尼可地尔片联合二甲双胍缓释片治疗糖尿病足周围神经病变的临床研究
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摘要
目的观察尼可地尔片联合二甲双胍缓释片治疗糖尿病足周围神经病变的临床疗效及安全性。方法将95例糖尿病足周围神经病变患者随机分为对照组47例和试验组48例。对照组予以二甲双胍每次0. 5 g,bid,口服;试验组在对照组治疗的基础上,予以尼可地尔每次5 mg,tid,口服。2组患者均治疗2个月。比较2组患者的临床疗效、血糖、神经传导速度,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为89. 58%(43例/48例)和72. 34%(34例/47例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的空腹血糖分别为(5. 70±0. 51)和(6. 84±0. 58) mmol·L~(-1),餐后2 h血糖分别为(9. 12±0. 87)和(10. 23±0. 81) mmol·L~(-1),正中神经运动传导速度分别为(55. 15±7. 23)和(49. 48±4. 78) m·s~(-1),腓总神经运动传导速度分别为(44. 34±4. 57)和(39. 72±4. 87) m·s-1,正中神经感觉传导速度分别为(50. 32±5. 29)和(46. 31±4. 89) m·s~(-1),腓总神经感觉传导速度分别为(43. 12±4. 38)和(37. 89±4. 33) m·s~(-1),差异均有统计学意义(均P <0. 05)。2组患者发生的药物不良反应主要有头痛、胃肠道反应和恶心呕吐。试验组和对照组的总药物不良反应总发生率分别为12. 50%和8. 51%,差异无统计学意义(P> 0. 05)。结论尼可地尔片联合二甲双胍缓释片治疗糖尿病足周围神经病变的临床疗效显著,其能有效改善患者的血糖和神经传导速度,且不增加药物不良反应的发生率。
Objective To observe the clinical efficacy and safety of nicorandil tablets combined with metformin sustained release tablets in the treatment of diabetic foot peripheral neuropathy. Methods A total of 95 patients with diabetic foot peripheral neuropathy were randomly divided into control group( n = 47 cases) and treatment group( n = 48 cases).Control group was treated with metformin 0. 5 g per time,bid,orally.Treatment group was given nicorandil 5 mg per time,tid,orally,on the basis of control group. Two groups were treated for 2 months. The clinical efficacy,blood glucose,nerve conduction velocity and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 89. 58%( 43 cases/48 cases) and 72. 34%( 13 cases/47 cases) with significant difference( P < 0. 05). After treatment,the main indexes of treatment and control groups were compared: the fasting blood glucose were( 5. 70 ± 0. 51) and( 6. 84 ± 0. 58) mmol·L~(-1),the postprandial 2 h blood glucose were( 9. 12 ± 0. 87) and( 10. 23 ± 0. 81) mmol·L~(-1),the motion conduction velocity of median nerve were( 55. 15 ± 7. 23) and( 49. 48 ± 4. 78) m·s~(-1),the motion conduction velocity of fibular nerve were( 44. 34 ± 4. 57) and( 39. 72 ± 4. 87) m · s~(-1),the sensory conduction velocity of median nerve were( 50. 32 ± 5. 29) and( 46. 31 ± 4. 89) m·s~(-1),the sensory conduction velocity of fibular nerve were( 43. 12 ± 4. 38)and( 37. 89 ± 4. 33) m·s~(-1),the differences were statistically significant( all P < 0. 05). The adverse drug reactions of two groups were headache,gastrointestinal reaction and nausea and vomiting. The total incidences of adverse drug reactions in the treatment and control groups were 12. 50% and 8. 51% without significant difference( P > 0. 05).Conclusion Nicorandil tablets combined with metformin sustained release tablets have a definitive clinical efficacy in the treatment of diabetic foot peripheral neuropathy,which can effectively improve the nerve conduction velocity,without increasing the incidence of adverse drug reactions.
