定紫膏穴位贴敷治疗肝郁气滞型中重度周期性乳痛症随机、双盲、安慰剂对照临床研究  

Acupoint Herbal Patching of Ding Zi Gao(定紫膏)in Treating Moderate to Severe Cyclic Mastalgia with Liver Constraint and Qi Stagnation Syndrome:A Randomized,Double-blind,Placebo-controlled Clinical Trial

作　　者：梁欢 黄巧[1] 东浩[1] 赵文洁[1] 付娜[1] 张董晓[1] LIANG Huan;HUANG Qiao;DONG Hao;ZHAO Wenjie;FU Na;ZHANG Dongxiao(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing,100010;Beijing University of Chinese Medicine)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]北京中医药大学

出　　处：《中医杂志》2022年第14期1350-1355,共6页Journal of Traditional Chinese Medicine

基　　金：北京市百千万人才工程(2019A31)。

摘　　要：目的观察定紫膏治疗中重度周期性乳痛症肝郁气滞型患者的临床疗效和安全性。方法60例中重度周期性乳痛症肝郁气滞型患者随机分为治疗组和对照组各30例。治疗组采用定紫膏穴位贴敷局部治疗,从月经结束后第3天开始贴敷,对照组给予安慰剂穴位贴敷治疗,均每天贴敷1次,每次贴敷时间6~8 h,共14天。治疗前及治疗结束后第1、3、5、7天对乳房疼痛进行视觉模拟疼痛评分(VAS评分);治疗前后进行乳腺McGiLL疼痛评分、中医全身症状综合评分和乳腺彩色超声影像学整体评分,并判定临床疗效和安全性。结果治疗组有2例脱落,对照组30例均完成研究。与本组治疗前比较,治疗组治疗结束后第1、3、5、7天VAS评分均降低(P<0.05),对照组仅治疗结束后第5、7天VAS评分明显降低(P<0.05)。治疗组治疗结束后第1、3、5、7天VAS评分均低于同期对照组(P<0.05)。与治疗前比较,治疗组治疗后乳腺McGiLL疼痛评分、中医全身症状综合评分均显著降低(P<0.05),且治疗组治疗后显著低于对照组(P<0.05)。治疗组治疗后乳腺彩色超声影像学整体评分较治疗前明显降低(P<0.05),两组治疗后比较差异无统计学意义(P>0.05)。治疗组临床疗效总有效率为96.55%,显著高于对照组的75.86%(P<0.01)。两组患者均未观察到严重不良事件,治疗组7例、对照组有4例穴位周边出现轻微胶布过敏,两组比较差异无统计学意义(P>0.05)。结论定紫膏穴位贴敷治疗中重度乳痛症肝郁气滞型患者可改善乳房疼痛和肿胀,提高临床疗效,且安全性好。ObjectiveTo explore the clinical effect and safety of Ding Zi Gao(定紫膏,DZG)in treating moderate to severe cyclic mastalgia with liver constraint and qi stagnation syndrome.MethodsSixty women of moderate to severe cyclic mastalgia with liver constraint and qi stagnation syndrome were randomly divided into 30 cases in the treatment group and 30 cases in the control group.The treatment group was given acupoint herbal patching(AHP)of DZG,starting from the 3rd day after menstruation,6-8 h each time,once a day for 14 days.The control group was given AHP of placebo,in the same administration way with the treatment group.The changes in VAS scores before the treatment and on the 1st,3rd,5th and 7th day after treatment were assessed.The McGiLL score of breast,the comprehensive score of traditional Chinese medicine(TCM)systemic symptoms,the overall breast color Doppler ultrasonography score before and after treatment were assessed,and the clinical effect and safety were determined.ResultsTwo cases in the treatment group dropped out,while all 30 cases in the control group completed the study.VAS scores in the treatment group decreased on the 1st,3rd,5th and 7th day(P0.05).Total effective rate in the treatment group was 96.55%,significantly higher than 75.86%in the control group(P0.05).Conclusion AHP of DZG can improve breast pain and swelling,increase clinical effect,and show safety in the treatment of moderate to severe cyclic mastalgia with liver constraint and qi stagnation syndrome.

关 键 词：乳痛症 穴位贴敷 定紫膏 肝郁气滞证 乳腺彩色超声 

分 类 号：R269[医药卫生—中西医结合]