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生物制剂对类风湿关节炎患者卒中与死亡率的潜在获益:一项基于全台湾人群的全国性队列研究。

Potential benefits of biologics on stroke and mortality in patients with rheumatoid arthritis: A nationwide population-based cohort study in Taiwan.

机构信息

School of Health Care Administration, Taipei Medical University, Taipei, Taiwan.

Pfizer Ltd., New Taipei City, Taiwan.

出版信息

Int J Rheum Dis. 2019 Aug;22(8):1544-1552. doi: 10.1111/1756-185X.13611. Epub 2019 Jun 25.

Abstract

AIM

To examine the changes in the risks of death and cardiovascular diseases (CVD) in rheumatoid arthritis (RA) patients treated with conventional synthetic or biologic disease-modifying antirheumatic drugs (csDMARD or bDMARD) during 1997-2013.

METHODS

Two cohorts of RA patients and their matched controls were identified from the National Health Insurance Research database. There were 1569 patients in the csDMARD cohort who received cyclosporine ≥50 mg/d with concomitant usage of ≥2 csDMARDs during 1997-2003. There were 1530 patients in the bDMARD cohort if patients had ≥1 claim for bDMARD during 2003-2011. Adjusted hazard ratios (aHRs) for the risk of death, myocardial infarction, and stroke, were assessed using the Kaplan-Meier survival curves and the Cox proportional hazards models.

RESULTS

Compared with matched cohorts, the incidence of death was higher with csDMARD with a more than 6-fold increase (csDMARD vs controls: 33% vs 5%); while it only increased with a much smaller magnitude with bDMARD (bDMARD vs controls: 15% vs 11%). In addition, an increase in the reduction of incidence rate of stroke with bDMARD (bDMARD vs controls: 2% vs 5%) than that with csDMARD (csDMARD vs controls: 3% vs 4%) was found. Results from multivariate analysis showed that RA patients receiving bDMARD had a significantly lower increase in the risk of deaths (aHR 1.05; 95% CI 0.84-1.33) compared with those receiving csDMARD (aHR 8.75; 95% CI 7.43-10.31). In addition, bDMARD was associated with a higher reduction in the risk of stroke compared with csDMARD (bDMARD: aHR 0.37; 95% CI 0.22-0.62; csDMARD: aHR 0.73; 95% CI 0.51-1.05).

CONCLUSION

Biologics used in RA patients have been shown to have a beneficial impact on improving clinical outcomes, including decreased risks of death and stroke. The economic burden from costs of biologics may be alleviated by improving outcomes.

摘要

目的

研究 1997-2013 年间,常规合成或生物改善病情抗风湿药物(csDMARD 或 bDMARD)治疗的类风湿关节炎(RA)患者的死亡和心血管疾病(CVD)风险变化。

方法

从国家健康保险研究数据库中确定了两个 RA 患者队列及其匹配对照。csDMARD 队列中有 1569 名患者在 1997-2003 年期间接受了环孢素≥50mg/d,并同时使用了≥2 种 csDMARD。如果患者在 2003-2011 年期间有≥1 次 bDMARD 用药,则 bDMARD 队列中有 1530 名患者。采用 Kaplan-Meier 生存曲线和 Cox 比例风险模型评估死亡、心肌梗死和中风风险的调整后风险比(aHR)。

结果

与匹配队列相比,csDMARD 组的死亡率更高,增加了 6 倍以上(csDMARD 组 vs 对照组:33% vs 5%);而 bDMARD 组的增加幅度要小得多(bDMARD 组 vs 对照组:15% vs 11%)。此外,发现 bDMARD 降低中风发生率的效果(bDMARD 组 vs 对照组:2% vs 5%)大于 csDMARD(csDMARD 组 vs 对照组:3% vs 4%)。多变量分析结果表明,与接受 csDMARD 的患者相比,接受 bDMARD 的 RA 患者的死亡风险增加明显较低(aHR 1.05;95%CI 0.84-1.33)。此外,与 csDMARD 相比,bDMARD 与降低中风风险相关(bDMARD:aHR 0.37;95%CI 0.22-0.62;csDMARD:aHR 0.73;95%CI 0.51-1.05)。

结论

生物制剂在 RA 患者中的应用已显示出改善临床结局的有益影响,包括降低死亡和中风风险。通过改善结局,可能减轻生物制剂成本带来的经济负担。

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