Clinical trials and meta-analysis最新文献

2nd State of the Art Conference on Methods in Phase I. Bron, France, February 9-10, 1995. Abstracts. 第二次第一阶段方法技术状况会议，1995年2月9日至10日，法国布朗。摘要。

Clinical trials and meta-analysis Pub Date : 1994-12-01

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Pre-hospital treatment of patients with suspected acute myocardial using a beta-blocking agent: a double-blind feasibility study. EMIP-BB Pilot Study Group. 院前使用β阻滞剂治疗疑似急性心肌患者:一项双盲可行性研究EMIP-BB试点研究小组。

Clinical trials and meta-analysis Pub Date : 1994-10-01

{"title":"Pre-hospital treatment of patients with suspected acute myocardial using a beta-blocking agent: a double-blind feasibility study. EMIP-BB Pilot Study Group.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"The efficacy of intravenous beta-blocker treatment in hospital patients with acute myocardial infarction (AMI) in reducing short-term mortality and morbidity has been demonstrated; the efficacy seems to be higher the earlier the treatment is administered. We assessed the feasibility of pre-hospital treatment of patients in a randomised, double-blind, controlled pilot study. Eligible patients (symptoms suggestive of AMI for less than 2 h) were randomised by mobile emergency unit staff to receive either pre-hospital beta-blocker treatment (intravenous injection of atenolol) immediately, followed by placebo in hospital, or the opposite. All patients received a 7-day course of oral atenolol at the discretion of the hospital physician. A total of 77 patients were included (41 in the pre-hospital beta-blocker group and 36 in the pre-hospital placebo group). Sixteen patients in each group received active treatment, but only 9 and 11 patients, respectively, received full treatment. The reasons for the non-administration of the second injection included the occurrence of adverse events after the first injection, and a certain reserve on the part of the hospital physicians to administer beta-blocker treatment in patients with suspected myocardial infarction. Three patients in each group died; the minor adverse event rate was similar in the two groups. The findings of the study suggest that this approach would be feasible in terms of safety. However, a large number of patients did not receive any hospital treatment for a number of reasons which must be considered if a large-scale trial is to be undertaken.","PeriodicalId":79833,"journal":{"name":"Clinical trials and meta-analysis","volume":"29 2-3","pages":"125-38"},"PeriodicalIF":0.0,"publicationDate":"1994-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21022284","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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A comparison of once daily versus twice daily nisoldipine as monotherapy in patients over 65 years of age. 65岁以上患者每日1次与每日2次尼索地平单药治疗的比较

Clinical trials and meta-analysis Pub Date : 1994-10-01

G K Davidsson, D J Smithard, J S Edwards, C Davidson

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Surrogate end-points: the case of trials on coronary atherosclerotic plaque regression. 替代终点:冠状动脉粥样硬化斑块消退试验案例。

Clinical trials and meta-analysis Pub Date : 1994-10-01

R Marchioli, J C Prieto, G Tognoni

{"title":"Surrogate end-points: the case of trials on coronary atherosclerotic plaque regression.","authors":"R Marchioli, J C Prieto, G Tognoni","doi":"","DOIUrl":"","url":null,"abstract":"The experimental progression-regression human model offers an excellent opportunity for testing the pathophysiological hypotheses that have arisen in the study of atherosclerosis. Nevertheless, it is still necessary to demonstrate that the modifications of angiographic patterns are strictly related to changes in coronary events, and this evidence is not yet supported to date by performed trials. Ten randomized controlled trials designed with the aim of angiographically evaluating the evolution of coronary lesions in patients with coronary heart disease made over the past 13 years were reviewed to perform a meta-analysis. Quality of design and execution of the trials, and the analysis of the primary and secondary end-points chosen for each trial, as well as the methods used to measure the changes in atherosclerotic plaques were also assessed. The phenomenon of plaque regression in human beings seems to occur, but clinical, methodological and physiopathologic heterogeneity between examined trials made it unfeasible to perform a meta-analysis. Coronary events are the consequence of the interaction of known and unknown factors, and coronary arterial narrowing from a mild to moderate degree is only one of these factors. The choice of the regression of atherosclerotic plaques as the primary end-point of a trial should probably be confined to phase 2 studies, while proof of clinical efficacy should be based on harder end-points that are representative of the very objective of medical interventions: amelioration and/or prolongation of a patient's life.","PeriodicalId":79833,"journal":{"name":"Clinical trials and meta-analysis","volume":"29 2-3","pages":"139-76"},"PeriodicalIF":0.0,"publicationDate":"1994-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21022285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Meta-analysis of phenobarbital usage for prevention of intraventricular hemorrhage in premature infants: factors related to variation in outcome. 苯巴比妥用于预防早产儿脑室内出血的meta分析:与结果变化相关的因素。

