Ma R, He Y, Xu L P, Zhang X H, Wang Y, Liu K Y, Huang X J, Sun Y Q
Department of Hematology, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Beijing 100044, China.
Zhonghua Nei Ke Za Zhi. 2023 Jan 1;62(1):76-83. doi: 10.3760/cma.j.cn112138-20220118-00058.
To evaluate and compare the efficacies of ganciclovir plus foscarnet and a single agent for the treatment of cytomegalovirus (CMV) infection after haploidentical hematopoietic stem cell transplantation. This study was a non-randomized clinical controlled trial. The data of patients who underwent haploidentical transplantation and developed CMV infection between January 1, 2021, and June 30, 2021, were retrospectively analyzed. Follow-up was conducted through telephone, inpatient consultations, and the review of outpatient medical records. The observed indicators included the incidence of CMV infection (including CMV disease), rate of recurrence of CMV infection, overall survival (OS), and disease-free survival (DFS). A total of 242 patients were diagnosed with post-transplantation CMV infection; 116 patients tested positive for CMV DNA for more than 14 days (=0.011). Of the 242 patients with CMV infection, 65 were treated with ganciclovir plus foscarnet, and 156 patients were treated with a single antiviral drug; the median durations of CMV seroconversion were 21 (3-60) and 14 (3-32) days for the combination and single-drug groups, respectively. There were no significant differences between their incidence of CMV infections and 1-year OS and DFS. Of the patients with refractory CMV infections, 53 (45.7%) were treated with ganciclovir plus foscarnet, and 63 (54.3%) were treated with a single antiviral agent. The median durations of CMV seroconversion for the combination and single-drug groups were 21 (15-60) days and 20 (15-45) days, respectively (=0.472). Two patients in each group progressed to CMV disease (=0.860). During follow-up, 12 patients (22.6%) in the combination group and 8 patients (12.7%) in the single-drug group experienced recurrent episode(s) of CMV infection (=0.158). The 1-year OS of the combination and single-drug groups were 92.0% and 87.1%, respectively (=0.543); the 1-year DFS were 90.3% and 85.7%, respectively (=0.665). Univariate analysis revealed no associations between the antiviral agents used and OS and DFS (OS: =0.644, =0.547; DFS: =0.757, =0.666). There were no significant differences in the duration of CMV infection, incidence of CMV disease, rate of recurrence of CMV infection, and survival of the patients treated with the combination of antiviral drugs and a single antiviral drug.
评估和比较更昔洛韦联合膦甲酸钠与单一药物治疗单倍体造血干细胞移植后巨细胞病毒(CMV)感染的疗效。本研究为非随机临床对照试验。回顾性分析了2021年1月1日至2021年6月30日期间接受单倍体移植并发生CMV感染的患者数据。通过电话、住院会诊和门诊病历审查进行随访。观察指标包括CMV感染发生率(包括CMV疾病)、CMV感染复发率、总生存期(OS)和无病生存期(DFS)。共有242例患者被诊断为移植后CMV感染;116例患者CMV DNA检测阳性超过14天(=0.011)。在242例CMV感染患者中,65例接受更昔洛韦联合膦甲酸钠治疗,156例接受单一抗病毒药物治疗;联合用药组和单一药物组CMV血清学转换的中位持续时间分别为21(3 - 60)天和14(3 - 32)天。两组的CMV感染发生率、1年OS和DFS之间无显著差异。在难治性CMV感染患者中,53例(45.7%)接受更昔洛韦联合膦甲酸钠治疗,63例(54.3%)接受单一抗病毒药物治疗。联合用药组和单一药物组CMV血清学转换的中位持续时间分别为21(15 - 60)天和20(15 - 45)天(=0.472)。每组各有2例患者进展为CMV疾病(=0.860)。随访期间,联合用药组12例患者(22.6%)和单一药物组8例患者(12.7%)经历了CMV感染复发(=0.158)。联合用药组和单一药物组的1年OS分别为92.0%和87.1%(=0.543);1年DFS分别为90.3%和85.7%(=0.665)。单因素分析显示,所用抗病毒药物与OS和DFS之间无关联(OS:=0.644,=0.547;DFS:=0.757,=0.666)。抗病毒药物联合治疗与单一抗病毒药物治疗的患者在CMV感染持续时间、CMV疾病发生率、CMV感染复发率和生存率方面无显著差异。