经不同静脉输液装置给予颅内恶性肿瘤患儿大剂量甲氨蝶呤的安全性比较  

Safety comparison of high-dose methotrexate via different intravenous infusion devices in pediatric patients with malignant brain tumors

作　　者：续茜桥 时正媛 杨春静 王淑梅 XU Xiqiao;SHI Zhengyuan;YANG Chunjing;WANG Shumei(Dept.of Pharmacy/Beijing Key Lab for Biometric Evaluation of Clinical Rational Drug Use,Beijing Shijitan Hospital Affiliated to Capital Medical University,Beijing 100038,China)

机构地区：[1]首都医科大学附属北京世纪坛医院药学部/临床合理用药生物特征谱学评价北京市重点实验室,北京100038

出　　处：《中国药房》2023年第7期844-848,共5页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81872926);临床合理用药生物特征谱学评价北京市重点实验室基金资助项目(No.BZ0439)。

摘　　要：目的比较颅内恶性肿瘤患儿经外周穿刺中心静脉导管(PICC)与植入式静脉输液港(TIVAP)给予大剂量甲氨蝶呤(HD-MTX)的安全性。方法回顾性分析本院2018年7月至2022年4月经PICC或TIVAP给予HD-MTX的颅内恶性肿瘤患儿病例,收集临床资料,比较两组患儿甲氨蝶呤(MTX)血药浓度、不良事件(包括药物不良反应和导管相关并发症)发生率及住院天数差异。应用多因素线性回归分析MTX血药浓度的影响因素。结果共纳入病例107例,其中PICC组65例、TIVAP组42例。TIVAP组给药后24 h MTX血药浓度(C24 h水平)显著高于PICC组[(126.87±61.99)μmol/L vs.(102.45±48.77)μmol/L,P<0.05],给药后42 h MTX血药浓度(C42 h水平)与PICC组比较差异无统计学意义(P>0.05)。多因素线性回归分析结果显示,经TIVAP给药与MTXC24 h水平升高有关(P<0.05)。两组间不良事件发生率与住院天数的差异均无统计学意义(P>0.05)。结论经TIVAP给药可能出现MTX C24 h水平升高,但不会提高不良事件发生率。在实施治疗药物监测的情况下,经TIVAP给予HD-MTX是较为安全的选择。OBJECTIVE To compare the safety of high-dose methotrexate(HD-MTX)via peripherally inserted central catheter(PICC)and totally implantable venous access port(TIVAP)in pediatric patients with malignant brain tumors.METHODS Patients with malignant brain tumors who received HD-MTX via PICCs or TIVAPs in our hospital from July 2018 to April 2022 were retrospectively analyzed.Clinical data were collected to compare differences in blood concentration of methotrexate(MTX),the incidence of adverse events(including adverse drug reactions and catheter-related complications)and length of stay in hospital.Multivariate linear regression was applied to analyze the factors that influenced the blood concentration of MTX.RESULTS A total of 107 patients were included in the study,with 65 patients in the PICC group and 42 patients in the TIVAP group.Blood concentration of MTX at 24 h(C24 h)in TIVAP group was significantly higher than PICC group[(126.87±61.99)μmol/L vs.(102.45±48.77)μmol/L,P<0.05).There was no significant difference in blood concentration of MTX at 42 h(C42 h),compared with PICC group(P>0.05).Results of multivariate linear regression analysis showed that TIVAP was associated with the increase of C24 h(P<0.05).No significant differences were observed in the incidence of adverse events and the length of stay in the hospital between 2 groups(P>0.05).CONCLUSIONS Risk of adverse events is not increased,although the MTX C24 h level is elevated after administration of TIVAP.TIVAP is a safe choice for HD-MTX therapy with implementing therapeutic drug monitoring.

关 键 词：甲氨蝶呤 植入式静脉输液港 外周穿刺中心静脉导管 颅内恶性肿瘤 治疗药物监测 血药浓度 不良事件 

分 类 号：R969.3[医药卫生—药理学] R979.1[医药卫生—药学]