痰热清注射剂对接受机械通气的ICU患者发生重症死亡的影响：一项基于大型登记数据库的时间依赖性Cox回归分析

WANG Wen; HE Qiao; WANG Ming-qi; XU Jia-yue; JI Peng; ZHANG Rui; ZOU Kang; SUN Xin

doi:10.1007/s11655-023-3634-z

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痰热清注射剂对接受机械通气的ICU患者发生重症死亡的影响：一项基于大型登记数据库的时间依赖性Cox回归分析

Original Article | Updated：2023-08-29

- 痰热清注射剂对接受机械通气的ICU患者发生重症死亡的影响：一项基于大型登记数据库的时间依赖性Cox回归分析
- Effects of Tanreqing Injection on ICU Mortality among ICU Patients Receiving Mechanical Ventilation: Time-Dependent Cox Regression Analysis of a Large Registry
- 中国结合医学杂志（英文版） 2023年29卷第9期页码：782-790
- Affiliations：
  
  1.Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu (610041), China
  2.NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu (610041), China
  3.Sichuan Center of Technology Innovation for Real World Data, Chengdu (610041), China
  4.Intensive Care Unit, West China Hospital, Sichuan University, Chengdu (610041), China
  5.Information Center, West China Hospital, Sichuan University, Chengdu (610041), China
- Author bio：
  
  Prof. SUN Xin, E-mail: sunxin@wchscu.cn
- Funds：
  
  the National Natural Science Foundation of China(72104155);Postdoctoral Research Project, West China Hospital, Sichuan University(2020HXBH148);the 1•3•5 Project for Disciplines of Excellence, West China Hospital,Sichuan University(ZYYC08003)
- DOI：10.1007/s11655-023-3634-z
  中图分类号：
- 纸质出版日期：2023-09，
  
  网络出版日期：2023-03-28，
  
  录用日期：2023-01-19
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痰热清注射剂对接受机械通气的ICU患者发生重症死亡的影响：一项基于大型登记数据库的时间依赖性Cox回归分析[J]. 中国结合医学杂志（英文版）, 2023,29(9):782-790.

WANG Wen, HE Qiao, WANG Ming-qi, et al. Effects of Tanreqing Injection on ICU Mortality among ICU Patients Receiving Mechanical Ventilation: Time-Dependent Cox Regression Analysis of a Large Registry[J]. Chinese Journal of Integrative Medicine, 2023,29(9):782-790.
痰热清注射剂对接受机械通气的ICU患者发生重症死亡的影响：一项基于大型登记数据库的时间依赖性Cox回归分析[J]. 中国结合医学杂志（英文版）, 2023,29(9):782-790. DOI： 10.1007/s11655-023-3634-z.

WANG Wen, HE Qiao, WANG Ming-qi, et al. Effects of Tanreqing Injection on ICU Mortality among ICU Patients Receiving Mechanical Ventilation: Time-Dependent Cox Regression Analysis of a Large Registry[J]. Chinese Journal of Integrative Medicine, 2023,29(9):782-790. DOI： 10.1007/s11655-023-3634-z.

摘要

目的:

探索使用痰热清注射剂是否能加快机械通气患者拔管

降低重症死亡、呼吸机相关事件(ventilator-associated events

VAEs)以及感染有关的呼吸机相关并发症 (infection-related ventilator associated complications

IVACs)的发生风险.

方法:

基于前期构建的华西医院重症患者医院感染登记数据库

纳入连续机械通气3天及以上的重症患者

采用时间依赖性暴露定义患者每日是否使用痰热清注射剂. 通过拟合时间依赖性Cox回归模型以及Fine-Gray竞争风险模型

在调整一系列可能相关的固定以及时间依赖性混杂变量后

比较痰热清注射剂使用者与非使用者呼吸机拔管时间、ICU死亡、VAEs以及IVACs的发生情况.

结果:

研究总共纳入7685例机械通气患者. 与未使用痰热清者比较

使用痰热清注射剂可能降低ICU患者重症死亡率 (HR 0.761

95% CI

0.581–0.997)

加快呼吸机拔管 (HR 1.105

95% CI

1.005–1.216)

提示痰热清注射剂可缩短患者通气时长. 两组患者在VAEs (HR 1.057

95% CI

0.912–1.225)和IVACs (HR 1.177

95% CI

0.929–1.491)上并未发现差异有统计学意义 (

0.05) . 采用不同的统计分析模型、不同的缺失值填补方式以及调整纳入排除标准的多个敏感性分析结果均和主分析结果一致.

结论:

研究结果提示

在对时间依赖性混杂进行严格控制后

痰热清可能加快机械通气患者拔管

降低ICU死亡.

Abstract

Objective:

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).

Methods:

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.

Results:

Overall

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.

Conclusion:

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.

关键词

Keywords

Tanreqing Injectioncritical caremechanical ventilationmortalityventilator-associated events

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