The randomized controlled trial of amifostine in improving neurotoxicity induced by oxaliplatin on gastroenteric tumor patients

目的：评价氨磷汀对胃肠道肿瘤化疗药物奥沙利铂所致神经毒性的改善作用。方法将行FOLF-OX6方案化疗的86例胃肠道肿瘤患者随机分为氨磷汀组（给予奥沙利铂前静脉注射氨磷汀，n＝43）和对照组（不予氨磷汀，n＝43）。每2个周期评估神经毒性。结果经过8个周期化疗后，氨磷汀组患者3～4级神经毒性发生率（4.9%）较对照组（16.3%）有明显降低，组间差异具有统计学意义（P＜0.001）。氨磷汀组患者化疗后正中神经和腓神经的感觉神经传导速度分别为（53.75±2.96）m/s和（54.94±2.98）m/s，均明显优于对照组的（45.16±3.13）m/s和（5.05±3.02）m/s，组间差异具有统计学意义（P＜0.001）。化疗近期有效率两组间无显著差异（P＝0.451）。结论氨磷汀对奥沙利铂化疗所致神经毒性具有明显改善作用，且不影响化疗的近期疗效。Objective To explore the effect of amifostine in improving neurotoxicity induced by oxaliplatin on gastroenteric tumor patients. Method A total of 86 patients with gastroenteric tumor were enrolled and randomized into treatment group (combined with intravenous amifostine 500 mg/m2 before oxaliplatin, 43 cases) and control group (43 cases). All patients received FOLFOX6 regimen. Neurological toxicities were assessed every 2 cycles. Re-sult The occurrence rates of grade 3-4 peripheral neurotoxicity after 8 cycles of chemotherapy were significantly lower in treatment group than in control group (4.9% vs 16.3%, P<0.001). The sensory nerve conduction velocity (SCV) was significantly improved in treatment group [SCVmedian nerve = (53.75 ± 2.96) m/s, SCVperoneal nerve = (54.94 ± 2.98) m/s] than in control group [SCVmedian nerve = (45.16 ± 3.13 m/s, SCVperoneal nerve = (5.05 ± 3.02 m/s] (P<0.001). The short-time efficacy of chemotherapy were similar in two groups (P=0.451). Conclusion Amifostine can im-prove the neurotoxicity induced by oxaliplatine, but do not affect response to chemotherapy.中国科技核心期刊(ISTIC)06571-57