维乳息痛软膏外治乳腺增生伴乳房疼痛的临床疗效

Effect of Weiruxitong ointment for breast pain induced by hyperplasia of mammary glands

目的评价维乳息痛软膏治疗乳腺增生伴有乳房疼痛的临床有效性及安全性。方法采用前瞻性随机对照临床试验设计,纳入2020年6月至9月在广东省中医院乳腺门诊诊断为乳腺增生病伴有周期性乳房疼痛的30例患者,随机双盲分为治疗组及对照组,每组15例,两组分别以维乳息痛软膏及安慰剂外用在双侧乳房上,采用简式麦吉尔疼痛问卷表(SF-MPQ)评价临床疗效,同时评估药物安全性。结果治疗组的简式McGill评分降低差值高于对照组,差异有统计学意义(P<0.01)。30例患者,脱落2例,28例患者用药疗程生命体征正常,均未出现不良事件。结论维乳息痛软膏外用可以有效治疗乳腺增生伴有乳房疼痛的症状,且方法简便、安全实用。

Objective To evaluate the clinical efficacy and safety of Weiruxitong ointment in the treatment of patients with breast pain induced by thyperplasia of mammary glands.Methods A prospective randomized clinical trial was designed to select 30 patients with breast pain induced by thyperplasia of mammary glands treated from June 2020 to September 2020.The patients were randomly divided into treatment group(using Weiruxitong ointment,n=15)and control group(using placebo,n=15).The short-form McGill Pain Questionnaire(SF-MPQ)was applied to evaluate the clinical efficacy and safety.Results SF-MPQ score reduction in treatment group was significantly higher than that in control group(P<0.01).Two patients fell off and 28 patients had normal vital signs during the course of medication without adverse events.Conclusions External use of Weiruxitong ointment can effectively treat breast pain induced by thyperplasia of mammary glands and is a simple,practical and safe method.