- 學位論文
抗血栓藥物rivaroxaban使用於接受人工膝關節及髖關節置換的病人深部靜脈栓塞預防的研究
A study of antithrombotic agent, rivaroxaban, in preventing venous thromboembolism after hip and knee replacement surgery
摘要
背景：人工髖關節及膝關節置換術後經常伴隨著靜脈血栓發生，抗血栓藥物介入在人工髖關節及膝關節置換術，雖可降低靜脈血栓發生，但也會增加出血的風險。本研究在以台灣健保資料庫抗血栓藥物及口服抗凝血藥rivaroxaban處方來探討台灣骨科醫師抗血栓藥物處方在人工髖關節及膝關節置換術後靜脈血栓預防的現況。 方法 : 本研究為回溯性的資料分析，研究執行期間為2007年至2012年，資料來源分為二部份 : 一、2007年至2011年健保資料庫醫院骨科人工髖關節，膝關節置換術(包括髖關節再置換術， 膝關節再置換術， 部份髖關節置換術， 全髖關節置換術， 全膝關節置換術) 及深部靜脈栓塞及急性肺栓塞性心臟病等其他靜脈栓塞症狀的抗血栓藥物處方數量，金額，看診人次。二、2012年國衛院健保百萬抽樣歸人檔資料的口服抗凝血藥物rivaroxaban處方分析。 結果 : 從2007年至2011年國衛院健保資料庫分析發現人工關節置換術的病人主要集中在醫學中心及區域醫院為37%， 地區醫院(26%)，地理區域依序為北區(45%)，南區(34%)，中區(18%)及花東區(3%)，但抗血栓藥物處方的金額，數量，看診人次都有逐年上升的趨勢，其中以heparin的金額最高。從2007年至2011年健保資料庫抗血栓藥物的金額，數量，看診人次及2010年至2013年口服抗凝血藥物rivaroxaban 用量可發現骨科醫師在人工關節置換術的抗血栓處方藥物都有增加的趨勢，不論是醫學中心，區域醫院及地區醫院各層級醫院都有增加，醫學中心骨科的深部靜脈栓塞抗血栓藥物處方的看診人次明顯下降，醫學中心人工關節置換術抗血栓藥物處方是13,600人次，骨科深層靜脈血栓抗血栓藥物處方是310人次(p=0.04)。 從2012年國衛院健保百萬抽樣歸人檔資料口服抗凝血藥物rivaroxaban處方分析發現2010上市的口服抗凝血藥物rivaroxaban很明顯的降低人工關節置換術後深層靜脈血栓的發生及住院的天數，但出血的發生率及藥費則和其它抗血栓藥物相比並無統計學上的差異。 結論 : 隨著人工關節置換術抗血栓藥物處方的逐年上升，骨科深部靜脈栓塞及合併急性肺栓塞性心臟病的病人似乎有下降趨勢。口服抗凝血藥物rivaroxaban可預防深層靜脈血栓的發生，出血風險及藥費則和其它抗血栓藥物相當，但未來仍需更多的臨床來證實rivaroxaban預防深層靜脈血栓發生的療效及安全性，以利在選擇高風險病人處方抗血栓藥物時符合全民健保經濟效益。
並列摘要
Objectives: Total hip replacement (THR) or total knee replacement (TKR) usually accompanies Venous thromboembolism (VTE). The inci-dence of VTE could be reduced but bleeding increased if preventive an-tithrombotic medicine was used for total joint replacement. Based on the data provided by the Department of National Heath in Taiwan, this study was designed to investigate the prophylactic approach with anticoagula-tion agents, including rivaroxaban prescribed to prevent the occurrence of DVT after THR or TKR by the orthopedic surgeon in Taiwan. Methods: This was a retrospective study of analyses on the data be-tween 2007 and 2013. The analyses were divided into two parts: (1) part I: the antithrombotic drugs prescribed by orthopedic surgeons for the pre-vention of DVT or PE after total joint replacement (including THR, TKR, revision for THR or TKR, partial joint replacement etc) between 2007 and 2011, based on the data provided by the National Health Insurance Administration (NHIA); and (2) part II: the prescription of rivaroxaban based on the same provided data in 2012. Results: Comparing the data between those obtained in 2007~2011 (part I) and in 2012 (part II), there was a tendency that the cost, amount of prescriptions, and number of cases received prescriptions, were in-creased in all 3 categories of medical facilities: medical centers, regional hospitals, and area hospitals. Further analysis indicated that the costs for the use of anticoagulation drugs (including Vitamin K antagonist and heparins) were reduced later. The amount of prescriptions and the total cases with prescriptions were reduced remarkably. From 2007~2011, there were no significant changes in the number of cases with total joint replacement; about 37 % of cases were performed in the medical centers or regional hospitals, and 26 % of cases in the area hospitals. Among them, 45% were performed in the north district, 34% in the south district, 18% in the middle district, and 3% in the east district. However, the total cost and the total amount of antithrombotic prescrip-tions, and total cases with antithrombotic prescriptions were increased progressively the highest cost was that for the prescription of heparins. Comparing the patients with DVT received antithrombotic agents therapy (n = 310) to the patients received total joint replacement treated with prophylactic antithrombotic agents (n = 13600), the occurrence of DVT was significantly reduced (p=0.044). The prescription of the new antico-agulation drug, rivaroxaban, reduced the incidence of venous thrombo-embolism significantly after THR and TKR and also reduced the dates of hospitalization significantly. However, there was no significant difference in the occurrence of bleeding comparing to those treated with other an-tithrombotic agents. Conclusions: The cases of thromboembolic complications after total joint replacements have been reduced gradually since the prescriptions of prophylactic antithrombotic drugs have been increased progressively. The prescription of the oral anticoagulation drug, rivaroxaban, reduced the in-cidence of venous thromboembolism after THR and TKR, but with equal incidence of bleeding and expenditures comparing to those treated with other antithrombotic agents. However, in future, further clinical studies of rivaroxaban in preventing the incidence of venous thrombolism are re-quired in order to confirm the cost-effective principle of National Health Insurance.