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一项关于乙酰左旋肉碱对紫杉醇和顺铂诱导的周围神经病变影响的初步研究。

A pilot study on the effect of acetyl-L-carnitine in paclitaxel- and cisplatin-induced peripheral neuropathy.

作者信息

Maestri Antonio, De Pasquale Ceratti Adolfo, Cundari Sante, Zanna Claudio, Cortesi Enrico, Crinò Lucio

机构信息

Medical Oncology Unit, Bellaria Hospital, Bologna, Italy.

出版信息

Tumori. 2005 Mar-Apr;91(2):135-8. doi: 10.1177/030089160509100206.

Abstract

AIMS AND BACKGROUND

In addition to bone marrow suppression and renal toxicity, neurotoxicity is a commonly occurring side effect of widely used chemotherapeutic agents like taxanes, cisplatin and vinca alkaloids. Neurotoxicity can cause antitumor therapy discontinuation or dose regimen modification. The aim of the present exploratory study was to investigate the activity of acetyl-L-carnitine in reversing peripheral neuropathy in patients with chemotherapy-induced peripheral neuropathy.

METHODS AND STUDY DESIGN

Twenty-seven patients (16 males and 11 females) with paclitaxel and/or cisplatin-induced neuropathy (according to WHO recommendations for the grading of acute and subacute toxic effects) were enrolled. Patients received at least one cisplatin- (n = 5) or one paclitaxel- (n = 11) based regimen, or a combination of both (n = 11). Patients with chemotherapy-induced peripheral neuropathy were treated with acetyl-L-carnitine 1 g/die i.v. infusion over 1-2 h for at least 10 days.

RESULTS

Twenty-six patients were evaluated for response having completed at least 10 days of acetyl-L-carnitine therapy (median, 14 days; range, 10-20). At least one WHO grade improvement in the peripheral neuropathy severity was shown in 73% of the patients. A case of insomnia related to ALC treatment was reported in one patient. Acetyl-L-carnitine seems to be an effective and well-tolerated agent for the treatment of chemotherapy-induced peripheral neuropathy.

CONCLUSIONS

Our preliminary results should be confirmed in double-blind, placebo controlled studies.

摘要

目的与背景

除骨髓抑制和肾毒性外,神经毒性是紫杉烷类、顺铂和长春花生物碱等广泛使用的化疗药物常见的副作用。神经毒性可导致抗肿瘤治疗中断或剂量方案调整。本探索性研究的目的是研究乙酰左旋肉碱对化疗所致周围神经病变患者周围神经病变的逆转作用。

方法与研究设计

纳入27例(16例男性和11例女性)因紫杉醇和/或顺铂导致神经病变的患者(根据世界卫生组织关于急性和亚急性毒性作用分级的建议)。患者接受至少一个基于顺铂的方案(n = 5)或一个基于紫杉醇的方案(n = 11),或两者联合方案(n = 11)。化疗所致周围神经病变患者接受乙酰左旋肉碱1 g/d静脉输注1 - 2小时,至少10天。

结果

26例患者在完成至少10天的乙酰左旋肉碱治疗后(中位数为14天;范围为10 - 20天)接受疗效评估。73%的患者周围神经病变严重程度至少有1级的改善。1例患者报告出现与乙酰左旋肉碱治疗相关的失眠。乙酰左旋肉碱似乎是治疗化疗所致周围神经病变的一种有效且耐受性良好的药物。

结论

我们的初步结果应在双盲、安慰剂对照研究中得到证实。

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