鼻渊通窍颗粒治疗慢性鼻窦炎有效性和安全性的系统评价与Meta分析

Systematic review and Meta-analysis of efficacy and safety of Biyuan Tongqiao Granules in treatment of chronic sinusitis

对鼻渊通窍颗粒治疗慢性鼻窦炎的有效性和安全性进行系统评价和Meta分析。通过全面检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane Library、EMbase、Web of Science数据库,筛选鼻渊通窍颗粒治疗慢性鼻窦炎的随机对照试验(RCTs),根据Cochrane偏倚风险评估工具对纳入的RCTs进行质量评价,采用RevMan 5.4.1软件进行Meta分析。共纳入54项RCTs,总样本量7278例。Meta分析显示,单独使用和联合使用鼻渊通窍颗粒治疗慢性鼻窦炎的临床有效率优于仅使用西药常规治疗、中药制剂或手术治疗(RR=1.19,95%CI[1.15,1.24],P<0.00001),对照组基础上联合使用鼻渊通窍颗粒在改善慢性鼻窦炎的主要症状及体征方面优于对照组(RR_(鼻塞)=1.33,95%CI[1.21,1.45],P<0.00001;RR_(流鼻涕)=1.28,95%CI[1.18,1.40],P<0.00001;RR_(鼻甲充血肿胀)=1.28,95%CI[1.16,1.41],P<0.00001);单独使用或联合使用鼻渊通窍颗粒可有效降低慢性鼻窦炎鼻腔鼻窦结局测试(Snot-20)评分,优于对照组(MD=-2.94,95%CI[-3.60,-2.28],P<0.00001);单独使用或联合使用鼻渊通窍颗粒可有效降低疼痛视觉模拟量表(VAS)评分,优于对照组(MD总评分=-4.44,95%CI[-6.05,-2.82],P<0.00001;MD_(鼻塞VAS评分)=-0.99,95%CI[-1.38,-0.60],P<0.00001;MD_(流涕VAS评分)=-1.19,95%CI[-1.62,-0.76],P<0.00001;MD_(嗅觉障碍VAS评分)=-0.96,95%CI[-1.26,-0.65],P<0.00001;MD_(头面部疼痛VAS评分)=-0.73,95%CI[-0.98,-0.47],P<0.00001);联合使用鼻渊通窍颗粒能够有效降低鼻窦CT和内径黏膜形态Lund-Mackey评分(MD鼻窦CT评分=-3.68,95%CI[-5.47,-1.88],P<0.0001;MD_(内镜黏膜形态评分)=-3.06,95%CI[-5.53,-0.59],P=0.02);联合鼻渊通窍颗粒相比仅使用西药常规治疗、中药制剂或手术治疗不会增加不良反应的发生(RR=0.68,95%CI[0.26,1.77],P=0.43)。基于现有证据,鼻渊通窍颗粒的使用可以提高慢性鼻窦炎的临床疗效,改善症状及体征,降低Snot-20评分、VAS评分、Lund-Mackey评分,未发生严重不良反应,表明单独或联合使用鼻渊通窍颗粒相比仅使用西药常规治疗、中药制剂或手术治疗,对于慢性鼻窦炎的有效性和安全性更好。但由于纳入研究的质量普遍较低,未来应采用符合国际规范标准的大样本、高质量、严谨的多中心随机及盲法设计对照试验,增加证据的强度与级别。

The present study conducted a systematic review and Meta-analysis on the efficacy and safety of Biyuan Tongqiao Granules in the treatment of chronic sinusitis.CNKI,Wanfang,VIP,SinoMed,PubMed,Cochrane Library,EMbase,and Web of Science were searched for randomized controlled trials(RCTs)of Biyuan Tongqiao Granules in the treatment of chronic sinusitis.The quality of the included RCTs was assessed according to the Cochrane risk-of-bias assessment tool and the final included trials underwent Meta-analysis with RevMan 5.4.1.Fifty-four RCTs were included,with a total sample size of 7278 cases.The results of Meta-analysis showed that the clinical efficacy of Biyuan Tongqiao Granules alone or in combination in the experimental group in the treatment of chronic sinusitis was superior to that in the control group with conventional western medicine,Chinese medicinal preparations,or surgery only(RR=1.19,95%CI[1.15,1.24],P<0.00001).The combined use of Biyuan Tongqiao Granules on the basis of the control group was superior to the control group in improving the main symptoms and signs of chronic sinusitis[RR_(nasal congestion)=1.33,95%CI[1.21,1.45],P<0.00001,RRrunny nose=1.28,95%CI[1.18,1.40],P<0.00001,RR_(turbinate congestion or swelling)=1.28,95%CI[1.16,1.41],P<0.00001].Biyuan Tongqiao Granules alone or in combination could effectively reduce the Snot-20 score,which was superior to the control group(MD=-2.94,95%CI[-3.60,-2.28],P<0.00001).Biyuan Tongqiao Granules alone and in combination could effectively reduce the VAS score,which was superior to the control group(MD_(total score)=-4.44,95%CI[-6.05,-2.82],P<0.00001;MD_(nasal congestion VAS score)=-0.99,95%CI[-1.38,-0.60],P<0.00001;MD_(runny nose VAS score)=-1.19,95%CI[-1.62,-0.76],P<0.00001;MD_(dysosmia VAS score)=-0.96,95%CI[-1.26,-0.65],P<0.00001;MD_(head and face pain VAS score)=-0.73,95%CI[-0.98,-0.47],P<0.00001).The combined use of Biyuan Tongqiao Granules could effectively reduce the_(sinus CT score)and the Lund-Mackey score of the endoscopic mucosal morphology(MD_(sinus CT score)=-3.68,95%CI[-5.47,-1.88],P<0.0001,MD_(endoscopic mucosal morphology score)=-3.06,95%CI[-5.53,-0.59],P=0.02).Compared with the control group with conventional western medicine,Chinese medicinal preparations,or surgery only,combined use of Biyuan Tongqiao Granules did not increase the occurrence of adverse reactions(RR=0.68,95%CI[0.26,1.77],P=0.43).As demonstrated by the existing evidence,Biyuan Tongqiao Granules can improve the clinical efficacy of chronic sinusitis,relieve the clinical symptoms and signs,and reduce the Snot-20 score,VAS score,and Lund-Mackey score,without inducing serious adverse reactions,indicating that Biyuan Tongqiao Granules alone or in combination are more effective and safe in the treatment of chronic sinusitis than conventional western medicine,Chinese medicinal preparations,or surgical treatment.Since the quality of the included trials was generally low,large-scale,high-quality,rigorous,multi-center,and blinded-designed RCTs that meet international standards should be adopted in the future to increase the strength and level of evidence.