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维生素E对奥沙利铂所致周围神经病变预防作用的随机对照试验

Effect of Vitamin E on Oxaliplatin-induced Peripheral Neuropathy Prevention: A Randomized Controlled Trial.

作者信息

Salehi Zeinab, Roayaei Mahnaz

机构信息

Department of Radiotherapy and Oncology, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

Int J Prev Med. 2015 Nov 2;6:104. doi: 10.4103/2008-7802.169021. eCollection 2015.

Abstract

BACKGROUND

Peripheral neuropathy is one of the most important limitations of oxaliplatin base regimen, which is the standard for the treatment of colorectal cancer. Evidence has shown that Vitamin E may be protective in chemotherapy-induced peripheral neuropathy. The aim of this study is to evaluate the effect of Vitamin E administration on prevention of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer.

METHODS

This was a prospective randomized, controlled clinical trial. Patients with colorectal cancer and scheduled to receive oxaliplatin-based regimens were enrolled in this study. Enrolled patients were randomized into two groups. The first group received Vitamin E at a dose of 400 mg daily and the second group observed, until after the sixth course of the oxaliplatin regimen. For oxaliplatin-induced peripheral neuropathy assessment, we used the symptom experience diary questionnaire that completed at baseline and after the sixth course of chemotherapy. Only patients with a score of zero at baseline were eligible for this study.

RESULTS

Thirty-two patients were randomized to the Vitamin E group and 33 to the control group. There was no difference in the mean peripheral neuropathy score changes (after - before) between two groups, after sixth course of the oxaliplatin base regimen (mean difference [after - before] of Vitamin E group = 6.37 ± 2.85, control group = 6.57 ± 2.94; P = 0.78). Peripheral neuropathy scores were significantly increased after intervention compared with a base line in each group (P < 0.001).

CONCLUSIONS

The results from this current trial demonstrate a lack of benefit for Vitamin E in preventing oxaliplatin-induced peripheral neuropathy.

摘要

背景

周围神经病变是奥沙利铂基础方案治疗结直肠癌的标准方案中最重要的限制因素之一。有证据表明,维生素E可能对化疗引起的周围神经病变具有保护作用。本研究的目的是评估补充维生素E对预防结直肠癌患者奥沙利铂引起的周围神经病变的效果。

方法

这是一项前瞻性随机对照临床试验。本研究纳入了计划接受奥沙利铂基础方案治疗的结直肠癌患者。将入选患者随机分为两组。第一组每天服用400毫克维生素E,第二组进行观察,直至完成奥沙利铂方案的第六个疗程。对于奥沙利铂引起的周围神经病变评估,我们使用了在基线时和化疗第六个疗程后完成的症状体验日记问卷。只有在基线时评分为零的患者才有资格参加本研究。

结果

32例患者被随机分配到维生素E组,33例被分配到对照组。在奥沙利铂基础方案的第六个疗程后,两组之间的平均周围神经病变评分变化(治疗后-治疗前)没有差异(维生素E组的平均差异[治疗后-治疗前]=6.37±2.85,对照组=6.57±2.94;P=0.78)。与每组的基线相比,干预后周围神经病变评分均显著增加(P<0.001)。

结论

本次试验结果表明,维生素E在预防奥沙利铂引起的周围神经病变方面没有益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e19/4671163/df08f1e22a68/IJPVM-6-104-g001.jpg

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