[目的]系统评估归脾丸治疗失眠的有效性和安全性.[方法]计算机检索中国知网(CNKI)、万方数据知识服务平台(Wanfang Data)、SinoMed、PubMed、Web of Science以及中医药临床证据数据库旗下智能化中成药临床证据数据库(AICED-CPM),搜集归脾丸治疗失眠的随机对照试验,检索时限均从建库至2024年10月.采用Cochrane系统评价员手册的偏倚风险评估工具(RoB)从7个方面评价方法学质量,采用AICED-CPM内置的R语言进行Meta分析.[结果]纳入5项研究,共382例患者,其中试验组192例,对照组190例.Meta分析结果:临床疗效方面,归脾丸疗效与西药相比疗效相当,但劣于中药汤剂,归脾丸与西药联用可提升疗效[RR=1.17,95％CI(1.00,1.36),P＜0.05].睡眠质量量表(SQ)睡眠指标方面,归脾丸具有明显疗效且与西药联用可明显提升疗效;睡眠进程参数、睡眠周期、抑郁自评量表(SDS)和焦虑自评量表(SAS)方面,归脾丸疗效明显,但效果不及中药汤剂;睡眠状况自评量表(SRSS)评分方面,归脾丸与西药联用可明显提升疗效,以上结果均具有统计学意义(P＜0.05).安全性方面,仅1项研究报告了不良事件,且未出现严重不良反应,整体安全性良好.[结论]归脾丸在治疗失眠方面具有疗效,且与西药联用可增强疗效,安全性良好.该研究尚存一定局限性,当前归脾丸的应用场景中,患者自行采购使用多,但临床研究开展较少,且对中医证型、患者基线等数据报告缺失,需推动开展更多高质量临床研究予以验证.
Efficacy and safety of Guipi Pills for insomnia:a systematic review and Meta-analysis
[Objective]To systematically evaluate the efficacy and safety of Guipi Pills in treating insomnia.[Methods]CNKI,Wanfang,SinoMed,PubMed,Web of Science,and Artificial Intelligence-enhanced Clinical Evidence Database for Chinese Patent Medicine(AICED-CPM)under the traditional Chinese medicine(TCM)Clinical Evidence Database were searched for randomized controlled trials of Guipi Pills for the treatment of insomnia,and the search time range was all from the establishment of the database to October 2024.The Cochrane Systematic Reviewer's Handbook Risk of Risk of Bias(RoB)was used to evaluate methodological quality from 7 aspects,and meta-analyses were performed using the R language built into AICED-CPM.[Results]Five studies with a total of 382 patients were included,including 192 in the experimental group and 190 in the control group.The results of Meta-analysis showed that in terms of clinical efficacy,Guipi Pills had obvious efficacy,which was comparable to that of Western medicine,but inferior to traditional Chinese medicine decoction,and the combination of Guipi Pills and Western medicine could improve the efficacy[RR=1.17,95％CI(1.00,1.36),P＜0.05].In terms of SQ sleep indicators,Guipi Pills has obvious curative effect and can significantly improve the efficacy when combined with Western medicine.In terms of sleep process parameters,sleep cycles,SDS and SAS self-rating scales,Guipi Pills had obvious curative effect,but the effect was not as good as that of traditional Chinese medicine decoction.In terms of SRSS score,the combination of Guipi Pills and Western medicine could significantly improve the efficacy,and the above results were statistically significant(P＜0.05).In terms of safety,only one study reported adverse events with no serious adverse effects,and the overall safety profile was good.[Conclusion]Guipi Pills has efficacy in the treatment of insomnia,and can enhance the efficacy when combined with Western medicine,and the safety is well.There are still some limitations in this study.In the current application scenario of Guipi Pills,patients buy and use it by themselves,but few clinical studies have been carried out,and there is a lack of data reporting on TCM syndrome types and patient baselines,so it is necessary to promote more high-quality clinical studies to verify them.
万方数据
维普