Clinical trials and meta-analysis Pub Date : 1994-10-01

D A Tholl, T Q Miller, W G Henderson, T F Myers

{"title":"Meta-analysis of phenobarbital usage for prevention of intraventricular hemorrhage in premature infants: factors related to variation in outcome.","authors":"D A Tholl, T Q Miller, W G Henderson, T F Myers","doi":"","DOIUrl":"","url":null,"abstract":"Purpose: To assess the efficacy of phenobarbital for the prevention of intraventricular hemorrhage (IVH) in premature infants and to identify study characteristics that were associated with beneficial or adverse effects.Data identification: Studies published from 1981 to 1994 were identified through a computerized search, and by searching the bibliographies of all identified articles.Study selection: Ten randomized, controlled clinical trials were selected.Data extraction: Data were extracted from each article, including the percentage of patients in the control and treatment groups with IVH, and key patient and study characteristics.Results of data analysis: Seven studies showed no statistically significant effects, two studies showed a beneficial effect of phenobarbital, and one study showed an adverse effect. The meta-analysis showed no significant difference in the percentage of IVH in treated and untreated infants when treatment effects were combined across all studies. However, prenatal administration of phenobarbital in two studies was associated with a beneficial effect.Conclusions: Overall, we did not find a significant beneficial effect of postnatal phenobarbital administration. The data suggests that prenatal phenobarbital is beneficial. Further evaluations of the efficacy of prenatal phenobarbital are warranted.","PeriodicalId":79833,"journal":{"name":"Clinical trials and meta-analysis","volume":"29 2-3","pages":"177-90"},"PeriodicalIF":0.0,"publicationDate":"1994-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21022225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Exploratory study of the decongestive effect of Rhinopront syrup in adults and in children with acute rhinitis. 鼻前糖浆对成人及儿童急性鼻炎消血效果的探索性研究。

Clinical trials and meta-analysis Pub Date : 1994-10-01

E Lebacq, J P Gline, P Joue, A Stockis, P Calderon, O Van Schoor, X Deroubaix, F Schwegler

{"title":"Exploratory study of the decongestive effect of Rhinopront syrup in adults and in children with acute rhinitis.","authors":"E Lebacq, J P Gline, P Joue, A Stockis, P Calderon, O Van Schoor, X Deroubaix, F Schwegler","doi":"","DOIUrl":"","url":null,"abstract":"The decongestive effect of Rhinopront syrup was assessed in 18 adults and 18 children with acute rhinitis, by comparison to a matching placebo syrup and to a commercial standard decongestant (Triaminic tablets or drops). The evolution of symptoms following single dose administration of each treatment was estimated both by objective measurements of nasal resistance using bilateral rhinomanometry and by subjective evaluation of nasal congestion and aspect of the mucosa. In children, the treatment was continued over the next 4 days and the global clinical efficacy of the formulations was subjectively evaluated by the parents. In adult patients, a significant decrease in nasal resistance was obtained after a single dose of Rhinopront (15 g). The effect was already important after 0.5 h and reached a minimum of approximately 50% of baseline within 1 to 2 h; the drop in nasal resistance was significantly less intense for Triaminic (p < 0.05; 0.5-1-h period) and for the placebo (p < 0.05; 0.5-2-h period). In children, the scatter of rhinomanometric measurements precluded the observation of any significant within- or between-group differences; however, a significantly lower nasal congestion score was observed for Rhinopront than placebo, between 4 and 10 h after single dose administration (1 g per year of age). The present work suggests that Rhinopront is an effective nasal decongestant in adults and children with acute congestive rhinitis and supports the adequacy of the proposed twice-daily dosing rate.","PeriodicalId":79833,"journal":{"name":"Clinical trials and meta-analysis","volume":"29 2-3","pages":"113-24"},"PeriodicalIF":0.0,"publicationDate":"1994-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21022933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Evaluation of treatment effects on patients' quality of life: what approach? From the concepts to the instruments. 治疗效果对患者生活质量的评价:什么方法?从概念到乐器。

