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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。
Objective To observe the safety and tolerability of octafluoropropane-loaded human albumin microsphere injection in Chinese healthy subjects and provide the basis for the determination of the dose administered in phase Ⅱ clinical trials. Methods In this study, 30 healthy Chinese male subjects who met the inclusion criteria were randomly divided into 5 groups with 6 patients in each group. Each group was injected with 0.8 mg of propofol human albumin microsphere 0.005, 0.01, 0.02, 0.03 and 0.04 mL · kg ~ (-1) respectively. The changes of clinical signs and laboratory indexes were observed. Results There was no adverse reaction in the dose of 0.005 ~ 0.04 mL · kg ~ (-1) of octafluoropropane human albumin microsphere injection. There was no clinically significant change in vital signs and laboratory tests. Conclusions The octafluoropropane microencapsulated human serum albumin injection at a dose of 0.005-0.04 mL · kg -1 is safe and well tolerated in healthy subjects. The recommended dosage is not more than 0.04 mL · kg ~ (-1) is appropriate.