氨磷汀防治奥沙利铂神经毒性的临床研究

Clinical Study of Amifostine for Preventing Oxaliplatin-Induced Neurotoxicity

目的研究氨磷汀防治奥沙利铂神经毒性的临床效果。方法将80例奥沙利铂胃肠道肿瘤患者随机均分为试验组和对照组,所有患者均采用含奥沙利铂的FOLFOX4方案进行化学治疗,化学治疗前试验组使用昂丹司琼8 mg、地塞米松5 mg和氨磷汀500 mg/m2,对照组仅予昂丹司琼8 mg和地塞米松5 mg。每个治疗周期评估患者外周神经毒性。结果 6个周期的化学治疗后,氨磷汀组有22.50%的患者发生Ⅰ～Ⅱ度外周神经毒性,明显低于对照组的47.50%(P<0.01),有7.50%的患者发生Ⅲ度外周神经毒性,显著低于对照组的17.50%(P<0.05)。其他化学治疗相关毒副反应发生率两组均无明显差别。结论应用氨磷汀能预防奥沙利铂神经毒性的发生,并降低神经毒性的严重程度。

Objective To assess the clinical efficacy of amifostine in preventing neurotoxicity induced by oxaliplatin.Methods A total of 80 patients with colorectal cancer or gastric cancer were enrolled and randomly assigned to the experimental group（amifostine,40 cases）and the control group（40 cases）.All cases received the chemotherapy with FOLFOX4 regimen.The experimental group was given amifostine 8 mg,dexamethasone 5 mg amifostine 500 mg/m2 just before chemotherapy,while the control group was given only amifostine 8 mg and dexamethasone 5 mg.The neurological toxicity was assessed in each therapeutical cycle.Results Twenty-two point five percent cases in amifostine group occurred degreeⅠ-Ⅱperipheral neurotoxicity after 6 therapeutical cycles of chemotherapy,which was significantly lower than 47.50%in the control group（P0.01）.Seven point five percent cases in amifostine group occurred degreeⅢperipheral neurotoxicity, which was significantly lower than 17.50%in the control group（P0.05）.The occurrence rate of other adverse reactions had no obvious difference between the two groups.Conclusion Amifostine could prevent the occurrence of oxaliplatin-induced neurotoxicity and reduce its severity in the patients with digestive tract tumors.