Tsakonas E, Fitzgerald A A, Fitzcharles M A, Cividino A, Thorne J C, M'Seffar A, Joseph L, Bombardier C, Esdaile J M
Department of Medicine, McGill University, Montreal, Quebec, Canada.
J Rheumatol. 2000 Mar;27(3):623-9.
To assess the longterm effect of delaying therapy with second-line agents in patients with early rheumatoid arthritis (RA).
One hundred nineteen patients who participated in a 9 month placebo controlled randomized trial of hydroxychloroquine sulfate (HCQ) were followed prospectively for an additional 3 years. Those randomized to HCQ are referred to as the early treatment group and those randomized to placebo as the delayed treatment group. Participants were assessed annually for pain [Arthritis Impact Measurement Scales (AIMS) and Stanford Health Assessment Questionnaire (HAQ)], physical disability (AIMS and HAQ), and the RA global well being scale (AIMS). Conversion of results into standard deviation (SD) units permitted defining a substantial difference as per Felson as > 0.30 SD units and a clinically indistinguishable difference as < or = 0.06 SD units.
One hundred fifteen patients (97%) participated and complete data were available on 104 (87%). Compared to the early treatment group, the delayed group remained worse for both the pain and the physical disability outcomes over the additional 3 year followup. The difference in the RA global well being score became clinically indistinguishable for the early and delayed groups only after the 2 year post-trial assessment. The between-group differences were not explained by post-trial therapy with corticosteroids, other second-line agents, or nonsteroidal antiinflammatory drugs and analgesic preparations.
These findings show that a delay in instituting therapy with second-line agents, even a 9 month delay in instituting a moderately powerful second-line agent such as HCQ, has significant effects on longterm patient outcome, and provides strong evidence in support of early therapy in RA.
评估延迟使用二线药物治疗早期类风湿关节炎（RA）患者的长期效果。
119名参与了为期9个月的硫酸羟氯喹（HCQ）安慰剂对照随机试验的患者，进行了为期3年的前瞻性随访。随机分配到HCQ组的患者称为早期治疗组，随机分配到安慰剂组的患者称为延迟治疗组。每年对参与者进行疼痛评估[关节炎影响测量量表（AIMS）和斯坦福健康评估问卷（HAQ）]、身体残疾评估（AIMS和HAQ）以及RA整体健康量表（AIMS）。将结果转换为标准差（SD）单位后，按照费尔森的定义，>0.30 SD单位为有显著差异，<或=0.06 SD单位为临床无显著差异。
115名患者（97%）参与了研究，104名患者（87%）有完整数据。与早期治疗组相比，在额外3年的随访中，延迟治疗组在疼痛和身体残疾方面的结果仍然更差。仅在试验后2年的评估中，早期和延迟治疗组在RA整体健康评分上的差异才在临床上变得无显著差异。组间差异不能用试验后使用皮质类固醇、其他二线药物或非甾体抗炎药及镇痛制剂来解释。
这些发现表明，延迟使用二线药物进行治疗，即使是延迟9个月使用如HCQ这样的中等强度二线药物，对患者的长期预后也有显著影响，并为RA的早期治疗提供了有力证据。
