莱特莫维尔治疗耐火性或耐药性细胞巨乳病毒感染或疾病或同时出现器官功能障碍的治疗方法:第二阶段开放标签研究
Matthew P Cheng1,2,3, Isabel H Gonzalez-Bocco4,5,6, Esther Arbonna-Haddad4
1Division of Infectious Diseases, Department of Medicine, McGill University Health Centre, Montreal, Quebec, Canada.
概括
莱特莫维尔在移植患者治疗耐火性细胞巨乳病毒 (CMV) 感染时显示出安全性和耐受性. 虽然60%的人获得了病毒学反应,但为了更广泛的应用,需要进一步的研究.
科学领域:
- 传染性疾病 传染性疾病
- 移植免疫学 移植免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 耐火性或耐药性细胞巨乳病毒 (CMV) 感染是一个重大的临床挑战,特别是在免疫功能低下的个体,如固体器官移植 (SOT) 和全原造血细胞移植 (allo-HCT) 接受者中.
- 在这些脆弱患者群体中,有效的CMV治疗选择对于预防疾病进展和改善结果至关重要.
研究的目的:
- 评估莱特莫维尔在治疗细胞巨乳病毒 (CMV) 感染或疾病时的安全性和有效性.
- 评估耐火性或耐药性CMV或同时存在器官功能障碍的CMV患者对莱特莫维尔治疗的病毒学和临床反应.
主要方法:
- 进行了一项开放式的II期非随机临床试验.
- 符合条件的参与者包括成人和儿科 (≥12岁) SOT或allo-HCT接受者,需要针对耐火/耐性CMV或CMV和器官功能障碍进行抗病毒治疗.
- 患者每天服用莱特莫维尔,长达12周,可选择二次预防.
主要成果:
- 招募了10名患者,其中7人完成了研究. 总体病毒学反应率为60%.
- 莱特莫维尔的耐受性一般很好,只有两名患者出现了与药物相关的毒性 (一名3级ALT升高).
- 没有观察到严重的不良事件,如急性损伤,肝毒性,心律失常或骨髓抑制.
结论:
- 莱特莫维尔似乎是一个安全和耐受性良好的治疗选择,在这个有限的免疫受损患者队列中治疗CMV.
- 需要进一步的研究,以确定莱特莫维尔在治疗耐火或耐药的CMV感染和疾病中的最终作用.
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