单次静滴D-聚甘酯注射液在中国健康人体的安全性

目的在中国健康成年志愿者中评价单次静滴D-聚甘酯注射液的安全性与耐受性。方法用区组随机化设计,选择18～50岁健康成人36名,随机分至50~300mg共6个剂量组,每组6人,男女各半。观察试验期间发生的药物不良事件,及临床症状、体征、实验室指标变化。用方差分析进行数据统计处理。结果各组入选受试者给药前各项指标测定值均在正常范围。给药后血常规、尿常规、肝、肾功能、电解质、心电图和脑电图等检查均在正常范围内。其中有5例受试者出现给药侧手部肿胀,1例出现头晕、冷汗等可能与药物相关的轻度一过性药物不良反应。试验中未见严重的药物不良反应。结论单次静滴D-聚甘酯注射液,最大剂量至300mg比较安全,耐受性较好。

Tolerance of single dose of D-polymannuronicate injection in Chinese healthy volunteers

Objective To evaluate the safety and tolerance of single-dose D-polymannuronicate injection in Chinese healthy volunteers. Methods After physicalexamination and laboratory tests were performed, 36 healthy volunteers in 18~50years old were divided into 50,100,150,200,250,300mg groups by randommethod, respectively. Clinical symptoms, vital signs and laboratory tests wereobserved or examined before and after administration of the drug. All data werecalculated by analysis of variance. Results The vital signs, clinical symptoms andlaboratory tests of every group were mainly in the normal range. All data were in thenormal range after administration, including routine blood tests, clotting function,routine urine tests, hepatic function, renal function, blood electrolytes,electrocardiogram, electroencephalogram. Swelling hand was observed in five casesand one of the cases felt dizzy and cold sweat. However, all these adverse drugreaction (ADR) were mild and transient. There are no serious ADR during the trial.Conclusion Single-dose of D-polymannuronicate injection, until the dosage of300mg was safe and tolerable for Chinese healthy volunteers.