沙丁胺醇多剂量干粉吸入器在持续性哮喘患者中使用12周和52周的安全性
2016/05/26
摘要
目的：沙丁胺醇多剂量干粉吸入器（MDPI）是在持续性哮喘患者中使用的一种新型的吸气驱动装置，不需要手口协同。本文将对其安全性进行评价。
方法：我们报道的大量的安全性数据来自于两个研究，一是两个12周、多中心、随机、双盲、重复剂量、平行组研究，另一个是52周多中心安全性研究的12周双盲阶段，以及52周安全研究的40周开放标签阶段。
在每一个研究中，适应症患者年龄≥12岁，有持续性哮喘，接受安慰剂MDPI或沙丁胺醇180µg（2吸× 90µg /吸）每天四次，持续12周。在52周的安全性研究中的40周的开放标签期，患者根据需要接受沙丁胺醇MDPI 180μg（2吸×90μg /吸）PRN）。
结果：在两个12周研究和52周研究中的12周的双盲阶段，安慰剂MDPI组（50%；n=333）的不良事件发生率比沙丁胺醇MDPI组（40%；n = 321）更高；最常见的是上呼吸道感染（安慰剂MDPI：11%、沙丁胺醇MDPI 10%）、鼻咽炎（6%，5%）和头痛（6%，4%）。对β2激动剂相关的事件的发生率（不包括头痛）在两组12周给药期间均很低（≤1%）。在40周的开放标签期用沙丁胺醇MDPI PRN的安全性 [最常见的不良事件： 鼻咽炎（12%）、鼻窦炎（11%）、上呼吸道感染（9%）]与在12周观察到的汇总分析是相似的。
结论：在这些研究中，沙丁胺醇MDPI 180μg的安全性与安慰剂MDPI相当，且与既往哮喘患者所使用的沙丁胺醇制剂的安全性数据相一致。
（苏欣 审校）
J Asthma. 2016 Mar;53(2):187-93. doi: 10.3109/02770903.2015.1070862. Epub 2015 Sep 15.
Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma.
Raphael G1, Taveras H2, Iverson H2, O'Brien C2, Miller D3.
Author information
Abstract
OBJECTIVE:Evaluate the safety of albuterol multidose dry powder inhaler (MDPI), a novel, inhalation-driven device that does not require coordination of actuation with inhalation, in patients with persistent asthma.
METHODS:We report pooled safety data from two 12-week, multicenter, randomized, double-blind, repeat-dose, parallel-group studies and the 12-week double-blind phase of a 52-week multicenter safety study as well as safety data from the 40-week open-label phase of the 52-week safety study. In each study, eligible patients aged ≥12 years with persistent asthma received placebo MDPI or albuterol MDPI 180 µg (2 inhalations × 90 µg/inhalation) 4 times/day for 12 weeks. In the 40-week open-label phase of the 52-week safety study, patients received albuterol MDPI 180 μg (2 inhalations × 90 μg/inhalation) as needed (PRN).
RESULTS:During both 12-week studies and the 12-week double-blind phase of the 52-week study, adverse events were more common with placebo MDPI (50%; n = 333) than albuterol MDPI (40%; n = 321); most frequent were upper respiratory tract infection (placebo MDPI 11%, albuterol MDPI 10%), nasopharyngitis (6%, 5%), and headache (6%, 4%). Incidences of β2-agonist-related events (excluding headache) during the pooled 12-week dosing periods were low (≤1%) in both groups. The safety profile with albuterol MDPI PRN during the 40-week open-label phase [most frequent adverse events: nasopharyngitis (12%), sinusitis (11%), upper respiratory tract infection (9%)] was similar to that observed during the 12-week pooled analysis.
CONCLUSIONS:The safety profile of albuterol MDPI 180 μg in these studies was comparable with placebo MDPI and consistent with the well-characterized profile of albuterol in patients with asthma.
KEYWORDS:Albuterol; asthma; dry powder inhaler; inhalation device; safety
J Asthma. 2016 Mar;53(2):187-93. doi: 10.3109/02770903.2015.1070862. Epub 2015 Sep 15.
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