鼻窦炎口服液治疗鼻-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 Bidouyan Oral Liquid in treatment of rhinosinusitis

作　　者：午玉琦 李辉[2] 付译节[2] 朱天民 龚心如 韩周彤 范红丽 WU Yu-qi;LI Hui;FU Yi-jie;ZHU Tian-min;GONG Xin-ru;HAN Zhou-tong;FAN Hong-li(School of Rehabilitation and Health Preservation,Chengdu University of Traditional Chinese Medicine,Chengdu 610075,China;School of Preclinical Medicine,Chengdu University,Chengdu 610106,China)

机构地区：[1]成都中医药大学养生康复学院,四川成都610075 [2]成都大学基础医学院,四川成都610106

出　　处：《中国中药杂志》2024年第2期534-549,共16页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金面上项目(81674037);四川省科技计划重点研发项目(2022YFS0421)。

摘　　要：系统评价鼻窦炎口服液治疗鼻-鼻窦炎(RS)的有效性与安全性。计算机检索中国知网(CNKI)、万方(Wanfang)、中国生物医学文献服务系统(SinoMed)、维普(VIP)、Cochrane Library、PubMed、EMbase、Web of Science、Ovid数据库,搜集鼻窦炎口服液治疗RS患者的随机对照试验(RCT),并手工检索相关研究的参考文献和灰色文献。2位研究者独立筛选文献、提取资料,根据Cochrane推荐的偏倚风险工具(RoB 2.0)对纳入研究进行质量评价,采用RevMan 5.3、Stata 12.0统计软件进行Meta分析,使用GRADE系统推荐分级方法进行证据质量评价。共纳入54篇RCTs(联合用药35篇、单独用药19篇),包含7511例患者,其中试验组3973例,对照组3538例。Meta分析结果显示,鼻窦炎口服液+常规治疗在提高RS患者的总有效率(RR=1.19,95%CI[1.15,1.24],P<0.00001),降低Lund-Kennedy评分(MD=-1.94,95%CI[-2.61,-1.26],P<0.00001)、Lund-Mackay评分(MD=-2.14,95%CI[-2.98,-1.31],P<0.00001)、视觉模拟量表(VAS)评分(MD_(总VAS评分)=-1.28,95%CI[-1.56,-1.01],P<0.00001;MD_(鼻塞VAS评分)=-0.58,95%CI[-0.89,-0.27],P=0.0002;MD_(流涕VAS评分)=-0.61,95%CI[-0.93,-0.29],P=0.0002;MD_(嗅觉障碍VAS评分)=-0.43,95%CI[-0.52,-0.34],P<0.00001;MD_(头面部胀痛VAS评分)=-0.41,95%CI[-0.57,-0.26],P<0.00001),改善鼻黏膜纤毛传输速率(MTR)(MD=1.64,95%CI[1.08,2.20],P<0.00001),降低炎症因子水平{肿瘤坏死因子-α(TNF-α)(SMD=-1.95,95%CI[-2.57,-1.33],P<0.00001);白细胞介素-6(IL-6)(SMD=-2.64,95%CI[-4.08,-1.21],P=0.0003)}方面优于单纯常规治疗,且不会增加不良反应的发生(RR=0.83,95%CI[0.44,1.57],P=0.57)。单用鼻窦炎口服液在提高总有效率(RR=1.25,95%CI[1.18,1.32],P<0.00001),降低Lund-Kennedy评分(P<0.01)、Lund-Mackay评分(P<0.05),改善VAS评分(P_(总VAS评分)<0.01、P_(鼻塞VAS评分)<0.01、P_(流涕VAS评分)<0.01、P_(嗅觉障碍VAS评分)<0.05、P_(头面部胀痛VAS评分)<0.01),降低不良反应发生率(P=0.03)方面均优于常规治疗。结果表明,This study aimed to systematically review the efficacy and safety of Bidouyan Oral Liquid in the treatment of rhinosinu-sitis(RS).CNKI,Wanfang,SinoMed,VIP,Cochrane Library,PubMed,EMbase,Web of Science,and Ovid were searched for the randomized controlled trial(RCT)of Bidouyan Oral Liquid for the treatment of RS patients.Moreover,the reference lists and the grey literature were searched manually.Two researchers independently screened the literature and extracted data.The Cochrane collaboration′s tool for assessing risk of bias(RoB 2.0)in randomized trial was used to assess the methodological quality of the included stu-dies.Meta-analysis was performed in RevMan 5.3 and Stata 12.0,and the grades of recommendation,assessment,development and evaluation(GRADE)was employed to evaluate the quality of evidence.A total of 54 RCTs(35 with drug combinations and 19 with single drugs)comprising 7511 patients(3973 in the observation group and 3538 in the control group)were included.Meta-analysis showed that Bidouyan Oral Liquid+conventional treatment was superior to conventional treatment alone in increasing the total response rate(RR=1.19,95%CI[1.15,1.24],P<0.00001)and decreasing the Lund-Kennedy scores(MD=-1.94,95%CI[-2.61,-1.26],P<0.00001),Lund-Mackay scores(MD=-2.14,95%CI[-2.98,-1.31],P<0.00001),and visual analogue scale(VAS)scores(MD_(total VAS scores)=-1.28,95%CI[-1.56,-1.01],P<0.00001;MD_(nasal congestion VAS scores)=-0.58,95%CI[-0.89,-0.27],P=0.0002;MD_(runny nose VAS scores)=-0.61,95%CI[-0.93,-0.29],P=0.0002;MD_(olfactory dysfunction VAS scores)=-0.43,95%CI[-0.52,-0.34],P<0.00001;MD_(head and facial pain VAS scores)=-0.41,95%CI[-0.57,-0.26],P<0.00001).Furthermore,the combined treatment outperformed conventional treatment alone in improving the mucociliary transport rate(MTR)(MD=1.64,95%CI[1.08,2.20],P<0.00001)and lowering the levels of inflammatory cytokines{tumor necrosis factor-α(TNF-α)(SMD=-1.95,95%CI[-2.57,-1.33],P<0.00001),interleukin-6(IL-6)(SMD=-2.64,95%CI[-4.08,-1.21],P=0.0003)}in RS patients.In addition,th

关 键 词：鼻窦炎口服液 鼻-鼻窦炎 随机对照试验 系统评价 META分析 

分 类 号：R276.1[医药卫生—中医五官科学]