Sublingual-oral administration of standardized allergenic results
Sublingual-oral administration of standardized allergenic results
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DOI：
10.1016/s1081-1206(10)60474-7
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发表时间：
2008-05-01
影响因子：
5.9
通讯作者：
Lockey, Richard F.
中科院分区：
文献类型：
--
作者：
Esch, Robert E.;Bush, Robert K.;Lockey, Richard F.
背景资料：欧洲的研究提供了舌下变应原免疫疗法（SLIT）安全性和有效性的优势证据，但他们使用的变应原产品与美国预期批准的产品不同。目的：确定4种美国许可的标准化SLIT变应原提取物的安全性和耐受性。患有过敏性鼻炎伴或不伴由于梯牧草花粉、短豚草花粉、屋尘螨或猫毛过敏引起的哮喘的18至50岁成人完成单次剂量递增，随后进行8周，开放标签的每日SLIT疗程。参与者记录的存在和严重程度的不良反应和坚持使用每日电子dialog.Results：九十一名参与者开始治疗，77完成了第1阶段的测试。猫毛和尘螨提取物的最大耐受剂量范围为50至2，090 BAU，短豚草花粉提取物的最大耐受剂量范围为31至91 Amb a 1单位，梯牧草花粉提取物的最大耐受剂量范围为50至21，090 BAU。在为期8周的治疗过程中，98.9%的参与者报告至少1次轻度不良反应，70.4%至少1次中度不良反应，13.6%至少1次重度不良反应。大多数不良反应（94.6%）被评定为轻度，5.2%为中度，0.1%为重度;鼻和口腔粘膜不良反应是最常报告的。没有发生危及生命的不良反应超过4,500管理doses.Conclusions：每日舌下口服剂量的标准化过敏性提取物在最大耐受剂量一般耐受良好。这些结果是建立美国许可的SLIT提取物在适当的自我管理和监测时的安全性的第一步。
Background: European studies provide a preponderance of evidence for sublingual allergen immunotherapy (SLIT) safety and efficacy, but they use allergen products that differ from those expected to be approved in the United States.Objective: To determine the safety and tolerability of 4 US-licensed standardized SLIT allergenic extracts.Methods: Adults 18 to 50 years old with allergic rhinitis with or without asthma due to timothy grass pollen, short ragweed pollen, house dust mite, or cat hair allergy completed a single-session dose escalation followed by an 8-week, open-label daily course of SLIT. Participants documented the presence and severity of adverse effects and adherence using a daily electronic diary.Results: Ninety-one participants initiated treatment, and 77 completed the phase 1 testing. Maximum tolerable doses ranged from 50 to 2,090 BAU for cat hair and dust mite extract, 31 to 91 Amb a 1 Units for short ragweed pollen extract, and 50 to 21,090 BAU for timothy grass pollen extract. During the 8-week treatment course, 98.9% of participants reported at least 1 mild, 70.4% at least 1 moderate, and 13.6% at least 1 severe adverse effect. Most adverse effects (94.6%) were rated as mild, 5.2% as moderate, and 0.1% as severe; nasal and oral-mucosal adverse effects were most commonly reported. No life-threatening adverse reactions occurred in more than 4,500 administered doses.Conclusions: Daily sublingual-oral dosing of standardized allergenic extracts at maximum tolerable doses was generally well tolerated. These results are a first step toward establishing the safety of US-licensed SLIT extracts when appropriately self-administered and monitored.