Clinical trials and meta-analysis Pub Date : 1994-04-01

A Dazord, P Gerin

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A randomised clinical trial of the effect of informed consent on the analgesic activity of placebo and naproxen in cancer pain. 知情同意对安慰剂和萘普生治疗癌症疼痛镇痛活性影响的随机临床试验。

Clinical trials and meta-analysis Pub Date : 1994-04-01

J F Bergmann, O Chassany, J Gandiol, P Deblois, J A Kanis, J M Segrestaa, C Caulin, R Dahan

{"title":"A randomised clinical trial of the effect of informed consent on the analgesic activity of placebo and naproxen in cancer pain.","authors":"J F Bergmann, O Chassany, J Gandiol, P Deblois, J A Kanis, J M Segrestaa, C Caulin, R Dahan","doi":"","DOIUrl":"","url":null,"abstract":"To determine whether informed consent in a therapeutic trial modifies the analgesic effect of naproxen and placebo, we conducted a prospective, randomised, single dose, placebo-controlled trial. Patients were randomly selected to receive or not information concerning the study. All patients included were then given a single dose of naproxen and placebo according to a crossover, double-blind design. Forty-nine patients with mild or moderate cancer pain which did not need narcotic analgesics entered the study. Twenty-five received both treatments without any information and constituted the uninformed group. Twenty-four had a complete information about the trial; six refused to participate. The 18 others constituted the informed-consent group. Visual analogue scales of pain before and 30, 60, 120 and 180 min after the intake of naproxen and placebo were recorded. As an analgesic, naproxen was more effective than placebo in both groups of patients (p = 0.001). For naproxen as well as for placebo, the analgesic effect was better in the informed-consent group compared to the uninformed group (p = 0.012). The difference in therapeutic activity between naproxen and placebo was moderately higher in the uninformed patients (p = 0.08). We concluded that, in contrast with parallel studies, giving information in a crossover, placebo-controlled trial may increase the apparent efficacy of both the tested agent and the placebo, and decrease the perceived difference the two.","PeriodicalId":79833,"journal":{"name":"Clinical trials and meta-analysis","volume":"29 1","pages":"41-7"},"PeriodicalIF":0.0,"publicationDate":"1994-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21022377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Lack of effects of trimetazidine on systemic hemodynamics in patients with coronary artery disease: a placebo-controlled study. 曲美他嗪对冠状动脉疾病患者全身血流动力学的影响不足:一项安慰剂对照研究

