CAJ | 학술논문

目的比较恩替卡韦(ETV)与拉米夫定(LAM)治疗HBeAg阴性乙型肝炎相关慢加急性肝衰竭(HBV-ACLF) 12周的疗效及安全性.方法 98例HBV DNA阳性且无核苷类似物抗病毒治疗史的HBeAg阴性HBV-ACLF随机分为ETV组、LAM组各49例,在内科综合治疗基础上分别予ETV(0.5 mgqd)或LAM (0.1,qd)抗病毒.比较12周时组间死亡率、临床好转率、完全病毒学应答率和不良事件的差异.结果 ①ETV组、LAM组的基线特征相似.②12周时ETV组死亡率低于LAM组(28.6％ vs 48.9％,P＜0.05);临床好转率呈高于LAM组趋势(65.3％ vs 48.3％,P=0.067),且主要来自基线终末期肝病模型(MELD)评分≤30患者(75.6％vs52.5％,P＜0.05);完全病毒学应答率高于LAM组(94.3％vs 72％,P＜0.05).③ETV组、LAM组间均无患者因药物不良事件而终止治疗.结论 ETV治疗HBeAg阴性HBV-ACLF能较LAM更强地抑制HBV复制,降低短期病死率,且安全性相当.
목적 비교은체잡위(ETV)여랍미부정(LAM)치료HBeAg음성을형간염상관만가급성간쇠갈(HBV-ACLF) 12주적료효급안전성.방법 98례HBV DNA양성차무핵감유사물항병독치료사적HBeAg음성HBV-ACLF수궤분위ETV조、LAM조각49례,재내과종합치료기출상분별여ETV(0.5 mgqd)혹LAM (0.1,qd)항병독.비교12주시조간사망솔、림상호전솔、완전병독학응답솔화불량사건적차이.결과 ①ETV조、LAM조적기선특정상사.②12주시ETV조사망솔저우LAM조(28.6％ vs 48.9％,P＜0.05);림상호전솔정고우LAM조추세(65.3％ vs 48.3％,P=0.067),차주요래자기선종말기간병모형(MELD)평분≤30환자(75.6％vs52.5％,P＜0.05);완전병독학응답솔고우LAM조(94.3％vs 72％,P＜0.05).③ETV조、LAM조간균무환자인약물불량사건이종지치료.결론 ETV치료HBeAg음성HBV-ACLF능교LAM경강지억제HBV복제,강저단기병사솔,차안전성상당.
Objective To compare the efficacy and safety of 12 weeks-entecavir (ETV) treatment in HBeAg-negative chronic hepatitis B patients with acute-on-chronic liver failure (HBV-ACLF) in comparison to lamivudine (LAM).Methods Ninety eight HBeAg-negative patients with HBV-ACLF who were nucleos(t) ide analogs treatment naive as well as with detectable serum HBV DNA were randomly divided into ETV group and LAM group,and each have 49 patients.Additional to the comprehensively basic internal medicine treatment,antiviral therapy with ETV (0.5 mg,qd) or LAM (0.1,qd) was performed,respectively.The differences of mortality rates,clinical improvement rates,complete virological response (CVR) rates and,adverse events between ETV group and LAM group were compared after 12 weeks of treatment.Results The baseline characteristics of patients in ETV group were comparable to those in LAM group.At week 12,a lower mortality rate of 28.6％ than that of LAM group (48.9％) was observed in ETV group (P ＜ 0.05).In terms of clinical improvement rate,ETV group indicated a higher tendency in total (65.3％ vs 48.3％,P =0.067) and a statistically significant value in subpopulation of model for end-stage liver disease scored no more than 30 than LAM group (75.6％ vs 52.5％,P ＜ 0.05).As expected,ETV group achieved a higher CVR rate than LAM group at week 12 (94.3％ vs 72％,P ＜0.05).Discontinuation of antiviral therapy occurred to none of the patients in both groups.Conclusions Comparing with LAM,ETV can safely inhibit HBV replication more intensively and reduce the 12 weeks mortality rate in HBeAg-negative patients with HBV-ACLF.