3D打印技术制备华法林钠药片的临床应用分析  

Analysis of the clinical application of 3D-printed warfarin sodium tablets

作　　者：刘江[1] 林璇 詹陆川 付开霞 杨帆[2,3] 林展翼 陈细兰 LIU jiang;LIN Xuan;ZHAN Luchan;FU Kaixia;YANG Fan;LIN Zhanyi;CHEN Xilan(Department of Pharmacy,Guangdong Provincial People’s Hospital(Guangdong Academy of Medical Sciences),Southern Medical University,Guangzhou 510080,China;Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems and Guangdong Provincial Engineering Center of Topical Precise Drug Delivery System,Teaching Laboratory Center,Guangdong Pharmaceutical University,Guangzhou 510006,China;Department of Pharmacy,The First Affiliated Hospital of Guangdong Pharmaceutical University,Guangzhou 510080,China;Guangdong Cardiovascular Institute,Guangdong Provincial People’s Hospital(Guangdong Academy of Medical Sciences),Southern Medical University,Guangzhou 510080,China)

机构地区：[1]南方医科大学附属广东省人民医院(广东省医学科学院)药学部,广州510080 [2]广东药科大学教学实验中心/广东省药物新剂型重点实验室和广东省局部精准药物递送制剂工程技术研究中心,广州510006 [3]广东药科大学第一附属医院药学部,广州510080 [4]南方医科大学附属广东省人民医院(广东省医学科学院)广东省心血管病研究所,广州510080

出　　处：《药学前沿》2025年第4期650-656,共7页China Pharmacist

基　　金：广东省普通高校创新团队项目(2024KCXTD035)。

摘　　要：目的本文对3D打印技术制备不同剂量的华法林钠药片在临床应用中的情况进行统计分析,旨在评估3D打印华法林钠片在临床应用中的可行性及其疗效。方法根据临床常用剂量,采用3D打印技术将华法林钠与辅料按设定比例制备成药片。通过医院信息系统和中国医院药物警戒系统回顾性统计2023年1月至12月3D打印华法林钠片在南方医科大学附属广东省人民医院各科室的应用情况及不同剂量的使用分布。评估服用3D打印华法林钠片的患者(3D打印组)和未服用3D打印华法林钠片的患者(非3D打印组)国际标准化比值(INR)达标情况和剂量调整次数,调查患者、药师及医护人员对3D打印华法林钠片的满意度。结果3D打印华法林钠片的主要应用科室为心外科,其次为心内科和产科。剂量分布中,使用最广泛的剂量为2.25 mg,其次为0.75 mg。在全院应用中,3D打印组的INR达标率显著高于非3D打印组(P<0.05)。3D打印组的剂量调整次数显著少于非3D打印组(P<0.05)。满意度调查显示,大部分的患者、药师及医护人员愿意继续使用3D打印华法林钠片这种剂型。结论3D打印技术制备华法林钠药片INR控制更稳定,剂量调整需求更少,可更好满足患者个体化用药需求,减少剂量误差,获临床医务工作者和患者的认可。Objective To conduct a statistical analysis of the clinical application of warfarin sodium tablets prepared with three-dimensional(3D)printing technology in different dosages,aiming to evaluate the feasibility and effectiveness of 3D-printed warfarin sodium tablets in clinical practice.Methods According to the commonly used clinical doses,warfarin sodium and excipients were prepared into tablets in set proportions using 3D printing technology.Retrospective statistics on the application of 3D printed warfarin sodium tablets in each department Guangdong Provincial People’s Hospital Southern Medical University and the distribution of the use of different dosages during the period from January 2023 to December 2023 were obtained through the hospital information system and the China Hospital Pharmacovigilance System.The international normalized ratio(INR)compliance rate and the number of dose adjustments were assessed in patients taking 3D printed warfarin sodium tablets(3D printing group)and patients not taking 3D printed warfarin sodium tablets(non-3D printing group),and the satisfaction of patients,pharmacists,and healthcare professionals with 3D printed warfarin sodium tablets was investigated.Results The main application departments of 3D printed warfarin sodium tablets were cardiac surgery,followed by cardiology and obstetrics.The most widely used dose distribution was 2.25 mg,followed by 0.75 mg.In the hospitalwide application,the INR compliance rate was significantly higher in the 3D printing group than that in the non-3D printing group(P<0.05).the number of dose adjustments in the 3D printing group was significantly less than that in the non-3D printing group(P<0.05).The satisfaction survey showed that most of the patients,pharmacists and healthcare professionals were willing to continue using 3D printed warfarin sodium tablets as a dosage form.Conclusion 3D printing technology for the preparation of warfarin sodium tablets has more stable INR control and less need for dose adjustment,which can better meet

关 键 词：3D打印技术 华法林钠 临床应用 国际标准化比值 满意度调查 

分 类 号：R979.9[医药卫生—药品]