散结消痛膏外敷治疗乳腺增生症冲任失调证61例随机对照研究  

Sanjie Xiaotong Ointment(散结消痛膏)Treating 61 Cases of Breast Hyperplasia with Pattern of Disharmony of the Chong(冲)and Ren(任)Meridian:A Randomized Controlled Trial

作　　者：徐留燕 程旭锋 王蓓蓓 孟冰心 XU Liuyan;CHENG Xufeng;WANG Beibei;MENG Bingxin(The Third Affiliated Hospital of Beijing University of Chinese Medicine,Beijing,100029;The First Affiliated Hospital of Henan University of Chinese Medicine;Graduate School of Henan University of Chinese Medicine)

机构地区：[1]北京中医药大学第三附属医院,北京市100029 [2]河南中医药大学第一附属医院 [3]河南中医药大学研究生院

出　　处：《中医杂志》2022年第17期1647-1653,共7页Journal of Traditional Chinese Medicine

基　　金：国家中医药管理局全国名老中医药专家传承工作室建设项目(2100601-CZ0175);河南省中医药科学研究专项课题(2018ZY2089);河南省教育厅河南省高等学校重点科研项目计划(21A360005)。

摘　　要：目的探讨散结消痛膏外敷治疗乳腺增生症冲任失调证的临床疗效和安全性。方法采用随机、单盲、安慰剂对照的研究方法,纳入女性乳腺增生症冲任失调证患者122例,随机分为治疗组和对照组各61例。治疗组患者给予散结消痛膏外敷,对照组患者给予安慰剂硬膏外敷,两组均连续治疗8周。分别于治疗前、治疗第4周、第8周(治疗后)及第12周(随访时)比较两组患者乳房疼痛总积分,于治疗前后比较乳腺彩色超声评分、触诊肿块评分、汉密顿抑郁量表评分、中医证候评分,治疗前后检测两组患者雌激素(E_(2))、孕激素(P)、泌乳素(PRL)水平,治疗后评价临床疗效及安全性。结果与治疗前比较,两组治疗后汉密尔顿抑郁量表评分、中医证候评分均降低(P<0.05);治疗组乳腺彩色超声评分、触诊肿块评分、E_(2)、PRL水平亦降低,且低于同期对照组(P<0.05),P水平明显升高,且高于同期对照组(P<0.05);对照组乳腺彩色超声评分、触诊肿块评分、E_(2)、PRL、P水平治疗前后差异均无统计学意义(P>0.05)。治疗组临床痊愈率(9.84%)、显效率(31.15%)、总有效率(86.89%)均明显高于对照组(分别为0、9.84%及32.79%),差异有统计学意义(P<0.05)。治疗期间治疗组局部皮肤发红2例,对照组局部皮肤瘙痒2例,两组均无全身不良反应,治疗后血常规、尿常规、大便常规、肝功能、肾功能均未见明显异常。结论散结消痛膏外敷治疗乳腺增生症冲任失调证具有良好的临床疗效及安全性。Objective To explore the clinical effect and safety of Sanjie Xiaotong Ointment(散结消痛膏)in the treatment of breast hyperplasia with disharmony of the chong(冲)and ren(任)meridian pattern.Methods A ran⁃domized,single-blinded,placebo-controlled trial was designed.Totally,122 female patients with breast hyperplasia and disharmony of the chong(冲)and ren(任)meridian pattern were randomly divided into treatment group and con⁃trol group,with 61 cases in each group.Patients in the treatment group were given Sanjie Xiaotong Ointment for exter⁃nal application,while the control group was given placebo ointment,both for eight weeks.The total score of breast pain was assessed and compared before treatment,and at week 4,8(after treatment)and 12(during follow up).The breast color Doppler ultrasound score,breast lumps score,Hamilton depression rating scale(HDRS)score,and tra⁃ditional Chinese medicine(TCM)syndrome score,as well as the levels of estrogen(E_(2)),progesterone(P),and pro⁃lactin(PRL)were assessed before and after treatment,and the clinical effect and safety were evaluated.Results After treatment,the HDRS score and TCM syndrome score significantly decreased in both groups(P<0.05).In the treatment group,the breast color Doppler ultrasound score,breast lumps score,E_(2)and PRL levels were significantly reduced,and were lower than those in the control group(P<0.05),while serum P level significantly increased and was higher than that in the control group(P<0.05).In the control group,the breast color Doppler ultrasound score,breast lumps score,E_(2),PRL and P levels were not significantly changed after treatment(P>0.05).The cure rate,markedly effective rate and total effective rate in the treatment group were 9.84%,31.15%,86.89%,respectively,higher than 0,9.84%and 32.79%in the control group with significant differences(P<0.05).Two cases of local skin redness occurred in the treatment group,and two cases of local skin itching occurred in the control group.There were no systematic adverse reactions,and

关 键 词：乳腺增生症 冲任失调 中药外敷 疼痛 散结消痛膏 

分 类 号：R269[医药卫生—中西医结合]