培土生金中药联合西医常规疗法治疗慢性阻塞性肺疾病稳定期的Meta分析与GRADE评价  

“Earth-banking up to Generate Metal” Method in Chinese Herbal Medicine Combined with Conventional Therapy for Stable Chronic Obstructive Pulmonary Disease: Meta Analysis with GRADE Assessment

作　　者：陈远彬 范斐婷 吴蕾 肖晶旻 梁紫尧 范龙 于旭华 林琳 CHEN Yuanbin;FAN Feiting;WU Lei;XIAO Jingmin;LIANG Ziyao;FAN Long;YU Xuhua;LIN Lin(Guangdong Province Traditional Chinese Medical Hospital/The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou,510120)

机构地区：[1]广东省中医院/广州中医药大学第二附属医院,广东省广州市510120

出　　处：《中医杂志》2021年第22期1970-1978,共9页Journal of Traditional Chinese Medicine

基　　金：广州市科技计划项目(202002020042);广东省中医院中医药科学技术研究专项(YN2019ML03,YN2018QL07);北京医卫健康公益基金会医学科学研究基金(B20260DS);广东省中医院名中医药专家学术经验传承工作室建设项目(中医二院[2014]89号);广州中医药大学“双一流”与高水平大学学科协同创新团队项目(2021xk27)。

摘　　要：目的系统评价培土生金中药联合西医常规疗法治疗慢性阻塞性肺疾病(简称慢阻肺)稳定期的有效性、安全性以及证据质量。方法检索中国生物医学文献数据库、维普数据库、中国知网、万方数据知识服务平台、Embase和PubMed数据库,收集培土生金中药联合西医常规疗法治疗慢阻肺稳定期的随机、双盲、安慰剂对照试验,检索时间范围为各数据库建库至2021年5月31日。采用Cochrane偏倚风险评估工具评价纳入研究的方法学质量,使用RevMan 5.3软件对结局指标[包括慢性阻塞性肺疾病评估测试(CAT)评分、圣乔治呼吸问卷(SGRQ)评分、急性加重频次、六分钟步行距离(6MWD)、改良版英国医学研究会呼吸困难量表(mMRC)评分、第一秒用力呼气容积(FEV1)、BODE指数和不良事件发生率]进行Meta分析,并参考GRADE标准对证据质量进行汇总和分级。结果共纳入14项研究,合计2209例患者。Meta分析结果显示:与对照组相比,培土生金中药联合西医常规疗法在减少急性加重频次[SMD=-0.76次,95%CI(-1.27,-0.25),P=0.004]和降低SGRQ评分[MD=-4.68分,95%CI(-9.14,0.22),P=0.04]方面,疗效更为显著,证据质量为中等,并可增加6MWD[MD=29.00 m,95%CI(6.04,51.96),P=0.01],但质量证据较低。培土生金中药联合西医常规疗法对CAT评分、BODE指数、FEV1和mMRC评分的改善并不优于对照组,证据质量为中至极低。结论培土生金中药联合西医常规疗法治疗慢阻肺稳定期可改善患者的生活质量,并减少急性加重,但在增加运动耐力和安全性评估方面的证据质量低,尚需更多高质量的研究证实并提升证据级别。To systematically evaluate the effectiveness and safety of Chinese herbal medicine that banks up earth to generate metal(CHM-BUEGM)in combination with conventional therapy for treatment of chronic obstructive pulmonary disease(COPD),and to assess the quality of the evidence.Methods SinoMed,VIP,CNKI,Wanfang,Embase and PubMed were searched from the inception dates to May 31 st,2021 for double-blind,placebo-controlled randomized trials that explores CHM-BUEGM in combination with conventional therapy for stable patients with COPD. Cochrane risk of bias tool was used to assess the methodological quality of the included studies;RevMan 5. 3 software was used to perform meta analyses of outcomes including COPD assessment test(CAT)score,St George’s Respiratory Questionnaire(SGRQ)score,frequency of acute exacerbation,six-minute walking distance(6 MWD),modified medical research council(mMRC)score,forced expiratory volume in one second(FEV1),BODE index and incidence of adverse events;the certainty of the evidence was evaluated by GRADE.Results compared to control group,CHM-BUEGM plus conventional therapy was superior in reducing frequency of acute exacerbation(SMD:-0. 76,95%CI:[-1. 27,-0. 25],P=0. 004),lowering SGRQ score(MD:-4. 68,95%CI:[-9. 14,0. 22],P=0. 04)and increasing 6 MWD(MD:29. 00,95%CI:[6. 04,51. 96],P=0. 01). CHM-BUEGM in combination with conventional therapy was not superior to control group in improving CAT score,BODE index,FEV1 and mMRC score with moderate to very low certainty of evidence.ConclusionCHM-BUEGM combined with conventional therapy can improve the quality of life and reduce acute exacerbation of patients with stable COPD,but the certainty of evidence on increasing exercise endurance and safety is low,which needs more high-quality studies for confirmation and improve level of evidence.

关 键 词：慢性阻塞性肺疾病 培土生金 稳定期 META分析 GRADE评价 

分 类 号：R563.9[医药卫生—呼吸系统]