中医杂志

目的 比较益肺灸不同灸量组合治疗慢性阻塞性肺疾病（简称慢阻肺）稳定期的临床疗效及安全性。方法 选取240例慢阻肺稳定期肺气虚证/肺脾气虚证/肺肾气虚证患者为研究对象，均给予西医规范治疗和益肺灸治疗。根据艾绒、姜泥厚度及治疗时间随机分为8组，A组：3.0 cm厚度艾绒，2.5 cm姜泥，60 min治疗时间；B组：3.0 cm厚度艾绒，2.5 cm姜泥，90 min治疗时间；C组：2.0 cm厚度艾绒，2.5 cm姜泥，60 min治疗时间；D组：2.0 cm厚度艾绒，2.5 cm姜泥，90 min治疗时间；E组：3.0 cm厚度艾绒，2.0 cm姜泥，60 min治疗时间；F组：3.0 cm厚度艾绒，2.0 cm姜泥，90 min治疗时间；G组：2.0 cm厚度艾绒，2.0 cm姜泥，60 min治疗时间；H组：2.0 cm厚度艾绒，2.0 cm姜泥，90 min治疗时间。各组均15天治疗1次，治疗3个月，共6次。主要结局指标是治疗前后慢阻肺稳定期临床症状和体征问卷评分（包括咳嗽、咳痰、喘息、胸闷、气短、乏力、紫绀7个症状评分及总分）。次要结局指标包括治疗前后慢阻肺患者报告结局量表修订版（mCOPD-PRO）评分（包括生理、心理、环境3个领域评分及总分），疗效满意度问卷修订版（mESQ-COPD）评分（包括临床症状、工作生活能力、环境适应能力、治疗效果评分及总分）；治疗过程中灸感评分（包括热感情况评分、特殊感觉强度评分）及达到的最高温度、≥43℃维持时间、达到43℃所需时间。治疗后进行安全性评价。结果 研究过程中脱落18例，最终纳入符合方案集的患者222例（A组27例、B组28例、C组28例、D组29例、E组27例、F组28例、G组27例、H组28例）进行结果分析。治疗后F组在临床症状和体征问卷总评分及咳嗽、胸闷评分均低于其他各组（P<0.05）。治疗后F组mCOPD-PRO总分及生理领域评分较其他各组降低（P<0.05）;F组mESQ-COPD总分及临床症状、治疗效果评分较其他各组降低（P<0.05）;F组热感情况评分显著高于其他各组（P<0.05）；治疗后E组和F组最高温度显著高于其他各组，F组≥43℃维持时间显著长于其他各组，E组和F组达到43℃所需时间显著少于C组、D组、G组、H组（P<0.05）。各组患者治疗前后血常规、肝功能、肾功能、尿常规、心电图未见明显异常，治疗期间未出现严重不良事件。结论 不同灸量组合益肺灸治疗慢阻肺稳定期疗效存在差异，其中3.0 cm厚度艾绒、2.0 cm姜泥、90 min治疗时间的灸量组合可获得相对更佳的疗效，且安全性好。

Objective To observe the clinical efficacy and safety of lung-boosting moxibustion with different moxibustion doses in the treatment of stable chronic obstructive pulmonary disease(COPD).Methods A total of 240 stable COPD patients with lung qi deficiency,lung-spleen qi deficiency,or lung-kidney qi deficiency syndrome were enrolled,all receiving standardized western medical treatment and lung-boosting moxibustion.According to the thickness of the moxa wool,the thickness of the ginger paste,and the treatment duration,patients were randomly divided into eight groups,which were Group A(3.0 cm thickness moxa,2.5 cm ginger mud,60 min treatment time),Group B(3.0 cm thickness moxa,2.5 cm ginger mud,90 min treatment time),Group C(2.0 cm thickness moxa,2.5 cm ginger mud,60 min treatment time),Group D(2.0 cm thickness moxa,2.5 cm ginger mud,90 min treatment time),Group E(3.0 cm thickness moxa,2.0 cm ginger mud,60 min treatment time),Group F(3.0 cm thickness moxa,2.0 cm ginger mud,90 min treatment time),Group G(2.0 cm thickness moxa,2.0 cm ginger mud,60 min treatment time),Group H(2.0 cm thickness moxa,2.0 cm ginger mud,90 min treatment time).Treatment was performed once every 15 days for 3 months,with a total of six sessions.The primary outcomes were the scores of the clinical symptoms and signs questionnaire for stable COPD before and after treatment,comprising seven symptom domains(cough,sputum production,wheezing,chest tightness,shortness of breath,fatigue,and cyanosis) and the total score.The secondary outcomes included the scores of the modified COPD patient-reported outcome questionnaire(mCOPD-PRO) involving the physical,psychological,and environmental domains and the total score,the scores of the modified Effectiveness Satisfaction Questionnaire for COPD(mESQ-COPD) involving clinical symptoms,work and daily living capacity,environmental adaptability,treatment efficacy,and the total score before and after treatment,the moxibustion sensation scores(heat sensation score and special sensation intensity score) during treatment,and cutaneous temperature(the maximum temperature achieved,the duration of temperature maintained at ≥43 ℃,and the time required to reach 43 ℃).The safety evaluation was carried out after treatment.Results During the study,18 patients withdrew,and 222 patients were included in the per-protocol set for analysis,including 27 in Group A,28 in Group B,28 in Group C,29 in Group D,27 in Group E,28 in Group F,27 in Group G,and 28 in Group H.After treatment,the total score on the clinical symptoms and signs questionnaire,as well as the cough and chest tightness symptom scores in Group F were significantly lower than those in other groups(P<0.05).Group F demonstrated statistically lower total mCOPD-PRO score and physical domain score(P<0.05),lower total mESQ-COPD score and the scores for clinical symptoms and treatment efficacy(P < 0.05),as well as higher heat sensation score(P<0.05) than other groups.The maximum temperature was significantly higher in Group E and Group F than in the other groups,while the duration of temperature maintained at ≥43 ℃ was significantly longer in Group F than other groups,and the time required to reach 43 ℃ was significantly shorter in Group E and Group F than in Groups C,D,G,and H(P<0.05).No significant abnormalities were observed in routine blood tests,liver function,renal function,urinalysis,or electrocardiograms before and after treatment in any group.No serious adverse events occurred during the treatment period.Conclusion There are differences in the efficacy of different moxibustion doses of lung-boosting moxibustion in the treatment of stable COPD.Moxibustion with 3.0 cm thickness moxa,2.0 cm ginger mud,and 90 min treatment time can obtain relatively superior efficacy while demonstrating a favorable safety profile.