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癸酸珠氯噻醇用于治疗精神分裂症和其他严重精神疾病。

Zuclopenthixol decanoate for schizophrenia and other serious mental illnesses.

作者信息

Coutinho E, Fenton M, Quraishi S

机构信息

Oswaldo Cruz Foundation, Av. Brasil, 4635, Manguinhos, Rio de Janeiro, Brazil.

出版信息

Cochrane Database Syst Rev. 2000;1999(2):CD001164. doi: 10.1002/14651858.CD001164.

Abstract

BACKGROUND

There is a clear link between stopping antipsychotic medications and a relapse of psychotic symptoms. A series of long-acting intra-muscular preparations has been developed since the 1960s in the hope of reducing the frequency of relapse and, hence, overall disability. These depot preparations, active for weeks at a time, are frequently used for those who find taking oral medication on a regular basis difficult or unacceptable. It has, however, been a consistent concern that any reduction in relapse rate afforded by depot preparations may be offset by an increase in adverse effects such as drug-induced movement disorders.

OBJECTIVES

To compare zuclopenthixol decanoate to oral zuclopenthixol and other antipsychotic preparations for the treatment of schizophrenia and similar serious mental illness.

SEARCH STRATEGY

Electronic searches of Biological Abstracts (1982-1998), CINAHL (1982-1998), The Cochrane Library (Issue 2, 1998), The Cochrane Schizophrenia Group's Register (April 1998), EMBASE (1980-1998), MEDLINE (1966-1998), and PsycLIT (1974-1998) were searched. References of all eligible studies were searched for further trials. The manufacturer of zuclopenthixol was contacted.

SELECTION CRITERIA

Inclusion criteria were that the clinical study should be randomised, focus on people with schizophrenia or other serious mental illness with psychotic symptoms, and compare the use of zuclopenthixol decanoate to oral zuclopenthixol or other antipsychotic preparations.

DATA COLLECTION AND ANALYSIS

Data was extracted independently by two reviewers (EC, MF). Authors of trials were contacted for additional and missing data. Odds ratios (ORs) and 95% confidence intervals (CIs) of homogenous dichotomous data were calculated with the Peto method. Where possible the number needed to treat (NNT) and its 95% confidence interval was also calculated.

MAIN RESULTS

Four studies relating to zuclopenthixol decanoate were included. All compared zuclopenthixol decanoate with other depot preparations. Zuclopenthixol decanoate prevented or postponed relapses when compared to other depots (NNT 8, CI 5-53). However, zuclopenthixol decanoate may induce more adverse effects (NNH 5, CI 3-31) although it decreases need for anticholinergic medication when compared to a group of other depot preparations (NNT 9, CI 5-38). For the risk of leaving the study early, there was also a trend for benefit to those allocated to zuclopenthixol decanoate. None of the studies reported outcomes on service utilisation, costs, or quality of life.

REVIEWER'S CONCLUSIONS: Choice of which depot to use must always take into account clinical judgement and the preferences of the recipients of care and their carers. Limited trial data suggests, however, that there are real differences between zuclopenthixol decanoate and other depots and these differences largely favour the former. This review highlights the need for good controlled clinical trials to fully address the effects of zuclopenthixol decanoate for those with schizophrenia. Future studies should report service utilisation data, as well as satisfaction with care and economic outcomes. Duration of such trials should be of a longer duration than the included studies (12 months or more).

摘要

背景

停用抗精神病药物与精神病症状复发之间存在明确关联。自20世纪60年代以来,已研发出一系列长效肌内注射制剂,以期降低复发频率,从而减少整体残疾程度。这些长效制剂每次药效可持续数周,常用于那些难以定期服用口服药物或无法接受口服药物治疗的患者。然而,一直令人担忧的是,长效制剂所带来的复发率降低可能会被诸如药物所致运动障碍等不良反应的增加所抵消。

目的

比较癸酸珠氯噻醇与口服珠氯噻醇及其他抗精神病制剂治疗精神分裂症及类似严重精神疾病的效果。

检索策略

检索了生物摘要数据库(1982 - 1998年)、护理学与健康领域数据库(1982 - 1998年)、考克兰图书馆(1998年第2期)、考克兰精神分裂症研究小组注册库(1998年4月)、荷兰医学文摘数据库(1980 - 1998年)、医学索引数据库(1966 - 1998年)以及心理学文摘数据库(1974 - 1998年)。对所有符合条件研究的参考文献进行检索,以查找更多试验。还联系了癸酸珠氯噻醇的制造商。

选择标准

纳入标准为临床研究应是随机的,针对患有精神分裂症或其他伴有精神病症状的严重精神疾病的患者,且要比较癸酸珠氯噻醇与口服珠氯噻醇或其他抗精神病制剂的使用情况。

数据收集与分析

由两名审阅者(EC,MF)独立提取数据。与试验作者联系以获取额外及缺失的数据。采用Peto方法计算同质二分数据的比值比(OR)和95%置信区间(CI)。在可能的情况下,还计算了需治疗人数(NNT)及其95%置信区间。

主要结果

纳入了四项关于癸酸珠氯噻醇的研究。所有研究均将癸酸珠氯噻醇与其他长效制剂进行了比较。与其他长效制剂相比,癸酸珠氯噻醇可预防或推迟复发(NNT为8,CI为5 - 53)。然而,癸酸珠氯噻醇可能会引发更多不良反应(NNH为5,CI为3 - 31),尽管与一组其他长效制剂相比,它可减少抗胆碱能药物的使用需求(NNT为9,CI为5 - 38)。对于提前退出研究的风险,分配到癸酸珠氯噻醇组的患者也有受益趋势。没有研究报告服务利用、成本或生活质量方面的结果。

审阅者结论

选择使用哪种长效制剂必须始终考虑临床判断以及护理接受者及其照顾者的偏好。然而,有限的试验数据表明,癸酸珠氯噻醇与其他长效制剂之间存在实际差异,且这些差异在很大程度上有利于前者。本综述强调需要进行良好的对照临床试验,以全面探讨癸酸珠氯噻醇对精神分裂症患者的影响。未来的研究应报告服务利用数据,以及对护理的满意度和经济结果。此类试验的持续时间应比纳入研究的时间更长(12个月或更长)。

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