论文部分内容阅读
FK506是治疗急性卒中的一种候选用药。决定一种药物是否可以用于临床试验,应当以全面的、无偏倚的动物实验数据的评估为依据,同时还应考虑到这些数据的局限性。这种评估不但应包括药物疗效,而且也应包括药效在体内的特征和局限性。本研究应用系统评价和Meta分析的方法对FK506在卒中动物模型中保护作用的证据进行评价。总共纳入了29个描述了实验步骤的研究,包括1759只动物。结果显示,FK506疗效的点估计值(结局指标的改善)是31.3%[95%CI(0.272~0.354)]。在采用氯胺酮麻醉和短暂性脑缺血的动物实验中,FK506的疗效更高,在使用大鼠,合并其他疾病的动物及仅以梗死面积为疗效指标的实验中,FK506疗效较低。已发表的实验研究质量均接近临床试验标准,但在高质量的研究中,FK506的疗效较低。FK506在实验性脑卒中的研究中,虽然显示出有明显的疗效,但是应注意由于研究质量和可能的发表偏倚等因素的影响,FK506的疗效可能被过高估计。
FK506 is a candidate for the treatment of acute stroke. Determining whether a drug can be used in clinical trials should be based on a comprehensive, unbiased assessment of animal data, taking into account the limitations of these data. This assessment should include not only the efficacy of the drug, but also the characteristics and limitations of the drug’s efficacy in the body. This study evaluated the protective effect of FK506 in stroke animal models using systematic reviews and Meta-analysis. A total of 29 studies describing the experimental procedure were included, including 1759 animals. The results showed that the point estimate of FK506 efficacy (improvement of outcome measures) was 31.3% [95% CI (0.272-0.354)]. FK506 is more effective in animal studies using ketamine anesthesia and transient ischemic attack and is less effective in rats using rats, animals with other diseases, and those with infarct size alone. The quality of published experimental studies is close to the standard of clinical trials, but FK506 is less effective in high-quality studies. Although experimental studies of stroke have shown significant efficacy, FK506 should be noted that the efficacy of FK506 may be overestimated due to factors such as the quality of study and possible publication bias.