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在 3 年上市后监测研究期间,对儿童和青少年进行超短疗程免疫疗法。

Ultra-short course immunotherapy in children and adolescents during a 3-yrs post-marketing surveillance study.

机构信息

Pediatric Pulmonology & Allergology, Goethe University, Frankfurt/M, Germany.

出版信息

Pediatr Allergy Immunol. 2010 Feb;21(1 Pt 2):e185-9. doi: 10.1111/j.1399-3038.2009.00953.x. Epub 2009 Dec 8.

Abstract

Ultra-short course immunotherapy (uSCIT) has shown good efficacy and tolerability in children and adolescents with seasonal allergic rhinitis (SAR), conjunctivitis and/or asthma in clinical studies. Here, we investigate the efficacy of uSCIT in the juvenile subpopulation of a 3-year post-marketing surveillance (PMS) study. To assess the differences in the efficacy of uSCIT between adults and children respectively adolescents enrolled in a PMS study. In a prospective open study 422 patients aged 6-18 years with SAR, conjunctivitis and/or asthma received four pre-seasonal injections with pollen allergoids formulated with monophosphoryl lipid A (MPL, Pollinex Quattro) over a minimum of 3 weeks. Efficacy was evaluated by response to therapy and consumption of anti-allergic medication during the pollen season. Tolerability was evaluated by patients' acceptance of therapy. These results were compared with the adult subpopulation of this study. Response to treatment was assessed as good or very good in 94% of patients, mirroring findings for the entire cohort. Further improvements were noted in patients receiving subsequent courses of therapy. Anti-allergic medication use decreased from 83% to 24% of patients after the first treatment course (p < 0.0001). Therapy was well accepted by children/adolescents and considered 'very good' or 'good' by 93% of juveniles. No serious adverse events or cases of anaphylaxis were reported. This subanalysis indicated that uSCIT with Pollinex Quattro had similar efficacy and tolerability in children/adolescents and adults. The convenient dosing regimen and favourable safety profile of uSCIT may support a wider uptake of uSCIT in this patient population.

摘要

超短疗程免疫疗法 (uSCIT) 在季节性过敏性鼻炎 (SAR)、结膜炎和/或哮喘的儿童和青少年的临床研究中显示出良好的疗效和耐受性。在这里,我们调查了 uSCIT 在 3 年上市后监测 (PMS) 研究的青少年人群中的疗效。评估 PMS 研究中分别招募的成年人和儿童在 uSCIT 疗效方面的差异。在一项前瞻性开放研究中,422 名年龄在 6-18 岁的 SAR、结膜炎和/或哮喘患者接受了四剂花粉过敏原与单磷酰脂质 A (MPL,Pollinex Quattro) 预先配制成的季节性免疫治疗,至少间隔 3 周。通过花粉季节的治疗反应和抗过敏药物的使用来评估疗效。通过患者对治疗的接受程度来评估耐受性。这些结果与该研究的成人亚组进行了比较。94%的患者治疗反应良好或非常好,与整个队列的结果一致。进一步的改善在接受后续疗程治疗的患者中观察到。第一疗程后,患者的抗过敏药物使用率从 83%降至 24%(p<0.0001)。儿童/青少年对治疗的接受程度良好,93%的青少年认为治疗“非常好”或“好”。没有严重不良事件或过敏反应的报告。这项亚分析表明,Pollinex Quattro 的 uSCIT 在儿童/青少年和成人中具有相似的疗效和耐受性。uSCIT 方便的给药方案和良好的安全性特征可能支持在该患者群体中更广泛地采用 uSCIT。

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