首页|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

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

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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 7 511例患者,其中试验组 3 973 例,对照组 3 538 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<0.000 01),降低Lund-Kennedy评分(MD=-1.94,95%CI[-2.61,-1.26],P<0.000 01)、Lund-Mackay评分(MD=-2.14,95%CI[-2.98,-1.31],P<0.000 01)、视觉模拟量表(VAS)评分(MD总VAS评分=-1.28,95%CI[-1.56,-1.01],P<0.000 01;MD鼻塞VAS评分=-0.58,95%CI[-0.89,-0.27],P=0.000 2;MD流涕VAS评分=-0.61,95%CI[-0.93,-0.29],P= 0.000 2;MD嗅觉障碍VAS评分=-0.43,95%CI[-0.52,-0.34],P<0.000 01;MD头面部胀痛VAS评分=-0.41,95%CI[-0.57,-0.26],P<0.000 01),改善鼻黏膜纤毛传输速率(MTR)(MD=1.64,95%CI[1.08,2.20],P<0.000 01),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<0.000 01);白细胞介素-6(IL-6)(SMD=-2.64,95%CI[-4.08,-1.21],P=0.000 3)}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<0.000 01),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,单用鼻窦炎口服液或鼻窦炎口服液+常规治疗均能提高总有效率,降低Lund-Kennedy评分、Lund-Mackay评分,并改善患者的主要症状.此外,鼻窦炎口服液+常规治疗还能改善患者的MTR,同时降低TNF-α、IL-6炎症因子的表达,且未有严重不良事件的发生.但因纳入研究的方法学质量有限,今后仍需开展更多大样本、高质量的RCT提供证据支撑.
Systematic review and Meta-analysis of efficacy and safety of Bidouyan Oral Liquid in treatment of rhinosinusitis
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 collabora-tion′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 7 511 patients(3 973 in the observation group and 3 538 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<0.000 01)and decreasing the Lund-Kennedy scores(MD=-1.94,95%CI[-2.61,-1.26],P<0.000 01),Lund-Mackay scores(MD=-2.14,95%CI[-2.98,-1.31],P<0.000 01),and visual analogue scale(VAS)scores(MDtotal VAS scores =-1.28,95%CI[-1.56,-1.01],P<0.000 01;MDnasal congestion VAS scores =-0.58,95%CI[-0.89,-0.27],P=0.000 2;MDrunny nose VAS scores =-0.61,95%CI[-0.93,-0.29],P= 0.000 2;MDolfactory dysfunction VAS scores =-0.43,95%CI[-0.52,-0.34],P<0.000 01;MDhead and facial pain VAS scores =-0.41,95%CI[-0.57,-0.26],P<0.000 01).Furthermore,the com-bined treatment outperformed conventional treatment alone in improving the mucociliary transport rate(MTR)(MD=1.64,95%CI[1.08,2.20],P<0.000 01)and lowering the levels of inflammatory cytokines{tumor necrosis factor-α(TNF-α)(SMD=-1.95,95%CI[-2.57,-1.33],P<0.000 01),interleukin-6(IL-6)(SMD=-2.64,95%CI[-4.08,-1.21],P=0.000 3)}in RS pa-tients.In addition,the combined treatment did not increase the incidence of adverse reactions(RR=0.83,95%CI[0.44,1.57],P=0.57).Bidouyan Oral Liquid was superior to conventional treatment in increasing total response rate(RR=1.25,95%CI[1.18,1.32],P<0.000 01),decreasing the Lund-Kennedy(P<0.01)and Lund-Mackay scores(P<0.05),alleviating major symptoms(Ptotal VAS scores<0.01;Pnasal congestion VAS scores<0.01;Prunny nose VAS scores<0.01;Polfactory dysfunction VAS scores<0.05;Phead and facial pain VAS scores<0.01),and decreasing adverse reactions(P=0.03).The results showed that either Bidouyan Oral Liquid or Bidouyan Oral Liquid + conven-tional treatment can increase the total response rate,decrease the Lund-Kennedy and Lund-Mackay scores,and mitigate major symp-toms.In addition,Bidouyan Oral Liquid + conventional treatment improved MTR and reduced the expression of TNF-α and IL-6 with-out causing serious adverse events.However,due to the limited methodological quality of the included studies,large-sample and high-quality RCTs are needed to provide evidence support.

Bidouyan Oral Liquidrhinosinusitisrandomized controlled trialsystematic reviewMeta-analysis

午玉琦、李辉、付译节、朱天民、龚心如、韩周彤、范红丽

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成都中医药大学 养生康复学院, 四川 成都 610075

成都大学 基础医学院, 四川 成都 610106

鼻窦炎口服液 鼻-鼻窦炎 随机对照试验 系统评价 Meta分析

国家自然科学基金面上项目四川省科技计划重点研发项目

816740372022YFS0421

2024

中国中药杂志
中国药学会

中国中药杂志

CSTPCD北大核心
影响因子:1.718
ISSN:1001-5302
年,卷(期):2024.49(2)
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