标题：甜梦口服液治疗失眠的有效性和安全性的Meta分析

      作者：姚苗苗 1，张玉荣 2    1.西安高新医院临床试验机构，陕西 西安 710075；2.西安医学院第一附属医院科研科，陕西 西安 710077

      卷次： 2021年32卷21期

      【摘要】 目的 评价甜梦口服液治疗失眠的临床疗效和安全性。方法 按照Cochrane系统评价的方法用计算机检索Cochrane图书馆、Web of Science、Medline、Embase、中国期刊全文数据库(CNKI)、维普数据库、万方数据库、中国生物医学文献数据库(CBM)，检索时限从建库截止 2020年 9月，进行文献检索和数据提取，用RevMan5.3软件对文献数据进行Meta分析。结果 纳入14项随机对照临床试验，涉及1 391例患者。Meta结果显示：临床总有效率试验组(92.61%)高于对照组(74.00%) (OR=4.51，95%CI：3.17~6.40，P<0.000 1)；汉密尔顿抑郁量表(HAMD)总分试验组低于对照组(MD=-3.57，95%CI：-5.41~-1.73，P<0.000 1)；匹兹堡睡眠质量指数(PSQI)总分试验组低于对照组(MD=-3.27，95%CI：-4.40~-2.13，P<0.000 1)；不良反应试验组发生率(6.21%)低于对照组(13.33%) (OR=0.45，95%CI：0.25~0.81，P=0.007)。结论 甜梦口服液可有效改善失眠患者的临床有效率，改善患者HAMD评分及PSQI评分，不增加ADR的风险，可用于失眠患者的治疗。
      【关键词】 甜梦口服液；临床疗效；失眠；有效性；安全性；Meta分析
      【中图分类号】 R256.23 【文献标识码】 A 【文章编号】 1003—6350（2021）21—2824—07

Efficacy and safety of Tianmeng oral liquid in the treatment of insomnia: a meta-analysis.
YAO Miao-miao 1,ZHANG Yu-rong 2. 1. Clinical Trial Institution, Xi'an Gaoxin Hospital, Xi'an 710075, Shaanxi, CHINA; 2. ScientificResearch Section, the First Affiliated Hospital of Xi'an Medical University, Xi'an 710077, Shaanxi, CHINA
【Abstract】 Objective To evaluate the clinical efficiency and safety of Tianmeng oral liquid in the treatment ofinsomnia. Methods According to the method of Cochrane systematic review, we searched the Cochrane Library, Webof Science, Medline, Embase, Chinese Journal Full-text Database (CNKI), VIP Database, Wanfang Database, China Bio-medical Literature Database (CBM), with the search time limit from inception to September 2020, for randomized con-trolled clinical trials (RCTs) involving Tianmeng oral liquid in the treatment of insomnia. Meta-analysis was performedby Rev Man 5.3. Results A total of 14 RCTs were included, involving 1 391 patients. Meta-analysis showed that the to-tal clinical effective rate in the treatment group was higher than that in the control group (92.61% vs 74.00%, OR=4.51,95%CI: 3.17 to 6.40, P<0.000 01). The total HAMA score of the treatment group was lower than that of control group(MD=-3.27, 95%CI: -4.40 to -2.13, P<0.000 01). The total PSQI score of the treatment group was lower than that ofcontrol group (MD= -3.27, 95% CI: -4.40 to -2.13, P<0.000 01). The incidence of ADR in the treatment group waslower than that in the control group (6.21% vs 13.33%, OR=0.45, 95%CI: 0.25 to 0.81, P=0.007). Conclusion TheTianmeng oral liquid can effectively improve the clinical effectiveness of patients with insomnia, and improve the HA-MA score and PSQI score of the patients, without increasing the risk of ADR, which can be used for the treatment of pa-tients with insomnia.
      【Key words】 Tianmeng oral liquid; Clinical efficacy; Insomnia; Efficacy; Safety; Meta-analysis·荟萃分析·doi:10.3969/j.issn.1003-6350.2021.21.028