Protective effect of N-acetylcysteine on oxaliplatin-induced neurotoxicity in patients with colorectal and gastric cancers: A randomized, double blind, placebo-controlled, clinical trial

Protective effect of N-acetylcysteine on oxaliplatin-induced neurotoxicity in patients with colorectal and gastric cancers: A randomized, double blind, placebo-controlled, clinical trial
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DOI:
10.1177/1078155219900788
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发表时间:
2020-02-17
影响因子:
1.3
通讯作者:
Allahyari, Abolghasem
Allahyari, Abolghasem
中科院分区:
医学4区
文献类型:
--
作者:
Bondad, Nazanin;Boostani, Reza;Allahyari, Abolghasem

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目的神经病变是铂类化疗药物最常见和剂量限制性的副作用之一。N-乙酰半胱氨酸是一种抗氧化剂硫醇,能够增加谷胱甘肽的全血浓度,这可能对化疗诱导的神经病变有保护作用。本研究的目的是评估N-乙酰半胱氨酸对奥沙利铂诱导的胃癌或结直肠癌患者的神经毒性的影响。MethodsDuring this randomized,double-blinded,placebo-controlled clinical trial,N-乙酰半胱氨酸片的预防作用进行了评估,与安慰剂相比,对神经病变的发生。32例结直肠癌或胃癌患者随机接受N-乙酰半胱氨酸(2片600 mg片剂)或安慰剂片剂,然后在XALIX(奥沙利铂和卡培他滨方案)中接受奥沙利铂剂量前1 h接受8个疗程的化疗。根据美国国家癌症研究所不良事件通用术语,在8个疗程化疗后评估神经病变严重程度结果奥沙利铂治疗8个疗程后,干预组患者的NCI-CTCAE神经病变分级评分明显低于安慰剂组,差异有统计学意义(P <0.05)感觉电生理评估结果差异无统计学意义(P = 0.501)。两组患者均无运动电生理改变。结论本研究结果表明,N-乙酰半胱氨酸可降低奥沙利铂引起的神经病变的发生率,延缓其在胃癌或结直肠癌患者中的发生。
PurposeNeuropathy is one of the most prevalent and dose-limiting side effects of platinum chemotherapeutic agents. N-acetylcysteine is an antioxidant thiol which is able to increase whole blood concentration of glutathione, which may be protective against chemotherapy-induced neuropathy. The aim of this study was to evaluate the effect of N-acetylcysteine on neurotoxicity induced by oxaliplatin in patients with gastric or colorectal cancers.MethodsDuring this randomized, double-blinded, placebo-controlled clinical trial, the preventive effect of N-acetylcysteine effervescent tablets was assessed in comparison with placebo, on neuropathy occurrence. Thirty-two patients with colorectal or gastric cancer randomly received N-acetylcysteine (two 600 mg tablets) or placebo tablets 1 h before receiving oxaliplatin in dose in XELOX (oxaliplatin and capecitabine regimen) for eight courses of chemotherapy. Neuropathy severity was assessed after eight courses of chemotherapy based on National Cancer Institute Common Terminology for Adverse Events (NCI-CTCAE) criteria neuropathy grading scale and also sensory and motor electrophysiological assessment was performed by a neurologist.ResultsThe NCI-CTCAE scale grade of patients in intervention group was significantly lower than placebo group after eight course of oxaliplatin (P = 0.01); however, the sensory electrophysiological assessment result was not significantly different (P = 0.501). No patient in both group had motor electrophysiological changes.ConclusionThe results of this study showed that N-acetylcysteine could reduce the incidence of the neuropathy induced by oxaliplatin and delay its occurrence in patients with gastric or colorectal cancers.