消癖颗粒治疗乳腺增生病痰瘀互结冲任失调证的临床研究

目的：评价消癖颗粒对乳腺增生病痰瘀互结冲任失调证的改善作用。方法：采用随机、双盲双模拟、多中心临床研究方法纳入8家医院478例乳腺增生病痰瘀互结冲任失调证患者。试验组359例服用消癖颗粒和乳核散结片模拟剂,对照组119例服用乳核散结片和消癖颗粒模拟剂。服药1个月经周期为1个疗程,连续观察时间为3个月经周期。临床痊愈者随访1个月。结果：消癖颗粒对乳腺增生病的治疗作用整体明显于乳核散结片,在治疗乳房疼痛、触痛、乳腺质地、中医症候疗效等方面,消癖颗粒优势明显。结论：消癖颗粒治疗乳腺增生病痰瘀互结、冲任失调证具有良好的临床疗效和安全性。

Clinical Research of Xiaopi Granule in Treating Hyperplasia of Mammary Glands with Phlegm and Blood Stasis and Chong Ren Dysfunction Syndrome

Objective： To evaluate Xiaopi Granule in improving hyperplasia of mammary glands with phlegm and blood stasis and Chong- ren dysfunction syndrome. Methods： A randomized,double-blind,double-dummy,multi-center clinical research was conducted,including eight hospitals,478 cases of hyperplasia of mammary glands with phlegm and blood stasis and Chong and Ren dysfunction Syndrome. The 359 cases in experimental group received Xiaopi Granule and placebo of Ruhesanjie tablet. And 119 cases in control group took Ruhes- hanjie tablets and placebo of Xiaopi Granule. One menstrual cycle was a course of treatment,and three menstrual cycles were continuous observed. Patients that were clinically recovered were followed up for one month. Results： Generally speaking,Xiaopi Granule were much better than Ruheshanjie tablets in treating hyperplasia of mammary glands with phlegm and blood stasis and Chong and Ren dys- function Syndrome,especially in improving breast pain,tenderness,breast texture,and Chinese medicine symptoms and syndromes. Con- clusion： Xiaopi Granule has good clinical efficacy and safety in treating hyperplasia of mammary glands with phlegm and blood stasis and Chong-ren dysfunction syndrome.