Identifying Allergic Drug Reactions Through Placebo-Controlled Graded Challenges
Identifying Allergic Drug Reactions Through Placebo-Controlled Graded Challenges
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DOI：
10.1016/j.jaip.2016.09.041
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发表时间：
2017-05-01
影响因子：
9.4
通讯作者：
Jerschow, Elina
中科院分区：
文献类型：
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作者：
Iammatteo, Melissa;Ferastraoaru, Denisa;Jerschow, Elina
背景：进行分级挑战是为了排除药物过敏可能性较低的患者的过敏反应。缺乏关于确定步骤数和使用安慰剂的最佳方案的文献。 目的：通过由安慰剂组成的 3 步方案，然后是 2 步分级药物挑战，来识别过敏药物反应 (ADR)。 方法：我们对 2010 年 10 月至 2015 年 11 月期间在门诊药物处接受单盲、安慰剂对照分级药物挑战的所有历史 ADR 患者进行了 5 年回顾性图表审查过敏诊所。获得患者的人口统计学特征和历史反应描述。按药物类别比较药物与安慰剂挑战的结果。结果：229 名患者接受了至少 1 次单盲安慰剂对照分级挑战。最常受到质疑的药物类别是β-内酰胺类药物（70.8%），其次是非甾体抗炎药（17.5%）。在 β-内酰胺挑战期间（9.4% vs 8.2%；P = .9）和非甾体抗炎药物挑战期间（14% vs 7%，P = .5），药物和安慰剂的反应率相似。只有 10 名患者 (4.4%) 在药物挑战期间有客观发现。与未反应者 (2.4 +/- 0.1) 和 β-内酰胺反应者 (3.3 +/- 0.7) 相比，在 β-内酰胺激发前对安慰剂有反应的患者的药物过敏次数 (4.3 +/- 1.0) 有所增加 (P = .002)。所有安慰剂反应者均为女性（183 名中的 20 名与 46 名男性中的 0 名；P = .02）。 结论：两步分级挑战对于适当选择的患者是安全的，反应风险较低。应考虑使用安慰剂来减少假阳性结果，尤其是女性和多种药物过敏的患者。 (C) 2016 年美国过敏、哮喘和免疫学学会
BACKGROUND: Graded challenges are performed to exclude hypersensitivity reactions in patients with a low likelihood of drug allergy. Literature regarding optimal protocols with a defined number of steps and use of placebo is lacking.OBJECTIVE: To identify allergic drug reactions (ADRs) through a 3-step protocol composed of placebo followed by a 2-step graded drug challenge.METHODS: We performed a 5-year retrospective chart review of all patients with historical ADRs who underwent single-blind, placebo-controlled graded drug challenges between October 2010 and November 2015 at an outpatient drug allergy clinic. Patients' demographic characteristics and description of historical reaction were obtained. Outcomes of challenges to drug versus placebo were compared by drug class.RESULTS: Two hundred twenty-nine patients underwent at least 1 single-blind placebo-controlled graded challenge. The most commonly challenged drug class was beta-lactams (70.8%) followed by nonsteroidal anti-inflammatory drugs (17.5%). The reaction rate to drug and placebo was similar during beta-lactam challenges (9.4% vs 8.2%; P = .9) and during nonsteroidal anti-inflammatory drug challenges (14% vs 7%, P = .5), respectively. Only 10 patients (4.4%) had objective findings during drug challenges. Patients who reacted to placebo before beta-lactam challenges had an increased number of drug allergies (4.3 +/- 1.0) compared with nonreactors (2.4 +/- 0.1) and to beta-lactam reactors (3.3 +/- 0.7) (P = .002). All placebo reactors were female (20 of 183 vs 0 of 46 males; P = .02).CONCLUSIONS: Two-step graded challenges are safe in appropriately selected patients with a low risk of reaction. Placebo should be considered to reduce false-positive results, especially in females and in patients with multiple drug allergies. (C) 2016 American Academy of Allergy, Asthma & Immunology