噻托溴铵治疗中重度症状性青少年哮喘:一项通过荟萃分析进行的系统性回顾
2015/10/30
摘要
背景:噻托溴铵治疗青少年哮喘疗效尚不明确。
目的:本文旨在评估吸入噻托溴铵治疗青少年中重度哮喘的有效性和安全性。
方法:本系统性回顾纳入随机、安慰剂对照试验。首要研究终点是1秒钟用力呼气量(FEV1)的最高值和最低值。
结果:该分析纳入3项研究(约1000名患者)。相较于安慰剂组,噻托溴铵治疗后FEV1最高值及最低值显著提高,最高值(基于基线水平的均数改变)升高120 mL (P < .001),最低值升高 (P < .001)。与安慰剂组相比,噻托溴铵显著降低应用哮喘控制问卷7定义的病情加重事件(评分较试验基线下降0.5或更多)的患者比例(2.1%比4.8%,需治疗患者38例);同时相较于安慰剂组,噻托溴铵显著降低至少发生过一次急性加重的患者数量(17.6比23.8%,需治疗患者16例)。试验中缓解药物使用、退出人数、因不良事件退出人数,不良事件发生率(27.3%比27.1%)及严重不良事件发生率(6.5%比7.1%)均无显著差异。使用噻托溴铵2.5μg每日一次与5.0μg 每日一次效果相同。
结论:在患有中重度哮喘的青少年患者中,使用吸入性糖皮质激素或添加了长效β受体激动药的糖皮质激素维持治疗的同时使用噻托溴铵耐受性良好且有效。现有数据并没有显示使用噻托溴铵5.0μg每日一次(成人剂量)相较于2.5μg每日一次具有优势。
(杨冬 审校)
AnnAllergy Asthma Immunol. 2015Jul28.pii:S1081-1206(15)00445-7.doi:10.1016/j.anai.2015.06.029. [Epub ahead of print]
Tiotropium for the treatment of adolescents with moderate to severe symptomaticasthma: a systematic review with meta-analysis.
Rodrigo GJ1, Castro-Rodríguez JA2.
Abstract
BACKGROUND:The role of tiotropium for the treatment of adolescents with asthma has not yet been clearly defined.
OBJECTIVE:To assess the efficacy and safety of inhaled tiotropium in adolescents with moderate to severe symptomatic asthma.
METHODS:Randomized, placebo-controlled trials were included in this systematic review. Primary outcomes were peak and trough forced expiratory volume in 1 second (FEV1).
RESULTS:Three studies (approximately 1,000 patients) were included. Tiotropium was associated with significant improvements in FEV1 peak (mean change from baseline) by 120 mL (P < .001) and trough by 100 mL (P < .001) compared with placebo. Tiotropium significantly reduced the percentage of patients who experienced an Asthma Control Questionnaire 7 worsening episode defined as a change from trial baseline of 0.5 points or more compared with placebo (2.1% vs 4.8%, number needed to treat = 38) and also was associated with a significantly decreased in the number of patients with at least one exacerbation compared with placebo (17.6 vs 23.8%, number needed to treat = 16). Finally, no significant differences were found in rescue medication use, withdrawals, withdrawals due to adverse events (AEs), AEs (27.3% vs 27.1%), and serious AEs (6.5% vs 7.1%). Tiotropium in doses of 2.5 μg once daily or 5.0 μg once daily resulted in equivalent effects.
CONCLUSIONS:Tiotropium was well tolerated and efficacious as an addition to maintenance treatment with an inhaled corticosteroid or an inhaled corticosteroid plus a long-acting β-agonist in adolescents with moderate to severe asthma. Available data do not suggest an advantage of the 5-μg once-daily dose (used in adults) compared with the 2.5-μg once-daily dose of tiotropium.
AnnAllergy Asthma Immunol. 2015Jul28.pii:S1081-1206(15)00445-7.doi:10.1016/j.anai.2015.06.029. [Epub ahead of print]
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75岁以上患者中的严重不可控哮喘:奥马珠单抗治疗
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在瑞典临床实践中,哮喘人群的布地奈德吸入装置的切换模式