国产八氟丙烷人血白蛋白微球注射液的安全耐受性

Study of the safety and tolerance of human albumin microsphere,injectable suspension octafluoropropane formulation

目的观察八氟丙烷人血白蛋白微球注射液在中国健康受试者中的安全性及耐受程度,为Ⅱ期临床试验给药剂量的确定提供依据。方法本研究采用开放、随机的试验设计,将符合入选标准的30名健康中国男性受试者随机分为5组,每组6名,分别注射八氟丙烷人血白蛋白微球注射液0.005、0.01、0.02、0.03、0.04 mL·kg^(-1),观察临床体征及实验室检查指标的变化。结果八氟丙烷人血白蛋白微球注射液在剂量0.005～0.04 mL·kg^(-1)内无任何不良反应发生,生命体征和实验室检查均未出现有临床意义的变化。结论在剂量0.005～0.04 mL·kg^(-1)内的八氟丙烷人血白蛋白微球注射液对健康受试者是安全和耐受良好的,临床推荐其剂量以不超过0.04 mL·kg^(-1)为宜。

AIM To study the safety and tolerance of human albumin microspheres, injectable suspension octafluoropropane formulation after intravenous administration to healthy volunteers. METHODS The study was an opened and randomized design. Five groups, each of 6 subjects, were given single ascending intravenous doses ranging from 0. 005 mL· kg- 1 to 0.04 mL·kg- 1. The changes of vital signs and laboratory values were recorded. RESULTS The subjects in all groups were well tolerated. There were no significant changes in vital signs. Some significant drug-related changes were encountered in the within-study haematology and biochemistry assessments. Octafluoropropane proved to be a echocardiographic contrast agent following intravenous administration at all doses. CONCLUSION Human albumin microspheres, injectable suspension octafluoropropane formulation are well tolerated from all perspective studied. The highest dose of the study drug is 0.04 mL·kg- 1