Effects of Shenfu Injection in the Treatment of Septic Shock Patients: A Multicenter, Controlled, Randomized, Open‐Label Trial

Abstract

The effect of Shenfu on biochemical parameters and survival during resuscitation in patients with septic shock was examined. This was a multicenter, controlled, randomized, open-label trial carried out in 210 patients with septic shock from seven medical centers in China. They were randomized to Shenfu or saline. The primary outcome was lactate clearance. The secondary outcomes were shock index normalization, dose of vasopressors, ICU stay, hospital stay, and mortality. A total of 199 patients completed the trial. Blood pressure, heart rate, and other routine lab tests showed no difference between the groups. Lactate levels and lactate clearance were similar between the two groups. Hospital and ICU stay were similar between the two groups. When considering all patients, the 7- and 28-day mortality were similar between the two groups, but when considering only patients with lactate levels ≥4.5 mmol/L, the Shenfu group showed a better 7-day survival than the control group (7 days: 83.3% versus 54.5%, P = 0.034; 28 days: 72.7% versus 47.6%, P = 0.092). Shenfu may improve the 7-day survival in patients with impaired lactate clearance (≥4.5 mmol/L), but the mechanism for this effect is unclear. Additional studies are necessary to characterize the hemodynamic changes after Shenfu infusion. This trial is registered with ChiCTR-TRC-11001369.

ShenFu Preparation Protects AML12 Cells Against Palmitic Acid-Induced Injury Through Inhibition of Both JNK/Nox4 and JNK/NFκB Pathways

“…Nevertheless, it should be noted that commercial SF preparation was used in this study. It has been recognized that aconitum alkaloids and ginsenosides are the main active components in SF preparation [13, 14]. Yang et al identified 23 trace diterpene alkaloids, 19 ginseng saponins, one panaxytriol, and one 5-hydroxymethylfurfural in SF preparation, and quantitated that the total concentrations of saponins and alkaloids were about 676 – 742 µg/mL and 3 – 7 µg/mL in five batches of SF preparation samples, respectively [13].…”

“…SF preparation is prepared by using countercurrent extraction and macroporous resin adsorption chromatography. In China, SF preparation is commonly used in clinical practice for the treatment of septic shock and ischemic diseases and has been shown to have a beneficial role against ischemic-reperfusion injuries on many organs including the brain, spinal cord, kidneys, intestines, liver and heart [14, 15]. Recently, it was reported that SF preparation has obviously protective effects on cardiomyocytes against apoptosis by inhibition of down-regulation of Bcl-2 and sequential activation of caspase 3 [15].…”

Effect of shenfu injection on microcirculation in shock patients

“…In China, although there have been many clinical trial reported the efficacy of Shenfu injection in shock, there are still some problems in these trials, such as small sample size and low methodological quality. [ 34 ] Also, Correcting microcirculation disorders plays a vital role in the prognosis of shock patients. [ 12 ]…”

Shen fu injection for patients with septic shock

“…[9] Although there have been many clinical trials reporting SFI's curative effect in septic shock in China, there are still some problems in these trials such as small sample sizes and low methodological quality. [10] For this reason, the objective of our study is to carry out a meta-analysis to evaluate its clinical efficacy and safety in septic shock patients and we expect that our study could provide a reference for further clinical practice.…”