疏可眠胶囊治疗失眠症(肝气郁结证)有效性和安全性的临床研究

目的 评价疏可眠胶囊治疗失眠症(肝气郁结证) 的有效性和安全性。 方法 采用分层分段随机、双盲、阳性药平行对照、多中心临床试验。选择失眠症(肝气郁结证) 患者440 例, 其中试验组330 例, 给予疏可眠胶囊每次4 粒, 每日2 次, 晚饭后及临睡前各服1 次;对照组完成110 例, 给予舒眠胶囊每次3粒, 每日2 次, 晚饭后及临睡均各服1 次。治疗2 周后, 评价有效性和安全性各种指标。 结果 用药2 周后对照组愈显率40.00 %(n=110), 试验组愈显率58.05 %(n=329), 试验组优于对照组(P <0.01),扣除中心效应结果相同。临床观察中未发现明显不良反应。 结论 疏可眠胶囊治疗失眠症(肝气郁结证), 安全有效。

Clinical study on efficiency and reliability of the shukemian capsule in treatment of patients with asomnia (liver-spirit blocked)

AIM: To evaluate the efficiency and safety of the shukemian capsule (SC) in treatment of patients with asomnia (liver-spirit blocked). METHODS: The double-dummy and randomized controlled method was adapted to assess 440 patients (liver-spirit blocked) who were divided into the treatment group (n=330, treated with SC 4 capsules, twice a day after supper and before sleeping) and the control group (n=110, treated with shumian capsule 3 capsules, twice a day after supper and before sleeping).The duration of treatment for both groups was 2 weeks. RESULTS: After 2 weeks, the rate of recover and effectiveness in control group was 40.0 % (n=110), and that in treatment group was 58.0 %(n=329) which was higher than that in treatment group (P < 0.01).No side effect was found in this clinical study. CONCLUSION: Shukemian capsule is a safe and effective agent in treating asomnia (liver-spirit blocked).