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作 者:刘继芳 刘烨 张岩 LIU Ji-Fang;LIU Ye;ZHANG Yan(Beijing Rongchang Pharmaceutical Research Institute Co.,Ltd.,Beijing 100078,China;Department of Neurology,Zhejiang quhua hospital,Quzhou 324004,China;Guoxin Pharmaceutical Technology(Beijing)Co.,Ltd.,Beijing 100043,China)
机构地区:[1]北京荣昌药物研究院有限公司,北京100078 [2]浙江衢化医院神经内科,浙江衡州324004 [3]国信医药科技(北京)有限公司,北京100043
出 处:《中国药物经济学》2023年第5期52-56,60,共6页China Journal of Pharmaceutical Economics
摘 要:目的通过Meta分析系统评价甜梦胶囊治疗失眠的临床疗效和安全性。方法检索中国生物医学文献数据库、万方数据知识服务平台、中文期刊全文数据库、中国期刊全文数据库、PubMed、Embase、Cochrane Library 7个数据库,时间为1998年1月1日至2021年5月15日,全面收集甜梦胶囊单独使用或联合西药治疗失眠的随机对照试验(RCT)。按照纳入排除标准筛选文献、提取资料并评价纳入研究的质量后,运用Endnote软件以及RevMan5.3软件进行Meta分析,对总有效率、匹兹堡睡眠质量指数(PSQI)积分差异、不良反应发生率进行归纳总结。结果对13个RCT进行Meta分析,结果显示甜梦胶囊联合用药组的总有效率显著优于其他药物单一使用组,差异有统计学意义[OR=1.84,95%CI(0.81~4.17),Z=2.79,P=0.005]。甜梦胶囊组患者PSQI积分与对照组比较,差异有统计学意义[MD=-1.82,95%CI(-2.96~-0.68),Z=3.12,P=0.002]。结论甜梦胶囊联合常规治疗失眠药物,与单一使用其他药物比较,改善睡眠质量更有优势。Objective To systematically evaluate the clinical efficacy and safety of tianmeng capsule in the treatment of insomnia by meta-analysis.Methods Seven databases including Chinese biomedical literature database(CBM),Wanfang Data knowledge service platform,Chinese Journal Full-text Database(VIP),Chinese Journal Full-text Database(CNKI),PubMed,Embase、Cochrane Library from January 1,1998 to May 15,2021.Randomized controlled trials of tianmeng capsule used alone or in combination with Western medicine for insomnia were comprehensively collected.After screening the literature according to the inclusion and exclusion criteria,extracting the data and evaluating the quality of the included studies,we used endnote software and revman5.3 software to conduct meta-analysis to comprehensively describe the total effective rate of clinical efficacy,the difference of PSQI score and the adverse reaction rate.Results 13 randomized controlled clinical trials(RCTs)were included.The results of meta-analysis showed that the total effective rate of the clinical efficacy of the trial group(tianmeng capsule combined group)was significantly better than that of the conventional insomnia treatment group in improving insomnia,and the difference was statistically significant[OR-1.84,95%CI(0.81~4.17),Z-2.79,P=0.005].The analysis showed that the PSQI score of tianmeng capsule group was significantly different from that of the control group[MD=-1.82,95%CI(-2.96~-0.68),Z-3.12,P=0.002].Conclusion The combination of tianmeng capsule and other drugs can significantly improve the sleep quality of patients with insomnia.
分 类 号:R256.23[医药卫生—中医内科学] R287[医药卫生—中医学]
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