DeSilva P, Fenton M, Rathbone J
The Anchorage, 11 Byland Road, Whitby, Yorkshire, UK.
Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD001948. doi: 10.1002/14651858.CD001948.pub2.
Zotepine is a relatively new antipsychotic often used for the treatment of people with schizophrenia. It is claimed to be particularly effective for negative symptoms.
To determine the effects of zotepine compared with placebo, typical and other atypical antipsychotic drugs for schizophrenia and related psychoses.
For the 2006 update we searched the Cochrane Schizophrenia Group's register of trials.
We included all randomised clinical trials comparing zotepine with other treatments for people with schizophrenia or other psychoses.
We independently inspected citations and abstracts, ordered papers, re-inspected these and assessed their quality. For homogenous dichotomous data we calculated the relative risk (RR), 95% confidence intervals (CI) and, where appropriate, numbers needed to treat/harm (NNT/H) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD). We inspected all data for heterogeneity.
The review currently includes 11 studies with 966 participants. Most outcomes were short term (4-12 weeks). We found no data for outcomes such as relapse, time in hospital, satisfaction with care and day-to-day functioning. Compared with placebo, mental state ratings favoured zotepine (n=106, 1 RCT, RR No 20% decrease in BPRS 0.44 CI 0.3 to 0.7, NNT 3 CI 2 to 6) using the last observation carried forward method. For the comparison with typical drugs, limited data suggest that zotepine may be as effective as these older medications. Mental state measures of 'no clinically important improvement' favour zotepine when compared with other active drugs (n=356, 4 RCTs, RR 0.77 CI 0.7 to 0.9, NNT 7 CI 4 to 22). About one third of people in both the zotepine and control groups left the studies before trial completion. Zotepine may result in less movement disorder adverse effects than typical antipsychotic drugs. Trials have not highlighted clear differences between zotepine and other atypical drugs.
AUTHORS' CONCLUSIONS: Zotepine may be a valuable addition to the class of atypical antipsychotic drugs. However, more data from existing studies is urgently needed to increase confidence in the findings of this review. In addition to this, new data from well planned, conducted and reported long term pragmatic randomised trials are needed. Otherwise clinical use of zotepine will be based upon speculation of short explanatory trials for everyday practice.
佐替平是一种相对较新的抗精神病药物,常用于治疗精神分裂症患者。据称它对阴性症状特别有效。
确定佐替平与安慰剂、传统及其他非典型抗精神病药物相比,对精神分裂症及相关精神病的疗效。
在2006年更新时,我们检索了Cochrane精神分裂症研究组的试验注册库。
我们纳入了所有比较佐替平与其他治疗方法用于精神分裂症或其他精神病患者的随机临床试验。
我们独立检查了文献引用和摘要,订购了论文,再次检查这些内容并评估其质量。对于同质二分数据,我们在意向性分析的基础上计算相对危险度(RR)、95%置信区间(CI),并在适当情况下计算治疗/伤害所需人数(NNT/H)。对于连续性数据,我们计算加权均数差(WMD)。我们检查了所有数据的异质性。
该综述目前包括11项研究,共966名参与者。大多数结果是短期的(4 - 12周)。我们没有找到关于复发、住院时间、护理满意度和日常功能等结果的数据。与安慰剂相比,采用末次观察结转法,精神状态评分更倾向于佐替平(n = 106,1项随机对照试验,RR 无BPRS降低20% 0.44,CI 0.3至0.7,NNT 3,CI 2至6)。与传统药物相比,有限的数据表明佐替平可能与这些较老的药物效果相当。与其他活性药物相比,“无临床重要改善”的精神状态测量结果更倾向于佐替平(n = 356,4项随机对照试验,RR 0.77,CI 0.7至0.9,NNT 7,CI 4至22)。佐替平组和对照组中约有三分之一的人在试验完成前退出了研究。佐替平可能比传统抗精神病药物导致的运动障碍不良反应更少。试验未突出佐替平与其他非典型药物之间的明显差异。
佐替平可能是一类非典型抗精神病药物中有价值的补充。然而,迫切需要现有研究提供更多数据,以增强对本综述结果的信心。除此之外,还需要精心设计、实施和报告的长期实用随机试验的新数据。否则,佐替平的临床应用将基于对日常实践中简短解释性试验的推测。