七叶神安滴丸治疗气虚型失眠症的随机、双盲、安慰剂平行对照多中心临床研究

A randomized, double-blind, placebo-controlled multicenter clinical study of Qiye Shen’an Dropping Pills in treatment of insomnia with Qi deficiency

目的评价七叶神安滴丸治疗气虚型失眠症的有效性和安全性。方法采用区组随机、双盲单模拟、安慰剂平行对照、多中心、优效性试验设计方法。将288例失眠患者以3∶1的比例随机分为试验组(216例)和对照组(72例)。试验组口服七叶神安滴丸,对照组口服安慰剂,6丸/次,3次/d。完成4周治疗后,通过失眠严重指数量表(ISI)治疗前后变化评价其有效性,通过生命体征、不良事件、实验室检查及体格检查评价药物安全性。结果治疗4周后,治疗后全分析集(FAS)中试验组的ISI评分显著低于对照组分(P<0.0001)。符合方案集(PPS)中试验组的ISI评分同样显著低于对照组(P<0.0001),PPS与FAS结果分析一致。治疗后试验组FAS集总有效率是85.64%,对照组是38.24%,两组比较差异有统计学意义(P<0.05)。试验组PPS集总有效率为88.11%,对照组是38.71%,两组比较差异有统计学意义(P<0.05),PPS与FAS结果分析一致。试验组共发生17例次不良事件,对照组共发生3例次不良事件,经评定与药物无关。结论七叶神安滴丸治疗气虚型失眠症疗效确切,能够改善失眠患者的失眠严重程度,且安全性良好。

Objective To evaluate the efficacy and safety of Qiye Shen’an Dropping Pills in treatment of insomnia with Qi deficiency.Methods A block randomized, double-blind, single simulation, placebo-controlled, multicenter, superiority trial design method was used. A total of 288 patients with insomnia were randomly divided into experimental group(216 cases) and control group(72 cases)with a ratio of 3∶1. Patients in the experimental group were po administered with Qiye Shenan Dropping Pills, while patients in the control group were po administered with placebo, 6 pills/time, 3 times daily. After 4 weeks of treatment, the efficacy was evaluated by insomnia Severity index(ISI) before and after treatment, and the safety was evaluated by vital signs, adverse events, laboratory tests and physical examination. Results After 4 weeks of treatment, ISI score in the full analysis set(FAS) of the experimental group was significantly lower than that of the control group(P < 0.000 1). The ISI score of the experimental group was also significantly lower than that of the control group(P < 0.000 1). The results of PPS and FAS were consistent. After treatment, the total effective rate of FAS was 85.64% in the experimental group and 38.24% in the control group, and the difference between the two groups was statistically significant(P < 0.05). The total effective rate of PPS in the experimental group was 88.11%, and that in the control group was 38.71%.The difference between the two groups was statistically significant(P < 0.05). The results of PPS and FAS were consistent. A total of 17 adverse events occurred in the experimental group and 3 adverse events occurred in the control group, which were assessed to be unrelated to drugs. Conclusion Qiye Shen’an Dropping Pills is effective in treatment of Qi deficiency insomnia, and can improve the severity of insomnia in patients with insomnia, which has good safety.