Preventing paclitaxel-induced peripheral neuropathy: A phase II trial of vitamin E supplementation
Preventing paclitaxel-induced peripheral neuropathy: A phase II trial of vitamin E supplementation
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DOI：
10.1016/j.jpainsymman.2006.03.013
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发表时间：
2006-09-01
影响因子：
4.7
通讯作者：
Kalofonos, Haralabos P.
中科院分区：
文献类型：
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作者：
Argyriou, Andreas A.;Chroni, Elisabeth;Kalofonos, Haralabos P.
进行了一项随机对照试验，以评估补充维生素 E 预防紫杉醇诱发的周围神经病变 (PIPN) 的功效和安全性。接受 6 个疗程紫杉醇化疗的 32 名患者被随机分配接受维生素 E 化疗（300 毫克，每天两次，第一组）或不补充维生素 E 的化疗（第二组）。化疗期间和化疗后 3 个月进行了详细的神经学检查和电生理学研究。 PIPN 的严重程度通过改良的周围神经病变 (PNP) 评分进行总结。神经毒性的发生率在各组之间存在显着差异，分配到维生素 E 补充剂组的患者中有 3/16 (18.7%) 发生，而对照组的神经毒性发生率为 10/16 (62.5%) (P = 0.03)。对照组患者发生 PIPN 的相对风险 (RR) 显着高于维生素 E 组患者（RR = 0.3，95% 置信区间 (CI) = 0.1-0.9）。 I 组患者的平均 PNP 评分为 2.25 +/- 5.1（范围 0-15），II 组患者的平均 PNP 评分为 11 +/- 11.63（范围 0-32）（P = 0.01）。维生素 E 补充剂的耐受性良好，并表现出出色的安全性。这项研究表明，维生素E有效且安全地保护癌症患者免受紫杉醇引起的周围神经损伤的发生。需要进行双盲、安慰剂对照试验来证实这些结果。
A randomized, controlled trial was performed to assess the efficacy and safety of vitamin E supplementation for Prophylaxis against paclitaxel-induced peripheral neuropathy (PIPN). Thirty-two patients undergoing six courses of paclitaxel-based chemotherapy were randomly assigned to receive either chemotherapy with vitamin E (300 mg twice a day, Group I) or chemotherapy without vitamin E supplementation (Group II). A detailed neurological examination and electrophysiological study was performed during and 3 months after chemotherapy. The severity of PIPN was summarized by means of a modified Peripheral Neuropathy (PNP) score. The incidence of neurotoxicity differed significantly between groups, occurring in 3/16 (18.7 %) patients assigned to the vitamin E supplementation group and in 10/16 (62.5%) controls (P = 0.03). The relative risk (RR) of developing PIPN was significantly higher in controls than in vitamin E group patients (RR = 0.3, 95 % confidence interval (CI) = 0.1- 0.9). Mean PNP scores were 2.25 +/- 5.1 (range 0-15) for patients in Group I and 11 +/- 11.63 (range 0-32) for those in Group II (P = 0.01). Vitamin E supplementation was well tolerated and showed an excellent safely profile. This study shows that vitamin E effectively and safely Protects Patients with cancer from the occurrence of paclitaxel-induced peripheral nerve damage. A double-blind, placebo-controlled trial is needed to confirm these results.