Rathbone J, McMonagle T
University of Leeds, Department of Psychiatry, 15 Hyde Terrace, Leeds, UK, LS2 9LT.
Cochrane Database Syst Rev. 2007 Jul 18(3):CD001949. doi: 10.1002/14651858.CD001949.pub2.
Pimozide, formulated in the 1960s, continues to be marketed for the care of people with schizophrenia or related psychoses such as delusional disorder. It has been associated with cardiotoxicity and sudden unexplained deaths. Electrocardiogram monitoring is now required before and during use.
To assess the clinical effects of pimozide for people with schizophrenia, non-affective psychotic mental illness and delusional disorder.
We searched the Cochrane Schizophrenia Group's Register (July 2005).
We sought all relevant randomised clinical trials comparing pimozide with other treatments.
Working independently, we inspected citations, ordered papers, and then re-inspected and quality assessed the studies and extracted data. For homogeneous dichotomous data, we calculated the relative risk (RR), 95% confidence interval (CI), and, where appropriate, the number needed to treat (NNT) and the number needed to harm (NNH), on an intention-to-treat basis. We calculated weighted mean differences (WMD) for continuous data. We excluded data if loss to follow-up was greater than 50%.
We found 35 relevant studies (total n=1348), all including people with schizophrenia but none with delusional disorder. 123 people were randomised to pimozide versus placebo. Data suggest that pimozide prevents relapse (2 RCTs, n=66, RR 0.45 CI 0.2 to 0.9, NNT 4 CI 3 to 22). Compared with typical antipsychotic drugs, pimozide has similar efficacy for outcomes of change in global functioning, mental state, relapse and leaving the study early. People allocated to pimozide did not have a higher mortality than those taking other antipsychotic drugs. Pimozide was more likely than typical antipsychotic drugs to cause tremor in the short-term (6 RCTs, n=192, RR 1.6 CI 1.1 to 2.3, NNH 6 CI 3 to 44) and lead to need for antiparkinsonian medication (4 RCTs, n=124, RR 1.8 CI 1.2 to 2.6, NNH 3 CI 2 to 5) than other drugs. In the medium-term, however, pimozide was less likely to cause sedation (5 RCTs, n=231, RR 0.6 CI 0.5 to 0.9, NNH 6 CI 4 to 16).
AUTHORS' CONCLUSIONS: Although there are shortcomings in the data, there is enough overall consistency over different outcomes and time scales to confirm that pimozide is a drug with similar efficacy to other more commonly used antipsychotic drugs such as chlorpromazine for people with schizophrenia. There are no data to support or refute its use for those with delusional disorder.
匹莫齐特于20世纪60年代被研制出来,目前仍在市场上销售,用于治疗精神分裂症患者或患有相关精神病(如妄想症)的人群。它与心脏毒性和不明原因的猝死有关。现在在使用前和使用期间都需要进行心电图监测。
评估匹莫齐特对精神分裂症、非情感性精神病性精神疾病和妄想症患者的临床疗效。
我们检索了Cochrane精神分裂症研究组的注册库(2005年7月)。
我们查找了所有比较匹莫齐特与其他治疗方法的相关随机临床试验。
我们独立工作,检查参考文献、订购论文,然后重新检查并对研究进行质量评估并提取数据。对于同质二分数据,我们在意向性分析的基础上计算相对风险(RR)、95%置信区间(CI),并在适当情况下计算治疗所需人数(NNT)和伤害所需人数(NNH)。对于连续数据,我们计算加权平均差(WMD)。如果失访率大于50%,我们将排除数据。
我们找到了35项相关研究(共1348人),所有研究均纳入了精神分裂症患者,但没有一项纳入妄想症患者。123人被随机分配接受匹莫齐特与安慰剂治疗。数据表明匹莫齐特可预防复发(2项随机对照试验,n = 66,RR 0.45,CI 0.2至0.9,NNT 4,CI 3至22)。与典型抗精神病药物相比,匹莫齐特在整体功能改变、精神状态、复发和提前退出研究等结果方面具有相似的疗效。分配接受匹莫齐特治疗的患者死亡率并不高于服用其他抗精神病药物的患者。与典型抗精神病药物相比,匹莫齐特在短期内更易引起震颤(6项随机对照试验,n = 192,RR 1.6,CI 1.1至2.3,NNH 6,CI 3至44),且比其他药物更易导致需要使用抗帕金森药物(4项随机对照试验,n = 124,RR 1.