阿立哌唑与氟哌啶醇治疗急性双相躁狂症的疗效比较：双盲、随机、对照12周试验。
Effectiveness of aripiprazole v. haloperidol in acute bipolar mania: double-blind, randomised, comparative 12-week trial.
作者信息
Vieta Eduard, Bourin Michel, Sanchez Raymond, Marcus Ronald, Stock Elyse, McQuade Robert, Carson William, Abou-Gharbia Neveen, Swanink Rene, Iwamoto Taro
机构信息
Director of Research, Clinical Institute of Neuroscience, Hospital Clinic, University of Barcelona, Spain.
出版信息
Br J Psychiatry. 2005 Sep;187:235-42. doi: 10.1192/bjp.187.3.235.
BACKGROUND
Despite several treatmentoptions, adherenceto therapy is poor in patients with bipolar disorder.
AIMS
A double-blind, controlled comparison of aripiprazole and haloperidol in patients with bipolar I disorder experiencing acute manic or mixed episodes.
METHOD
Patients (n=347) were randomised to receive aripiprazole or haloperidol in this 12-week, multicentre study. The primary outcome measure was the number of patients in response (greater, similar 50% improvement from baseline in Young Mania Rating Scale score) and receiving therapy at week 12.
RESULTS
At week 12, significantly more patients taking aripiprazole (49.7%) were in response and receiving therapy compared with those taking haloperidol (28.4%; P < 0.001). Continuation rates differed markedly between treatments (week 12: aripiprazole, 50.9%; haloperidol, 29.1%). Extrapyramidal adverse events were more frequent with haloperidol than aripiprazole (62.7% v. 24.0%).
CONCLUSIONS
Aripiprazole showed superior levels of response and tolerability to haloperidol in the treatment of an acute manic episode for up to 12 weeks.
背景
尽管有多种治疗选择，但双相情感障碍患者的治疗依从性较差。
目的
对阿立哌唑和氟哌啶醇在患有I型双相情感障碍且经历急性躁狂或混合发作的患者中进行双盲对照比较。
方法
在这项为期12周的多中心研究中，347名患者被随机分配接受阿立哌唑或氟哌啶醇治疗。主要结局指标是在第12周时出现反应（青年躁狂评定量表评分较基线改善50%以上、相似）并接受治疗的患者数量。
结果
在第12周时，与服用氟哌啶醇的患者（28.4%）相比，服用阿立哌唑的患者中有更多患者出现反应并接受治疗（49.7%；P<0.001）。不同治疗组的持续治疗率差异显著（第12周：阿立哌唑为50.9%；氟哌啶醇为29.1%）。氟哌啶醇组的锥体外系不良事件比阿立哌唑组更频繁（62.7%对24.0%）。
结论
在长达12周的急性躁狂发作治疗中，阿立哌唑在反应水平和耐受性方面均优于氟哌啶醇。
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