CAJ | 학술논문

目的观察替诺福韦酯(TDF)对拉米夫定(LAM)初治失败后,LAM联合阿德福韦酯(ADV)方案病毒学应答不佳的慢性乙型肝炎患者的疗效,同时与治疗队列中恩替卡韦(ETV)单药挽救治疗的疗效进行比较.方法对LAM初治失败后应用LAM联合ADV方案病毒学应答不佳的57例患者给予单药TDF 300 mg/d,在12周、24周和48周检测HBV DNA、肝肾功能、HBV标志物等指标.与慢性乙型肝炎患者治疗队列中ETV 1 mg/d(40例)挽救治疗组疗效进行比较.结果两组患者采用挽救治疗之前的基线情况差异无统计学意义.挽救治疗24周时,ETV组仅有1例(2.5％)达到HBV DNA转阴,TDF组则有49例(86.0％)达到HBV DNA转阴,x2=22.26,P＜0.001.治疗48周时,ETV组5例(12.5％)HBV DNA转阴,31例(77.5％) ALT复常,而TDF组50例(87.7％)患者HBV DNA转阴,48例(84.2％)达到ALT复常.HBV DNA转阴率TDF组明显高于ETV组(x2=24.17,P＜0.001).ALT复常率比较两组差异无统计学意义(x2=0.702,P=0.431).ETV组和TDF组在48周时各有1例患者发生血清HBeAg阴转(2.5％比1.8％,P=0.964).结论对于LAM治疗失败后LAM联合ADV方案病毒学应答不佳的慢性乙型肝炎患者,采用TDF 300 mg/d的挽救方案较ETV 1 mg/d方案更为有效,可以实现更好的病毒学应答.
목적 관찰체낙복위지(TDF)대랍미부정(LAM)초치실패후,LAM연합아덕복위지(ADV)방안병독학응답불가적만성을형간염환자적료효,동시여치료대렬중은체잡위(ETV)단약만구치료적료효진행비교.방법 대LAM초치실패후응용LAM연합ADV방안병독학응답불가적57례환자급여단약TDF 300 mg/d,재12주、24주화48주검측HBV DNA、간신공능、HBV표지물등지표.여만성을형간염환자치료대렬중ETV 1 mg/d(40례)만구치료조료효진행비교.결과 량조환자채용만구치료지전적기선정황차이무통계학의의.만구치료24주시,ETV조부유1례(2.5％)체도HBV DNA전음,TDF조칙유49례(86.0％)체도HBV DNA전음,x2=22.26,P＜0.001.치료48주시,ETV조5례(12.5％)HBV DNA전음,31례(77.5％) ALT복상,이TDF조50례(87.7％)환자HBV DNA전음,48례(84.2％)체도ALT복상.HBV DNA전음솔TDF조명현고우ETV조(x2=24.17,P＜0.001).ALT복상솔비교량조차이무통계학의의(x2=0.702,P=0.431).ETV조화TDF조재48주시각유1례환자발생혈청HBeAg음전(2.5％비1.8％,P=0.964).결론 대우LAM치료실패후LAM연합ADV방안병독학응답불가적만성을형간염환자,채용TDF 300 mg/d적만구방안교ETV 1 mg/d방안경위유효,가이실현경호적병독학응답.
Objective To evaluate the efficacy of tenofovir (TDF) 300 mg/d,comparing with entecavir (ETV),in adults with chronic HBV infection who had previously virologic failure with lamivudine (LAM) and failed with rescue treatment of LAM combined adefovir (ADV).Methods Fifty-seven patients of chronic hepatitis B on rescue treatment with TDF were analyzed retrospectively.The serum HBV DNA levels,HBeAg,ALT and serum creatinine (Cr) were detected after treatment for 12,24 and 48 weeks respectively.In addition,data of 40 cases treated with ETV 1 mg per day as a control group were also collected.Results The baseline characteristics including HBV viral loads,median age,serum levels of ALT and Cr were compatible between TDF group and ETV group.At the time point of 24 weeks,there was only one patient (2.5％) in ETV group with HBV DNA ＜ 100 IU/ml,which means negative viral replication,while 49 patients in TDF group reached HBV negativity (86.0％ vs 2.5％,x2 =22.26,P ＜0.001).At the time point of 48 weeks,the proportion of patients with HBV DNA ＜ 100 IU/ml in TDF group was significantly higher than that in ETV group (87.7％ vs 12.5％,x2 =24.17,P ＜0.001).The ratios of ALT normalization (84.2％ vs 77.5％,P =0.431) and HBeAg seroconversion were similar in both groups.Elevated Cr was not found in both cohorts at the end of treatment.Conclusions Tenofovir (300 mg/d) is an effective and safe rescue therapy in chronic hepatitis B patients who failed initial treatment with LAM and secondary treatment of LAM plus ADV.