Characteristics and Efficacy of Warfarin Sodium Tablet Subdivided by 3D Printing Technology: A Retrospective Cohort Study of Patients After Prosthetic Valve Replacement

Résumé fourni par la source

Background: Due to the individual-level clinical variation in dosing requirements in commercially available drugs, attaining the objective of clinical individualization and precise drug administration continues to pose a global challenge. Currently, the optimal approach for preparing personalized and precise medications within the clinical setting is unknown. Aim: This study aimed to explore the effectiveness, safety and satisfaction of three-dimensional (3D) printing technology as a novel subdivision method in providing precise warfarin sodium (WFS) subdivided tablets for patients after prosthetic valve replacement (PVR). Methods: The optimal formulation, preparation process, parameters, and the relationship between dose and the printing volume were investigated, and the quality of the six specifications of WFS 3D-printed subdivided and pharmacist-split tablets was studied. A retrospective cohort study evaluated the effectiveness, safety, and satisfaction of patients taking WFS 3D-printed subdivided or pharmacist-split tablets. Results: The hardness, weight variation, drug content, and content uniformity of the six specifications of WFS pharmacist-split tablets did not comply with the European Pharmacopoeia, United States Pharmacopoeia, and Chinese Pharmacopoeia. In contrast, all doses of 3D-printed subdivided tablets met the requirements. The 3D-printed subdivided group showed a significantly higher target international normalized ratio (INR) compliance rate (P<0.05) and lower over-anticoagulation rate (P<0.05) than the pharmacist-split group. Also, 66.67% of patients preferred taking 3D-printed subdivided tablets. Conclusion: 3D printing technology is superior to the traditional subdivision method, as it can improve the effectiveness and safety of patients receiving WFS anticoagulation after PVR.

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