Rao Ravi D, Michalak John C, Sloan Jeff A, Loprinzi Charles L, Soori Gamini S, Nikcevich Daniel A, Warner David O, Novotny Paul, Kutteh Leila A, Wong Gilbert Y
Department of Medical Oncology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA.
Cancer. 2007 Nov 1;110(9):2110-8. doi: 10.1002/cncr.23008.
The antiepileptic agent, gabapentin, has been demonstrated to relieve symptoms of peripheral neuropathy due to various etiologies. On the basis of these data, a multicenter, double-blind, placebo-controlled, crossover, randomized trial was conducted to evaluate the effect of gabapentin on symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Patients with symptomatic CIPN who complained of 'average' daily pain scores of either 1) >/=4 on a 0-10 numerical rating scale (NRS); or 2) >/=1 on the 0-3 Eastern Cooperative Oncology Group neuropathy scale (ENS) were eligible (higher numbers indicate greater severity of symptoms in both scales). Patients were randomized to receive gabapentin (target dose, 2700 mg) or placebo for 6 weeks. Crossover occurred after a 2-week washout period. CIPN-related symptoms were evaluated weekly by questionnaires. Statistical methods followed established methods for crossover designs, including Student t tests to compare average intrapatient differences between treatments and linear models to adjust for potential concomitant covariates.
There were 115 patients who were randomly assigned to the treatment or control arm. Both groups were well matched by symptoms at study entry. Changes in symptom severity were statistically similar between the 2 groups during the study. Adverse events were mild and similar in both groups.
This trial failed to demonstrate any benefit to using gabapentin to treat symptoms caused by CIPN.
抗癫痫药物加巴喷丁已被证明可缓解各种病因引起的周围神经病变症状。基于这些数据，开展了一项多中心、双盲、安慰剂对照、交叉、随机试验，以评估加巴喷丁对化疗引起的周围神经病变（CIPN）症状的影响。
有症状的CIPN患者，若其在0至10的数字评分量表（NRS）上的“平均”每日疼痛评分满足以下条件之一：1）≥4；或2）在0至3的东部肿瘤协作组神经病变量表（ENS）上≥1，则符合入选标准（两个量表中分数越高表明症状越严重）。患者被随机分配接受加巴喷丁（目标剂量2700毫克）或安慰剂治疗6周。在2周的洗脱期后进行交叉治疗。通过问卷每周评估与CIPN相关的症状。统计方法遵循既定的交叉设计方法，包括采用学生t检验比较治疗组间患者的平均差异，并采用线性模型调整潜在的伴随协变量。
共有115名患者被随机分配至治疗组或对照组。两组在研究入组时症状匹配良好。研究期间两组症状严重程度的变化在统计学上相似。不良事件轻微，两组相似。
该试验未能证明使用加巴喷丁治疗CIPN引起的症状有任何益处。
