Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group
Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group
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DOI：
10.1182/blood-2008-07-162503
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发表时间：
2009-03-12
期刊：
影响因子：
20.3
通讯作者：
George, James N.
中科院分区：
文献类型：
--
作者：
Rodeghiero, Francesco;Stasi, Roberto;George, James N.
免疫性血小板减少性紫癜（ITP）的诊断和治疗在很大程度上仍然依赖于临床专业知识和观察，而不是来自高质量临床试验的证据。实施此类研究以及对现有数据进行可靠的荟萃分析的一个主要障碍是缺乏对标准化关键定义、结果标准和术语的共识。此外，自从血小板生成素受体激动剂等新型治疗剂和抗CD 20抗体等创新治疗方式的引入以来，对比较临床试验的需求急剧增加。为了克服目前的异质性，由公认的专家临床医生组成的国际工作组召开了为期 2 天的结构化会议（维琴察共识会议），以定义原发性 ITP 及其不同阶段和严重程度分级标准以及具有临床意义的结果和反应的标准术语和定义。这些共识标准和定义可用于研究性临床试验或队列研究。这些建议的采用将有助于改善研究者之间的沟通，增强临床试验之间的可比性，促进荟萃分析和治疗指南的制定，并为监管机构提供标准化框架。 （血。2009；113：2386-2393）
Diagnosis and management of immune thrombocytopenic purpura (ITP) remain largely dependent on clinical expertise and observations more than on evidence derived from clinical trials of high scientific quality. One major obstacle to the implementation of such studies and in producing reliable meta-analyses of existing data is a lack of consensus on standardized critical definitions, outcome criteria, and terminology. Moreover, the demand for comparative clinical trials has dramatically increased since the introduction of new classes of therapeutic agents, such as thrombopoietin receptor agonists, and innovative treatment modalities, such as anti-CD 20 antibodies. To overcome the present heterogeneity, an International Working Group of recognized expert clinicians convened a 2-day structured meeting (the Vicenza Consensus Conference) to define standard terminology and definitions for primary ITP and its different phases and criteria for the grading of severity, and clinically meaningful outcomes and response. These consensus criteria and definitions could be used by investigational clinical trials or cohort studies. Adoption of these recommendations would serve to improve communication among investigators, to enhance comparability among clinical trials, to facilitate meta-analyses and development of therapeutic guidelines, and to provide a standardized framework for regulatory agencies. (Blood. 2009; 113: 2386-2393)