Koulaeinejad Neda, Haddadi Kaveh, Ehteshami Saeid, Shafizad Misagh, Salehifar Ebrahim, Emadian Omid, Ali Mohammadpour Reza, Ala Shahram
Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Department of Neurosurgery, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.
Iran J Pharm Res. 2019 Spring;18(2):1086-1096. doi: 10.22037/ijpr.2019.1100677.
Traumatic brain injury (TBI) is a public health problem worldwide. Secondary damage of brain injury begins within a few minutes after the trauma and can last a long time. It can be reversible, unlike primary injury. Therefore, therapeutic intervention can be used. The aims of this study were to assess the effects of minocycline on neurological function and serum S100B protein and neuron-specific enolase (NSE) levels in patients with moderate to severe TBI. Patients with acute onset of TBI and surgical evacuation of hematoma were randomized to receive either minocycline 100 mg orally twice daily or placebo for 7 days. The primary outcomes included changes in level of S100B and NSE at different time points during the trial. Additionally, changes in Glasgow coma scale (GCS) score were evaluated. The Glasgow Outcome Scale-Extended (GOS-E) score at 6 months after injury was assessed in discharge patients. Thirty four patients were randomized into the placebo (n = 20) and treatment (n = 14) groups. There was a marginal statistically significant differences in the normalized value of S100B between groups ( < 0.1). The reduction in serum NSE level from baseline to day 5 was statistically significant ( = 0.01) in minocycline group while it was not significantly decrease in placebo group ( = 0.2). Also, GCS improvement over time within the minocycline group was significant ( = 0.04) while was not significant in placebo group ( = 0.11). The GOS-E scores were not significantly different between minocycline and placebo group. Based on this study, it seems that the use of minocycline may be effective in acute TBI.
创伤性脑损伤（TBI）是一个全球性的公共卫生问题。脑损伤的继发性损害在创伤后几分钟内开始，并可持续很长时间。与原发性损伤不同，它可以是可逆的。因此，可以进行治疗干预。本研究的目的是评估米诺环素对中重度TBI患者神经功能、血清S100B蛋白和神经元特异性烯醇化酶（NSE）水平的影响。急性TBI发病且接受血肿手术清除的患者被随机分为两组，一组每天口服两次100mg米诺环素，另一组服用安慰剂，为期7天。主要结局包括试验期间不同时间点S100B和NSE水平的变化。此外，还评估了格拉斯哥昏迷量表（GCS）评分的变化。对出院患者评估伤后6个月的格拉斯哥预后量表扩展版（GOS-E）评分。34例患者被随机分为安慰剂组（n = 20）和治疗组（n = 14）。两组之间S100B标准化值存在边缘性统计学显著差异（<0.1）。米诺环素组血清NSE水平从基线到第5天的降低具有统计学意义（P = 0.01），而安慰剂组无显著下降（P = 0.2）。此外，米诺环素组GCS随时间的改善具有显著性（P = 0.04），而安慰剂组不显著（P = 0.11）。米诺环素组和安慰剂组的GOS-E评分无显著差异。基于本研究，使用米诺环素似乎对急性TBI有效。
