生物测定法替代研究中统计学的应用

目的: 对适用于生物活性测定法替代研究的相关统计学概念和受试者工作特征(receiver operating characteristic，ROC)曲线法进行介绍。方法: 以生物测定中热原检测法的替代研究为例，采用各种热原检测方法对规定样品进行检测，对所获结果进行ROC曲线分析。结果和结论: 4种新的体外热原检测方法(人全血白介素6法、人全血白介素1法、人外周血单个核细胞白介素6法、MM6细胞白介素6法)及家兔热原检查法的灵敏度与特异度分别为88.9%，96.6%；72.7%，93.2%；92.5%，95%；95.5%，89.8%；57.9%，88.3%。ROC曲线表明新方法的诊断效率均优于家兔法。ROC曲线法可以更加直观、清晰地说明各种热原检测法的优劣性，是一种可用于生物测定法桥接研究或替代研究中的实用方法。

Objective: To introduce a useful analysis method for receiver operating characteristic (ROC) curve in alternative research of bioassays.Methods: The results,which were obtained through several pyrogen tests to detect assigned samples,were analyzed by ROC curve.Results and Conclusion: The sensitivity and specificity of five pyrogen tests,including WBT—IL-6,WBT—IL-1,PBMC—IL-6,MM6—IL-6,rabbit test,was 88.9%,96.6%;72.7%,93.2%;92.5%,95%;95.5%,89.8%;57.9%,88.3% respectively.ROC curve indicated that the predictive capability of four novel pyrogen tests were better than that of rabbit test.ROC curve is a practical method in bridge study or alternative research of bioassays,which can intuitively and clearly illustrate the relative merits of those pyrogen tests.

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