目的:美国单采协会写作委员会于2023年发布了第九版治疗性单采指南。自第一版以来,类别一直是准则的一部分,在第五版中引入了评分系统,每个新版本都有更新。在这项研究中,我们通过最新的五个版本调查了类别和等级的变化趋势,专注于治疗性血浆置换,作为循证医学的一部分,提出未来的方向。
方法:收集治疗性血浆置换(TPE)的类别和等级,并对其进行分析。我们将分类更改与第九版的临床背景保持一致,并将其类别和等级与指南中引入的类别和等级进行了比较。
结果:在第九版的166个适应症中,118包括TPE程序,作为唯一的治疗或作为治疗性单采技术之一。适应症的总数发生变化,但是第三类在整个版本中仍然占主导地位。同样,2C级始终是最普遍的等级。值得注意的是,24例有等级变化。在16例证据质量发生变化的案例中,质量在6个中减弱,在10个中改善。在整个研究期间,102种临床疾病的证据水平没有改善。
结论:为了解决证据质量方面的差距,建立全面的大规模研究或随机对照试验的国际合作势在必行.这将完善治疗性单采的使用,包括TPE,促进临床实践中循证的进步。
OBJECTIVE: The Writing Committee of American Society for Apheresis released the ninth edition of
guidelines for therapeutic apheresis in 2023. Categories have been a part of the
guidelines since the first edition, and the grading system was introduced in the fifth edition, with updates in every new edition. In this study, we investigated the category and grade change trends through the latest five editions, focusing on therapeutic plasma exchange, to suggest future directions as part of evidence-based medicine.
METHODS: Categories and grades for therapeutic plasma exchange (TPE) were collected and analysed from the fifth through ninth editions. We aligned classification changes to the ninth edition\'s clinical context and compared its categories and grades with those introduced in the
guideline.
RESULTS: Among 166 total indications in the ninth edition, 118 included TPE procedure, either as a sole treatment or as one of the therapeutic apheresis techniques. The total number of indications changed, but Category III remained predominant throughout the editions. Similarly, Grade 2C consistently emerged as the most prevalent grade. Notably, 24 cases had grade changes. Of the 16 cases with evidence quality changes, the quality weakened in six and improved in 10. Evidence levels were not improved throughout the study period for 102 clinical conditions.
CONCLUSIONS: To address gaps in evidence quality, international collaboration is imperative to establish comprehensive large-scale studies or randomized controlled trials. This will refine the use of therapeutic apheresis, including TPE, to foster evidence-based advancements in clinical practice.