吸入糖皮质激素后未控制的儿童哮喘的升级治疗
2010/04/08
背景：缺乏用以指导吸入低剂量糖皮质激素未控制的儿童哮喘患者升级治疗的研究。
方法：我们将182名吸入氟替卡松100ug每日2次未控制的儿童哮喘患者（6-17岁）随机分成3组：氟替卡松250ug Bid（ICS升级组）；氟替卡松100ug Bid加上长效β受体激动剂50ug Bid（LABA升级组）；氟替卡松100ug Bid加上5或10mg白三烯受体拮抗剂（LTRA升级组）。我们运用三重交叉法，观察三个结果的组合（急性加重，哮喘控制天数，第一秒用力呼气量），对升级治疗有不同反应的频率超过25%有统计学意义。
结果：最终入选165名儿童哮喘患者中有161名治疗效果好于升级治疗前（P<0.001）。LABA升级组的治疗反应最好，LTRA 升级组 (相对概率, 1.6; 95% 可信区间, 1.1 to 2.3; P = 0.004) 和 ICS 升级组 (相对概率, 1.7; 95% 可信区间, 1.2 to 2.4; P = 0.002)。随机分组之前哮喘控制评分高分者（指升级前为控制良好者）可做为对LABA治疗反应好的预测指标(P = 0.009)。白种人对LABA升级组治疗反应好，而黑种人对LTRA升级组治疗反应最不好。
结论：几乎所有入选的哮喘患儿对每种升级治疗都有不同的治疗反应。LABA升级组的治疗反应好于ICS升级组和LTRA升级组，差异有统计学意义。然而，还有许多患儿对于ICS升级组或LTRA升级组呈现出更好的治疗反应。说明规律监测每一名哮喘患儿的病情，并根据监测情况正确调整治疗，较固定的升级方案更为重要。
（张晓岩 卫生部中日友好医院呼吸内科 100029 摘译）
(Lemanske RF Jr, Mauger DT,et al. N Engl J Med. 2010 Mar 18;362(11):975-85. Epub 2010 Mar 2.)
Step-up Therapy for Children with Uncontrolled Asthma Receiving Inhaled Corticosteroids.
Lemanske RF Jr, Mauger DT,et al. N Engl J Med. 2010 Mar 18;362(11):975-85. Epub 2010 Mar 2.
Background
For children who have uncontrolled asthma despite the use of low-dose inhaled
corticosteroids (ICS), evidence to guide step-up therapy is lacking.
Methods
We randomly assigned 182 children (6 to 17 years of age), who had uncontrolled
asthma while receiving 100 μg of fluticasone twice daily, to receive each of three
blinded step-up therapies in random order for 16 weeks: 250 μg of fluticasone
twice daily (ICS step-up), 100 μg of fluticasone plus 50 μg of a long-acting betaagonist
twice daily (LABA step-up), or 100 μg of fluticasone twice daily plus 5 or 10 mg
of a leukotriene-receptor antagonist daily (LTRA step-up). We used a triple-crossover
design and a composite of three outcomes (exacerbations, asthma-control days,
and the forced expiratory volume in 1 second) to determine whether the frequency
of a differential response to the step-up regimens was more than 25%.
Results
A differential response occurred in 161 of 165 patients who were evaluated (P<0.001).
The response to LABA step-up therapy was most likely to be the best response, as
compared with responses to LTRA step-up (relative probability, 1.6; 95% confidence
interval [CI], 1.1 to 2.3; P = 0.004) and ICS step-up (relative probability, 1.7; 95% CI,
1.2 to 2.4; P = 0.002). Higher scores on the Asthma Control Test before randomization
(indicating better control at baseline) predicted a better response to LABA
step-up (P = 0.009). White race predicted a better response to LABA step-up, whereas
black patients were least likely to have a best response to LTRA step-up (P = 0.005).
Conclusions
Nearly all the children had a differential response to each step-up therapy. LABA
step-up was significantly more likely to provide the best response than either ICS or
LTRA step-up. However, many children had a best response to ICS or LTRA step-up
therapy, highlighting the need to regularly monitor and appropriately adjust each
child’s asthma therapy. (ClinicalTrials.gov number, NCT00395304.)
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难治性哮喘持续气道炎症的治疗靶点
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哮喘患儿早期糖皮质激素治疗不能改善10岁时的肺功能
