口服抗血栓藥品使用於頭頸部癌接受放射線治療病人之效果及安全性評估

Evaluating the Effectiveness and Safety of Oral Antithrombotic Therapy in Head and Neck Cancer Patients with Radiation Therapy

許晉瑋(Chin-Wei Hsu)

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(2016年)

摘要

研究背景與目的：
頭頸部癌治療中，放射線治療是常用且有效的治療方式。許多研究顯示放射線治療會增加頭頸部癌病人缺血性中風或短暫性腦缺血發作的風險。口服抗血栓藥物包含抗血小板與抗凝血藥物，常用於預防腦血管事件發生，但目前尚未有評估口服抗血栓藥物，用於頭頸部癌接受放射線治療病人的研究。因此，本研究欲探討口服抗血栓藥物用於頭頸部癌接受放射線治療病人的效果與安全性。

研究方法：
本研究利用台灣全民健康保險資料庫，篩選出接受放射線治療之頭頸部癌病人進行回顧型世代研究。並且將納入研究的個案分為使用口服抗血栓藥物者與未使用藥物者。主要研究事件為缺血性中風或短暫性腦缺血發作風險。次要研究事件為任何原因死亡事件與嚴重出血事件的風險。統計方法使用Cox proportional hazard model，計算其風險比率與95%信賴區間。

研究結果：
本研究共納入37,638位案例。關於缺血性中風或短暫性腦缺血發作風險，未停用口服抗血栓藥物的使用者與未使用者相比，沒有統計上的顯著差異 (adjusted HR: 0.828; 95% CI: 0.203 – 3.376)，但在死亡風險方面，卻發現顯著增加死亡風險(adjusted HR: 1.653; 95% CI: 1.054 – 2.594)。在嚴重出血事件方面，並沒有發現統計顯著結果。

研究結論：
口服抗血栓藥物對於頭頸部癌接受放射線治療病人而言，無法顯著降低缺血性中風或短暫性腦缺血發作風險，也不會顯著增加嚴重出血事件風險。

關鍵字

頭頸部癌 ； 放射線治療 ； 缺血性中風 ； 抗血栓藥品

並列摘要

Background and objective:
Radiation therapy (RT) is a common and effective treatment in patients with head and neck cancer (HNC). Studies have shown that RT increases risk of ischemic stroke or transient ischemic attack (TIA) in patients with HNC. Oral antithrombotic therapy, including antiplatelets and anticoagulants, are usually used to prevent cerebrovascular events. However, no study assesses the use of oral antithrombotic therapy in this population. Our study objective is to evaluate the effectiveness and safety of oral antithrombotic therapy in HNC patients with RT.

Methods:
This population-based retrospective cohort study identified the cases of HNC after RT by using National Health Insurance Research Database. Cases were classified into the users of oral antithrombotic therapy and the non-users. Primary outcome was ischemic stroke or TIA. Secondary outcomes were any cause of death and major bleeding. Cox proportional hazard models were performed to calculate hazard ratio (HR) and 95% confidence interval (CI).

Results:
A total of 37,638 patients were included in this study. No significant decreased risk of ischemic stroke or TIA was found between users without discontinuation of oral antithrombotic therapy and non-users (adjusted HR: 0.828; 95% CI: 0.203 – 3.376), but significantly increased risk of death was seen (adjusted HR: 1.653; 95% CI: 1.054 - 2.594). No statistical significance was revealed in major bleeding.

Conclusion:
For HNC patients with RT, oral antithrombotic therapy does not significantly reduce the risk of ischemic stroke or TIA and significantly increase risk of major bleeding.

並列關鍵字

head and neck cancer ； radiation therapy ； ischemic stroke ； antithrombotic therapy

參考文獻

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