the efficacy of thymosin alpha 1 for severe sepsis (etass) a multicenter, single-blind, randomized and controlled trial胸腺素α1对严重脓毒症的疗效(贱民)多中心、单盲、随机、对照试验.pdfVIP

Wu et al. Critical Care 2013, 17:R8 /content/17/1/R8 RESEARCH Open Access The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial 1 2 3 4 5 6 1 1 Jianfeng Wu , Lixin Zhou , Jiyun Liu , Gang Ma , Qiuye Kou , Zhijie He , Juan Chen , Bin Ou-Yang , 1 2 3 4 5 6 2 3 Minying Chen , Yinan Li , Xiaoqin Wu , Baochun Gu , Lei Chen , Zijun Zou , Xinhua Qiang , Yuanyuan Chen , Aihua Lin7, Guanrong Zhang7 and Xiangdong Guan1* Abstract Introduction: Severe sepsis is associated with a high mortality rate despite implementation of guideline recommendations. Adjunctive treatment may be efficient and require further investigation. In light of the crucial role of immunologic derangement in severe sepsis, thymosin alpha 1 (Ta 1) is considered as a promising beneficial immunomodulatory drug. The trial is to evaluate whether Ta 1 improves 28-day all-cause mortality rates and immunofunction in patients with severe sepsis. Methods: We performed a multicenter randomized controlled trial in six tertiary, teaching hospitals in China between May 12, 2008 and Dec 22, 2010. Eligible patients admitted in ICU with severe sepsis were randomly allocated by a central randomization center to the control group or Ta 1 group (1:1 ratio). The primary outcome was death from any cause and was assessed 28 days after enrollment. Secondary outcomes included dynamic changes of Sequential Organ Failure Assessment (SOFA) and monocyte human leukocyte antigen-DR (mHLA-DR) on day 0, 3, 7 in both groups. All analyses were done on an intention-to-treat basis. Results: A tot