中西医结合治疗帕金森病睡眠障碍随机对照试验的Meta分析  

Meta-analysis on Randomized Controlled Trials of Integrated Chinese and Western Medicine for Parkinson's Disease with Sleep Disorders

作　　者：许玉珉 黑赏艳 章时杰 王馨晨 许婷婷 李宏英 陈云波 王奇 梁伟雄 XU Yu-Min;HEI Shang-Yan;ZHANG Shi-Jie;WANG Xin-Chen;XU Ting-Ting;LI Hong-Ying;CHEN Yun-Bo;WANG Qi;LIANG Wei-Xiong(DMECenter, the Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou 510405 Guangdong, China)

机构地区：[1]广州中医药大学第二临床医学院DME中心,广东广州510405

出　　处：《广州中医药大学学报》2018年第3期540-548,共9页Journal of Guangzhou University of Traditional Chinese Medicine

基　　金：国家重大新药创制专项资助项目(编号:2012ZX09303009-003)

摘　　要：【目的】系统评价中西医结合治疗帕金森病睡眠障碍的有效性及安全性。【方法】在中文数据库如中国知网(CNKI)、万方数据库(Wanfang Data)、中国生物医学文献数据库(CBM)、维普数据库(VIP)以及国外数据库如Pub Med、Web of Science、The Cochrane Library、Embase、MEDLINE(Ovid)数据库中,全面检索国内外期刊已公开发表的有关中西医结合用药(治疗组)对照单纯西药(对照组)干预帕金森病睡眠障碍的随机对照试验(RCTs),采用Cochrane协作网Meta分析的方法进行文献质量的评价,应用Rev Man5.3软件进行数据分析。【结果】最终符合纳入标准的文献共17篇,样本量为1 346例。Meta分析结果显示:与单纯西药治疗比较,中西医结合用药的临床疗效显著提高[OR=4.12,95%CI(2.97,5.72),P<0.01];在改善帕金森病睡眠量表(PDSS)评分[SMD=0.85,95%CI(0.16,1.55),P<0.05]、Epworth嗜睡量表(ESS)评分[SMD=-0.85,95%CI(-1.35,-0.36),P<0.01]、帕金森病综合评定量(UPDRS)评分[SMD=-1.15,95%CI(-1.40,-0.90),P<0.01]、匹兹堡睡眠质量指数(PSQI)评分[SMD=-0.38,95%CI(-0.64,-0.11),P<0.01]和不良反应发生率[SMD=0.07,95%CI(0.01,0.41),P<0.01]方面,中西医结合用药均优于单纯西药治疗;安全性评估方面,治疗组的不良事件发生率(3.08%)明显低于单纯西药干预(9.45%)。【结论】中医药联合西药治疗帕金森病睡眠障碍较单纯西药更为安全可靠,且不良反应较少,但尚需更多高质量大样本的临床随机对照试验予以证实。Objective To make a systematic evaluation of the efficacy and safety of integrated Chinese andwestern medicine for Parkinson＇s disease with sleep disorders. Methods After retrieving the randomizedcontrolled trials（RCTs）of integrated Chinese and western medicine（treatment group）vs western medicine alone（control group）for Parkinson＇s disease with sleep disorders from the databases of CNKI,Wanfang Data,CBM,VIP, Pub Med, Web of Science, the Cochrane Library, Embase, MEDLINE（Ovid）, we made a systematicevaluation and Meta-analysis for the literatures with the methods of Cochrane and Rev Man5.3 software. Results Atotal of 17 RCTs involving 1 346 cases were included into the analysis. The results of Meta-analysis showed thatintegrated Chinese and western medicine had stronger effect than western medicine alone for Parkinson＇s diseasewith sleep disorders [OR = 4.12, 95% CI（2.97, 5.72）, P〈0.01], and was more effective on improving Parkinson＇s Disease Sleep Scale（PDSS） scores [SMD = 0.85, 95% CI（0.16, 1.55）, P〈0.05], EpworthSleeping Scale（ESS）scores [SMD =-0.85, 95% CI（-1.35,-0.36）, P〈0.01], Unified Parkinson＇s DiseaseRating Scale（UPDRS）scores [SMD =-1.15,95%CI（-1.40,-0.90）,P〈0.01],Pittsburgh Sleep Quality Index（PSQI）scores [SMD =-0.38,95%CI（-0.64,-0.11）,P〈0.01] and adverse reaction incidence [SMD = 0.07,95%CI（0.01,0.41）,P〈0.01]. The incidence of adverse events of the treatment group was 3.08%,lower than thewestern medicine（9.45%）. Conclusion Integrated Chinese and western medicine exerts stronger effect and is moresafer than western medicine alone for Parkinson＇s disease with sleep disorders. But the conclusion needs morehigh-quality large-scale RCTs to verify.

关 键 词：帕金森病睡眠障碍/中西医结合疗法 随机对照试验 META分析 系统评价 

分 类 号：R256.23[医药卫生—中医内科学] R742.5[医药卫生—中医学]