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.
Zhongguo Zhong Yao Za Zhi. 2024 Jan;49(2):534-549. doi: 10.19540/j.cnki.cjcmm.20230918.502.
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.
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。检索中国知网、万方、中国生物医学文献数据库、维普、考克兰图书馆、PubMed、EMbase、Web of Science和Ovid等数据库，查找鼻窦炎口服液治疗RS患者的随机对照试验（RCT）。此外，还手动检索了参考文献列表和灰色文献。两名研究人员独立筛选文献并提取数据。采用考克兰协作组随机试验偏倚风险评估工具（RoB 2.0）评估纳入研究的方法学质量。使用RevMan 5.3和Stata 12.0进行荟萃分析，并采用推荐意见、评估、制定与评价（GRADE）分级来评估证据质量。共纳入54项RCT（35项为联合用药，19项为单一用药），涉及7511例患者（观察组3973例，对照组3538例）。荟萃分析表明，鼻窦炎口服液+传统治疗在提高总有效率（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）以及视觉模拟量表（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（头面部疼痛VAS评分）=-0.41，95%CI[-0.57，-0.26]，P<0.000 01）方面优于单纯传统治疗。此外，联合治疗在提高黏液纤毛传输率（MTR）（MD=1.64，95%CI[1.08，2.20]，P<0.000 01）和降低RS患者炎症细胞因子水平{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）}方面也优于单纯传统治疗。另外，联合治疗并未增加不良反应的发生率（RR=0.83，95%CI[0.44，1.57]，P=0.57）。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）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（流涕VAS评分）<0.01；P（嗅觉障碍VAS评分）<0.05；P（头面部疼痛VAS评分）<0.01）以及减少不良反应（P=0.03）方面优于传统治疗。结果表明，鼻窦炎口服液或鼻窦炎口服液+传统治疗均可提高总有效率，降低Lund-Kennedy和Lund-Mackay评分，并减轻主要症状。此外，鼻窦炎口服液+传统治疗可改善MTR，降低TNF-α和IL-6的表达，且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、高质量的RCT来提供证据支持。
