更昔洛韦和膦甲酸钠预防异基因造血干细胞移植后巨细胞病毒感染效果比较的单中心、前瞻性随机对照研究

谭栩; 张璇; 高力; 高蕾; 刘耀; 孔佩艳; 张诚; 张曦

doi:10.13201/j.issn.1004-2806.2020.09.007

更昔洛韦和膦甲酸钠预防异基因造血干细胞移植后巨细胞病毒感染效果比较的单中心、前瞻性随机对照研究

- 陆军军医大学新桥医院血液病医学中心(重庆, 400037)
基金项目:
国家重点研究计划“干细胞及转化研究”重点专项(No:2017YFA0105502)

详细信息

通讯作者: 张诚,E-mail:chzhang2003@hotmail.com

中图分类号: R457.7

收稿日期: 2020-02-25

A single center, prospective randomized controlled study of ganciclovir and foscarnet in the prevention of cytomegalovirus infection after allogeneic hematopoietic stem cell transplantation

- Hematology Medical Center, Xinqiao Hospital of Army Medical University, Chongqing, 400037, China

More Information

Corresponding author: ZHANG Cheng, E-mail: chzhang2003@hotmail.com

Received Date: 25 February 2020

摘要

摘要: 目的:比较膦甲酸钠和更昔洛韦预防用药对异基因造血干细胞移植(allo-HSCT)后巨细胞病毒(CMV)感染的疗效及安全性,为有效预防allo-HSCT后CMV感染提供临床参考。方法:前瞻性随机选取行allo-HSCT的69例患者,随机分为膦甲酸钠组60 mg/(kg·d)和更昔洛韦组5 mg/(kg·d),对2组患者用药期间和移植+100 d CMV感染及毒副作用进行临床观察,比较2种药物在allo-HSCT后CMV感染预防中的效果和安全性。结果:预防用药期间、移植+100 d CMV感染和CMV病发生率,更昔洛韦组分别是2.9%、20.6%、0,而膦甲酸钠组分别为11.4%、31.4%、11.4%;2组上述指标差异均无统计学意义(P>0.05);但膦甲酸钠预防组CMV感染出现时间明显先于更昔洛韦预防组(P=0.015);毒副作用方面:2组用药期间,Ⅲ度粒细胞减少的发生,更昔洛韦组明显高于膦甲酸钠组(P=0.016);Ⅳ度粒细胞减少在2组间差异无统计学意义;2组在Ⅰ、Ⅱ度血小板减少的发生率上差异也无统计学意义;2组肾功能损害发生率相似,但电解质紊乱发生率在膦甲酸钠预防组较更昔洛韦预防组更常见(P=0.024)。用药预防期间,因不良反应停药的膦甲酸钠组有4例,更昔洛韦预防组未发生。结论:膦甲酸钠和更昔洛韦在预防allo-HSCT后CMV感染上疗效相当,但2组的不良反应有一定差异,因此预防使用膦甲酸钠或更昔洛韦应当个体化。
- 巨细胞病毒感染 /
- 异基因造血干细胞移植 /
- 预防 /
- 膦甲酸钠 /
- 更昔洛韦
Abstract: Objective: To compare the safety and efficacy of ganciclovir and foscarnet in the prophylaxis of cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (allo-HSCT),providing a clinical reference to effectively prevent CMV infection after allo-HSCT.Method: Sixty-nine patients receiving allo-HSCT were prospectively selected as research objects.These recipients were randomized into two groups to receive ganciclovir 5 mg/(kg·d) or foscarnet 60 mg/(kg·d) as the prophylaxis of CMV infection after hematopoietic reconstitution.The incidences of CMV infection and adverse events were observed during the period of prevention and within 100 days after allo-HSCT.Result: In the ganciclovir group,the incidence of CMV infection during the period of prevention,CMV infection within 100 days after allo-HSCT and CMV disease were 2.9%,20.6% and 0 respectively.And in the foscarnet group,the incidence of CMV infection during the period of prevention,CMV infection within 100 days after allo-HSCT and CMV disease were 11.4%,31.4% and 11.4% respectively.There was no significant difference in the incidence of CMV infection between the two groups(P>0.05).However,the occurrence time of CMV infection in the foscarnet group was significantly earlier than that of the ganciclovir group(P=0.015).Grade 3 neutropenia (ANC<1.0×10⁹/L) occurred more frequently in the ganciclovir group than that in the foscarnet group (P=0.016),whereas there was no significant difference in the rate of grade 4 neutropenia (ANC<0.5×10⁹/L) and grade 1/2 thrombocytopenia between the two groups (P=0.024).The prevalence of electrolyte disorders was more common in the foscarnet group than that in the ganciclovir group.There was no significant difference in impaired renal function between the two groups.Four patients in the foscarnet group[HK]
- cytomegalovirus infection /
- allogeneic hematopoietic stem cell transplantation /
- prophylaxis /
- foscarnet /
- ganciclovir

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