甜梦胶囊(口服液)治疗睡眠障碍的Meta分析及GRADE评价  

Meta-analysis and GRADE evaluation of Tianmeng capsule(oral liquid)in the treatment of sleep disorders

作　　者：张东旭 孙伟新[2] 史海波[1,3] 封婕 ZHANG Dongxu;SUN Weixin;SHI Haibo;FENG Jie(Nanjing University of Chinese Medicine,Nanjing 210009;Cardiovascular Internal Medicine Department,Yancheng Hospital of Traditional Chinese Medicine,Nanjing University of Chinese Medicine,Yancheng 224000;Cardiovascular Internal Medicine Department,Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing 210001;Jiangsu Health Development Research Center,Nanjing 210036,China)

机构地区：[1]南京中医药大学,江苏南京210009 [2]南京中医药大学附属盐城中医院心血管内科,江苏盐城224000 [3]南京中医药大学附属医院心血管内科,江苏南京210001 [4]江苏省卫生健康发展研究中心,江苏南京210036

出　　处：《临床医学研究与实践》2025年第1期1-7,共7页Clinical Research and Practice

基　　金：江苏省卫生健康发展研究中心2022年度开放课题经费资助项目(No.JSHD2022010);溧阳市科学技术局项目(No.LC2020001)。

摘　　要：目的 系统评价甜梦胶囊(口服液)治疗睡眠障碍的有效性与安全性。方法 通过计算机检索中国期刊全文数据库(CNKI)、万方数据知识服务平台(Wanfang)、维普中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM)、PubMed、Embase、EBSCO、Cochrane Library数据库,检索时间均为建库至2021年3月,收集采用甜梦胶囊(口服液)治疗睡眠障碍的随机对照试验(RCT)。使用Cochrane偏倚风险评估工具评估纳入研究的质量。采用RevMan5.4及Stata14.0进行Meta分析,并使用GRADE profiler评价证据质量。结果 共纳入17篇文献,涉及1 396例患者。Meta分析结果显示,试验组的治疗有效率显著高于对照组(P<0.00001)。治疗后,试验组的匹兹堡睡眠质量指数(PSQI)评分显著低于对照组(P<0.00001)。治疗后,试验组的多导睡眠图(PSG)睡眠效率显著高于对照组(P<0.00001)。试验组的不良反应发生率低于对照组(P=0.03)。根据GRADE标准,有效率、PSQI评分、PSG睡眠效率为低质量证据,不良反应发生率为中等质量证据。结论 现有证据表明,甜梦胶囊(口服液)能有效提高睡眠效率,减少不良反应的发生,但上述结论尚需更多更高质量研究进一步验证。Objective To systematically evaluate the clinical efficacy and safety of Tianmeng capsule(oral liquid)in the treatment of sleep disorders.Methods The China National Knowledge Infrastructure(CNKI),Wanfang Data Knowledge Service Platform(Wanfang),VIP Chinese Science and Technology Journal Database(VIP),Chinese Biomedical Literature Database(CBM),PubMed,Embase,EBSCO and Cochrane Library databases were searched by computer.The search time was from the establishment of the database to March 2021,and randomized controlled trial(RCT)using Tianmeng capsule(oral liquid)for the treatment of sleep disorders were collected.The quality of the included studies was assessed using the Cochrane bias risk assessment tool.Meta-analysis was performed using RevMan5.4 and Stata14.0,and GRADE profiler was used to evaluate the quality of evidence.Results A total of 17 articles were included,involving 1396 patients.The results of Meta-analysis showed that the effective rate of treatment in the experimental group was significantly higher than that in the control group(P<0.00001).After treatment,the Pittsburgh Sleep Quality Index(PSQI)score of the experimental group was significantly lower than that of the control group(P<0.00001).After treatment,the polysomnography(PSG)sleep efficiency of the experimental group was significantly higher than that of the control group(P<0.00001).The incidence of adverse reactions in the experimental group was lower than that in the control group(P=0.03).According to the GRADE criteria,the effective rate,PSQI score and PSG sleep efficiency were low-quality evidence,and the incidence of adverse reactions was medium-quality evidence.Conclusion The existing evidence shows that Tianmeng capsule(oral liquid)can effectively improve sleep efficiency and reduce the incidence of adverse reactions,but the above conclusions need to be further verified by more high-quality studies.

关 键 词：甜梦胶囊(口服液) 睡眠障碍 META分析 GRADE评价 

分 类 号：R275.9[医药卫生—中西医结合]