清热中药对支气管扩张症稳定期患者临床症状及生活质量的影响——一项50例单病例随机对照研究  

Effects of Heat-clearing Chinese Medicinals on Clinical Symptoms and Quality of Life in Stable Bronchiectasis:N-of-1 Trials of 50 Cases

作　　者：王明莉 毛灵 訾素娜 张谊[1] 张恩丝 王振伟[1] 沈丽华 葛飞 杨佩兰[1] 黄海茵[1] WANG Mingli;MAO Ling;ZI Suna;ZHANG Yi;ZHANG Ensi;WANG Zhenwei;SHEN Lihua;GE Fei;YANG Peilan;HUANG Haiyin(Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai,200437;Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine)

机构地区：[1]上海中医药大学附属岳阳中西医结合医院,上海市 [2]上海市光华中西医结合医院

出　　处：《中医杂志》2023年第6期600-608,共9页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(81874515);上海市卫生和计划生育委员会中医药科研专项(2016LP047);上海市进一步加快中医药事业发展三年行动计划[ZY(2018-2020)-ZYBZ-08]。

摘　　要：目的比较个体化方、个体化减清热方的疗效与安全性差异,评价清热中药在支气管扩张症稳定期的价值。方法采用随机、双盲的单病例随机对照试验方法,对50例支气管扩张症稳定期患者进行3轮试验,每轮试验期和对照期各4周。患者在试验期服用辨证施治的个体化方,对照期服用个体化减清热方(在个体化方中去除清热中药),每一期服药3周,停药1周进行指标采集。主要结局指标为总体症状(Likert量表)评分,次要结局指标为慢性阻塞性肺疾病评估测试(CAT)评分、24 h痰量。分别采用配对t检验和Meta分析评估不同方剂的个体及群体疗效差异。结果个体水平上,6例Likert量表评分、1例24 h痰量个体化方优于个体化减清热方(P<0.05)。群体数据Meta分析结果显示,在总体症状评分[MD=-0.10,95%CI(-0.13,-0.06)(P<0.01)]、CAT评分[MD=-0.48,95%CI(-0.86,-0.11)(P=0.01)]、24 h痰量[MD=-0.48,95%CI(-1.29,0.04)(P=0.07)]上个体化方均优于个体化减清热方。两种方剂均未出现严重不良反应。结论清热中药可减轻支气管扩张症稳定期患者临床症状,提高生活质量,安全性良好,但较不使用清热中药疗效提高程度有限。Objective To compare the differences in the efficacy and safety of the individualized decoctions and the individualized decoctions that removed of heat-clearing medicinals,and to evaluate the value of heat-clearing Chinese medicinals in the stable stage of bronchiectasis.Methods Fifty patients in the stable stage of bronchiectasis were enrolled in a double-blind,randomized,N-of-1 trials.The trial was consisted of three rounds,each round having testing period and control period,4 weeks respectively.Patients took individualized decoction based on syndrome differentiation during the testing period,and took individualized decoction that removed heat-clearing medicinals during the control period.The medication time during each period was three weeks,and the primary outcome measures including overall symptom score(Likert scale),secondary outcome including chronic obstructive pulmonary disease assessment test(CAT)score and 24-hour sputum volume were evaluated one week after stopping medication.Paired t-test and meta-analysis were used to evaluate the efficacy differences of different prescriptions at the individual and group level.Results At the individual level,there were statistically significant differences in favor of individualized decoction than that removing heat-clearing medicinals in the Likert scale score(6 cases)and 24-hour sputum volume(1 case)of certain patients(P<0.05).At the group level,the results of meta-analyses showed that individualized decoction was better than that removing the heat-clearing medicinals in overall symptom score(MD=-0.10,95%CI-0.13,-0.06,P<0.001),CAT score(MD=-0.48,95%CI-0.86,-0.11,P=0.01)and 24-hour sputum volue(MD=-0.48,95%CI-1.29,0.04,P=0.07).There were no serious adverse reactions of the two TCM prescriptions.Conclusion Heat-clearing Chinese medicinals can relieve symptoms and improve quality of life in patients with stable bronchiectasis with good safety,but the degree of improvement is limited.

关 键 词：支气管扩张症 稳定期 个体化治疗 清热中药 临床症状 生活质量 单病例随机对照试验 

分 类 号：R259[医药卫生—中西医结合]