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[JAMA Intern Med论文]:抗病毒治疗预防免疫功能正常的危重病患者CMV的重新激活
2017年06月17日 时讯速递, 进展交流 暂无评论

Safety and Efficacy of Antiviral Therapy for Prevention of Cytomegalovirus Reactivation in Immunocompetent Critically Ill Patients: A Randomized Clinical Trial.

Cowley NJ, Owen A, Shiels SC, et al

JAMA Intern Med. 2017;177(6):774-783

doi: 10.1001/jamainternmed.2017.0895. [Epub ahead of print]

Abstract

IMPORTANCE: 背景

Latent cytomegalovirus (CMV) infection is present in more than half the adult population, and a viral reactivation (ie, when the virus becomes measurable in body fluids such as blood) can occur in up to one-third of these individuals during episodes of critical illness.

超过半数的成年人有潜在的CMV感染,罹患危重病期间多达1/3的患者发生病毒重新激活(即体液如血液中能够测到病毒)。

OBJECTIVE: 目的

To determine whether antiviral therapy is safe and effective for preventing CMV reactivation in a general population of critically ill patients.

确定抗病毒治疗预防危重病患者的CMV重新激活是否安全有效。

DESIGN, SETTING, AND PARTICIPANTS: 设计,场景及研究人群

A single-center, open-label, randomized, controlled clinical trial recruited 124 CMV-seropositive patients undergoing mechanical ventilation for at least 24 hours in the intensive care unit between January 1, 2012, and January 31, 2014. The mean baseline Acute Physiology and Chronic Health Evaluation II score of all patients was 17.6.

2012年1月1日至2014年1月31日期间进行的单中心、开放、随机对照临床试验,124名CMV血清阳性患者入选,所有患者在ICU接受机械通气至少24小时。所有患者基线APACHE II评分平均为17.6分。

INTERVENTIONS: 干预

Patients were randomized to receive anti-CMV prophylaxis with valacyclovir hydrochloride (n = 34) or low-dose valganciclovir hydrochloride (n = 46) for up to 28 days to suppress viral reactivation, or to a control group with no intervention (n = 44).

患者被随机分为接受盐酸万乃韦洛(valacyclovir hydrochloride) (n = 34)或小剂量盐酸缬更昔洛韦(valganciclovir hydrochloride) (n = 46)预防CMV组(疗程不超过28天以抑制病毒重新激活),或无干预的对照组(n = 44)。

MAIN OUTCOMES AND MEASURES: 主要预后指标

Time to first CMV reactivation in blood within the 28-day follow-up period following initiation of the study drug.

开始使用研究药物后28天随访期间首次出现血液中CMV重新激活的时间。

RESULTS: 结果

Among the 124 patients in the study (46 women and 78 men; mean [SD] age, 56.9 [16.9] years), viral reactivation in the blood occurred in 12 patients in the control group, compared with 1 patient in the valganciclovir group and 2 patients in the valacyclovir group (combined treatment groups vs control: hazard ratio, 0.14; 95% CI 0.04-0.50). Although this trial was not powered to assess clinical end points, the valacyclovir arm was halted prematurely because of higher mortality; 14 of 34 patients (41.2%) had died by 28 days, compared with 5 of 37 (13.5%) patients in the control arm at the point of the decision to halt this arm. Other safety end points showed similar outcomes between groups.

研究入选的124名患者中(46例女性,78例男性,平均年龄56.9 [16.9]岁),对照组12例患者血液中病毒重新激活,缬更昔洛韦组1例,万乃韦洛组2例(两个治疗组与对照组比较:风险比0.14; 95% CI 0.04-0.50)。尽管试验样本量不足以评价临床终点,但万乃韦洛组因病死率高提前终止;28天时34名患者中14例(41.2%)死亡,而决定终止万乃韦洛组时,对照组37例患者仅死亡5例(13.5%)。各组间其他安全终点相似。

CONCLUSIONS AND RELEVANCE: 结论及意义

Antiviral prophylaxis with valacyclovir or low-dose valganciclovir suppresses CMV reactivation in patients with critical illness. However, given the higher mortality, a large-scale trial would be needed to determine the clinical efficacy and safety of CMV suppression.

预防性应用抗病毒药万乃韦洛或小剂量缬更昔洛韦能够抑制危重病患者的CMV重新激活。然而,由于病死率很高,因此需要大样本研究确定抑制CMV的临床疗效及安全性。

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT01503918

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