来特莫韦预防异基因造血干细胞移植后巨细胞病毒感染的有效性与安全性分析
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篇名: 来特莫韦预防异基因造血干细胞移植后巨细胞病毒感染的有效性与安全性分析
TITLE: Efficacy and safety of letermovir in preventing cytomegalovirus infection after allogeneic hematopoietic stem cell transplantation
摘要: 目的 评估异基因造血干细胞移植(allo-HSCT)后以来特莫韦预防巨细胞病毒(CMV)感染的有效性与安全性。方法采用回顾性队列研究,纳入2022年8月30日至2024年2月21日在上海交通大学医学院附属第一人民医院血液科接受allo-HSCT的患者为研究对象。移植后28d内启用来特莫韦预防的患者为试验组(99例),未在28d内启用来特莫韦预防的患者为对照组(18例)。记录两组患者CMV感染的发生情况和临床特征(包括CMV感染例数、进展为CMV疾病例数、再发CMV疾病、CMV感染的起病时间和治疗时长等)、在移植后120d内的免疫功能恢复及移植相关并发症(包括CD4+和CD8+T细胞恢复情况、EB病毒感染、急性移植物抗宿主病、人疱疹病毒6感染、移植后淋巴细胞增殖性疾病)发生情况、不良事件发生情况,并采用单因素和多因素Cox回归分析探讨CMV感染的影响因素。结果共纳入117例患者,其中15例发生CMV感染,5例进展为CMV疾病,2例出现了再发CMV疾病。试验组CMV感染率显著低于对照组(P<0.001),且感染的起病时间明显推迟(P=0.014)。试验组CD4+T细胞≥200个/μL的比例显著低于对照组(P=0.022)。随访期间初步观察到1例患者出现肌酐水平升高,2例患者出现恶心、呕吐症状。多因素Cox回归分析显示,使用大剂量糖皮质激素为CMV感染的风险因素(HR=6.230,95%CI为1.255~30.926,P=0.025),而移植后28d内启用来特莫韦为保护因素(HR=0.125,95%CI为0.045~0.348,P<0.001)。结论allo-HSCT后早期启用来特莫韦能显著降低CMV感染率并推迟感染时间,且短期内安全性良好。
ABSTRACT: OBJECTIVE To evaluate the efficacy and safety of letermovir in preventing cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (allo-HSCT). METHODS A retrospective cohort study was conducted, enrolling patients who underwent allo-HSCT at the Department of Hematology, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, from August 30, 2022, to February 21, 2024. Patients who initiated letermovir prophylaxis within 28 days post-transplantation were assigned to the experimental group (99 cases), while those who did not initiate letermovir within this period were assigned to the control group (18 cases). The incidence and clinical characteristics of CMV infection (including the number of wangranran@xinhuamed.com.cn CMV infection cases, the number of cases progressing to CMV disease, recurrent CMV disease, onset time of CMV infection, and treatment duration), immune function recovery within 120 days post-transplantation, and the occurrence of transplantation-related complications (including CD4+ and CD8+ T-cell recovery, Epstein-Barr virus infection, acute graft-versus-host disease, human herpesvirus 6 infection, and posttransplant lymphoproliferative disorders) and adverse events were recorded. Univariate and multivariate Cox regression analyses were performed to identify factors influencing CMV infection. RESULTS A total of 117 patients were included, among whom 15 developed CMV infection, 5 progressed to CMV disease, and 2 experienced recurrent CMV disease. The CMV infection rate in the experimental group was significantly lower than that in the control group (P<0.001), and the onset time of CMV infection was significantly delayed (P=0.014). The proportion of patients with CD4+ T-cell counts ≥200 cells/μL in the experimental group was significantly lower than that in the control group (P=0.022). During the follow-up period, elevated creatinine levels were observed in 1 patient, and nausea and vomiting were observed in 2 patients. Multivariate Cox regression analysis revealed that the use of high-dose corticosteroids was a risk factor for CMV infection (HR=6.230, 95%CI of 1.255-30.926, P=0.025), while initiating letermovir within 28 days post-transplantation was a protective factor (HR=0.125, 95%CI of 0.045-0.348, P<0.001). CONCLUSIONS Early initiation of letermovir after allo-HSCT significantly reduces the CMV infection rate and delays the onset of infection, with favorable short-term safety.
期刊: 2025年第36卷第15期
作者: 王冉冉;李舒悦;梁然然;宋献民;唐原君;高君伟
AUTHORS: WANG Ranran,LI Shuyue,LIANG Ranran,SONG Xianmin,TANG Yuanjun,GAO Junwei
关键字: 异基因造血干细胞移植;巨细胞病毒感染;来特莫韦;预防;有效性;安全性
KEYWORDS: allogeneic hematopoietic stem cell transplantation; cytomegalovirus infection; letermovir; prevention; efficacy;
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