哮喘联盟

   摘要
   背景:奥马珠单抗已证明对中重度过敏性哮喘有临床作用。然而，尚没有在日本儿童中的研究证实过。 本研究的目的是评价包括抑制游离IgE的功效和奥马珠单抗在患有重度哮喘的日本儿童身上的安全性。主要目标是检测血清中游离IgE水平是否降至低于25 ng/ml（目标抑制水平）。
   方法:38名日本儿童(6～15岁）尽管吸入糖皮质激素（>200 μg/day丙酸氟替卡松或等效品）仍为严重过敏性哮喘，使用2种或以上控制器附加奥马珠单抗的治疗，这是一项为期24周，多中心，非对照，非盲的研究。
   结果:24周后的游离IgE的几何平均值是15.6 ng/mL。相较于基线水平，总的哮喘症状评分、每日活动评分和夜间睡眠评分在24周时都显著改善。哮喘急性发作率和住院率较于基线分别降低 69.2%和78.2% (p < 0.001)。生活质量评分显著改善 (p < 0.001).。另外，11例 (28.9%) 患者减少了哮喘控制药物的使用。 36例(94.7%)患者在治疗过程中经受至少一次不良反应。所有的不良反应都是轻到中度的，未发现新的安全性问题。没有患者中途退出研究。
   结论:对于患有重度哮喘的日本儿童，奥马珠单抗降低游离IgE水平至低于25 ng/mL。奥马珠单抗可以改善哮喘控制并且耐受良好。
 

（苏欣 审校）
Allergol Int.2015 Oct;64(4):364-70. doi: 10.1016/j.alit.2015.05.006. Epub 2015 Jun 10.


 

Omalizumab in Japanese children with severe allergic asthma uncontrolled with standard therapy.
 

Odajima H1, Ebisawa M2, Nagakura T3, Fujisawa T4, Akasawa A5, Ito K6, Doi S7, Yamaguchi K8, Katsunuma T9, Kurihara K10, Kondo N11, Sugai K12,Nambu M13, Hoshioka A14, Yoshihara S15, Sato N16, Seko N16, Nishima S17.
 

Abstract
BACKGROUND:Omalizumab has demonstrated clinical benefits in children with moderate to severe allergic asthma. However, no studies have been performed in Japanese asthmatic children. The aim of this study was to evaluate the efficacy including free IgE suppression and safety of omalizumab in Japanese children with severe allergic asthma. The primary objective was to examine whether omalizumab decreases serum free IgE levels to less than 25 ng/ml (target level of suppression).
METHODS:Thirty-eight Japanese children (6-15 years) with uncontrolled severe allergic asthma despite inhaled corticosteroids (>200 μg/day fluticasone propionate or equivalent) and two or more controller therapies received add-on treatment with omalizumab in a 24-week, multicenter, uncontrolled, open-label study.
RESULTS:The geometric mean serum free IgE level at 24 weeks was 15.6 ng/mL. Compared with baseline, total asthma symptom scores, daily activity scores and nocturnal sleep scores at 24 weeks were significantly improved. The rates of asthma exacerbation and hospitalization due to asthma were reduced by 69.2% and 78.2%, respectively (p < 0.001), versus baseline. Quality-of-life scores were also significantly improved (p < 0.001). In addition, 11 (28.9%) patients reduced the dose of any asthma controller medications. Thirty-six (94.7%) patients experienced at least one adverse event during the treatment period. All adverse events were mild or moderate in severity and no new safety concerns were detected. No patients discontinued the study.
CONCLUSIONS:In Japanese children with severe allergic asthma, omalizumab decreased free IgE levels to less than 25 ng/mL. Omalizumab improved asthma control and was well-tolerated, as well.
 

Allergol Int.2015 Oct;64(4):364-70. doi: 10.1016/j.alit.2015.05.006. Epub 2015 Jun 10.