未经授权:皮下毒液免疫疗法(VIT)是一种有效的治疗蜂毒过敏的方法。然而,它涉及很长的治疗时间,高成本,和不良事件(AE)的风险。更短,更安全,因此,寻求更便宜的治疗选择。
UNASSIGNED:要确定安全性,免疫原性,蜂毒淋巴内免疫治疗(ILIT)的疗效。
未经评估:在一项开放的试点研究中,12名患者分三个疗程接受蜂毒ILIT,间隔14天:0.1-5μg/剂。应用超声成像来引导注射并记录淋巴结结构。在第二项研究中,来自欧洲和澳大利亚15个中心的67名患者被随机分配接受4种剂量的10或20μg蜂毒ILIT,间隔28天。临床终点包括特异性IgE和IgG以及蜜蜂叮咬攻击后的保护。这些研究是在2000-2003年进行的。
未经评估:在概念验证研究中,没有观察到严重的AE。观察到变应原特异性IgG1的增加,但未观察到IgG4和IgE的增加。ILIT在8名受到攻击的患者中的7名诱导了针对蜜蜂叮咬攻击的保护。在一项多中心研究中,观察到过敏原特异性IgG和IgE的增加,接受较高ILIT剂量的患者增加最高。该研究由于在完成治疗后的刺痛激发后的几个严重AE而终止。然而,在45名受到挑战的患者中,10和20μg组中有15例(65%)和18例(82%)患者,分别,表现出两个等级或更多的改进。在抗体水平和刺痛保护之间没有观察到相关性。
未经证实:虽然一项初步研究表明蜂毒ILIT的安全性和有效性,一项随机研究后,在刺痛攻击后发现大量AE,表明蜂毒ILIT提供的免疫学保护不足.值得注意的是,两项研究中使用的蜂毒过敏原提取物来自两个不同的提供者。虽然第一项研究使用了一种批准用于皮下VIT的制剂,第二项研究使用了一种从未在人体中测试过的未经批准的制剂.应对批准的制剂进行进一步研究,以得出有关蜂毒ILIT的安全性和有效性的结论性结果。
UNASSIGNED: Subcutaneous venom immunotherapy (VIT) represents an effective treatment against bee venom allergy. However, it involves long treatment times, high costs, and the risk of adverse events (AEs). Shorter, safer, and cheaper treatment options are therefore pursued.
UNASSIGNED: To determine the safety, immunogenicity, and efficacy of bee venom intralymphatic immunotherapy (ILIT).
UNASSIGNED: In an open pilot
study, 12 patients received bee venom ILIT in three sessions with 14-day intervals: 0.1-5 μg/dose. Ultrasound imaging was applied to guide an injection and to document the lymph node structure. In a second
study, 67 patients from 15 centers in Europe and Australia were randomized to receive four doses of either 10- or 20-μg bee venom ILIT with 28-day intervals. Clinical endpoints included specific IgE and IgG and protection after a bee sting challenge. These studies were performed in the years 2000-2003.
UNASSIGNED: In a proof-of-concept
study, no serious AEs were observed. An increase in allergen-specific IgG1 but no IgG4 and IgE was observed. ILIT induced the protection against a bee sting challenge in 7 out of 8 challenged patients. In a multicenter study, an increase in allergen-specific IgG and IgE was observed, with the highest increase in patients receiving a higher ILIT dose. The study was terminated due to several serious AEs upon the sting challenge provocation after the completion of treatment. However, out of 45 patients challenged, 15 (65%) and 18 (82%) patients in the 10- and 20-μg group, respectively, showed an improvement of two grades or more. No correlation was observed between antibody levels and sting protection.
UNASSIGNED: While a pilot
study suggested the safety and efficacy of bee venom ILIT, a high number of AEs seen after the sting challenge following a randomized study indicate that the immunology protection offered by bee venom ILIT is insufficient. Of note, the bee venom allergen extract used in the two studies were from the two different providers. While the first
study used a formulation approved for use in subcutaneous VIT, the second
study used a nonapproved formulation never tested in humans. Further studies on approved formulations should be performed to generate conclusive results regarding the safety and efficacy of bee venom ILIT.