通过定量气雾剂吸入甲磺酸比托特罗治疗儿童哮喘的疗效与安全性。

Efficacy and safety of inhaled bitolterol mesylate via metered-dose inhaler in children with asthma.

作者信息

Bierman C W, Kemp J P, Nathan R A

机构信息

ASTHMA, Inc., Seattle, Washington, USA.

出版信息

Ann Allergy Asthma Immunol. 1996 Jan;76(1):27-35. doi: 10.1016/s1081-1206(10)63403-5.

DOI:10.1016/s1081-1206(10)63403-5

PMID:8564625

Abstract

BACKGROUND

There have been numerous studies in asthmatic adults demonstrating the efficacy and safety of bitolterol mesylate metered-dose inhaler; however, only one additional study has examined bitolterol metered-dose inhaler in pediatric asthma.

OBJECTIVE

To establish the safety and effectiveness of bitolterol mesylate metered-dose inhaler at one, two, and three inhalations in pediatric asthmatic patients 4 to 12 years of age.

METHODS

A multicenter, double-blind, randomized, crossover, placebo-controlled, dose-ranging study. Forty-six patients were evaluated in three centers. Patients were stratified by age, 4 to 6, 7 to 9, 10 to 12 years at each center. One, two, or three inhalations were administered along with an additional double-blind, randomized, placebo dose. Bronchodilation was defined as a 15% or greater increase in FEV1 over baseline. Onset, maximum improvement, and duration of action were obtained for each patient. Serial pulse rate, blood pressure, and respiratory rate determinations were obtained for each patient.

RESULTS

Onset within five minutes occurred in 56.6% to 71% of patients, depending on the dose. Mean maximum improvement, which was dose dependent, overall ranged from 28.2% to 40.3% with a peak response in 66.7 to 69.8 minutes. In direct relationship of magnitude with regard to dose of bitolterol was observed, (P < .001). A significant correlation, r = .732, in response between bronchodilation and baseline FEV1 was observed (P < .001). Median duration of action ranged from three to four hours in responding patients across all doses. Up to 31% of patients had durations greater than eight hours after three inhalations. Adverse effects were reported in five of 46 patients for all doses with mild transient tremor occurring in two patients, 4.3%. Also, there was little effect on pulse rate, 2.2%.

CONCLUSION

Bitolterol is an effective bronchodilator with durations of activity up to eight hours and minimal adverse effects in children.

摘要

背景

已有大量针对成年哮喘患者的研究证明了甲磺酸比托特罗定量吸入器的有效性和安全性；然而，仅有一项额外研究考察了甲磺酸比托特罗定量吸入器在儿童哮喘中的应用。

目的

确定甲磺酸比托特罗定量吸入器在4至12岁儿童哮喘患者中单次、两次和三次吸入时的安全性和有效性。

方法

一项多中心、双盲、随机、交叉、安慰剂对照、剂量范围研究。在三个中心对46例患者进行了评估。每个中心的患者按年龄分层为4至6岁、7至9岁、10至12岁。单次、两次或三次吸入，同时给予另一双盲、随机、安慰剂剂量。支气管扩张定义为第一秒用力呼气容积（FEV1）较基线增加15%或更多。记录每位患者的起效时间、最大改善程度和作用持续时间。记录每位患者的系列脉搏率、血压和呼吸频率测定值。

结果

根据剂量不同，56.6%至71%的患者在5分钟内起效。平均最大改善程度呈剂量依赖性，总体范围为28.2%至40.3%，峰值反应出现在66.7至69.8分钟。观察到比托特罗剂量与效应大小呈直接关系（P < 0.001）。观察到支气管扩张与基线FEV1之间存在显著相关性，r = 0.732（P < 0.001）。所有剂量下有反应的患者中，中位作用持续时间为3至4小时。高达31%的患者在三次吸入后作用持续时间超过8小时。所有剂量下，46例患者中有5例报告了不良反应，2例患者出现轻度短暂震颤，占4.3%。此外，对脉搏率影响很小，为2.2%。