二巯丙磺钠注射液致肝豆状核变性患者过敏反应危险因素及其预测价值分析  

Risk factors of anaphylaxis caused by sodium dimercaptopropane injection in patients with hepato⁃lenticular degeneration and an analysis of its predictive value

作　　者：曹康 罗欢[1] 李祥 韩燕全[1] 陈浩[1] 李颖[1] Cao Kang;Luo Huan;Li Xiang;Han Yanquan;Chen Hao;Li Ying(Department of Pharmacy,the First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230031,China;Key Laboratory of Xin′an Medicine,Ministry of Education,Anhui University of Chinese Medicine,Hefei 230038,China)

机构地区：[1]安徽中医药大学第一附属医院药学部,合肥230031 [2]安徽中医药大学新安医学教育部重点实验室,合肥230038

出　　处：《药物不良反应杂志》2023年第7期398-404,共7页Adverse Drug Reactions Journal

基　　金：安徽省重点研究与开发计划项目(202004j07020048)。

摘　　要：目的分析二巯丙磺钠(DMPS)注射液致肝豆状核变性(HLD)患者过敏反应的危险因素及其对过敏反应风险的预测价值。方法收集2019年1月至2021年12月因HLD首次在安徽中医药大学第一附属医院住院且接受DMPS治疗患者的电子病历,记录患者基本信息、应用DMPS前有关实验室指标检查结果、DMPS日剂量及过敏反应发生情况、治疗和转归。根据是否发生DMPS相关过敏反应将患者分为过敏组和对照组,比较2组患者临床特征,采用二元logistic回归法分析DMPS致过敏反应的危险因素,计算比值比(OR)及其95%置信区间(CI);将所有独立危险因素合并为联合预测因子,应用受试者工作特征(ROC)曲线分析单个危险因素和联合预测因子对过敏反应发生风险的预测价值。结果纳入分析的患者共477例。过敏组124例,男性80例,女性44例,年龄1~51岁,<18岁者55例;对照组353例,男性237例,女性116例,年龄2~66岁,<18岁者106例。过敏组124例患者共发生过敏反应191例次,主要表现为皮肤瘙痒(67例次、35.1%)和药物性皮炎(58例次、30.4%);发生过敏反应的时间为用药第1~5个疗程,发生在第1、2个疗程者分别为74例(59.7%)和31例(25.0%)。发生过敏反应后所有患者均停用DMPS,5例因症状轻微未予其他干预,其余患者予抗过敏治疗后症状均消退。2组患者比较,年龄、入院前DMPS用药史、药物过敏史,以及应用DMPS前外周血淋巴细胞计数、铜蓝蛋白、丙氨酸转氨酶(ALT)、天冬氨酸转氨酶、碱性磷酸酶(ALP)、γ-谷氨酰转移酶、乳酸脱氢酶和血尿素氮水平差异有统计学意义(均P<0.05)。二元logistic回归分析显示,药物过敏史(OR=3.698,95%CI:2.233~6.124,P<0.001)、用药前ALT水平(OR=1.004,95%CI:1.000~1.007,P=0.044)和ALP水平(OR=1.003,95%CI:1.002~1.005,P<0.001)是DMPS致HLD患者过敏反应的独立危险因素。ROC曲线分析显示,用药前ALT水平曲线下面积(AUC)为0.613(95%CI:0.553~0.673),截断值50 U/L,Objective To analyze the risk factors of anaphylaxis caused by sodium dimercapto-propane sulfonate(DMPS)in patients with hepatolenticular degeneration(HLD)and its predictive value.Methods The electronic medical records of patients who were hospitalized for the first time in the First Affiliated Hospital of Anhui University of Chinese Medicine due to HLD from January 2019 to December 2021 and received DMPS treatment were collected.The basic information,relevant laboratory test results before the application of DMPS,daily dose of DMPS,and occurrence,treatment and outcome of allergic reac⁃tions in patients were recorded.The patients were divided into allergy group and control group based on whether DMPS⁃related anaphylaxis occurred.The clinical characteristics in patients in the 2 groups were compared.The risk factors of DMPS⁃induced anaphylaxis were analyzed using binary logistic regression,and the odds ratio(OR)and its 95%confidence interval(CI)were calculated.All independent risk factors were merged into joint predictor and the predictive value of individual risk factors and joint predictor for risk of anaphylaxis were analyzed using receiver operating characteristic(ROC)curve.Results A total of 477 patients were enrolled in the study,including 124 patients in the allergy group and 353 patients in the control group.Among the 124 patients in the allergy group,80 were male and 44 were female,aged 1⁃51 years,with 55 patients<18 years of age.Among the 353 patients in the control group,237 were male and 116 were female,aged 2⁃66 years,with 106 patients<18 years of age.A total of 191 times of allergic reactions occurred in patients in the allergy group,the main manifestations were pruritus(67 times,35.1%)and drug⁃induced dermatitis(58 times,30.4%).The allergic reactions occurred during the 1st to the 5th course of treatment,with 74(59.7%)and 31 cases(25.0%)occurring in the 1st and 2nd course of treatment,respectively.DMPS was discontinued in all patients.Of them,5 patients did not receive any intervention b

关 键 词：肝豆状核变性 过敏反应 危险性评估 二巯基丙磺酸钠 

分 类 号：R969.3[医药卫生—药理学]