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

Efficacy of Wentong Formula Combined with Local Lesion Resection in Treating Granulomatous Lobular Mastitis Patients with Yang Deficiency Phlegm Coagulation Syndrome:A Randomized Controlled Trial

目的观察温通方联合局部病灶切除术治疗肉芽肿性小叶性乳腺炎(GLM)阳虚痰凝证的临床疗效。方法本研究采用随机对照试验(RCT)方法,将80例阳虚痰凝证GLM患者随机分为治疗组和对照组,每组40例。治疗组采用温通方联合局部病灶切术治疗;对照组采用单纯温通方中药治疗,观察2组患者临床疗效、愈后乳房外形评价及复发率情况。结果治疗组在治疗6个月时治愈率为40%(16/40),优于对照组[12.50%(5/40)],差异有统计学意义(χ^(2)=7.813,P<0.01)。治疗组在治疗1年时治愈率为90%(36/40),与对照组[75%(30/40)]比较,差异无统计学意义(χ^(2)=3.117,P>0.05。治疗组平均总病程为(7.78±3.83)个月,优于对照组[(11.78±2.98)个月],差异有统计学意义(t=-5.215,P<0.01)。治疗前后两组乳房外形评价比较,差异无统计学意义(Z=-0.124,P>0.05)。治疗组术后6个月复发率为2.5%(1/40),与对照组[7.5%(3/40)]比较,差异无统计学意义(χ^(2)=0.263,P>0.05)。治疗组术后1年复发率为5%(2/40),优于对照组[20%(8/40)],差异有统计学意义(χ^(2)=4.114,P<0.05)。结论温通方联合局部病灶切除术治疗GLM阳虚痰凝证可明显缩短临床治疗病程,降低复发率。

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(χ^(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)](χ^(2)=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);χ^(2)=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(χ^(2)=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.