Finally waited until your first "Chinese Expert Consensus on Pharmacokinetics to Guide the Treatment of Hemophilia A" was released!

The preventive treatment of hemophilia patients with fixed infusion mode does not achieve the optimal effect
.

Among the factors that affect the efficacy of FⅧ replacement therapy, the difference in the pharmacokinetics (PK) of FⅧ products between individuals is an important factor
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The Third Edition of the World Federation of Hemophilia (WFH) Guidelines for Management of Hemophilia and the "Guidelines for the Treatment of Hemophilia in China (2020 Edition)" both recommend individualized PK monitoring for hemophilia A patients receiving FⅧ treatment 1-2
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However, the clinical understanding of individualized FⅧ substitution therapy under the guidance of PK is not sufficient
.

Recently, the Chinese Hemophilia Collaborative Group combined with relevant evidence-based medicine at home and abroad and the latest guidelines, formally issued the "Chinese Expert Consensus on Pharmacokinetics Guiding the Treatment of Hemophilia A"3, which is the clinical practice of hemophilia A in China FⅧ PK detection, interpretation and application to provide guidance
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Key point 1: The clinical significance and influencing factors of FⅧ PK parameters 1 Definition of FⅧ PK designated amount to study the distribution, metabolism, and elimination of exogenous FⅧ in the human body
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After exogenous infusion of FⅧ, the level of plasma FⅧ activity (FⅧ:C) in the patient's body and its drug-time curve are mainly determined by the infusion dose and PK parameters
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2 The main PK parameters and their clinical significance (Figure 1, Table 1) Figure 1 FⅧ PK parameters Table 1 FⅧ PK parameters clinical significance 3 Factors affecting FⅧ PK parameters FⅧ: C detection impact: due to the stability of FⅧ: C in plasma The performance is susceptible to many factors, and the collection, transportation, storage, inspection and other links of the specimen can affect the experimental results.
Therefore, the first thing to carry out the FⅧ PK test is the accuracy of the FⅧ:C test
.

The influence of individual differences: The PK parameters of FⅧ are affected by factors such as age, weight, blood type, von Willebrand factor (vWF) and inhibitors
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There are significant differences in PK parameters between different individuals, and the PK of different FⅧ products are also different, so individualized administration based on PK parameters is beneficial
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Point 2: FⅧ PK evaluation model/software based on population (pop) PK model + Bayesian probability algorithm is currently recognized and effective individualized drug delivery method, which can predict individual PK parameters relatively accurately and reliably
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In addition, domestic scholars have also proposed an improved one-room model method based on the classic PK model to obtain individual PK parameters
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The comparison between different methods is shown in Table 2
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Table 2 Comparison of different PK analysis methods is to be continued! Recently launched: finally waiting for you | The first edition of "The Chinese Expert Consensus on Pharmacokinetics to Guide the Treatment of Hemophilia A" is released! (2) References: 1.
Srivastava A .
et al.
Haemophilia.
2020;00:1–158.
2.
Thrombosis and Hemostasis Group, Chinese Hematology Branch, Chinese Hemophilia Collaborative Group.
Chinese Journal of Blood.
2020; 41 (4):265-271.
3.
Chinese Hemophilia Collaborative Group, Chinese Clinical Research
.

2021;34(5):577-581,591.
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