Effectiveness and safety of Shenfu injection in septic patients with hypoperfusion:A multi-center,open-label,randomized,controlled trial

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外文摘要：Background:To evaluate the effectiveness and safety of the Shenfu injection(SFI)combined with standard bundle treatment in septic patients with hypoperfusion.Method:This study was a multi-center,randomized,open-label,controlled trial conducted in four teaching hos-pitals in China.The septic patients with hypoperfusion and traditional Chinese medicine(TCM)syndrome with Yang-Qi deficiency were enrolled from January 2019,through September 2020.Eligible patients were randomly allocated in a 1∶1 ratio to either receive 60 mL of SFI infusion per day plus standard treatment(SFI group)or stan-dard bundle treatment alone(control group).The primary outcome was 28-day all-cause mortality.Secondary outcomes were 90-day all-cause mortality time to weaning from mechanical ventilation,time to weaning from vasopressors,time to discharge from the ICU and hospital,and laboratory results after randomization.Results:A total of 188 patients completed the trail.This study revealed that the results of the SFI group and the control groups were not statistically significant in 28-day all-cause mortality(10.6％vs.20.2％,respectively;P=0.106).The infusion of SFI was associated with a significant reduction in the duration of vasopressor use(median=4.0 days,interquartile range[IQR]:2.0 days-6.0 days vs.median=5.0 days,IQR:3.0 days-8.0 days,respectively;P=0.043).Patients in the SFI group had statistically greater reductions in plasma lactate levels compared with those in the control group at the first 12 h(median=1.1 mmol/L,IQR:0.3-2.0 mmol/L vs.median=0.0 mmol/L,IQR:-0.2 to 0.8 mmol/L,respectively;P＜0.001)and 24 h(median=1.4 mmol/L,IQR:0.3-2.2 mmol/L vs.median=0.4 mmol/L,IQR:-0.4 to 1.6 mmol/L,respectively;P=0.001).Conclusion:SFI plus standard therapy did not significantly decrease 28-day all-cause mortality for septic patients with hypoperfusion and TCM syndrome with Yang-Qi deficiency.

外文关键词：

SepsisShenfu injectionTraditional Chinese medicinePrognosis

作者：

Di Liu、Tingting Pan、Xiang Li、Duming Zhu、Yingchuan Li、Hongyu He、Fang Wu、Lijing Jiang、Yang Chen、Xiaoli Wang、Jialin Liu、Ruoming Tan、Hongping Qu

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作者单位：

Department of Critical Care Medicine,Ruijin Hospital,Shanghai Jiaotong University School of Medicine,Shanghai,China

Department of Critical Care Medicine,Minhang Hospital,Fudan University,Shanghai,China

Department of Critical Care Medicine,Zhongshan Hospital,Fudan University,Shanghai,China

Department of Critical Care Medicine,Shanghai Jiaotong University Affiliated Sixth People's Hospital,Shanghai,China

Department of Critical Care Medicine,Tenth People's Hospital of Tongji University,Shanghai,China

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基金：

Shanghai Municipal Health and Family Planning Commission General Hospital Chinese and Western Medicine Clinical Cooperation

项目编号：

ZY2018-2020-FWTX-1108

出版年：

2024

DOI：

10.1016/j.jointm.2024.01.007

重症医学(英文)

ISSN：

年,卷(期)：2024.4(4)