百乐眠治疗失眠的疗效和安全性的Meta分析

发布时间：2018-10-18 16:30

【摘要】：目的评价百乐眠治疗失眠障碍的疗效、安全性及与疗程的关系。方法检索中国知网(CNKI)、万方数据库、中国优秀硕士/博士学位论文数据库、维普中文科技期刊数据库(VIP)、Cochrane图书馆、Pubmed、EMBASE、中国学术会议论文数据库中截至到2016年12月的百乐眠治疗失眠的文献,用Jadad量表评价文献质量,用Stata 14软件进行Meta分析。结果纳入文献20篇,共计2235例(观察组1284例,对照组951例)。百乐眠组治疗失眠的总有效率显著高于对照组(RR=1.20,95%CI:1.10~1.31),百乐眠治疗失眠的有效率显著高于西药亚组(RR=1.24,95%CI:1.07~1.44)及其他中药亚组(RR=1.13,95%CI:1.03~1.23)。百乐眠组治疗失眠降低匹兹堡睡眠质量指数(PSQI)评分优于对照组[标准化均数差(SMD)=-0.53,95%CI:-0.81~-0.26]。随着用药疗程的增加(第2、3、4周),百乐眠治疗失眠降低PSQI评分较西药亚组的优势逐渐显现(SMD2=-0.50,95%CI:0.83~-0.16;SMD3=-0.60,95%CI:-0.97~-0.24;SMD4=-1.67,95%CI:-0.63~-0.05)。百乐眠组治疗失眠的不良反应事件发生率显著低于对照组(RR=0.25,95%CI:0.16~0.38)。百乐眠组不良反应事件发生率显著低于西药亚组(RR=0.23,95%CI:0.15~0.36)。随着用药疗程的增加(第2、3、4、8周),百乐眠组不良反应事件发生率逐渐低于西药亚组(RR2=0.45,95%CI:0.22~0.92;RR3=0.23,95%CI:0.04~1.33;RR4=0.16,95%CI:0.08~0.33;RR8=0.19,95%CI:0.06~0.59)。结论百乐眠胶囊治疗失眠障碍的总体有效率、降低PSQI评分均优于西药和其他中药,具有较高的安全性,值得在临床上进一步推广使用。但是否随着用药疗程的增加总体有效率及降低PSQI评分优势越显著仍有待进一步研究验证。
[Abstract]:Objective to evaluate the efficacy, safety and relationship with the course of treatment of insomnia. Methods (CNKI), Wanfang database and excellent master / doctoral thesis database were searched. The Chinese scientific and technological journal database (VIP), Cochrane library and the Pubmed,EMBASE, China academic conference paper database were used to evaluate the quality of the literature by using Jadad scale to evaluate the quality of the literature. The Meta analysis was carried out with Stata 14 software in the database of Chinese scientific and technological journals and papers in the database of Pubmed,EMBASE, China academic Conference from December 2016 to December 2016. Results A total of 2235 cases were included in 20 articles (1284 cases in the observation group and 951 cases in the control group). The total effective rate of treatment of insomnia was significantly higher than that of the control group (RR=1.20,95%CI:1.10~1.31), and the effective rate of the treatment of insomnia was significantly higher than that of the western medicine subgroup (RR=1.24,95%CI:1.07~1.44) and other Chinese medicine subgroup (RR=1.13,95%CI:1.03~1.23). The score of Pittsburgh sleep quality index (PSQI) in the treatment group with insomnia was better than that in the control group [standardized mean difference (SMD) = -0.5395% -0.81% -0.26]. With the increase of the course of treatment (2 ~ 3 ~ 4 weeks), the advantage (SMD2=-0.50,95%CI:0.83~-0.16;SMD3=-0.60,95%CI:-0.97~-0.24;SMD4=-1.67,95%CI:-0.63~-0.05) of reducing PSQI score in the treatment of insomnia was gradually revealed (SMD2=-0.50,95%CI:0.83~-0.16;SMD3=-0.60,95%CI:-0.97~-0.24;SMD4=-1.67,95%CI:-0.63~-0.05). The incidence of adverse events in the parlurium group was significantly lower than that in the control group (RR=0.25,95%CI:0.16~0.38). The incidence of adverse events in Paramol group was significantly lower than that in western medicine subgroup (RR=0.23,95%CI:0.15~0.36). With the increase of the course of treatment (2nd week, 3rd week, 4 weeks), the incidence of adverse events in the parlomide group was lower than that in the western medicine subgroup (RR2=0.45,95%CI:0.22~0.92;RR3=0.23,95%CI:0.04~1.33;RR4=0.16,95%CI:0.08~0.33;RR8=0.19,95%CI:0.06~0.59). Conclusion the total effective rate of Baile Mian capsule in treating insomnia disorder is better than that of western medicine and other traditional Chinese medicine in reducing PSQI score. It is worth popularizing in clinic. But the more significant the overall effective rate and the lower PSQI score are with the increase of the course of treatment, the further research remains to be done.
【作者单位】： 复旦大学公共卫生学院临床流行病学研究中心公共卫生安全教育部重点实验室;
【分类号】：R740
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本文编号：2279706