Clinical trials and meta-analysis Pub Date : 1994-04-01

M Pornin, C Harpey, J Allal, P Sellier, P Ourbak

{"title":"Lack of effects of trimetazidine on systemic hemodynamics in patients with coronary artery disease: a placebo-controlled study.","authors":"M Pornin, C Harpey, J Allal, P Sellier, P Ourbak","doi":"","DOIUrl":"","url":null,"abstract":"Trimetazidine has been shown to improve anginal symptoms and exercise tolerance in patients with coronary artery disease (CAD). To determine the hemodynamic effects of trimetazidine, systemic hemodynamics were studied in 15 patients suffering from CAD (12 male, 3 female, mean age +/- SEM = 58.6 +/- 1.8 years). Cardiac index was determined by thermodilution method. Left ventricular and aortic pressures were measured using micromanometers (Miller Instruments). After basal measurements, patients were randomly given either placebo (n = 5) or one of two therapeutic doses of trimetazidine 1 mg.kg-1 (n = 5) or trimetazidine 1.5 mg.kg-1 (n = 5) in a double-blind procedure. Data were recorded 5, 10 and 20 min after intravenous drug bolus. Throughout the procedure, the evolution of systemic hemodynamic parameters was not statistically different between the three groups, in particular heart rate, cardiac index, systolic, diastolic and mean aortic pressures, end-diastolic ventricular pressure, mean capillary wedge pressure, pulmonary artery pressures or systemic vascular resistances. We conclude that, unlike other antianginal drugs (particularly beta-blockers, nitrates and calcium-channel inhibitors), trimetazidine does not modify systemic hemodynamics in patients with CAD. These results are consistent with a direct effect of trimetazidine on the ischemic myocardial cell previously reported.","PeriodicalId":79833,"journal":{"name":"Clinical trials and meta-analysis","volume":"29 1","pages":"49-56"},"PeriodicalIF":0.0,"publicationDate":"1994-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21022378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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From pharmacological promises to controlled clinical trials to meta-analysis and back: the case of nimodipine in cerebrovascular disorders. 从药理学承诺到对照临床试验再到荟萃分析再回来:尼莫地平治疗脑血管疾病的案例。

Clinical trials and meta-analysis Pub Date : 1994-04-01

R Di Mascio, R Marchioli, G Tognoni

{"title":"From pharmacological promises to controlled clinical trials to meta-analysis and back: the case of nimodipine in cerebrovascular disorders.","authors":"R Di Mascio, R Marchioli, G Tognoni","doi":"","DOIUrl":"","url":null,"abstract":"On the basis of their promising experimental evidence, calcium channel blockers are today largely used in clinical practice for treatment of patients with cerebrovascular disorders. We propose a meta-analytical evaluation of published clinical trials on nimodipine, a dihydropiridin calcium antagonist, in subarachnoid hemorrhage and in ischemic stroke. In seven trials of subarachnoid hemorrhage, 112 deaths occurred among 682 patients randomized to active treatment compared with 154 deaths among 689 control patients (odds ratio of 0.68, 95% confidence interval of 0.52 to 0.90). Poor outcome due to delayed cerebral ischemia following subarachnoid hemorrhage was also lower in the group allocated to receive nimodipine (odds ratio of 0.47, 95% confidence interval of 0.36 to 0.62). In 12 trials of ischemic stroke, 382 deaths occurred among 2056 patients allocated to receive nimodipine compared to 288 deaths among 1462 control patients (odds ratio of 0.98, 95% confidence interval of 0.82 to 1.18). Pooled results strongly suggest a protective effect of nimodipine in delayed cerebral ischemia following subarachnoid hemorrhage and no effect in ischemic stroke, but the direction and the significance of these results are due to the contribution of a single large trial on subarachnoid hemorrhage and of two trials on ischemic stroke, which account respectively for 40% and 65% of randomized patients. The dissociated effect of nimodipine on these similar conditions could be related to its preventive role in ischemic damage, resembling animal models of ischemic stroke where a beneficial effect of calcium antagonists was clearly shown only when treatment was started before experimental cerebral artery occlusion. In this view, the negative results obtained from the clinical setting of ischemic stroke seem to indicate nimodipine as an aspecific neuroprotective agent without a curative effect.","PeriodicalId":79833,"journal":{"name":"Clinical trials and meta-analysis","volume":"29 1","pages":"57-79"},"PeriodicalIF":0.0,"publicationDate":"1994-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21022379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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