A prospective multicenter clinical study of Xuebijing injection in the treatment of sepsis and multiple organ dysfunction syndrome

Abstract

To evaluate the clinical efficacy and safety of Xuebijing injection in treatment of sepsis and multiple organ dysfunction syndrome (MODS). A prospective multicenter clinical study was conducted. The patients with sepsis, severe sepsis, or MODS admitted to Department of Emergency and Critical Care Medicine of 70 hospitals across the country during 2006 to 2008 were enrolled. All of the patients received the basis treatment of conventional therapy, plus Xuebijing injection of 50-100 mL, 2-3 times a day for 5-7 days, and the dose might be increased in serious cases. The vital signs, 24-hour urine output, Glasgow coma score (GCS), white blood cell count (WBC), platelet count (PLT), Marshall score, gastrointestinal function score, syndrome of traditional Chinese medicine (TCM), blood lactate (Lac), blood glucose, serum creatinine (SCr), and total bilirubin (TBil) were observed before treatment, 1, 3, and 5 days after treatment, and at the end of the treatment. The results of above mentioned parameters after the treatment were compared with that before treatment in each patient. At the same time, the occurrence and the degree of adverse reactions were recorded to evaluate the safety of Xuebijing injection. A total of 2,574 patients were enrolled, and in 2,509 cases the treatment was completed in, with a drop of 65 cases. 704 cases were diagnosed to have sepsis, 768 with severe sepsis, and 1,037 with MODS. According to TCM, in 1,951 cases syndrome of stasis-toxin in the interior, and in 558 syndrome of excessive exuberance of heat-toxic in the interior were diagnosed. After the treatment of Xuebijing injection combined with conventional therapy, the temperature, heart rate, respiration rate, blood pressure, WBC, PLT, GCS, 24-hour urine output, blood glucose, Lac, SCr, TBil, Marshall score, gastrointestinal function score, as well as the symptoms, signs and TCM tongue condition and pulse condition, and TCM scores were significantly improved in all patients as well as the patients with sepsis, severe sepsis, or MODS (P<0.05 or P<0.01). The effective rate of all patients and the patients with sepsis, severe sepsis, or MODS was 89.20% (2,238/2,509), 92.76% (653/704), 91.54% (703/768), 85.05% (882/1,037), respectively, and the 28-day survival rate was 93.90% (2,356/2,509), 98.01% (690/704), 96.35% (740/768), 89.30% (926/1,037), respectively. In 3 patients with MODS adverse events (0.12%) occurred, including 2 cases of stress ulcer and 1 case of Adams-Stokes syndrome. After clinical evaluation, the adverse events were found to be unrelated with the study medication, and Xuebijing injection was continued till the end of treatment. Xuebijing injection combined with conventional therapy may effectively ameliorate systemic inflammatory response, protect organ function, alleviate the symptoms, improve organ functions, and elevate the clinical cure rate. Adverse events occur occasionally. Xuebijing injection is found to be safe.