背景:糖尿病性神经病会增加心血管疾病的风险,外周动脉疾病,足部截肢和总死亡率。使用目前批准的药物,不仅高血糖症引起的神经损伤更难修复,而且,这些药物的使用通常受到所提供的疼痛缓解程度和副作用的限制。
方法:在此前瞻性中,开放标签,试点研究,2型糖尿病患者20例(男/女=13/7,平均年龄-56.1±8.04岁),符合纳入/排除标准,用二肽基肽酶-4(DPP-4)抑制剂治疗,Teneligliptin,20mg,每日一次,持续三个月。功效参数:速动功能(Sudoscan评分);使用Ewing标准评估的副交感神经功能障碍,即心率对站立的反应(HRS),-valsalva(HRV)和-深呼吸(HRD);交感神经功能障碍评估为对-站立(BPS)和-握力(BPH)的血压反应;踝臂指数(ABI),振动感知阈值(VPT),C反应蛋白,血糖状况和健康相关生活质量(HRQoL);耐受性参数:全血细胞计数,肝功能检查,血清肌酐,促甲状腺激素,QT间期和血清维生素B12水平,被测量。
结果:BMI无统计学差异,SBP,DBP,HRD,BPH和所有安全参数。治疗12周后,HRS(p<0.01)和HRV(p<0.01)均有改善,但不在HRD中(p=0.12)。BPS显著降低(p<0.01),但不是BPH(p=0.06)。Sudoscan评分增加,而VPT显著降低(均p<0.01)。
结论:Teneligliptin不仅可以改善血糖状态,还可以改善sudomotor功能,外周和自主神经病变,减少2型糖尿病患者的血管炎症。
BACKGROUND: Diabetic neuropathy increases risk of cardiovascular disease, peripheral artery disease, foot amputation and overall mortality. Not only hyperglycaemia induced nerve damage is harder to repair using currently approved medications, but also, the use of these agents is often limited by the extent of pain relief provided and side effects.
METHODS: In this prospective, open-label, pilot
study, 20 type-2 diabetes mellitus patients (male/female=13/7, mean age- 56.1±8.04 years), meeting inclusion/exclusion criteria, were treated with dipeptidyl peptidase-4 (DPP-4) inhibitor, Teneligliptin, 20mg once a day for three months. Efficacy parameters: Sudomotor function (Sudoscan score); parasympathetic dysfunction assessed using Ewing\'s criteria i.e. heart rate response to -standing (HRS), -valsalva (HRV) and -deep breath (HRD); sympathetic dysfunction assessed as blood pressure response to -standing (BPS) and -handgrip (BPH); ankle brachial index (ABI), vibration perception threshold (VPT), C-reactive protein, glycemic profile and health related quality of life (HRQoL); and, tolerability parameters: complete blood count, liver function tests, serum creatinine, thyroid stimulating hormone, QT- interval and serum vitamin B12 levels, were measured.
RESULTS: There was no statistical difference in BMI, SBP, DBP, HRD, BPH and all safety parameters. After 12 weeks treatment, there was improvement in HRS (p<0.01) and HRV (p<0.01), but not in HRD (p=0.12). BPS was significantly lowered (p <0.01), but not the BPH (p =0.06). Sudoscan score was increased, while VPT was significantly decreased (both p<0.01).
CONCLUSIONS: Teneligliptin not only improves the glycemic status but also improves sudomotor function, peripheral and autonomic neuropathy, and reduces vascular inflammation in type 2 diabetes.