Direkord II期临床试验:随机、双盲、安慰剂对照、平行组和前瞻性研究,以选择最佳剂量,研究缺血性卒中早期恢复期患者的疗效、安全性和耐受性

IF 0.1 Q4 MEDICINE, GENERAL & INTERNAL
I. A. Pomytkin, V. V. Pisarev, M. E. Merkulov, E. B. Kuznetsova, E. A. Salina, A. Yu. Malygin, N. N. Karkischenko
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引用次数: 0

摘要

Direkord是一种含有琥珀酸二胆碱活性物质的原药,它能提高神经元中胰岛素受体对胰岛素的敏感性。本研究的目的是选择最佳剂量,并研究肌内注射溶液Direkord在缺血性脑卒中恢复期早期的疗效、安全性和耐受性。132例颈动脉系统首次缺血性卒中患者,经计算机或磁共振成像证实,卒中距离为3周~ 2个月,平均年龄为64.35±8.03岁,随机分为3个治疗组。第一组(n=44)和第二组(n=44)患者分别以400 mg/天和600 mg/天的剂量肌肉注射Direkord,为期两周。第三组患者接受安慰剂。根据神经状态、功能状态和认知功能的改善来评估治疗反应,包括NIHSS总分至少降低两倍,Barthel总分≥95分,MoCA总分≥26分。研究开始四周后,第一组、第二组和第三组分别有34.1%、43.2%和18.2%的患者对治疗有反应。基于Fisher精确检验的分析显示,两组之间存在统计学显著差异(p=0.036)。这些结果表明,在早期恢复期缺血性颈动脉卒中患者中,Direkord以600 mg/天的剂量进行为期两周的肌肉注射治疗,在统计学和临床上均显著优于安慰剂。在各种治疗方案中使用Direkord的安全性与安慰剂没有区别。第三期研究应确认在目前工作中获得的初步结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Phase II Clinical Trial of Direkord: Randomized, Double-Blind, Placebo-Controlled, Parallel Group, and Prospective Studies to Select Optimal Dosage and to Study the Efficacy, Safety, and Tolerability in Ischemic Stroke Patients in the Early Recovery Period
Direkord is an original drug containing the active substance of dicholine succinate, which improves the sensitivity of insulin receptors in neurons to insulin. The aim of the work was to select an optimal dosage and to study the efficacy, safety, and tolerability of Direkord, a solution for intramuscular injection, in ischemic stroke patients in the early recovery period. In total, 132 patients after the first ischemic stroke in the carotid system, confirmed by computed or magnetic resonance imaging, with the stroke remoteness from 3 weeks to 2 months and the mean age of 64.35±8.03 years, were randomized into three treatment groups. Patients in the first (n=44) and second (n=44) groups received Direkord intramuscularly for two weeks at a dose of 400 mg/day and 600 mg/day, respectively. Patients in the third group received placebo. The treatment response was assessed in terms of improved neurological status, functional state, and cognitive functions, including at least a two-fold decrease in the total score on the NIHSS scale, the total score on the Barthel scale ≥95, and the total score on the MoCA scale ≥26. Four weeks after the onset of the study, 34.1, 43.2, and 18.2% of the patients responded to therapy in the first, second, and third group, respectively. An analysis based on the Fisher’s exact test revealed a statistically significant difference between the groups (p=0.036). These results suggest that Direkord is statistically and clinically significantly superior to placebo at a two-week intramuscular therapy at a dose of 600 mg/day in patients with ischemic carotid stroke in the early recovery period. The safety profile of Direkord when used in various therapy regimens does not differ from that of placebo. The phase III study should confirm the preliminary results obtained in the current work.
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Avances en Biomedicina
Avances en Biomedicina MEDICINE, GENERAL & INTERNAL-
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