中药解郁丸治疗失眠31例临床观察

Clinical Observation on 31 Cases of Insomnia Treated by Chinese Drug Jieyu Pills

目的:验证解郁丸治疗失眠的临床疗效、不良反应及安全性。方法:通过随机对照试验,将53例患者分为中药组31例.对照组22例,于用药前及用药后第11天、28天分别采用睡眠状态问卷量表(SQ)、抑郁自评量表(SDS)、焦虑自评量表(SAS)评定药物疗效,采用临床总体印象量表(CGI)中对疗效和副反应的评分法评定不良反应和疗效指数。结果:中药组显效率(54.9%)与对照组(59.1%)相当(P>0.05):中药组与对照组治疗后SQ、SDS和SAS分数均明显低于治疗前(P<0.01),两组间比较差异无显著性(P>0.05)。治疗后中药组的副反应分数明显低于对照组(P<0.01),中药组疗效指数显著高于对照组(P<0.01)。结论:解郁丸治疗失眠疗效与曲唑酮相当,不良反应明显少于曲唑酮。

Objective: To invesigate the clinical thertapeutic effect, adverse effects and safety of Jieyu Pills in treatment of insomnia. Methods: 53 cases of insomnia were randomly divided into treatment group (n=31) treated by Jieyu Fills and control group (n= 22)treated by Trazodone. The therapeutic effects were assessed before administration and at the 14th and 28th days after administration with Sleeping Questionnaire (SQ), Self-Rating Depression Scale (SDS)and Self-Rating Anxiety Scale(SAS), and the adverse effect and the efficacy index were evaluated by the method in the scale of Clinical Global Impression (CGI). Results: The marked improvement rate was 54. 9%. in the treatment group and 59. 1% in the control group. with no significant difference between the two groups (P>0. 05). After treatment, the scores for SQ, SIXS and SAS decreased significantly as compared with those before treatment (P<0. 01 )with no significant difference between the two groups (P>0. 05). and the score in the treatment group was lower than that in the control group (P<0. 01) and the efficacy index in the treatment group was higher than that in the control group (P<0. 01). Conclusion: Jieyu Pills and Trazodone have similar therapeutic effect on insomnia. but Jieyu Pills have less adverse effects.