Data Sheet 1_Effects of Tanreqing injection against ventilator-associated pneumonia: a meta-analysis and systematic review of clinical studies.docx

ObjectiveVentilator-associated pneumonia (VAP) frequently results in difficulties with weaning, high mortality rates, and is often caused by drug-resistant pathogens, emphasizing the critical importance of effective treatment. The efficacy and safety of Tanreqing injection (TRQI) in the treatment of VAP patients have been demonstrated, but further validation is required. The objective of this study is to synthesize the findings of clinical research on TRQI for the treatment of VAP, thereby providing clinical evidence for its effectiveness and importance.
MethodsA comprehensive search of eight databases was conducted, covering all records up to 30 August 2024. The data were extracted, quality-assessed, and analyzed rigorously. The methodological quality of the included studies was evaluated using the RoB-2 tool. The statistical analyses were conducted using RevMan 5.4 software, with either a fixed-effect or random-effect model employed as appropriate. The evidence quality of the included literature was evaluated using Grade pro 3.6.1 software.
ResultsA total of 20 clinical studies, comprising a total of 1,446 patients, were included in the review. The meta-analysis of these studies demonstrated that TRQI significantly improved inflammatory markers (CRP, PCT, WBC) (P < 0.00001) and reduced the duration of antibiotic use (P < 0.00001). Furthermore, the intervention resulted in a shorter duration of ventilator usage (P < 0.0001), an increased initial weaning success rate (P = 0.001), and a reduction in the length of stay in the intensive care unit (ICU) (P < 0.00001). Furthermore, the TRQI demonstrated superior performance compared to the control group in CPIS (Clinical Pulmonary Infection Score) assessments (P < 0.00001). Meanwhile, the quality of evidence for CRP, PCT, Duration of Antibiotic Use, Duration of Ventilator Use, and Length of ICU Stay is Moderate.
ConclusionThis study provides further evidence-based support for the clinical application of TRQI in the treatment of VAP. Additionally, it summarizes previous clinical research through a literature quality assessment, offering insights and recommendations for the design and implementation of future research protocols. The findings indicate that TRQI can improve inflammatory markers and pulmonary infection scores in VAP patients, reduce ventilator dependence, and shorten antibiotic use duration. Moreover, it has a low overall incidence of adverse reactions, demonstrating good efficacy and safety as an adjuvant therapy for VAP. However, some of the included clinical studies had limitations such as small sample sizes, lack of sample size calculations. Therefore, future study designs should be more rigorous to enhance the reliability of findings.
Systematic Review Registration:https://inplasy.com/inplasy-2025-2-0008/.

目的 呼吸机相关性肺炎（Ventilator-associated pneumonia, VAP）常导致脱机困难、高病死率，且多由耐药病原菌引发，因此其有效治疗至关重要。痰热清注射液（Tanreqing injection, TRQI）治疗VAP患者的有效性与安全性已得到初步证实，但仍需进一步验证。本研究旨在综合梳理TRQI治疗VAP的临床研究成果，为其临床应用的有效性与价值提供循证依据。
方法 本研究全面检索了8个数据库，检索时限覆盖截至2024年8月30日的所有相关记录。研究团队严格开展数据提取、质量评价与统计分析工作：采用RoB-2工具对纳入研究的方法学质量进行评价；使用RevMan 5.4软件进行统计分析，根据研究异质性情况选择固定效应模型或随机效应模型；采用Grade pro 3.6.1软件评价纳入文献的证据质量等级。
结果 本研究共纳入20项临床研究，合计涉及1446例患者。Meta分析结果显示，痰热清注射液可显著改善VAP患者的炎症标志物[C反应蛋白（CRP）、降钙素原（PCT）、白细胞计数（WBC）]水平（P < 0.00001），缩短抗生素使用时长（P < 0.00001）。此外，干预组的呼吸机使用时长更短（P < 0.0001）、初始脱机成功率更高（P = 0.001），且重症监护病房（intensive care unit, ICU）住院时长更短（P < 0.00001）。在临床肺部感染评分（Clinical Pulmonary Infection Score, CPIS）评估中，痰热清注射液组的表现亦优于对照组（P < 0.00001）。针对CRP、PCT、抗生素使用时长、呼吸机使用时长及ICU住院时长的证据质量等级为中等。
结论 本研究为痰热清注射液治疗VAP的临床应用提供了进一步的循证支持。同时，本研究通过文献质量评价梳理了既往临床研究，为未来研究方案的设计与实施提供了参考与建议。研究结果表明，痰热清注射液可改善VAP患者的炎症标志物水平与肺部感染评分，降低呼吸机依赖，缩短抗生素使用时长；且总体不良反应发生率较低，作为VAP的辅助治疗手段具有良好的有效性与安全性。但纳入的部分临床研究存在样本量较小、未进行样本量估算等局限性。因此，未来的研究设计应更为严谨，以提升研究结果的可靠性。
系统评价注册信息：https://inplasy.com/inplasy-2025-2-0008/。