心房顫動合併冠狀動脈支架置放術後病人使用口服三合一抗血栓藥物治療效果及安全性之相關性研究

Efficacy and Safety of Triple Oral Antithrombotic Therapy in Atrial Fibrillation and Coronary Artery Stenting

洪智中(Chih-Chung Hung)

高雄醫學大學/藥學院/藥學系碩士在職專班/碩士(2015年)

https://doi.org/10.6832/KMU.2015.00058

摘要

背景: 心房顫動是臨床上最常見並且嚴重的一種心律不整，容易引發心臟血管栓塞至腦部產生缺血性中風導致死亡。心房顫動的治療除了減少心臟症狀之外，也必須預防心臟血管栓塞引起的腦部缺血性中風，依據ACCF/ AHA/HRS治療準則建議，高風險的病人(CHADS2 score≧1)可給予抗凝血藥品以預防中風的發生，目前除了傳統的口服維生素K拮抗劑-Warfarin之外，最近這幾年研發的新型口服抗凝血劑亦是治療指引建議使用之藥品。
心肌梗塞是目前心臟猝死、衰竭最常見的原因，最常見的臨床症狀為胸痛，當病人出現心肌梗塞症狀時，通常需要立即送至醫院急診治療，急診科醫師必須要迅速評估確定胸部不適的原因，並且及時採取適當的治療，目前建議治療方式為緊急經皮冠狀動脈介入治療或給予血栓溶解劑。
目的：本研究將針對使用抗凝血劑之心房顫動病人，發生急性心肌梗塞給予治療後，後續抗血栓藥品治療策略的選擇，了解不同治療方式的療效及安全性。
方法：本研究採病歷回溯方式，納入自2004~2012年心房顫動服用口服抗凝血劑的病人，並於南部某區域教學醫院進行經皮冠狀動脈介入治療後醫師給予抗血栓藥品治療，將使用抗血栓藥品的病人分成2組，分別為三合一療法組與非三合一療法組，觀察6個月後期間使用不同組合抗血栓藥品的療效性與安全性，結果如：腦血管事件、心血管事件、出血事件與時間、病人死亡率…等之關係，是否具統計學上的差異性。

研究結果：以病歷回溯性研究納入符合條件者共332位。再依據入院後第一天臨床上使用抗血栓藥品類型來進行分為2組，三合一抗血栓療法組(TOAT group)樣本數共57位；非三合一抗血栓療法組(NTOAT group)樣本數共275位。以心血管、腦血管事件、死亡作為兩組病人來呈現療效性效果。總心血管事件發生的情形觀察，三合一治療組有27(47%)人，非三合一治療組有144(52%)人，相對風險值為0.84(95% CI 0.52-1.36)，兩者無統計學上顯著差異(p=0.624>0.05) ，以腦血管事件發生的情形觀察，三合一治療組有7(12%)人，非三合一治療組有91(33%)人，相對風險值為0.33(95% CI 0.15-0.71)，兩者有統計學上顯著差異(p=0.002<0.05)，最後以死亡事件發生的情形觀察，三合一治療組有12(21%)人，非三合一治療組有103(37%)人，相對風險值為0.50(95% CI 0.27-0.91)，兩者有統計學上顯著差異(p=0.018<0.05)，以大、小出血事件作為兩組病人來呈現安全性效果。以總出血事件發生的情形觀察，三合一治療組有35(62%)人，非三合一治療組發生123(44%)人，相對風險值為1.75(95% CI 1.75-2.85)，兩者有統計學上顯著差異(p=0.022<0.05)。
結論：由本研究結果得知，具有心房顫動合併冠狀動脈支架置放術後的這些病人使用口服三合一抗血栓藥品治療效果確實可有效預防缺血性中風或死亡，但是相對的是造成出血事件也提升許多，因此如何增加既準確又安全有效的使用抗血栓藥品，是目前更謹慎評估來使用。

