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>Convenience Comparison Study of Reconstitution Devices for the Blood Coagulation Factor VIII Products Rurioctocog Alfa Pegol and Antihemophilic Factor (Recombinant)
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Convenience Comparison Study of Reconstitution Devices for the Blood Coagulation Factor VIII Products Rurioctocog Alfa Pegol and Antihemophilic Factor (Recombinant)
Introduction:The Baxject ? II Hi-Flow device has previously been used to reconstitute the factor VIII products antihemophilic factor (recombinant) (ADVATE ? ) and rurioctocog alfa pegol (ADYNOVATE ? ).Methods:In this crossover study in healthy men, the convenience of an advanced device, Baxject III ? with and without a nonslip sleeve, was compared with that of Baxject II Hi-Flow. The primary endpoint was the operational time for reconstitution; secondary endpoints included participants' assessment of the usability of the devices for reconstitution and their preference for using each of the devices.Results:Twelve healthy adult men (mean ± standard deviation [SD] age: 36.7 ± 7.0 years) and 12 healthy elderly men (mean ± SD age: 70.3 ± 4.8 years) participated in the study. In the adult group, the mean operational time for reconstitution was shorter using Baxject III (mean ± SD: 19.7 ± 2.7 and 19.9 ± 5.2 seconds with and without a nonslip sleeve, respectively) than when using Baxject II Hi-Flow (49.6 ± 7.2 seconds, P 0.0001 for both comparisons). Adult participants rated preference (P 0.0001) and ease of reconstitution (P 0.0001) as higher for Baxject III with a nonslip sleeve than for Baxject II Hi-Flow. Results were consistent regardless of age group or the use of the nonslip sleeve.Conclusion:Owing to the convenience of Baxject III, this device will improve the reconstitution process for patients with hemophilia treated with rurioctocog alfa pegol or antihemophilic factor (recombinant) at home.? 2020 Ueda et al.
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机译：简介：Baxject？ II Hi-Flow装置先前已被用于重建因子VIII产品含助反血症因子（重组）（推进？）和RURIOCTOCOG ALFA PEGOL（adynovate？）。方法：在这种在健康男性的交叉研究中，方便的装置， Baxject III？在没有NONSLIP套筒的情况下，与Baxject II Hi-Flow的套筒进行比较。主要终点是重建的运营时间;辅助端点包括参与者对重建设备的可用性的评估及其对使用每个设备的偏好。结果：12个健康成年男性（平均值±标准偏差[SD]年龄：36.7±7.0岁）和12名健康的老年人（平均值±SD AGE：70.3±4.8岁）参与了该研究。在成人组中，使用Baxject III（平均值±SD：19.7±2.7和19.9±5.2秒，分别使用Baxject II Hi-Flow时（49.6±7.2秒，P <0.0001对于两个比较）。成人参与者的偏好（P <0.0001），并且易于重构（P <0.0001），对于Baxject III而不是Baxject II Hi-Flow的Baxject III更高。结果是一致的，无论年龄组还是使用Nonslip套管。结论：由于Baxject III的便利性，该装置将改善用RURIOCTOCOG ALFA PEGOL或HOUSE的硫醇患者治疗血友病患者的重建过程。还是2020 UEDA等人。
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