连花清瘟（LHQW）颗粒是一种植物药物制剂，常被用作肺炎支原体肺炎（MPP）的辅助治疗。然而，该治疗的临床疗效和安全性仍不确定。本研究旨在评价LHQW颗粒联合阿奇霉素（AZM）治疗儿童MPP的疗效和安全性。收集LHQW颗粒联合阿奇霉素（AZM）治疗的所有随机对照试验（RCT） AZM，对8个中英文数据库（CNKI、万方、维普、Sinomed、PubMed、Embase、Web of Science和Cochrane Library）进行检索，从建库到2023年12月25日。采用荟萃回归和亚组分析来研究异质性。进行敏感性分析和试验序贯分析（TSA）以评估研究结果的稳健性。此外，还利用建议评估、制定和评估分级（GRADE）系统来评估证据质量。本研究共纳入了15项随机对照试验，涉及1909名受试者。 Meta分析结果表明，LHQW颗粒与AZM联合治疗在疗效和安全性方面均与单独使用AZM有显着差异，具体表现在以下结果：有效率（RR = 1.17，95% CI：1.12至1.22，p） < 0.01）、退热时间（MD = -1.32，95% CI：-1.66 至 -0.98，p < 0.01）、咳嗽消失时间（MD = -1.76，95% CI：-2.47 至 -1.05，p < 0.01） ，肺部啰音消失时间（MD = -1.54，95% CI：-2.06 至 -1.02，p < 0.01），C 反应蛋白（CRP）（MD = -5.50，95% CI：-6.92 至 -4.07，p < 0.01)、降钙素原 (PCT)（MD = -0.31，95% CI：-0.38 至 -0.24，p < 0.01）、白细胞介素 6 (IL-6)（MD = -5.97，95% CI：-7.39 至 - 4.54，p<0.01)、肿瘤坏死因子 α (TNF-α)（MD = -5.74，95% CI：-7.44 至 -4.04，p < 0.01）、用力肺活量 (FVC)（SMD = 0.48，95%） CI：0.34 至 0.62，p < 0.01)，第一秒用力呼气量 (FEV1)（SMD = 0.55，95% CI：0.44 至 0.67，p < 0.01），FEV1/FVC（SMD = 0.49，95% CI） : 0.32 至 0.67, p < 0.01), CD4 T 淋巴细胞 (CD4 ) (MD = 4.04, 95% CI: 3.09 至 4.98, p < 0.01), CD8 T 淋巴细胞 (CD8 ) (MD = -3.32, 95% CI: 4.27 至 2.38，p < 0.01）和不良事件（RR = 0.65，95% CI：0.43 至 0.96，p < 0.01）。 LHQW 颗粒与 AZM 联合治疗可能是治疗儿童 MPP 的更好策略。但LHQW颗粒的临床疗效和安全性还需要进一步验证。https://www.crd.york.ac.uk/PROSPERO/。版权所有©2024 Li、Ma、Qi、Hao、Wang、Wu。

Lianhua Qingwen (LHQW) granule, a botanical drug preparation, is frequently utilized as an adjuvant treatment for mycoplasma pneumoniae pneumonia (MPP). Nevertheless, the clinical efficacy and safety of this treatment remain uncertain.This study aims to evaluate the efficacy and safety of LHQW granule combined with azithromycin (AZM) in treating MPP in children.To identify all randomized controlled trials (RCTs) of LHQW granule plus AZM, a search was conducted in eight Chinese and English databases (CNKI, Wan Fang, VIP, Sinomed, PubMed, Embase, Web of Science, and Cochrane Library) from their inception until 25 December 2023. Meta-regression and subgroup analysis were employed to investigate heterogeneity. Sensitivity analysis and trial sequential analysis (TSA) were conducted to assess the robustness of the findings. Additionally, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was utilized to evaluate the quality of evidence.A total of 15 RCTs involving 1909 participants were included in this study. The meta-analysis results indicated combination therapy of LHQW granule and AZM is significant different from AZM alone in both efficacy and safety, which are specifically observed in the following outcomes: response rate (RR = 1.17, 95% CI: 1.12 to 1.22, p < 0.01), antipyretic time (MD = -1.32, 95% CI: -1.66 to -0.98, p < 0.01), cough disappearance time (MD = -1.76, 95% CI: -2.47 to -1.05, p < 0.01), pulmonary rale disappearance time (MD = -1.54, 95% CI: -2.06 to -1.02, p < 0.01), c-reactive protein (CRP) (MD = -5.50, 95% CI: -6.92 to -4.07, p < 0.01), procalcitonin (PCT) (MD = -0.31, 95% CI: -0.38 to -0.24, p < 0.01), interleukin 6 (IL-6) (MD = -5.97, 95% CI: -7.39 to -4.54, p<0.01), tumor necrosis factor α (TNF-α) (MD = -5.74, 95% CI: -7.44 to -4.04, p < 0.01), forced vital capacity (FVC) (SMD = 0.48, 95% CI: 0.34 to 0.62, p < 0.01), forced expiratory volume in the first second (FEV1) (SMD = 0.55, 95% CI: 0.44 to 0.67, p < 0.01), FEV1/FVC (SMD = 0.49, 95% CI: 0.32 to 0.67, p < 0.01), CD4+ T lymphocyte (CD4+) (MD = 4.04, 95% CI: 3.09 to 4.98, p < 0.01), CD8+ T lymphocyte (CD8+) (MD = -3.32, 95% CI: 4.27 to 2.38, p < 0.01) and adverse events (RR = 0.65, 95% CI: 0.43 to 0.96, p < 0.01).The combination therapy of LHQW granule and AZM may be a better strategy to treat MPP in children. However, the clinical efficacy and safety of LHQW granule require further validation.https://www.crd.york.ac.uk/PROSPERO/.Copyright © 2024 Li, Ma, Qi, Hao, Wang and Wu.