门诊乙肝患者长期使用阿德福韦酯疗效及安全性评价  

Evaluation of the Efficacy and Safety of Out-patients with Hepatitis B by Long-term Administration of Adefovir Dipivoxil

作　　者：曹恒斌[1] 钱佳平[1] 叶勇[1] 袁玉梅[1] 杨水新[1] 

机构地区：[1]湖州市中心医院,浙江湖州313000

出　　处：《药物流行病学杂志》2012年第3期109-113,共5页Chinese Journal of Pharmacoepidemiology

基　　金：默沙东临床药学科研专项(编号:2007ZYC46)

摘　　要：目的:评价门诊乙肝患者长期使用阿德福韦酯的有效性与安全性。方法:2005～2008年我院门诊慢性乙肝患者336例,接受阿德福韦酯10 mg·d^(-1)治疗,进行为期2年的跟踪随访,记录治疗0,3,6,12,18,24个月的血尿常规、血生化、血清HBV-DNA、乙型肝炎病毒血清标志物、肝、肾功能及腹部B超等各项检测指标及患者症状、体征变化及不良事件。结果:336例入选者中28例脱落,总脱落率为8.3%。治疗24个月后,患者肝功能相关指标异常率、HBV-DNA载量、甲胎蛋白及HBe血清学变化较治疗前有显著好转。对血常规、尿常规指标无明显影响,但肾功能指标中,血肌酐与用药时间有显著相关性,尿素氮与用药时间相关不显著,且与患者性别和年龄无关。不良反应与文献报道相一致,其中以胃肠道反应与脱发最为常见。结论:门诊乙肝患者长期使用阿德福韦酯10 mg·d^(-1)可以有效抑制病毒复制与促使ALT复常,且对肾功能影响较小,不良反应轻微,具有良好的耐受性与安全性。Objective：To evaluate the efficacy and safety of the long-term administration of adefovir by out-patients with hepatitis B.Methods：336 patients with chronic hepatitis B receiving adefovir dipivoxil at 10 mg · d^（-1） between 2005 to 2008 had been followed up for 2 years.Such examinations as urine routine,blood biochemistry,serum HBV-DNA, hepatitis B virus serum markers,function of liver and kidney,symptoms and adverse events were recorded.Results：28 of the 336 patients were selected off,and the loss rate was 8.3%.The abnormal rates of the examination of liver functions, HBV-DNA,α-fetoprotein（AFP） and HBe in serum were significantly improved except blood biochemistry and urine routine. However,the serum creatinine results had an obvious relationship with medication time but sex and age.Adverse events were consistent with previous reports,in which gastrointestinal reaction and hair loss were the most common.Conclusion： The long-term administration of adefovir at 10 mg · d ^（-1）in out-patients with chronic hepatitis B suppressed the replication of virus and effectively improved the recovery of ALT,but had some light adverse reactions in kidney,which suggests the efficacy,good tolerance and safety of the long-term administration of adefovir.

关 键 词：乙肝患者 门诊 阿德福韦酯 疗效 安全性 

分 类 号：R978.7[医药卫生—药品]