Serrano P, Algorta J, Martínez A, González-Quevedo T, Velázquez E, Díaz M
Department of Allergology, Hospital Virgen del Rocio (Spain).
J Investig Allergol Clin Immunol. 2004;14(4):312-9.
Cluster immunotherapy is becoming an alternative to conventional IT due to its shorter schedule, but the safety of such schedule is still controversial. At present, only few studies assess the risk of immunotherapy in a prospective manner, in well-controlled patients, using the same extract and intending to evaluate a single schedule. The aim of the present study is to evaluate the safety of a cluster immunotherapy administration regimen. A total of 91 outpatients (41 male and 50 female), with a mean age of 25 years old (range: 16-50) were included. Sixty-one patients were diagnosed mild to moderate asthma and 30 rhinoconjunctivitis. Forty-six of the enrolled patients were sensitised to pollen (Lolium perenne and/or Olea europea), 38 to Dermatophagoides pteronyssinus and 7 to Alternaria alternata. Patients received specific immunotherapy following a five-week cluster schedule. It was considered as a preseasonal treatment, that is, it was accomplished before olive and grass initial pollinating months in this area (March--April). A total 1029 injections were administered during the induction phase. Adverse reactions were assessed and classified according to the EAACI criteria. The average number of visits to maximum dose was 6 (range 2-10), and 70 patients (77%) reached the maximum between 5-7 visits. In each of the visits an average of 2 (range 1-3) injections were administered. Eighty-one of the 91 initially enrolled patients (89%) completed the cluster schedule. The total number of reactions were 47 (24 local and 23 systemic). No fatal reactions were observed. Since the total number of administered injections was 1029, the relative frequency of adverse reactions was 4.6% (2.3% local and 2.2% systemic). The percentage of patients affected by systemic reaction was 18% and by local reaction 14%. No relationship can be shown between adverse reactions and gender or disease. However, a clear relationship with the composition of immunotherapy has been shown, with a lower risk of adverse reactions associated with the extract of D. pteronyssinus. The shorter period required to achieve the maintenance dose, with a similar frequency of adverse events, leads to the conclusion that the proposed administration regimen can be an alternative to conventional schedule to increase patient compliance.
由于疗程较短，集群免疫疗法正成为传统免疫疗法的一种替代方法，但这种疗程的安全性仍存在争议。目前，只有少数研究以前瞻性方式评估免疫疗法的风险，研究对象为病情得到良好控制的患者，使用相同的提取物，并打算评估单一疗程。本研究的目的是评估集群免疫疗法给药方案的安全性。共纳入91名门诊患者（41名男性和50名女性），平均年龄25岁（范围：16 - 50岁）。61名患者被诊断为轻度至中度哮喘，30名患有鼻结膜炎。46名入选患者对花粉（黑麦草和/或油橄榄）过敏，38名对粉尘螨过敏，7名对链格孢属过敏。患者按照为期五周的集群疗程接受特异性免疫疗法。该疗法被视为季节性前治疗，即在该地区油橄榄和草开始授粉的月份（3月至4月）之前完成。诱导期共注射1029针。根据欧洲变态反应和临床免疫学会（EAACI）标准评估并分类不良反应。达到最大剂量的平均就诊次数为6次（范围2 - 10次），70名患者（77%）在5 - 7次就诊时达到最大剂量。每次就诊平均注射2针（范围1 - 3针）。91名最初入选的患者中有81名（89%）完成了集群疗程。反应总数为47次（24次局部反应和23次全身反应）。未观察到致命反应。由于注射总次数为1029次，不良反应的相对发生率为4.6%（局部反应2.3%，全身反应2.2%）。受全身反应影响的患者百分比为18%，受局部反应影响的为14%。不良反应与性别或疾病之间无关联。然而，已表明与免疫疗法的成分有明确关系，与粉尘螨提取物相关的不良反应风险较低。达到维持剂量所需时间较短，且不良事件发生率相似，由此得出结论，所提议的给药方案可作为传统疗程的替代方案，以提高患者的依从性。