Objective To observe the clinical efficacy and safety of nicorandil tablets combined with metformin sustained release tablets in the treatment of diabetic foot peripheral neuropathy. Methods A total of 95 patients with diabetic foot peripheral neuropathy were randomly divided into control group( n = 47 cases) and treatment group( n = 48 cases).Control group was treated with metformin 0. 5 g per time,bid,orally.Treatment group was given nicorandil 5 mg per time,tid,orally,on the basis of control group. Two groups were treated for 2 months. The clinical efficacy,blood glucose,nerve conduction velocity and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 89. 58%( 43 cases/48 cases) and 72. 34%( 13 cases/47 cases) with significant difference( P < 0. 05). After treatment,the main indexes of treatment and control groups were compared: the fasting blood glucose were( 5. 70 ± 0. 51) and( 6. 84 ± 0. 58) mmol·L~(-1),the postprandial 2 h blood glucose were( 9. 12 ± 0. 87) and( 10. 23 ± 0. 81) mmol·L~(-1),the motion conduction velocity of median nerve were( 55. 15 ± 7. 23) and( 49. 48 ± 4. 78) m·s~(-1),the motion conduction velocity of fibular nerve were( 44. 34 ± 4. 57) and( 39. 72 ± 4. 87) m · s~(-1),the sensory conduction velocity of median nerve were( 50. 32 ± 5. 29) and( 46. 31 ± 4. 89) m·s~(-1),the sensory conduction velocity of fibular nerve were( 43. 12 ± 4. 38)and( 37. 89 ± 4. 33) m·s~(-1),the differences were statistically significant( all P < 0. 05). The adverse drug reactions of two groups were headache,gastrointestinal reaction and nausea and vomiting. The total incidences of adverse drug reactions in the treatment and control groups were 12. 50% and 8. 51% without significant difference( P > 0. 05).Conclusion Nicorandil tablets combined with metformin sustained release tablets have a definitive clinical efficacy in the treatment of diabetic foot peripheral neuropathy,which can effectively improve the nerve conduction velocity,without increasing the incidence of adverse drug reactions.
引文
[1]韩莉,伊力哈木江·依马木.糖尿病足病发病机制及诊疗现况[J].医学综述,2014,20(7):1259-1261.
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[4] GUPTA K,JAIN A,ROHATGI A. An observational study of vitamin B12levels and peripheral neuropathy profile in patients of diabetes mellitus on metformin therapy[J]. Diabetes Metab Syndr,2018,12(1):51-58.
[5] RAIZADA N,JYOTSNA VP,SREENIVAS V,et al. Serum vitamin B12levels in type 2 diabetes patients on metformin compared to those never on metformin:A cross-sectional study[J]. Indian J Endocrinol Metab,2017,21(3):424-428.
[6]赵明明,王海蓉,熊峰,等.尼可地尔治疗不稳定型心绞痛疗效和安全性的Meta分析[J].中国循证心血管医学杂志,2014,6(2):131-135.
[7] KATOH M,TAKEDA N,ARIMOTO T,et al. Bevacizumab-related microvascular angina and its management with nicorandil[J]. Int Heart J,2017,58(5):803-805.
[2] SULEIMANI H F,ESHRAGHI A,DALOEE M H,et al. Effect of nicorandil on QT dispersion in patients with stable angina pectoris undergoing elective angioplasty:A triple-blind,randomized,placebo-controlled study[J]. Electron Physician, 2017,9(8):4934-4941.
[3]中华医学会糖尿病学分会.中国2型糖尿病防治指南(2013年版)[J].中国糖尿病杂志,2014,22(8):2-42.
[4] GUPTA K,JAIN A,ROHATGI A. An observational study of vitamin B12levels and peripheral neuropathy profile in patients of diabetes mellitus on metformin therapy[J]. Diabetes Metab Syndr,2018,12(1):51-58.
[5] RAIZADA N,JYOTSNA VP,SREENIVAS V,et al. Serum vitamin B12levels in type 2 diabetes patients on metformin compared to those never on metformin:A cross-sectional study[J]. Indian J Endocrinol Metab,2017,21(3):424-428.
[6]赵明明,王海蓉,熊峰,等.尼可地尔治疗不稳定型心绞痛疗效和安全性的Meta分析[J].中国循证心血管医学杂志,2014,6(2):131-135.
[7] KATOH M,TAKEDA N,ARIMOTO T,et al. Bevacizumab-related microvascular angina and its management with nicorandil[J]. Int Heart J,2017,58(5):803-805.