Cytomegalovirus pp65 antigen-guided preemptive therapy with ganciclovir in solid organ transplant recipients: a prospective, double-blind, placebo-controlled study.

Cytomegalovirus pp65 antigen-guided preemptive therapy with ganciclovir in solid organ transplant recipients: a prospective, double-blind, placebo-controlled study.
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巨细胞病毒 pp65 抗原引导的实体器官移植受者更昔洛韦先发性治疗:一项前瞻性、双盲、安慰剂对照研究。

DOI:
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发表时间:
2001
期刊:
影响因子:
6.2
通讯作者:
U. Meyer
U. Meyer
中科院分区:
医学2区
文献类型:
--
作者:
A. Koetz;R. Delbrück;A. Furtwängler;F. Hufert;D. Neumann‐Haefelin;G. Kirste;U. Meyer

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背景 本研究的目的是评估pp 65抗原指导的抗病毒治疗在实体器官移植受者中预防人巨细胞病毒(HCMV)感染的作用。 方法 在一项前瞻性、双盲研究中,10例肾移植和2例肝移植无症状HCMV感染受者随机接受静脉注射更昔洛韦或安慰剂治疗。所有患者均通过HCMV pp 65抗原检测呈阳性,水平>5个阳性细胞/2 x 10(5)个研究细胞。 结果 未发生HCMV终末器官病变。与安慰剂组患者(5/7)相比,更昔洛韦组患者(0/5)均未出现HCMV相关症状(P=0.01)。然而,由于患者人数少,所有三名高危患者(供体血清阳性,受体血清阴性)被随机分配至安慰剂组,三名患者均出现症状。 结论 由pp 65抗原检测指导的预防性抗病毒治疗似乎对预防肾和肝移植受者的HCMV相关症状有有益作用。
BACKGROUND The aim of this study was to evaluate pp65 antigen-guided antiviral therapy in preventing human cytomegalovirus (HCMV) infection in solid organ transplant recipients. METHODS Ten kidney and two liver transplant recipients with asymptomatic HCMV infection were randomized either for i.v. ganciclovir or placebo treatment in a prospective, double-blind study. All patients were positive by HCMV pp65 antigen test at levels >5 positive cells/2 x 10(5) investigated cells. RESULTS No cases of HCMV end-organ disease occurred. In contrast to patients on placebo (5/7), none of the patients on ganciclovir (0/5) developed HCMV-associated symptoms (P=0.01). However, because of the small number of patients, all three high-risk patients (donor seropositive, recipient seronegative) were randomized to placebo and all three developed symptoms. CONCLUSIONS Preemptive antiviral therapy guided by the pp65 antigen test seems to have a beneficial effect on preventing HCMV-associated symptoms in kidney and liver transplant recipients.