天麻醒脑胶囊治疗失眠（肝肾不足、肝风上扰证）的随机、双盲、平行对照、多中心临床研究

A randomized,double-blind,parallel controlled,multicenter clinical study of Tianma Xingnao Capsule in the treatment of primary insomnia (liver and kidney deficiency,liver-wind disturbance)

关键词:  天麻醒脑胶囊  失眠  肝肾不足  肝风上扰  多中心  随机化

Key words:  Tianma Xingnao Capsule  primary insomnia  liver and kidney deficiency  liver-wind disturbance  multicenter  randomized

摘要:

[目的] 评价天麻醒脑胶囊治疗失眠属肝肾不足，肝风上扰证的有效性及安全性。[方法] 本研究采用随机、双盲、平行对照、多中心的临床研究方法。将9个分中心的144 例失眠患者（证型为肝肾不足、肝风上扰证）随机分为试验组（108例）与阳性药对照组（36例），试验组用药为天麻醒脑胶囊，对照组用药为复方钩藤片。两组疗程均为8周。比较两组患者试验前后中医证候疗效、匹兹堡睡眠质量指数（PSQI）、失眠严重指数、睡眠日记评分（包括：睡眠持续时间、入睡所需时间、觉醒次数）及安全性。[结果] 本次试验共136例患者完成实验（试验组102例，对照组34例），8例违背试验方案（试验组6例，对照组2例）。中医症候疗效总有效率试验组为92.16%高于对照组的76.47%（P=0.0270）。PSQI总分，试验组和对照组分别下降（7.53±3.22）和（4.88±2.87），组间比较有统计学差异[（6.21±3.37） vs （8.18±3.17）]。在睡眠日记评分中，入睡所需时间（min）在用药8周后试验组为（20.30±12.56）低于对照组（25.33±12.54）；睡眠持续时间（h）在用药8周后试验组为（6.70±1.17）高于对照组（5.90±1.23）（P=0.0011）。在失眠严重指数、觉醒次数方面两组比较未显示差异。药物不良反应发生率分别为试验组1.96%，对照组2.94%，两组比较未显示差异。[结论] 天麻醒脑胶囊治疗肝肾不足，肝风上扰型失眠8周后可改善中医证候，缩短入眠所需时间，延长睡眠持续时间，减少睡眠觉醒次数，从而起到改善睡眠质量的效果，且安全性良好。

Abstract:

[Objective] To evaluate the clinical efficacy and safety of Tianma Xingnao Capsule in the treatment of primary insomnia (liver and kidney deficiency,liver disturbance). [Methods] A randomized,double blind,parallel controlled and multicenter trial method was used for clinical research. A total of 144 cases of patients with primary insomnia(liver and kidney deficiency,liver-wind disturbance) from eight hospitals were randomly divided into experimental group(108 cases) and control group(36 cases). The experimental group was given Tianma Xingnao Capsule and compound Gouteng Tablet simulator,while the control group was given compound Gouteng Tablet and Tianma Xingnao Capsule simulator. The two groups were treated for 8 weeks. The traditional Chinese medicine syndrome curative effects,Pittsburgh sleep quality index (PSQI),insomnia severity index,sleep diary score (sleep duration,time to sleep,arousal times) and safety were compared between the two groups. [Results] The total effective rate and PSQI of experimental group was superior than that of the control group(P<0.05). The experimental group also have better performance in sleep duration and time to sleep of sleep diary score than control group (P<0.05). There was no significant difference in the incidences of adverse events between the two groups(P>0.05). [Conclusion] Tianma Xingnao Capsule in the treatment of insomnia(liver and kidney deficiency,liver-wind disturbance) is safe and effective, which can improve the clinical symptoms,shorten the time needed to sleep,prolong the sleep time and reduce the number of sleep wakes,so as to improve the quality of sleep.