Shenfu Injection For Improving Cellular Immunity And Clinical Outcome In Patients With Sepsis Or Septic Shock

Purpose: To assess the efficacy of Shenfu injection (SFI) for enhancing cellular immunity and improving the clinical outcomes of patients with septic shock.Methods: Patientswith sepsiswere randomly assigned to receive either SFI at a dose of 100 mL every 24 hours for 7 consecutive days or a placebo in addition to conventional therapy. The immunologic parameters were collected on days 1, 3, and 7 after the above treatments, and the clinical outcomes were updated for 28 days.Results: Of these160 patients, 3were excluded fromthe analysis due to protocol violation andwithdrawal of consent; thus, 157 completed the study (78 in the SFI group and 79 in the placebo group). We found that SFI increased both CD4+ and CD8+ T cells in peripheral blood and up-regulated HLA-DR expression in monocytes (P <.05). Furthermore, SFI was also found to restore ex vivo monocytic tumor necrosis factor a and interleukin 6 proinflammatory cytokine release in response to the endotoxin (P <.05). Importantly, the SFI group showed better clinical outcomes than did the placebo group in terms of the duration of vasopressor use (P =.008), Acute Physiology and Chronic Health Evaluation II score (P =.034), Marshall score (P =.01), and length of intensive care unit stay (10.5 +/- 3.2 vs 12.2 +/- 2.8 days; P=. 012). However, the 28-day mortality rate was not significantly different between the SFI (20.5%; 16/78) and placebo groups (27.8%; -22/79; P =.28).Conclusion: These findings suggest that SFI can enhance the cellular immunity of patients with septic shock and could be a promising adjunctive treatment for patients with septic shock. (C) 2016 Elsevier Inc. All rights reserved.