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在接受血液透析的患者中,使用基于索福斯布维尔的通用疗法治疗C型肝炎
Nawal Afredj1,2, Mustapha Boumendjel3,4, Hassen Mahiou2,5
1Hepatology Department, Centre Hospitalo Universitaire Mustapha, Algiers, Algeria.
概括
在当地生产的基于索福斯布维尔的通用直接作用抗病毒药物在接受维护血液透析的C型肝炎病毒 (HCV) 患者中显示出高的疗效和安全性. 建议在治疗期间密切监测并发症和潜在并发症的管理.
科学领域:
- 肝病学和病毒性胃肠病学
- 腎病學和透析醫學 腎病學和透析醫學
- 药理学和药物开发领域
背景情况:
- 型肝炎病毒 (HCV) 感染对健康造成重大负担,特别是在需要维护血液透析的慢性病患者中.
- 直接作用抗病毒药物 (DAA) 已经彻底改变了HCV治疗方法,但对特定患者群体 (如血液透析患者) 的通用配方的数据至关重要.
- 在这个易受伤害的群体中,本地生产的基于索福斯布维尔的仿制疗法的疗效和安全性需要进行彻底的评估.
研究的目的:
- 评估基于索福斯布维尔的通用直接作用抗病毒 (DAA) 方案的有效性和安全性.
- 评估C型肝炎病毒 (HCV) 感染,接受维护血液透析的患者的治疗结果.
- 在这个患者队列中确定与严重不良事件相关的潜在风险因素.
主要方法:
- 进行了一项回顾性多中心研究,涉及120名维持血液透析的患者,他们在2017年1月至2021年9月期间接受了基于索福斯布维尔的通用疗法 (索福斯布维尔-莱迪帕斯维尔或索福斯布维尔-达克拉塔斯维尔) 的治疗.
- 治疗持续时间为12或24周,持续的病毒学反应 (SVR) 被定义为治疗后12周无法检测到的HCVRNA.
- 通过严重不良事件 (SAE) 的发生来评估安全性,并使用SPSS版本25进行统计分析.
主要成果:
- 在接受治疗的患者中,达到93.3%的高SVR率.
- 严重不良事件 (SAE) 的发生率为10.8%,其中有两个与DAA无关的死亡.
- 多变量分析确定了晚期肝纤维化,血小板缩,低albuminemia,高胆红素水平和治疗前状态作为SAEs的风险因素.
结论:
- 在当地制造的基于索福斯布维尔的通用疗法在接受维护血液透析的患者中安全有效治疗C型肝炎病毒 (HCV).
- 尽管疗效很高,但仔细监测患者至关重要,以积极管理治疗期间出现的并发症和潜在并发症.
- 进一步的研究可能将重点放在优化DAA治疗策略和对血液透析患者的风险分层.
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