Marques L O, Lima M S, Soares B G O
Psychiatry, Mestrado de Saúde e Comportamento-Universidade Católica de Pelotas, Gonçalves Chaves 962 sala 302, Pelotas, Rio Grande do Sul, Brazil.
Cochrane Database Syst Rev. 2004;2004(1):CD003545. doi: 10.1002/14651858.CD003545.pub2.
Trifluoperazine is an inexpensive accessible 'high potency' antipsychotic drug, widely used to treat schizophrenia or related psychoses.
To estimate the effects of trifluoperazine compared with placebo and other drugs.
Searches of the Cochrane Schizophrenia Group's register of trials (March 2002), supplemented with hand searching, reference searching, personal communication and contact with industry.
All clinical randomised trials involving people with schizophrenia and comparing trifluoperazine with any other treatment.
Studies were reliably selected and quality rated and data was extracted. For dichotomous data, relative risks (RR) were estimated, with 95% confidence intervals (CI). Where possible, we undertook intention-to-treat analyses. For statistically significant results, the number needed to treat (NNT) was calculated. We estimated heterogeneity (I-square technique) and publication bias.
1162 people from 13 studies were randomised to trifluoperazine or placebo. For global improvement, small short-term studies favoured trifluoperazine (n=95, 3 RCTs, RR 0.62 CI 0.49 to 0.78 NNT 3 CI 2 to 4). Loss to follow up was about 12% in both groups (n=280, 7 RCTs, RR 0.99 CI 0.62 to 1.57) and more people allocated trifluoperazine used antiparkinson drugs to alleviate movements disorders compared with placebo (n=195, 4 RCTs, RR 5.06 CI 2.49 to 10.27, NNH 4 CI 2 to 9). 2230 people from 49 studies were randomised to trifluoperazine or another older generation antipsychotic. Trifluoperazine was not clearly different in terms of 'no substantial improvement' (n=1016, 27 RCTs, RR 1.06 CI 0.98 to 1.14) or leaving the study early (n=930, 22 RCTs, RR 1.15 CI 0.83 to 1.58). Almost identical numbers of people reported at least one adverse event (60%) in each group (n=585, 14 RCTs, RR 0.99 CI 0.87 to 1.13), although trifluoperazine was more likely to cause extrapyramidal adverse effects overall when compared to low potency antipsychotics such as chlorpromazine (n=130, 3 RCTs, RR 1.66 CI 1.03 to 2.67, NNH 6 CI 3 to 121). One small study (n=38) found no clear differences between trifluoperazine and the atypical drug, sulpiride.
REVIEWER'S CONCLUSIONS: Although there are shortcomings and gaps in the data, there appears to be enough consistency over different outcomes and periods to confirm that trifluoperazine is an antipsychotic of similar efficacy to other commonly used neuroleptics for people with schizophrenia. Its adverse events profile is similar to that of other drugs. It has been claimed that trifluoperazine is effective at low doses for patients with schizophrenia but this does not appear to be based on good quality trial based evidence.
三氟拉嗪是一种价格低廉、易于获取的“高效能”抗精神病药物,广泛用于治疗精神分裂症或相关精神病。
评估三氟拉嗪与安慰剂及其他药物相比的效果。
检索Cochrane精神分裂症研究组的试验注册库(2002年3月),并辅以手工检索、参考文献检索、个人交流以及与制药行业联系。
所有涉及精神分裂症患者且比较三氟拉嗪与其他任何治疗方法的临床随机试验。
对研究进行可靠选择、质量评级并提取数据。对于二分数据,估计相对风险(RR)及95%置信区间(CI)。尽可能进行意向性分析。对于具有统计学显著性的结果,计算需治疗人数(NNT)。估计异质性(I²技术)和发表偏倚。
13项研究中的1162人被随机分配至三氟拉嗪组或安慰剂组。对于整体改善情况,小型短期研究更倾向于三氟拉嗪(n = 95,3项随机对照试验,RR 0.62,CI 0.49至0.78,NNT 3,CI 2至4)。两组的失访率约为12%(n = 280,7项随机对照试验,RR 0.99,CI 0.62至1.57),与安慰剂相比,更多分配至三氟拉嗪组的人使用抗帕金森药物来缓解运动障碍(n = 195,4项随机对照试验,RR 5.06,CI 2.49至10.27,NNH 4,CI 2至9)。49项研究中的2230人被随机分配至三氟拉嗪组或另一种第一代抗精神病药物组。在“无显著改善”(n = 1016,27项随机对照试验,RR 1.06,CI 0.98至1.14)或提前退出研究(n = 930,22项随机对照试验,RR 1.15,CI 0.83至1.58)方面,三氟拉嗪没有明显差异。每组中报告至少一项不良事件的人数几乎相同(60%)(n = 585,14项随机对照试验,RR 0.99,CI 0.87至1.13),尽管与氯丙嗪等低效价抗精神病药物相比,三氟拉嗪总体上更易引起锥体外系不良反应(n = 130,3项随机对照试验,RR 1.66,CI 1.03至2.67,NNH 6,CI 3至121)。一项小型研究(n = 38)发现三氟拉嗪与非典型药物舒必利之间没有明显差异。
尽管数据存在缺点和差距,但在不同结果和时间段上似乎有足够的一致性来证实,对于精神分裂症患者,三氟拉嗪是一种与其他常用抗精神病药物疗效相似的抗精神病药物。其不良事件情况与其他药物相似。有人声称三氟拉嗪对精神分裂症患者低剂量有效,但这似乎并非基于高质量的试验证据。