis. The European Captopril Radionuclide Test Multicenter Study Group.

Captopril radionuclide test (CRT) has been introduced in clinical practice as a screening test for renovascular hypertension, since it allows the detection of the decrease of glomerular filtration rate that may be induced by angiotensin converting enzyme inhibition (25 mg oral captopril) in kidneys ipsilateral to a renal artery stenosis. However, due to the low prevalence of the disease, experiences in single centers may hardly satisfy the need for representative series of patients to validate the test. Nineteen centers participated in a collaborative study (CRT European Multicenter Study) that collected data from 424 patients. Here we report on the first results obtained by inspective renographic analysis. The captopril radionuclide test greatly potentiated the diagnostic performance of conventional renography and the accuracy was maximal when relying simply on postcaptopril findings alone. Specificity was 84.1% in the overall population and 91.8% in uncomplicated patients without nephropathy and renal insufficiency. Taking into account the sole arteriographic diagnosis, sensitivity was 73.2% or 90.7% for the subjects with unilateral or bilateral stenosis and an angiographic degree of stenosis greater than or equal to 70%. On the other hand, when a successful outcome of blood pressure after revascularization or nephrectomy was considered as the gold standard for the diagnosis of renovascular hypertension, a high sensitivity was obtained (92.7%). Moreover, the test became negative after intervention in the great majority (88%) of patients who had a positive preintervention CRT and a normalization of blood pressure after revascularization.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Adipose tissue omega-3 and omega-6 fatty acid content and breast cancer in the EURAMIC study. European Community Multicenter Study on Antioxidants, Myocardial Infarction, and Breast Cancer.

The fatty acid content of adipose tissue in postmenopausal breast cancer cases and controls from five European countries in the European Community Multicenter Study on Antioxidants, Myocardial Infarction, and Cancer (EURAMIC) breast cancer study (1991-1992) was used to explore the hypothesis that fatty acids of the omega-3 family inhibit breast cancer and that the degree of inhibition depends on background levels of omega-6 polyunsaturates. Considered in isolation, the level of omega-3 or omega-6 fat in adipose tissue displayed little consistent association with breast cancer across study centers. The ratio of long-chain omega-3 fatty acids to total omega-6 fat showed an inverse association with breast cancer in four of five centers. In Malaga, Spain, the odds ratio for the highest tertile relative to the lowest reached 0.32 (95% confidence interval 0.13-0.82). In this center, total omega-6 fatty acid was strongly associated with breast cancer. With all centers pooled, the odds ratio for long-chain omega-3 to total omega-6 reached 0.80 for the second tertile and 0.65 for the third tertile, a downward trend bordering on statistical significance (p for trend = 0.055). While not definitive, these results provide evidence for the hypothesis that the balance between omega-3 and omega-6 fat may play a role in breast cancer.

Adipose Tissue↗

Reversal of central benzodiazepine effects by flumazenil after intravenous conscious sedation with diazepam and opioids: report of a double-blind multicenter study. The Flumazenil in Intravenous Conscious Sedation with Diazepam Multicenter Study Group II.

The efficacy and safety of a new benzodiazepine antagonist, flumazenil, were assessed in a double-blind multicenter study. Flumazenil (mean dose, 0.76 mg) or placebo (mean dose, 8.9 ml) was administered intravenously to 130 and 67 patients, respectively, who had been given diazepam in conjunction with an opioid (fentanyl, meperidine, or morphine) for the induction and maintenance of intravenous conscious sedation for diagnostic or therapeutic surgical procedures. The group assessable for efficacy comprised 122 patients treated with flumazenil and 64 patients given placebo. After 5 minutes, 80/115 (70%) flumazenil-treated patients, compared with 21/63 (33%) placebo-treated patients, were completely awake and alert, as indicated by a score of 5 on the Observer's Assessment of Alertness/Sedation Scale. Ninety-five percent of patients in each group who attained a score of 5 at the 5-minute assessment showed no loss of alertness throughout the 180-minute assessment period. Flumazenil-treated patients also performed significantly better on the Finger-to-Nose Test and the recall of pictures shown at the 5-minute assessment. Flumazenil was well tolerated, with no serious adverse effects reported. Thirty-nine (30%) of flumazenil-treated patients, compared with 17 (25%) of placebo-treated patients had one or more drug-related adverse experiences. The most common adverse effects were nausea and vomiting in the flumazenil group and nausea and injection-site pain in the placebo group. Flumazenil was found to promptly reverse sedation induced by diazepam in the presence of opioids.

