温通方联合局部病灶切除术治疗肉芽肿性小叶性乳腺炎阳虚痰凝证随机对照研究OA北大核心CSTPCD

Objective To observe the clinical efficacy of Wentong Formula combined with local lesion resection in treating granulomatous lobular mastitis(GLM)patients with yang deficiency phlegm coagulation syndrome(YDPCS).Methods This was a randomized controlled clinical study.Totally 80 GLM patients with YDPCS were randomly assigned to a treatment group and a control group,with 40 cases in each group.Patients in the treatment group took Wentong Formula combined with local lesion resection,and those in the control group took Wentong Formula alone.The clinical efficacy,postoperative breast shape evaluation,and recurrence rate of the 2 groups were observed.Results The cure rate of the treatment group was 40.00％(16/40)at 6 months of treatment,better than that of the control group[12.50％(5/40)],with statistically significant difference(x 2=7.813,P＜0.01).The cure rate of the treatment group was 90.00％(36/40)at the first year of treatment,and there was no significant difference when compared with the control group[75.00％(30/40)](x2=3.117,P＞0.05).The average course of disease in the treatment group was(7.78±3.83)months,better than that of the control group[(11.78±2.98)months],with statistical difference(t=-5.215,P＜0.01).And there was no statistically significant difference in the evaluation of breast appearance between the 2 groups before and after treatment(Z=-0.124,P＞0.05).The recurrence rate at post-operational 6 months was 2.50％(1/40)in the treatment group,and there was no statistically significant difference when compared with the control group[(7.50％(3/40);x2=0.263,P＞0.05].The post-operational 1 year recurrence rate was 5.00％(2/40)in the treatment group,better than that of the control group[20.00％(8/40)],with statistically significant difference(x2=4.114,P＜0.05).Conclusion Wentong Formula combined with local lesion resection significantly shortened the clinical treatment course and reduced the recurrence rate of GLM patients with YDPCS.