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项波,周毅骏,金巧菲,刘惠敏.索磷布韦/维帕他韦治疗慢性丙型肝炎患者的疗效及安全性分析[J].浙江中西医结合杂志,2021,31(9):
索磷布韦/维帕他韦治疗慢性丙型肝炎患者的疗效及安全性分析
Analysis of the therapeutic effect and safety of Sofosbuvir / velpatasvir (SOF/VEL) towards chronic hepatitis C (CHC) patients Xiang Bo1, Zhou Yijun1, Jin Qiaofei1, Liu Huimin1. 1 Department of hepatology, Hangzhou Xixi Hospital, Zhejiang province, 310023, China.
投稿时间:2021-03-20  修订日期:2021-07-28
DOI:
中文关键词:  肝炎, 丙型, 慢性  索磷布韦  维帕他韦  治疗结果  安全性
英文关键词:Hepatitis C  Sofosbuvir  velpatasvir  therapeutic effect  safty
基金项目:
作者单位E-mail
项波 杭州市西溪医院 xb791126@tom.com 
周毅骏* 杭州市西溪医院 348611334@qq.com 
金巧菲 杭州市西溪医院  
刘惠敏 杭州市西溪医院  
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中文摘要:
      目的 探讨索磷布韦/维帕他韦治疗慢性丙型肝炎患者的疗效及安全性。方法 回顾性分析2019年1月1日至2019年12月31日在浙江省杭州市西溪医院肝病中心门诊及住院使用索磷布韦/维帕他韦治疗12周的慢性丙型肝炎患者23例,最终纳入研究22例。分别于治疗第4、12周及治疗结束后12周进行随访HCV RNA水平,评估病毒学应答情况;监测治疗前后生化学、血常规、天门冬氨酸氨基转移酶/血小板比值指数(APRI)、基于4因子的纤维化指数水平(FIB-4)的变化,评估安全性;统计治疗中常见的不良反应。结果 基因型(genotype,GT)-1、2、6型患者,无论初治或经治,无肝硬化或代偿期肝硬化,持续病毒学应答(sustained virologic response,SVR)12率均为100%(22/22);GT-3型有1例GT-3b型代偿期肝硬化的患者治疗失败,该型SVR12率为85.7%(6/7);总体SVR12率为95.5%(21/22)。与治疗前相比,治疗结束后12周时血清总胆红素、丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、白细胞、APRI较前显著好转(P<0.05);索磷布韦/维帕他韦安全性良好,最常见的不良反应为乏力(22.7%,5/22)、反复上呼吸道感染(9.1%,2/22)。结论 索磷布韦/维帕他韦治疗GT-1、2、3、6型、经治或初治、合并代偿期肝硬化或无肝硬化的慢性丙型肝炎(chronic hepatitis C,CHC)患者疗效确切,总体安全性良好,是值得临床推荐的优选抗病毒方案。
英文摘要:
      Objective To discuss the therapeutic effect and safety of Sofosbuvir / velpatasvir (SOF/VEL) towards genotype 1-6 chronic hepatitis C (CHC) patients. Methods 23 cases CHC patients, who received 12 weeks of SOF/VEL therapy in Hangzhou Xixi Hepatology center from January 1st 2019 to December 31th 2019, was retrospectively analyzed, and 22 cases were finally enrolled. Virologic response was evaluated in week 4, week12 and week 12 after therapy by testing HCV RNA level. Safety of SOF/VEL was evaluated by changes of biochemical test, blood routine test, APRI index and FIB-4 index. Any adverse events were collected. Results The sustained virologic response (SVR) 12 rate of GT-1, 2, 6 patients were 100%, regardless of treatment na?ve or experienced, non-cirrhotic or compensated cirrhotic. 1 case of GT-3b with compensated cirrhosis was failed, thus the SVR12 rate of GT-3 was 85.7%. Total SVR12 rate of our research was 95.5%. Compared with prior treatment, total bilirubin, ALT, AST, WBC, APRI index was significantly improved (P<0.05). The safety of SOF/VEL therapy is satisfied. The most frequent adverse events were fatigue (22.7%) and upper respiratory infection (9%). Conclusion SOF/VEL is an optimal choice for GT-1, 2, 3, 6 CHC patients, regardless of treatment na?ve or experienced, non-cirrhotic or compensated cirrhotic and worth applied in clinical practice.
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