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直接作用抗病毒药物治疗慢性HCV感染者的初步临床分析
作者:程丹颖  刘晓民  欧蔚妮  王笑梅  成军  邢卉春 
单位:首都医科大学附属北京地坛医院 肝病中心 新发突发传染病研究北京市重点实验室 北京 100015 
关键词:肝炎 丙型 慢性 肝硬化 直接抗病毒药物 疗效 安全性 
分类号:
出版年,卷(期):页码:2018,10(1):40-44
摘要:

摘要:目的 观察直接作用抗病毒药物(direct-acting antiviral agents,DAAs)治疗我国慢性丙型肝炎
病毒(hepatitis C virus,HCV)感染者的疗效和安全性。方法 回顾性分析2015年1月至2016年1月于首
都医科大学附属北京地坛医院就诊并使用DAAs抗病毒治疗的慢性丙型肝炎和丙型肝炎肝硬化患者的
临床特点及治疗方案,观察治疗过程中患者HCV RNA载量、肝功能、生物化学指标及不良反应。结
果 共纳入64例患者,平均年龄(51.91 ± 11.32)岁,HCV RNA载量为1.63 × 10 3 ~2.72 × 10 7 IU/ml。
其中慢性丙型肝炎患者41例,丙型肝炎肝硬化患者23例(失代偿期肝硬化11例);初治患者28例,
干扰素经治患者36例;HCV RNA基因分型1b型46例,2a型14例,3a型2例,3b型2例。治疗方案为
sofosbuvir + daclatasvir +利巴韦林(ribavirin,RBV)17例、sofosbuvir + daclatasvir 10例、sofosbuvir +
ledipasvir + RBV 15例、sofosbuvir + ledipasvir 11例、sofosbuvir + RBV 9例、sofosbuvir +聚乙二醇化
干扰素(pegylated interferons,PegIFN)+ RBV 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63例患者均完成了治疗并已停药随访24周以上,所有患者均获得快速
病毒学应答(rapid virological response,RVR)和治疗结束时病毒学应答(end of treatment virological
response,ETVR),62例患者获得持续病毒学应答(sustained virologic response,SVR)。抗病毒
治疗后ALT、AST和甲胎蛋白(alpha fetoprotein,AFP)水平显著下降(z = -6.10,P < 0.001;z =
-6.15,P < 0.001;z = -3.18,P = 0.001),白蛋白(albumin,ALB)和胆碱酯酶(cholinesterase,
CHE)水平显著升高(t = -2.75,P = 0.008;t = -3.20,P = 0.002),肾功能无减退。不良反应轻,均
可自行缓解,不影响治疗。结论 DAAs治疗我国慢性丙型肝炎及丙型肝炎肝硬化患者疗效肯定,安全
性好,对失代偿期丙型肝炎肝硬化患者的远期疗效有待进一步观察。

Abstract: Objective To investigate the clinical efficacy and safety of direct-acting antiviral agents (DAAs)
in patients with chronic hepatitis C virus (HCV) infection in China. Methods The clinical characteristics
and treatment protocols of patients with chronic hepatitis C and HCV-related liver cirrhosis in Beijing Ditan
Hospital, Capital Medical University from January 2015 to January 2016 were analyzed by descriptive method.
HCV RNA, liver function, safety and adverse reactions were observed during the treatment. Results Total of
64 cases were enrolled in this study. The average age was (51.91 ± 11.32) years. Total of 41 patients were with
chronic hepatitis C and 23 patients were with HCV-related liver cirrhosis (11 cases were with decompensated
cirrhosis). Total of 28 patients were initially treated while 36 patients were treated with interferon previously.
HCV RNA load ranged from 1.63 × 10 3 IU/ml to 2.72 × 10 7 IU/ml. Total of 46 cases were genotype 1b, 14 cases
were genotype 2a, 2 cases were genotype 3a and 2 cases were genotype 3b. All patients were treated with DAAs,

of whom 17 cases were treated with sofosbuvir + daclatasvir + ribavirin (RBV), 10 cases were treated with
sofosbuvir + daclatasvir, 15 cases were treated with sofosbuvir + ledipasvir + RBV, 11 cases were treated with
sofosbuvir + ledipasvir, 9 cases were treated with sofosbuvir + RBV and 2 cases were treated with sofosbuvir +
pegylated interferon (PegIFN) + RBV. Total of 63 patients completed the treatment and followed for 24 weeks
after drug withdrawal while one case was died of gastrointestinal bleeding during the treatment. All patients
achieved rapid virological response (RVR) and end treatment virological response (ETVR), and 62 patients
achieved sustained virologic response (SVR). Aftrer treatment, the levels of ALT, AST and alphafetoprotein (AFP)
decreased significantly (z = -6.10, P < 0.001; z = -6.15, P < 0.001; z = -3.18, P = 0.001) while albumin (ALB)
and cholinesterase (CHE) increased significantly (t = -2.75, P = 0.008; t = -3.20, P = 0.002). No obvious change
of renal function was found. Only slight adverse reactions were observed during treatment. These discomforts
were transient and alleviate by themselves, which did not affect the treatment. Conclusions DAAs are effective
and safe in treatment of patients with chronic hepatitis C and HCV-related liver cirrhosis in China. For
decompensated HCV-related liver cirrhosis patients, the long-term therapeutic efficacy needs furtherly evaluated.

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