CAJ | 학술논문

目的评估恩替卡韦及阿德福韦酯片单药治疗慢性乙型肝炎相关性肝病患者240周的疗效. 方法 90例确诊为慢性乙型肝炎肝硬化(代偿期和失代偿期)患者,随机分成两组,分别接受恩替卡韦0.5 mg/d(38例)或阿德福韦酯片10 mg/d(52例),于治疗前及治疗24、48、96、144、192周和240周,检测HBV DNA、生物化学指标、腹部B型超声、乙型肝炎病毒血清学标志物,同时观察并发症及药物相关不良反应.治疗48周未获得完全病毒学应答或治疗期间出现病毒学突破的患者,均可改变原治疗方案加用一种更强且无交叉耐药的药物继续治疗并观察.两组间均数比较采用t检验,计数资料比较采用x2检验,多因素分析采用COX回归. 结果恩替卡韦组脱落1例,阿德福韦酯组脱落7例;治疗240周后,恩替卡韦组与阿德福韦酯组HBV DNA转阴率分别为91.9％和57.8％(x2=10.362,P=0.001);HBeAg转阴率分别为46.2％和24.0％ (x2=5.055,P=0.025);HBeAg血清转换率分别为23.1％和8.0％(P=0.047),差异均有统计学意义,两组进行符合方案集分析与意向性分析结论相一致.恩替卡韦组与阿德福韦酯组原发性肝癌发生率分别为8.1％和6.7％(x2=0.000,P=1.000),病死率分别为8.1％和4.4％(x2=0.051,P=0.821),差异均无统计学意义.进行COX回归分析,恩替卡韦组HBV DNA转阴的可能性为阿德福韦酯组的2.761倍(95％可信区间为1.630 ～ 4.679);男性HBeAg血清转换的可能性为女性的0.192倍(95％可信区间为0.046 ～0.806). 结论恩替卡韦在抗乙型肝炎病毒治疗过程中,具有高效、迅速抑制病毒的作用,是理想的一线抗病毒药物.
목적 평고은체잡위급아덕복위지편단약치료만성을형간염상관성간병환자240주적료효. 방법 90례학진위만성을형간염간경화(대상기화실대상기)환자,수궤분성량조,분별접수은체잡위0.5 mg/d(38례)혹아덕복위지편10 mg/d(52례),우치료전급치료24、48、96、144、192주화240주,검측HBV DNA、생물화학지표、복부B형초성、을형간염병독혈청학표지물,동시관찰병발증급약물상관불량반응.치료48주미획득완전병독학응답혹치료기간출현병독학돌파적환자,균가개변원치료방안가용일충경강차무교차내약적약물계속치료병관찰.량조간균수비교채용t검험,계수자료비교채용x2검험,다인소분석채용COX회귀. 결과 은체잡위조탈락1례,아덕복위지조탈락7례;치료240주후,은체잡위조여아덕복위지조HBV DNA전음솔분별위91.9％화57.8％(x2=10.362,P=0.001);HBeAg전음솔분별위46.2％화24.0％ (x2=5.055,P=0.025);HBeAg혈청전환솔분별위23.1％화8.0％(P=0.047),차이균유통계학의의,량조진행부합방안집분석여의향성분석결론상일치.은체잡위조여아덕복위지조원발성간암발생솔분별위8.1％화6.7％(x2=0.000,P=1.000),병사솔분별위8.1％화4.4％(x2=0.051,P=0.821),차이균무통계학의의.진행COX회귀분석,은체잡위조HBV DNA전음적가능성위아덕복위지조적2.761배(95％가신구간위1.630 ～ 4.679);남성HBeAg혈청전환적가능성위녀성적0.192배(95％가신구간위0.046 ～0.806). 결론 은체잡위재항을형간염병독치료과정중,구유고효、신속억제병독적작용,시이상적일선항병독약물.
Objective To compare the efficacies ofentecavir and adefovir in patients with chronic hepatitis B (CHB) and cirrhosis when administered as monotherapies using a 240-week course.Methods Ninety patients diagnosed with CHB and cirrhosis (compensated or decompensated) were randomly divided into two treatment groups for administration of either entecavir (0.5 mg/day, oral;n =38) or adefovir (10 mg/day, oral;n =52) for 240 weeks.All participants underwent B-ultrasound and were tested for levels of HBV-DNA, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, creatinine, alpha-fetoprotein (AFP) and various serological markers of the hepatitis B virus at baseline and at treatment weeks 24, 48, 96, 144, 192, and 240.Instances of drug-related complications and adverse reactions were recorded.Patients who did not achieve complete virological response by treatment week 48 or who experienced virological breakthrough at any time during the study course were recorded and started on an appropriate combination therapy regimen.Statistical analyses were carried out using the t-test, chi-square test, and Cox regression modeling.Results The dropout rate in the entecavir group was 2.6％ and in the adefovir group was 13.5％.At treatment week 240, significantly more patients in the entecavir group had undetectable serum HBV-DNA (91.9％ vs.adefovir group: 57.8％;x 2 =10.362, P =0.001), a negative conversion rate of hepatitis B e antigen (HBeAg) (46.2％ vs.adefovir group: 24％;x 2 =5.055,P =0.025), and rate of HBeAg seroconversion (23.1％ vs.adefovir group: 8％,P =0.047).The entecavir group and the adefovir group showed no significant differences upon per-protocol analysis and intention-to-treat analysis, nor in the rates of hepatocellular carcinoma development (entecavir group: 8.1％ vs.adefovir group: 6.7％;x2 =0.000, P =1.000)or mortality (entecavir group: 8.1％ vs.adefovir group: 4.4％;x 2 =0.051, P =0.821).The possibility of achieving undetectable serum HBV-DNA was 2.761 times higher in the entecavir group than in the adefovir group (95.0％ CI: 1.630 ～ 4.679).The possibility of HBeAg seroconversion was 0.192 times higher for males than for females (95.0％ CI: 0.046 ～ 0.806).Conclusion Compared to adefovir, entecavir provides high efficiency and rapid viral suppression as a monotherapy for CHB patients when administered in a 240-week course.