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目的:评价健康志愿者连续口服国家一类新药D-聚甘酯片的安全性和耐受性。方法:29名18～55岁健康受试者,男女不限。将受试者随机分配至100,200,400,500,600和700mg剂量组,连续口服不同剂量D-聚甘酯片。各组观察指标为临床症状、生命体征和血常规、血沉、尿常规、肝、肾功能、电解质等实验室检查,并监测心电图、脑电图。结果:服药后各组受试者体征和实验室检查结果与给药前比较没有区别。个别受试者出现轻微不适及一过性肌酸激酶、丙氨酸氨基转移酶和天冬氨酸氨基转移酶增高,提示D-聚甘酯片有可能导致肌肉受损。结论:健康受试者对D-聚甘酯片连续口服有很好耐受性。最大剂量至500mg仍比较安全。
Objective: To evaluate the safety and tolerability of continuous oral administration of a new class of D-polyglycerol tablets in healthy volunteers. Methods: Twenty-nine healthy subjects aged 18- 55 years old, male or female. Subjects were randomly assigned to 100, 200, 400, 500, 600 and 700 mg dose groups and consecutive oral doses of D-polyglycerol tablets. Each group of observation indicators for clinical symptoms, vital signs and blood, ESR, urine, liver, kidney function, electrolytes and other laboratory tests, and monitoring of ECG, EEG. Results: After taking the medication, the signs of the subjects and the results of the laboratory tests were not different from those before the administration. Individual subjects with minor discomfort and transient creatine kinase, alanine aminotransferase and aspartate aminotransferase increased, suggesting that D-polyglycerol tablets may cause muscle damage. CONCLUSIONS: Healthy subjects are well tolerated with continuous oral administration of D-polyglycerol tablets. The maximum dose to 500mg is still safer.