盐酸纳美芬对急性创伤性颅脑损伤患者脑保护作用的临床研究

Clinical trial of brain-protective effect of nalmefene hydrochloride in patients with acute traumatic brain injury

目的研究急性创伤性颅脑损伤患者应用盐酸纳美芬后血清β-内啡肽(β-EP)、强啡肽(DynA1-13)、神经元特异性烯醇化酶(NSE)的变化,评价盐酸纳美芬对急性创伤性颅脑损伤患者的脑保护作用及不良反应。方法选取急性创伤性颅脑损伤患者40例,并随机分为盐酸纳美芬治疗组和对照组各20例。对照组采用常规治疗,不加用盐酸纳美芬治疗;治疗组在与对照组相同的常规治疗基础上加用盐酸纳美芬治疗。所有患者在治疗前以及治疗后第1、2、3、5、7、10天测定血清β-EP、DynA1-13、NSE的含量,同时记录患者的心率、呼吸频率变化及药物不良反应,对比两组患者3个月后的格拉斯哥预后评分(GOS)。结果治疗组的血清β-EP、DynA1-13、NSE的含量明显低于对照组,其总体变化趋势是下降。对照组的β-EP、DynA1-13的总体变化趋势升高,对照组的NSE总体变化趋势下降。以上三个指标在治疗组与对照组间比较均有显著差异。治疗组的呼吸异常率及心率异常率均低于对照组,差异显著(P<0.05)。两组治疗过程中出现的药物不良反应患者例数无显著差异(P>0.05)。治疗组与对照组的GOS评分对比有显著差异。结论盐酸纳美芬可降低急性创伤性颅脑损伤后患者血清β-EP、DynA1-13、NSE的含量,能减轻急性创伤性颅脑损伤患者的继发性病理损伤,有一定的脑保护作用,可改善急性创伤性颅脑损伤患者的心率异常率、呼吸异常率及预后。应用盐酸纳美芬后未加重和出现新的不良反应。

Objective To study the changes in serum β-endorphin （ β-EP）, dynorphin （ DynA1 - 13 ）, and neuron-specific enolase （NSE） in patients with acute traumatic brain injury （TBI） after treatment with nalmefene hydrochloride and to evaluate the brain-protective effect and adverse reactions of nalmefene hydrochloride in TBI patients. Methods Forty patients with acute TBI were randomly divided into nalmefene hydrochloride treatment group （ n = 20） and control group （ n = 20 ）. The patients in control group received conventional treatment, while those in nalmefene hydrochloride treatment group were given nalmefene hydrochloride in addition to the conventional treatment. Serum levels of β-EP, DynA1 - 13, and NSE were measured before treatment and on days 1,2, 3, 5, 7, and 10 of treatment in all patients ; meanwhile, the heart rate, respiratory rate, and medication-related adverse events were recorded. Glasgow Outcome Scale （GOS） scores were compared between the two groups after three months. Results Serum levels of β-EP, DynA1 - 13, and NSE were significantly lower in the treatment group than in the control group. The three indices showed an overall decreasing trend in the treatment group; serum β-EP and DynA1 -13 showed an overall increasing trend in the control group, while serum NSE showed an overall decreasing trend. The treatment group had significantly lower proportions of individuals with abnormal heart rate and abnormal respiratory rate than the control group（ P 〈 0.05 ）. The incidence of medication-related adverse events showed no significant difference between the two groups（ P 〉 0.05 ） , while GOS scores showed a significant difference between the two groups. Conclusions For patients with acute TBI, nalmefene hydrochloride can reduce serum β-EP, DynA1 - 13, and NSE and the secondary pathological damage, exert a certain brain-protective effect, reduce the abnormalities of heart rate and respiratory rate, and improve prognosis, and it causes little adverse reactions.