高剂量阿昔洛韦用于疑似和确诊新生儿单纯疱疹病毒感染婴儿的安全性
Safety of High-dose Acyclovir in Infants With Suspected and Confirmed Neonatal Herpes Simplex Virus Infections.
作者信息
Ericson Jessica E, Gostelow Martyn, Autmizguine Julie, Hornik Christoph P, Clark Reese H, Benjamin Daniel K, Smith P Brian
机构信息
From the *Duke Clinical Research Institute, Durham, North Carolina; †Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania; ‡Department of Pediatrics, CHU Sainte Justine, §Department of Pharmacology, University of Montreal, Montreal, Quebec, Canada; ¶Department of Pediatrics, Duke University, Durham, North Carolina; and ‖Pediatrix-Obstetrix Center for Research and Education, Sunrise, Florida.
出版信息
Pediatr Infect Dis J. 2017 Apr;36(4):369-373. doi: 10.1097/INF.0000000000001451.
BACKGROUND
Acyclovir is used to treat herpes simplex virus disease in infants. Treatment with high-dose acyclovir, 60 mg/kg/d, is recommended; however, the safety of this dosage has not been assessed in the past 15 years, and this dosage is not currently approved for infants by the US Food and Drug Administration.
METHODS
We included infants with neonatal herpes simplex virus disease treated with ≥14 days of intravenous acyclovir starting in the first 120 days of life admitted to 1 of 42 neonatal intensive care units managed by the Pediatrix Medical Group between 2002 and 2012. We determined the frequency and proportion of infants with clinical and laboratory adverse events (AEs) as well as the number and proportion of infant days with laboratory AEs occurring during acyclovir exposure.
RESULTS
We identified 89 infants during the study period with 1658 days of acyclovir exposure. Almost all received high-dose acyclovir therapy (79/89, 89%). The most common clinical AEs were hypotension and seizure, both occurring in 9% of infants. Thrombocytopenia was the most common laboratory AE occurring in 25% of infants and on 9% of infant-days. Elevated creatinine occurred in 2% of infants and 0.2% of infant-days and no infants developed renal failure requiring dialysis. Overall, 45% of infants had ≥1 AE.
CONCLUSIONS
In this cohort of infants treated during the high-dose acyclovir era, AEs were common but usually not severe. Many of the AEs reported in this cohort may be related to the underlying infection rather than due to acyclovir exposure.
背景
阿昔洛韦用于治疗婴儿单纯疱疹病毒疾病。推荐使用高剂量阿昔洛韦治疗，剂量为60mg/kg/d；然而，该剂量的安全性在过去15年中未得到评估，且目前美国食品药品监督管理局未批准该剂量用于婴儿。
方法
我们纳入了2002年至2012年间在Pediatrix医疗集团管理的42个新生儿重症监护病房之一住院的、在出生后120天内开始接受≥14天静脉注射阿昔洛韦治疗的新生儿单纯疱疹病毒疾病婴儿。我们确定了发生临床和实验室不良事件（AE）的婴儿的频率和比例，以及在阿昔洛韦暴露期间发生实验室AE的婴儿天数和比例。
结果
在研究期间，我们确定了89名婴儿，阿昔洛韦暴露天数为1658天。几乎所有婴儿都接受了高剂量阿昔洛韦治疗（79/89，89%）。最常见的临床AE是低血压和惊厥，均发生在9%的婴儿中。血小板减少是最常见的实验室AE，发生在25%的婴儿中，占婴儿天数的9%。2%的婴儿肌酐升高，占婴儿天数的0.2%，没有婴儿发展为需要透析的肾衰竭。总体而言，45%的婴儿发生了≥1次AE。
结论
在这个高剂量阿昔洛韦治疗时代的婴儿队列中，AE很常见但通常不严重。该队列中报告的许多AE可能与潜在感染有关，而非阿昔洛韦暴露所致。
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