活血化痰为核心综合调理脏腑治疗乳腺增生病临床疗效的研究

目的:验证以化痰散瘀为核心、综合调理脏腑的开郁散结颗粒辨证论治乳腺增生病的临床疗效。方法:360例乳腺增生病患者辨证分型,采用多中心、随机、双盲法,按2∶1分为试验组和对照组,分别予开郁散结颗粒和安慰剂,8周为1个疗程,观察疾病疗效、安全性指标及不良反应,比较组间差异。结果:治疗8周、停药8周比治疗前疾病疗效组间比较有统计学差异,治疗8周比治疗4周在病情改善率及反复率上组间比较有统计学差异。结论:治疗8周后,开郁散结颗粒对痰瘀互结型乳腺增生病患者疗效优于安慰剂,且疗效持久,反复率低,适宜推广应用。

Research on Clinical Effect of Comprehensive Zang-Fu-regulating Therapy on Hyperplasia of Mammary Glands

Objective:Verify the clinical efficacy of Kaiyu Sanjie particles which takes phlegm stasis as the core and conditioning organs comprehensively.Method:360 cases of patients with mammary gland were randomly divided into two groups according to 2-1,treatment group(Kaiyu Sanjie granule) had 240 cases,the control group(placebo) had 120 cases.8 weeks was a course.Observe the primary endpoint including breast pain and lumps,and the secondary indicator was performance of TCM,safety indicators and adverse reactions,then statistical analysis on the difference between the two groups was made.Result:The difference was statistically significant between two groups in the cure rate and the total efficiency when they were interviewed at the third and fourth time.The improvement of the disease rate and recurrent rate between the two groups also had obvious difference when they were interviewed at the third time and the fourth time.Conclusion:After 8 weeks of treatment in mammary glands,Kaiyu Sanjie granule is better than the placebo,and has lasting effect,so it is suitable for clinical application.