2.5 毫克和 1.25 毫克雾化舒喘宁与安慰剂相比对新生儿短暂性呼吸过速的安全性和有效性:三盲 II/III 期平行随机对照试验》。

IF 2 4区 医学 Q3 RESPIRATORY SYSTEM
Farhad Abolhasan Choobdar, Zahra Vahedi, Ali Mazouri, Mohammad Torkaman, Nastaran Khosravi, Nasrin Khalesi, Zahra Soltani, Arash Mohazzab, Rezvan Ashkanipour
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引用次数: 0

摘要

背景:与安慰剂相比,评估 2.5 毫克和 1.25 毫克雾化沙丁胺醇对新生儿短暂性呼吸过速(TTN)的安全性和有效性。研究方法我们在两家设有新生儿重症监护室的大学附属医院开展了一项三盲 II/III 期平行随机对照试验。试验对象包括确诊为 TTN、胎龄大于 35 周、胎重大于 2 千克的新生儿。窒息、胎粪吸入综合征和持续肺动脉高压病例除外。90 名符合条件的患者被随机分配到三个干预组(2.5 毫克沙丁胺醇、1.25 毫克沙丁胺醇和安慰剂),并在产后 6 小时服用单剂量雾化产品。安全性结果包括干预后心动过速、高血糖、低血钾和血压变化。为了评估疗效,对干预后呼吸过速的持续时间、TTN 临床评分以及临床和辅助临床呼吸指数进行了评估。家长、结果评估员和数据分析师对干预措施视而不见。结果未出现心动过速、低钾血症和烦躁不安等不良反应。与安慰剂相比,两组沙丁胺醇受试者的呼吸频率、TTN临床评分和氧合指数均有明显改善(P值 结论:沙丁胺醇的治疗效果与安慰剂相比有明显改善(P值 结论:沙丁胺醇的治疗效果与安慰剂相比有明显改善(P值 结论):新应用的单次大剂量 2.5 毫克雾化沙丁胺醇治疗 TTN 是安全的,可明显加快呼吸状况的改善,且无明显不良反应。注册编号:IRCT2019032804313IRCT20190328043133N1.
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and Efficacy of 2.5 mg and 1.25 mg Nebulized Salbutamol Compared with Placebo on Transient Tachypnea of the Newborns: A Triple-Blind Phase II/III Parallel Randomized Controlled Trial.

Background: To evaluate the safety and efficacy of 2.5 and 1.25 mg nebulized salbutamol on Transient Tachypnea of the Newborn (TTN) compared with placebo. Methods: We conducted a triple-blind, phase II/III parallel randomized controlled trial in two university-affiliated hospitals with neonatal intensive care units. Newborns with a confirmed diagnosis of TTN, with gestational age >35 weeks and gestational weight >2 kg were included. Cases of asphyxia, meconium aspiration syndrome, and persistent pulmonary hypertension were excluded. Ninety eligible patients were randomly allocated in three intervention groups (2.5 mg salbutamol, 1.25 mg salbutamol, and placebo), and a single-dose nebulized product was prescribed 6 hours after the birth. Safety outcomes included postintervention tachycardia, hyperglycemia, hypokalemia, and changes in blood pressure. To evaluate the efficacy, the duration of postintervention tachypnea, TTN clinical score, and clinical and paraclinical respiratory indices were assessed. Parents, Outcome assessors, and data analyzer were blind to the intervention. Results: There was no adverse reaction, including tachycardia, hypokalemia, and jitteriness. Both groups of salbutamol recipients showed significant improvement regarding respiratory rate, TTN clinical score, and oxygenation indices compared with the placebo (p-values <0.001). Nonstatistically significant higher hospital stay was observed in the placebo group. Single 2.5 mg salbutamol nebulization showed a little better outcome than the dose of 1.25 mg, although we could not find statistical superiority. Conclusion: The newly applied single high dose of 2.5 mg nebulized salbutamol is safe in treating TTN and leads to notable faster improvement of respiratory status without any considerable adverse reaction. Registry code: IRCT20190328043133N1.

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来源期刊
CiteScore
6.70
自引率
2.90%
发文量
34
审稿时长
>12 weeks
期刊介绍: Journal of Aerosol Medicine and Pulmonary Drug Delivery is the only peer-reviewed journal delivering innovative, authoritative coverage of the health effects of inhaled aerosols and delivery of drugs through the pulmonary system. The Journal is a forum for leading experts, addressing novel topics such as aerosolized chemotherapy, aerosolized vaccines, methods to determine toxicities, and delivery of aerosolized drugs in the intubated patient. Journal of Aerosol Medicine and Pulmonary Drug Delivery coverage includes: Pulmonary drug delivery Airway reactivity and asthma treatment Inhalation of particles and gases in the respiratory tract Toxic effects of inhaled agents Aerosols as tools for studying basic physiologic phenomena.
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