Dropout rates in randomised antipsychotic drug trials
Dropout rates in randomised antipsychotic drug trials
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DOI：
10.1007/s002130100711
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发表时间：
2001-05-01
影响因子：
3.4
通讯作者：
Leucht, S
中科院分区：
文献类型：
--
作者：
Wahlbeck, K;Tuunainen, A;Leucht, S
依据：假设新的非典型药物由于不良反应较少而提高了治疗依从性。支持这一假设的数据很少。目的：本研究的目的是研究口服常规抗精神病药物、非典型抗精神病药物和安慰剂的随机对照试验中的脱落率。方法：本研究利用科克伦图书馆的精神分裂症模块数据库。科克伦模块中的数据是通过从多个电子数据库和其他来源中识别相关的随机对照试验来收集的。脱落人数定义为由于任何原因而提前退出研究的患者。结果：来自328个治疗组的数据，包括来自163项药物试验的18，585名随机受试者，进入分析。三分之一的受试者退出了试验。每一历年的辍学率都显著增加。试验发表年份、药物类型和试验持续时间对脱落率仍有统计学显著影响。在一个包含发表年份和试验长度的模型中，安慰剂组和常规抗精神病药物治疗组的脱落率显著高于非典型药物治疗组。当从分析中排除氯氮平治疗组时，非典型药物与常规药物相比没有统计学显著优势。结论：试验数据表明，在精神分裂症的治疗中，通过使用非典型药物而不是传统药物，可以实现更好的依从性。然而，只有当非典型抗精神病药氯氮平治疗组被纳入分析时，才发现这种效应。我们的研究没有发现与传统抗精神病药物相比，新型非典型药物在可接受性方面具有统计学显著优势的证据。
Rationale: It has been assumed that new atypical drugs improve treatment compliance due to fewer adverse effects. Data supporting this assumption are scarce. Objectives: The aim of this study was to study attrition rates in randomised controlled trials of oral administration of conventional antipsychotic drugs, atypical antipsychotic drugs and placebo. Methods: The database of the Schizophrenia Module of the Cochrane Library was utilised for the present study. The data in the Cochrane Module are collected by identifying relevant randomised controlled trials from several electronic databases and other sources. Number of dropouts was defined as patients leaving the study preterm due to any reason. Results: Data from 328 treatment groups, consisting of 18,585 randomised subjects from 163 drug trials, were entered in the analysis. One-third of the subjects had dropped out of the trials. The dropout rates significantly increased for each calendar year. Year of trial publication, type of drug and trial length remained statistically significant contributors to dropout rates. In a model incorporating year of publication and trial length, placebo groups and groups treated with conventional antipsychotics had significantly higher attrition rates than groups treated with atypical drugs. When clozapine-treated groups were excluded from the analysis, no statistically significant advantage for atypical drugs over conventional drugs remained. Conclusions: Trial data implicate that a better compliance can be achieved by favouring atypical drugs rather than conventional alternatives in the treatment of schizophrenia. However, this effect is found only when groups treated with the atypical antipsychotic clozapine are included in the analysis. Our study did not find evidence for a statistically significant superiority in acceptability of novel atypical drugs when compared to conventional antipsychotics.