Safety of sildenafil in extremely premature infants: a phase I trial.
Safety of sildenafil in extremely premature infants: a phase I trial.
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DOI：
10.1038/s41372-021-01261-w
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发表时间：
2022-01
期刊：
影响因子：
--
通讯作者：
Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee
中科院分区：
文献类型：
--
作者：
Jackson W;Gonzalez D;Smith PB;Ambalavanan N;Atz AM;Sokol GM;Hornik CD;Stewart D;Mundakel G;Poindexter BB;Ahlfeld SK;Mills M;Cohen-Wolkowiez M;Martz K;Hornik CP;Laughon MM;Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee
描述西地那非在早产儿中的安全性。一项在接受常规临床护理西地那非（队列1）或接受西地那非单次IV给药（队列2）的早产儿中进行的西地那非I期、开放标签试验。根据不良事件（AE）、转氨酶水平和平均动脉压监测评价安全性。队列1中的24名婴儿（n = 25）接受了西地那非肠内给药。在队列2中，婴儿接受了0.25 mg/kg（n = 7）或0.125 mg/kg（n = 2）单次IV西地那非给药。在队列2中，发生了1起与研究药物相关的严重AE，涉及与输注速率快于方案规定相关的低血压。未发生与转氨酶升高相关的AE。研究人群对西地那非的耐受性良好。给药时间和冲洗速率需要仔细注意，以防止早产儿静脉输注西地那非加快相关的输注相关低血压。ClinicalTrials.gov标识符：NCT 01670136。
To characterize the safety of sildenafil in premature infants. 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. 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. 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. ClinicalTrials.gov Identifier: NCT01670136.
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影响因子：
4.6
作者：
Fujioka K;Shibata A;Yokota T;Koda T;Nagasaka M;Yagi M;Takeshima Y;Yamada H;Iijima K;Morioka I
通讯作者：
Morioka I
影响因子：
1
作者：
Hornik, Christoph P.;Onufrak, Nikolas J.;Gonzalez, Daniel
通讯作者：
Gonzalez, Daniel
影响因子：
2.5
作者：
Kim, Do-Hyun;Kim, Han-Suk;Choi, Jung-Hwan
通讯作者：
Choi, Jung-Hwan
影响因子：
3.6
作者：
Jobe AH
通讯作者：
Jobe AH
影响因子：
3.4
作者：
Gonzalez, Daniel;Laughon, Matthew M.;Wade, Kelly
通讯作者：
Wade, Kelly