Optimized inflammation regulating decoction in the treatment of septic shock:A randomized,controlled,multi-center clinical trial
Objective It is to observe the clinical efficacy and safety of optimized inflammation regulating decoction in the treatment of patients with septic shock.Methods A total of 124 patients with septic shock treated in the emergency ward and emergency ICU of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai Baos-han Hospital of Integrated Traditional Chinese and Western Medicine,and Anhui Hospital of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from July 2021 to October 2023 were enrolled in this study.They were randomly divided into treatment group (62 cases) and control group (62 cases).The control group was given basic therapy of western medicine,and the treatment group was given basic therapy of western medicine+optimized inflammation regulating decoction by nasal feeding or oral administration.Both groups were treated for 14 days.The 28-day survival rate,APACHE Ⅱ score,Sequential Organ Failure Assessment ( SOFA) score,traditional Chinese medicine ( TCM) syndrome scores,laboratory parameters[white blood cell count ( WBC),neutrophil percentage ( N%),C-reactive protein ( CRP),tumor necrosis factor-α(TNF-α),interleukin-6 (IL-6),interleukin-8 (IL-8),procalcitonin (PCT),lactic acid,heparin-binding protein ( HBP)]before and after treatment,and the efficacy of TCM syndrome after treatment for 14 days were compared between the two groups.Results During the trial,3 cases in the control group and 2 cases in the treatment group were dropped,and finally 60 cases in the treatment group and 59 cases in the control group completed the study.The 28-day survival rate of the treatment group was significantly higher than that of the control group[78.3% (47/60) VS.42.4% (25/59),P<0.05].The APACHEⅡscore,SOFA score,TCM syndrome score,and the levels of WBC,N%,CRP,TNF-α,IL-6,IL-8,PCT,lactic acid,and HBP were significantly lower after treatment than those before treatment in the two groups (all P<0.05),and the APACHE Ⅱ score,SOFA score,TCM syndrome score and levels of CRP,IL-6,PCT,HBP of the treatment group were significantly lower than those of the control group after treatment (all P<0.05).The total effective rate of TCM syndrome in the treatment group was significantly higher than that in the control group after 14 days of treatment[81.7% (49/60) VS.62.7% (37/59),P<0.05].Conclusion Optimized inflammation regulating decoction can significantly raise 28-day survival rate of patients with septic shock,and can obviously alleviate their symp-toms and improve their prognosis.
optimized inflammation regulating decoctionseptic shocksurvival ratetraditional Chinese medicine syndrome