抗栓塞藥物於透析並伴隨心房顫動病人之效果與風險評估

Evaluating effectiveness and risk of antithrombotic drugs in dialysis patients with atrial fibrillation

張雅菁(Ya-Ching Chang)

指導教授 ： 黃耀斌

高雄醫學大學/藥學院/藥學系臨床藥學碩士班/碩士(2018年)

摘要

研究背景與目的：
根據文獻資料慢性腎臟病與心房顫動具有密切相關性，此特殊族群進入末期腎臟病比率提高，而在此時期接受透析並伴有心房顫動者發生缺血性中風與出血風險提高，另研究顯示透析前後死亡率及栓塞事件風險亦明顯提高。目前臨床指引對該族群使用抗栓塞藥品仍有爭議。本研究將評估該族群病人於透析前後藥物使用以及透析期間，抗栓塞藥品轉換對於死亡率、栓塞或出血風險之影響。

研究方法：
本研究為回溯性觀察性研究，利用台灣衛生福利部之全人口檔篩選透析病人並伴有心房顫動病人。依其透析前後抗栓塞藥品處方型態轉換共分為十六組，藉此了解透析病人在抗栓塞藥品的處方。此外也進一步針對前五大處方轉換組別進行結果分析，運用Kaplan-Meier 以及 cox-regression在五組間進行主要終點(死亡率、栓塞事件)及次要試驗終點 (主要出血事件)進行評估。

研究結果：
本研究發現在台灣透析伴有心房顫動者，其使用抗栓塞藥品以抗血小板藥為大宗 (40,17%)，抗凝血藥次之 (4.73%)。前五大處方轉換組別運用cox-regression分析，全因死亡中在noAT-PLT (a-HR=1.484, P=0.0054) 與PLT-PLT (a-HR=1.16, P=0.0482)較高，心血管事件死亡則在COA-COA (a-HR=2.459, P=0.0158)較高，心肌梗塞則在PLT-PLT (a-HR=2.267, P=0.0002) 較高。另外在安全性上該五組間則沒有顯著差異。

研究結論：
本研究結果顯示:在透析伴有心房顫動者，在臨床上的處方以抗血小板藥居多。而noAT-PLT組在全因死亡有較高風險，PLT-PLT組在全因死亡與心肌梗塞有較高風險，COA-COA組在心因性死亡有較高風險。然而這結果可能受到組別間病人疾病嚴重程度影響，因此在未來需要進一步的研究進行研究。

關鍵字

透析 ； 心房顫動 ； 抗栓塞藥品 ； 處方使用情形 ； 處方改變

並列摘要

Background and objectives:
Chronic kidney disease (CKD) and atrial fibrillation (AF) had the closely bidirectional relationship. The special population is prone to end-stage renal disease (ESRD). Risk of Ischemic stroke and bleeding increased in ESRD patients undergoing dialysis with AF. Risk of mortality and cardiovascular events increased between commencing dialysis duration. To date, the clinical guidelines had inconsistent recommendations on these population. In our study, we evaluated the prescription patterns of antithrombotic therapy before and after dialysis. We also assessed the effect of antithrombotic therapy change during dialysis on mortality, thrombosis events and bleeding in these population.

Methods:
This was a retrospective cohort study of dialysis with AF extracted from the National Health Insurance (NHI) database. We used the prescription type of antithrombotic therapy before and after dialysis to further divide into sixteen drug groups to realize the prescription change before and after dialysis. Besides, we chose the top five groups for further analysis. Kaplan-Meier survival plot and cox-regression were performed on primary endpoints (mortality and thrombosis events) and secondary endpoints (major bleeding) in five groups.

Results:
Antiplatelet drugs (40.17%) were the most drug of use in dialysis patients with AF. Anticoagulants (4.73%) were the second. In Cox regression model, noAT-PLT group (a-HR=1.484, P=0.0054) and PLT-PLT group (a-HR=1.16, P=0.0482) showed the higher risk for all-cause mortality. COA-COA group (a-HR=2.459, P=0.0158) had a higher risk for CV death. PLT-PLT group (a-HR=2.267, P=0.0002) had a higher risk of myocardial infarction. There was no significant difference on safety outcome among groups.

Conclusions:
In dialysis patients with AF, the most antithrombotic prescription type were antiplatelet drugs. NoAT-PLT group had a higher risk for all-cause mortality. PLT-PLT group had a higher risk of all-cause mortality and myocardial infarction. COA-COA group had a higher risk for CV death.
However, these results may be caused by unbalance of patients’ disease severity. Further study may need in the future.

並列關鍵字

dialysis ； antithrombotic therapy ； prescription pattern ； prescription change

參考文獻

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