冬虫夏草胶囊(女士型)对肝郁脾虚证候的调节作用:随机对照试验

The Regulatory Effect of Cordyceps Sinensis Capsule(Lady Type)on Gan Depression Pi Deficiency Syndrome:A Randomised Controlled Trial

目的评价冬虫夏草胶囊(女士型)对肝郁脾虚证候的调节作用及安全性。方法采用随机、安慰剂对照试验,将98例肝郁脾虚证女性受试者随机分入试验组和对照组,每组49例。试验组服用冬虫夏草胶囊(女士型),每次2粒(0.55g/粒),每天2次。对照组予安慰剂口服。两组试验周期均为90天。观察两组试验前后中医证候(体倦乏力、脘腹痞闷、烦躁易怒、口燥咽干、多汗、排便不爽、面色萎黄或无华、易感冒)积分及中医证候改善效果,并观察其安全性。结果与本组试验前比较,两组试验后中医证候积分均降低(P<0.01),且试验组中医证候积分低于对照组(P<0.01);对照组除多汗、易感冒外,其他症状均有改善(P<0.01,P<0.05),试验组各症状均有改善(P<0.01,P<0.05)。试验组体倦乏力、烦躁易怒、面色萎黄或无华评分低于对照组(P<0.01)。试验组中医证候改善总有效率为80.5%(33/41),高于对照组[47.5%(19/40),P<0.01]。两组均未发现不良反应。结论冬虫夏草胶囊(女士型)对女性肝郁脾虚证候有一定改善效果,且安全性良好。

Objective To evaluate the regulatory effect and safety of Cordyceps Sinensis Capsule（lady type）on women with Gan depression Pi deficiency syndrome.Methods A randomized placebo controlled trial was conducted in98 females with Gan depression Pi deficiency syndrome,they were randomly assigned to the experimental group and the control group,49 cases in each group.Subjects in the experimental group were given 2 pills of Cordyceps Sinensis Capsule（lady type 0.55 g/pill）each time,2 times a day.The control group was given placebo.The trial period for all was 90 days.The TCM syndromes（including lassitude,abdominal distension,agitation and irritability,dry mouth and throat,hidrosis,ungratifying defecation,lusterless or sallow complexion,and susceptible to colds）score was calculated before and after trial,the safety and efficacy of the capsule were observed.ResultsCompared with before trial in the same group,the TCM syndromes score decreased in the both groups after trial（P〈0.01）,it was lower in the experimental group than in the control group;besides hidrosis and susceptible to colds,the other symptoms were improved in the control group after trial（P〈0.01,P〈0.05）,and all the symptoms were improved in the experimental group（P〈0.01,P〈0.05）;the score of lassitude,agitation and irritability and lusterless or sallow complexion in the experimental group were lower than in the control group（P〈0.01）.The total effective rate was 80.5%（33/41）in the experimental group,which was higher than the control group[47.5%（19/40）,P〈0.01].No adverse reactions were found in both groups.Conclusion The Cordyceps Sinensis Capsule（lady type）issafe and effective in improving women with Gan depression Pi deficiency syndrome.