Comparison of the administration of progesterone versus progesterone and vitamin D in improvement of outcomes in patients with traumatic brain injury: A randomized clinical trial with placebo group.
Comparison of the administration of progesterone versus progesterone and vitamin D in improvement of outcomes in patients with traumatic brain injury: A randomized clinical trial with placebo group.
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DOI：
10.4103/2277-9175.100176
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发表时间：
2012
影响因子：
1
通讯作者：
Moradi M
中科院分区：
文献类型：
--
作者：
Aminmansour B;Nikbakht H;Ghorbani A;Rezvani M;Rahmani P;Torkashvand M;Nourian M;Moradi M
由于创伤性脑损伤（TBI）的异质性，许多单一的治疗方法并不能成功地预防和治愈这类损伤。黄体酮类药物对重型脑损伤的神经保护作用已被证实，近年来对维生素D的神经保护作用也进行了研究，在一些研究中，这两种药物联合使用在动物样本上显示出更好的效果。本研究旨在探讨维生素D和黄体酮对脑外伤后脑损伤治疗的影响。本研究于2011年4月至9月对格拉斯哥昏迷评分(GCS)≤8分的重型颅脑外伤患者进行研究。将患者分为3组（安慰剂组、黄体酮组、黄体酮维生素D组），每组20人。在患者入院时，记录他们的GCS和人口统计信息。3个月后重新评估，记录GCS和GOS （Glasgow outcome scale）评分。收集的数据使用SPSS 18软件（SPSS Inc., Chicago IL， USA）进行分析。干预前，安慰剂组、黄体酮组、黄体酮-维生素D组GCS均值分别为6.3±0.88、6.31±0.87、6±0.88。干预3个月后分别为9.16±1.11、10.25±1.34、11.27±2.27。三组GCS均值比较差异有统计学意义（p值= 0.001）。GOS分为有利和不利两大类，其中安慰剂组、黄体酮组和黄体酮-维生素D组的有利回收率分别为25%、45%和60%，组间差异有统计学意义（p值= 0.03）。结果显示，黄体酮和维生素D联合治疗组重型颅脑损伤患者的康复率明显高于黄体酮组，而黄体酮组又高于安慰剂组。
Due to the heterogeneity of traumatic brain injury (TBI), many of single treatments have not been successful in prevention and cure of these kinds of injuries. The neuroprotective effect of progesterone drug on severe brain injuries has been identified, and recently, the neuroprotective effect of vitamin D has also been studied as the combination of these two drugs has shown better effects on animal samples in some studies. This study was conducted to examine the effect of vitamin D and progesterone on brain injury treatment after brain trauma. This study was performed on patients with severe brain trauma (Glasgow Coma Scale (GCS) ≤ 8) from April to September, 2011. The patients were divided to 3 groups (placebo, progesterone, progesterone-vitamin D), each with 20 people. Upon the patients’ admission, their GCS and demographic information were recorded. After 3 months, they were reassessed, and their GCS and GOS (Glasgow outcome scale) were recorded. The collected data were analyzed using SPSS 18 software (SPSS Inc., Chicago IL, USA). Before intervention, GCS mean of the placebo, progesterone, and progesterone-vitamin D groups were 6.3 ± 0.88, 6.31 ± 0.87, and 6 ± 0.88, respectively. They increased to 9.16 ± 1.11, 10.25 ± 1.34, and 11.27 ± 2.27, respectively 3 months after intervention. There was a significant difference among GCS means of the 3 groups (P-value = 0.001). GOS was classified to 2 main categories of favorable and unfavorable recovery, of which, favorable recovery in placebo, progesterone, and progesterone-vitamin D was 25%, 45%, and 60%, respectively which showed a statistical significant difference among the groups (P-value = 0.03). The results showed that recovery rate in patients with severe brain trauma in the group receiving progesterone and vitamin D together was significantly higher than that of progesterone group, which was in turn higher than that of placebo group.