關鍵字

心房顫動 ； 心肌梗塞 ； 經皮冠狀動脈介入治療 ； 三合一抗血栓治療

並列摘要

Background: Atrial fibrillation is a very common and severe cardiac arrhythmia which easily lead to heart blood clots to the brain ischemic stroke leading to death. Treatments of atrial fibrillation are not only to reduce cardiac symptoms, but also to prevent blood clots caused by cardiac ischemic stroke. According to ACCF/AHA/HRS therapeutic guideline, patient with high-risk (CHADS2 score≧1) can have anticoagulants to prevent stroke. Besides traditional oral Vitamin K Antagonists (Warfarin), In recent years, the development of new oral anticoagulant treatment which recommended in therapeutic guideline.
Acute myocardial infarction (AMI) is a common reason for sudden cardiac death or heart failure, and the most common symptom is chest pain. When patient has MI’s symptom, he or she need to be sent to a emergency department (ED). Doctor from ED has to evaluate the reason for chest pain as soon as possible, and gives appropriate treatment in time. So far, the recommended treatments are percutaneous coronary intervention (PCI) or giving tissue plasminogen activator (tPA).
Purpose: The study is base on to understand efficacy and safety with different treatments of antithrombotic agents selections that patient with atrial fibrillation and using anticoagulants has treatment after AMI occurred.
Method: The study is using retrospective cohort study which included patient from 2004 to 2012 year. All patients in this study has atrial fibrillation and using anticoagulants, and they all had triple or non-triple antithrombotic agents therapy after Percutaneous coronary intervention (PCI) treatment in this hospital. Patients will use antithrombotic drugs are divided into two groups, namely the Triple oral antithrombotic therapy (TOAT group)and non- Triple oral antithrombotic therapy(NTOAT group). efficacy and safety clinical outcomes six months after the period of use of different combinations of antithrombotic drugs, such as: cerebrovascular relations events, cardiovascular events, bleeding events and time, patient mortality ,etc, whether or not a statistical difference.
Results: In a retrospective study of medical records included a total of 332 patients met the criteria. And then based on the first day after admission, the clinical use of antithrombotic drugs for type divided into two groups, triple antithrombotic therapy group (TOAT group) A total of 57 patients; non-triple antithrombotic therapy group (NTOAT group) A total of 275 patients. Cardiovascular, cerebrovascular events and death as the efficacy of the two groups of patients presenting results. The case of total cardiovascular events were observed, triple therapy group 27 (47%) patients, non-triple therapy group 144 (52%) patients, the relative risk is 0.84 (95% CI 0.52-1.36), there was no statistically significant difference (p = 0.624> 0.05), in the case of cerebrovascular events were observed, the triple therapy group 7 (12%) patients, non-triple therapy group 91 (33%) patients, the relative risk is 0.33 (95% CI 0.15-0.71), the two group are statistically significant differences (P = 0.002 <0.05), and finally to the situation observed deaths, triple therapy group 12 (21 %) patients, non-triple therapy group, 103 (372%) patients, the relative risk is 0.50 (95% CI 0.27-0.91), the two are statistically significant differences (P = 0.018 <0.05), bleeding of patients as a vascular event to present safety. In the case of total bleeding events were observed, triple therapy group, 35 (62%) patients, non-triple therapy group had 123 (44%) patients, the relative risk is 1.75 (95% CI 1.75-2.85), There are statistically significant differences between the two group (P = 0.022 <0.05).
Conclusion: According to the results from this study with atrial fibrillation after coronary artery stenting in these patients using oral medication triple antithrombotic effect is indeed effective in the prevention of ischemic stroke or death, but the opposite is caused by bleeding events also raised a lot, so how to increase both accurate and safe and effective use of antithrombotic drugs are currently used to assess more carefully.

並列關鍵字

Atrial Fibrillation ； Stroke ； Acute Myocardial Infarction ； Percutaneous Coronary Intervention ； Triple Antithrombotic Therapy ； Triple Antithrombotic Therapy

參考文獻

第八章 參考文獻

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