THE HYMENOPTERA VENOM STUDY III--SAFETY OF VENOM IMMUNOTHERAPY

膜翅目毒液研究 III--毒液免疫治疗的安全性

• 批准号: 3810955
• 负责人: P C TURKELTAUB
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3810955
• 关键词: Hymenoptera; disease /disorder proneness /risk; dosage; health surveys; human subject; immunization; immunologic skin test; immunological substance; immunotoxicity; insect poison; interview

A post marketing survey of the safety of venom immunotherapy was carried out. One thousand four hundred and ten insect sting alergic patients who were sensitive to FDA licensed hymenoptera venom by skin test were immunized. Twelve percent of patients immunized experienced adverse reactions, similar to the European experience with venom products. Most patients (92%) reached maintenance, most often 8 weeks into treatment, consistent with the dose regimen in the approved insert. Most adverse reactions occurred during buildup (1-50 %g) and at maintenance. No history of venom reactivity or skin sensitivity to venom predicted which patient was at risk of an allergic adverse reaction during venom therapy. These data demonstrate the relative safety of FDA licensed hymenoptera venom extracts when used according to package insert.

对蛇毒免疫疗法的安全性进行了上市后调查 出去 1410例昆虫叮咬过敏患者 通过皮肤试验对FDA许可的雨蛙毒液敏感的人， 免疫。 12%的免疫患者出现不良反应 反应，类似于欧洲的经验与毒液产品。 最 患者（92%）达到维持水平，最常见的是治疗8周， 与获批说明书中的给药方案一致。 最不利 反应发生在累积（1- 50%g）期间和维持期间。 没有 毒液反应史或皮肤对毒液的敏感性预示着 患者在使用毒液期间有过敏不良反应的风险 疗法 这些数据证明了FDA许可的Hyplittera的相对安全性 根据包装说明书使用毒液提取物。