Tardy Magdolna, Dold Markus, Engel Rolf R, Leucht Stefan
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München Klinikum rechts der Isar, Möhlstr. 26, München, Germany, 81675.
Cochrane Database Syst Rev. 2014 Jul 8;2014(7):CD009396. doi: 10.1002/14651858.CD009396.pub2.
Antipsychotic drugs are the core treatment for schizophrenia. Treatment guidelines state that there is no difference in efficacy between any other antipsychotic compounds, however, low-potency antipsychotic drugs are often perceived as less efficacious than high-potency compounds by clinicians, and they also seem to differ in their side-effects.
To review the effects in response to treatment of trifluoperazine and low-potency antipsychotics for people with schizophrenia.
We searched the Cochrane Schizophrenia Group's Trials Register (November 2010).
We included all randomised trials comparing trifluoperazine with first-generation low-potency antipsychotic drugs for people with schizophrenia or schizophrenia-like psychosis.
We extracted data independently. For dichotomous data we calculated risk ratios (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis based on a random-effects model.
The review currently includes seven randomised trials involving 422 participants that compared trifluoperazine with low-potency antipsychotic drugs. The size of the included studies was between 20 and 157 participants with a study length between four and 52 weeks. Overall, sequence generation, allocation procedures and blinding were poorly reported. Trifluoperazine was not significantly different from low-potency antipsychotic drugs in terms of response to treatment (trifluoperazine 26%, low-potency drug 27%, 3 RCTs, n = 120, RR 0.96 CI 0.59 to 1.56, moderate quality evidence). There was also no significant difference in acceptability of treatment with equivocal number of participants leaving the studies early due to any reason (trifluoperazine 20%, low-potency antipsychotics 16%, 3 RCTs, n = 239, RR 1.25, CI 0.72 to 2.17,low quality evidence). There was no significant difference in numbers with at least one adverse effect (trifluoperazine 60%, low-potency antipsychotics 38%, 1 RCT, n = 60, RR 1.60, CI 0.94 to 2.74, moderate quality evidence). However, at least one movement disorder was significantly more frequent in the trifluoperazine group (trifluoperazine 23%, low-potency antipsychotics 13%, 2 RCTs, n = 123, RR 2.08 CI 0.78 to 5.55, very low quality evidence) as well as incoordination (trifluoperazine 20%, low-potency antipsychotics 5%, 1 RCT, n = 60, RR 7.00, CI 1.60 to 30.66) and rigor (trifluoperazine 45%, low-potency antipsychotics 10%, 1 RCT, n = 60, RR 4.50, CI 1.58 to 12.84). No data were available for other outcomes of interest death, sedation and quality of life.
AUTHORS' CONCLUSIONS: The results did not show a difference in efficacy between trifluoperazine and low-potency antipsychotics. Trifluoperazine produced more movement disorders. The number of randomised studies as well as their quality is low, the quality of evidence for outcomes of interest ranged from moderate to very low quality, so more, newer studies would be needed for conclusions about the relative effects of trifluoperazine and low-potency antipsychotics.
抗精神病药物是精神分裂症的核心治疗药物。治疗指南指出,任何其他抗精神病药物在疗效上并无差异,然而,临床医生通常认为低效价抗精神病药物的疗效不如高效价药物,而且它们在副作用方面似乎也有所不同。
综述三氟拉嗪和低效价抗精神病药物对精神分裂症患者的治疗效果。
我们检索了Cochrane精神分裂症研究组的试验注册库(2010年11月)。
我们纳入了所有比较三氟拉嗪与第一代低效价抗精神病药物治疗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,我们基于随机效应模型,在意向性分析的基础上计算风险比(RR)及其95%置信区间(CI)。
该综述目前包括7项随机试验,涉及422名参与者,比较了三氟拉嗪与低效价抗精神病药物。纳入研究的样本量在20至157名参与者之间,研究时长在4至52周之间。总体而言,序列生成、分配程序和盲法的报告质量较差。在治疗反应方面,三氟拉嗪与低效价抗精神病药物无显著差异(三氟拉嗪26%,低效价药物27%,3项随机对照试验,n = 120,RR 0.96,CI 0.59至1.56,中等质量证据)。因任何原因提前退出研究的参与者数量不明确,在治疗可接受性方面也无显著差异(三氟拉嗪20%,低效价抗精神病药物16%,3项随机对照试验,n = 239,RR 1.25,CI 0.72至2.17,低质量证据)。至少出现一种不良反应的人数无显著差异(三氟拉嗪60%,低效价抗精神病药物38%,1项随机对照试验,n = 60,RR 1.60,CI 0.94至2.74,中等质量证据)。然而,三氟拉嗪组至少出现一种运动障碍的频率显著更高(三氟拉嗪23%,低效价抗精神病药物13%,2项随机对照试验,n = 123,RR 2.08,CI 0.78至5.55,极低质量证据),还有共济失调(三氟拉嗪20%,低效价抗精神病药物5%,1项随机对照试验,n = 60,RR 7.00,CI 1.60至30.66)和强直(三氟拉嗪45%,低效价抗精神病药物10%,1项随机对照试验,n = 60,RR 4.50,CI 1.58至12.84)。关于其他感兴趣的结局,如死亡、镇静和生活质量,没有可用数据。
结果未显示三氟拉嗪与低效价抗精神病药物在疗效上存在差异。三氟拉嗪会产生更多的运动障碍。随机研究的数量及其质量较低,感兴趣结局的证据质量从中等质量到极低质量不等,因此需要更多、更新的研究来得出关于三氟拉嗪和低效价抗精神病药物相对效果的结论。