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 4 40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 4 0 .0 0 % (n =110 ) ,试验组愈显率5 8.0 5 % (n =32 9) ,试验组优于对照组 (P <0 .0 1) ,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).