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七叶神安片与艾司唑仑治疗原发性失眠症近期疗效比较
作者姓名:李六水  付二连  夏路风  王飞  陈世才
作者单位:首都医科大学附属北京潞河医院,北京,101149;北京医院,北京,100730;上海市金山区中西医结合医院,上海,201501
摘    要:目的 观察和比较七叶神安片与艾司唑仑治疗失眠症的临床疗效和不良反应。方法 将200例原发性失眠症患者随机分为七叶神安片组和艾司唑仑组,每组100例,两组患者分别采用七叶神安片和艾司唑仑治疗,疗程均为4周。观察和比较两组患者的匹兹堡睡眠质量指数(Pittsburgh sleep quality index,PSQI),并以PSQI总分减分率作为疗效判定标准。在治疗过程中随时记录患者出现的药物不良反应,治疗结束后比较两种药物的不良反应发生率。结果 艾司唑仑组临床疗效优于七叶神安片组(P<0.05);治疗后两组患者PSQI评分较治疗前均显著降低(P<0.05),七叶神安片组患者PSQI评分降低值显著小于艾司唑仑组(P<0.05);七叶神安片组的不良反应发生率显著低于艾司唑仑组(P<0.05)。结论 七叶神安片和艾司唑仑均可有效治疗失眠症,艾司唑仑临床疗效更佳,有效性更高,而七叶神安片的不良反应少而轻微,安全性高。

关 键 词:失眠症  七叶神安片  艾司唑仑

Short- term Efficacy of Qiye Shen'an Tablet versus Estazolam in Treatment of Primary Insomnia
Institution:1.Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing 101149, China; 2. Beijing Hospital, Beijing 100730, China; 3. Shanghai Jinshan Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai 201501, China
Abstract:Objective To investigate the efficacy and adverse effects of Qiye Shen''an Tablet versus estazolam tablets in the treatment of primary insomnia. Methods A total of 200 patients with primary insomnia were enrolled and randomly divided into Qiye Shen''an group and estazolam tablet group, with 100 patients in each group. The patients in the Qiye Shen''an Tablet group were treated with Qiye Shen''an Tablet, and those in the estazolam group were treated with estazolam tablets. The course of treatment was 4 weeks for both groups. The Pittsburgh sleep quality index (PSQI) was observed and compared between the two groups, and the reduction rate of total PSQI score was used to evaluate the therapeutic effect. Adverse drug reactions were recorded at any time during treatment, and the incidence rate of adverse events was compared between the two groups after the treatment ended. Results The estazolam group had a better clinical outcome than the Qiye Shen''an Tablet group (P<0.05). Both groups had a significant reduction in PSQI score after treatment (P<0.05), while the estazolam group had a significantly greater reduction in PSQI score compared with the Qiye Shen''an Tablet group (P<0.05). The Qiye Shen''an Tablet group had a significantly lower incidence rate of adverse events than the estazolam group (P<0.05). Conclusion Both Qiye Shen''an Tablet and estazolam are effective in the treatment of insomnia; estazolam have a better clinical effect than Qiye Shen''an Tablet, while Qiye Shen''an Tablet has fewer and milder adverse effects and higher safety than estazolam.
Keywords:Insomnia  Qiye Shen''an Tablet  Estazolam
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