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目的评价健康志愿者口服阿德福韦酯片的安全性和耐受性。方法42名健康志愿者,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60mg5个剂量组(每组6～10人),进行单次给药耐受性试验,由最小剂量组开始,逐组进行试验。10名健康志愿者,男女各半,每日1次口服阿德福韦酯10mg,连续用药7日,进行多次给药耐受性试验。观察记录志愿者给药前后不同时间的临床症状、生命体征、心电图、血常规、尿常规、凝血功能、血液生化等。结果阿德福韦酯口服后主要不良反应为恶心、腹痛及腹泻等,多次给药易引起乏力症状,个别志愿者出现丙氨酸氨基转移酶、胆红素、肌酸激酶及乳酸脱氢酶升高,均为轻度,未发现剂量相关性。结论阿德福韦酯单次给药剂量60mg范围内安全,推荐临床使用剂量为每日1次10mg,但长期用药需注意肝、肾功能,肌酸激酶,血清淀粉酶及乳酸脱氢酶等的变化。
Objective To evaluate the safety and tolerability of oral adefovir dipivoxil tablets in healthy volunteers. Methods Forty-two healthy volunteers, male and female, were randomly divided into 5, 10, 20, 40 and 60 mg five-dose groups (6 to 10 in each group) according to sex and weight. The test, starting with the minimum dose group, was performed on a group-by-group basis. Ten healthy volunteers, half male and female, once daily oral adefovir dipivoxil 10mg, continuous medication on the 7th, multiple drug tolerance test. The clinical symptoms, vital signs, electrocardiogram, blood routine, urine routine, blood coagulation, blood biochemistry and so on were observed and recorded before and after the administration of the volunteers. Results The main side effects of adefovir dipivoxil were nausea, abdominal pain and diarrhea after oral administration. The administration of adefovir dipivoxil was easy to cause fatigue symptoms. Some volunteers showed alanine aminotransferase, bilirubin, creatine kinase and lactate dehydrogenation Enzyme increased, all mild, no dose-related. Conclusions A single dose of adefovir dipivoxil is safe within the single dose of 60mg. The recommended dosage is 10mg daily, but long-term medication should pay attention to liver and kidney function, creatine kinase, serum amylase and lactate dehydrogenase The change.