索磷布韦联合达拉他韦治疗初治1b型慢性丙型肝炎患者临床疗效及安全性分析  

Efficacy and safety of Sofosbuvir/Daclatasvir(SOF/DCA)in treatment of naive patients with genotype-1b chronic hepatitis C

作　　者：金巧菲 杨国华[2] 周毅骏 刘寿荣 Jin Qiaofei;Yang Guohua;Zhou Yijun;Liu Shourong(Department of Hepatology,Hangzhou Xixi Hospital,Hangzhou 310023,China;Department of Infectious Diseases,Jiande Second People′s Hospital,Jiande 311604,China)

机构地区：[1]杭州市西溪医院肝病科,310023 [2]浙江省建德市第二人民医院感染科,311604

出　　处：《中华全科医师杂志》2020年第11期1043-1047,共5页Chinese Journal of General Practitioners

摘　　要：回顾性分析2018年8月至2019年6月杭州市西溪医院、建德市第二人民医院应用索磷布韦联合达拉他韦治疗的289例初治1b型慢性丙型肝炎患者的临床资料。其中236例无肝硬化(无肝硬化组)、48例为代偿期肝硬化(代偿期肝硬化组)、5例为失代偿期肝硬化患者(失代偿期肝硬化组),索磷布韦(400 mg/片)和达拉他韦(60 mg/片)治疗剂量为各1片/d,治疗12周。289例患者治疗结束后12、24周随访,分别失访15和26例,均为无肝硬化组患者。治疗结束后12周持续病毒学应答(SVR12)率、24周SVR24率无肝硬化组分别为82.2%(194/236)和81.7%(193/236),代偿期肝硬化组及失代偿期肝硬化组分别为100.0%(48/48)和5/5,3组比较差异均无统计学意义(均P>0.05);治疗结束后12、24周时血丙氨酸氨基转移酶[14(6,23)和14(5,72)U/L]、天门冬氨酸氨基转移酶(AST)[22(14,24)和23(15,52)U/L]、白蛋白[46(42,48)和46(34,51)g/L]、球蛋白[(32.6±4.0)和(31.6±3.8)g/L]、外周血血小板计数[(145.0±49.7)×10^9/L和(142.0±47.4)×10^9/L]、AST/血小板计数比值指数(APRI)[0.4(0.2,0.4),0.4(0.3,1.5)],与治疗前[44(8,175)U/L,44(23,154)U/L,45(41,49)g/L,(33.0±4.0)g/L,(153.0±53.7)×10^9/L,0.7(0.3,6.3)]比较,差异均有统计学意义(均P<0.05);治疗结束后12周时血总胆红素[(15.4±5.8)μmol/L]、外周血白细胞计数[(6.2±1.8)×10^9/L]、基于4因子的纤维化指数[3.2(1.5,13.7)],均较治疗前[(16.1±5.4)μmol/L,(5.7±1.5)×10^9/L,3.4(1.2,15.2)]好转(均P<0.05)。治疗期间不良反应有乏力(14.8%,36/248)、头痛(9.3%,23/248)、腹泻(5.6%,14/248)以及皮疹、皮肤瘙痒(4.8%,12/248),经对症处理后好转。提示,索磷布韦/达拉他韦治疗初治的1b型慢性丙型肝炎患者总体SVR12和SVR24率均较高,安全性良好。A total of 291 patients with genotype-1b chronic hepatitis C(CHC)admitted in Hangzhou Xixi Hospital and Jiande Second People′s Hospital between August 2018 to June 2019.All patients received sofosbuvir/daclatasvir(SOF/DCA)therapy for 12 weeks,and were followed up for 24 weeks after treatment.Data were missed in 2 cases,among remaining 289 cases,there were 238 cases without cirrhosis(non-cirrhosis group),48 cases with compensated cirrhosis(compensated cirrhosis group)and 5 cases with decompensated cirrhosis(decompensated cirrhosis group).The biochemical indexes,blood routine test results,aspartate aminotransferase-to-platelet ratio index(APRI),fibrosis-4(FIB-4)and related adverse event were collected.In non-cirrhotic group,15 cases and 41 cases were lost follow-up after 12 weeks and 24 weeks of treatment,respectively.The sustained virologic response rate on week 12(SVR12)and SVR24 in non-cirrhotic group were 82.2%(194/236)and 81.7%(193/236)respectively;whole SVR12 and SVR24 rates in compensated cirrhosis group(48/48)and decompensated cirrhosis group(5/5)were all 100%(χ^2=0.96,χ^2=0.44,P>0.05).The blood ALT[14(6,23)and 14(5,72)U/L],AST[22(14,24)and 23(15,52)U/L],hemoglobin[46(42,48)and 46(34,51)g/L],globulin[(32.6±4.0)和(31.6±3.8)g/L],PLT[(145.0±49.7)and(142.0±47.4)×10^9/L],APRI[0.4(0.2,0.4),0.4(0.3,1.5)]of 289 cases on week 12 and 24 after treatment were significantly improved;compared with baseline values[44(8,175)U/L,44(23,154)U/L,45(41,49)g/L,(33.0±4.0)g/L,(150.0±53.7)×10^9/L,0.7(0.3,6.3)](Week 12:Z=-14.21,Z=-13.97,Z=-14.72,t=2.00,t=5.22,Z=-13.52);(Week 24:Z=-13.12,Z=-13.04,Z=-4.63,t=7.18,t=7.25,Z=-9.48,all P<0.05).Compared with baseline values[(16.1±5.4)μmol/L,(5.7±1.5)×10^9/L,3.4(1.2,15.2)],the total bilirubin(15.4±5.8)μmol/L,WBC(6.2±1.8)×10^9/L,FIB-4[3.2(1.5,13.7)]levels were also improved(t=2.34,t=-5.51,Z=-3.40,all P<0.05).Univariate logistic analysis did not find factors influencing the SVR24 of Sofosbuvir/Daclatasvir therapy.The most common adverse events were fatigue(14.8%,36/248),he

关 键 词：肝炎 丙型 慢性 索磷布韦 达拉他韦 治疗结果 安全性 

分 类 号：R512.63[医药卫生—内科学]