单次静滴D聚甘酯注射液安全性耐受性研讨.pdfVIP

单次静滴D-聚甘酯注射液安全性耐受性研究 * * ** * * * 方翼 王睿 陈騉 梁蓓蓓 裴斐 柴栋 *解放军总医院临床药理室 北京 100853 ** 中国海洋大学 青岛 266003 摘要 目的 在中国健康成年志愿者中评估单次静滴 D-聚甘酯注射液的安全 性 耐受性 方法 根据新药临床试验指导原则设计试验方案 并获得解放军总 医院伦理委员会审查通过 选择 18 50 岁健康成人 用区组随机化设计方法 将36 名受试者随机分配至50mg-300mg 共6 个剂量组 每组6 名受试者 男女 各半 观察试验期间发生的不良事件 以及临床症状 体征 实验室指标变化 应用方差分析进行数据统计学处理 结果 各组入选受试者各项指标测定值均在 正常范围 条件均衡 具较好可比性 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 例受试者出现给药测手 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不良反应 各给药 组PT 和aPTT 等凝血指标给药后有轻微增高 但无统计学意义 试验中未见严 重的临床不良反应 结论 36 名中国健康受试者分组单次静滴D-聚甘酯注射液 最大剂量至300mg 比较安全 耐受性较好 关键词 D-聚甘酯 耐受性 中国志愿者 The Tolerance of Single –Dose of D-polymannuronicate injection in Chinese Healthy Volunteers FANG Yi, WANG Rui, CHEN Kun, LIANG Beibei, PEI Fei, CAI Dong (Department of clinical pharmacology , Chinese PLA General Hospital Beijing 100853 ) Abstract Objictive To evaluate the safety and tolerance of single-dose D-polymannuronicate injection in Chinese healthy volunteers. Methods The clinical trial protocol was designed according to the Good Clinical Practice (GCP) and passed by the ethics committee. After physical examination and laboratory tests were performed, 36 healthy volunteers in 18 50 years old were divided into50mg 100mg 150mg 200mg 250mg 300mg groups respectively by random method. Clinical symptoms, vital signs and laboratory tests were observed or examined before and after administration. We calculated all data by analysis of variance. Results The vital signs, clinical symptoms and laboratory tests of every group were mainly in the normal range. All data were in the normal range after administration, including routine blood tests, clotting function, routine urine