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目的：评价血必净注射液治疗脓毒症及多器官功能障碍综合征（MODS）的临床疗效和安全性。方法采用前瞻性多中心临床研究方法，纳入2006年至2008年全国70家医院急诊科和重症医学科收治的脓毒症、严重脓毒症、MODS成人患者。所有患者在常规综合治疗的基础上加用血必净注射液50～100 mL，每日2～3次，疗程5～7 d，病情重者可加量使用。观察用药前及用药1、3、5 d和疗程结束时的生命体征、24 h尿量、格拉斯哥昏迷评分（GCS）、白细胞计数（WBC）、血小板计数（PLT）、血乳酸、血糖、血清肌酐（SCr）、总胆红素（TBil）、Marshall评分、胃肠功能评分、中医证候。对以上指标进行治疗前后的自身对照。同时记录不良反应的发生和程度，以评价血必净注射液的安全性。结果共入选患者2574例，其中2509例按治疗方案完成临床试验，脱落65例。脓毒症704例，严重脓毒症768例，MODS 1037例；瘀毒内阻证1951例，毒热内盛证558例。联合血必净注射液治疗后，所有患者以及脓毒症、严重脓毒症、MODS患者体温、心率、呼吸频率、血压、WBC、PLT、GCS、24 h尿量、血糖、乳酸、SCr、TBil、Marshall评分、胃肠功能评分以及临床症状、体征、舌象、脉象、中医总积分均明显改善（P＜0.05或P＜0.01）。所有患者以及脓毒症、严重脓毒症、MODS患者治疗总有效率分别为89.20%（2238/2509）、92.76%（653/704）、91.54%（703/768）、85.05%（882/1037）；28 d存活率分别为93.90%（2356/2509）、98.01%（690/704）、96.35%（740/768）、89.30%（926/1037）。全部患者中有3例MODS患者发生不良事件，发生率为0.12%，其中应激性溃疡2例，阿斯综合征1例，经临床判定均与试验药物无关，继续使用血必净注射液至疗程结束。结论在常规综合治疗基础上联合血必净注射液能够有效改善脓毒症及MODS患者全身炎症反应，保护器官功能，改善患者的临床症状和指标，从而有效提高临床治疗有效率；偶见不良事件，安全性较高。“,”Objective To evaluate the clinical efficacy and safety of Xuebijing injection in treatment of sepsis and multiple organ dysfunction syndrome ( MODS ). Methods 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. Results 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 diagnosedto 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. Conclusion 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.