还原型谷胱甘肽预防奥沙利铂慢性神经毒性的临床研究(1)
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【摘要】 目的 评价还原型谷胱甘肽对奥沙利铂(OXA)引起的慢性神经毒性的预防作用。方法 采用随机、对照的方法，将接受FOLFOX4方案辅助化疗的105例肿瘤患者随机分为治疗组和对照组，在化疗的同时分别给予还原型谷胱甘肽(54例)和生理盐水(51例)，观察两组慢性神经毒性的发生率及严重程度。结果 化疗2个周期时,两组的慢性神经毒性发生率分别是37.1%和41.1%，差异无统计学意义(P>0.05)；化疗4个周期时,两组的慢性神经毒性发生率分别是58.5%和66.7%，差异无统计学意义(P>0.05)；化疗6个周期时,两组的慢性神经毒性发生率分别是74.0%和89.7%，差异具有显著性统计学意义(P<0.05)。结论 还原型谷胱甘肽是一种有效的预防奥沙利铂引起的慢性神经毒性的治疗措施，值得临床进一步推广应用。
【关键词】 奥沙利铂；神经毒性；还原型谷胱甘肽；预防
Clinical study of the protective effect of reduced glutathion on oxaliplatin-induced chronic neurotoxicity
LIU Shu-hong,WEI Ping,ZHANG Ling-zhi,et al.
Linyi Tumor Hospital of Shandong Province,Linyi 276000,China
【Abstract】 Objective To assess the efficacy of reduced glutathion for preventing the chronic neurotoxicity induced by oxaliplatin.Methods This is a randomized and placebo controlled clinical trail.The patients receiving FOLFOX4 chemotherapy for their solid tumor were randomized to receive reduced glutathion or normal saline with chemotherapy simultaneously.The incidence and severity of oxaliplatin-induced chronic neurotoxicity were observed.Results One hundred and five patients admitted in our department from January 2008 to March 2010 were entered into this study,including 54 patients in the trial group and 51 patients in the control group.After 2 cycles,the incidences of chronic neurotoxicity were 37.1% and 41.1%, respectively.After 4 cycles,the incidences of chronic neurotoxicity were 58.5% and 66.7%, respectively. After 6 cycles,the incidences of chronic neurotoxicity were 74.0% and 89.7%.The difference was significant between the two groups(P<0.05).Conclusion Reduced glutathion is effective in preventing chronic neurotoxicity of oxaliplatin.
【Key words】 Oxaliplatin:Neurotoxicity; Reduced glutathion;Precaution
奥沙利铂(Oxaliplatin，OXA)是第三代铂类抗癌药，在治疗消化系统肿瘤中应用广泛。OXA的剂量限制性毒性是神经毒性，包括急性神经毒性和慢性神经毒性两类，其急性神经毒性发生率可高达100%，慢性神经毒性发生率为65%~98%[1]。目前常用的预防OXA神经毒性的一般方法包括治疗前告知患者用药期间减少接触冷刺激，延长滴注时间(2~6 h)来避免血浆峰值；药物治疗包括钙镁合剂、卡马西平、弥可保等，但主要是针对急性神经毒性，针对慢性神经毒性尚无有效的预防和治疗方法。我们采用随机、对照的方法，通过接受FOLFOX4方案(OXA+5-氟尿嘧啶+甲酰四氢叶酸)辅助化疗的胃肠道肿瘤患者，观察了还原型谷胱甘肽在预防OXA引起的慢性神经毒性方面的作用。
1 资料与方法
1.1 一般资料
1.1.1 入组标准 ①符合相应恶性肿瘤诊断标准且有病理学证据；②年龄18~75岁 ......
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