首页|舒眠胶囊治疗失眠有效性和安全性的系统评价与Meta分析

舒眠胶囊治疗失眠有效性和安全性的系统评价与Meta分析

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系统评价舒眠胶囊治疗失眠的有效性和安全性.检索数据库中舒眠胶囊治疗失眠的随机对照试验(RCT),采用RevMan 5.4 软件对纳入研究进行Meta分析.最终纳入 23 篇RCTs,样本量 2 621 例.Meta分析结果显示,舒眠胶囊治疗失眠(RR=1.07,95%CI[1.03,1.10],P=0.000 2)与失眠伴抑郁(RR=1.13,95%CI[1.02,1.25],P=0.02)患者临床总有效率均具有优势.舒眠胶囊改善失眠(MD=-0.75,95%CI[-1.33,-0.17],P= 0.01)和失眠伴抑郁(MD=-2.51,95%CI[-2.96,-2.06],P<0.000 01)患者匹茨堡睡眠质量指数量表(Pittsburgh sleep quality index,PSQI)评分均具有优势.舒眠胶囊单用(RR=0.33,95%CI[0.24,0.46],P<0.000 01)或舒眠胶囊+常规西药(RR=0.71,95%CI[0.54,0.95],P=0.02)治疗失眠与单纯常规西药比较均可降低不良事件发生率.另外,舒眠胶囊改善失眠伴抑郁患者汉密尔顿抑郁量表(Hamilton depression scale,HAMD)评分具有优势(P<0.000 1),可降低失眠患者血清中 5-羟色胺(5-HT)、促甲状腺激素(TSH)、三碘甲状腺原氨酸(T3)、甲状腺素(T4)水平(P<0.05).证据质量评价多为中、低级质量.结果表明,舒眠胶囊治疗失眠具有较好的有效性和安全性,且可改善症状评分,可能与降低血清中 5-HT、TSH、T3、T4 水平有关.鉴于研究证据质量,临床实践中应综合判定后再考虑应用.
Systematic review and Meta-analysis of efficacy and safety of Shumian Capsules in treatment of insomnia
This study aims to assess the safety and efficacy of Shumian Capsules in the treatment of insomnia.Randomized con-trolled trial(RCT)about Shumian Capsules for insomnia were retrieved from databases.RevMan 5.4 was used for statistical analysis.A total of 23 articles were included,involving 2 621 patients.Meta-analysis showed that Shumian Capsules had advantages in the treat-ment of insomnia(RR= 1.07,95%CI[1.03,1.10],P= 0.000 2)and insomnia with depression(RR= 1.13,95%CI[1.02,1.25],P=0.02)in terms of total response rate.Shumian Capsules had advantages in the treatment of insomnia(MD=-0.75,95%CI[-1.33,-0.17],P=0.01)and insomnia with depression(MD=-2.51,95%CI[-2.96,-2.06],P<0.000 01)in terms of PSQI score.The incidence of adverse events in the Shumian Capsules(RR=0.33,95%CI[0.24,0.46],P<0.000 01)and Shumian Capsules + conventional western medicine(RR=0.71,95%CI[0.54,0.95],P=0.02)was lower than that in the conventional wes-tern medicine alone.In addition,Shumian Capsules had an advantage in treating insomnia complicated with depression in terms of HAMD score(P<0.000 1)and reducing the serum levels of 5-HT,TSH,T3,and T4 in insomnia patients(P<0.05).The quality of evidence was mostly medium or low.The studies demonstrate that Shumian Capsules is effective and safe for treating insomnia,which may be related to the mechanism of lowering the levels of 5-HT,TSH,T3,and T4 in the serum.In view of the quality of evidence,the application of Shumian Capsules should be considered after comprehensive evaluation in clinical practice.

Shumian Capsulesinsomniasystematic reviewMeta-analysis

单心觉、康丹、陈哲、张诗语、刘春香

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天津中医药大学 第一附属医院 国家中医针灸临床研究中心, 天津 300381

天津中医药大学 循证医学中心, 天津 301617

东北师范大学, 吉林 长春 130024

舒眠胶囊 失眠 系统评价 Meta分析

天津市教委天津市高等学校创新团队培养计划

TD13-5047

2024

中国中药杂志
中国药学会

中国中药杂志

CSTPCD北大核心
影响因子:1.718
ISSN:1001-5302
年,卷(期):2024.49(1)
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