【摘要】 目的:系统评价中医药治疗脑卒中后睡眠障碍(PSSD)的疗效与安全性,为临床用药决策提供科学依据。方法:全面搜集单纯中医药与中西医结合对比西药治疗PSSD的相关随机对照(RCT)文献,计算机综合检索维普数据库、万方数据库、中国知网及中国生物医学文献数据库、国外数据库Cochrane Library、EMbase与Pub Med,检索时间止于2014年10月31日;同时在大学图书馆以手工方式检索期刊资料库,对纳入研究的试验则依据Cochrane Handbook 5.1评估偏倚性风险及文献质量;采用软件Rev Man 5.2.6进行相关数据分析,并结合软件GRADE profiler对本研究其证据质量进行标化测评。结果:本研究共纳入22个RCT临床干预文献,受试者2 198例;Meta分析提示:在有效率评测层面,中西医结合其疗效优于单纯西药治疗(OR=2.71,95%CI[1.69,4.37]),单纯中医药与西药的有效率比较差异无统计学意义;在痊愈率评测层面,中西医结合其效应优于单纯西药治疗,单纯中医药和西药的痊愈率(临床控制率)比较差异无统计学意义;在PSQI评分层面,中西医结合其效应优于单纯西药治疗;在PSQI评分对单纯中医药与西药进行亚组分析,即干预2、4、8及12周其组间评分差异皆无统计学意义。在PSSD症状改善层面,中西医结合干预在入睡时间、睡眠质量、睡眠时间、睡眠效率、睡眠紊乱、催眠药物的应用、日间功能、AIS评分及SQ评分方面其疗效均优于单纯西药治疗;单纯中医药治疗与西药组比较,在上述方面评价,其组间评分差异皆无统计学意义。参考GRADE证据等级评估分析,本系统评价其测评级别为"很低"。安全性分析层面,中西医结合治疗PSSD患者其不良反应事件的发生率(1.88%)显著低于西药干预(11.57%),提示中医药干预相对更为可靠。结论:作为PSSD治疗的一种有效的干预措施,中医药相对更为安全可靠,不良反应较少,在结合西药对改善患者睡眠症状等方面显示其相对有效的趋势,单纯中医药与西药干预其效应相当。由于所纳入的文献质量不高,还不能得出可靠的结论,故仍亟需更多高质量的临床试验予以支持,才可为诊断性实践提供相对可靠的决策依据。更多还原

【Abstract】 Objective: To systematically evaluate efficacy and adverse events of Chinese herbal medicine(CHM) for the treatment of Post-stroke sleep disorders(PSSD). Methods: RCT involving CHM or integrative medicine comparing with routine pharmacotherapy for PSSD were retrieved and collected from Database of VIP, WANFANG, CNKI, CBM, Pub Med, EMbase, and the Cochrane Library. The journals related to the research were also manually searched from college library. The quality of literature was conducted by the risk of bias and quality evaluation based on the Cochrane Handbook 5.1, while the data analysis was handled by the software Rev Man 5.2.6 of Cochrane Collaboration. The evidence quality grading evaluation for the system review was operated by the software of ‘GRADE profiler’. Results: Twenty-two studies involving 2,198 participants were contained in the meta-analysis. The main meta-analysis results indicated relative benefits for the effective rate in five studies(odds ratio [OR] 2.71, 95% confidence interval [CI] 1.69, 4.37), the cure(control) rate, the symptoms improvement of sleep disorders i.e. time of sleeping, quality of sleep, hour of sleep, efficiency of sleep, disorders of sleep, application of hypnotic drugs, function in daytime, total scale of Pittsburgh Sleep Quality Index(PSQI), scale of Athens Insomnia(AIS) and scale of Sleeping Quotient(SQ) in favor of the CHM plus routine pharmacotherapy group. For CHM compared with routine pharmacotherapy, no significant difference was revealed in effective rate, cure rate, and the detailed sub-group of PSQI score at the timing-point of week-2, week-4, week-8 and week-12, and other symptoms improvement of sleep disorders. The GRADE quality level of this systematic review indicated "very low". Compared to the routine pharmacotherapy group(11.57%), the incidence of adverse events of CHM(1.88%) was much lower, indicated CHM relatively safer than the routine pharmacotherapy. Conclusions: As a relative safe intervention method for PSSD, CHM showed benefits with few adverse reactions and relative better effect of symptoms improvement incorporated with the routine pharmacotherapy; CHM revealed no statistical difference while in contrast with routine pharmacotherapy. Further studies of rigorous design were required to conducted and provided reference for the decision-making of clinical practice.更多还原