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

Huan LIANG; Qiao HUANG; Hao DONG; Wenjie ZHAO; Na FU; Dongxiao ZHANG

doi:10.13288/j.11-2166/r.2022.14.009

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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

更新时间：2022-07-11

- 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
- Journal of Traditional Chinese Medicine Vol. 63, Issue 14, Pages: 1350-1355(2022)
- 作者机构：
  
  1.首都医科大学附属北京中医医院，北京市东城区美术馆后街23号，100010
  2.北京中医药大学
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2022.14.009
  CLC：
- Received：27 December 2021，
  
  Revised：2022-04-28，
  
  Published：17 July 2022
- 稿件说明：
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梁欢,黄巧,东浩等.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[J].中医杂志,2022,63(14):1350-1355.

LIANG Huan,HUANG Qiao,DONG Hao,et al.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[J].Journal of Traditional Chinese Medicine,2022,63(14):1350-1355.
梁欢,黄巧,东浩等.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[J].中医杂志,2022,63(14):1350-1355. DOI： 10.13288/j.11-2166/r.2022.14.009.

LIANG Huan,HUANG Qiao,DONG Hao,et al.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[J].Journal of Traditional Chinese Medicine,2022,63(14):1350-1355. DOI： 10.13288/j.11-2166/r.2022.14.009.

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（

＜0.05），对照组仅治疗结束后第5、7天VAS评分明显降低（

＜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（

＜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（

＜0.05），且治疗组治疗后显著低于对照组（

＜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（

＜0.05），两组治疗后比较差异无统计学意义（

＞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%（

＜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（

＞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。

Abstract

Objective

To explore the clinical effect and safety of

Ding Zi Gao

（定紫膏， DZG） in treating mode-rate to severe cyclic mastalgia with liver constraint and

stagnation syndrome.

Methods

Sixty women of moderate to severe cyclic mastalgia with liver constraint and

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.

Results

Two 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 （

＜0.05） after treatment finished， while that in the control group decreased on the 5th and 7th day （

＜0.05）. Lower VAS scores were found in the treatment group than the control group on the 1st， 3rd， 5th and 7th day after treatment finish（

＜0.05）. After treatment， the breast McGiLL score and the TCM systemic symptoms score significantly decreased in the treatment group （

＜0.05）， and were significantly lower than those in the control group （

＜0.05）. The overall breast color Doppler ultrasonography score significantly decreased in the treatment group after treatment （

＜0.05）， and there was no statistically significant difference between groups （

＞0.05）. Total effective rate in the treatment group was 96.55%， significantly higher than 75.86% in the control group（

＜0.01）. No serious adverse events were observed in either group. Seven cases in the treatment group and four cases in the control group showed allergy to the adhesive tape around the acupoints， and the difference between groups was not statistically significant （

＞0.05）.

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

stagnation syndrome.

关键词

Keywords

references

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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

DOI：10.13288/j.11-2166/r.2022.14.009

摘要

Abstract

关键词

Keywords

references