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目的评估联合抗炎和免疫刺激治疗严重脓毒症方法的有效性。方法本研究采用多中心、前瞻、随机、对照方法。共433例患者进入本研究。进入 ICU 内严重脓毒症(Marshall 评分5～20)的患者入选,随机分为对照组:常规治疗;治疗组1(第1阶段):常规治疗+乌司他丁30万 U/日,α1胸腺肽(迈普新)1.6 mg/d,连续7 d;治疗组2(第2阶段):常规治疗+乌司他丁60万 U/日,迈普新3.2 mg/日,连续7 d,进行28 d 和90 d 预后等疗效评估。结果第1阶段91例,治疗组(治疗组1)与对照组28 d 预后等各项疗效评估指标差异均无统计学意义。第2阶段342例,治疗组(治疗组2)与对照组相比(意向治疗分析),28 d 病死率为25.1%vs 38.3%(P=0.0088),90 d 病死率为37.1%vs 52.1%(P=0.0054),28 d APACHEⅡ评分12.7±9.4 vs 14.3±9.2(P=0.0384),28 d 单核细胞 HLA-DR/CD14+(51.7±26.5)%vs(40.1±22.0)%(P=0.0092)。其他疗效评估指标,如 ICU内治疗天数、呼吸机使用天数、抗生素使用时间等,两组差异无统计学意义。结论本研究治疗方案能够明显改善严重脓毒症患者28 d 和90 d 预后,具有积极推广价值;治疗的有效性具有剂量依赖性,最佳剂量有待进一步探讨。
Objective To evaluate the effectiveness of a combination of anti-inflammatory and immunostimulatory approaches in the treatment of severe sepsis. Methods This study used a multicenter, prospective, randomized, controlled approach. A total of 433 patients entered the study. Patients admitted to the ICU with severe sepsis (Marshall score 5 to 20) were enrolled and randomly assigned to control group: conventional treatment; Treatment Group 1 (Phase 1): routine treatment + ulinastatin 300,000 U / day, α1 Thymosin (Maipu Xin) 1.6 mg / d for 7 days; treatment group 2 (phase 2): routine treatment + Ulinastatin 600,000 U / day, Maipuxin 3.2 mg / day for 7 days 28 d and 90 d prognosis and other efficacy evaluation. Results There were no significant differences between the 91 cases in the first stage, the prognosis of the treatment group (treatment group 1) and the control group on the 28th day. Compared with the control group (intention-to-treat analysis), the mortality at 28 days was 25.1% vs 38.3% (P = 0.0088). The 90-day mortality rate was 37.1% vs 52.1% (P = 0.0054). On the 28th day, the APACHEⅡ score was 12.7 ± 9.4 vs 14.3 ± 9.2 (P = 0.0384), the percentage of HLA-DR / CD14 + ). Other indicators of efficacy evaluation, such as the number of days within the ICU treatment, ventilator days, the use of antibiotics, no significant difference between the two groups. Conclusion The treatment regimen of this study can significantly improve the prognosis of patients with severe sepsis 28 d and 90 d, and has a positive promotion value; the effectiveness of the treatment is dose-dependent, and the optimal dose needs to be further explored.