清热败毒合剂加乳癖散结胶囊或红金消结胶囊对肉芽肿性小叶性乳腺炎恢复期患者复发率的影响

Effect of Qingre Baidu Mixture Plus Rupi Sanjie Capsule or Hongjin Xiaojie Capsule on the Recurrence Rate with Granulomatous Lobular Mastitis in Convalescent Period

目的 观察在肉芽肿性小叶性乳腺炎(GLM)恢复期,服用中成药的治疗时间对患者复发率的影响,并分析GLM复发危险因素。方法 从上海中医药大学附属龙华医院刘胜教授门诊数据库中,抽取恢复期服用中成药(清热败毒合剂加乳癖散结胶囊或红金消结胶囊)且治愈后随访1年的GLM患者。将服用中成药的治疗时间设定为暴露因素,共纳入207例GLM患者,其中对照组85例(治疗<6个月),治疗组122例(治疗6个月)。比较两组GLM复发率;并分析复发的危险因素。结果 本研究中GLM患者总复发率为6.28%(13/207),治疗组复发率3.28%(4/122)低于对照组10.59%(9/85),差异有统计学意义(χ;=4.548,P=0.033)。经Logistic回归模型分析,中成药治疗6个月是GLM复发的独立保护因素[OR=0.244,95%CI(0.068,0.873),P=0.030],体重指数(BMI) 24及乳头凹陷是GLM复发的独立危险因素。结论 在GLM恢复期,服用中成药治疗时间6个月可明显降低GLM复发率。

Objective To observe the effect of taking Chinese patent medicine during the convalescence of granulomatous lobular mastitis(GLM) on the recurrence rate of patients,and to analyze the risk factors of GLM recurrence.Methods From the database of Professor LIU Sheng,Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine,GLM patients who were cured by Chinese patent medicines(Qingre Baidu Mixture + Rupi Sanjie Capsules/Hongjin Xiaojie Capsules) during the convalescence period and were followed up for greater than or equal to one year.The treatment duration was set as the exposure factor,and a total of 207 GLM patients were enrolled,including 85 cases in the control group(treatment < 6 months) and 122cases in the treatment group(treatment 6 months).The recurrence rate of GLM was compared between the two groups,and the risk factors for recurrence were analyzed.Results In this study,the total recurrence rate of GLM patients was 6.28%(13/207),and it was 3.28%(4/122) in the treatment group,lower than that of the control group [10.59%(9/85)].The difference was statistically significant(χ~2=4.548,P=0.033).Logistic multivariate regression analysis showed Chinese patent medicine treatment for≥6 months was an independent protective factor for GLM recurrence [OR=0.244,95% CI(0.068,0.873),P=0.030],body mass index(BMI) 24 and nipple depression were independent risk factors for GLM recurrence.Conclusion During the convalescence period of GLM,treatment of Chinese patent medicine for equal to or more than 6 months significantly reduced the recurrence rate of GLM.