枣仁安神胶囊治疗失眠症有效性、安全性的随机双盲安慰剂平行对照研究  

Observation on the Efficacy and Safety of Zaoren Anshen Capsule in the Treatment of Insomnia

作　　者：吴时可 姜雪松 WU Shike;JIANG Xuesong(The Third Affiliated Hospital of Wenzhou Medical University,Wenzhou 325200,China;The Third Hospital of Quzhou,Quzhou 324003,China)

机构地区：[1]温州医科大学附属第三医院,温州325200 [2]衢州市第三医院神经内科,衢州324003

出　　处：《世界睡眠医学杂志》2020年第1期5-8,共4页World Journal of Sleep Medicine

摘　　要：目的:探讨枣仁安神胶囊治疗失眠的有效性及安全性.方法:采用随机、双盲、安慰剂对照试验设计.采用区组随机化法将受试者分为对照组和观察组,每组120例,对照组予以枣仁安神胶囊模拟剂,观察组予以枣仁安神胶囊,2组均连续服药4周.比较2组的临床疗效、匹兹堡睡眠质量指数(Pittsburgh Sleep Quality Index,PSQI)及各因子的变化、中医证候疗效及不良事件情况.结果:观察组的临床有效率为86.67%,对照组的临床有效率为50.83%,2组有效率比较,差异有统计学意义(P<0.01).疗后观察组PSQI评分、中医证候疗效均显著低于对照组(P<0.05).观察组能够显著减少失眠患者的夜间觉醒的次数,与对照组比较差异有统计学意义(P<0.05),同时增加总睡眠时间.观察组的不良事件发生率为11.6%,对照组的不良事件发生率为10.0%,2组比较差异无统计学意义(P>0.05).结论:枣仁安神胶囊治疗失眠疗效肯定,显著缓解临床症状,提高睡眠质量,且不良反应少.Objective:To explore the efficacy and safety of Zaoren Anshen capsule in the treatment of insomnia.Methods:A randomized,double-blind,placebo-controlled trial was designed.The subjects were block-randomly divided into the observation group and the control group with 120 cases each.The control group was given placebo,while the observation group was given Zaoren Anshen capsules.The clinical efficacy,Pittsburgh Sleep Quality Index(PSQI),TCM syndromes grade and adverse events in the two groups were compared.Results:The clinical effective rate of the observation group was 86.67%,and that of control group was 50.83%.There were significant differences(P<0.01).After treatment,the scores of PSQI and TCM syndromes in the observation group were significantly lower than those in the control group(P<0.05).The number of nocturnal arousal in observation group could be significantly reduced,which was statistically different from that in the control group(P<0.05).And sleep duration were increased at the same time.There were no significance differences in the incidence of adverse events(P>0.05)between the observation group(11.6%)and the control group(10.0%).Conclusion:Zaoren Anshen capsule is effective in the treatment of insomnia,which can significantly alleviate clinical symptoms,improve sleep quality with few adverse reactions.

关 键 词：枣仁安神胶囊 失眠 临床疗效 安全性 

分 类 号：R256.23[医药卫生—中医内科学]