Novak V, Kanard R, Kissel J T, Mendell J R
Department of Neurology, The Ohio State University, Columbus, USA.
Clin Auton Res. 2001 Dec;11(6):357-61. doi: 10.1007/BF02292767.
To evaluate the effect of tiagabine hydrochloride in painful neuropathy in a pilot, open-label study. Painful neuropathy is characterized by preferential involvement of small sensory and autonomic fibers. Tiagabine increases gamma-aminobutyric acid and might enhance the central pain-control mechanisms. Seventeen patients (10 men, 7 women; mean age 51.4 +/- 7.7 y) with chronic painful neuropathy (>6 months) were enrolled in this study. Week 0: All pain medications were discontinued. Weeks 1-4: Dose of tiagabine was increased weekly by 4 mg orally up to 16 mg in week 4. Quantitative sensory testing for vibration, cooling, and heat-pain, and quantitative sudomotor axon reflex test (QSART) were done at week 0 and week 4. The McGill Pain Questionnaire was administered weekly. Nine patients completed the study; 8 patients discontinued the treatment. Baseline pain intensity was 6.2 +/- 3.1 on the McGill Pain Questionnaire scale (0-10 range). Low doses (4-8 mg) of tiagabine reduced pain symptoms by 16-38%, improving surface pain (37.5%), skin sensitivity (32.8%), burning (38.6%), cold (25.4%) and pain sharpness (29%; p <0.03). Dull and deep pain did not improve. Quantitative sensory testing abnormalities diminished with treatment (p <0.02). Autonomic test results did not change. This pilot study evaluated the potential of tiagabine hydrochloride (Gabitril) in treatment of painful sensory neuropathy. Pain symptoms and quantitative sensory test results improved with treatment, especially at low doses of tiagabine (4-8 mg). Higher doses (12-16 mg) were associated with increased number of adverse events. Tiagabine may have potential benefits for treatment of painful neuropathy; however, assessment of its efficacy in a larger study is needed.
在一项开放性试点研究中评估盐酸噻加宾治疗疼痛性神经病变的效果。疼痛性神经病变的特征是小感觉神经纤维和自主神经纤维优先受累。噻加宾可增加γ-氨基丁酸水平，并可能增强中枢性疼痛控制机制。17例慢性疼痛性神经病变（病程>6个月）患者（10例男性，7例女性；平均年龄51.4±7.7岁）纳入本研究。第0周：停用所有止痛药物。第1 - 4周：噻加宾剂量每周口服增加4 mg，至第4周达到16 mg。在第0周和第4周进行振动觉、冷觉和热痛觉的定量感觉测试以及定量汗腺轴突反射试验（QSART）。每周进行麦吉尔疼痛问卷评估。9例患者完成研究；8例患者中断治疗。麦吉尔疼痛问卷量表上的基线疼痛强度为6.2±3.1（范围0 - 10）。低剂量（4 - 8 mg）的噻加宾使疼痛症状减轻16% - 38%，改善了体表疼痛（37.5%）、皮肤敏感性（32.8%）、烧灼感（38.6%）、冷感（25.4%）和疼痛锐度（29%；p<0.03）。钝痛和深部疼痛未改善。定量感觉测试异常随着治疗而减轻（p<0.02）。自主神经测试结果未改变。这项试点研究评估了盐酸噻加宾（加巴喷丁）治疗疼痛性感觉神经病变的潜力。治疗后疼痛症状和定量感觉测试结果有所改善，尤其是在噻加宾低剂量（4 - 8 mg）时。较高剂量（12 - 16 mg）与不良事件数量增加相关。噻加宾可能对疼痛性神经病变的治疗有潜在益处；然而，需要在更大规模的研究中评估其疗效。
