Sodium valproate in the management of painful neuropathy in type 2 diabetes - a randomized placebo controlled study
Sodium valproate in the management of painful neuropathy in type 2 diabetes - a randomized placebo controlled study
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DOI：
10.1034/j.1600-0404.2002.01229.x
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发表时间：
2002-11-01
影响因子：
3.5
通讯作者：
Gupta, S
中科院分区：
文献类型：
--
作者：
Kochar, DK;Jain, N;Gupta, S
目的：研究丙戊酸钠治疗2型糖尿病患者痛性神经病变的有效性和安全性。材料和方法-丙戊酸钠在2型糖尿病患者中进行了一项随机、双盲、安慰剂对照试验，以评估其在治疗痛性神经病变中的有效性和安全性。我们筛选了60名患者，但有8名患者未能完成研究；因此，本研究对52名患者进行了研究。治疗前和治疗1个月末分别进行临床检查、麦吉尔疼痛问卷简式疼痛评分(SF-MPQ)和电生理检查，包括运动神经和感觉神经传导速度、波幅和H反射。结果：与服用安慰剂的患者相比，服用丙戊酸钠的患者在1个月末的疼痛评分显著改善(P<；0.05)。电生理指标变化不明显。除了一名患者在治疗15天后天冬氨酸转氨酶(AST)/丙氨酸转氨酶(ALT)水平升高外，所有患者对该药物的耐受性都很好。结论：丙戊酸钠是一种耐受性良好的药物，对疼痛的糖尿病神经病变有显著的主观改善作用。这些数据为未来在更大的患者群体中进行更长持续时间的试验提供了基础。
Objective - To study the effectiveness and safety aspects of sodium valproate in the management of painful neuropathy in patients of type 2 diabetes mellitus. Material and methods - A randomized double-blind placebo controlled trial of sodium valproate was done in type 2 diabetic patients to assess its efficacy and safety in the management of painful neuropathy. We screened 60 patients but eight patients could not complete the study; hence, the present study was done on 52 patients. Each patient was assessed by clinical examination, pain score by short form of the McGill pain questionnaire (SF-MPQ) and electrophysiological examination, which included motor and sensory nerve conduction velocity, amplitude and H-reflex initially and at the end of 1 month of treatment. Results - Significant improvement was noticed in the pain score of patients receiving sodium valproate in comparison to patients receiving placebo at the end of 1 month (P < 0.05). The changes in electrophysiological data were not significant. The drug was well tolerated by all patients except one who developed a raised aspartate transaminase (AST)/alanine transaminase (ALT) level after 15 days of treatment. Conclusion - Sodium valproate is a well-tolerated drug and provides significant subjective improvement in painful diabetic neuropathy. These data provide a basis for future trials of longer duration in a larger group of patients.