Komossa Katja, Rummel-Kluge Christine, Hunger Heike, Schwarz Sandra, Schmidt Franziska, Lewis Ruth, 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. 2009 Apr 15(2):CD006752. doi: 10.1002/14651858.CD006752.pub2.
In many countries of the industrialised world second generation (atypical) antipsychotics have become the first line drug treatment for people with schizophrenia. The question as to whether and, if so, how much the effects of the various second generation antipsychotics differ is a matter of debate.
To evaluate the effects of sertindole compared with other second generation antipsychotics for people with schizophrenia and schizophrenia-like psychosis.
We searched the Cochrane Schizophrenia Group Trials Register (April 2007) and ClinicalTrials.gov (February 2009).
We included all randomised trials comparing oral sertindole with oral forms of amisulpride, aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone or zotepine for people with schizophrenia or schizophrenia-like psychosis.
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. For continuous data, we calculated weighted mean differences (WMD) again based on a random-effects model.
The review currently includes two short-term low-quality randomised trials (total n=508) both comparing sertindole with risperidone. One third of participants left the studies early (2 RCTs, n=504, RR 1.23 CI 0.94 to 1.60). There was no difference in efficacy (2 RCTs, n=493, WMD PANSS total change from baseline 1.98 CI -8.24 to 12.20). Compared with relatively high doses of risperidone (between 4 and 12 mg/day), sertindole produced significantly less akathisia and parkinsonism (1 RCT, n=321, RR 0.24 CI 0.09 to 0.69, NNT 14, CI 8 to 100). Sertindole produced more cardiac effects (2 RCTs, n=508, RR QTc prolongation 4.86 CI 1.94 to 12.18), weight change (2 RCTs, n=328, WMD 0.99 CI 0.12 to 1.86) and male sexual dysfunction (2 RCTs, n=437, RR 2.90 CI 1.32 to 6.35, NNH 13 CI 8 to 33).
AUTHORS' CONCLUSIONS: Sertindole may induce fewer movement disorders, but more cardiac effects, weight change and male sexual dysfunction than risperidone. However these data are based on only two studies and are too limited to allow firm conclusions. Nothing can be said about the effects of sertindole compared with second generation antipsychotics other than risperidone. There are several relevant trials underway or completed and about to report.
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药物治疗。各种第二代抗精神病药物的效果是否存在差异以及差异程度如何,这一问题仍存在争议。
评估与其他第二代抗精神病药物相比,舍吲哚对精神分裂症及精神分裂症样精神病患者的疗效。
我们检索了Cochrane精神分裂症研究组试验注册库(2007年4月)和ClinicalTrials.gov(2009年2月)。
我们纳入了所有将口服舍吲哚与口服氨磺必利、阿立哌唑、氯氮平、奥氮平、喹硫平、利培酮、齐拉西酮或佐替平用于精神分裂症或精神分裂症样精神病患者的随机试验。
我们独立提取数据。对于二分数据,我们基于意向性分析,采用随机效应模型计算相对风险(RR)及其95%置信区间(CI)。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(WMD)。
本综述目前纳入了两项短期低质量随机试验(共508例),均为舍吲哚与利培酮的比较试验。三分之一的参与者提前退出研究(2项随机对照试验[n = 504],RR 1.23,CI 0.94至1.60)。疗效方面无差异(2项随机对照试验[n = 493],WMD 阳性和阴性症状量表总分较基线的变化 1.98,CI -8.24至12.20)。与相对高剂量的利培酮(4至12毫克/天)相比,舍吲哚引起的静坐不能和帕金森综合征明显更少(1项随机对照试验[n = 321],RR 0.24,CI 0.09至0.69,需治疗人数14,CI 8至100)。舍吲哚导致更多的心脏效应(2项随机对照试验[n = 508],RR QTc延长 4.86,CI 1.94至12.18)、体重变化(2项随机对照试验[n = 328],WMD 0.99,CI 0.12至1.