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[奥马珠单抗治疗儿童难治性哮喘:在哥伦比亚开展的一项真实世界研究]

[Omalizumab in children with uncontrolled asthma: a real-life study carried out in Colombia].

作者信息

Morales-Múnera Olga, Pedraza Ángela, Niño-Serna Laura

机构信息

Hospital San Vicente Fundación, Departamento de Pediatría, Medellín, Colombia.

出版信息

Rev Alerg Mex. 2018 Jul-Sep;65(3):222-232. doi: 10.29262/ram.v65i3.510.

Abstract

BACKGROUND

Omalizumab efficacy and safety in children older than 6 years has been clearly demonstrated in controlled clinical trials, but only in few real-life studies.

OBJECTIVE

To assess the response with omalizumab addition in children with moderate to severe persistent asthma in real-life conditions.

METHODS

Observational study with a 12-month real-life follow-up in a group of 61 children older than 6 years who were assessed for asthma control before treatment was started and at 4 and 12 months.

RESULTS

After 12 months of treatment with omalizumab, there was symptom improvement both for those younger and older than 12 years (p = 0.001). There was a decrease in controller drug consumption in 73% of patients; in 61%, inhaled corticosteroid dose was reduced, and 8% discontinued its use. Inhaled corticosteroid average dose was decreased to 396 ± 298 µg, with this being statistically significant (p = 0.02).

CONCLUSION

Omalizumab is an efficacious, safe and well-tolerated drug as add-on therapy for clinical control of moderate and severe allergic asthma that has not improved with standard therapies.

摘要

背景

在对照临床试验中已明确证明奥马珠单抗对6岁以上儿童的疗效和安全性,但在实际研究中仅有少数报道。

目的

评估在实际临床环境中,加用奥马珠单抗治疗对中重度持续性哮喘患儿的疗效。

方法

对61例6岁以上儿童进行观察性研究,在治疗开始前、治疗4个月及12个月时评估哮喘控制情况,进行为期12个月的随访。

结果

使用奥马珠单抗治疗12个月后,12岁及以上和12岁以下患儿的症状均有改善(p = 0.001)。73%的患者控制药物用量减少;61%的患者吸入性糖皮质激素剂量减少,8%的患者停用吸入性糖皮质激素。吸入性糖皮质激素的平均剂量降至396±298μg,具有统计学意义(p = 0.02)。

结论

对于标准治疗效果不佳的中重度过敏性哮喘,奥马珠单抗作为附加治疗药物,在临床控制方面有效、安全且耐受性良好。

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