Department of Pediatrics, Division of Pediatric Rheumatology, Hacettepe University, Ankara 06100, Turkey.
Department of Rheumatology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
Rheumatology (Oxford). 2021 Aug 2;60(8):3799-3808. doi: 10.1093/rheumatology/keaa863.
Colchicine is the main treatment for FMF. Although a number of individuals with FMF are intolerant/resistant to colchicine, there is no standard definition of colchicine resistance/intolerance. We developed a set of evidence-based core statements defining colchicine resistance/intolerance in patients with FMF that may serve as a guide for clinicians and health authorities.
A set of statements was identified using a modified-Delphi consensus-based approach. The process involved development of an initial colchicine resistance/intolerance-related questionnaire derived from a systematic literature review. The questionnaire, which was completed by an international panel of 11 adult and paediatric rheumatologists with expertise in FMF, was analysed anonymously. The results informed draft consensus statements that were discussed by a round-table expert panel, using a nominal group technique to agree on the selection and wording of the final statements.
Consensus among the panel was achieved on eight core statements defining colchicine resistance/intolerance in patients with FMF. A definition of resistance was agreed upon that included recurrent clinical attacks (average one or more attacks per month over a 3-month period) or persistent laboratory inflammation in between attacks. Other core statements recognize the importance of assessing treatment adherence, and the impact of active disease and intolerance to colchicine on quality of life.
Based on expert opinion, a set of evidence-based core statements defining colchicine resistance/intolerance in patients with FMF were identified to help guide clinicians and health authorities in the management of patients with FMF.
秋水仙碱是 FMF 的主要治疗药物。尽管许多 FMF 患者对秋水仙碱不耐受/耐药,但目前尚无秋水仙碱耐药/不耐受的标准定义。我们制定了一套基于证据的核心声明,定义了 FMF 患者的秋水仙碱耐药/不耐受,可作为临床医生和卫生当局的指南。
使用改良 Delphi 共识方法确定了一组声明。该过程涉及从系统文献综述中得出的初始秋水仙碱耐药/不耐受相关问卷的开发。该问卷由 11 名具有 FMF 专业知识的成人和儿科风湿病学家国际小组匿名填写。分析结果为共识声明草案提供了信息,这些草案由一个圆桌专家小组使用名义群体技术进行讨论,以就最终声明的选择和措辞达成一致。
专家组就定义 FMF 患者秋水仙碱耐药/不耐受的八项核心声明达成共识。达成了耐药的定义,包括在 3 个月期间内每月出现一次或多次临床发作(平均一次或多次发作)或在发作之间持续存在实验室炎症。其他核心声明认识到评估治疗依从性以及疾病活动和对秋水仙碱不耐受对生活质量的影响的重要性。
基于专家意见,确定了一套基于证据的核心声明,定义了 FMF 患者的秋水仙碱耐药/不耐受,以帮助指导临床医生和卫生当局管理 FMF 患者。