Abstract：
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 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(MD_(total VAS scores)=-1.28, 95%CI[-1.56,-1.01], P<0.000 01; MD_(nasal congestion VAS scores)=-0.58, 95%CI[-0.89,-0.27], P=0.000 2; MD_(runny nose VAS scores)=-0.61, 95%CI[-0.93,-0.29], P=0.000 2; MD_(olfactory dysfunction VAS scores)=-0.43, 95%CI[-0.52,-0.34], P<0.000 01; MD_(head and facial pain VAS scores)=-0.41, 95%CI[-0.57,-0.26], P<0.000 01). 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<0.000 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 patients. 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(P_(total VAS scores)<0.01; P_(nasal congestion VAS scores)<0.01; P_(runny nose VAS scores)<0.01; P_(olfactory dysfunction VAS scores)<0.05; P_(head 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 + conventional treatment can increase the total response rate, decrease the Lund-Kennedy and Lund-Mackay scores, and mitigate major symptoms. In addition, Bidouyan Oral Liquid + conventional treatment improved MTR and reduced the expression of TNF-α and IL-6 without 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.
摘要：
本研究旨在系统评价鼻窦炎口服液治疗鼻窦炎(RS)的有效性和安全性。CNKI,万方,SinoMed,VIP,科克伦图书馆,PubMed,EMBase,WebofScience,和Ovid进行了Bidouyan口服液治疗RS患者的随机对照试验（RCT）。此外，参考列表和灰色文献是手动搜索的.两名研究者独立筛选文献并提取数据。在随机试验中，Cochrane协作评估偏倚风险的工具（RoB2.0）用于评估纳入研究对象的方法学质量。在RevMan5.3和Stata12.0中进行Meta分析，推荐等级，评估，采用开发和评估(GRADE)来评估证据质量。共纳入54个RCTs（35个药物组合和19个单一药物），包括7511例患者（观察组3973例，对照组3538例）。Meta分析显示,鼻窦炎口服液+常规治疗在提高总缓解率方面优于单纯常规治疗(RR=1.19,95CI[1.15,1.24],P＆lt;0.00001）并降低Lund-Kennedy得分（MD=-1.94，95CI[-2.61，-1.26]，P<0.00001)，Lund-Mackay得分（MD=-2.14，95CI[-2.98，-1.31]，P<0.00001)，和视觉模拟量表（VAS）评分（MD_（总VAS评分）=-1.28，95CI[-1.56，-1.01]，P＆lt;0.00001;MD_（鼻塞VAS评分）=-0.58，95CI[-0.89，-0.27]，P=0.0002；MD_（流鼻涕VAS评分）=-0.61，95CI[-0.93，-0.29]，P=0.0002；MD_（嗅觉功能障碍VAS评分）=-0.43，95CI[-0.52，-0.34]，P＆lt;0.00001;MD_（头部和面部疼痛VAS评分）=-0.41，95CI[-0.57，-0.26]，P<0.00001)。此外，联合治疗在提高粘膜纤毛转运率（MTR）方面优于常规治疗（MD=1.64，95CI[1.08，2.20]，P＆lt;0.00001）和降低炎性细胞因子{肿瘤坏死因子-α（TNF-α）（SMD=-1.95，95CI[-2.57，-1.33]，P<0.00001)，白细胞介素-6（IL-6）（SMD=-2.64，95CI[-4.08，-1.21]，RS患者P=0.0003)}。此外,联合治疗并没有增加不良反应的发生率(RR=0.83,95CI[0.44,1.57],P=0.57）。Bidouyan口服液在增加总反应率方面优于常规治疗（RR=1.25,95CI[1.18,1.32]，P<0.00001)，降低Lund-Kennedy(P<0.01)和Lund-Mackay评分(P<0.05)，缓解主要症状(P_(总VAS评分)<0.01;P_(鼻塞VAS评分)<0.01;P_(流鼻涕VAS评分)<0.01;P_(嗅觉功能障碍VAS评分)<0.05;P_(头面部疼痛VAS评分)<0.01),不良反应减少(P=0.03)。结果表明，鼻窦炎口服液或鼻窦炎口服液+常规治疗均可提高总有效率，降低Lund-Kennedy和Lund-Mackay的得分,减轻主要症状。此外,Bidouyan口服液+常规治疗可改善MTR，降低TNF-α和IL-6的表达，未引起严重不良事件。然而,由于纳入研究的方法学质量有限，需要大样本和高质量的随机对照试验来提供证据支持。
