Tardy Magdolna, Huhn Maximilian, Kissling Werner, 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 9;2014(7):CD009268. doi: 10.1002/14651858.CD009268.pub2.
Antipsychotic drugs are the core treatment for schizophrenia. Treatment guidelines state that there is no difference in efficacy between antipsychotic compounds, however, low-potency antipsychotic drugs are often clinically perceived as less efficacious than high-potency compounds, and they also seem to differ in their side-effects.
To review the effects in clinical response of haloperidol and low-potency antipsychotics for people with schizophrenia.
We searched the Cochrane Schizophrenia Group Trials Register (July 2010).
We included all randomised trials comparing haloperidol 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. For continuous data, we calculated mean differences (MD), again based on a random-effects model.
The review currently includes 17 randomised trials and 877 participants. The size of the included studies was between 16 and 109 participants. All studies were short-term with a study length between two and 12 weeks. Overall, sequence generation, allocation procedures and blinding were poorly reported. We found no clear evidence that haloperidol was superior to low-potency antipsychotic drugs in terms of clinical response (haloperidol 40%, low-potency drug 36%, 14 RCTs, n = 574, RR 1.11, CI 0.86 to 1.44 lowquality evidence). There was also no clear evidence of benefit for either group in acceptability of treatment with equivocal difference in the number of participants leaving the studies early due to any reason (haloperidol 13%, low-potency antipsychotics 17%, 11 RCTs, n = 408, RR 0.82, CI 0.38 to 1.77, low quality evidence). Similar equivocal results were found between groups for experiencing at least one adverse effect (haloperidol 70%, low-potency antipsychotics 35%, 5 RCTs n = 158, RR 1.97, CI 0.69 to 5.66, very low quality evidence ). More participants from the low-potency drug group experienced sedation (haloperidol 14%, low-potency antipsychotics 41%, 2 RCTs, n = 44, RR 0.30, CI 0.11 to 0.82, moderate quality evidence), orthostasis problems (haloperidol 25%, low-potency antipsychotics 71%, 1 RCT, n = 41, RR 0.35, CI 0.16 to 0.78) and weight gain (haloperidol 5%, low-potency antipsychotics 29%, 3 RCTs, n = 88, RR 0.22, CI 0.06 to 0.81). In contrast, the outcome 'at least one movement disorder' was more frequent in the haloperidol group (haloperidol 72%, low-potency antipsychotics 41%, 5 RCTs, n = 170, RR 1.64, CI 1.22 to 2.21, low quality evidence). No data were available for death or quality of life. The results of the primary outcome were robust in several subgroup and sensitivity analyses.
AUTHORS' CONCLUSIONS: The results do not clearly show a superiority in efficacy of haloperidol compared with low-potency antipsychotics. Differences in adverse events were found for movement disorders, which were more frequent in the haloperidol group, and orthostatic problems, sedation and weight gain, which were more frequent in the low-potency antipsychotic group. The quality of studies was low, and the quality of evidence for the main outcomes of interest varied from moderate to very low, so more newer studies would be needed in order to draw a definite conclusion about whether or not haloperidol is superior or inferior to low-potency antipsychotics.
抗精神病药物是精神分裂症的核心治疗手段。治疗指南指出,各抗精神病药物在疗效上并无差异,然而,低效价抗精神病药物在临床上常被认为疗效不如高效价药物,且它们在副作用方面似乎也有所不同。
综述氟哌啶醇和低效价抗精神病药物对精神分裂症患者临床反应的影响。
我们检索了Cochrane精神分裂症组试验注册库(2010年7月)。
我们纳入了所有比较氟哌啶醇与第一代低效价抗精神病药物用于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)。对于连续性数据,同样基于随机效应模型计算平均差(MD)。
该综述目前纳入了17项随机试验和877名参与者。纳入研究的样本量在16至109名参与者之间。所有研究均为短期,研究时长在2至12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。我们没有发现明确证据表明氟哌啶醇在临床反应方面优于低效价抗精神病药物(氟哌啶醇40%,低效价药物36%,14项随机对照试验,n = 574,RR 1.11,CI 0.86至1.44,低质量证据)。在因任何原因提前退出研究的参与者数量上,两组在治疗可接受性方面也没有明显的益处差异(氟哌啶醇13%,低效价抗精神病药物17%,11项随机对照试验,n = 408,RR 0.82,CI 0.38至1.77,低质量证据)。在至少经历一种不良反应方面,两组也有类似的不明确结果(氟哌啶醇70%,低效价抗精神病药物35%,5项随机对照试验,n = 158,RR 1.97,CI 0.69至5.66,极低质量证据)。更多来自低效价药物组的参与者出现了镇静作用(氟哌啶醇14%,低效价抗精神病药物41%,2项随机对照试验,n = 44,RR 0.30,CI 0.11至0.82,中等质量证据)、体位性低血压问题(氟哌啶醇25%,低效价抗精神病药物71%,1项随机对照试验,n = 41,RR 0.35,CI 0.16至0.78)和体重增加(氟哌啶醇5%,低效价抗精神病药物29%,3项随机对照试验,n = 88,RR 0.22,CI 0.06至0.81)。相比之下,“至少出现一种运动障碍”这一结果在氟哌啶醇组更为常见(氟哌啶醇72%,低效价抗精神病药物41%,5项随机对照试验,n = 170,RR 1.64,CI 1.22至2.21,低质量证据)。没有关于死亡或生活质量的数据。主要结果在多个亚组分析和敏感性分析中较为稳健。
结果并未明确显示氟哌啶醇在疗效上优于低效价抗精神病药物。在不良事件方面存在差异,运动障碍在氟哌啶醇组更为常见,而体位性低血压问题、镇静作用和体重增加在低效价抗精神病药物组更为常见。研究质量较低,主要关注结果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才能得出关于氟哌啶醇优于或劣于低效价抗精神病药物的确切结论。