Argyriou Andreas A, Chroni Elisabeth, Koutras Angelos, Iconomou Gregoris, Papapetropoulos Spiridon, Polychronopoulos Panagiotis, Kalofonos Haralabos P
EMG/ENG Laboratory, Department of Neurology, University of Patras Medical School, Rion-Patras, Greece.
Support Care Cancer. 2006 Nov;14(11):1134-40. doi: 10.1007/s00520-006-0072-3. Epub 2006 Apr 19.
A randomized, open label with blind assessment, controlled trial was performed to assess efficacy and adverse-event profile of vitamin E, given as supplementation for prophylaxis against cisplatin-induced peripheral neuropathy (CIPN).
A total of 30 patients scheduled to receive six courses of cumulative cisplatin-based regimens were randomly allocated to treatment and control groups and were then studied by means of neurological examination and electrophysiological study. Patients assigned to group I (n=14) orally received vitamin E at a daily dose of 600 mg/day during chemotherapy and 3 months after its cessation were compared to patients of group II (n=16), who received no vitamin E supplementation and served as controls. The severity of neurotoxicity was summarized by means of a modified Peripheral Neuropathy (PNP) score.
The incidence of neurotoxicity differed significantly between groups, occurring in 3/14 (21.4%) of patients assigned to the vitamin E supplementation group and in 11/16 (68.5%) of controls (p=0.026). The relative risk (RR) of developing neurotoxicity was significantly higher in case of controls, RR=2.51, 95% C.I.=1.16-5.47. Mean PNP scores were 4.99+/-1.33 for patients of group I and 10.47+/-10.62 for controls, (p=0.023). None of the adverse events or deaths occurred, were judged as likely to be related to the vitamin E supplementation.
Vitamin E effectively and safely protects patients with cancer from occurrence of cisplatin neurotoxicity.
开展一项随机、开放标签且采用盲法评估的对照试验，以评估补充维生素E预防顺铂诱导的周围神经病变（CIPN）的疗效和不良事件情况。
总共30例计划接受六个疗程基于顺铂方案治疗的患者被随机分配至治疗组和对照组，然后通过神经学检查和电生理学研究进行观察。分配至I组（n = 14）的患者在化疗期间每天口服600毫克维生素E，并在化疗结束后3个月继续服用，将其与未补充维生素E作为对照的II组（n = 16）患者进行比较。通过改良的周围神经病变（PNP）评分总结神经毒性的严重程度。
两组之间神经毒性的发生率存在显著差异，维生素E补充组的3/14（21.4%）患者和对照组的11/16（68.5%）患者发生了神经毒性（p = 0.026）。对照组发生神经毒性时的相对风险（RR）显著更高，RR = 2.51，95%置信区间 = 1.16 - 5.47。I组患者的平均PNP评分为4.99 ± 1.33，对照组为10.47 ± 10.62，（p = 0.023）。未发生被判定可能与补充维生素E相关的不良事件或死亡。
维生素E能有效且安全地保护癌症患者免受顺铂神经毒性的影响。
