Fenton M, Rathbone J, Reilly J, Sultana A
Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD001944. doi: 10.1002/14651858.CD001944.pub2.
Thioridazine is an antipsychotic that can still be used for schizophrenia although it is associated with the cardiac arrhythmia, torsades de pointe.
To review the effects of thioridazine for people with schizophrenia.
For this 2006 update, we searched the Cochrane Schizophrenia Group's Register (June 2006).
We included all randomised clinical trials comparing thioridazine with other treatments for people with schizophrenia or other psychoses.
We reliably selected, quality rated and extracted data from relevant studies. For dichotomous data, we estimated relative risks (RR), with the 95% confidence intervals (CI). Where possible, we calculated the number needed to treat/harm statistic (NNT/H) on an intention-to-treat basis.
This review currently includes 42 RCTs with 3498 participants. When thioridazine was compared with placebo (total n=668, 14 RCTs) we found global state outcomes favoured thioridazine (n=105, 3 RCTs, RR 'no change or worse' by 6 months 0.33 CI 0.2 to 0.5, NNT of 2 CI 2 to 3). Thioridazine is sedating (n=324, 3 RCTs, RR 5.37 CI 3.2 to 9.1, NNH 4 CI 2 to 74). Generally, thioridazine did not cause more movement disorders than placebo.Twenty-seven studies (total n=2598) compared thioridazine with typical antipsychotics. We found no significant difference in global state (n=743, 11 RCTs, RR no short-term change or worse 0.98 CI 0.8 to 1.2) and medium-term assessments (n=142, 3 RCTs, RR 0.99, CI 0.6 to 1.6). We found no significant differences in the number of people leaving the study early 'for any reason' (short-term, n=1587, 19 RCTs, RR 1.07 CI 0.9 to 1.3). Extrapyramidal adverse events lower for those allocated to thioridazine (n=1082, 7 RCTs, RR use of antiparkinsonian drugs 0.45 CI 0.4 to 0.6). Thioridazine did seem associated with cardiac adverse effects (n=74, 1 RCT, RR 'any cardiovascular adverse event' 3.17 CI 1.4 to 7.0, NNH 3 CI 2 to 5). Electrocardiogram changes were significantly more frequent in the thioridazine group (n=254, 2 RCTs, RR 2.38, CI 1.6 to 3.6, NNH 4 CI 3 to 10). Six RCTs (total n=344) randomised thioridazine against atypical antipsychotics. Global state rating did not reveal any short-term difference between thioridazine and remoxipride and sulpiride (n=203, RR not improved or worse 1.00 CI 0.8 to 1.3). Limited data did not highlight differences in adverse event profiles.
AUTHORS' CONCLUSIONS: Although there are shortcomings, there appears to be enough consistency over different outcomes and periods to confirm that thioridazine is an antipsychotic of similar efficacy to other commonly used antipsychotics for people with schizophrenia. Its adverse events profile is similar to that of other drugs, but it may have a lower level of extrapyramidal problems and higher level of ECG changes. We would advocate the use of alternative drugs, but if its use in unavoidable, cardiac monitoring is justified.
硫利达嗪是一种抗精神病药物,尽管它与尖端扭转型室性心动过速这种心律失常有关,但仍可用于治疗精神分裂症。
综述硫利达嗪对精神分裂症患者的疗效。
为进行2006年的更新,我们检索了Cochrane精神分裂症研究组注册库(2006年6月)。
我们纳入了所有比较硫利达嗪与其他治疗方法治疗精神分裂症或其他精神病患者的随机临床试验。
我们从相关研究中可靠地选择、进行质量评分并提取数据。对于二分法数据,我们估计相对风险(RR)及95%置信区间(CI)。在可能的情况下,我们基于意向性分析计算治疗所需人数/伤害统计量(NNT/H)。
本综述目前纳入了42项随机对照试验,共3498名参与者。当将硫利达嗪与安慰剂进行比较时(共668例,14项随机对照试验),我们发现总体状态结果更倾向于硫利达嗪(105例,3项随机对照试验,6个月时RR“无变化或更差”为0.33,CI为0.2至0.5,NNT为2,CI为2至3)。硫利达嗪具有镇静作用(324例,3项随机对照试验,RR为5.37,CI为3.2至9.1,NNH为4,CI为2至74)。一般来说,硫利达嗪引起的运动障碍并不比安慰剂多。27项研究(共2598例)比较了硫利达嗪与典型抗精神病药物。我们发现在总体状态方面(743例,11项随机对照试验,RR短期无变化或更差为0.98,CI为0.8至1.2)以及中期评估中(142例,3项随机对照试验,RR为0.99,CI为0.6至1.6)无显著差异。我们发现在“因任何原因”提前退出研究的人数方面无显著差异(短期,1587例,19项随机对照试验,RR为1.07,CI为0.9至1.3)。分配至硫利达嗪组的患者锥体外系不良事件较少(1082例,7项随机对照试验,RR使用抗帕金森药物为0.45,CI为0.4至0.6)。硫利达嗪似乎确实与心脏不良反应有关(74例,1项随机对照试验,RR“任何心血管不良事件”为3.17,CI为1.4至7.0,NNH为3,CI为2至5)。硫利达嗪组心电图改变明显更频繁(254例,2项随机对照试验,RR为2.38,CI为1.6至3.6,NNH为4,CI为3至10)。6项随机对照试验(共344例)将硫利达嗪与非典型抗精神病药物进行随机分组。总体状态评分未显示硫利达嗪与瑞莫必利及舒必利之间有任何短期差异(203例,RR未改善或更差为1.00,CI为0.8至1.3)。有限的数据未突出不良事件谱的差异。
尽管存在不足,但在不同结局和时间段上似乎有足够的一致性来证实硫利达嗪对于精神分裂症患者是一种疗效与其他常用抗精神病药物相似的抗精神病药物。其不良事件谱与其他药物相似,但可能锥体外系问题水平较低而心电图改变水平较高。我们主张使用替代药物,但如果不可避免地要使用,进行心脏监测是合理的。