Adolescent↗

The effect of fresh lymphocytes on increased sensitivity of HIV-1 isolation: a multicenter study.

A multicenter study was undertaken to determine the sensitivity and reproducibility of markers for human immunodeficiency virus type 1 (HIV-1) viral growth and the effect of various preparations of lymphocytes on the sensitivity of standard and routinely used procedures for HIV-1 isolation. In phase 1, cocultivated culture supernatants obtained from 10 HIV-1 cultures were transported to three Multicenter AIDS Cohort Study (MACS) Virology Laboratories. Three commercial HIV-p24 antigen capture (AC) tests and two reverse transcriptase (RT) assays were used to ascertain the replication of HIV-1. The Du Pont and Abbott AC assays were found to be most sensitive (85-100%), and the RT assay with 24-h incubation period had comparable sensitivity (75-100%). In phase II, the sensitivity of standard cocultivation procedure for HIV-1 isolation was compared using freshly phytohemagglutinin-P (PHA-P)-stimulated, stimulated-frozen, and frozen-thawed and then stimulated normal human peripheral blood mononuclear cells (PBMCs) as cocultivating cells. Blood samples from 13 HIV-1 infected individuals with various CD4+ cell counts were cocultivated in each of the three MACS laboratories using one of the aforementioned normal PBMCs. The PHA-P-stimulated fresh normal PBMC showed a maximum isolation rate of 100% (13 of 13) with an average of 8 days to positivity. This rate of isolation was significantly greater than other rates using any one of the other PBMC preparations. These findings demonstrated that the use of freshly PHA-P stimulated PBMCs maximized HIV-1 isolation from blood when a sensitive HIV-1 p24 AC assay or RT assay with overnight incubation is employed for the detection of HIV in culture supernatant.

Blood Preservation↗

[Metacarpal fractures: treatment indications and options. Results of a multicenter study].

This multicenter study analyzes data on metacarpal fractures in 1260 patients to determine optimal treatment concepts. Of the 740 patients followed up, 487 (66%) presented with fractures of a single metacarpal in one of the three most frequently observed locations (distal fractures of the 4th and 5th metacarpal, shaft fractures of the 2nd to 5th metacarpal, and fractures of the base of the first metacarpal). The overall clinical and radiological results were good to excellent. The "path" analysis used to identify baseline parameters and treatment options influencing outcome led to recommendations for metacarpal fracture treatment. Functional protocols are predominantly applied for postoperative/post-traumatic treatment. Pain and regional pain syndromes should be prevented whenever possible and early adequate treatment should be initiated due to their significant impact on outcome.

Bone Plates↗

Spironolactone and altizide in systemic hypertension: ambulatory multicenter study.

A multicenter study was performed in 919 hypertensive patients, 780 of whom could be evaluated. Patients in group I (n = 482) were treated with Aldactazine alone (altizide + spironolactone, 2 tablets per day). The other 298 patients (group II) were treated with 1 or 2 tablets per day of Aldactazine plus a conventional antihypertensive agent, e.g., a beta blocker, alpha-methyldopa or clonidine. After 45 days of treatment with Aldactazine alone, mean systolic and diastolic blood pressure (BP) decreased by 15 and 14%, respectively, vs baseline values. The addition of the other antihypertensive agent decreased BP further; however, the best results were obtained with the combination of Aldactazine and clonidine. With this combination, systolic and diastolic BP decreased by 16.6 and 18%, respectively, vs baseline. In terms of adverse effects, a few cases of gastrointestinal disturbances and orthostatic hypotension were reported.

Adrenergic beta-Antagonists↗