疏风解毒胶囊治疗慢性阻塞性肺疾病急性加重期的Meta分析

Meta-analysis of Shufeng Jiedu Capsule in treatment of acute exacerbation of chronic obstructive pulmonary disease

目的系统评价疏风解毒胶囊治疗慢性阻塞性肺疾病急性加重期(AECOPD)的临床有效性、安全性。方法检索中文学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、万方数据库(WanFang Data)、维普中文期刊全文数据库(VIP)、PubMed、Cochrane Library等数据库已发表的疏风解毒胶囊治疗AECOPD的临床随机对照试验(RCT),时限从建库至2021年1月,使用Cochrane手册对纳入文献进行质量评价,使用Review Manager 5.3进行Meta分析。结果最终纳入16篇RCTs,包括1753例患者。Meta分析结果显示:疏风解毒胶囊联合西医常规治疗(试验组)有效率优于单纯西医常规治疗(对照组),组间比较差异具有统计学意义[RR=1.20,95%CI=(1.15,1.26),P<0.00001];试验组患者血气分析,二氧化碳分压[MD=−3.65,95%CI=(−10.79,3.50),P=0.32]、氧分压[MD=6.80,95%CI=(5.40,8.20),P<0.00001]改善优于对照组;试验组患者肺功能指标,第1秒用力呼气容积[MD=1.35,95%CI=(0.68,2.03),P<0.0001]、第1秒用力呼气容积占用力肺活量百分比[MD=0.83,95%CI=(0.66,1.00),P<0.00001]改善优于对照组;试验组炎症指标,C反应蛋白[MD=−4.81,95%CI=(−7.41,−2.20),P<0.00001]改善优于对照组,降钙素原[MD=−0.51,95%CI=(−0.79,−0.23),P=0.0004]改善优于对照组。不良反应少且无严重不良反应发生。结论西医常规治疗联用疏风解毒胶囊治疗AECOPD,可以提高临床疗效,改善患者血气、肺功能、炎症指标,安全性好,但部分结局指标有异质性,可能存在发表偏倚,因此未来仍需更大样本、高质量、多中心RCT研究以进一步评价其疗效及安全性。

Objective To systematically evaluate the clinical effectiveness and safety of Shufeng Jiedu Capsule in the treatment of acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Methods Search the Chinese Academic Journals Full-text Database(CNKI),China Biomedical Literature Database(CBM),WanFang Data,VIP Chinese Journal Full-text Database(VIP),PubMed,Cochrane Library and other databases that have published Shufeng Jiedu Capsules Clinical randomized controlled trials(RCTs)for the treatment of AECOPD,the time frame is from the establishment of the database to January 2021,the quality of the included literature is evaluated using the Cochrane manual,and the Meta analysis is performed using Review Manager 5.3.Results A total of 16 RCTs were finally included,including 1753 patients.Meta-analysis results show that:Shufeng Jiedu Capsule combined with Western medicine conventional treatment is more effective than conventional treatment alone,and the difference between the groups is statistically significant[RR=1.20,95%CI=(1.15,1.26),P<0.00001];The blood gas analysis of the patients in the test group showed that the partial pressure of carbon dioxide[MD=−3.65,95%CI=(−10.79,3.50),P=0.32],the partial pressure of oxygen[MD=6.80,95%CI=(5.40,8.20),P<0.00001]improved better than the control group;the lung function index of the test group patients,the forced expiratory volume in the first second(FEV1)[MD=1.35,95%CI=(0.68,2.03),P<0.0001],FEV1/FVC[MD=0.83,95%CI=(0.66,1.00),P<0.00001]improved better than the control group;the inflammatory index of the test group,C-reactive protein[MD=−4.81,95%CI=(−7.41,−2.20),P<0.00001]improved better than the control group,procalcitonin[MD=−0.51,95%CI=(−0.79,−0.23),P=0.0004]Improvement is better than the control group.There were few adverse reactions and no serious adverse reactions occurred.Conclusion The combination of conventional western medicine treatment and Shufeng Jiedu capsule in the treatment of AECOPD can improve the clinical efficacy,improve the blood gas,lung function,and inflammation indexes of patients,and have good safety.However,some outcome indexes are heterogeneous,and there may be publication bias.Therefore,it is still in the future.More large-sample,high-quality,multi-center RCT studies are needed to further evaluate its efficacy and safety.