Ibañez Maria Dolores, Kaiser Friedrich, Knecht Roland, Armentia Alicia, Schöpfer Helmut, Tholstrup Bente, Bufe Albrecht
Servicio de Alergia, Hospital Universitario Niño Jesús, Madrid, Spain.
Pediatr Allergy Immunol. 2007 Sep;18(6):516-22. doi: 10.1111/j.1399-3038.2007.00556.x.
The aim of the study was to confirm the safety of an orodispersible grass allergen tablet 75,000 SQ-T (Grazax, ALK-Abelló A/S, Hørsholm, Denmark) in children aged 5-12 yr. The study was randomized, double-blinded and placebo-controlled. Sixty children aged 5-12 yr suffering from grass pollen-induced rhinoconjunctivitis (with or without asthma) from five centres in two countries (three in Germany and two in Spain) participated in the study. They were randomized at the ratio of 3:1 as receiving either Grazax or placebo tablet given sublingually once daily for 28 days outside the grass pollen season. A total of 810 treatment-related adverse events were reported in the Grazax group. The majority of these were local reactions in the mouth or throat and were mostly mild (71%) to moderate (27%) in severity and resolved within days. Thirty-five (78%) subjects treated with Grazax and five (33%) treated with placebo reported at least one treatment-related adverse event. Oral pruritus, throat irritation, mouth oedema and ear pruritus appeared as the most frequently reported treatment-related adverse events. 62% (28 of 45) of the actively treated subjects reported oral pruritus, 36% (16 of 45) throat irritation, 31% (14 of 45) mouth oedema and 22% (10 of 45) ear pruritus. Two actively treated subjects withdrew from the study: one subject due to four adverse events (moderate eye pruritus, moderate pharyngolaryngeal pain, moderate non-cardiac chest pain and moderate dysphagia) and one subject due to a serious adverse event (asthmatic attack). The subjects recovered completely from the events. In conclusion, in the present study, Grazax was in general tolerated in a paediatric population and considered suitable for further clinical investigations in children.
该研究的目的是证实一种口腔崩解型草过敏原片剂75,000 SQ-T（Grazax，ALK-阿贝罗公司，丹麦霍斯霍尔姆）在5至12岁儿童中的安全性。该研究为随机、双盲且安慰剂对照试验。来自两个国家五个中心（德国三个，西班牙两个）的60名5至12岁患有草花粉诱发的鼻结膜炎（伴或不伴哮喘）的儿童参与了该研究。他们按3:1的比例随机分组，分别接受Grazax或安慰剂片剂，于草花粉季节之外每天舌下含服一次，共28天。Grazax组共报告了810起与治疗相关的不良事件。其中大多数为口腔或咽喉局部反应，严重程度大多为轻度（71%）至中度（27%），且数天内即缓解。接受Grazax治疗的35名（78%）受试者和接受安慰剂治疗的5名（33%）受试者报告了至少一起与治疗相关的不良事件。口腔瘙痒、咽喉刺激、口腔水肿和耳部瘙痒是报告最频繁的与治疗相关的不良事件。62%（45名中的28名）接受积极治疗的受试者报告了口腔瘙痒，36%（45名中的16名）报告了咽喉刺激，31%（45名中的14名）报告了口腔水肿，22%（45名中的10名）报告了耳部瘙痒。两名接受积极治疗的受试者退出了研究：一名受试者因四项不良事件（中度眼部瘙痒、中度咽喉疼痛、中度非心脏性胸痛和中度吞咽困难）退出，另一名受试者因一起严重不良事件（哮喘发作）退出。这些受试者的不良事件均完全康复。总之，在本研究中，Grazax在儿科人群中总体耐受性良好，被认为适合在儿童中进行进一步的临床研究。
