- 學位論文
常見的風濕病患者中使用羥氯奎寧與心律不整的風險
Hydroxychloroquine and the Risk of Cardiac Arrhythmia in Patients with Common Rheumatic Diseases
摘要
研究目的：羥氯奎寧（Hydroxychloroquine, HCQ）是在某些風濕性疾病，例如系統性紅斑性狼瘡（Systemic lupus erythematosus, SLE），類風濕性關節炎（Rheumatoid arthritis, RA）或乾燥症（Sjögren’s syndrome, SS）的一種標準治療藥物。接受HCQ治療的患者中是否增加心律不整的風險是一個重要的安全問題。關於HCQ治療是否增加心律不整的臨床結果仍然不一致。 研究方法及資料：這是一項回顧性的研究，利用台灣的長期健康保險資料庫進行。從2000年到2012年，選擇年齡≥20歲新診斷的RA、SLE或SS的患者。通過傾向評分匹配法將接受HCQ治療和未接受HCQ治療的患者分兩組。使用Cox比例風險模型，在控制相關變數後，分析兩組之間心律不整風險的差異。我們還分析了不同人群和不同研究設計，以研究HCQ和心律不整風險之間的關聯。 研究結果：在使用HCQ的患者和未使用HCQ的患者中，所有心律不整的風險並無差異（調整風險比為0.81，95% CI 0.61–1.07），包括心室心律不整在內。無論每日HCQ劑量是否小於400毫克或大於等於400毫克，以及持續追蹤時間是否小於或等於4個月或大於4個月，心律不整的風險也沒有差異。我們在相同資料來源（台灣健康保險資料庫）中對不同的人群（單一RA疾病）與也使用了不同統計方法（巢式病例對照研究）對SLE患者進行了另外分析。結果使用HCQ與心律不整風險之間顯示相似中性的結果。 結論：在常見的自體免疫病患者，HCQ的使用並沒有增加所有心律不整的風險和心室性心律不整。無論藥物治療時間或每日劑量差異，結果均一致。 關鍵詞 羥氯奎寧、心律不整、類風濕性關節炎、系統性紅斑性狼瘡、乾燥症。
並列摘要
Objectives: Hydroxychloroquine (HCQ) is widely used to treat rheumatic diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and Sjögren’s syndrome (SS). Cardiac arrhythmia has been concerned as important safety issue for HCQ. The aim of this study was to investigate whether HCQ increases new onset arrhythmia among patients with RA, SLE or SS. Methods: This was a retrospective study that conducted from the longitudinal health insurance database of Taiwan. Patients with newly diagnosed RA, SLE or SS with age ≥20 years old were selected from 2000 to 2012. Patients who received HCQ and without HCQ treatment groups were matched by propensity score to minimize the effect of selection bias and confounders. The Cox proportional hazard model was used to analyze the risk of arrhythmia between the two groups after controlling for related variables. We also analyzed different population with different study design for the association of HCQ and the risk of arrhythmia. Results: There was no different risk of all arrhythmia in patients using HCQ than without HCQ (adjusted hazards ratio 0.81, 95% CI 0.61–1.07) and ventricular arrhythmia as well. The arrhythmia risk was also not different regardless of daily HCQ dose <400mg or ≥400mg or follow-up duration of ≦4 months or >4 months. We also analyzed the different population (RA patients alone) and used a different method (nested case-control) in SLE patients using the same data source from the Longitudinal Health Insurance Database of Taiwan. The similar neutral result between the use of HCQ and the arrhythmia risk was found. Conclusion: The administration of HCQ did not increase the risk of all cardiac arrhythmia and ventricular arrhythmia regardless of different duration of treatment or cumulative dose. Keywords: Hydroxychloroquine, arrhythmia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome