The effectiveness of XueBiJing injection in therapy of sepsis: a multicenter clinical study

Abstract

Objective To evaluate the effectiveness and safety of Xuebijing (XBJ) injection in therapy of sepsis.Methods It is a prospective,randomized controlled trial conducted in multicenter.Totally 731 patients with sepsis were enrolled from January to December 2011 at 37 centers and randomly (random number) separated into the XBJ group (n =392) and the control group (n =339).Basic therapy was adoptd in the both groups,but XBJ injection was additionally used in the XBJ group.The effectiveness of XBJ injection was evaluated by comparing the differences of MEDS score,APACHE Ⅱ score,DIC score,SOFA score,coagulation parameters,duration of mechanical ventilation and antibiotic therapy between the two groups.The influence on the outcome of XBJ injection was assessed by mortalities of 28-day and 90-day.The side-effects of XBJ injection were recorded.Results The score of each system and the abnormal rates of coagulation parameters were significantly higher in the XBJ group than in the control group at admission (P ＜ 0.05).After combined treatment of XBJ injection and basic therapy,the score values of the XBJ group decreased distinctly,and the differences of pre-therapy and post-therapy in the two groups had statistical significance (P＜0.01).The abnormal rates of coagulation parameters in the XBJ group decreased after therapy.The 90-day mortality of the XBJ group was lower than the control group (P ＜ 0.05).No severe side-effects were found during study.Conclusions This study proved that the severity of sepsis can be alleviated by XBJ injection.Meanwhile,the organ function and the coagulation status can be protected,and then the prognosis can be improved.The safety of XBJ injection was good. Key words: Sepsis; Xuebijing injection; Therapy; Score system; Coagulation; Prognosis; RCT; Multicenter