中国全科医学

• •

天灸散穴位贴敷治疗支气管哮喘前期62例的随机对照研究

郭鑫, 周明娟, 范斐婷, 肖晶旻, 池逸和, 吴蕾, 林琳, 陈远彬   

  • 收稿日期:2024-02-27 接受日期:2024-03-15
  • 通讯作者: 陈远彬
  • 基金资助:
    省部共建中医湿证国家重点实验室项目(SZ2021ZZ42、SZ2023ZZ11); 2020广东省科技创新战略专项资金(粤港澳联合实验室)项目(2020B1212030006); 广东省科技计划项目(2016A020215187、2023B1212060063); 广州市中医药防治慢性咳喘病重点实验室(2023A03J0226); 广东省中医药局科研项目(20221175、20233020); 广东省中医院中医药科学技术研究专项(YN2022MS02); 广东省中医院周仲瑛学术经验传承工作室(中医二院[2014]89号)

Acupoint Application of Tianjiu Powder for Preliminary Asthma: A Randomised,Double-blind,Placebo-controlled Trial

GUO Xin,ZHOU Mingjuan,FAN Feiting,XIAO Jingmin,CHI Yihe,WU Lei,LIN Lin,CHEN Yuanbin   

  • Received:2024-02-27 Accepted:2024-03-15
  • Contact: CHEN Yuanbin
分享到

摘要: 目的 评价广东省中医院医院制剂“天灸散”穴位贴敷治疗支气管哮喘(简称哮喘)前期的临床疗效与安全性,形成哮喘前期的中医治未病外治方案。方法 123例哮喘前期患者随机分为试验组62例,对照组61例。试验组给予天灸散穴位贴敷,对照组给予安慰剂穴位贴敷。疗程24周,治疗结束后随访24周。比较两组患者治疗前后支气管激发/舒张转阴率、支气管激发/舒张阳性率、中医症状积分、SF-36健康调查量表评分,肺功能FEV1和小气道功能指标、嗜酸性粒细胞炎症水平(EOS%)、总免疫球蛋白IgE的变化,治疗期间观察不良反应发生情况。结果 第12周、24周、48周试验组支气管激发/舒张试验转阴率(66.1%,64.5%,58.1%)高于对照组(47.5%,44.3%,36.1%)(P<0.05);第12周、24周试验组呼气峰值流量(PEF)治疗前后差值大于对照组(P<0.05);第48周试验组SF-36量表的生理机能(PF)、生理职能(RP)维度评分高于对照组(P<0.05);第12周、24周、48周试验组支气管激发/舒张阳性率、可疑阳性率及中医证候总积分均低于对照组,但组间差异无统计学意义(P>0.05);治疗前、第24周两组血清嗜酸性粒细胞(EOS%)和血清总IgE组间比较差异无统计学意义(P>0.05)。两组不良事件发生率的差异无统计学意义(P>0.05)。结论 天灸散穴位贴敷有效提高哮喘前期患者的支气管激发/舒张试验转阴率,增加PEF,改善生活质量,且安全性好,为哮喘早期防控策略提供了新的治疗思路。

关键词: 支气管哮喘, 前期, 中医外治法, 中药穴位贴敷, 随机对照试验

Abstract: Purpose To assess the efficacy and safety of acupoint application of Tianjiu Powder for the treatment of preliminary asthma,forming a traditional Chinese medicine(TCM) external therapy plan of preliminary asthma. Methods  123 preliminary asthma patients were randomly divided into 62 in the treatment group and 61 in the control group with 24 weeks for treating and 24 weeks for following after the end of treatment. Acupoint application of Tianjiu Powder was given to the treatment group,placebo acupoint application was given to the control group. The negative rate and positive rate of bronchial provocation /dilation test,TCM syndrome score,the SF-36,lung function FEV1 and small airway function,eosinophil(EOS%) and total serum immunoglobulin E(IgE) were compared between the treatment group and the control group before and after treatment. Adverse reactions were recorded during treatment. Results The negative rate of bronchial provocation /dilation test in the treatment group(66.1%,64.5%,58.1%) was higher than that in the control group(47.5%,44.3%,36.1%)(P < 0.05) at week 12,week 24 and week 48. The difference before and after treatment of lung function PEF in the treatment group was higher than that in the control group(P < 0.05) at week 12 and week 24 . PF and RP score which belonged to SF-36 in the treatment group were higher than them in the control group(P < 0.05) at week 48. The positive rate and doubtful positive rate of bronchial provocation /dilation test and TCM syndrome score in the treatment group were lower than them in the control group at week 12,week 24 and week 48,however,there was no significant difference between the two groups(P > 0.05). There was no significant difference of EOS% and IgE between the two groups at pre-treatment and week 24. There was no significant difference of the incidence of adverse reactions between the two groups(P > 0.05). Conclusions Acupoint application of Tianjiu Powder can enhance the negative rate of bronchial provocation /dilation test,improve PEF and the quality of life in preliminary asthma patients. It suggested that preliminary asthma could be prevented and controlled,provided a new idea for early prevention and control of asthma.

Key words: Bronchial asthma, Preliminary, External therapy of Chinese medicine, Acupoint application of Chinese medicine, Randomised controlled trial