一项多中心、随机、开放标签、活性对照试验，以确定静脉注射布洛芬治疗住院儿科患者发热的疗效、安全性和药代动力学。
A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients.
作者信息
Khalil Samia N, Hahn Barry J, Chumpitazi Corrie E, Rock Amy D, Kaelin Byron A, Macias Charles G
机构信息
Department of Anesthesiology, The University of Texas Medical School at Houston, 6431 Fannin Street, MSB 5.020, Houston, TX, 77030, USA.
Department of Emergency Medicine, Staten Island University Hospital, 475 Seaview Avenue, Staten Island, New York, 10305, USA.
出版信息
BMC Pediatr. 2017 Feb 1;17(1):42. doi: 10.1186/s12887-017-0795-y.
BACKGROUND
Oral antipyretics are commonly used to treat pediatric patients who develop fevers. However, patients presenting to the emergency department or undergoing surgery are frequently unable to tolerate oral antipyretics. Rectal formulations are available; however, this route of administration is unpredictable. The main objectives of this randomized controlled study was to evaluate the efficacy and safety of single or multiple doses of intravenous ibuprofen to acetaminophen (oral or suppository) in pediatric patients with fever and to assess plasma ibuprofen concentrations.
METHODS
This multi-center study was conducted in hospitalized patients, ≤ 16 years, with a new onset of fever ≥ 38.3°C. Patients were randomly assigned to receive either 10 mg/kg intravenous ibuprofen or acetaminophen. Study drug was administered at hour 0, and thereafter every 4 h as needed, up to 5 days. The primary outcome was to evaluate the effect of a single dose of intravenous ibuprofen compared to acetaminophen in reducing temperature in the first 2 h after administration. Data were compared using an analysis of variance model for continuous measurements and Cochran-Mantel-Haenszel test of general association for categorical data. A two-sided testing was used and a p-value ≤ 0.05 was considered significant.
RESULTS
A total of 103 patients received study medication. Intravenous ibuprofen resulted in a greater reduction in temperature as measured by the area under the change from baseline at 2 h (p = 0.005) and 4 h (<0.001); in a greater reduction in change from baseline temperature compared to treatment with acetaminophen, and it reduced fever throughout a 24 h dosing period. There were no differences in safety parameters or serious adverse events.
CONCLUSIONS
A single 10 mg/kg dose of intravenous ibuprofen provided a significant reduction of temperature for febrile pediatric patients compared to those that received 10 mg/kg acetaminophen at 2 h and 4 h post-treatment. A reduction in temperature was also demonstrated over 24 h; however the reduction was not considered statically significant. Intravenous ibuprofen provides an effective option for reducing fever in hospitalized pediatric patients.
TRIAL REGISTRATION
The study was registered on ClinicalTrials.gov on 26 October 2009, Study Identifier: NCT01002573.
背景
口服退烧药常用于治疗发热的儿科患者。然而，前往急诊科就诊或接受手术的患者通常无法耐受口服退烧药。有直肠给药制剂；然而，这种给药途径效果不可预测。这项随机对照研究的主要目的是评估单剂量或多剂量静脉注射布洛芬与对乙酰氨基酚（口服或栓剂）相比，在发热儿科患者中的疗效和安全性，并评估血浆布洛芬浓度。
方法
这项多中心研究在年龄≤16岁、新出现发热且体温≥38.3°C的住院患者中进行。患者被随机分配接受10mg/kg静脉注射布洛芬或对乙酰氨基酚。研究药物在0小时给药，此后根据需要每4小时给药一次，最长给药5天。主要结局是评估单剂量静脉注射布洛芬与对乙酰氨基酚相比，在给药后前2小时降低体温的效果。使用方差分析模型对连续测量数据进行比较，使用Cochran-Mantel-Haenszel一般关联性检验对分类数据进行比较。采用双侧检验，p值≤0.05被认为具有统计学意义。
结果
共有103名患者接受了研究药物治疗。静脉注射布洛芬导致体温下降幅度更大，以给药后2小时（p = 0.005）和4小时（<0.001）相对于基线变化的曲线下面积衡量；与对乙酰氨基酚治疗相比，相对于基线体温的变化下降幅度更大，并且在24小时给药期间持续降低体温。安全参数或严重不良事件方面没有差异。
结论
与接受10mg/kg对乙酰氨基酚治疗的患者相比，单剂量10mg/kg静脉注射布洛芬在治疗后2小时和4小时能使发热儿科患者体温显著降低。在24小时内也观察到体温下降；然而，这种下降在统计学上不被认为具有显著性。静脉注射布洛芬为住院儿科患者降低体温提供了一种有效的选择。
试验注册
该研究于2009年10月26日在ClinicalTrials.gov上注册，研究标识符：NCT01002573。
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