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对于因草花粉引起的过敏性鼻炎和/或哮喘的儿科患者,不增加剂量舌下含服片剂中的单体变应原的疗效、安全性和耐受性。

Efficacy, safety and tolerability of sublingual monomeric allergoid in tablets given without up-dosing to pediatric patients with allergic rhinitis and/or asthma due to grass pollen.

作者信息

Agostinis F, Foglia C, Bruno M E, Falagiani P

机构信息

Pediatric Division, Ospedali Riuniti, Bergamo.

出版信息

Eur Ann Allergy Clin Immunol. 2009 Dec;41(6):177-80.

PMID:20128231
Abstract

The efficacy and safety of monomeric allergoid (Lofarma, Milan) have been demonstrated in adults but very few studies have examined it in children. This study therefore investigated the efficacy and safety of this sublingual immunotherapy (SLIT) at the dosage of 1000 AU five times a week without any up-dosing. Forty allergic children (17 M and 23 F, mean age 7 years, range 4-16 years), 16 with rhinitis and 24 with rhinitis and asthma, were randomized to SLIT or drug therapy. All the patients were sensitized to grass; some were also sensitized, though to a lesser extent, to Parietaria, Olea and Betulaceae. The patients were treated pre-/co-seasonally for two years. A visual analogue scale (VAS) was used at baseline and at the end of the first and second pollen seasons to rate the patients' well-being. The VAS score was significantly higher after both the first and the second year of treatment in the SLIT group than in the controls (p<0.05). It improved in comparison to baseline only in the active group. All 40 children tolerated the therapy very well. The monomeric allergoid at the dosage of 5000 AU/week thus appears to have a good efficacy and safety profile in children.

摘要

单体变应原疫苗(罗法马公司,米兰)在成人中的疗效和安全性已得到证实,但针对儿童的研究却很少。因此,本研究调查了这种舌下免疫疗法(SLIT)在每周五次、每次1000AU剂量且不进行任何剂量递增情况下的疗效和安全性。40名过敏儿童(17名男性和23名女性,平均年龄7岁,年龄范围4至16岁),其中16名患有鼻炎,24名患有鼻炎和哮喘,被随机分为接受舌下免疫疗法组或药物治疗组。所有患者均对草过敏;部分患者还对墙草属、油橄榄属和桦木科过敏,不过程度较轻。患者在花粉季节前/期间接受了两年的治疗。在基线以及第一个和第二个花粉季节结束时,使用视觉模拟量表(VAS)对患者的健康状况进行评分。与对照组相比,舌下免疫疗法组在治疗的第一年和第二年结束后,VAS评分均显著更高(p<0.05)。仅在治疗组中,与基线相比评分有所改善。所有40名儿童对该疗法耐受性良好。因此,每周5000AU剂量的单体变应原疫苗在儿童中似乎具有良好的疗效和安全性。

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