阿立哌唑每月 1 次治疗精神分裂症的疗效：双盲、随机、非劣效性研究。
Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study.
机构信息
W. Wolfgang Fleischhacker, MD, Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria; Raymond Sanchez, MD, Pamela P. Perry, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Na Jin, MS, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA; Timothy Peters-Strickland, MD, Brian R. Johnson, MS, Ross A. Baker, PhD, MBA, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; Anna Eramo, MD, Lundbeck LLC, Deerfield, Illinois, USA; Robert D. McQuade, PhD, William H. Carson, MD, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA; David Walling, PhD, Collaborative NeuroScience Network, Inc., Garden Grove, California, USA; John M. Kane, MD, The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine, Hempstead, New York, USA.
出版信息
Br J Psychiatry. 2014 Aug;205(2):135-44. doi: 10.1192/bjp.bp.113.134213. Epub 2014 Jun 12.
BACKGROUND
Long-acting injectable formulations of antipsychotics are treatment alternatives to oral agents.
AIMS
To assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia.
METHOD
A 38-week, double-blind, active-controlled, non-inferiority study; randomisation (2:2:1) to aripiprazole once-monthly 400 mg, oral aripiprazole (10-30 mg/day) or aripiprazole once-monthly 50 mg (a dose below the therapeutic threshold for assay sensitivity). (
TRIAL REGISTRATION
clinicaltrials.gov, NCT00706654.)
RESULTS
A total of 1118 patients were screened, and 662 responders to oral aripiprazole were randomised. Kaplan-Meier estimated impending relapse rates at week 26 were 7.12% for aripiprazole once-monthly 400 mg and 7.76% for oral aripiprazole. This difference (-0.64%, 95% CI -5.26 to 3.99) excluded the predefined non-inferiority margin of 11.5%. Treatments were superior to aripiprazole once-monthly 50 mg (21.80%, P < or = 0.001).
CONCLUSIONS
Aripiprazole once-monthly 400 mg was non-inferior to oral aripiprazole, and the reduction in Kaplan-Meier estimated impending relapse rate at week 26 was statistically significant v. aripiprazole once-monthly 50 mg.
背景
长效注射用抗精神病药物是口服药物的替代治疗方法。
目的
评估阿立哌唑每月 1 次与口服阿立哌唑用于精神分裂症维持治疗的疗效。
方法
一项 38 周、双盲、活性对照、非劣效性研究；按 2:2:1 比例随机分配至阿立哌唑每月 400mg、口服阿立哌唑（10-30mg/天）或阿立哌唑每月 50mg（低于检测灵敏度的治疗阈值剂量）。（临床试验.gov，NCT00706654。）
结果
共筛选了 1118 例患者，其中 662 例口服阿立哌唑应答者被随机分组。Kaplan-Meier 估计在第 26 周即将发生的复发率，阿立哌唑每月 400mg 组为 7.12%，口服阿立哌唑组为 7.76%。该差异（-0.64%，95%CI-5.26 至 3.99）排除了预先设定的非劣效性界值 11.5%。两种治疗均优于阿立哌唑每月 50mg 组（21.80%，P<或=0.001）。
结论
阿立哌唑每月 400mg 与口服阿立哌唑相当，且第 26 周时Kaplan-Meier 估计的即将复发率降低具有统计学意义，优于阿立哌唑每月 50mg 组。
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