Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China.
NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, 610041, China.
Chin J Integr Med. 2023 Sep;29(9):782-790. doi: 10.1007/s11655-023-3634-z. Epub 2023 Mar 28.
To assess whether the use of Tanreqing (TRQ) Injection could show improvements in time to extubation, intensive care unit (ICU) mortality, ventilator-associated events (VAEs) and infection-related ventilator associated complication (IVAC) among patients receiving mechanical ventilation (MV).
A time-dependent cox-regression analysis was conducted using data from a well-established registry of healthcare-associated infections at ICUs in China. Patients receiving continuous MV for 3 days or more were included. A time-varying exposure definition was used for TRQ Injection, which were recorded on daily basis. The outcomes included time to extubation, ICU mortality, VAEs and IVAC. Time-dependent Cox models were used to compare the clinical outcomes between TRQ Injection and non-use, after controlling for the influence of comorbidities/conditions and other medications with both fixed and time-varying covariates. For the analyses of time to extubation and ICU mortality, Fine-Gray competing risk models were also used to measure competing risks and outcomes of interest.
Overall, 7,685 patients were included for the analyses of MV duration, and 7,273 patients for the analysis of ICU mortality. Compared to non-use, patients with TRQ Injection had a lower risk of ICU mortality (Hazards ratios (HR) 0.761, 95% CI, 0.581-0.997), and was associated with a higher hazard for time to extubation (HR 1.105, 95% CI, 1.005-1.216), suggesting a beneficial effect on shortened time to extubation. No significant differences were observed between TRQ Injection and non-use regarding VAEs (HR 1.057, 95% CI, 0.912-1.225) and IVAC (HR 1.177, 95% CI, 0.929-1.491). The effect estimates were robust when using alternative statistic models, applying alternative inclusion and exclusion criteria, and handling missing data by alternative approaches.
Our findings suggested that the use of TRQ Injection might lower mortality and improve time to extubation among patients receiving MV, even after controlling for the factor that the use of TRQ changed over time.
评估痰热清注射液（TRQ）的使用是否能缩短机械通气（MV）患者的拔管时间、重症监护病房（ICU）死亡率、呼吸机相关事件（VAEs）和与感染相关的呼吸机相关并发症（IVAC）。
采用时间依赖性 Cox 回归分析方法，利用中国 ICU 中建立的医疗相关感染登记处的数据。纳入连续 MV 治疗 3 天或以上的患者。TRQ 注射液的暴露定义是随时间变化的，每天记录。结果包括拔管时间、ICU 死亡率、VAEs 和 IVAC。使用时间依赖性 Cox 模型，在固定和时间依赖性协变量的同时控制合并症/情况和其他药物的影响，比较 TRQ 注射液与非使用患者的临床结局。对于拔管时间和 ICU 死亡率的分析，还使用 Fine-Gray 竞争风险模型来衡量竞争风险和感兴趣的结果。
总体而言，7685 例患者被纳入 MV 持续时间分析，7273 例患者被纳入 ICU 死亡率分析。与非使用相比，使用 TRQ 注射液的患者 ICU 死亡率较低（风险比（HR）0.761，95%CI，0.581-0.997），拔管时间较长（HR 1.105，95%CI，1.005-1.216），提示缩短拔管时间有获益。在 VAEs（HR 1.057，95%CI，0.912-1.225）和 IVAC（HR 1.177，95%CI，0.929-1.491）方面，TRQ 注射液与非使用之间无显著差异。使用替代统计模型、应用替代纳入和排除标准以及通过替代方法处理缺失数据时，效应估计值仍然稳健。
我们的研究结果表明，即使在考虑到 TRQ 注射液的使用随时间变化的因素后，使用 TRQ 注射液可能会降低 MV 患者的死亡率并缩短拔管时间。
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