钙镁预防奥沙利铂急性神经毒性的临床研究  

Clinical study of prevention of oxaliplatin-induced acute neurotoxicity by calcium and magnesium infusions

作　　者：喻建华[1] 万会平[1] 喻建勇[1] 

机构地区：[1]江西省人民医院肿瘤科,南昌330006

出　　处：《肿瘤研究与临床》2007年第6期388-390,共3页Cancer Research and Clinic

摘　　要：目的评价钙、镁注射液对奥沙利铂急性神经毒性的预防作用。方法将42例晚期大肠癌患者随机分为化疗+钙、镁组(研究组)和单纯化疗组(对照组),每组各21例。两组患者采用的化疗方案基本相同,均以奥沙利铂为基础,对照组用奥沙利铂130 mg/m^2加入5%葡萄糖液500 ml中静脉滴注3 h,第1天;雷替曲塞3mg/m^2,静脉推注15min,第1天或四氢叶酸钙(CF)200mg/m^2,静脉滴注,第1天至第5天。5-氟尿嘧啶(5-Fu)500 mg/m^2,静脉滴注,第1天至第5天,每3周为1个周期,共2～6个周期。研究组在奥沙利铂滴注前后,加用10%葡萄糖酸钙和25%硫酸镁各1 g,静脉推注15 min以上。神经毒性采用奥沙利铂特定的分级标准进行评价。结果研究组和对照组的急性神经毒性的发生率分别为47.62%和90.48%,差异具有统计学意义(x^2=9.02,P<0.005),其中研究组Ⅲ度神经毒性的发生率为4.76%,显著低于对照组的33.33%(x^z=5.56,P<0.05)。另外钙、镁注射液未显示有明显的毒副作用,研究组和对照组的客观有效率(OR)分别为33.33%和28.57%,差异无统计学意义(P>0.05)。结论钙、镁可有效预防奥沙利铂的急性神经毒性,且不影响奥沙利铂的疗效,但钙、镁的药物剂量和实施方法有待进一步探讨。Objective To evaluate the efficacy of calcium(Ca)and magnesium(Mg)infusions in pre- vention of oxaliplatin-induced acute neurotoxicity.Methods Fourty-two patients with advanced colorectal carcinoma were eligible for the study:21 were assigned to the Ca/Mg ann and 21 to the control arm.The Ca/ Mg arm and the control arm were comparable for patients'characteristics.Chemotherapy regimen were al- most the same in both arms.Chemotherapy regimen consisted of oxaliplatin 130 mg/m^2 on day 1,given as a 3-hour infusion in 500 ml of 5% glucose,concurrent with rahitrexed 3 mg/m^2 as a 15-minute intravenous (Ⅳ)infusion or calcium folinate(CF)200 mg·m^(-2)·d^(-1),days 1～5,5-Fluorouracil(5-Fu)500 mg·m^(-2)·d^(-1),days 1～5.Therapy was repeated every 3 weeks.The treatment consisted of Ca gluconate and Mg sulfate,1 g each, delivered i.v.over 15 min just before the oxaliplatin infusion and repeated at the same dose after the comple- tion of the oxaliplatin infusion.A specific neurotoxicity scale was used for oxaliplatin-related neurotoxicity. Results Ten patients(47.62%)had acute neurotoxicity in the Ca/Mg arm compared with 19 patients (90.48%)in the control arm(P<0.005).Remarkably,the incidence of grade 3 acute neurotoxicity was 4.76% in the Ca/Mg arm,which was significantly lower than 33.33 % in the control ann(P<0.05).No Ca/ Mg-induced toxicity has been reported in patients of Ca/Mg arm.The overall response rate was 33.33% in the Ca/Mg ann compared with 28.57% in the control arm(P>0.05).Conclusion Ca/Mg infusions seem to reduce incidence and intensity of oxaliplatin-induced acute neurotoxicity,and they do not reduce the clinical activity of oxaliplatin,but dosage and administration schedule could be optimized.

关 键 词：葡萄糖酸钙 硫酸镁 奥沙利铂 毒性作用 

分 类 号：R96[医药卫生—药理学] R735.34[医药卫生—药学]