不良临床事件报告

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摘要

一名79岁女性患者在开始使用阿法替尼治疗转移性非小细胞肺癌约64天后,出现局部皮肤病变,脸颊出现瘙痒丘疹和小泡。同时使用的药物包括左甲状腺素、胆骨化醇、缬沙坦和奈比洛尔。症状发展为弥漫性丘疹和小泡,继而发展为躯干上的非典型靶样斑,最终发展为松弛大疱。其他症状包括口腔溃疡、结膜炎、弥漫性脱发和味觉丧失。史蒂文斯-约翰逊综合征被诊断出来。治疗包括停用阿法替尼和口服类固醇(1mg /kg/天)、外用类固醇、哌拉西林/他唑巴坦和地氯雷他定。治疗未能成功地改善病人的病情。其他原因的血清学检测呈阴性。皮肤活检显示急性界面皮炎。临床症状和皮肤病变在20天内缓慢改善,最终在停药约2个月后恢复。作者得出结论,由于给药与症状的出现和消退之间的时间关系,该患者经历了与阿法替尼给药相关的史蒂文斯-约翰逊综合征。他们提醒临床医生注意与该药物相关的潜在不良事件。阿法替尼[Gilotrif] Doesch J et al (W Brueckl,呼吸医学、过敏症和睡眠医学系,Paracelsus医科大学,纽伦堡总医院教授,ernst - nahan - str 1,90410纽伦堡,德国;e-mail: Wolfgang.brueckl@klinikum-nuernberg.de) egfr突变肺癌患者的afatinib相关Stevens-Johnson综合征。肺癌95:35-38(5月)2016
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Reporting on Adverse Clinical Events
A 79-year-old female patient developed localized skin lesions with itchy papules and vesicles on the cheek approximately 64 days after the initiation of afatinib for the treatment of metastatic non–small cell lung cancer. Concurrent medication included levothyroxine, cholecalciferol, valsartan, and nebivolol. Symptoms progressed to diffuse papules and vesicles, which evolved into atypical targetoid maculae on the trunk and eventually to flaccid bullae. Additional symptoms included oral ulcers, conjunctivitis, diffuse alopecia, and development of taste loss. Stevens-Johnson syndrome was diagnosed. Treatment included the discontinuation of afatinib and the administration of oral steroids (1 mg/kg/day), topical steroids, piperacillin/tazobactam, and desloratadine. Treatment was not successful in improving the patient’s condition. Serological testing for other causes was negative. A skin biopsy revealed acute interface dermatitis. Clinical symptoms and skin lesions slowly improved over a 20-day period with eventual recovery approximately 2 months after the drug was stopped. The authors concluded that this patient experienced Stevens-Johnson syndrome related to the administration of afatinib due to the temporal relationship between the administration of the drug and the appearance and resolution of symptoms. They cautioned clinicians to be aware of this potential adverse event associated with the drug. Afatinib [“Gilotrif”] Doesch J et al (W Brueckl, Department of Respiratory Medicine, Allergology and Sleep Medicine, Paracelsus Medical University, General Hospital Nuernberg Prof.-Ernst-Nathan-Str 1, 90410 Nuremberg, Germany; e-mail: Wolfgang.brueckl@klinikum-nuernberg.de) Afatinib-associated Stevens-Johnson syndrome in an EGFR-mutated lung cancer patient. Lung Cancer 95:35–38 (May) 2016
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