Komossa Katja, Rummel-Kluge Christine, Hunger Heike, Schmid Franziska, Schwarz Sandra, Kissling Werner, Leucht Stefan
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München Klinikum rechts der Isar, Moehlstrasse 26, München, Germany, 81675.
Cochrane Database Syst Rev. 2010 Jan 20(1):CD006628. doi: 10.1002/14651858.CD006628.pub2.
In many countries of the industrialised world, second generation (atypical) antipsychotic drugs have become first line treatment for people with schizophrenia. The question as to whether the effects of various second generation antipsychotic drugs differ is a matter of debate. In this review we examined how the efficacy and tolerability of zotepine differs from that of other second generation antipsychotic drugs.
To evaluate the effects of zotepine compared with other second generation antipsychotic drugs for people with schizophrenia and schizophrenia-like psychoses.
We searched the Cochrane Schizophrenia Group Trials Register (April 2007) which is based on regular searches of BIOSIS, CENTRAL CINAHL, EMBASE, MEDLINE and PsycINFO.
We included all randomised trials comparing oral zotepine with oral forms of amisulpride, aripiprazole, clozapine, olanzapine, risperidone, sertindole or ziprasidone in people with schizophrenia or schizophrenia-like psychoses.
We extracted data independently. For dichotomous data we calculated relative risks (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis based on a random effects model. We calculated numbers needed to treat/harm (NNT/NNH) where appropriate. For continuous data, we calculated weighted mean differences (MD) again based on a random effects model.
The review currently includes data from two short term, ill reported trials (total n=109). Both studies compared zotepine with clozapine. 34% of people left early but there was no significant difference between groups. Zotepine was less effective than clozapine (no clinically significant response: n=59, 1 RCT, RR 8.23 CI 1.14 to 59.17, NNH 3 CI 2 to 8; average score (BPRS total) at endpoint (n=59, 1 RCT, MD 6.00 CI 2.17 to 9.83). Zotepine induced more movement disorders than clozapine (use of antiparkinson medication: n=59, 1 RCT, RR 18.75 CI 1.17 to 301.08, NNH 3 CI 2 to 5) and higher prolactin levels (n=59, 1 RCT, MD 33.40 CI 14.87 to 51.93). Data on important other outcomes such as other adverse events, service use or satisfaction with care were not available.
AUTHORS' CONCLUSIONS: Zotepine may be less effective than clozapine and associated with more movement disorders and higher prolactin levels, but the evidence base is too small and prone to bias, making any practical recommendations impossible. There is no randomised evidence on the effects of zotepine compared to second generation antipsychotic drugs other than clozapine. More studies are possible to justify.
在许多工业化国家,第二代(非典型)抗精神病药物已成为精神分裂症患者的一线治疗药物。各种第二代抗精神病药物的疗效是否存在差异是一个有争议的问题。在本综述中,我们研究了佐替平与其他第二代抗精神病药物在疗效和耐受性方面的差异。
评估佐替平与其他第二代抗精神病药物相比,对精神分裂症和类精神分裂症精神病患者的疗效。
我们检索了Cochrane精神分裂症研究组试验注册库(2007年4月),该注册库基于对BIOSIS、CINAHL中心数据库、EMBASE、MEDLINE和PsycINFO的定期检索。
我们纳入了所有比较口服佐替平与口服氨磺必利、阿立哌唑、氯氮平、奥氮平、利培酮、舍吲哚或齐拉西酮治疗精神分裂症或类精神分裂症精神病患者的随机试验。
我们独立提取数据。对于二分数据,我们基于随机效应模型,在意向性分析的基础上计算相对风险(RR)及其95%置信区间(CI)。在适当情况下,我们计算治疗所需人数/伤害人数(NNT/NNH)。对于连续数据,我们同样基于随机效应模型计算加权平均差(MD)。
本综述目前纳入了两项短期、报告不佳的试验数据(总共n = 109)。两项研究均比较了佐替平与氯氮平。34%的患者提前退出,但两组之间无显著差异。佐替平的疗效低于氯氮平(无临床显著反应:n = 59,1项随机对照试验,RR 8.23,CI 1.14至59.17,NNH 3,CI 2至8;终点时平均评分(BPRS总分)(n = 59,1项随机对照试验,MD 6.00,CI 2.17至9.83)。佐替平比氯氮平引起更多的运动障碍(使用抗帕金森药物:n = 59,1项随机对照试验,RR 18.75,CI 1.17至301.08)以及更高的催乳素水平(n = 59,1项随机对照试验,MD 33.40,CI 14.87至51.93)。关于其他重要结局的数据,如其他不良事件、服务使用情况或对治疗的满意度,均未获得。
佐替平可能比氯氮平疗效更差,且与更多的运动障碍和更高的催乳素水平相关,但证据基础过小且容易产生偏差,无法给出任何实际建议。除氯氮平外,没有关于佐替平与其他第二代抗精神病药物疗效对比的随机证据。有必要开展更多研究。