CAJ | 학술논문

目的观察核苷类药物对乙型肝炎肝硬化患者的抗病毒疗效及安全性.方法采用队列研究,将143例乙型肝炎肝硬化患者分为治疗组73例和对照组70例,两组患者的基线情况相当.治疗组在常规治疗的基础上加用核苷类药物抗病毒治疗48周,其中恩替卡韦30例、阿德福韦酯25例、拉米夫定16例、替比夫定2例;对照组给予常规治疗.两组间率的比较采用χ~2检验或Fisher确切概率法检验,均数比较采用t检验.结果治疗48周后,治疗组与对照组相比,AST、ALT,TBil明显下降,Alb及胆碱酯酶明显上升,差异有统计学意义(t=4.020、2.410、2.067、-5.369、-3.713,均P<0.05).治疗组HBV DNA转阴率为93.2%,高于对照组的2.9%,差异有统计学意义(t=116.6,P=0.001).治疗组及对照组的HBeAg转阴率分别为65.4%及19.0%,差异有统计学意义(t=10.091,P=0.001).治疗组腹膜炎发生率低于对照组(1.37%比11.43%,P=0.016).治疗组无肝细胞癌发生,对照组有4例,差异无统计学意义(P=0.055).治疗组消化道出血5例,占6.85%,对照组8例,占11.43%,差异无统计学意义(χ~2=0.907,P=0.341).治疗组中1例采用拉米夫定治疗的患者在42周出现病毒学反弹.HBeAg由阴性转为阳性,肝功能恶化死亡,对照组2例死亡,两组病死率比较差异无统计学意义(P=0.614).结论核苷类药物能改善乙型肝炎肝硬化患者的肝功能,降低HBV复制,提高HBeAg转阴率.治疗过程中须密切观察病毒变异耐药情况,防止肝功能恶化.
목적 관찰핵감류약물대을형간염간경화환자적항병독료효급안전성.방법 채용대렬연구,장143례을형간염간경화환자분위치료조73례화대조조70례,량조환자적기선정황상당.치료조재상규치료적기출상가용핵감류약물항병독치료48주,기중은체잡위30례、아덕복위지25례、랍미부정16례、체비부정2례;대조조급여상규치료.량조간솔적비교채용χ~2검험혹Fisher학절개솔법검험,균수비교채용t검험.결과 치료48주후,치료조여대조조상비,AST、ALT,TBil명현하강,Alb급담감지매명현상승,차이유통계학의의(t=4.020、2.410、2.067、-5.369、-3.713,균P<0.05).치료조HBV DNA전음솔위93.2%,고우대조조적2.9%,차이유통계학의의(t=116.6,P=0.001).치료조급대조조적HBeAg전음솔분별위65.4%급19.0%,차이유통계학의의(t=10.091,P=0.001).치료조복막염발생솔저우대조조(1.37%비11.43%,P=0.016).치료조무간세포암발생,대조조유4례,차이무통계학의의(P=0.055).치료조소화도출혈5례,점6.85%,대조조8례,점11.43%,차이무통계학의의(χ~2=0.907,P=0.341).치료조중1례채용랍미부정치료적환자재42주출현병독학반탄.HBeAg유음성전위양성,간공능악화사망,대조조2례사망,량조병사솔비교차이무통계학의의(P=0.614).결론 핵감류약물능개선을형간염간경화환자적간공능,강저HBV복제,제고HBeAg전음솔.치료과정중수밀절관찰병독변이내약정황,방지간공능악화.
Objective To evaluate the efficacy and safety of nucleoside(s) analogues in patients with hepatitis B virus (HBV) related cirrhosis. Methods In this cohort study, 143 patients with HBV related cirrhosis were divided into treatment group (73 cases) and control group (70 cases). Age, gender, liver function and Child-Pugh score in two groups were comparable. In treatment group, patients were treated with nucleoside(s) analog for 48 weeks on the basis of conventional therapy, including 30 cases treated with entecavir, 25 with adefovir dipivoxil, 16 with lamivudine and 2 with telbivudine. Patients in control group were treated with conventional therapy only. Comparison of rates between two groups were done by X test or Fisher's exact test, and means were compared by t test. Results At week 48 of treatment, levels of aspartate transaminase (AST), alanine amiotransferase (ALT) and total bilirubin (TBil) in treatment group decreased more significantly than those in control group (t = 4. 020, P = 0.001; t = 2. 410, P = 0. 018( t= 2. 067, P = 0.042, respectively); levels of albumin (Alb) and cholinesterase (CHE) in treatment group increased more significantly than those in control group (t =-5.369. P = 0. 001; t =-3.713, P = 0.006, respectively). At week 48, the negative rate of HBV DNA in treatment group was 93. 2% , which was significantly higher than that in control group (2.9%, t = 116. 6,P = 0. 001). The negative rate of hepatitis B e antigen ( HBeAg) in treatment group was 65.4%, which was higher than that in control group (19. 0%, t=10. 091, P = 0. 001). The incidence of spontaneous peritonitis in treatment group was lower than that in control group (1. 37% vs 11. 43%, P = 0. 016). No patient developed hepatocellular carcinoma (HCC) in treatment group while 4 out of 70 patients developed HCC in control group (P = 0. 055). Five patients (6. 85%) in treatment group and 8 (11. 43%) in control group developed gastrointestinal hemorrhage, which were not significantly different (χ~2 = 0. 907,P = 0.341). One patient treated with lamivudine in treatment group developed viral breakthrough and HBeAg turned positive from negative at week 42 and died from liver function deterioration, and 2 died in control group. The mortalities between two groups were not significantly different (P = 0. 614). Conclusions The nucleoside(s) analogues treatment could improve liver function, inhibit HBV replication and increase HBeAg clearance rate in patients with HBV related cirrhosis. During the treatment, viral mutation and drug resistance must be carefully monitored to prevent the acute exacerbation of liver function.