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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.

DOI:10.1111/1756-185X.13611
PMID:31240863
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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