Criado Molina A, Guerra Pasadas F, Daza Muñoz J C, Moreno Aguilar C, Almeda Llamas E, Muñoz Gomariz E, Font Ugalde P, Alonso Díaz C, Germán Cárdenas M, Sánchez Guijo P
Departamento de Medicina. Unidad de Docente de Patología General. Servicio de Alergia. Hospital Universitario Reina Sofia. Córdoba. España.
Allergol Immunopathol (Madr). 2002 Nov-Dec;30(6):319-30. doi: 10.1016/s0301-0546(02)79147-7.
Studies of immunotherapy with oral Alternaria extracts are scarce. We decided to perform a clinical trial of the clinical safety and efficacy of this extract as well as of its effects on in vivo and in vitro parameters in 39 patients with Alternaria allergy, aged between 7 and 17 years, who are also sensitized extract was used. Allergic activity was determined through RAST inhibition and skin prick test. Quantification of the principal allerten (Alt a 1) was performed through the 2-site binding assay, with a mean content of 34.2 ng Alt a 1/micro g protein. The parameters analyzed were the symptom-medication score, skin prick using the end-point technique, specific bronchial challenge test, peak flow, total and specific IgE and IgG4. Nineteen patiens received active treatment with oral immunotherapy and another 19 received symptomatic treatment. The initial phase of immunotherapy lasted 3 months until the maximum dose was reached. This was maintained for 12 months; the mean accumulated dos was 280,000 PNU. Significant differences were found in reduction in the symptom-medication score in the treated group after 12 months of immunotherapy. No differences were found in the control group. Immunotherapy was well tolerated with 0.42 adverse reactions per 100 doses administered. All adverse reactions were mild-to-moderate. In the treated group, papule size was significantly reduced. Values for the specific bronchial challenge test, expressed through PD20, were significantly higher in the immunotherapy group. Peak flow showed no changes in either group. Values of IgG4 were significantly higher in the immunotherapy group. Total and specific IgE levels showed no significant changes in either group. In conclusion, oral immunotherapy with Alternaria extract is clinically effective in pediatric patients. In general, the therapy was well tolerated. It modified specific cutaneous and bronchial reactivity in our sample and increased levels of specific IgG4, wich are implicated in humoral response.
关于口服链格孢菌提取物免疫疗法的研究很少。我们决定对39名年龄在7至17岁之间、对链格孢菌过敏且也致敏的患者进行该提取物临床安全性和疗效及其对体内和体外参数影响的临床试验。通过RAST抑制和皮肤点刺试验确定过敏活性。通过双位点结合测定法对主要变应原（Alt a 1）进行定量，平均含量为34.2 ng Alt a 1/μg蛋白质。分析的参数包括症状 - 药物评分、采用终点技术的皮肤点刺、特异性支气管激发试验、呼气峰流速、总IgE和特异性IgE以及IgG4。19名患者接受口服免疫疗法的积极治疗，另外19名接受对症治疗。免疫疗法的初始阶段持续3个月直至达到最大剂量。该剂量维持12个月；平均累积剂量为280,000 PNU。免疫疗法12个月后，治疗组的症状 - 药物评分降低有显著差异。对照组未发现差异。免疫疗法耐受性良好，每100剂给药的不良反应为0.42次。所有不良反应均为轻度至中度。在治疗组中，丘疹大小显著减小。通过PD20表示的特异性支气管激发试验值在免疫疗法组中显著更高。呼气峰流速在两组中均无变化。免疫疗法组中IgG4值显著更高。两组中总IgE和特异性IgE水平均无显著变化。总之，链格孢菌提取物口服免疫疗法在儿科患者中临床有效。总体而言，该疗法耐受性良好。它改变了我们样本中的特异性皮肤和支气管反应性，并增加了与体液反应有关的特异性IgG4水平。
