摘要
目的通过对比131I－美妥昔单克隆抗体（简称单抗）2种给药途径所致患者近期不良反应的差异，探讨131I－美妥昔单抗经外周静脉给药治疗肝癌的安全性和优势。
方法分析2010年10月至2013年3月在天津医科大学肿瘤医院接受131I－美妥昔单抗治疗的54例肝癌患者（男45例，女9例，年龄33～80岁）的临床资料。根据不同给药途径将患者分为静脉组（经外周静脉给药）和动脉组（经肝动脉给药），例数分别为33和21。分别对治疗前1周、治疗后4周和12周2组患者血常规、肝肾功能及甲状腺功能变化情况进行比较，并对比2组患者治疗后不良反应的出现情况及进展情况。患者均在治疗后10 d行γ显像，观察其体内药物分布。采用χ2检验或两样本t检验进行统计比较。结果静脉组与动脉组年龄、性别、TNM分期等差异无统计学意义（t＝0.721, χ2：0.561、4.769，均P〉0.05），组间具有可比性。静脉组患者治疗后4周出现一定程度的血液毒性和肝功能损伤，主要表现为较治疗前WBC减少和总胆红素水平升高（χ2＝7.041和10.297，均P〈0.05），12周后均恢复到基线水平；动脉组患者治疗后肝肾功能均未明显受损，WBC和PLT较治疗前减少（χ2＝8.949和8.778，均P〈0.05），12周后基本恢复。2组中治疗前ALT正常的患者治疗后不良反应发生率差异有统计学意义，分别为3.33%（1/30）和5/19（χ2＝5.718，P〈0.05）；其余肝肾功能、血常规指标正常的患者组间不良反应发生率及各术前指标异常的患者不良反应进展率差异无统计学意义（χ2：0.000～2.500，均P〉0.05）。2组患者在药物体内分布、甲状腺功能损伤方面无明显差异。结论经外周静脉途径行131I－美妥昔单抗治疗安全性良好，并没有明显加重不良反应。
Objective To compare the recent adverse reactions caused by 131I-Metuximab （licartin） treatment via two different routes and to assess the safety and advantages of peripheral intravenous bolus of licartin for the treatment of advanced HCC. Methods Clinical data of 54 patients （45 males, 9 females, age 33-80 years） with advanced HCC treated with Licartin in Tianjin Medical University Cancer Institute and Hospital from October 2010 to March 2013 were collected and analyzed. The patients were divided into vein group （n = 33） with Licartin injected through peripheral vein and artery group （n = 21 ） with Licartin injected through hepatic artery. The results of blood routine examination, liver and kidney function and thy- roid function between the two groups （1 week before treatment, 4 and 12 weeks after treatment） were com- pared. The adverse reaction rate （ARR） and adverse reaction progression rate （ARPR） were also compared between the 2 groups. Ten days after Licartin treatment, all patients underwent gamma imaging to access the drug distribution in vivo. Xz test and two-sample t test were used to analyze data. Results There were no sig- nificant differences on age, gender and TNM staging between the vein group and the artery group （t= 0.72l, X2 = 0. 561 and 4.769, all P〉0.05）. The vein group showed temporary drug-related leucopenia （X2 = 7.041, P〈0. 05） and increased level of serum total bilirubin （ STB ; X2 = 10.297, P〈0.05） 4 weeks post-treatment. Twelve weeks later, the above parameters returned to baseline. In artery group, no influence on liver and kidney functions was observed, but the numbers of WBC and PLT decreased significantly （X2= 8.949 and 8. 778, both P〈0.05） and returned to baseline 12 weeks post-treatment. The ARR in patients who had nor- mal ALT levels before treatment between the two groups was significantly different（3.33%（1/30） vs 5/19, X2= 5.718, P〈0.05）. No significant difference was observed on ARR in patients with normal level of
出处
《中华核医学与分子影像杂志》
CAS
北大核心
2016年第4期334-339,共6页
Chinese Journal of Nuclear Medicine and Molecular Imaging
基金
国家自然科学基金（81302003）
关键词
肝肿瘤
抗体
单克隆
碘放射性同位素
注射
静脉内
注射
动脉内
副作用
Liver neoplasms
Antibodies, monoelonal
Iodine radioisotopes
Injections, intravenous
Injections, intra-arterial
Adverese effects
