CAJ | 학술논문

目的比较采用替比夫定(LdT)单药及其联合阿德福韦酯(ADV)治疗HBeAg阳性,高病毒载量的慢性乙型肝炎初治患者的疗效与安全性,分析服药依从性与治疗结局的关系. 方法选择HBeAg阳性、HBV DNA≥107拷贝/ml的慢性乙型肝炎初治患者123例进行回顾性研究.联合组53例采用LdT 600 mg/d联合ADV 10 mg/d治疗,70例单药组采用LdT 600 mg/d治疗.观察两组在治疗第12、24、48周时的HBV DNA阴转率、丙氨酸转氨酶(ALT)的复常率、血清HBeAg转换率、耐药和不良反应发生率,同时对患者进行依从性调查,分析与病毒耐药的相关性.符合正态分布的资料采用t检验;计量资料采用x2检验或Fisher精确检验.结果联合组在治疗第12、24、48周时血清HBV DNA低于检测下限者分别为62.3％ (33/53)、88.7％ (47/53)、94.3％ (50/53),其中治疗第12周和第24周与单药组相比较,差异有统计学意义(p＜ 0.05);两组ALT复常率在治疗第12周时分别为94.3％和77.1％,差异有统计学意义(p＜ 0.05);联合组HBeAg血清转换率在第48周时为39.6％,与单药组相比较,差异有统计学意义(P＜0.05).联合治疗组与单药治疗组在48周时的总耐药率分别为3.8％和11.4％,其中依从性差的比例占53.3％(8/15),依从性与治疗结局有关(P＜0.05).治疗过程中两组均未观察到明显不良反应.结论对HBeAg阳性且病毒载量高的慢性乙型肝炎患者,起始启动LdT联合ADV治疗比LdT单药起效更快,且耐药率更低.患者的依从性是影响治疗结局的关键因素.
목적 비교채용체비부정(LdT)단약급기연합아덕복위지(ADV)치료HBeAg양성,고병독재량적만성을형간염초치환자적료효여안전성,분석복약의종성여치료결국적관계. 방법 선택HBeAg양성、HBV DNA≥107고패/ml적만성을형간염초치환자123례진행회고성연구.연합조53례채용LdT 600 mg/d연합ADV 10 mg/d치료,70례단약조채용LdT 600 mg/d치료.관찰량조재치료제12、24、48주시적HBV DNA음전솔、병안산전안매(ALT)적복상솔、혈청HBeAg전환솔、내약화불량반응발생솔,동시대환자진행의종성조사,분석여병독내약적상관성.부합정태분포적자료채용t검험;계량자료채용x2검험혹Fisher정학검험.결과 연합조재치료제12、24、48주시혈청HBV DNA저우검측하한자분별위62.3％ (33/53)、88.7％ (47/53)、94.3％ (50/53),기중치료제12주화제24주여단약조상비교,차이유통계학의의(p＜ 0.05);량조ALT복상솔재치료제12주시분별위94.3％화77.1％,차이유통계학의의(p＜ 0.05);연합조HBeAg혈청전환솔재제48주시위39.6％,여단약조상비교,차이유통계학의의(P＜0.05).연합치료조여단약치료조재48주시적총내약솔분별위3.8％화11.4％,기중의종성차적비례점53.3％(8/15),의종성여치료결국유관(P＜0.05).치료과정중량조균미관찰도명현불량반응.결론 대HBeAg양성차병독재량고적만성을형간염환자,기시계동LdT연합ADV치료비LdT단약기효경쾌,차내약솔경저.환자적의종성시영향치료결국적관건인소.
Objective To compare the efficacy of telbivudine monotherapy and telbivudine combination therapy with adefovir in patients with nucleos(t)ide-naive chronic hepatitis B,high-level hepatitis B virus (HBV) load and hepatitis B e antigen (HBeAg)-positivity,and to explore the relationship between treatment regimen adherence and treatment outcomes.Methods A retrospective study was performed with 123 HBeAg-positive,high-level viral load (HBV DNA ≥ 107copies/ml),nucleos(t)ide-naive chronic hepatitis B patients.Fifty-three of the patients received combination therapy with telbivudine and adefovir dipivoxil,while 70 patients received the telbivudine monotherapy.All patients were tested for rates of conversion to HBV DNA-negative status,alanine aminotransferase (ALT) normalization,HBeAg seroconversion,drug resistance,and side effects at treatment weeks 12,24,and 48.Treatment regimen adherence was assessed through self-reporting,and interviews were used to explore the relationships to treatment outcomes.The chisquare test,t test and Fisher's exact test were used for statistical analyses.Results The rates of HBV DNA negative conversion in the combination group at treatment weeks 12,24 and 48 were 62.3％ (33/53),88.7％ (47/53) and 94.3％ (50/53) and were significantly different from those in the monotherapy group at weeks 12 and 24.The rates of ALT normalization were significantly different between the two groups at treatment week 12 (94.3％ vs.77.1％).The rate of HBeAg seroconversion in the combination group at treatment week 48 was 39.6％,and significantly different than that of the monotherapy group.The rates of drug-resistance in the combination and monotherapy groups at treatment week 48 were 3.8％ and 11.4％,and the proportion of non-adherence to the treatment regimen was 53.3％,which significantly affected treatment outcome.No side effects occurred in either treatment group.Conclusion Telbivudine combination treatment with adefovir was more effective than telbivudine monotherapy and elicited a low drug resistance rate in nucleos(t)idenaive chronic hepatitis B patients with high-level HBV load and HBeAg-positivity.Adherence to the therapy regimen was a key factor influencing treatment outcomes.