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一项关于使用质量单位标准化提取物对螨过敏患者进行免疫治疗的前瞻性安全性监测研究。

A prospective safety-monitoring study of immunotherapy in mite-allergy patients with mass-units-standardized extract.

作者信息

González de la Cuesta C, Feijoo R, Rico P

机构信息

Immunotherapy Unit, Hospital Santa María Madre, Orense, Spain.

出版信息

Allergy. 1997 May;52(5):580-3. doi: 10.1111/j.1398-9995.1997.tb02604.x.

DOI:10.1111/j.1398-9995.1997.tb02604.x
PMID:9201372
Abstract

To determine the tolerance of an allergen extract standardized in mass units, we closely monitored the side-effects, during the buildup phase of immunotherapy treatment, in 88 patients with well-documented respiratory allergy to house-dust mite (Dermatophagoides pteronyssinus). Thirty-four patients (38.6%) suffered from moderate perennial rhinitis, and 54 had mild to moderate bronchial asthma (61.4%). For the desensitizing treatment, we used a depot extract adsorbed in aluminum hydroxide of D. pteronyssinus (Pangramin Depot UM), biologically standardized and having the major allergens Der p 1 and Der p 2 quantified in micrograms. A total of 1244 doses were administered. All patients except one (98.9%) reached the expected maximum dose of 4 micrograms Der p 1. Only five patients suffered mild adverse reactions (5.7%). All adverse reactions except one appeared to be related to the vial of maximum concentration: vial III (4 micrograms Der p 1). Considering the number of patients who had adverse reactions and the frequency of adverse reactions per dose, we found no significant differences between rhinitis and asthma sufferers. We think that immunotherapy in doses of 4 micrograms Der p 1 and 2 micrograms Der p 2 is well tolerated and should not be avoided in mildly to moderately asthmatic patients when treating house-dust mite allergy.

摘要

为确定以质量单位标准化的变应原提取物的耐受性,我们在免疫治疗的递增阶段,对88例有充分记录的对屋尘螨(粉尘螨)有呼吸道过敏反应的患者的副作用进行了密切监测。34例患者(38.6%)患有中度常年性鼻炎,54例患有轻度至中度支气管哮喘(61.4%)。对于脱敏治疗,我们使用了一种吸附于氢氧化铝的粉尘螨长效提取物(泛敏补长效单位制剂),该提取物经过生物学标准化,主要变应原Der p 1和Der p 2的含量以微克计。总共给予了1244剂。除1例患者外(98.9%),所有患者均达到了4微克Der p 1的预期最大剂量。只有5例患者出现轻度不良反应(5.7%)。除1例不良反应外,所有不良反应似乎都与最高浓度的药瓶有关:药瓶III(4微克Der p 1)。考虑到出现不良反应的患者数量和每剂不良反应的发生率,我们发现鼻炎患者和哮喘患者之间没有显著差异。我们认为,对于屋尘螨过敏的轻度至中度哮喘患者,4微克Der p 1和2微克Der p 2剂量的免疫治疗耐受性良好,不应避免使用。

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A prospective safety-monitoring study of immunotherapy in mite-allergy patients with mass-units-standardized extract.一项关于使用质量单位标准化提取物对螨过敏患者进行免疫治疗的前瞻性安全性监测研究。
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