Ear, Nose, and Throat Clinic, University of Siena, Siena, Italy.
Acta Otorhinolaryngol Ital. 2010 Jun;30(3):131-7.
Sublingual immunotherapy with monomeric allergoid, given according to the standard schedule, was reported to be effective and safe in many clinical trials. However, a long period of time may elapse before achievement of a clinical benefit. This study was thus performed using two different shortened (4-day) induction (= up-dosing) schedules, which allowed a rapid achievement of the maintenance dosage. Overall, 86 patients suffering from rhinitis and oculorhinitis have been recruited, none of whom had received immunotherapy before. The study design was prospective, randomized, with three parallel groups receiving, according to a randomization list, one of the three induction (two up-dosing one no-up-dosing) phase schedules under study. A fourth group of patients served as controls, and did not receive any sublingual immunotherapy but only rescue medications if and when necessary. All patients were evaluated to assess their baseline conditions, and thereafter at 3 and 6 months. The evaluation parameters were: Visual Analogue Scale, symptom-medication scores, nasal provocation test. All three induction schedules under study were well accepted by the patients, with very few adverse reactions. The clinical efficacy, evaluated with Visual Analogue Scale (p < 0.001), symptom-medication scores (p < 0.02) and nasal provocation tests (p < 0.01), was found to be significant in all three sublingual immunotherapy-treated groups of 64 (n86) patients, but was not significant in controls 22 (n86). According to the Authors, with this simplified schedule process, sublingual immunotherapy is a therapeutic option that is becoming increasingly well-accepted not only by allergy specialists but also by patients.
舌下免疫治疗用单体过敏原，按照标准方案给药，在许多临床试验中被报道是有效和安全的。然而，在获得临床益处之前，可能需要很长时间。因此，本研究使用了两种不同的缩短（4 天）诱导（=加量）方案，这允许快速达到维持剂量。共有 86 名患有鼻炎和眼结膜炎的患者参与了这项研究，他们以前都没有接受过免疫治疗。研究设计是前瞻性、随机的，根据随机分组表，将 86 名患者分为三组，分别接受三种正在研究的诱导（两种加量，一种不加量）方案之一。第四组患者作为对照组，不接受任何舌下免疫治疗，但如果有需要，只接受急救药物。所有患者均进行评估，以评估其基线情况，然后在 3 个月和 6 个月时进行评估。评估参数包括：视觉模拟评分、症状-药物评分、鼻激发试验。研究中所有三种诱导方案均被患者很好地接受，仅有极少数不良反应。临床疗效用视觉模拟评分（p<0.001）、症状-药物评分（p<0.02）和鼻激发试验（p<0.01）评估，在接受舌下免疫治疗的 64 名（n=86）患者的三组中均有显著效果，但在对照组 22 名（n=86）中无显著效果。作者认为，通过这种简化的方案，舌下免疫治疗不仅被过敏专科医生，也被患者越来越多地接受，成为一种治疗选择。
