[泌尿外科中的数字健康应用]
[Digital health applications in urology].
作者信息
Schönburg Sandra, Gratzke Christian, Miller Kurt, Wiemer Laura, Kliesch Sabine
机构信息
Urologische Universitätsklinik Halle, Martin Luther University, Ernst-Grube-Straße 40, Halle (Saale), Deutschland.
Neuro-Urologie, BG Klinikum Bergmannstrost, Halle (Saale), Deutschland.
出版信息
Urologie. 2024 Sep;63(9):850-859. doi: 10.1007/s00120-024-02398-0. Epub 2024 Aug 12.
BACKGROUND
Digital health applications (DiGA) were included in the German healthcare system in 2020. They are available for prescription and reimbursed by public and private insurance companies. For the specialty of urology, there are currently two DiGA available: for the treatment of erectile dysfunction and benign prostatic hyperplasia/overactive bladder (BPH/OAB). The legal basis, clinical results and practical implementation are presented.
METHODS
Evaluation of websites and publications to show the regulatory requirements, mode of action, results of clinical trials and prescribing practice with DiGA.
RESULTS
Since 2020, 63 DiGA have been listed in the register of the Federal Office for Drugs and Medical Devices (BfArM), 35 of them definitively. Two urological DiGA aim to treat erectile dysfunction and BPH/OAB. Randomized, controlled studies have shown a significant and clinically relevant patient benefit for both DiGA. Further urological DiGA are in clinical development.
CONCLUSIONS
DiGAs offer multimodal therapy combinations that have not yet been used in clinical practice and show a multidimensional benefit for the patient.
背景
数字健康应用程序（DiGA）于2020年被纳入德国医疗保健系统。它们可供处方使用，并由公共和私人保险公司报销。对于泌尿外科专业，目前有两种DiGA可供使用：用于治疗勃起功能障碍和良性前列腺增生/膀胱过度活动症（BPH/OAB）。本文介绍了其法律依据、临床结果和实际应用情况。
方法
评估网站和出版物，以展示DiGA的监管要求、作用方式、临床试验结果和处方实践。
结果
自2020年以来，63种DiGA已列入联邦药品和医疗器械办公室（BfArM）的登记册，其中35种已确定。两种泌尿外科DiGA旨在治疗勃起功能障碍和BPH/OAB。随机对照研究表明，这两种DiGA都能为患者带来显著且具有临床意义的益处。更多的泌尿外科DiGA正在临床开发中。
结论
DiGA提供了尚未在临床实践中使用的多模式治疗组合，并为患者带来多维度的益处。
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