| 健康志愿者口服阿德福韦酯片的Ⅰ期临床安全性和耐受性研究 |
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| 引用本文： | 孙德清,倪梅媛,王本杰,郭瑞臣. 健康志愿者口服阿德福韦酯片的Ⅰ期临床安全性和耐受性研究[J]. 中国药学, 2005, 14(4): 217-222 |
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| 作者姓名： | 孙德清 倪梅媛 王本杰 郭瑞臣 |
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| 作者单位： | 山东大学第二医院药剂科 山东济南250033(孙德清)，山东大学齐鲁医院制剂科 山东济南250012(倪梅媛)，山东大学齐鲁医院临床药理研究所 山东济南250012(王本杰，郭瑞臣) |
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| 摘 要： | 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。
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| 关 键 词： | 阿德福韦酯 安全性 耐受性 I期临床试验 |
| 文章编号： | 1003-1057（2005）4-217-06 |
| 收稿时间： | 2005-01-17 |
| 修稿时间： | 2005-01-17 |
Safety and Tolerance of Adefovir Dipivoxil in Chinese Healthy Volunteers: A PhaseⅠRandomized and Open-Label Trial |
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| SUN De-qing,NI Mei-yuan,WANG Ben-jie,GUO Rui-chen. Safety and Tolerance of Adefovir Dipivoxil in Chinese Healthy Volunteers: A PhaseⅠRandomized and Open-Label Trial[J]. Journal of Chinese Pharmaceutical Sciences, 2005, 14(4): 217-222 |
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| Authors: | SUN De-qing NI Mei-yuan WANG Ben-jie GUO Rui-chen |
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| Affiliation: | 1. Department of Pharmacy, the Second Hospital of Shandong University, Jinan 250033, China ; 2. Department of Pharmaceutics, Qilu Hospital of Shandong University, Jinan 250012, China ; 3. Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan 250012, China |
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| Abstract: | Aim To assess the safety and tolerance of adefovir dipivoxil (ADV) in Chinese healthy volunteers. Methods A total of 52 healthy volunteers, 26 males and 26 females, aged from 19 to 26 were enrolled in the study. Forty-two subjects were randomized into 5, 10, 20, 40, and 60 mg dose groups (6-10 subjects in each) matched by sex and weight for single-dose trial. Ten subjects were orally given 10 mg of ADV tablets once daily for 7 d for multiple-dose trial. Physical examination, vital signs examination, electrocardiography, type-B ultrasonography, chest fluoroscopy, routine blood test, routine urine test, coagulation tests, and blood biochemical test were conducted on schedule and statistically evaluated. Results Asthenia frequently occurred in multiple-dose trial, nausea, abdominal pain, and diarrhea occurred in both single- and multiple-dose trials. ALT, bilirubin, CK, and LDH were slightly elevated. All adverse reactions and laboratory abnormalities were mild, and the frequency and severity were not related to doses. Conclusion ADV is safe and well tolerated in Chinese healthy volunteers at dose of 5-60 mg once daily or 10 mg once daily for 7 d. The recommended oral dosage regimen is 10 mg once daily. Attention should be paid to renal and liver functions, CK, AMY and LDH, if we take ADV for a long period of time. |
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| Keywords: | adefovir dipivoxil safety tolerance phase I trial |
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