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背景 尽管采用有效的强力抗生素和精心护理,败血病体克的死亡率仍达40％～70％。作者评估了用人肿瘤坏死因子α(TNFα,MAb)的鼠单克隆抗体治疗败血病休克的安全性和有效性。方法:在105家美国和加拿大医院中进行随机多中心的双盲安慰剂对照临床试验。作者随机分配1879名病人,单独输入7.5mg/kgTNF αMAb (n=949)或安慰剂(0.25％人血清蛋白n=930)。作者主要测量在28天内的总的死亡率。发现接受TNFα MAb 948人中的382例(40.3％)和接受安慰剂930人中的398
Background Despite the use of potent antibiotics and meticulous care, the mortality rate of septicemia is still between 40% and 70%. The authors evaluated the safety and efficacy of murine monoclonal antibodies against tumor necrosis factor alpha (TNFα, MAb) in the treatment of septic shock. METHODS: A randomized, double-blind placebo-controlled clinical trial was conducted in 105 U.S. and Canadian hospitals. The authors randomized 1879 patients to 7.5 mg / kg TNF αMAb (n = 949) or placebo (0.25% human serum protein n = 930). The authors mainly measure the total mortality within 28 days. 382 (40.3%) of the TNFα MAb 948 patients and 398 of the 930 patients who received placebo