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A parallel randomized double-blind multi-centre clinical trial of the efficacy and safety of JinErLun (hydrochloride naloxone) in acute traumatic brain injury
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- Author:
- No author available
- Journal Title:
- CHINESE JOURNAL OF NEUROSURGERY
- Issue:
- 3
- DOI:
- 10.3760/j.issn:1001-2346.2001.03.002
- Key Word:
- 纳洛酮;颅脑外伤;临床试验
Abstract： 背景本试验是由中华医学会神经外科学会和中华神经外科杂志编辑部组织、国内18家医院实施,完成金尔伦(盐酸纳洛酮)对受试患者的疗效和用药安全性观察.目的证明金尔伦在治疗急性中、重型颅脑损伤患者的疗效和安全性.方法设计并实施了随机双盲前瞻性临床对照试验计划,比较大剂量金尔伦和生理盐水安慰剂的疗效差异.每位受试患者接受为期10天随机分组治疗和3个月随访.分析对比治疗前后和治疗过程中患者的病情和重要辅助检查指标的变化趋势,并同时对比随访结束时患者神经功能恢复情况和生活质量状况.全部试验结束后进行揭盲并对结果进行统计学分析.结果实际完成530例,有效病例511例,其中金尔伦组256例,安慰剂组255例.金尔伦组和安慰剂组死亡率分别为治疗组12.5%,安慰剂组17.3%(P＜0.05).金尔伦组患者GCS评分在用药后第5天开始明显优于安慰剂组(P＜0.05).治疗结束后金尔伦组患者GOS评分明显优于安慰剂组(P＜0.05).金尔伦组患者语言功能评分和生活质量状况评分也明显优于安慰剂组(P＜0.05).另外,试验过程中未发现因用药造成的毒副反应.结论早期应用大剂量金尔伦能明显降低急性颅脑损伤患者死亡率、促进脑神经功能恢复、改善远期生活质量状况,并且具有相当可靠的安全性.
- [1]Pierre N Tariot,Ajaya Upadhyaya,Trey Sunderland,etc.Physiologic and neuroendocrine responses to intravenous naloxone in subjects with Alzheimer’s disease and age-matched controls[J].1999,46(3).
- [2]朱诚,江基尧,王成海,等.纳洛酮对猫急性颅脑伤影响的实验研究[J].1989,(8).
- [3]J, Prudic,L, Fitzsimons,M S, Nobler,etc.Naloxone in the prevention of the adverse cognitive effects of ECT: a within-subject, placebo controlled study.[J].1999,21.
- [4]N. Attal,V. Kayser,G. Guilbaud.The bidirectional dose-dependent effect of systemic naloxone is also related to the intensity and duration of pain-related disorders: a study in a rat model of peripheral mononeuropathy[J].1990,525(1).
- [5]朱诚,江基尧,陈长策,等.急性颅脑伤后各脑区和血浆中β-ELI含量变化的实验研究[J].1989,(6).
- [6]Y, Olsson,H S, Sharma,F, Nyberg,etc.The opioid receptor antagonist naloxone influences the pathophysiology of spinal cord injury.[J].1995,104.
- [7]江基尧 朱诚.现代颅脑损伤学[M].1999.
- [8]R L, Hayes,B J, Galinat,P, Kulkarne,etc.Effects of naloxone on systemic and cerebral responses to experimental concussive brain injury in cats.[J].1983,58.
- [9]江基尧,朱诚,陈长策,等.急性颅脑伤患者脑脊液中β-ELI含量变化及其临床意义[J].1988,(8).
- [10]江基尧.β-内啡肽与中枢神经系统损伤的研究进展[J].1988,(5).
- [11]Glover RE,Rota C,Chang RC,etc.A novel effect of an opioid receptor antagonist, naloxone, on the production of reactive oxygen species by microglia: a study by electron paramagnetic resonance spectroscopy.[J].2000,854(1).
- [12]T K, McIntosh,S, Fernyak,R L, Hayes,etc.Beneficial effect of the nonselective opiate antagonist naloxone hydrochloride and the thyrotropin-releasing hormone (TRH) analog YM-14673 on long-term neurobehavioral outcome following experimental brain injury in the rat.[J].1993,10.
- [13]靳伟民,韩树堂.盐酸纳洛酮治疗颅脑损伤合并呼吸骤停（附49例报告）[J].1997,(6).