Agrawal R P, Jain S, Goyal S, Singhal S, Lindgren L, Sthengel E
J Assoc Physicians India. 2014 May;62(5):385-90.
Impaired nitric oxide synthesis has been implicated as one of the underlying causes of diabetic painful neuropathy (DPN). Hence, effects of a cutaneous, nitric oxide releasing patch (NitroSense Derma Protect) were evaluated in subjects with DPN.
Fifty diabetics were randomised to active/placebo arms after a 2 wk wash-out period. Patients received 24 mg patches (each patch releases around 9 nmol/cm2/min of nitric oxide) for 3 hrs, every other day during a 3 wks period, or indistinguishable placebo patches. The extent of pain was recorded at start, at each visit and following completion of the study. Changes in pain from baseline were measured using the 11 point lickert scale (PLS), visual analogue scale (VAS), short form mcgill, pain questionnaire (SF-MPQ), present pain intensity (PPI) scale.
Subjects treated with patch experienced a statistically significant reduction in pain from baseline when compared to placebo (PLS scale; p = 0.05). Defining responders as subjects with a > 50% reduction in PLS score from baseline, the number needed to treat (NNT) was calculated as 3.0. A significant post-treatment decrease (p = 0.009) in vibration perception threshold (VPT) for left foot after active treatment was observed.
Present results highlight utility of NitroSense Derma Protect as controllable nitric oxide source for patients with DPN.
一氧化氮合成受损被认为是糖尿病性疼痛性神经病变（DPN）的潜在病因之一。因此，对一种可释放一氧化氮的皮肤贴片（NitroSense Derma Protect）在DPN患者中的效果进行了评估。
50名糖尿病患者在经过2周的洗脱期后被随机分为活性药物组/安慰剂组。患者在3周期间每隔一天接受24毫克贴片（每片贴片每分钟释放约9纳摩尔/平方厘米的一氧化氮）3小时，或接受难以区分的安慰剂贴片。在研究开始时、每次访视时以及研究结束后记录疼痛程度。使用11点李克特量表（PLS）、视觉模拟量表（VAS）、简短麦吉尔疼痛问卷（SF-MPQ）、当前疼痛强度（PPI）量表测量与基线相比疼痛的变化。
与安慰剂相比，接受贴片治疗的受试者疼痛较基线有统计学显著降低（PLS量表；p = 0.05）。将反应者定义为PLS评分较基线降低>50%的受试者，计算得出治疗所需人数（NNT）为3.0。活性治疗后观察到左脚振动感觉阈值（VPT）有显著的治疗后降低（p = 0.009）。
目前的结果突出了NitroSense Derma Protect作为DPN患者可控一氧化氮来源的效用。
