Effects of progesterone and vitamin D on outcome of patients with acute traumatic spinal cord injury; a randomized, double-blind, placebo controlled study
Effects of progesterone and vitamin D on outcome of patients with acute traumatic spinal cord injury; a randomized, double-blind, placebo controlled study
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DOI：
10.1080/10790268.2015.1114224
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发表时间：
2016-01-01
影响因子：
1.7
通讯作者：
Abdollahzadeh, Parisa
中科院分区：
文献类型：
--
作者：
Aminmansour, Bahram;Asnaashari, Ali;Abdollahzadeh, Parisa
工作背景：类固醇激素在脊髓损伤（SCI）的急性期提供了有前途的治疗前景，而孕酮和维生素D的作用仍然存在争议。本研究的目的是探讨孕激素和维生素D对急性创伤性SCI.Methods患者的功能结果的影响：这是一项随机临床试验，包括64例成人急性创伤性SCI入院8小时内受伤。所有患者在入院时根据标准方案接受甲基强的松龙（30 mg/kg作为推注剂量，15 mg/kg每3小时一次，直至24小时）。患者被随机分配接受肌肉注射0.5毫克/公斤孕酮，每天两次和5微克/公斤口服维生素D3，每天两次，长达5天（n = 32）或安慰剂（n = 32）。结果：两组患者在年龄（P = 0.341）、性别（P = 0.802）和治疗延迟（P = 0.609）方面均无显著性差异。6个月后，两组患者的运动能力和感觉功能均显著提高。接受孕酮和维生素D治疗的患者在治疗6个月后运动能力和感觉功能显著提高。伤后4 h内接受治疗者，孕激素和维生素D组治疗后6个月的运动能力和感觉功能明显高于对照组。治疗滞后呈负相关，6个月的运动能力和感觉功能在孕激素和维生素D group.Conclusions：孕激素和维生素D在创伤性SCI急性期的管理与更好的功能恢复和结果。
Background: Steroid hormones offer promising therapeutic perspectives during the acute phase of spinal cord injury (SCI) while the role of progesterone and vitamin D remain controversial. The aim of the current study was to investigate the effects of progesterone and vitamin D on functional outcome of patients with acute traumatic SCI.Methods: This was a randomized clinical trial including 64 adult patients with acute traumatic SCI admitted within 8 hours of injury. All the patients received methylprednisolone on admission according to standard protocol (30 mg/kg as bolus dose and 15 mg/kg each 3 hours up to 24 hours). Patients were randomly assigned to receive intramuscular injection of 0.5 mg/kg progesterone twice daily and 5 mu g/kg oral vitamin D3 twice daily up to 5 days (n = 32) or placebo (n = 32). Patients were visited 6 days, 3 and 6 months after injury and motor and sensory function was assessed according to American Spinal Injury Association (ASIA) score.Results: There was no significant difference between two study groups regarding age (P = 0.341), sex (P = 0.802) and therapy lag (P = 0.609). The motor powers and sensory function increased significantly after 6 months in both study groups. Those who received progesterone and vitamin D had significantly higher motor powers and sensory function after 6 months of therapy. Those who received the therapy within 4 hours of injury, had significantly higher motor powers and sensory function 6 months after treatment in progesterone and vitamin D group. Therapy lag was negatively associated with 6-month motor powers and sensory function in progesterone and vitamin D group.Conclusions: Administration of progesterone and vitamin D in acute phase of traumatic SCI is associated with better functional recovery and outcome.