血必净注射液通过改善严重脓毒症患者凝血功能保护肾功能的多中心随机对照临床研究

Clinical trial of Xuebijing's kidney protection effect for severe sepsis by improving the coagulation function

目的探讨血必净注射液通过改善严重脓毒症患者凝血功能来保护肾功能的治疗作用和机制。方法采用多中心、随机、对照的试验设计方法,将128例严重脓毒症患者随机分为血必净治疗组60例与对照组68例。测定血肌酐(Cr)、尿素氮(BUN)、血小板计数(PLT)、凝血酶原时间(PT)、纤维蛋白原(FIB)、活化部分凝血活酶时间(APTT),并观察患者28d生存率。结果根据凝血功能进行分层分析,治疗组改善肾功能优于对照组,治疗组凝血功能异常亚组对肾功能改善优于治疗组凝血功能正常亚组,治疗组改善28d生存率优于对照组,治疗组凝血功能异常亚组和治疗组凝血功能正常亚组对改善28d生存率两组比较差异无统计学意义。结论血必净注射液可通过改善严重脓毒症患者凝血功能来保护肾功能,从而降低严重脓毒症患者28d死亡率。

Objective To observe the kidney protection effect of Xuebijing injection by improving the coagulation function and 28 - day survival rate in severe sepsis patients. Methods Randomized, blind and controlled trial was applied. 128 severe sepsis patients were assigned randomly to the Xuebijing group or control group. 28 - day survival rate was observed and blood Cr, BUN, PLT, APTT, PT and Fib before and after the test were detected. Results According to coagulation function, the patients were divided into normal coagulation subgroup and abnormal coagulation subgroup. Kidney protection was improved significantly in treatment group compared with control group and in abnormal coagulation treatment subgroup compared with normal coagulation treatment subgroup. 28 - day survival rate was improved significantly in treatment group compared with control group. There was no significant difference in 28 - day survival rate between abnormal coagulation treatment subgroup and normal coagulation treatment subgroup. Conclusions Xuebijing injection can protect renal function by improving coagulation function and increase 28 -day survival rate in severe sepsis patients.