西地那非在极早产儿中的安全性：一项I期试验。
Safety of sildenafil in extremely premature infants: a phase I trial.
作者信息
Jackson Wesley, Gonzalez Daniel, Smith P Brian, Ambalavanan Namasivayam, Atz Andrew M, Sokol Gregory M, Hornik Chi D, Stewart Dan, Mundakel Gratias, Poindexter Brenda B, Ahlfeld Shawn K, Mills Mary, Cohen-Wolkowiez Michael, Martz Karen, Hornik Christoph P, Laughon Matthew M
机构信息
Department of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
出版信息
J Perinatol. 2022 Jan;42(1):31-36. doi: 10.1038/s41372-021-01261-w. Epub 2021 Nov 5.
OBJECTIVE
To characterize the safety of sildenafil in premature infants.
STUDY DESIGN
A phase I, open-label trial of sildenafil in premature infants receiving sildenafil per usual clinical care (cohort 1) or receiving a single IV dose of sildenafil (cohort 2). Safety was evaluated based on adverse events (AEs), transaminase levels, and mean arterial pressure monitoring.
RESULTS
Twenty-four infants in cohort 1 (n = 25) received enteral sildenafil. In cohort 2, infants received a single IV sildenafil dose of 0.25 mg/kg (n = 7) or 0.125 mg/kg (n = 2). In cohort 2, there was one serious AE related to study drug involving hypotension associated with a faster infusion rate than specified by the protocol. There were no AEs related to elevated transaminases.
CONCLUSION
Sildenafil was well tolerated by the study population. Drug administration times and flush rates require careful attention to prevent infusion-related hypotension associated with faster infusions of IV sildenafil in premature infants.
CLINICAL TRIAL
ClinicalTrials.gov Identifier: NCT01670136.
目的
评估西地那非在早产儿中的安全性。
研究设计
一项I期开放标签试验，在接受常规临床护理的早产儿中使用西地那非（队列1）或接受单次静脉注射西地那非（队列2）。基于不良事件（AE）、转氨酶水平和平均动脉压监测来评估安全性。
结果
队列1中的24名婴儿（共25名）接受了口服西地那非。在队列2中，婴儿接受了0.25mg/kg（n = 7）或0.125mg/kg（n = 2）的单次静脉注射西地那非剂量。在队列2中，有1例严重不良事件与研究药物有关，涉及低血压，其输注速度比方案规定的速度快。没有与转氨酶升高相关的不良事件。
结论
研究人群对西地那非耐受性良好。给药时间和冲洗速度需要仔细关注，以预防早产儿因静脉注射西地那非输注速度过快而导致的与输注相关的低血压。
临床试验
ClinicalTrials.gov标识符：NCT01670136。
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