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CLIN CHEM LAB MED：基于ETP的活化蛋白C抗药性试验的验证和标准化，用于女性类固醇避孕药的临床研究

2020-03-17 MedSci原创 MedSci原创

女性；类固醇避孕药
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目前，监管机构建议使用一种基于内源性凝血酶潜力(ETP)评估的分析方法来调查女性类固醇避孕药开发中活化蛋白C耐药性(APCr)。

目前，监管机构建议使用一种基于内源性凝血酶潜力(ETP)评估的分析方法来调查女性类固醇避孕药开发中活化蛋白C耐药性(APCr)。然而，文献中描述的检测方法是自创的，在方法、试剂、参考血浆和质量控制方面尚未标准化。在没有任何商业可用的方法的情况下，我们的目标是验证基于ETP的APCr检测。

根据法规标准进行验证。该方法的目标是在有APC的健康供体中对ETP的抑制率为90%，而在没有APC的健康供体中，ETP的抑制率为90%。由于从精心挑选的健康供体中大规模生产血浆是不可能的，因此将算法应用于商业参考血浆以与所选的血浆进行关联。

研究结果显示，重复性和中间精度通过验收标准。该实验显示了对蛋白S和APC浓度的曲线剂量响应(R2 > 0.99)。对47名健康个体(22名未服用复合激素类避孕药[CHC]的女性和25名未携带莱顿V因子的男性)的血浆样本分析证实了该测试的有效性，平均抑制率为90%。对15名服用不同避孕药具的妇女和2名感染了V因子的受试者的调查证实了该方法的敏感性和有效性。

研究表明，该验证方法可为制药业、监管机构和医生提供一种可重复、灵敏且经过验证的金标准ETP为基础的APCr测定方法。

原始出处：

Jonathan Douxfils,Laure Morimont,Validation and standardization of the ETP-based activated protein C resistance test for the clinical investigation of steroid contraceptives in women: an unmet clinical and regulatory need

本文系梅斯医学（MedSci）原创编译整理，转载需授权！

 

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    2020-12-04 108807375_62823139

    #标准化#

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    2020-09-18 446798725_87912765

    #蛋白C#

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    2020-03-19 30397604

    #类固醇#

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    2020-03-19 songbq

    #抗药性#

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    2020-03-19 ms3994565386320060

    #Med#

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