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盐酸美金刚治疗糖尿病周围神经病变的随机临床试验

Management of diabetic neuropathy with memantine: A randomized clinical trial.

机构信息

Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.

Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

Diab Vasc Dis Res. 2023 Jul-Aug;20(4):14791641231191093. doi: 10.1177/14791641231191093.

DOI:10.1177/14791641231191093
PMID:37495223
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10387673/
Abstract

BACKGROUND

Diabetes patients frequently experience diabetic neuropathy (DN), a microvascular complication that significantly reduces patients' quality of life. Memantine has demonstrated potential benefits for neuropathic pains in preclinical studies. This study aimed to assess the efficacy of memantine in the management of peripheral neuropathy in patients with type 2 diabetes mellitus (T2DM).

METHOD

This randomized clinical trial includes 143 diabetic patients (aged between 18 and 75 years) with a confirmed diagnosis of diabetic neuropathy. Patients were randomly assigned to receive memantine 5 mg twice daily for 1 week, followed by 10 mg twice daily plus gabapentin 300 mg daily ( = 72) or just gabapentin 300 mg daily ( = 71) for 8 weeks. The DN4 questionnaire, monofilament, tuning fork, and Tip-therm tests were used to measure neuropathy at baseline and after the 8-week intervention.

RESULTS

The mean score of the DN4 questionnaire in the memantine group was significantly lower than the control group (. value: .001). The number of patients with diabetic neuropathy remarkably decreased in the memantine group at the end of the study based on the performed tests (. value: .001).

CONCLUSION

Memantine functions as a beneficial agent in the management of diabetic neuropathy, which would significantly improve the quality of life in diabetic patients.

摘要

背景

糖尿病患者常患有糖尿病周围神经病变(DN),这是一种微血管并发症,显著降低了患者的生活质量。美金刚在临床前研究中已显示出对神经病理性疼痛的潜在益处。本研究旨在评估美金刚在管理 2 型糖尿病(T2DM)患者周围神经病变中的疗效。

方法

这是一项随机临床试验,纳入了 143 名确诊为糖尿病神经病变的糖尿病患者(年龄 18-75 岁)。患者被随机分为两组,分别接受美金刚 5mg,每日两次,持续 1 周,随后接受美金刚 10mg,每日两次,加加巴喷丁 300mg,每日一次(=72 例)或仅接受加巴喷丁 300mg,每日一次(=71 例),持续 8 周。使用 DN4 问卷、单丝、音叉和 Tip-therm 测试在基线和 8 周干预后评估神经病变。

结果

美金刚组的 DN4 问卷评分均值显著低于对照组(p 值:0.001)。根据所进行的测试,美金刚组在研究结束时糖尿病周围神经病变患者数量明显减少(p 值:0.001)。

结论

美金刚作为一种治疗糖尿病周围神经病变的有效药物,可显著改善糖尿病患者的生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33ff/10387673/f1c794c302b8/10.1177_14791641231191093-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33ff/10387673/f1c794c302b8/10.1177_14791641231191093-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33ff/10387673/f1c794c302b8/10.1177_14791641231191093-fig1.jpg

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Physiol Rev. 2021 Jan 1;101(1):259-301. doi: 10.1152/physrev.00045.2019. Epub 2020 Jun 25.
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Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes.
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