李庆娜¹，高蕊 ¹，陆芳 ¹，栗蕊 ^2,3，訾明杰 ¹，赵阳 ¹，邱攀博 ¹，李辰飞 ¹，迟慧彦 ⁴

1.中国中医科学院西苑医院临床药理研究所，中药临床研究与评价重点实验室， 国家中医心血管病临床医学研究中心，北京 100091；2.中国中医科学院博士后流动站，北京 100700；3.亚宝药业集团股份有限公司博士后工作站，山西 运城 044602；4.中国中医科学院西苑医院，北京 100091

摘要: 目的 了解中医穴位敷贴疗法在基层临床应用不良事件发生情况，探讨如何预防或减少不良事件的发生。 方法 采用横断面研究设计，利用电子问卷对中华中医药学会“春播行动”所有合作的基层医生进行普 查。重点调查不良事件发生率、不良事件表现及其影响因素。 结果 全国 31 个省份 12705 名基层医生参与了本次调查。基层医生临床使用含有中医穴位敷贴疗法治疗方案的比例(敷贴率)平均值为 46.8%，81.8%的基层医生对中医穴位敷贴疗法总体疗效满意或非常满意。根据临床经验，基层医生估计不良事件发生率平均值为 19.5%，联合其他疗法敷贴组基层医生估计的不良事件发生率高于单纯敷贴组(P<0.05)。74.2%(9 429/12 705) 的基层医生回答临床中出现过第一类不良事件；14.8%(1 874/12 705)的基层医生回答临床中出现过第二类不良事件；0.7%(95/12 705)的基层医生回答在临床中出现过第三类不良事件。68.5%(8 702/12 705)的基层医生回答会采取相关措施预防或减少皮肤反应，包括皮肤清洁或酒精消毒、使用洗剂、药膏等药物进行处理、缩短敷贴时长等。针对皮肤反应类不良事件发生相关因素这一问题，选择人数前 5 位的因素包括过敏体质、单次敷贴的时长、药贴中的胶布、累计敷贴的次数、敷贴的部位。结论 中医穴位敷贴疗法基层临床应用不良事件大多为敷贴部位局部皮肤反应，应针对上述不良事件发生可能相关因素，采取适当措施预防或减少不良事件的发生。

关键词：穴位敷贴； 基层医疗； 横断面研究； 不良事件

中图分类号:R  文献标识码:A

DOI: 10.19879/j.cnki.1005-5304.202107079

 

Cross-Sectional Study on the Occurrence of Adverse Events of Chinese Medical Acupoint Plaster Therapy in Primary Care

LI Qingna¹ , GAO Rui¹ , LU Fang^1 , LI Rui ^2,3, ZI Mingjie¹, ZHAO Yang¹ , QIU Panbo¹ , LI Chenfei¹ , CHI Huiyan⁴

1. Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences; NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine; National Clinical Research Center for Chinese Medicine Cardiology; Beijing 100091, China; 2. Postdoctoral Station of China Academy of Chinese Medical Sciences, Beijing 100700, China; 3. Postdoctoral Station of Yabao Pharmaceutical Group Co., Ltd.,

 

Abstract: Objective To understand the occurrence of adverse events (AE) of TCM acupoint application therapy in grass-roots medical service; To discuss how to prevent or reduce the occurrence of AE. Methods Based on a cross-sectional study, the electronic questionnaire was used to conduct a general survey of all grass-roots doctors cooperating with "Spring Sowing Action" of China Association of Chinese Medicine. The incidence, manifestations and the factors contributing to AE were investigated. Results Totally 12705 doctors from 31 provinces, autonomous regions or municipalities were surveyed. The average proportion of using TCM acupoint application therapy in grass-roots medical service was 46.8%. 81.8% of the grass-roots doctors were satisfied or very satisfied with the overall efficacy of TCM acupoint application therapy. Based on clinical experience, the estimated average incidence of AE was 19.5%. The average incidence of AE estimated by grass-roots doctors using TCM acupoint application therapy with other therapies was higher than singly using TCM acupoint application therapy (P<0.05). 74.2% (9 429/12 705) of the grass-roots doctors answered that the first type of AE. 14.8% (1 874/12 705) of the grass-roots doctors answered that the second type of AE. Other than that, 0.7% (95/12 705) of the grass-roots doctors answered that the third type of AE happened in clinical practice. 68.5% (8 702/12 705) of the grass-roots doctors answered that they would take relevant measures to prevent or reduce skin reactions, including skin cleansing or alcohol disinfecting, using lotions, ointments and other medications, and shortening the duration of application, etc. Regarding the factors related to skin reactions, the top five factors were allergies, single application duration, adhesive tape, cumulative application times and application sites. Conclusion The major AE of TCM acupoint application therapy is local skin reactions. Appropriate measures should be taken to prevent or reduce the occurrence of AE according to the above possible factors.

Keywords: acupoint application; grass-roots medical service; cross-sectional study; adverse events