经典名方清金化痰汤加减联合西医治疗痰热证患者有效性与安全性的系统评价和Meta分析  

Efficacy and Safety of Modified Qingjin Huatantang Combined with Western Medicine in Treatment of Phlegm-heat:A Systematic Review and Meta-analysis

作　　者：王露[1,2,3] 王佳佳 刘嘉敏[1,2,3] 李建生 WANG Lu;WANG Jiajia;LIU Jiamin;LI Jiansheng(Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province and 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 Chinese Medicine,Zhengzhou 450000,China;The First Clinical Medical School of Henan University of Chinese Medicine,Zhengzhou 450000,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450000 [3]河南中医药大学第一临床医学院,郑州450000

出　　处：《中国实验方剂学杂志》2024年第19期154-162,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：河南省中医药科学研究专项(2023ZY2039,2024ZY2022);河南省卫生健康委国家中医药传承创新中心科研专项(2023ZXZX1126);河南省“双一流”创建学科中医学科学研究专项(HSRP-DFCTCM-2023-4-09)。

摘　　要：目的:系统评价经典名方清金化痰汤加减联合西医治疗痰热证患者的有效性与安全性,为其临床应用及新药研发提供参考。方法:计算机检索中国生物医学文献数据库、中国知网、万方数据知识服务平台、维普中文期刊服务平台和PubMed收录的有关清金化痰汤加减治疗痰热证患者的随机对照试验,检索时限自建库至2023年11月01日。2名研究者独立筛选文献、提取数据,并采用Cochrane协作网风险偏倚评估工具进行方法学质量评估,采用Revman 5.4软件对结局指标进行Meta分析。结果:共纳入91篇随机对照试验,涉及7868例患者,其中试验组3942例,对照组3926例。Meta分析结果显示,与单纯西医治疗比较,清金化痰汤加减联合西医治疗在提高临床有效率[相对危险度(RR)=1.16,95%CI置信区间(95%CI)[1.14,1.19],P<0.00001]、氧分压(均数差(MD)=4.65,95%CI[1.88,7.43],P=0.001)方面疗效显著;在降低症状积分(咳嗽(MD)=-0.69,95%CI[-1.33,-0.06],P=0.03)、咳痰(MD=-1.04,95%CI[-2.02,-0.07],P=0.04)、痰量(MD=-0.38,95%CI[-0.69,-0.07],P=0.02)、发热(MD=-0.22,95%CI[-0.36,-0.09],P=0.0008)、喘息(MD=-0.34,95%CI[-0.40,-0.29],P<0.00001)、胸闷(MD=-0.32,95%CI[-0.39,-0.26],P<0.00001)、啰音(MD=-0.35,95%CI[-0.42,-0.27],P<0.00001)、二氧化碳分压(MD=-5.42,95%CI[-7.12,-3.72],P<0.00001)和炎症因子{白细胞计数(MD=-1.27,95%CI[-1.56,-0.97],P<0.00001)、C反应蛋白[标准化均属差(SMD)=-1.52,95%CI[-1.96,-1.07],P<0.00001]、降钙素原(SMD=-1.23,95%CI[-1.87,-0.58],P=0.0002)、肿瘤坏死因子-α(SMD=-2.63,95%CI[-3.19,-2.08],P<0.00001)}方面具有优势;在缩短住院时间[MD=-2.45,95%CI(-3.34,-1.57),P<0.00001]方面有优势,能降低不良反应[RR=0.66,95%C(I 0.49,0.88),P=0.005]。结论:清金化痰汤加减联合西医治疗痰热证患者在提高临床有效率、氧分压,降低症状积分、炎症因子,缩短住院时间方面具有优势,且安全性高。Objective:To evaluate the efficacy and safety of modified Qingjin Huatantang combined with Western medicine in the treatment of phlegm-heat and to provide reference for the clinical application of this therapy and development of new drugs.Method:China Biology Medicine(CBM),Chinan National Knowledge Infrastructure(CNKI),Wanfang Data,VIP,and PubMed were searched for the randomized controlled trials(RCTs)of modified Qingjin Huatantang in the treatment of phlegm-heat that were published from inception to November 1,2023.Two researchers independently screened the RCTs and extracted data according to pre-set inclusion and exclusion criteria.The Cochrane Collaboration's tool for assessing risk of bias was used for quality evaluation.Revman 5.4 was used for the Meta-analysis of outcome indicators.Result:A total of 91 RCTs were included,involving 7868 patients(3942 patients in the experimental group and 3926 patients in the control group).The results of Meta-analysis showed that compared with simple Western medicine treatment,modified Qingjin Huatantang combined with Western medicine improved the clinical response rate[relative risk(RR)=1.16,95% confidence interval(CI)[1.14,1.19],P<0.00001]and PaO_(2)[mean difference(MD)=4.65,95%CI[1.88,7.43],P=0.001].The combined therapy had advantages in decreasing the scores of clinical symptoms including cough[MD=-0.69,95%CI[-1.33,-0.06],P=0.03],expectoration[MD=-1.04,95%CI[-2.02,-0.07],P=0.04],phlegm volume[MD=-0.38,95%CI[-0.69,-0.07],P=0.02],fever[MD=-0.22,95%CI[-0.36,-0.09],P=0.0008],wheezing[MD=-0.34,95%CI[-0.40,-0.29],P<0.00001],chest tightness[MD=-0.32,95%CI[-0.39,-0.26],P<0.00001],and rales[MD=-0.35,95%CI[-0.42,-0.27],P<0.00001].Moreover,the combined therapy outperformed Western medicine treatment alone in reducing PaCO_(2)[MD=-5.42,95%CI[-7.12,-3.72],P<0.00001],white blood cell count(WBC)[MD=-1.27,95%CI[-1.56,-0.97],P<0.00001],C-reactive protein(CRP)[standard mean difference(SMD)=-1.52,95%CI[-1.96,-1.07],P<0.00001],procalcitonin(PCT)[SMD=-1.23,95%CI[-1.87,-0.58],P=0.0002],and

关 键 词：清金化痰汤 痰热证 随机对照试验 META分析 

分 类 号：R242[医药卫生—中医临床基础] R289[医药卫生—中医学] R2-031R256.1