消癥丸(青香丸)治疗乳腺增生病的临床研究

目的:对消丸治疗乳腺增生病的有效性及安全性作出评价。方法:临床研究在5所医院进行,每家医院的试验组24例与对照组24例,共240例。试验采用随机、双盲、双模拟法进行。试验组口服消丸外,同时口服乳结康安慰剂;对照组口服乳结康,同时口服消丸安慰剂。用药1个疗程,观察治疗前后临床症状的改善、临床疗效和相关实验室指标的变化情况、以及不良反应发生率、安全性评价情况等。结果:试验组的总有效率为93.8%,对照组的总有效率为88.6%,2组疗效比较无明显差异。在主症改善方面2组比较无显著差异。2组中均未发生不良事件,安全性指标无异常。结论:消丸治疗乳腺增生病有显著疗效,具有舒肝行气、活血化痰、软坚散结的作用,可用于治疗气滞血瘀痰凝所致的乳腺增生病,临床应用安全、有效。

Clinical trial on mastoplasia treated by Xiaozheng pills(Qing xiang pills)

Objective: To assess the efficacy and safety of Xiaozheng pills in treating mastoplasia.Method: Clinical trials were carried out by five hospitals.In each hospital,patients were divided into two groups with one group 24 patients(trial group) and the other 24 patients(control group).Total 240 patients were included in the study.According to randomized,double-blinded and placebo-controlled clinical study,the trial groups were treated by Xiaozheng pills with Rujiekang mimetic(placebo) and the control groups were treated by Rujiekang with Xiaozheng pills mimetic(placebo).Symptoms,laboratory test results as well as ADR were evaluated after 1 period of treatment.Result: The overall response rates of trial group and control group were 93.8% and 88.6% respectively,no statistic difference between the two groups.No deleterious effect in both groups and the indexes of safety were normal.Conclusion: These results suggest that Xiaozheng pills are effective and safe in treating mastoplasia caused by qi stagnation,blood stasis or/and stagnation of phlegm.