褪黑素治疗精神分裂症患者迟发性运动障碍的meta分析

目的:此荟萃分析基于随机对照试验(RCTs)文献系统评估褪黑素对精神分裂症患者迟发性运动障碍的临床疗效和安全性.方法:两位独立评估者从以下数据库对相关的临床随机对照试验(RCT)文献进行检索(万方数据、中国知网(CNKI)、中国生物医学文摘数据库和PubMed、PsycINFO、Embase、Cochrane Library数据库),检索时间截止于2017年6月8日.以TD症状严重程度为主要结局指标,采用Rev Man 5.3版本进行统计分析,对RCTs的质量评估采用Cochrane风险评估偏倚和Jadad量表来评估各种偏倚的风险性.采用GRADE(Grades of Recommendation,Assessment,Development,and Evaluation)系统推荐分级方法对meta-分析结果的整体证据质量水平进行分级评价.结果:最终筛选确定4个RCTs(n=130).3个RCTs采用双盲法,1个RCT单盲,根据Cochrane风险评估偏倚和Jadad量表显示3个RCTs的疗效评估指标的证据质量被评定为"高质量".与对照组相比,根据不自主运动量表(AIMS)评定褪黑素可改善TD严重程度(4个RCTs,n=130,加权平均差值(WMD):-1.52(95%CI:-3.24,0.20),p=0.08;I2=0%),但尚没有达到显著差异.根据等级方法,改善TD症状的meta分析结果的整体证据质量被评为"低",而关于不良反应和认知损害方面则数据太少.结论:荟萃分析表明,褪黑素或可改善精神分裂症TD症状.但仍有待今后更高质量和更大样本的RCTs验证.

Adjuncitve melatonin for tardive dyskinesia in paitents with schizophrenia: a meta-analysis

Aims:This meta-analysis based on randomized controlled trials (RCTs) systematically assessed the therapeuitc effect and tolerability of melatonin for TD in schizophrenia.Methods: A computerized and systematical search of both Chinese (Wanfang Data, Chinese National Knowledge Infrastructure (CNKI), SINOMED) and English (PubMed, PsycINFO, Embase, Cochrane Library databases) databases, from their incepiton unitl June 8, 2017,was conducted by two independent authors. The severity of TD symptoms were the primary outcome measure and analyzed using a random effects model by the Review Manager (RevMan) Version 5.3. Quality evaluaiton of included RCTs was conducted using the Cochrane risk of bias and Jadad scale. The GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system recommendation grading method was used to assess the overall quality level of meta-analyitc outcomes.Results: Four RCTs (n=130) were identified and analyzed. Three RCTs used double blind and 1 RCT used masked assessors using the Cochrane risk of bias, and 3 RCTs were rated as high quality based on Jadad scale. Compared with the control group, adjuncitve melatonin was superior in reducing the severity of TD as measured by the Abnormal Involuntary Movement Scale (AIMS) (4 RCTs, n=130, weighted mean difference (WMD): -1.52 (95% confidence intervals (CI): -3.24, 0.20),p=0.08;I2=0%) although the improvement did not reach a significant level. The overall evidence quality of the improvement of TD symptoms, according to GRADE approach, was rated as "Low". The data on the ADRs and cognitive effect were limited.Conclusions:This meta-analysis shows that melatonin has potential for improving TD symptoms in schizophrenia. Future higher quality and larger RCTs are warranted to conifrm the ifndings.