Tandan R, Lewis G A, Krusinski P B, Badger G B, Fries T J
Department of Neurology, University of Vermont College of Medicine, Burlington.
Diabetes Care. 1992 Jan;15(1):8-14. doi: 10.2337/diacare.15.1.8.
We conducted an 8-wk controlled study with topical 0.075% capsaicin in subjects with chronic severe painful diabetic neuropathy who were unresponsive or intolerant to conventional therapy. Capsaicin is an alkaloid found in capsicum peppers and produces desensitization to noxious thermal, chemical, and mechanical stimuli when applied topically.
In 22 randomly assigned subjects, either capsaicin or vehicle cream was applied to painful areas 4 times/day. Pain measurements were recorded at baseline and at 2-wk intervals for 8 wk.
Capsaicin treatment was more beneficial than vehicle treatment in the overall clinical improvement of pain status, as measured by physician's global evaluation (P = 0.038) and by a categorical pain severity scale (P = 0.057). Decrease in mean pain intensity by a visual analogue scale was 16% in capsaicin-treated and 4.1% in vehicle-treated subjects. Mean pain relief on visual analogue scale was 44.6 and 23.2%, respectively. In a follow-up open-label study, approximately 50% of subjects reported improved pain control or were cured, and 25% each were unchanged or worse. A burning sensation at the application site was noted by some subjects but both its magnitude and duration decreased with time.
Results from this preliminary study suggest that topical 0.075% capsaicin may be of value in subjects with diabetic neuropathy and intractable pain.
我们对慢性重度疼痛性糖尿病神经病变且对传统治疗无反应或不耐受的受试者进行了一项为期8周的对照研究，使用局部0.075%辣椒素。辣椒素是一种存在于辣椒中的生物碱，局部应用时可使对有害热、化学和机械刺激产生脱敏作用。
在22名随机分组的受试者中，辣椒素或赋形剂乳膏每天4次涂抹于疼痛部位。在基线及之后8周内每2周记录一次疼痛测量值。
通过医生整体评估（P = 0.038）和分类疼痛严重程度量表（P = 0.057）测量，辣椒素治疗在疼痛状态的总体临床改善方面比赋形剂治疗更有益。用视觉模拟量表测量，辣椒素治疗组的平均疼痛强度降低了16%，赋形剂治疗组降低了4.1%。视觉模拟量表上的平均疼痛缓解率分别为44.6%和23.2%。在一项随访开放标签研究中，约50%的受试者报告疼痛控制改善或治愈，各有25%的受试者情况无变化或恶化。一些受试者注意到涂抹部位有烧灼感，但随着时间推移其程度和持续时间均有所减轻。
这项初步研究的结果表明，局部应用0.075%辣椒素可能对糖尿病神经病变和顽固性疼痛的受试者有价值。
