Mehta Sanjana, Nain Parminder, Agrawal Bimal K, Singh Rajinder P, Kaur Jaspreet, Maity Sabyasachi, Bhattacharjee Aniruddha, Peela Jagannadha, Nauhria Shreya, Nauhria Samal
Department of Pharmacy Practice, Maharishi Markandeshwar College of Pharmacy, Maharishi Markandeshwar (Deemed to be University), Ambala, IND.
Department of Internal Medicine, Maharishi Markandeshwar Institute of Medical Science and Research, Maharishi Markandeshwar (Deemed to be University), Ambala, IND.
Cureus. 2021 Dec 6;13(12):e20208. doi: 10.7759/cureus.20208. eCollection 2021 Dec.
Neuropathy is the most prevalent broad-spectrum microvascular complication of diabetes. The present study aims to evaluate the effect of empagliflozin with vitamin D supplementation on diabetic peripheral neuropathy.
A prospective, randomized, controlled study was conducted for six months including 150 type 2 diabetic patients, divided into three groups (n=50/group): Group 1, patients on oral hypoglycemic agents; Group 2, patients on empagliflozin and Group 3, patients on empagliflozin with vitamin D. Biochemical parameters were estimated for outcome measurements and patients' neuropathic pain was analysed using Douleur Neuropathique 4 Questions, Neuropathic Pain Symptom Inventory and Ipswich Touch the toes test questionnaire. Data were analysed using a one-way analysis of variance.
Diabetic neuropathy in males was more prevalent (more than 50%) as compared to females in all three groups, with an average age of 50±6 years, along with a diabetic history of 15±4.5 years and a glycated hemoglobin A1C (HbA1C) level of >10%. The mean value of serum vitamin D level significantly increased by 64.7% (19±5 to 54±8 ng/mL; <0.05). A remarkable decrease (by 17.4%) from baseline in the HbA1C level was observed after six months of treatment only in Group 3, whereas in other groups (1 and 2), there was a non-significant decrease in HbA1C levels when compared to baseline. Moreover, a significant improvement in neuropathic condition was seen only in Group 3.
The results indicated that empagliflozin with vitamin D supplementation significantly controlled or reduced HbA1C and improved diabetic neuropathic symptoms in patients. It is suggested that this combination can be considered as the primary therapeutic approach for neuropathic complications in diabetic patients.
神经病变是糖尿病最常见的广谱微血管并发症。本研究旨在评估恩格列净联合补充维生素D对糖尿病周围神经病变的影响。
对150例2型糖尿病患者进行了为期6个月的前瞻性、随机对照研究，分为三组（每组n = 50）：第1组，口服降糖药患者；第2组，恩格列净治疗患者；第3组，恩格列净联合维生素D治疗患者。评估生化参数以测量结果，并使用神经病理性疼痛4项问卷、神经病理性疼痛症状量表和伊普斯威奇触趾测试问卷分析患者的神经病理性疼痛。数据采用单因素方差分析。
在所有三组中，男性糖尿病神经病变比女性更普遍（超过50%），平均年龄为50±6岁，糖尿病病史为15±4.5年，糖化血红蛋白A1C（HbA1C）水平>10%。血清维生素D水平的平均值显著升高了64.7%（从19±5至54±8 ng/mL；<0.05）。仅在第3组治疗6个月后观察到HbA1C水平较基线显著降低（17.4%），而在其他组（第1组和第2组）中，与基线相比HbA1C水平无显著降低。此外，仅在第3组中观察到神经病变状况有显著改善。
结果表明，恩格列净联合补充维生素D可显著控制或降低HbA1C，并改善患者的糖尿病神经病变症状。建议该联合治疗可作为糖尿病患者神经病变并发症的主要治疗方法。
