活血化痰为核心综合调理脏腑对乳腺增生病疼痛的作用疗效研究

Research on Effect of Treating Pain Due to Mammary Glands Hyperplasia by Regulating Organs through Activating Blood and Resolving Phlegm

目的:观察以化痰散瘀为核心、综合调理脏腑的"开郁散结颗粒"对乳腺增生病疼痛的作用疗效。方法:将360例乳腺增生病患者辨证分型,按2∶1分为试验组和对照组,分别予开郁散结颗粒Ⅰ-Ⅲ号和安慰剂。治疗前、治疗第4、8周末及治疗结束第8周末各访视1次,观察乳房疼痛、安全性指标及不良反应,统计疗效的差异。结果:治疗前乳房疼痛组间比较,无统计学差异(P>0.05),具有可比性。治疗后第2次访视在疼痛评分、评分减少、触痛评分、疼痛总积分及总积分减少方面,组间比较,均有统计学差异(P<0.05);第3次访视疼痛评分、评分减少、疼痛分级及消失情况、触痛评分、评分减少及触痛消失情况、疼痛总积分及总积分减少,组间比较,均有统计学差异(P<0.05);第4次访视以上各项组间比较,均有统计学差异(P<0.05)。结论:开郁散结颗粒对乳腺增生病患者在缓解乳房疼痛方面优于对照组,用药4周后即产生疗效,用药8周疗效最显著,且疗效持久。

Objective：To observe the clinical efficacy of Kaiyu Sanjie particles,which can activate blood and resolve phlegm as the core of regulating organs,on pain due to mammary glands hyperplasia.Method：360 cases of patients with mammary gland hyperplasia 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.Taking 8 weeks as a course,the patients visited us at the time of treatment after 4 weeks、8 weeks and 4 months.The primary endpoint including breast pain,safety indicators and adverse reactions were evaluated,then the difference between the two groups was compared.Result：There were no significant differences between the two groups at the first interview.The difference was statistically significant between two groups in the pain score,the tenderness score and the total score when they interviewed at the second time.The pain score,the tenderness score,the total score and disappearance rate of pain between the two groups also had obvious difference when they interviewed at the third time.At the fourth time,all the above had obvious difference beween the two groups.Conclusion：Kaiyu Sanjie granule is better than the placebo in alleviating pain in breast,the effect arrises after 4 weeks of treatment,the effect is the most obvious at the 8th week.It also has alasting effect.