Department of Rheumatology, Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, Tel Aviv 64239, Israel.
Autoimmun Rev. 2012 Dec;12(2):329-36. doi: 10.1016/j.autrev.2012.05.009. Epub 2012 Jun 7.
Biologic registries have been established in several countries to supplement information obtained from randomized controlled trials with regards to the efficacy and safety of biologic agents in the treatment of rheumatic diseases. The unique features that characterized several of the cohorts included in these registries allow analysis to answer certain research questions such as the relation of biologic use and the incidence of tuberculosis, lymphoma, or its effect on pregnancy. The availability of such population-specific registries in Europe with different biologic uses, comorbidity patterns, and various socio-demographic and geographic factors provides real-life information valuable to clinical practice in the management of rheumatic diseases. Certain challenges including logistics, methodologies, human, and financial resources, remain in the implementation and maintenance of registries and steps have been proposed to address these issues.
生物制剂注册已经在多个国家建立，以补充随机对照试验中获得的关于生物制剂在治疗风湿性疾病方面的疗效和安全性的信息。这些注册中包含的几个队列的独特特征允许进行分析，以回答某些研究问题，例如生物制剂的使用与结核病、淋巴瘤的发生率之间的关系，或其对妊娠的影响。欧洲具有不同生物制剂使用、合并症模式以及各种社会人口和地理因素的此类特定人群注册的可用性为风湿性疾病的管理提供了有价值的临床实践的真实信息。在注册的实施和维护中仍然存在一些挑战，包括物流、方法、人力和财力资源，已经提出了一些步骤来解决这些问题。
