Tesfaye S, Watt J, Benbow S J, Pang K A, Miles J, MacFarlane I A
Walton Diabetes Centre, Walton Hospital, Liverpool, UK.
Lancet. 1996;348(9043):1698-701. doi: 10.1016/S0140-6736(96)02467-1.
Conventional treatment for painful peripheral diabetic neuropathy is largely symptomatic and often ineffective, with unacceptable side-effects. We tested electrical spinal-cord stimulation for the management of chronic neuropathic pain.
Ten diabetic patients who did not respond to conventional treatment (mean age 51 [SD 9.3] years, six with type II diabetes, mean duration of diabetes 12 [6.3] years, mean duration of neuropathy 5 [2.1] years) were studied. The electrode was implanted in the thoracic/lumbar epidural space. Immediate neuropathic pain relief was assessed by visual analogue scale (VAS) after connecting the electrode, in a random order, to a percutaneous electrical stimulator or to a placebo stimulator. Exercise tolerance was assessed on a treadmill.
Eight subjects had statistically significant pain relief with the electrical stimulator (p < 0.02) and were therefore converted to a permanent system. Statistically significant relief of both background and peak neuropathic pain was achieved at 3 months (n = 7, p = 0.016), at 6 months (n = 7, p = 0.03), and at the end of the study (14 months, n = 7, background pain p = 0.06, peak pain p = 0.03). One patient died 2 months after the start of the study of unrelated cause while continuing to benefit from treatment and another patient ceased to benefit at 4 months. McGill pain questionnaire scores with the stimulator turned off did not change significantly from baseline scores, indicating that the severity of the underlying pain was unaltered. However, with the stimulator turned on, there was a statistically significant (p < 0.05) improvement in all four components of the score, by the end of the study. At the end of the study, six patients continued to gain significant pain relief and used the stimulator as the sole treatment for their neuropathic pain. For example, median background and peak pain scores at the end of study, were, respectively, 77 and 81 with the stimulator off and 23 and 20 with the stimulator on. Exercise tolerance significantly improved at 3 months (n = 7, median % increase 85 [IQR, 62-360], p = 0.015) and at 6 months (n = 6, 163 [61-425], p = 0.0007). Electrophysiological tests, vibration perception-threshold, and glycaemic control were unchanged.
Electrical spinal-cord stimulation offers a new and effective way of relieving chronic diabetic neuropathic pain and improves exercise tolerance. The technique should be considered in patients with neuropathic pain who do not respond to conventional treatment.
疼痛性外周糖尿病神经病变的传统治疗主要是对症治疗，且往往无效，还伴有难以接受的副作用。我们对脊髓电刺激治疗慢性神经病理性疼痛进行了测试。
研究了10例对传统治疗无反应的糖尿病患者（平均年龄51[标准差9.3]岁，6例为II型糖尿病，糖尿病平均病程12[6.3]年，神经病变平均病程5[2.1]年）。将电极植入胸段/腰段硬膜外间隙。在将电极以随机顺序连接到经皮电刺激器或安慰剂刺激器后，通过视觉模拟量表（VAS）评估即刻神经病理性疼痛缓解情况。在跑步机上评估运动耐量。
8名受试者使用电刺激器后疼痛得到统计学显著缓解（p<0.02），因此转换为永久性系统。在3个月（n=7，p=0.016）、6个月（n=7，p=0.03）以及研究结束时（14个月，n=7，背景疼痛p=0.06，峰值疼痛p=0.03），背景性和峰值性神经病理性疼痛均得到统计学显著缓解。1例患者在研究开始2个月后因无关原因死亡，但其仍继续从治疗中获益，另1例患者在4个月后不再获益。关闭刺激器时麦吉尔疼痛问卷评分与基线评分相比无显著变化，表明潜在疼痛的严重程度未改变。然而，在研究结束时，打开刺激器时评分的所有四个组成部分均有统计学显著改善（p<0.05）。在研究结束时，6例患者持续获得显著的疼痛缓解，并将刺激器作为其神经病理性疼痛的唯一治疗方法。例如，研究结束时，关闭刺激器时背景疼痛和峰值疼痛评分的中位数分别为77和81，打开刺激器时分别为23和20。运动耐量在3个月时显著改善（n=7，中位数增加百分比85[四分位间距，62 - 360]，p=0.015），在6个月时也显著改善（n=6，163[61 - 425]，p=0.0007）。电生理测试、振动觉阈值和血糖控制均未改变。
脊髓电刺激为缓解慢性糖尿病神经病理性疼痛提供了一种新的有效方法，并改善了运动耐量。对于对传统治疗无反应的神经病理性疼痛患者，应考虑采用该技术。
