Soares B G, Fenton M, Chue P
Evidence Based Medicine Center, Universidade Federal de Pelotas, Av. Duque de Caxias, 250, Pelotas, RS, Brazil, 96100.
Cochrane Database Syst Rev. 2000;1999(2):CD001162. doi: 10.1002/14651858.CD001162.
The antipsychotic drug sulpiride was formulated over 20 years ago and was marked as having a low incidence of adverse effects and an effect on the negative symptoms of schizophrenia. This relatively inexpensive antipsychotic drug has a similar neuropharmacological profile to several novel atypical drugs.
To estimate the clinical efficacy and tolerability of sulpiride.
Electronic searches of Biological Abstracts (1982-1997), CINAHL (1982-1998), Cochrane Schizophrenia Group's Register (March 1998), Cochrane Library (Issue 1, 1998), EMBASE (1980-1998), MEDLINE (1966-1998), PsycLIT (1974-1997), SIGLE (1994-1998), and Sociofile (1974-1997) were supplemented by reference searching, contacting authors and the manufacturers of sulpiride.
All randomised or quasi-randomised clinical trials focusing on the use of different doses of sulpiride or comparing sulpiride to (i) placebo; (ii) typical antipsychotic drugs; or (iii) atypical antipsychotic drugs, for those with schizophrenia or serious mental illness were selected.
Trials were reliably selected and quality rated. Data were independently extracted, by two reviewers (BGOS, MF), and analysed on an intention-to-treat basis. It was assumed that people who did not complete the follow up had no improvement. Authors of trials were contacted for additional and missing data. Relative risk (RR) and 95% confidence intervals (CI) of dichotomous data were calculated with the random effects model and weighted mean difference (WMD) was calculated for continuous data.
The review currently includes 18 studies (30 citations). Studies are generally small and of poor quality. Limited evidence suggests that there is little difference between sulpiride and other drugs although the incidence of side effects may be less for sulpiride. There are no clear findings relating to negative symptoms.
REVIEWER'S CONCLUSIONS: Sulpiride may be an effective antipsychotic drug but evidence is limited and data relating to claims for its value against negative symptoms is not trial-based.
抗精神病药物舒必利于20多年前研制而成,其特点是不良反应发生率低且对精神分裂症的阴性症状有疗效。这种相对便宜的抗精神病药物与几种新型非典型药物具有相似的神经药理学特征。
评估舒必利的临床疗效和耐受性。
通过电子检索生物摘要数据库(1982 - 1997年)、护理学与健康领域数据库(1982 - 1998年)、Cochrane精神分裂症研究组注册库(1998年3月)、Cochrane图书馆(1998年第1期)、EMBASE数据库(1980 - 1998年)、医学索引数据库(1966 - 1998年)、心理学文摘数据库(1974 - 1997年)、科技灰色文献数据库(1994 - 1998年)以及社会科学数据库(1974 - 1997年),并通过参考文献检索、联系作者及舒必利制造商进行补充。
纳入所有针对不同剂量舒必利的使用或舒必利与以下药物比较的随机或半随机临床试验:(i)安慰剂;(ii)典型抗精神病药物;或(iii)非典型抗精神病药物,受试对象为精神分裂症患者或患有严重精神疾病的患者。
可靠地选择试验并进行质量评级。由两位评审员(BGOS、MF)独立提取数据,并基于意向性分析原则进行分析。假设未完成随访的患者病情无改善。与试验作者联系获取额外及缺失的数据。二分类数据的相对危险度(RR)及95%置信区间(CI)采用随机效应模型计算,连续数据计算加权均数差(WMD)。
本综述目前纳入18项研究(30篇引文)。研究规模普遍较小且质量欠佳。有限的证据表明舒必利与其他药物之间差异不大,尽管舒必利的副作用发生率可能较低。关于阴性症状尚无明确研究结果。
舒必利可能是一种有效的抗精神病药物,但证据有限,且有关其对阴性症状疗效的说法缺乏基于试验的数据支持。