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[季节性变应性鼻炎的集群免疫疗法:长效变应原类毒素(普雷沙尔)诱导治疗的安全性]

[Cluster-immunotherapy in seasonal allergic rhinitis: safety aspects of induction therapy with depot allergoids (Purethal)].

作者信息

Hansen I, Hörmann K, Stuck B A, Schneider-Gêne S, Mösges R, Klimek L

机构信息

HNO-Universitätsklinik Mannheim, Ruprecht-Karls-Universität Heidelberg.

出版信息

Laryngorhinootologie. 2003 Aug;82(8):558-63. doi: 10.1055/s-2003-41234.

Abstract

BACKGROUND

Specific immunotherapy (SIT) represents the only specific treatment that can be offered to allergic patients apart from allergen avoidance. SIT has been widely used in pollen allergic rhinitis. Clinical efficacy has been demonstrated in several controlled clinical trials and depends on the specific allergen the individual patient is sensitive to, the quality and total amount of allergen applied, and the SIT schedule. In classic SIT, gradually increasing dosages of the allergen extract are injected subcutaneously. Several dosage schedules for subcutaneous SIT can be applied. In Cluster-SIT, 2 - 3 injections per day of treatment are given once a week during induction treatment.

PATIENTS

In this study, we investigated 64 patients (33 female, 31 male) from 18 to 54 years (26.9 +/- 5.1 years) in terms of side-effects of Cluster-SIT during induction treatment.

RESULTS

The total amount of enlarged local reactions (> grade 1) was n = 77 or 15.2 % of all injections. Of these, 68 (88 %) were classified as immediate reactions, 8 (11 %) were late phase reactions and 1 (1 %) was immediate as well as late phase reaction. Of all enlarged local reactions, 48 (62 %) were grade 1 reactions, 13 (17 %) were grade 2 reactions, 13 (17 %) were grade 3 reactions and 1 (1 %) was a grade 4 reaction. The total amount of systemic reactions was n = 22 or 4.3 % of all injections. Of these, 19 (86 %) were classified as immediate reactions, 3 (14 %) were delayed reactions. Of all systemic reactions, 18 (82 %) were grade 1 reactions and 4 (18 %) grade 2 reactions. Grade 3 or grade 4 reactions did not occur. There were no differences in gender or age regarding the occurrence of side effects (all p > 0.05).

CONCLUSIONS

Frequency and severity of adverse side effects in Cluster-SIT correspond to those in other dosage schedules. On behalf of security aspects, Cluster-SIT could become an interesting alternative dosage schedule for dose increase during SIT. Furthermore, in Cluster-SIT with allergoids, induction treatment can be carried out in two treatment days of approximately 2.5 hours each.

摘要

背景

特异性免疫疗法(SIT)是除避免接触过敏原外唯一可用于过敏患者的特异性治疗方法。SIT已广泛应用于花粉过敏性鼻炎。多项对照临床试验已证明其临床疗效,疗效取决于个体患者所敏感的特定过敏原、所应用过敏原的质量和总量以及SIT方案。在经典的SIT中,逐渐增加剂量的过敏原提取物皮下注射。皮下SIT可采用多种剂量方案。在集群式SIT中,诱导治疗期间每周一次,每天进行2至3次注射治疗。

患者

在本研究中,我们调查了64例年龄在18至54岁(26.9±5.1岁)的患者(33例女性,31例男性)诱导治疗期间集群式SIT的副作用。

结果

局部反应增大(>1级)的总数为n = 77,占所有注射次数的15.2%。其中,68例(88%)为速发反应,8例(11%)为迟发反应,1例(1%)为速发及迟发反应。在所有局部反应增大中,48例(62%)为1级反应,13例(17%)为2级反应,13例(17%)为3级反应,1例(1%)为4级反应。全身反应总数为n = 22,占所有注射次数的4.3%。其中,19例(86%)为速发反应,3例(14%)为迟发反应。在所有全身反应中,18例(82%)为1级反应,4例(18%)为2级反应未出现3级或4级反应。副作用的发生在性别或年龄方面无差异(所有p>0.05)。

结论

集群式SIT中不良副作用的频率和严重程度与其他剂量方案相当。从安全性角度来看,集群式SIT可能成为SIT期间增加剂量的一种有趣的替代剂量方案。此外,在使用变应原疫苗的集群式SIT中,诱导治疗可在两个约2.5小时的治疗日内进行。

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