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首页> 外文期刊>Iranian Journal of Neurology >The effects of botulinum toxin type A injection on pain symptoms, quality of life, and sleep quality of patients with diabetic neuropathy: A randomized double-blind clinical trial
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The effects of botulinum toxin type A injection on pain symptoms, quality of life, and sleep quality of patients with diabetic neuropathy: A randomized double-blind clinical trial

机译:甲型肉毒杆菌毒素注射对糖尿病性神经病患者的疼痛症状,生活质量和睡眠质量的影响:一项随机双盲临床试验

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Background: Neuropathic pain is one of the most common problems in patients with diabetes mellitus (DM). In this study, the effect of botulinum toxin type A (BTX-A) on neuropathic pain, quality of sleep, and quality of life of diabetic patients with sensorimotor polyneuropathy was studied. Methods: This randomized placebo-controlled trial study was carried out in a double-blind (patient-researcher) method. The study was performed on 32 patients with type 2 DM. Neuropathy was confirmed by Douleur Neuropathique 4 (DN4) Questionnaire and nerve conduction study (NCS). The patients were randomly assigned to two intervention and control groups based on the random numbers table. After selecting the subjects, we used 36-Item Short Form Health Survey (SF-36), Neuropathic Pain Scale (NPS), Visual Analogue Scale (VAS), and Pittsburgh Sleep Quality Index (PSQI) questionnaires before and after 3 months of 100 units BTX-A injection (as intervention group) or same amount of chloride sodium (as control group) to the subjects' feet. The data were analyzed by SPSS software using independent two-sample t-test, chi-square test, and one-way repeated measures analysis of variance (ANOVA). Results: 12 male and 20 female patients participated in this study. There was a significant difference in the mean VAS, PSQI, physical dimension of the SF-36, and some NPS indices over time (12 weeks) (P 0.001). Conclusion: The results of this study showed that BTX-A reduced neuropathic pain and improved the quality of life and sleep in people with diabetic neuropathy.
机译:背景:神经性疼痛是糖尿病(DM)患者最常见的问题之一。在这项研究中,研究了A型肉毒毒素(BTX-A)对糖尿病合并感觉运动性多发性神经病患者的神经性疼痛,睡眠质量和生活质量的影响。方法:这项随机安慰剂对照试验研究以双盲(患者研究者)方法进行。该研究针对32位2型DM患者进行。通过Douleur Neuropathique 4(DN4)问卷和神经传导研究(NCS)确认了神经病变。根据随机数表将患者随机分为两个干预组和对照组。在选择受试者之后,我们在3个月的100个月前后使用了36项简短形式健康调查(SF-36),神经性疼痛量表(NPS),视觉类比量表(VAS)和匹兹堡睡眠质量指数(PSQI)问卷。向受试者的脚注射BTX-A单位(作为干预组)或等量的氯化钠(作为对照组)。通过SPSS软件使用独立的两样本t检验,卡方检验和单向重复方差分析(ANOVA)对数据进行分析。结果:12例男性和20例女性患者参加了这项研究。随着时间的推移(12周),平均VAS,PSQI,SF-36的物理尺寸以及一些NPS指数存在显着差异(P <0.001)。结论:这项研究的结果表明,BTX-A可减轻糖尿病性神经病患者的神经性疼痛并改善其生活和睡眠质量。

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