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背景难治性哮喘儿童,尽管采用了低剂量吸入性皮质激素(ICS),但还缺乏可指导递增剂量疗法的证据。方法将患难治性哮喘,用氟替卡松100μg 2次/d 182例儿童(6至17岁)随机分组,接受1种三盲递增疗法组,16周:氟替卡松250μg 2次/d(ICS递增);氟替卡松100μg+50μg长效β-促效剂,2次/d(LABA递增);氟替卡松100μg,2次/d+5或10mg白细胞三烯受体拮抗剂,1次/d(LTRA递增)。我们采用了三元设计和三种结果组合(恶化、哮喘控制天数和1秒用力呼气量),以确定递增疗法差异性反应发生频率是否>25%。结果经评估,165例中有161例患者发生了差异性反应(P<0.001)。与LTRA递增疗法[相对概率1.6;95%CI(1.1,2.3);P=0.004]和ICS递增疗法[相对概率1.7;95%CI(1.2,2.4);P=0.002]比较,对LABA递增疗法反应最好。在做LABA随机化前(提示基线水平控制较好),哮喘控制测试分数要高,说明对LABA递增疗法反应要好(P=0.009)。白人对LABA递增疗法预示反应要好,而黑人对LTRA递增疗法产生最佳反应的可能性最小(P=0.005)。结论几乎所有儿童对每种递增疗法都产生了差异性反应。与用ICS或LTRA递增疗法比较,LABA递增疗法更有可能产生最佳反应。然而,许多儿童对ICS或LTRA递增疗法反应最好,对每例儿童哮喘的治疗做恰当调节,亮化了对常规监测的需求。
Background Children with refractory asthma lack evidence of an escalating dose regimen in spite of low-dose inhaled corticosteroids (ICS). Methods A total of 182 children (aged 6 to 17 years) with fluticasone 100 μg twice daily were randomized to receive a triple-blind incremental therapy regimen for 16 weeks: 250 μg fluticasone 2 times daily (ICS increase), fluticasone 100μg + 50μg long-acting β-agonist, 2 times / d (LABA increase); fluticasone 100μg, 2 times / d + 5 or 10mg leukotriene receptor antagonist, 1 time / L (LTRA increase). We used a ternary design and a combination of three outcomes (deterioration, days of asthma control, and forced expiratory volume of 1 second) to determine if the frequency of response to progressive therapy was> 25%. Results A total of 161 patients in 165 patients were evaluated as having a differential response (P <0.001). Compared with LTRA incremental therapy (relative probability 1.6; 95% CI (1.1,2.3); P = 0.004] and ICS incremental therapy [relative probability 1.7; 95% CI (1.2,2.4); P = 0.002] The best response. Prior to LABA randomization (indicating better baseline control), the asthma control test scores were higher, indicating better response to LABA incremental therapy (p = 0.009). Whites responded better to LABA ascending regimens and blacks were least likely to respond optimally to LTRA regimen (P = 0.005). Conclusions Almost all children have a differential response to each incremental treatment. LABA asymptomatic therapy is more likely to produce the best response compared with ICS or LTRA asymptomatic therapy. However, many children respond best to ICS or LTRA regimens, adjusting the treatment of each child’s asthma appropriately and highlighting the need for routine monitoring.