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虽然导致败血症和败血性休克的病理生理学因素比较复杂,但TNF-α似乎在其中起着重要的作用。动物实验证明,抗TNF抗体能够保护动物免于由内毒素、革兰阴性菌(大肠杆菌)或革兰阳性菌(金黄色葡萄球菌)引起的病死;另有两个大规模临床试验证明,鼠抗人TNF-α单克隆抗体(McAb)可减少休克及器官衰竭病人的病死率。本试验采用双盲、随机和安慰剂对照临床试验进一步评估TNF-α McAb治疗败血性休克的效果及安全性。
Although the pathophysiological factors responsible for sepsis and septic shock are complex, TNF-α seems to play an important role. Animal experiments show that anti-TNF antibodies can protect animals from endotoxin, Gram-negative bacteria (Escherichia coli) or Gram-positive bacteria (Staphylococcus aureus) caused by the death; another two large-scale clinical trials show that rats Anti-human TNF-α monoclonal antibody (McAb) can reduce the mortality of patients with shock and organ failure. This trial used double-blind, randomized, and placebo-controlled clinical trials to further evaluate the efficacy and safety of TNF-α McAb in the treatment of septic shock.