Ibero M, Castillo M J
Unitat d'Allergia, Hospital de Terrassa, Barcelona, Spain.
J Investig Allergol Clin Immunol. 2006;16(3):194-202.
The clinical efficacy of allergen immunotherapy using therapeutic vaccines containing modified allergen extracts has been previously shown.
To evaluate the clinical efficacy of a vaccine containing depigmented, polymerized extract of Dermatophagoides pteronyssinus in asthmatic children, monosensitized to mites, after 4 months of treatment.
A total of 30 mite-allergic, asthmatic children (age range, 8-16 years) were entered in the study; 15 were treated with the modified allergen extract (active group) and 15 received only pharmacologic treatment (control group). The study was open, controlled and parallel with random allocation of the patients to each of the groups. Efficacy was evaluated using allergen-specific bronchial challenge tests, dose-response skin-prick tests, and symptom and medication scores. The results of the bronchial challenges and dose-response skin-prick tests were compared at baseline and after 4 months of treatment. The build up phase consisted of 4 injections in 2 days, followed by 4 injections of the maintenance dose.
All patients of the active group concluded the study, whereas 2 of the control group did not. In the active group, there was a significant difference in the PC20FEV1 (P <.01) after 4 months. The mean allergen quantity needed was 26 microg at baseline vs. 309 microg after 4 months (a 12.8-fold increase). There was no difference in the control group (5 tg at baseline vs 8 microg at the end). A significant reduction in the number of cases with dual bronchial response was observed in the treated group (P < .05). Two treated patients of this group experienced a negative bronchial challenge after 4 months of treatment. The group of active patients also experienced significant improvement in skin reactivity and symptom and medication scores.
Vaccines containing depigmented polymerized extracts of D pteronyssinus are safe and effective in the treatment of mite allergic asthmatic children, and provide clinical benefit after 4 months of treatment.
先前已证实使用含有改良变应原提取物的治疗性疫苗进行变应原免疫治疗的临床疗效。
评估一种含有尘螨去色素聚合提取物的疫苗对单一致敏于螨的哮喘儿童治疗4个月后的临床疗效。
共有30名单一致敏于螨的哮喘儿童(年龄范围8至16岁)纳入本研究;15名接受改良变应原提取物治疗(治疗组),15名仅接受药物治疗(对照组)。本研究为开放性、对照性且平行设计,患者随机分配至各组。采用变应原特异性支气管激发试验、剂量反应性皮肤点刺试验以及症状和药物评分评估疗效。比较支气管激发试验和剂量反应性皮肤点刺试验在基线及治疗4个月后的结果。起始阶段为2天内注射4针,随后注射4针维持剂量。
治疗组所有患者均完成研究,而对照组有2名患者未完成。治疗组在治疗4个月后PC20FEV1有显著差异(P <.01)。基线时所需变应原平均量为26微克,4个月后为309微克(增加了12.8倍)。对照组无差异(基线时5微克,结束时8微克)。治疗组双相支气管反应病例数显著减少(P <.05)。该组2名接受治疗的患者在治疗4个月后支气管激发试验结果为阴性。治疗组患者的皮肤反应性以及症状和药物评分也有显著改善。
含有尘螨去色素聚合提取物的疫苗治疗螨过敏性哮喘儿童安全有效,治疗4个月后可带来临床益处。