Management and outcome of hypersensitivity reactions to oxaliplatin: a real-word study in a single center
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摘要:
目的 通过对输注奥沙利铂导致的超敏反应的临床特点、处理方式和临床转归进行分析,为临床诊治提供依据。 方法 回顾性分析2015年1月至2017年12月北京大学肿瘤医院上报国家药品不良反应监测中心的62例奥沙利铂超敏反应患者的临床资料,按国际通用标准分型为标准输液反应与严重过敏反应,分析其临床特征、超敏反应亚型、严重程度分级、处理方式及转归。 结果 患者平均年龄(52.9±11.3)岁,男女比例1.07:1。59.7%(37/62)患者在输注奥沙利铂前使用了糖皮质激素预处理。发生超敏反应时奥沙利铂中位治疗为6(4~7.25)个周期,中位累积剂量456.9(263.5~651.0)mg/m2。30.6%(19/62)患者存在无奥沙利铂间隔期。41例(66.1%)患者诊断为标准输液反应,21例(33.9%)诊断为严重过敏反应。在处理方式上,所有患者均采取了暂停用药、更换输液器的处理,无患者使用肾上腺素;所有患者症状均缓解,无死亡病例。58.6%(17/29)需要继续进行治疗的2级标准输液反应患者进行了再次用药,其中70.6%(12/17)未再次出现超敏反应。 结论 临床对奥沙利铂输注前预处理不足,严重过敏反应的肾上腺素的一线使用尚未得到足够重视,大部分轻中度奥沙利铂超敏反应后续可再次安全用药。 Abstract:Objective To review the clinical characteristics of patients with hypersensitivity to oxaliplatin, symptom management, and treatment outcomes to guide further treatment. Methods From January 2015 to December 2017, 62 cases of hypersensitivity reactions to oxaliplatin were reported to the National Center for Adverse Drug Reaction(ADR) Monitoring in the Daycare Center of Peking University Cancer Hospital & Institute. The hypersensitivity reactions were classified into standard infusion-related reactions and anaphylaxis in accordance with international standards. The clinical data, treatment information, and outcomes of these patients were retrospectively collected and analyzed. Results The mean age of the 62 patients was (52.9±11.3) years, the male-to-female radio was 1.07:1, and 59.7% (37/62) of patients received premedication with glucocorticoids before oxaliplatin. The median onset time was 6 (interquartile range 4-7.25) cycles with a median cumulative dose of 456.9 (263.5-651.0) mg/m2. Of the 62 patients, 19 (30.6%) patients had an oxaliplatin-free interval, 41 (66.1%) patients were diagnosed with a standard infusion-related reaction, and 21 (33.9%) patients were diagnosed with anaphylaxis based on clinical criteria. The medication was suspended for all patients and the infusion set was replaced. No patient received epinephrine for symptom management. All patients recovered completely; no deaths were reported. In addition, 58.6% (17/29) of patients with grade 2 standard infusion-related reactions who need further treatment were subsequently rechallenged with oxaliplatin, 70.6% (12/17) showed no symptoms of hypersensitivity. Conclusions Premedication before oxaliplatin was not sufficient and the management of hypersensitivity was not standardized; therefore, the first-line usage of epinephrine should be performed with caution. Most cases of moderate hypersensitivity for soxaliplatin can be rechallenged successfully. -
Key words:
- soxaliplatin /
- hypersensitivity /
- standard infusion-related reaction /
- anaphylaxis /
- rechallenge
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表 1 不同亚型超敏反应患者的临床特征
表 2 不同亚型超敏反应的临床症状及体征
n(%) 表 3 不同亚型超敏反应的发生时间、治疗、转归及再用药情况
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