DAAs治疗丙型肝炎肝硬化患者疗效及安全性研究*

doi:10.3969/j.issn.1672-5069.2020.06.021

摘要/Abstract

摘要： 目的探讨应用直接抗病毒药物(DAAs)治疗慢性丙型肝炎肝硬化(CHC-C)患者的安全性和有效性。方法 2016年3月~2017年10月在我院接受DAAs治疗的CHC-C患者30例,感染HCV基因型均为1b型。将患者分为3组,每组10例。给予A组索非布韦联合利巴韦林,给予B组索非布韦联合雷迪帕韦和利巴韦林治疗,给予C组索非布韦联和达卡他韦合利巴韦林治疗,所有患者均治疗12周。采用荧光PCR法检测血清HCV RNA,使用日立008AS全自动生化分析仪检测血生化指标,采用基因芯片法或PCR探针法检测HCV基因分型。按照丙型肝炎防治指南的标准,比较各组快速病毒学应答(RVR)、早期病毒学应答(EVR) 、治疗结束时病毒学应答(ETVR)和持续病毒学应答(SVR)。结果 B组和C组RVR和ETVR均为100%,均显著高于A组的40%和50%,差异有统计学意义(P<0.05);在DAAs治疗结束时,A组、B组和C组血清ALT水平分别为(24.2±6.7)IU/L、(22.3±5.6)IU/L和(25.3±4.6)IU/L,血清AST水平分别为(23.2±8.1)IU/L、(24.6±3.8)IU/L和(28.4±4.8)IU/L,无显著性差异(P>0.05);三组血清白蛋白和肾功能指标变化无显著性差异(P>0.05);血清CK水平分别为(63.3±11.8)U/L、(68.5±8.9)U/L和(62.1±10.2) U/L,也无显著性差异(P>0.05);A组出现恶心7例、乏力1例、头痛1例、心悸1例,B组出现恶心4例、乏力3例、头痛1例、心悸1例、皮疹1例,C组出现恶心5例、乏力2例、头痛1例、心悸1例和皮疹1例。结论 DAAs治疗基因1b型HCV感染引发的CHC-C患者近期疗效较好,安全,值得进一步观察。

关键词: 肝硬化, 慢性丙型肝炎, 直接抗病毒药物, 疗效, 安全性

Abstract: Objective The aim of this study was to investigate the efficacy and safety of direct acting antiviral agents (DAAs) in the treatment of patients with chronic hepatitis C viral infection-induced liver cirrhosis (CHC-C). Methods 30 patients with CHC-C received DAAs treatment in our hospital between March 2016 and October 2017, and the genotype of hepatitis C virus was 1b type in all patients. The patients with CHC-C were divided into three groups, receiving sophibavi and ribavirin in group A, receiving sophibavi, repaavi plus ribavirin in group B, and took suopavir, daclatasvir and ribavirin in group C, with 10 cases in each group, and all patients were treated for 12 weeks. Serum HCV RNA loads were measured by reverse transcription polymerase chain reaction (RT-PCR), serum level of alanine aminotransferase (ALT), glutaminase (AST), total bilirubin (TBIL), blood urea nitrogen (BUN), serum creatinine (Cr), creatine kinase (CK) and creatine kinase isoenzyme (CK-MB) were measured. The extremely rapid virologic response(RVR), early virologic response(EVR) , end of treatment virologic response(ETVR) and sustained virologic response were compared among the groups. Results The RVR and ETVR in group B and in group C were 100%, all significantly higher than 40% and 50% in group A(P<0.05); at the end of 12 week DAAs treatment, serum ALT levels in group A, group B and group C were (24.2±6.7)IU/L, (22.3±5.6)IU/L and (25.3±4.6)IU/L, serum AST levels were (23.2±8.1)IU/L, (24.6±3.8)IU/L and (28.4±4.8)IU/L, not significantly different among them(P>0.05); serum albumin and renal function index in the three groups were not significantly different (P>0.05), serum creatine kinase levels in the three groups were (63.3±11.8)U/L, (68.5±8.9)U/L and (62.1±10.2) U/L, not significantly different (P>0.05); there were 7 patients reporting nausea, and fatigue in one, headache in one and palpitation in one in group A, nausea in four, fatigue in three, headache in one, palpitation in one and rash in one in group B, and nausea in five, fatigue in two, headache in one, palpitation in one and rash in one in group C. Conclusion DAAs is efficacious and safe in the treatment of patients with CHC-C with HCV genotype 1b infection.

Key words: Liver cirrhosis, Chronic hepatitis C, Direct antiviral drugs, Efficacy, Safety

刁青, 段银环, 苗亮, 王守云. DAAs治疗丙型肝炎肝硬化患者疗效及安全性研究^*[J]. 实用肝脏病杂志, 2020, 23(6): 841-844.

Diao Qing, Duan Yinhuan, Miao Liang, et al. Efficacy and safety of direct acting antiviral agents in the treatment of patients with hepatitis C cirrhosis[J]. Journal of Practical Hepatology, 2020, 23(6): 841-844.

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DAAs治疗丙型肝炎肝硬化患者疗效及安全性研究^*

Efficacy and safety of direct acting antiviral agents in the treatment of patients with hepatitis C cirrhosis

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