乌司他丁在真实世界危重症患者中的有效性：一项回顾性多中心研究。

Effectiveness of ulinastatin in critical care patients in real world: a retrospective multi-center study.

作者信息

Xu Deduo, Shan Yi, Liu Qinghua, Liang Pei, Hao Xin, Zhang Jinyuan, Yu Ze, Li Wenfang, Gao Fei, Tao Xia, Gu Qin, Ma Yabin, Chen Wansheng

机构信息

Department of Pharmacy, Second Affiliated Hospital of Naval Medical University, Shanghai, China.

Department of Emergency and Critical Care Medicine, Second Affiliated Hospital of Naval Medical University, Shanghai, China.

出版信息

Expert Rev Clin Pharmacol. 2024 Oct 3:1-8. doi: 10.1080/17512433.2024.2402433.

DOI:10.1080/17512433.2024.2402433

PMID:39351759

Abstract

OBJECTIVES

Ulinastatin has been applied in various diseases associated with inflammation, but its effectiveness lacks real-world evidence. We aimed to evaluate the effectiveness of ulinastatin based on a real-world database in the intensive care unit (ICU) patients.

METHODS

This was a retrospective cohort study. ICU patient data from multi-centers in China were collected. Propensity score matching (PSM) was applied. The effectiveness of ulinastatin was evaluated by mortality, length of stay in the ICU and mechanical ventilation duration. Kaplan-Meier method was used to estimate the hazard ratio and plot the survival curve.

RESULTS

A total of 2036 patients were analyzed after PSM. Mortality was significantly lower in the ulinastatin group than in the non-ulinastatin group (hazard ratio for death: 0.77; 95% confidence interval: 0.62-0.96; = 0.018). Ulinastatin significantly reduced mortality at 28 days (10.0% vs. 13.6%), 60 days (13.9% vs. 18.2%) and 90 days (14.7% vs. 18.5%), length of stay in the ICU (median 8.0 d vs. 13.0 d), and mechanical ventilation duration (median 24.0 h vs. 25.0 h; < 0.05).

CONCLUSIONS

Ulinastatin was beneficial for patients in the ICU, mainly by reducing mortality, length of ICU stay, and mechanical ventilation duration. This study provides evidence of the clinical effectiveness of ulinastatin.

摘要

目的

乌司他丁已应用于各种与炎症相关的疾病，但其实效性缺乏真实世界证据。我们旨在基于重症监护病房（ICU）患者的真实世界数据库评估乌司他丁的有效性。

方法

这是一项回顾性队列研究。收集了来自中国多中心的ICU患者数据。应用倾向评分匹配（PSM）。通过死亡率、ICU住院时间和机械通气时间评估乌司他丁的有效性。采用Kaplan-Meier方法估计风险比并绘制生存曲线。

结果

PSM后共分析了2036例患者。乌司他丁组的死亡率显著低于非乌司他丁组（死亡风险比：0.77；95%置信区间：0.62 - 0.96；P = 0.018）。乌司他丁显著降低了28天（10.0%对13.6%）、60天（13.9%对18.2%）和90天（14.7%对18.5%）的死亡率、ICU住院时间（中位数8.0天对13.0天）以及机械通气时间（中位数24.0小时对25.0小时；P < 0.05）。