Chen Hao, He Ming-yan, Li Yu-min
The Key Laboratory of Organ Transplantation of Public Health Ministry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang 310003, China.
Chin Med J (Engl). 2009 Apr 20;122(8):883-8.
BACKGROUND: Tradition treatment of sepsis and new therapies, including high dose corticosteroids and non-steroidal anti-inflammatory drugs, have proven unsuccessful in improving survival. This study aimed to evaluate the potential efficacy of immunomodulating therapy using Ulinastatin (UTI) plus Thymosin alpha1 (Talpha1) for improving organ function and reducing mortality in patients with severe sepsis. METHODS: A prospective study was carried out with randomized and controlled clinical analysis of 114 patients conforming to the enrollment standard. All patients had severe sepsis and received standard supportive care and antimicrobial therapy. Fifty-nine patients were also administered UTI plus Talpha1 (defined as Group A), 55 patients were given a placebo (defined as Group B). Clinical parameters were determined by evaluation with the Acute Physiology and Chronic Health Evaluation II (APACHE II), multiple organ failure (MOF) and the Glasgow Coma Scores (GCS) on entry and after therapy on the 3rd, 8th, and 28th day. By flow cytometery and ELISA lymphocyte subsets and cytokines were analyzed. Survival analysis was determined by the Kaplan-Meier method at 28, 60, and 90 days. RESULTS: Based on comparison of the two groups, patients in Group A exhibited a better performance in organ failure scores which was noticeable soon after initiation of treatment. Patients in Group A also demonstrated a better resolution of pre-existing organ failures during the observation period. After initiation of treatment, significant improvements in the CD(4)(+)/CD(8)(+) ratio, a quicker balance between proinflammatory mediators such as tumor necrosis factor alpha, interleukin 6 and anti-inflammatory cytokines including interleukin 4 and interleukin 10 were found. This was followed by cumulative survival increases of 17.3% at 28 days, 28.9% at 60 days, and 31.4% at 90 days in Group A. The reduction in mortality was accompanied by a considerably shorter stay in the ICU and a shorter length of supportive ventilation, antimicrobial and dopamine therapy. CONCLUSION: UTI plus Talpha(1) has a beneficial role in the treatment of severe sepsis.
背景：脓毒症的传统治疗方法以及包括大剂量皮质类固醇和非甾体类抗炎药在内的新疗法，均未成功提高生存率。本研究旨在评估使用乌司他丁（UTI）加胸腺肽α1（Tα1）进行免疫调节治疗对改善重症脓毒症患者器官功能和降低死亡率的潜在疗效。 方法：对114例符合入选标准的患者进行前瞻性随机对照临床分析研究。所有患者均患有重症脓毒症，并接受标准的支持治疗和抗菌治疗。59例患者还接受了UTI加Tα1治疗（定义为A组），55例患者给予安慰剂（定义为B组）。通过急性生理与慢性健康状况评分系统II（APACHE II）、多器官功能衰竭（MOF）以及格拉斯哥昏迷评分（GCS）在入院时以及治疗后第3天、第8天和第28天对临床参数进行评估。通过流式细胞术和酶联免疫吸附测定法分析淋巴细胞亚群和细胞因子。采用Kaplan-Meier方法对28天、60天和90天的生存率进行分析。 结果：基于两组比较，A组患者在器官功能衰竭评分方面表现更佳，治疗开始后不久就很明显。A组患者在观察期内原有器官功能衰竭的缓解情况也更好。治疗开始后，发现CD(4)(+)/CD(8)(+)比值显著改善，促炎介质如肿瘤坏死因子α、白细胞介素6与抗炎细胞因子如白细胞介素4和白细胞介素10之间的平衡更快。随后，A组在28天时累积生存率提高了17.3%，60天时提高了28.9%，90天时提高了31.4%。死亡率的降低伴随着在重症监护病房的住院时间显著缩短以及支持通气、抗菌和多巴胺治疗的时间缩短。 结论：UTI加Tα1在重症脓毒症治疗中具有有益作用。
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