摘要
目的复习国内外保护性药物治疗颅脑损伤痛人前瞻性随机双盲临床研究,为即将开展同类型的省科研立项课题做准备。资料与方法所借助的专业数据库:Cochrane图书馆网页中的RCT数据库(E-maail:injuries@shun.ac.uk)、万方数据库数字化期刊、清华同方CHKD期刊全文库。在比较、归纳和摘录有关内容的基础上进行分析。结果搜集到国外已完成与药物治疗颅脑损伤药物治疗有关的系统评价6个;国内有关研究报告3篇、译文3篇、专题讲座6篇。国内有关研究报告显示,盐酸纳洛酮、镁离子、甘油果糖等对颅脑损伤病人有效;而国外已完成的200多项临床多中心随机双盲前瞻性研究中,少有药物被证实对颅脑损伤病人有肯定的疗效。结论有诸多因素干扰临床研究效果。改进本类研究的方法学是排除干扰因素的有效方法。在本类临床研究过程中应当遵守以下原则:①必须是随机双盲前瞻性临床研究;②临床治疗必须规范化;③收集临床资料必须客观严格;④明确药物有效治疗窗;⑤明确药物在病人脑组织中药物浓度和安全性;⑥GOS(格拉斯哥预后评分Glasgow Outcome Soale)作为疗效判断基本标准;⑦伤后6个月作为疗效判断时间。
OBJECTIVE Reviews the domestic and foreign protection medicine treatment brain to injure the patient foresightedness stochastic double blind clinical research,for soon develops the similar province scientific research to set up a topic to prepare.METHODS Draws support specialized database;Cochrane in library homepage RCT database(E-maail:Injuries@shtm.Ac.Uk),wanfang databases digitization periodical,Qinghuatongfang CHKD periodical entire library.In the comparison,the induction carries on the analysis with in the extract related content foundation.RESULTS Collects overseas to has completed with the medicine treatment brain injure medicine treatment related system appraises 6;domestic related memoir 3,translation 3,special course 6.Domestic related memoir demonstration,The hydrochloride naloxone,the magnesium ion,the glycerol and fructose and so on injure the patient to the brain to be effective;But overseas has completed in more than 200 clinical multi- central stochastic double blind foresightedness research,The unusual medicine was confirmed injures the patient to the brain to have the affirmation the curative effect.CONCLUSION Some many factors disturbance clinical research effect.Improves this kind of research the methodology is removes the disturbance factor the effective method.Must observe the principle below this kind of clinical research process:(1) Must be the stochastic double blind foresightedness clinical research;(2) The clinical treatment must standardize;(3) Collects the clinical material to have objective to be strict;(4) Is clear about the medicine effective treatment window;(5) Is clear about the medicine to organize the Chinese native medicine density and the security in sickness human brain;(6) COS(Glasgow Outcome Scale) to take the curative effect judgment primary standard;(7) Wound latter 6 months achievement curative effect judgment time.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2005年第z2期760-764,共5页
Chinese Journal of Modern Applied Pharmacy
关键词
循证医学
颅脑损伤
保护性药物治疗
evidence-based medicine
brain injure
protection medicine treatment