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Abstract：
Objective: This study constitutes a pioneering systematic review and meta analysis delving into the clinical efficacy and safety of the combined therapy involving Wuhu Decoction and azithromycin for treating Mycoplasma pneumoniae pneumonia in pediatric patients. Methods: This study conducted a comprehensive computerized search, covering 6 Chinese databases and 6 English databases, to collect randomized controlled trials related to the combined use of Wuhu Decoction and azithromycin for treating Mycoplasma pneumoniae pneumonia in pediatric patients. The search was extended until August 2023. Two independent researchers were involved in literature screening, data extraction, and bias risk assessment. Meta-analysis was performed using Stata 14.0 and RevMan 5.4 software. Additionally, meta-regression analysis and subgroup analysis were carried out on primary outcomes to identify potential sources of heterogeneity and confounding factors. Results: A total of 22 randomized controlled trials involving 2,026 patients were included in this study. The combined therapy of Wuhu Decoction and azithromycin demonstrated superior efficacy compared to azithromycin alone (RR = 1.17, 95% CI [1.13, 1.21], p < 0.00001; low certainty of evidence). Additionally, patients receiving the combination therapy experienced significantly reduced the disappearance time of fever (MD = -1.42, 95% CI [-1.84, -1.00], p < 0.00001; very low certainty of evidence), disappearance time of cough (MD = -2.08, 95% CI [-2.44, -1.71], p < 0.00001; very low certainty of evidence), disappearance of pulmonary rales (MD = -1.97, 95% CI [-2.31, -1.63], p < 0.00001; very low certainty of evidence), and disappearance time of wheezing (MD = -1.47, 95% CI [-1.72, -1.22], p < 0.00001; very low certainty of evidence). Meta-regression analysis suggested that course of disease, sample size, and age might be sources of heterogeneity. Subgroup and sensitivity analyses reaffirmed the stability of these results. Furthermore, analyses of secondary outcomes such as T lymphocytes, serum inflammatory factors, and the incidence rate of adverse reactions consistently favored the combination therapy of WHD and azithromycin over azithromycin alone, with statistically significant differences. Conclusion: Based on our meta-analysis findings, the combined therapy of Wuhu Decoction and azithromycin for treating pediatric Mycoplasma pneumoniae pneumonia exhibited superior overall efficacy in comparison to azithromycin monotherapy. However, in the included 22 studies, the majority of evaluated factors showed unclear bias risks, and a persistent bias risk was consistently present within one category. Moreover, due to the low quality of evidence, interpreting these results should be approached with caution. Hence, we emphasize the necessity for future high-quality, multicenter, and large-sample clinical randomized controlled trials. These trials are essential to provide more robust data for evidence-based research and to establish higher-quality evidence support. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42023465606.
摘要：
目的：本研究是一项开创性的系统评价和荟萃分析，探讨五湖汤联合阿奇霉素治疗小儿肺炎支原体肺炎的临床疗效和安全性。方法:本研究进行了全面的计算机搜索,涵盖6个中文数据库和6个英文数据库，收集五湖汤联合阿奇霉素治疗小儿肺炎支原体肺炎的随机对照试验。搜索时间延长至2023年8月。两名独立研究人员参与文献筛选，数据提取,和偏差风险评估。采用Stata14.0和RevMan5.4软件进行Meta分析。此外,对主要结局进行荟萃回归分析和亚组分析,以确定异质性和混杂因素的潜在来源.结果：共纳入22项随机对照试验，涉及2,026例患者。五湖汤联合阿奇霉素治疗效果优于单用阿奇霉素(RR=1.17,95%CI[1.13,1.21],p<0.00001；证据的确定性低)。此外,接受联合治疗的患者发热消失时间显著缩短(MD=-1.42,95%CI[-1.84,-1.00],p<0.00001；证据的确定性非常低)，咳嗽消失时间（MD=-2.08，95%CI[-2.44，-1.71]，p<0.00001；证据的确定性非常低)，肺部啰音消失（MD=-1.97，95%CI[-2.31，-1.63]，p<0.00001；证据的确定性非常低)，和喘息消失时间（MD=-1.47，95%CI[-1.72，-1.22]，p<0.00001；证据的确定性非常低)。Meta回归分析表明，病程，样本量,年龄可能是异质性的来源。亚组和敏感性分析重申了这些结果的稳定性。此外，分析次要结果，如T淋巴细胞，血清炎症因子,与单用阿奇霉素相比，WHD和阿奇霉素联合治疗的不良反应发生率始终较高，具有统计学上的显著差异。结论：根据我们的荟萃分析结果，五湖汤联合阿奇霉素治疗小儿肺炎支原体肺炎的总体疗效优于阿奇霉素单药治疗。然而,在纳入的22项研究中，大多数被评估的因素显示出不清楚的偏见风险，并且在一个类别中始终存在持续的偏倚风险。此外，由于证据质量低,解释这些结果应谨慎。因此，我们强调未来高质量的必要性，多中心，和大样本临床随机对照试验。这些试验对于为循证研究提供更可靠的数据和建立更高质量的证据支持至关重要。系统审查注册：https://www。crd.约克。AC.英国/普华永道/，标识符CRD42023465606。
