An international collaborative study to establish the WHO 4th International Standard for Streptokinase: Communication from the SSC of the ISTH
An international collaborative study to establish the WHO 4th International Standard for Streptokinase: Communication from the SSC of the ISTH
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DOI：
10.1111/jth.14787
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发表时间：
2020-06-01
影响因子：
10.4
通讯作者：
Longstaff, Colin
中科院分区：
文献类型：
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作者：
Locke, Matthew;Rigsby, Peter;Longstaff, Colin
链激酶在世界范围内被用作急性心肌梗死的一种具有成本效益的治疗方法。制造商使用世界卫生组织（WHO）链激酶国际标准（IS）来标记其产品的效价，以确保一致，安全和有效的剂量。链激酶的第三种IS（编码00/464）的库存量正在减少，组织了一项国际合作研究以校准替代品。共有来自9个国家的15个实验室参与，使用显色和/或纤维蛋白凝块溶解方法测定两种候选制剂（编码为16/356（样品B）和16/358（样品C））相对于第三种IS（00/464）的效价。还纳入了第三份样本（88/824，样本A），该样本用于协作研究以确定第二份和第三份IS。不同测定方法的效价估计值具有良好的一致性，实验室内和实验室间的变异性较低。长期稳定性建模表明候选物非常稳定。将88/824（样品A）的效价估计值与先前研究中计算的效价进行比较，发现在三项跨越30年和50多年链激酶标准化的合作研究过程中，变异性仅为1.9%。这表明国际单位（IU）和测定方法具有良好的连续性。在研究参与者和国际血栓形成和止血学会科学和标准化委员会专家达成一致后，世卫组织生物标准化专家委员会于2019年10月将16/358（样本C）确定为链激酶的第四个IS，效价为1013 IU/ml。
Streptokinase is used worldwide as a cost-effective treatment for acute myocardial infarction. Manufacturers use the World Health Organization (WHO) International Standard (IS) for Streptokinase to potency label their products, ensuring consistent, safe, and effective dosing. Stocks of the third IS for streptokinase (coded 00/464) are running low, and an international collaborative study was organized to calibrate a replacement. A total of 15 laboratories from nine countries took part, using chromogenic and/or fibrin clot lysis methods to determine the potency of two candidate preparations, coded 16/356 (sample B) and 16/358 (sample C), relative to the third IS (00/464). A third sample (88/824, sample A), which was used in the collaborative studies to establish the second and third IS, was also included. There was good agreement in potency estimates from different assay methods and low variability both within and between laboratories. Long-term stability modeling indicated the candidates are very stable. Comparison of potency estimates for 88/824 (sample A) with potencies calculated in previous studies revealed a variability of only 1.9% over the course of three collaborative studies spanning 30 years and more than 50 years of streptokinase standardization. This indicates excellent continuity of the International Unit (IU) and assay methods. Following agreement by study participants and Scientific and Standardization Committee experts of the International Society on Thrombosis and Haemostasis, the WHO Expert Committee on Biological Standardization established 16/358 (sample C) as the fourth IS for Streptokinase with a potency of 1013 IU per ampoule in October 2019.