Effectiveness and safety of Shenfu injection in septic patients with hypoperfusion: A multi-center, open-label, randomized, controlled trial
Journal of Intensive Medicine(2024)
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 hospitals in China. A total of 188 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 standard bundle treatment alone (control group). The primary outcome was 28-day all-cause mortality. Secondary outcomes were 90-day all-cause mortality and laboratory results after randomization.
Results
This study revealed that the results of the SFI group and the control groups were not statistically significant in 28-day 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, interquartile range [IQR]: 2–6 vs. median=5, IQR: 3–8, 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, IQR: 0.3–2.0 vs. median=0.0, IQR: −0.2 to 0.8, respectively; P <0.001) and 24 h (median=1.4, IQR: 0.3–2.2 vs. median=0.4, IQR: −0.4 to 1.6, 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.Trial registration Chinese Clinical Trial Registry Identifier: ChiCTR1800020435
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关键词
Sepsis,Shenfu injection,Traditional Chinese medicine,Prognosis
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