奥沙利铂脱敏治疗及皮试的探索性研究

Exploratory study of oxaliplatin desensitization and skin test

目的:探讨运用抗过敏药物预处理、奥沙利铂减慢速率输注或脱敏治疗进行奥沙利铂再化疗的可能性。尝试对奥沙利铂过敏的患者进行3个浓度梯度的皮试,同时分析奥沙利铂皮试结果与临床奥沙利铂过敏的符合率,了解皮试结果与临床奥沙利铂过敏的符合率。方法:对在本中心接受含奥沙利铂方案治疗的患者进行筛选,经临床医师根据临床症状和体征判断为奥沙利铂Ⅰ-Ⅲ度过敏反应的患者进入本研究。对Ⅰ-Ⅲ度奥沙利铂过敏的患者进行3个浓度梯度(0.01 mg/ml、0.1 mg/ml和5 mg/ml)的奥沙利铂皮试,并以5%葡萄糖水作为阴性对照。15~20分钟读取测试结果。如果皮疹最大径大于阴性对照3 mm判为阳性结果。之后根据奥沙利铂过敏反应的等级进行不同方式的干预措施。主要研究终点为奥沙利铂再次化疗3周期的完成率,次要终点为奥沙利铂皮试结果与临床医师判断之间的符合率。结果:2016年6月至2017年4月126例在本中心接受含奥沙利铂方案治疗的患者中,14例(11.1%)发生奥沙利铂过敏。发生奥沙利铂过敏反应的中位疗程数为第8疗程,过敏反应时患者已接受的奥沙利铂中位累积剂量为1 200 mg(600~1 500mg),男性8例,女性6例,中位年龄51岁(43~73岁)。Ⅰ、Ⅱ度过敏反应10例,Ⅲ度过敏反应4例,无Ⅳ度过敏反应的患者。14例患者的皮试结果为:13例阳性。皮试结果与临床的符合率为92.9%。除1例Ⅲ度过敏反应的患者拒绝继续接受奥沙利铂治疗,其余13例均接受了奥沙利铂的再化疗。总体再化疗成功率为100%。结论:本研究证实了本中心设计的奥沙利铂过敏的干预措施是可行的。奥沙利铂皮试与临床医师判断之间的符合率高。

Objective： This prospective study aimed to explore the possibility of oxaliplatin chemotherapy with the use of anti-allergy drugs,slow rate infusion,or desensitization.Try the 3 concentration gradients of oxaliplatin in patients allergic skin test,the coincidence rate between oxaliplatin skin test results and clinical oxaliplatin sensitivity was analyzed,and the coincidence rate between skin test result and clinical oxaliplatin sensitivity was obtained.Methods：The patients who received oxaliplatin treatment in our center were screened,and the patients with grade Ⅰ-Ⅲ hypersensitivity reactions（ HSRs） were enrolled in the study according to clinical symptoms and signs.Patients with grade Ⅰ-Ⅲ HSRs were tested with oxaliplatin at 3 concentration gradients（ 0.01 mg/ml,0.1 mg/ml,and 5 mg/ml） and 5% glucose water as negative control.Read the test results in 15 ~ 20 minutes.If the rash maximum diameter is greater than the negative control,3 mm is positive.Then different intervention measures were performed based on oxaliplatin allergic reaction level.The primary endpoint was the completion rate of 3 cycles of oxaliplatin re-chemotherapy.The secondary endpoint was the coincidence between the oxaliplatin skin test and the clinician＇s judgment.Results： From June 2016 to April 2017,in the 126 patients receiving oxaliplatin treatment at the center,oxaliplatin sensitization occurred in 14 cases（ 11.1%） of the patients.There were 10 cases of grade Ⅰ/Ⅱ HSRs,4 cases of allergic reaction of grade Ⅲ HSRs,and no patients with grade Ⅳ HSRs.In the 14 patients,13 were positive for skin tests.The coincidence rate between skin test and clinic was 92.9%.With the exception of 1 patient with grade Ⅲ HSRs who refused to continue receiving oxaliplatin,the remaining underwent oxaliplatin chemotherapy.The overall successful rate of re-chemotherapy was 100%.Conclusion： This study confirmed the feasibility of the oxaliplatin allergy intervention designed by our center.The coincidence rate between the oxaliplatin skin test and the clinician ＇s judgment is high.