CAJ | 학술논문

目的：探讨阿德福韦酯致不良反应（ADR）发生的一般规律、特点及风险因素，为临床安全用药提供参考。方法对山东省 ADR 数据库中160例涉及阿德福韦酯的 ADR 报告进行回顾性分析，对不良反应表现的时间分布等进行了探讨，重点对骨骼系统损害和低磷血症的不良反应进行分析。结果阿德福韦酯的 ADR 主要累及胃肠系统损害、皮肤及其附件损害；严重 ADR 主要累及骨骼肌肉系统损害、泌尿系统损害，多于长时间用药后发生。胃肠系统损害、皮肤及其附件损害主要是用药半年内出现，肝肾功能异常、血磷降低可于用药半年以上出现，骨骼肌肉损害可于用药1年以上出现，骨软化症可于用药4年以上出现。结论阿德福韦酯的 ADR 的具有时间关联性，长期用药产生肾毒性而导致血磷降低和骨软化症，高龄和肝硬化患者可能更易发生严重 ADR，应加强用药期间的肝肾功能及血磷的定期监测，正确诊断，及时治疗。
목적：탐토아덕복위지치불량반응（ADR）발생적일반규률、특점급풍험인소，위림상안전용약제공삼고。방법대산동성 ADR 수거고중160례섭급아덕복위지적 ADR 보고진행회고성분석，대불량반응표현적시간분포등진행료탐토，중점대골격계통손해화저린혈증적불량반응진행분석。결과아덕복위지적 ADR 주요루급위장계통손해、피부급기부건손해；엄중 ADR 주요루급골격기육계통손해、비뇨계통손해，다우장시간용약후발생。위장계통손해、피부급기부건손해주요시용약반년내출현，간신공능이상、혈린강저가우용약반년이상출현，골격기육손해가우용약1년이상출현，골연화증가우용약4년이상출현。결론아덕복위지적 ADR 적구유시간관련성，장기용약산생신독성이도치혈린강저화골연화증，고령화간경화환자가능경역발생엄중 ADR，응가강용약기간적간신공능급혈린적정기감측，정학진단，급시치료。
Objective To probe into the general rules, characteristics and risk factors of the ADR induced by adefovir so as to provide references for clinical safe medication. Methods We retrospectively analyzed 160 ADR cases induced by adefovir which were collected by Shandong adverse drug reaction database, discussed the time distribution of the ADRs, and emphatically analyzed the ADRs of the skeletal muscle system lesions and hypophosphatemia. Results The ADRs induced by adefovir mainly involved in stomach intestinal system lesions and skin and local lesions. The serious ADRs by adefovir mainly involved in skeletal muscle system lesions and urinary system lesions, and usually appeared after a long-term administration. Stomach intestinal system lesions and skin and local lesions usually appeared within half a year, abnormal liver and renal function and hypophosphatemia usually appeared after half a year, skeletal muscle system lesions usually appeared after one year, osteomalacia usually appeared after four years. Conclusion The ADRs induced by adefovir were related to administration time, and would lead to nephrotoxicity, hypophosphatemic and osteomalacia after long-term administration of adefovir. The serious ADRs by adefovir were easy to appeare in the patients with liver cirrhosis or who were elderly. The regular monitoring of liver and renal function and serum phosphorus should be strengthened with correct diagnosis and timely treatment.