核苷类似物治疗早中期HBV-ACLF患者随机对照临床研究  

Lamivudine and entecavir significantly improved the prognosis of early-to-mid stage hepatitis B related acute on chronic liver failure

作　　者：胡瑾华[1] 王慧芬[1] 何卫平[1] 刘晓燕[1] 杜宁[1] 黄坤[1] 丁晋标[1] 段学章[1] 陈婧[1] 陈菊梅[1] 

机构地区：[1]解放军第三0二医院肝衰竭诊疗研究中心,北京100039

出　　处：《中华实验和临床病毒学杂志》2010年第3期205-208,共4页Chinese Journal of Experimental and Clinical Virology

基　　金：国家＂十一五＂科技重大专项课题项目（2008ZX10002005-6）;军队＂十一五＂中医药研发推广专项重大临床攻关课题（2006231001）;首都医学发展科研基金重点课题（20072026）

摘　　要：目的 研究核苷类似物抗病毒治疗慢加急性乙型肝炎肝衰竭（HBV-ACLF）早中期患者的疗效和安全性.方法 采用前瞻性随机开放平行对照临床实验设计,设基础治疗组、拉米夫定＋基础治疗组及恩替卡韦＋基础治疗组三组进行对照观察研究.结果 治疗1个月时三组生存率相近,但拉米夫定、恩替卡韦治疗组临床好转率显著高于基础治疗组;治疗随访6个月拉米夫定及恩替卡韦累积生存率分别为65.8%、60.1%,显著高于基础治疗组42%（P〈0.05）.治疗前HBV DNA〉107IU/L患者接受抗病毒治疗组累积生存率高于基础治疗组,治疗前MELD评分〉30患者累积生存率低于MELD评分≤30患者,但MELD评分〉30患者抗病毒治疗的疗效反应性更好.结论 核苷类似物恩替卡韦及拉米夫定治疗HBV-ACLF早中期患者可以显著提高治疗1个月的好转率,降低3个月、6个月的病死率,提高患者生存率.Objective To clinically study the antiviral effects of lamivudine and entecavir on patients with early-to-mid stage Hepatitis B related acute on chronic liver failure（HBV-ACLF）.Methods A prospective,randomized,open and parallel controlled clinical trial was designed to observe the antiviral effects of nucleoside analogues on patients with early-to-mid stage HBV-ACLF.Three groups were set for controlled study,i.e.basic treatment group,lamivudine plus basic treatment group and entecavir plus basic treatment group.Results One month after treatment,the improvement rates of lamivudine group and entecavir group were 58.85% and 59.15% respectively,significantly hisher than that of basic treatment group which was 34.84%（X2=9.8323,P=0.043）.By the end of six months,the cumulative survival rates of patients with the antiviral treatments,i.e.,lamivudine,entecavir,were 65.8%,60.1%,significantly higher than that（42%） without the antiviral treatment（P=0.045,P=0.04 respectively）.The cumulative survival rate in patients with a MELD score 〈30 was higher than that with a MELD score over 30（X2= 3.920 P=0.048）.For the patients with pretreatment HBV DNA≥107,the cumulative survival rate in patients with entecavir treatments group was higher than that of patients in basic treatment group（X2=5.014 P=0.025）.According to the Ordinal Regression analysis,antiviral therapy by using either lamivudine or entecavia could significantly increase the improvement rate of patients with early-to-mid stage HBV-ACLF. But severe complications, including hepatorenal syndrome, electrolyte imbalance and hepatic encephalopathy,medical history of liver cirrhosis,and pretreatment HBV DNA≥107 had significant impacts on prognosis of this group patients.Conclusions Antiviral therapy by using either lamivudine or entecavia could significantly increase the survival rate of patients with early-to-mid stage HBV-ACLF.

关 键 词：肝功能衰竭 肝炎 乙型 核苷类 抗病毒治疗 随机对照试验 

分 类 号：R512.62[医药卫生—内科学] R575.3[医药卫生—临床医学]