最近审阅: 26 九月 2020
最近更新: 25 八月 2020
25 Aug 2020

美国 FDA 加强对孟鲁司特引发严重神经精神事件的风险警告,并建议对于变应性鼻炎限制使用

美国食品药品监督管理局(Food and Drug Administration, FDA)加强对孟鲁司特(一种白三烯受体拮抗剂)引发严重精神行为事件和情绪相关改变的风险警告。对已提交病例报道和已发表观察性和动物研究进行回顾,并对 FDA 安全性数据进行观察性研究后,FDA 重新评估了孟鲁司特的风险和获益,从而采取措施。

对于变应性鼻炎,FDA 认定孟鲁司特应当用于其他抗过敏药物未能有效治疗,或对于其他抗过敏药物无法耐受者。

神经精神事件(包括自杀意念或行为)风险警告已写入孟鲁司特处方信息,但许多医疗卫生专业人士和患者/照护者仍未意识到这一风险。

孟鲁司特应用指征为缓解变应性鼻炎症状、哮喘预防和长期治疗,以及预防运动性支气管痉挛急性发作。

查看治疗:治疗方案

查看治疗:治疗流程

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小结

定义

病史和体格检查

关键诊断因素

  • 存在的危险因素
  • 打喷嚏
  • 鼻痒

其他诊断因素

  • 腭、喉、耳以及眼痒
  • 眼睛红、眼袋以及流泪
  • 疲乏和易激惹
  • 鼻塞
  • 鼻溢(流涕)
  • 变应性黑眼圈
  • 结膜充血
  • 眼部黏液分泌
  • 鼻上褶皱
  • 鼻黏膜苍白
  • 鼻黏膜和鼻甲肿胀
  • 大量的鼻分泌物
  • Dennie-Morgan 线(下眼睑下折痕)

危险因素

  • 特应性家族史
  • 年龄< 20 岁
  • 变应原皮肤点刺试验阳性
  • 在早期生活中,未充分暴露于动物和其他的微生物丰富的环境
  • 西方生活方式
  • 种族
  • 环境污染
  • 暴露于室内变应原,例如动物皮屑和尘螨
  • 母亲重度吸烟(在孩子 1 岁以内,每日抽 20 支或 20 支以上的烟)
  • 过早摄入食物或配方奶
  • 母乳喂养
  • 存在其他变应性疾病(湿疹、食物过敏、喘息/哮喘)

诊断性检查

首要检查

  • 抗组胺或者鼻内皮质类固醇试验性治疗
更多 首要检查

需考虑的检查

  • 变应原皮肤点刺试验
  • 体外特异性 IgE 检测
更多 需考虑的检查

治疗流程

撰稿人

Regent

American College of Allergy, Asthma & Immunology

Medical Director

American Academy of Allergy, Asthma & Immunology Registry

Assistant Clinical Professor of Medicine

Medical College of Wisconsin

Adjunct Clinical Instructor

College of Nursing

University of Wisconsin-Milwaukee

Executive Director

Fight Asthma Milwaukee Allies

Allergy, Asthma & Sinus Center

Milwaukee

WI

利益声明

GCS has taken part in sponsored research for the ALK clinical trial of the house dust mite SLIT tablet for use in paediatric patients. He is a member of the Joint Task Force on Practice Parameters Workgroup on the Allergic Rhinitis Practice Parameter.

Dr Gary C. Steven would like to gratefully acknowledge Dr Alexander Greiner, a previous contributor to this topic.

利益声明

AG has received grant/research support from: Astra Zeneca; Boehringer Ingelheim; Cephalon Circassia Ltd; Clement Clarke Cytos biotechnology; GlaxoSmithKline; Glenmark Specialty, S.A.; Hoffman-LaRoche/Genentech; HRA/Novartis; Janssen Research & Development; Kalypsys , Inc.; Lupin; Merck; Mylan Pharmaceuticals, Inc.; Nestle (Nestec Ltd); Novartis Ono Pharmaceutical Co., Ltd.; Perrigo; Rigel Pharmaceuticals, Inc.; Roxane Laboratories Inc.; Shionogi Inc.; Sunovion TEVA Branded Pharmaceutical Products; UBC (United Biosource Corporation)/Amgen Pharmaceuticals; and sponsorship for pharmaceutical trials from Allergen Research Corporation/Aimmune Therapeutics, Inc. and Astra Zeneca.

同行评议者展开全部内容

Clinical Immunology Coordinator

Division of Rheumatology, Immunology and Allergy

Winthrop-University Hospital

Mineola

NY

利益声明

MDL declares that he has no competing interests.

Consultant Allergist/Rhinologist

Allergy & Rhinology Department

Royal National Throat, Nose and Ear Hospital

London

UK

利益声明

GS is a consultant/advisory board member for ALK, Britannia Pharmaceuticals, CMP Therapeutics, Groupo Uriach, GSK, Merck, Sanofi-Aventis, Schering Plough, and UCB. She has received research funds from ALK, GSK, UCB, and Schering Plough. She has given talks for ALK, GSK, Merck, Schering Plough, and UCB and has co-written articles for Schering Plough and GSK.

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