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评估N-乙酰半胱氨酸作为乳腺癌化疗引起的神经病变保护剂的效果:一项三盲随机临床试验

Evaluating N-acetylcysteine as a Protective Agent Against Chemotherapy-induced Neuropathy in Breast Cancer: A Triple-blind, Randomized Clinical Trial.

作者信息

Hassanzadeh Elyas, Sedighi Pashaki Abdolazim, Akbari Hamed Ehsan, Mehrpooya Maryam, Mohammadian Kamal, Bayani Reyhaneh, Sheikhi Kamran, Ranjbar Hossein, Abbasi Mohammad

机构信息

Department of Radiation Oncology.

Cancer Research Center, Hamedan University of Medical Science, Hamedan.

出版信息

Am J Clin Oncol. 2025 Mar 1;48(3):122-126. doi: 10.1097/COC.0000000000001153. Epub 2024 Nov 4.

Abstract

OBJECTIVES

Chemotherapy-induced peripheral neuropathy (CIPN) is a significant clinical issue that affects patients' quality of life and can limit the dosing of chemotherapeutic agents. N-acetylcysteine (NAC) has been proposed as a potential chemoprotective agent against CIPN due to its antioxidant properties. This study aimed to investigate the efficacy of oral NAC in preventing and controlling taxane-induced neuropathy in patients with breast cancer.

METHODS

This randomized, triple-blind, placebo-controlled trial included 80 breast cancer patients undergoing taxane-based chemotherapy. Participants were divided into 2 groups: an intervention group receiving 1200 mg of oral NAC in divided doses per day and a placebo group. Patients were evaluated for neuropathy grade and functional status at 1 and 12 weeks postintervention.

RESULTS

Our analysis revealed no significant difference in the incidence and severity of neuropathy between the intervention and placebo groups at 1 ( P =0.328) and 12 weeks ( P =0.569) postchemotherapy. Baseline characteristics such as age, number of treatment cycles, and disease stage were similar between groups, indicating a homogeneous population.

CONCLUSIONS

Oral NAC at a dose of 1200 mg per day did not significantly reduce the incidence or severity of taxane-induced neuropathy. These findings suggest that the oral bioavailability of NAC may be insufficient to exert a protective effect and that future studies should consider alternative dosing strategies or routes of administration. The need for further research to optimize NAC's chemoprotective role in CIPN remains evident.

摘要

目的

化疗引起的周围神经病变(CIPN)是一个重要的临床问题,会影响患者的生活质量,并可能限制化疗药物的剂量。由于其抗氧化特性,N-乙酰半胱氨酸(NAC)已被提议作为一种潜在的针对CIPN的化学保护剂。本研究旨在探讨口服NAC预防和控制乳腺癌患者紫杉烷引起的神经病变的疗效。

方法

这项随机、三盲、安慰剂对照试验纳入了80例接受紫杉烷类化疗的乳腺癌患者。参与者被分为两组:干预组每天分剂量服用1200毫克口服NAC,以及安慰剂组。在干预后1周和12周对患者的神经病变分级和功能状态进行评估。

结果

我们的分析显示,化疗后1周(P = 0.328)和12周(P = 0.569)时,干预组和安慰剂组之间神经病变的发生率和严重程度没有显著差异。两组之间的基线特征如年龄、治疗周期数和疾病分期相似,表明人群具有同质性。

结论

每天服用1200毫克的口服NAC并不能显著降低紫杉烷引起的神经病变的发生率或严重程度。这些发现表明,NAC的口服生物利用度可能不足以发挥保护作用,未来的研究应考虑替代给药策略或给药途径。显然仍需要进一步研究以优化NAC在CIPN中的化学保护作用。

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