散结止痛膏外敷治疗乳腺增生病(冲任失调证)的大样本、多中心、随机对照临床研究

Large Sample and Multi-Center RCT on Treatment of Hyperplastic Disease of Breast by Sanjie Zhitong Plaster External Application

目的：评价中药敷贴,治疗具有周期性经前乳痛症的乳腺增生病（冲任失调证）的临床疗效及安全性。方法：采用多中心、随机、双盲、安慰剂对照的设计。选择符合西医诊断乳腺增生病及中医辨证冲任失调型标准的18~50岁女性患者325例,按1∶1比例随机分配到试验组（散结止痛膏）与对照组（安慰剂）。治疗组给予中药敷贴,对照组给予安慰剂,一侧乳房一贴,贴于乳房最痛处。月经干净后开始进行贴敷,隔日1次,每次6~8 h,1个月经周期为1个疗程,共用2个疗程,月经期不用药,观察两组临床疗效和主要症状体征积分的变化情况,并作安全性评价。结果：散结止痛膏外敷治疗乳腺增生病,在缓解乳房疼痛,改善中医证候积分方面有良好的疗效,与治疗前比较有统计学意义（P〈0.05）。结论：散结止痛膏外敷方法简便,患者的依从性较好,可作为治疗乳腺增生病的常用外治药物。

Objective： The study estimates the clinical effectiveness and safety of herbal external application to hyperplasic disease of breast（disturbance of Chong and Ren） characterized as periodic breast ache before menstruation. Methods： Adopting multi-center,random,double-blinded and placebo controlling clinical trial methods,325 women between 18 to 50 who met the diagnosis of hyperplasic disease of breast by western medicine and the dialectical criterion of TCM（disturbance of Chong and Ren）were randomly assigned to the trial group（Sanjie Zhitong Plaster） and control group（placebo） by 1： 1. Trial group was given plaster while control group given the placebo. Each side used one plaster on the most pain region of breast after menstruation finished,once every two days,6 ~ 8 hours for one time. One menstrual cycle was for a period of treatment,totally 2 courses of treatment and menstrual period did not use. After treatment,the therapeutic effect and the changes of main symptom score were observed. Meanwhile,the safety was also evaluated. Results： Sanjie Zhitong plaster treats hyperplasic disease of breast（disturbance of Chong and Ren） has better clinical total curative effect than that of the placebo group（P〈0. 01）. Conclusion： Ssanjie Zhitong Plaster external treatment method is simple and the patients＇ compliance is better. Therefore it can be commonly used as the external drug for hyperplasic disease of breast.