Liang Matthew H
Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, Boston, MA 02115, USA.
Rheum Dis Clin North Am. 2006 Feb;32(1):1-8, vii. doi: 10.1016/j.rdc.2005.09.001.
This article discusses the clinimetrics of disease activity and organ damage, and response criteria using systemic lupus erythematosus as a paradigm. Similar considerations apply to the other systemic rheumatic illnesses. Clinically relevant and psychometrically tested measures of disease states aid the conduct of clinical studies and trials that are more rigorous, efficient, and relevant to patients' concerns. These same measures used in clinical trials will likely improve clinical outcomes if they are used in the monitoring and titration of therapy in patients who have these disorders. For this use to really occur, clinical trials will have to demonstrate treatments that alter these therapies in a meaningful way and the measures or modifications of them will need to meet the desiderata of techniques that can be used in practice.
本文以系统性红斑狼疮为例,讨论了疾病活动度和器官损害的临床测量指标以及反应标准。类似的考量也适用于其他系统性风湿性疾病。对疾病状态进行临床相关且经过心理测量学测试的测量,有助于开展更严谨、高效且与患者关切相关的临床研究和试验。如果将这些相同的测量指标用于患有这些疾病患者的治疗监测和剂量调整中,临床试验中使用的这些指标可能会改善临床结局。为了真正实现这种应用,临床试验必须证明有能以有意义的方式改变这些治疗的疗法,并且这些指标或其修改需要满足可在实践中使用的技术要求。