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目的 :评价健康志愿者单次口服D 聚甘酯片的安全性和耐受性。方法 :选择 18～ 5 5岁健康受试者4 1例 ,随机分为 5 0 ,10 0 ,15 0 ,2 0 0 ,30 0 ,4 0 0 ,5 0 0 ,6 0 0和 80 0mg共 9个剂量组 ,观察指标为临床症状、生命体征、血尿常规、血沉、肝肾功能、电解质等实验室检查 ,并检测心电图、脑电图和经颅多普勒脑血流图。结果 :大部分受试者于给药后不同时间出现纤维蛋白原含量 (FIB)降低 ,凝血酶原时间 (PT)、部分凝血活酶时间 (APTT)延长甚至血不凝现象。不良反应发生率约为 4 .88% (2 / 4 1)。结论 :单次口服D 聚甘酯片最大剂量至 80 0mg仍比较安全 ,耐受性较好。
Objective: To evaluate the safety and tolerability of single oral D-polyglycerol tablets in healthy volunteers. METHODS: Forty-one healthy subjects aged 18-55 years were enrolled in this study. They were randomly divided into 5 0, 10 0, 15 0, 2 0 0, 30 0, 4 0 0, 5 0 0, 6 0 0 and 80 0 mg Nine dose groups were used to observe the clinical symptoms, vital signs, hematuria, ESR, liver and kidney function, electrolytes and other laboratory tests, and to detect ECG, EEG and transcranial Doppler cerebral blood flow diagram. Results: Most of the subjects showed decreased fibrinogen content (FIB), prolonged prothrombin time (PT), partial thromboplastin time (APTT) and even blood coagulation at different time points after administration. The incidence of adverse reactions was about 4.88% (2/4 1). Conclusion: The single oral dose of D-polyglycerol ester is still safe and well tolerated.