一个随机的,安慰剂控制的,剂量升级的I/II期多中心试验低剂量cidofovir用于BK多重瘤病毒脏病
Hannah Imlay1, John W Gnann2, James Rooney3
1Department of Internal Medicine, University of Utah, Salt Lake City, Utah, USA.
概括
低剂量的cidofovir在患有BK多重瘤病毒相关脏病 (BKPyVAN) 的脏移植接受者中显示出安全性. 然而,它没有在这个患者群体中显示出对BK多重瘤病毒 (BKPyV) 的显著抗病毒作用.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 病毒学 病毒学
- 移植医学 移植医学 移植医学
背景情况:
- 结核多重瘤病毒相关性病 (BKPyVAN) 是移植功能障碍的一个重要原因.
- 目前,BKPyVAN缺乏有效的治疗方法.
- 在之前的研究中,cidofovir 已经显示出对BK多重瘤病毒 (BKPyV) 的潜在活性.
研究的目的:
- 为了评估低剂量cidofovir在接受BKPyVAN的移植患者 (KTRs) 的安全性和有效性.
- 为了评估cidofovir对BKPyVDNAemia的抗病毒作用.
主要方法:
- 进行了一项I/II期,双盲,安慰剂控制的随机剂量升级试验.
- 通过活检确认的BKPyVAN和eGFR≥30毫升/分钟的KTR接受了静脉注射cidofovir (0.25或0.5毫克/公斤) 或安慰剂.
- 治疗是在0,7,21和35日进行的,随访时间是49日.
主要成果:
- 由于患者积累缓慢,试验被提前停止.
- 发现cidofovir在研究的剂量中是安全的,并且耐受性良好.
- 在cidofovir和安慰剂组之间没有观察到BKPyVDNAemia减少的显著差异.
结论:
- 低剂量cidofovir是安全的和可以容忍的KTRs与BKPyVAN.
- 在这项试验中,cidofovir没有显示出显著的BKPyV特异性抗病毒作用.
- 可能需要进一步的研究来探索替代剂量或治疗策略.
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