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为评价HA-lA降低G~-菌血症死亡率的功效及其安全性,进行了一项前瞻、多中心、随机、双盲和安慰剂对照的临床试验。由美国、加拿大等24所医学研究中心参与,由Maryland医学研究所负责总体协调。研究对象为患脓毒症和拟诊革兰阴性菌感染病人共543例,其中262例以HA-lA治疗(以3.5克人体血清白蛋白稀释HA-lA 100mg),另281例以安慰剂治疗(3.5克人体血清白蛋白)。研究药物均稀释成50ml,在15～20分钟内由静脉一次注入。这些病人的抗生素使用、静脉输液、呼吸循
A prospective, multicenter, randomized, double-blind, and placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of HA-1A in reducing mortality from G-meconosis. By the United States, Canada, 24 medical research center to participate, by the Maryland Institute of Medicine is responsible for overall coordination. A total of 543 patients with sepsis and suspected Gram-negative infections were enrolled. Of these, 262 were treated with HA-1A (HA-lA 100 mg diluted with 3.5 g of human serum albumin) and 281 were treated with placebo 3.5 grams of human serum albumin). Study drugs were diluted into 50ml, intravenous infusion in 15 ~ 20 minutes. Antibiotic use of these patients, intravenous fluids, breathing cycles