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艾尔巴韦/格拉瑞韦治疗基因1型慢性丙型肝炎效果的真实世界研究
Efficacy of elbasvir/grazoprevir in treatment of genotype 1 chronic hepatitis C: A real-world study
文章发布日期:2020年11月13日  来源:  作者:夏阳,黄晶,吴树铎,等  点击次数:3520次  下载次数:46次

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【摘要】:目的 评估艾尔巴韦/格拉瑞韦在丙型肝炎基因1型患者真实世界中的疗效和安全性。 方法 选取2018年8月-2019年3月就诊于广州市第八人民医院、广东省中医医院、广东省人民医院接受艾尔巴韦/格拉瑞韦治疗的丙型肝炎患者35例,治疗12周,停药后随访12周。观察停药后12周持续病毒学应答(SVR12)、生化学应答和治疗随访期间的不良事件发生率。非正态分布的计量资料组间比较采用Kruskal-Wallis H检验,组内进一步两两比较采用Mann-Whitney U检验;计数资料的组间比较采用χ2检验。采用logistic回归分析探讨影响丙型肝炎病毒学应答的危险因素。结果 35例HCV患者中97.1%(34/35)为HCV基因1b型,2.9%(1/35)为HCV基因1a型,28例(80.0%)为慢性丙型肝炎非肝硬化患者,7例(20.0%)为代偿期肝硬化患者。治疗结束时的病毒应答率为100%(28/28),SVR12率为94.74%(18/19)。另外,年龄、性别、HCV RNA基线载量、初治或经治、是否存在肝硬化、肾功能情况、是否合并其他疾病均不影响疗效(P值均>0.05)。患者的ALT、AST、GGT、白蛋白水平在基线与治疗12周比较差异有统计学意义(Z值分别为-7.131、-6.797、-3.060、-2.875,P值均<0.05)。治疗期间,无患者因不良反应停药。 结论 本研究证实,在国内真实世界研究中,艾尔巴韦/格拉瑞韦抗丙型肝炎治疗有效性较高,安全性良好。
【Abstract】:Objective To investigate the efficacy and safety of elbasvir/grazoprevir in patients with genotype 1 hepatitis C in the real world. Methods A total of 35 patients with hepatitis C who received elbasvir/grazoprevir treatment in Guangzhou Eighth People’s Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, and Guangdong General Hospital from August 2018 to March 2019 were enrolled, treated for 12 weeks, and then followed up for 12 weeks after drug withdrawal. The patients were observed in terms of sustained virologic response at week 12 after drug withdrawal (SVR12), biochemical response, and incidence rate of adverse events during treatment and follow-up. The Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data between groups, and the Mann-Whitney U test was used for further comparison between two groups; the chi-square test was used for comparison of categorical data between groups. A logistic regression analysis was used to investigate the risk factors for virologic response in patients with hepatitis C. Results Among the 35 patients with HCV infection, 97.1% (34/35) had genotype 1b HCV and 2.9% (1/35) had genotype 1a HCV; of all patients, 28 (80%) were non-cirrhotic patients with chronic hepatitis C and 7 (20%) had compensated liver cirrhosis. At the end of treatment, the virologic response rate of 100% (28/28) and SVR12 was 94.74% (18/19). In addition, age, sex, baseline HCV RNA load, previous treatment history, presence or absence of liver cirrhosis, renal function, and presence or absence of other diseases did not affect the treatment outcome (all P>0.05). There were significant changes in the levels of alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, and albumin from baseline to the end of 12-week treatment (Z=-7.131, -6.797, -3.060, and -2.875, all P<0.05). No patient experienced drug withdrawal during treatment. Conclusion This study confirms that elbasvir/grazoprevir has good efficacy and safety in the treatment of hepatitis C in domestic real-world studies.
【关键字】:丙型肝炎,慢性; 抗病毒药; 治疗学
【Key words】:hepatitis C,chronic; antiviral agents; therapeutics
【引证本文】:XIA Y, HUANG J, WU SD, et al. Efficacy of elbasvir/grazoprevir in treatment of genotype 1 chronic hepatitis C: A real-world study[J]. J Clin Hepatol, 2020, 36(12): 2700-2704. (in Chinese)
夏阳, 黄晶, 吴树铎, 等. 艾尔巴韦/格拉瑞韦治疗基因1型慢性丙型肝炎效果的真实世界研究[J]. 临床肝胆病杂志, 2020, 36(12): 2700-2704.

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