Department of Pharmacology, Medical College, Kolkata, India.
Indian J Pharmacol. 2013 Jul-Aug;45(4):334-8. doi: 10.4103/0253-7613.115000.
To assess the efficacy and safety of gabapentin and amitriptyline along with opioids in patients suffering from neuropathic pain in malignancy.
Eighty-eight adult patients between 18 and 70 years of age with neuropathic pain in stage III malignant disease, matched for baseline charactistics, were randomly assigned to two groups. Group A received oral tramadol and gabapentin and group B received oral tramadol and amitriptyline. The treatment duration of each patient was 6 months. Visual analog scale (VAS) was the primary efficacy parameter. Verbal rating scale (VRS) score, percentage of pain relief (PPR), and global pain score (GPS) were the secondary efficacy parameters. Oral morphine tablets or fentanyl transdermal patch were used as rescue medication. Data analysis was carried out in Graph Pad instat.
There was decline in VAS pain score from baseline in both the groups in the early phase of the study though there was no statistically detectable difference between them at any study point. Similar changes were seen in the secondary efficacy parameters too. Thus both the drugs were effective in providing relief to cancer patients with neuropathic pain though there was no statistically detectable difference in efficacy between them. Six patients in group A and eight patients in group B required rescue medication. A total of 12 subjects in the gabapentin group and 15 subjects in the amitriptyline group experienced adverse events which were of mild to moderate grades.
Amitriptyline may be a suitable alternative for management of neuropathic pain in cancer patients although gabapentin is widely used for this purpose. The lower cost of amitriptyline may favor patient compliance with lesser number of drop-outs.
评估加巴喷丁和阿米替林与阿片类药物联合用于恶性肿瘤神经病理性疼痛患者的疗效和安全性。
88 例年龄在 18 至 70 岁之间的 III 期恶性疾病伴神经病理性疼痛的成年患者,按基线特征匹配,随机分为两组。A 组给予口服曲马多和加巴喷丁,B 组给予口服曲马多和阿米替林。每位患者的治疗持续时间为 6 个月。视觉模拟评分(VAS)是主要疗效参数。言语评定量表(VRS)评分、疼痛缓解率(PPR)和全球疼痛评分(GPS)是次要疗效参数。口服吗啡片或芬太尼透皮贴剂作为解救药物。数据分析使用 Graph Pad instat 进行。
两组患者在研究早期 VAS 疼痛评分均从基线下降,但在任何研究点均无统计学差异。次要疗效参数也有类似的变化。因此,两种药物都能有效缓解癌症伴神经病理性疼痛患者的疼痛,尽管它们的疗效之间没有统计学差异。A 组 6 例和 B 组 8 例患者需要解救药物。加巴喷丁组共有 12 例和阿米替林组 15 例患者出现不良反应,均为轻度至中度。
阿米替林可能是治疗癌症患者神经病理性疼痛的一种合适选择,尽管加巴喷丁广泛用于此目的。阿米替林的成本较低,可能有利于患者的依从性,减少脱落率。