鼻渊通窍颗粒联合抗生素治疗急性鼻窦炎有效性和安全性的系统评价和Meta分析

A Systematic Review and Meta-Analysis of Efficacy and Safety of Biyuan Tongqiao Granules(鼻渊通窍颗粒)Combined with Antibiotics in Treatment of Acute Sinusitis

目的对鼻渊通窍颗粒联合抗生素治疗急性鼻窦炎的有效性和安全性进行系统评价和Meta分析。方法检索万方、CNKI、VIP、CBM 4个中文数据库和PubMed、Cochrane Library、EMBASE、Web of science 4个英文数据库,结合“Cochrane偏倚风险评估”工具,筛选鼻渊通窍颗粒治疗急性鼻窦炎的随机对照试验(RCT),评估纳入的随机对照试验文献的质量,并使用Revman5.4.1软件对最终纳入的研究进行荟萃分析。结果最终共纳入14项RCT研究,总样本量为1849例患者,试验组(西医常规治疗+鼻渊通窍颗粒)930例,对照组为西医常规治疗919例。Meta分析结果显示,常规治疗基础上联合鼻渊通窍颗粒的临床有效率(RR=1.19,95%CI[1.15,1.24],P<0.0001)优于常规治疗;不良反应方面,治疗组与对照组之间差异无统计学意义(RR=-0.57,95%CI[0.29,1.09],P=0.09);常规治疗基础上联合鼻渊通窍颗粒的临床症状总得分(MD=-5.86,95%CI[-6.98,-4.74],P<0.00001);鼻塞评分(MD=-1.16,95%CI[-1.48,-0.85],P<0.00001);鼻涕评分(MD=-1.38,95%CI[-2.01,-0.75],P<0.0001);头痛评分(MD=-0.95,95%CI[-1.01,-0.98],P<0.00001);嗅觉障碍评分(MD=-1.69,95%CI[-2.00,-1.38],P<0.00001)。结论基于现有证据,鼻渊通窍颗粒联合西医常规治疗可以提高急性鼻窦炎的临床疗效,降低临床症状评分,改善其症状,且未发生严重不良反应。GRADE系统进行评估总有效率、不良反应发生率证据质量等级评为低级别。建议今后需采用符合国际规范的样本量大、多中心及盲法设计严谨的试验,提高其证据质量等级来验证其有效性和安全性。

Objective To conduct a systematic review and Meta-analysis on the efficacy and safety of Biyuan Tongqiao Granules(鼻渊通窍颗粒)combined with antibiotics in the treatment of acute sinusitis.Methods Four Chinese databases(Wanfang,CNKI,VIP and CBM)and four English databases(PubMed,Cochrane Library,EMBASE and Web of science)were searched,and combined with the“Cochrane risk of bias assessment”tool,the efficacy of Biyuan Tongqiao Granules in the treatment of acute sinusitis was screened.The quality of the included randomized controlled trials(RCTs)was assessed and a Meta-analysis of the final included studies was performed by using Revman 5.4.1 software.Results A total of 14 RCT studies were finally included,with a total sample size of 1849 patients,930 patients in the experimental group(conventional western medicine treatment+Biyuan Tongqiao Granules),and 919 patients in the control group(conventional western medicine treatment).The results of Meta-analysis showed that the clinical effective rate(RR=1.19,95%CI[1.15,1.24],P<0.0001)combined with Biyuan Tongqiao Granules on the basis of conventional treatment was better than conventional treatment.In terms of adverse reactions,the treatment group and the control group had no significant difference(RR=-0.57,95%CI[0.29,1.09],P=0.09).The total score of clinical symptoms combined with Biyuan Tongqiao Granules on the basis of conventional treatment(MD=-5.86,95%CI[-6.98,-4.74],P<0.00001),nasal congestion score(MD=-1.16,95%CI[-1.48,-0.85],P<0.00001),nasal mucus score(MD=-1.38,95%CI[-2.01,-0.75],P<0.0001),headache score(MD=-0.95,95%CI[-1.01,-0.98],P<0.00001)and smell disorder score(MD=-1.69,95%CI[-2.00],-1.38],P<0.00001).Conclusion Based on the existing evidence,Biyuan Tongqiao Granules combined with conventional western medicine treatment can improve the clinical efficacy of acute sinusitis,reduce the clinical symptom score and improve its symptoms without serious adverse reactions.The GRADE system evaluated the overall response rate and the incidence of adverse reactions.The quality of evidence was rated as low.It is suggested that large-scale,multi-center and blindly designed trials that conform to international norms should be used in the future to improve the quality of evidence to verify its efficacy and safety.