舒眠胶囊与解郁安神胶囊治疗失眠症(肝郁伤神证)多中心随机双盲对照研究

A randomized study comparing the efficacy and safety of Shumian capsules and Jieyuanshen capsules in the treatment of insomnia

目的:评价舒眠胶囊治疗失眠症(肝郁伤神证)的临床疗效和安全性。方法:本研究为大样本多中心随机双盲对照临床试验。选取480例符合CCMD-3中失眠症(非器质性睡眠障碍)诊断标准的患者,按3∶1随机分为舒眠胶囊组(n=360)和解郁安神组(n=120),接受28 d的舒眠胶囊或解郁安神胶囊治疗。入组时和治疗d 7,d 14,d 28进行临床评估,采用PSQI,CGI-GI和SDS评估临床症状并采用PSQI减分率为主要疗效指标。基线和治疗d 28进行体格检查、实验室检查与心电图检查。每次临床评估时记录生命体征和不良反应情况。结果:d 28,舒眠胶囊组和解郁安神组的总有效率分别为86.1%和70.8%,PSQI总分变化值分别为(6.2±3.3)和(5.1±3.1)分,差异具有统计学意义(t=4.06,P<0.05)。舒眠胶囊组和解郁安神组治疗前后SDS评分变化分别为(10.0±5.6)和(6.5±5.6)分,差异具有统计学意义(t=5.28,P<0.05)。舒眠胶囊组共有2例发生不良事件,发生率为0.56%,主要为便秘。结论:舒眠胶囊治疗失眠症(肝郁伤神证)疗效确切,安全性高、耐受性好。

Objective： To further evaluate the efficacy and safety of Shumian capsules and Jieyuanshen capsules in the treatment of insomnia. Methods： A total of 480 patients with insomnia were enrolled in a 28-day multi-center randomized, double-blind controlled trial. Patients were randomized into two groups, and 360 patients treated with Jieyuanshen capsules and 40 with Jieyuanshen capsules were enrolled for efficacy and safety analysis. Pittsburgh Sleep Quality Index （PSQI）, Clinical Global Impression-Global Improvement （CGI-GI） and Self-Rating Depression Scale （SDS） were used to assess efficacy. Safety issues including vital signs, lab assays and ECG ex- aminations were measured before and at 28 days after the treatment. Results： At the end of 28 days, incidences of clinical response were 86.1% and 70.8% in groups of Shumian capsules and Jieyuanshen capsules. The score of PSQI was significantly decreased by （6.2 ±3.3） and （5.1 ±3.1） at the end of the trial （t =4.06, P 〈0.05） ; the score of SDS was significantly decreased by （10.0 ± 5.6） and （6.5 ± 5.6） at the end of the trial （t = 5.28, P 〈 0.05） , respectively, in two groups. There were 2 patients with constipation in Shumian capsules group, and the incidence was 0.56%. Conclusion： Shumian capsules is effective in the management of insomnia with fewer adverse events.