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抗肿瘤药物过敏和脱敏:189 例采用新的短方案和新型诊断工具评估的程序的结果。

Hypersensitivity and desensitization to antineoplastic agents: outcomes of 189 procedures with a new short protocol and novel diagnostic tools assessment.

机构信息

Allergy Division, Ramon y Cajal University Hospital, Madrid, Spain.

出版信息

Allergy. 2013 Jul;68(7):853-61. doi: 10.1111/all.12105. Epub 2013 May 6.

DOI:10.1111/all.12105
PMID:23647576
Abstract

BACKGROUND

Desensitization to antineoplastic agents is becoming a standard of care. Efforts to establish and improve these techniques are being made at many institutions. Our aims are to evaluate a new rapid desensitization protocol designed to be shorter (approximately 4 h) and safer (reducing hazardous drugs exposure risks) and to assess the oxaliplatin-specific immunoglobulin E (IgE) as a novel diagnostic tool.

METHODS

Prospective, observational, longitudinal study with patients who, for a 1-year period, suffered reactions to antineoplastic agents and were referred to the Desensitization Program at Ramon y Cajal University Hospital (RCUH). Patients were included or excluded as desensitization candidates after anamnesis, skin testing, risk assessment, and graded challenge. Specific IgE was determined in oxaliplatin-reactive patients. Candidate patients were desensitized using the new RCUH rapid desensitization protocol.

RESULTS

Of 189 intravenous rapid desensitizations, 188 were successfully accomplished in the 23 patients who met inclusion criteria for desensitization (of 58 referred patients). No breakthrough reactions occurred in 94% of desensitizations, and most breakthrough reactions were mild. In 10 oxaliplatin-reactive patients, 38 desensitizations were successfully accomplished. Sensitivity for oxaliplatin-specific IgE was 38% (0.35UI/l cutoff point) and 54% (0.10UI/l cutoff point); specificity was 100% for both cutoff points.

CONCLUSIONS

In the hands of a Desensitization Program, managed by drug desensitization experts, this new protocol has proven an effective therapeutic tool for hypersensitivity to several antineoplastic agents (oxaliplatin, carboplatin, paclitaxel, docetaxel, cyclophosphamide, and rituximab); moreover, it improves safety handling of hazardous drugs. We report the first large series of oxaliplatin desensitizations. Oxaliplatin-specific IgE determination could be helpful.

摘要

背景

抗肿瘤药物脱敏治疗已成为一种常规治疗手段。许多机构正在努力建立和完善这些技术。我们的目的是评估一种新的快速脱敏方案,该方案旨在更短(约 4 小时)和更安全(降低危险药物暴露风险),并评估奥沙利铂特异性免疫球蛋白 E(IgE)作为一种新的诊断工具。

方法

前瞻性、观察性、纵向研究,纳入 1 年内因抗肿瘤药物发生反应并被转诊至拉蒙·卡哈尔大学医院(RCUH)脱敏治疗项目的患者。患者在进行病史、皮肤测试、风险评估和分级挑战后被纳入或排除为脱敏候选者。对奥沙利铂反应性患者进行特异性 IgE 检测。候选患者采用新的 RCUH 快速脱敏方案进行脱敏。

结果

在符合脱敏条件的 23 名患者(58 名转诊患者)中,189 次静脉快速脱敏中有 188 次成功完成。94%的脱敏中未发生突破性反应,且大多数突破性反应为轻度。在 10 名奥沙利铂反应性患者中,成功完成了 38 次脱敏。奥沙利铂特异性 IgE 的敏感性为 38%(0.35UI/l 截断值)和 54%(0.10UI/l 截断值);两个截断值的特异性均为 100%。

结论

在药物脱敏专家管理的脱敏治疗项目中,这种新方案已被证明是一种有效的治疗多种抗肿瘤药物(奥沙利铂、卡铂、紫杉醇、多西他赛、环磷酰胺和利妥昔单抗)过敏的工具;此外,它还提高了危险药物的安全处理能力。我们报告了第一个大系列的奥沙利铂脱敏治疗。奥沙利铂特异性 IgE 测定可能会有所帮助。

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