疏风解毒胶囊治疗慢性支气管炎急性发作的系统评价

Systematic review of Shufeng Jiedu capsules for acute attack of chronic bronchitis

目的:系统评价疏风解毒胶囊治疗慢性支气管炎急性发作(acute exacerbation of chronic bronchitis,AECB)的有效性和安全性。方法:计算机检索中国知网(CNKI)、中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM)、万方数据库(WanFang)、PubMed、EMbase、Cochrane Library以及中国临床试验注册中心(ChiCTR),检索时间从建库之日到2020年12月31日,筛选疏风解毒胶囊治疗AECB的随机对照试验(RCT)。采用RevMan 5.3软件对结局指标,包括有效率、C反应蛋白(C-reactive protein,CRP)、肺功能[FEV1%和(或)FEV1/FVC]、白细胞介素8(interleukin-8,IL-8)和肿瘤坏死因子α(tumornecrosis factor-α,TNF-α)进行Meta分析,对有效率进行试验序贯分析(trial sequential analysis,TSA),并按照GRADE标准进行证据质量评价。结果:共纳入8个RCT,总计680例患者。Meta分析结果显示:疏风解毒胶囊能提高临床治疗的有效率[RR=1.20,95%CI(1.13,1.28)],改善肺功能[FEV1:MD=0.33,95%CI(0.22,0.45);FEV1/FVC:MD=10.17,95%CI(8.15,12.19)],降低CRP[MD=-7.32,95%CI(-8.42,-6.22)]、IL-8[MD=-63.39,95%CI(-73.49,-53.29)]、TNF-α[MD=-7.44,95%CI(-8.35,-6.53)]水平。以上差异均有统计学意义(P<0.05),所有研究未报道严重不良反应。TSA表明疏风解毒胶囊提高有效率证据可靠。根据GRADE评价系统,结局指标有效率、TNF-α为中等质量证据,FEV1为低质量证据,FEV1/FVC、CRP、IL-8为极低质量证据。结论:疏风解毒胶囊联合西药治疗AECB的疗效优于单用西药治疗。但由于样本量较少、纳入文献质量的限制,未来仍需更高质量的RCT进一步去证实其有效性和安全性。

Objective:To systematically evaluate the efficacy and safety of Shufeng Jiedu capsules in the treatment of acute exacerbation of chronic bronchitis(AECB). Methods:CNKI,VIP,CBM,WanFang,PubMed,EMbase,Cochrane Library and ChiCTR were searched by computer,and randomized controlled trials about Shufeng Jiedu capsules in the treatment of AECB were integrated. The retrieval time was from the inception of the database to December 31,2020. Meta-analyses of outcome indicators,including effective rate,C-reactive protein(CRP),lung function(FEV1% and/or FEV1/FVC),interleukin-8(IL-8),tumor necrosis factor-α(TNF-α),were carried out by RevMan 5.3 software,and the effective rate was tested by trial sequential analysis(TSA),and the quality of evidence was evaluated according to GRADE standards. Results:A total of 680 cases in 8 articles were included. Shufeng Jiedu capsules raised the effective rate of clinical treatment[RR=1.20,95% CI(1.13,1.28)],improved lung function[FEV1:MD=0.33,95% CI(0.22,0.45),FEV1/FVC:MD=10.17,95% CI(8.15,12.19)],and reduced CRP[MD=-7.32,95% CI(-8.42,-6.22)],IL-8[MD=-63.39,95% CI(-73.49,-53.29)] and TNF-α[MD=-7.44,95% CI(-8.35,-6.53)]levels. The above differences were statistically significant(P<0.05),and no serious adverse reactions were reported in all studies. The results of TSA analysis showed that the experimental group had definite evidence for improving the efficiency. According to the GRADE evaluation system,the efficiency and TNF-α were medium-quality evidence,FEV1 was low-quality evidence,and FEV1/FVC,CRP,and IL-8 were extremely low-quality evidence. Conclusion:The curative effect of Shufeng Jiedu capsule combined with western medicine in the treatment of AECB was better than that of single western medicine. Nevertheless,considering the limited sample size and the quality of included articles,higher quality RCTs are still needed to further confirm its effectiveness and safety.