直接抗病毒药物治疗丙型肝炎肝硬化患者的疗效观察  

Clinical efficacy of direct-acting antiviral agents in patients with HCV-related liver cirrhosis

作　　者：程丹颖[1] 刘晓民[1] 欧蔚妮[1] 庄立伟[1] 邢卉春[1] 成军[1] 

机构地区：[1]首都医科大学附属北京地坛医院肝病中心,北京100015

出　　处：《中华实验和临床感染病杂志（电子版）》2017年第6期545-549,共5页Chinese Journal of Experimental and Clinical Infectious Diseases(Electronic Edition)

基　　金：吴阶平医学基金会肝病医学部肝硬化门脉高压并发症科研项目(No.LDWJPMF-MMGY-2016002);北京市中医药科技项目(No.JJ2014-25);北京市医管局项目(No.DFL2015170;No.ZYLX201402)

摘　　要：目的观察直接作用抗病毒药物(DAAs)治疗丙型肝炎肝硬化患者的疗效和安全性。方法回顾性分析2015年1月至2016年1月于本院就诊并使用DAAs抗病毒治疗的丙型肝炎肝硬化患者的临床特点及治疗方案,观察治疗过程中丙型肝炎病毒(HCV)RNA、肝功能、安全性指标及不良反应。结果 24例患者中,男性10例,女性14例,年龄43~77岁,平均年龄为(56.38±8.99)岁,代偿期、失代偿期肝硬化各12例,干扰素经治患者(停药复发/干扰素不耐受)18例。HCV RNA基因分型1b型20例,2a型2例,3b型2例,HCV RNA载量为1.63×103~2.72×107 IU/ml。治疗方案为索非布韦(SOF)+达卡他韦(DCV)+利巴韦林(RBV)患者4例、SOF+DCV治疗患者6例、SOF+雷迪帕韦(LDV)+RBV治疗患者5例、SOF+LDV治疗患者7例、SOF+RBV治疗患者2例。除1例失代偿期丙型肝炎肝硬化患者在治疗过程中因消化道出血死亡外,其余23例患者均完成了治疗,并且均已停药随访24周以上,所有患者均获得快速病毒学应答(RVR)、治疗结束时病毒学应答(ETVR),22例(95.65%)患者获得持续病毒学应答(SVR)。抗病毒治疗后肝功能改善,丙氨酸氨基转移酶(ALT)下降(t=4.90,P<0.001),天门冬氨酸氨基转移酶(AST)下降(t=4.24,P<0.001),胆碱酯酶(CHE)升高(t=2.30,P=0.03),甲胎蛋白(AFP)下降(Z=2.43,P=0.02),Child-Pugh评分下降(Z=2.06,P=0.04);肾功能无减退。不良反应主要表现为乏力者5例、头晕者2例、头痛者1例、发热者1例、腹泻者1例、皮疹者2例,以上不适症状均为一过性,自行缓解,不影响治疗。结论 DAAs治疗我国丙型肝炎肝硬化患者疗效和安全性良好;对失代偿期肝硬化的远期疗效待观察。Objective To investigate the clinical efficacy and safety of direct-acting antiviral agents （DAAs） in patients with hepatitis C virus （HCV）-related liver cirrhosis. Methods The clinical characteristics and treatment protocols of patients with HCV-related liver cirrhosis in our hospital from January 2015 to January 2016 were analyzed by descriptive method. HCV RNA, liver function, safety and adverse reactions were observed during treatment, respectively. Results Total of 24 cases including l0 male and 14 female were collected. The patients were aged 43-77 years old, and the mean age was （56.38 - 8.99） years old. There were 12 cases with compensated and decompensated cirrhosis, respectively. There were 18 patients with interferon via treated （recurrence of drug withdrawal or could not tolerate）. There were 20 cases with genotype lb, 2 cases with genotype 2a and 2 cases with genotype 3b. HCV RNA ranged from 1.63×10^3 to 2.72 × 10^7IU/ml. All patients were treated with DAAs, among whom 4 were treated with sofosbuvir （SOF） ＋ daclatasvir （DCV） ＋ ribavirin （RBV）, 6 patients treated with SOF ＋ DCV, 5 patients treated with SOF ＋ ledipasvir （LDV） ＋ RBV, 7 patients treated with SOF ＋ LDV, and 2 patients treated with SOF ＋ RBV. There were 23 patients who completed the treatment and followed for 24 weeks after drug withdrawal while one patient was died of gastrointestinal bleeding during the treatment. All patients achieved rapid virological response （RVR） and end treatment virological response （ETVR）. There were 22 （95.65%） patients achieved sustained virologic response （SVR）. Liver function were improved after treatment with decreased alanine aminotransferase （ALT） （t = 4.90, P 〈 0.001） and aspartate amino transferase （AST） （t = 4.24, P 〈 0.001）. While cholinesterase （CHE） was increased （t = 2.30, P = 0.03）, alphafetoprotein （AFP） （Z = 2.43, P = 0.02） and Child-Pugh score （Z = 2.06, P = 0.04） were decreased, with signific

关 键 词：肝炎 丙型 肝硬化 直接抗病毒药物 疗效 安全性 

分 类 号：R512.63[医药卫生—内科学]