摘要
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。
OBJEIVE: To assess the safety and tolerance of D-polymannuronicate in Chinese healthy volunteers. METHODS: The trial protocol was designed in accordance with the good clinical praice(GCP) of the State Drug Administration (SDA), and approved by the ethics committee of the General Hospital of PLA. Informed consent was obtained after all appropriate information had been given about the trial. A total of 29 healthy volunteers ranging from 18 to 55 years old were enrolled in the study. The subjes were randomly divided into 6 groups, including 100, 200,400, 500,600 and 700mg dosing groups, by 4 to 6 subjes in each group. Clinical symptoms, vital signs, routine blood tests, routine urine tests, hepatic funions, renal funions, blood elerolytes, elerocardiogram, eleroencephalogram were observed or monitored. RESULTS: In all groups, no significant change was found in the clinical symptoms and laboratory examinations after dosing, except that transient acnes, headache and marked elevation of creatine kinase were observed in several volunteers. CONCLUSIONS: This study provided evidence that multiple oral doses of D-polymannuronicate to an amount of 500mg was safe and tolerable.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2003年第3期178-180,共3页
The Chinese Journal of Clinical Pharmacology
