Evaluation of the Clinical Outcomes of Cyclosporine Short Infusion Versus Continuous Infusion Postallogenic Stem Cell Transplantation.

IF 1.9 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Shaymaa M M El-Awady, Amal M El Afifi, Rania Afifi, Nagwa A Sabri, Marwa Adel Ahmed
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引用次数: 0

Abstract

Background and objective: Cyclosporin A (CsA) exhibits a narrow therapeutic index and large inter-individual variation in pharmacokinetics. Two intermittent and 24-h continuous infusions (CI) are both commonly used regimens in hematopoietic stem cell transplantation (HSCT), with no universal consensus. The objective of this study was to assess whether CsA as a 2-h, twice-daily intravenous infusion (2 h/12 h) is non-inferior to 22 h CI every 24 h (22 h-CI/24 h) in terms of acute graft-versus-host disease (aGVHD) incidence and adverse events in allogeneic HSCT adult patients.

Methods: An open-label randomized trial recruited 31 allogeneic HSCT patients to receive the 2 h/12 h or 22 h-CI/24 h regimen. The primary outcomes were the incidence of aGVHD and CsA-related adverse events. The secondary outcomes included the correlation between the time concentration and area under the concentration-time curve (AUC) of 2 h/12 h versus 22 h-CI/24 h regimens.

Results: Six (19.4%) patients developed aGVHD. There was no statistically significant difference between the two groups concerning the incidence of aGVHD (13.3% in 2 h/12 h vs. 25% in 22 h-CI/24 h; p = 0.359). The distribution of different aGVHD types (p = 0.20) and mortality (p = 0.9) were not significantly different between the two groups. The two groups did not differ at any time with respect to AUCs, nephrotoxicity, hepatotoxicity, or electrolyte disturbance.

Conclusion: The study suggested that the 2 h/12 h regimen is non-inferior to the conventional regimen (22 h CI/24 h) in terms of aGVHD incidence and adverse events. Further research is necessary to validate these findings and to guide practice, considering the small sample size of this study.

Trial registration: ClinicalTrials.gov identifier NCT04575779 with initial release on 19 September 2020-Retrospectively registered, https://clinicaltrials.gov/study/NCT04575779 .

评估成体干细胞移植术后环孢素短时间输注与连续输注的临床疗效。
背景和目的:环孢素 A(CsA)的治疗指数较窄,药代动力学的个体差异较大。两次间歇输注和24小时连续输注(CI)都是造血干细胞移植(HSCT)中常用的方案,但尚未达成普遍共识。本研究的目的是评估在异基因造血干细胞移植成人患者中,每日两次静脉输注(2小时/12小时)的CsA在急性移植物抗宿主病(aGVHD)发生率和不良事件方面是否不劣于每24小时一次的22小时CI(22小时-CI/24小时):一项开放标签随机试验招募了31名异体造血干细胞移植患者,让他们接受2小时/12小时或22小时-CI/24小时方案。主要结果是 aGVHD 和 CsA 相关不良事件的发生率。次要结果包括2小时/12小时与22小时-CI/24小时方案的时间浓度和浓度-时间曲线下面积(AUC)之间的相关性:结果:六名(19.4%)患者出现了急性肾脏功能障碍。两组患者的 aGVHD 发生率无明显统计学差异(2 小时/12 小时方案为 13.3%,22 小时-CI/24 小时方案为 25%;P = 0.359)。两组不同类型 aGVHD 的分布(p = 0.20)和死亡率(p = 0.9)无显著差异。在AUC、肾毒性、肝毒性或电解质紊乱方面,两组在任何时间都没有差异:该研究表明,就aGVHD发生率和不良事件而言,2小时/12小时方案不劣于常规方案(22小时CI/24小时)。考虑到这项研究的样本量较小,有必要开展进一步研究以验证这些发现并指导实践:ClinicalTrials.gov标识符NCT04575779,2020年9月19日首次发布-回顾性注册,https://clinicaltrials.gov/study/NCT04575779 。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
3.70
自引率
0.00%
发文量
64
审稿时长
>12 weeks
期刊介绍: Hepatology International is a peer-reviewed journal featuring articles written by clinicians, clinical researchers and basic scientists is dedicated to research and patient care issues in hepatology. This journal focuses mainly on new and emerging diagnostic and treatment options, protocols and molecular and cellular basis of disease pathogenesis, new technologies, in liver and biliary sciences. Hepatology International publishes original research articles related to clinical care and basic research; review articles; consensus guidelines for diagnosis and treatment; invited editorials, and controversies in contemporary issues. The journal does not publish case reports.
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