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目的评价健康志愿者单次口服阿德福韦酯片的安全性及耐受性。方法42名19～26岁的健康志愿者,男女各半,筛选合格后根据性别和体重随机分配到5、10、20、40及60mg共5个剂量组(每组6～10人),由最小剂量组开始,逐组进行试验。观察指标有临床症状、生命体征、心电图、血常规、尿常规、凝血功能、血液生化等。结果给药后各组志愿者的生命体征、心电图、尿常规、血常规及凝血功能未发现有临床意义的异常变化,2名志愿者丙氨酸氨基转移酶轻度升高,6名志愿者胆红素轻度升高,3名志愿者出现轻度恶心、腹泻等胃肠道症状,但上述不良反应未发现剂量相关性。结论单次口服阿德福韦酯的剂量在60mg内较安全,志愿者耐受性良好。
Objective To evaluate the safety and tolerability of single oral adefovir dipivoxil tablets in healthy volunteers. Methods Forty-two healthy volunteers aged 19 to 26 years old were divided into two groups: male and female, and were randomly divided into 5, 10, 20, 40 and 60 mg doses (6 to 10) according to their sex and weight. The lowest dose group began, one by one for testing. Observed indicators of clinical symptoms, vital signs, ECG, blood, urine, coagulation, blood biochemistry. Results There was no clinically significant abnormal changes of vital signs, electrocardiogram, urine routine, blood routine and coagulation function in each group of volunteers after administration. The levels of alanine aminotransferase in two volunteers were slightly elevated. Six volunteers Bilirubin slightly increased, 3 volunteers showed mild nausea, diarrhea and other gastrointestinal symptoms, but the above adverse reactions found no dose-related. Conclusions A single oral dose of adefovir dipivoxil is safe within 60 mg, and volunteers are well tolerated.