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文拉法辛预防奥沙利铂所致神经毒性的临床观察

Assessment of the protective effect of venlafaxine on oxaliplatin-induced neurotoxicity

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【作者】 宋敏李磊常志伟孟宇畅捷

【Author】 SONG Min,LI Lei,CHANG Zhi-wei,MENG Yu,CHANG Jie Department of Oncology,First Affiliated Hospital,Zhengzhou University,Zhengzhou 450052,P.R.China

【机构】 郑州大学第一附属医院肿瘤科

【摘要】 目的:探讨文拉法辛对奥沙利铂所致神经毒性的预防作用。方法:将103例接受含奥沙利铂方案化疗的恶性肿瘤患者随机分成文拉法辛组(58例)和对照组(45例),文拉法辛组(随机分为A、B两组)化疗同时给予口服文拉法辛,其中A组28例给予文拉法辛37.5mg,1次/d,B组30例给予文拉法辛75.0mg,1次/d,对照组化疗同时给予口服安慰剂。按照NCI-CTC 3.0奥沙利铂神经毒性分级标准,观察不同组别急、慢性神经毒性以及不良反应发生的差异。结果:A组急性神经毒性的发生率(57.1%)稍高于B组(56.7%),但A、B两组均明显低于对照组的80.0%,A组与对照组发生率比较差异有统计学意义,P=0.036;B组与对照组发生率差异有统计学意义,P=0.03;而A组与B组发生率差异无统计学意义,P=0.971。化疗3个周期时,A组、B组和对照组Ⅰ~Ⅱ度神经毒性的发生率分别为35.7%、40.0%和42.4%,差异无统计学意义,P>0.05。化疗6个周期时,A组Ⅰ~Ⅱ度神经毒性发生率为48.0%,低于B组的53.6%,差异无统计学意义,P=0.685;而A组慢性神经毒性发生率低于对照组的76.9%,差异有统计学意义,P=0.017;B组慢性神经毒性发生率低于对照组,差异有统计学意义,P=0.022。化疗9个周期时,A组慢性神经毒性发生率为59.1%低于B组的62.5%,但差异无统计学意义,P=0.813;而A组Ⅰ~Ⅱ度神经毒性发生率低于对照组的87.9%,差异有统计学意义,P=0.027。B组慢性神经毒性发生率低于对照组,差异有统计学意义,P=0.046。A、B两组恶心、呕吐、乏力不良反应的发生率均较对照组明显增多,差异有统计学意义,P<0.05。结论:文拉法辛能明显减少奥沙利铂所致急慢性神经毒性发生。

【Abstract】 OBJECTIVE:To observe the therapeutic effect of Venlafaxine for oxaliplatin-induced neurotoxicity.METHODS:A total of 103 cases with Oxaliplatin combined chemotherapy were randomly divided into control group,treatment group A(n=28,37.5 mg,1 f/d) and B(n=30,75.0 mg,1 f/d):the control group was treated with placebo;the treatment group A and B were treated with Venlafaxine prior to chemotherapy.The incidence of oxaliplatin-induced neurotoxicity and adverse reactions of Venlafaxine were observed.RESULTS:The incidence of acute neurotoxicity for the treatment group A,B and the control group were 57.1%,56.7% and 80.0%,respectively.The incidence of acute neurotoxicity was statistically significant between the A group and the control group,P=0.036;the incidence of acute neurotoxicity was statistically significant between the B group and the control group,P=0.03;but no statistically significant difference between the A group and the B group,P=0.971.At the third cycle,the incidence of grade Ⅰ-Ⅱ chronic neurotoxicity for the treatment group A,B and the control group were 35.7%,40.0% and 42.4% respectively,and there was no statistically significant difference(P>0.05).After 6 cycles the incidence of grade Ⅰ-Ⅱ chronic neurotoxicity for the treatment group A,B and the control group were 48.0% and 53.6%,respectively.The incidence of chronic neurotoxicity was statistically significant between the A group and the control group(P=0.017),between the B group and the control group(P=0.022),and between A and B group(P=0.685).After 9 cycles,the incidence of grade Ⅰ-Ⅱ chronic neurotoxicity for the treatment group A,B and the control group were 59.1%,62.5% and 87.9%,respectively.The difference was statistically significant between A and control group(P=0.027),between A and B group(P=0.813) and between B and control group(P=0.046).The main adverse events in venlafaxine were asthenia,nausea and vomiting which were more frequent than in control group(P<0.05).CONCLUSION:Venlafaxine has clinical activity against oxaliplatin-induced neurotoxicity toxicity.

【基金】 河南省教育厅科学技术研究重点项目(12A320048)
  • 【文献出处】 中华肿瘤防治杂志 ,Chinese Journal of Cancer Prevention and Treatment , 编辑部邮箱 ,2013年07期
  • 【分类号】R730.5
  • 【被引频次】17
  • 【下载频次】238
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