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靶向治疗前后类风湿关节炎不良事件和资源利用:一项随机对照试验的事后分析。

Adverse Events and Resource Use Before and After Treat-to-Target in Rheumatoid Arthritis: A Post Hoc Analysis of a Randomized Controlled Trial.

机构信息

Brigham and Women's Hospital, Boston, Massachusetts.

Yale School of Medicine, New Haven, Connecticut.

出版信息

Arthritis Care Res (Hoboken). 2019 Sep;71(9):1243-1248. doi: 10.1002/acr.23755. Epub 2019 Jul 19.

Abstract

OBJECTIVE

Treat-to-target (TTT) is an accepted paradigm for care of patients with rheumatoid arthritis (RA). Because TTT can be associated with more medication switches, concerns arise regarding whether implementing TTT may increase adverse events and/or resource use. The aim of this study was to examine adverse events and resource use during the preintervention and intervention periods of the TTT intervention trial.

METHODS

We used data from 6 practices enrolled in an 18-month cluster-randomized controlled trial to compare adverse events and resource use before (months 1-9) and during (months 10-18) a TTT intervention. The outcomes of interest, adverse events and resource use, were based on medical record review of all rheumatology visits for RA patients before and during the intervention.

RESULTS

We examined records for 321 patients before the intervention and 315 during the intervention. An adverse event was recorded in 10.2% of visits before the intervention and 8.8% of visits during the intervention (P = 0.41). Biologic disease-modifying antirheumatic drugs were taken by 53.6% of patients before the intervention and 49.8% of patients during the intervention (P = 0.73). Rheumatology visits were more frequent before the intervention (mean ± SD 4.0 ± 1.4) than during the intervention (mean ± SD 3.6 ± 1.2; P = 0.02). More visits were accompanied by monitoring laboratory tests before the intervention (90.0%) compared with during the intervention (52.7%; P < 0.001). A greater percentage of visits before the intervention included diagnostic imaging (15.4%) versus during the intervention (8.9%; P < 0.001).

CONCLUSION

We observed similar rates of adverse events before and during the implementation of TTT for RA. Rheumatology visits, use of laboratory monitoring, and diagnostic imaging did not increase during the TTT intervention.

摘要

目的

达标治疗(Treat-to-target,TTT)是类风湿关节炎(rheumatoid arthritis,RA)患者治疗的公认模式。由于 TTT 可能与更多的药物转换相关联,因此人们担心实施 TTT 是否会增加不良事件和/或资源使用。本研究旨在检查 TTT 干预试验的干预前和干预期间不良事件和资源使用情况。

方法

我们使用了来自参与 18 个月的群组随机对照试验的 6 个实践的数据,以比较 TTT 干预前(第 1-9 个月)和期间(第 10-18 个月)的不良事件和资源使用情况。感兴趣的结局是基于 RA 患者在干预前后所有风湿病就诊的病历回顾。

结果

我们检查了干预前的 321 例患者和干预期间的 315 例患者的记录。干预前就诊中有 10.2%记录了不良事件,而干预期间就诊中有 8.8%记录了不良事件(P = 0.41)。干预前有 53.6%的患者接受了生物疾病修饰抗风湿药物治疗,而干预期间有 49.8%的患者接受了生物疾病修饰抗风湿药物治疗(P = 0.73)。干预前就诊的频率较高(平均 ± 标准差 4.0 ± 1.4),而干预期间就诊的频率较低(平均 ± 标准差 3.6 ± 1.2;P = 0.02)。干预前就诊时,实验室监测检查的比例较高(90.0%),而干预期间就诊时,实验室监测检查的比例较低(52.7%;P < 0.001)。干预前就诊中,包括诊断性影像学检查的比例较高(15.4%),而干预期间就诊中,包括诊断性影像学检查的比例较低(8.9%;P < 0.001)。

结论

我们观察到 RA 患者在实施 TTT 前后不良事件的发生率相似。在 TTT 干预期间,风湿病就诊次数、实验室监测使用和诊断性影像学检查并未增加。

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