辨证治疗对慢性阻塞性肺疾病急性加重患者临床症状体征评分及生活质量影响的多中心随机对照研究  

Multi-center randomized controlled study on the effect of syndrome differentiation therapy on clinical symptoms and signs score and quality of life in patients with AECOPD

作　　者：张海龙[1,2] 阮欢荣 司一妹 孙子凯[3] 刘红[4] 封继宏[5] 王燕青[6] 李利华[7] 白丽 孙辉[9] 李建生[1,2] ZHANG Hailong;RUAN Huanrong;SI Yimei;SUN Zikai;LIU Hong;FENG Jihong;WANG Yanqing;LI Lihua;BAI Li;SUN Hui;LI Jiansheng(Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan&Education Ministry of P.R.China,Henan Key Laboratory of Chinese Medicine for Respiratory Disease,Henan University of Chinese Medicine,Zhengzhou 450046,China;The First Affiliated Hospital of Henan University of CM,Zhengzhou 450003,China;Jiangsu Province Hospital of Chinese Medicine,Nanjing 210029,China;The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300250,China;Qingdao Haici Hospital,Qingdao 266032,China;Zhengzhou People’s Hospital,Zhengzhou 450003,China;Shanxi Hospital of Integrated Traditional and Western Medicine,Taiyuan 030001,China;Nanyang City Center Hospital,Nanyang 473003,China)

机构地区：[1]河南中医药大学,呼吸疾病中医药防治省部共建协同创新中心,河南省中医药防治呼吸病重点实验室,郑州450046 [2]河南中医药大学第一附属医院,郑州450003 [3]江苏省中医院,南京210029 [4]郑州大学第一附属医院,郑州450052 [5]天津中医药大学第二附属医院,天津300250 [6]青岛海慈医疗集团,青岛266032 [7]郑州人民医院,郑州450003 [8]山西中西医结合医院,太原030001 [9]南阳市中心医院,南阳473003

出　　处：《中华中医药杂志》2024年第1期485-490,共6页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：河南省中医药科学研究专项课题(No.2019JDZX2004);国家中医药管理局中医药科学技术研究专项(No.GZYKJS-2021-016);河南省特色学科中医学学科建设项目(No.STS-ZYX-2017006)。

摘　　要：目的:评价辨证治疗对慢性阻塞性肺疾病急性加重(AECOPD)患者临床症状体征评分及生活质量的影响。方法:采用多中心、随机、双盲、安慰剂平行对照试验设计,8家三级甲等医院的378例AECOPD患者为研究对象,中央动态分层区组随机法分为试验组和对照组,各189例。在西医规范治疗基础上,试验组给予中医辨证治疗:根据证候类型分别给予散寒化饮方(外寒内饮证)、清热化痰方(痰热壅肺证)、燥湿化痰方(痰湿阻肺证),均为颗粒剂;对照组分别给予相应安慰剂颗粒剂;每次10 g,每天2次;治疗14 d,随访12周。第0、4、7、10、14、28、42、98天分别观察记录《肺炎医生报告结局量表》(CAP-CRO)和第0、14、28、42、98天分别观察记录健康调查简表(SF-36)。结果:两组CAP-CRO量表的症状积分和症状体征总积分组间效应差异均有统计学意义(P<0.05);治疗14 d后试验组在减轻症状积分和症状体征总积分方面优于对照组(P<0.01)。两组SF-36量表的生理机能、生理职能、精力、社会功能、精神健康和健康变化领域得分的组间效应差异均有统计学意义(P<0.05);治疗14 d后,除躯体疼痛领域外,试验组在提升其他各领域得分方面优于对照组(P<0.05,P<0.01)。结论:中医辨证治疗AECOPD在减轻临床症状、提高生活质量方面具有较好的疗效。Objective:To evaluate the effect of syndrome differentiation therapy on clinical symptoms and signs score and quality of life of patients with AECOPD.Methods:A multicenter,randomized,double-blind,placebo-controlled parallel trial design was used and 378 participants with AECOPD from eight centers were randomly divided into experimental group and control group,189 respectively.On the basis of conventional medicine,the experimental group was given TCM syndrome differentiation treatment:Sanhanhuayin granule for a syndrome of external cold and internal fluid,Qingrehuatan granule for a syndrome of phlegm-heat congesting lung and Zaoshihuatan granule for a syndrome of phlegm-damp amassing in the lung.The control group was given corresponding placebo granules;10 g each time,twice a day;14 days of treatment and 12 weeks of follow-up.The COPD patient-reported outcome scale(CAP-CRO)was measured at baseline,4days,7days,10days,14 days(end of treatment),28 days,42 days(after a follow-up of 4 weeks),and 98 days(after a follow-up of 12 weeks).The MOS item short from health survey(SF-36)was measured at baseline,14 days,42 days,and 98 days.Results:There were significant differences between the two groups in terms of symptoms score and total score of symptoms and signs in CAP-CRO scale(P<0.05).After 14 days of treatment,the experimental group outperformed the control group in reducing symptom scores and total symptom and sign scores(P<0.01).There were significant differences between the two groups in terms of Physical Functioning score,Role-Physical score,Vitality score,Social Functioning score,Mental Health score and Reported Health Transition score in SF-36 scale(P<0.05).After 14 days of treatment,the experimental group outperformed the control group in improving scores in all other areas except for Bodily Pain(P<0.05,P<0.01).Conclusion:The treatment of AECOPD with syndrome differentiation therapy has a good effect in reducing clinical symptoms and improving quality of life.

关 键 词：慢性阻塞性肺疾病 急性加重 辨证治疗 生活质量 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]