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| 研究生： |
張玉婷 Chang, Yu-ting |
|---|---|
| 論文名稱： |
心臟動脈血管支架置入之病人投予Clopidogrel時機與其預後之研究 Study on The Timing of Clopidogrel and The Prognosis of Stent-implanted Patients |
| 指導教授： |
高雅慧
Kao, Yea-Huei 趙庭興 Chao, Ting-hsing 蔡慧珊 Tsai, Hui-shan |
| 學位類別： |
碩士 Master |
| 系所名稱： |
醫學院 - 臨床藥學研究所 Institute of Clinical Pharmacy |
| 論文出版年： | 2007 |
| 畢業學年度： | 95 |
| 語文別： | 中文 |
| 論文頁數： | 157 |
| 中文關鍵詞： | 動脈血管支架 、經皮冠狀動脈介入手術 、術前速效劑量 、clopidogrel 、術後速效劑量 、ADP受器拮抗劑 |
| 外文關鍵詞： | ADP receptor antagonist, Intracoronary stenting, Percutaneous coronary intervention, clopidogrel, pretreatment loading dose, post-treatment |
| 相關次數： | 點閱：109 下載：1 |
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Clopidogrel，為ADP受器之拮抗劑，許多研究證實術前給予300mg速效劑量，並且合併aspirin的使用下，能夠有效的降低病患在經皮冠狀動脈介入手術(percutaneous coronary intervention，PCI)後，產生血栓的發生率，並且在歐美的治療方針內，也提出PCI手術之病患，應於術前使用clopidogrel 300mg速效劑量，合併aspirin以改善病患之預後，但於美國胸腔學院(ACCP)在2004年治療方針內文中提及，此建議乃針對PCI手術之病患，但針對動脈血管支架置入之病患而言，clopidogrel 300mg速效劑量合併aspirin之使用療效是未知的; 且於真正的醫療環境中，除了上述之處方類型外，術前或術後每天ㄧ顆75mg、或是術後300mg速效劑量的給予，都相當常見，故欲藉由本研究了解各不同處方間療效上以及安全性上之差異。
本研究中總共納入606位自民國91年至95年底間，於台南市成功大學醫學中心裝置動脈血管支架之病患。回溯性檢閱病歷並紀錄相關資料，並且排除僅使用單一抗血小板製劑(單用aspirin或clopidogrel)、或使用ticlopidine之患者。依照醫囑單上護理人員給藥時間，將病患分成術前組、術後組，並評估病患於術後第30天、及一年內是否發生死亡、心肌梗塞、血管再造手術、中風、不穩定型心絞痛的情形，同時也觀察病患是否有出血之不良反應發生。
結果顯示在術前或術後給予clopidogrel (不管有沒有使用速效劑量)，所有的心血管事件率在兩組之間都沒有統計上之差異。但不管在短期(30天)或長期(ㄧ年)的追蹤下，所有的事件發生率，皆傾向以使用術前clopidogrel速效劑量之病患為最低(30天: 術前速效劑量1.7%， 術後速效劑量3.1%，術前ㄧ顆75mg 2.9%， 術後ㄧ顆75mg 3.1%; ㄧ年: 術前速效劑量6.5%， 術後速效劑量8.9%，術前ㄧ顆75mg 7.1%，術後ㄧ顆75mg 8.5% ); 並依不同疾病類型病患作進一步分析，發現ST波上升型心肌梗塞之病患中，有使用術前clopidogrel速效劑量之患者，和術後使用速效劑量之患者相較之下，術後之心血管事件發生率，相差較大，並且同樣以術前速效劑量之患者傾向有較佳之預後(30天: 2.7% vs 7.5%, p=0.191; ㄧ年: 6.7% vs 11.9%, p=0.365)。
多變項分析校正基礎共變項後，發現影響事件發生率之因子有兩個，分別是術後使用clopidogrel的時間長度以及killip IV之病患。在短期內(30天)，術後每增加clopidogrel使用的天數ㄧ天，發生的風險是降低的(HR 0.892, CI 0.822-0.969, p=0.0006); 除此之外，Killip IV的病患在一年的追蹤後，發現其發生事件之危險性，是其他病患的17-68倍(所有處方型態: HR 17.825，CI 5.054-62.864, p<0.001; 僅包括使用速效劑量: HR 68.629, CI 6.394-736.632, p<0.001)。
本研究之結果顯示，術前使用clopidogrel 300mg速效劑量之病患傾向有較佳之預後，其心血管事件發生率，皆較其他種類處方型態低; 而其他型態之處方行為: 術前或術後使用每天ㄧ顆75mg clopidogrel、術後clopidogrel 300mg速效劑量等，其術後發生之心血管事件率，較為相似。並由本研究發現術後使用clopidogrel時間與心血管事件發生率有相關性，建議不管使用塗藥或未塗藥支架之患者，皆應於術後至少使用clopidogrel 30天。
Background/ Aims: Clopidogrel 300mg loading dose has been shown to benefit patients who undergo percutaneous coronary intervention (PCI) after short-term or long -term follow up in big clinical trials. Guidelines either in American College of Cardiology/American Heart Association (ACC/AHA) or European Society of Cardiology (ESC) recommend the 300mg loading dose clopidogrel combined with aspirin in PCI patients for better prognosis. But those recommendations were limited in heterogeneous procedures, including stenting, balloon angioplasty, etc., the accurate efficacy and safety profile in stent-implanted patients are unknown. Besides, in real world practice, there are still other prescriptions, such as 75mg clopidogrel per day either before or after the procedures, or 300mg loading dose clopidogrel given after the procedures. To the best of our knowledge, the clinical effects of the recommended dose are not well-known in Taiwan.This study aimed to compare the outcome benefits among all regimens in stent-implanted patients who had stable coronary artery disease or acute coronary syndrome.
Methods: Patients who had their stent implantation during 2002-2006 were recruited in this study, but the one using ticlopidine or didn’t receive dual antiplatelet therapy will be excluded. All data are collected retrospectively by chart review. 606 eligible subjects were included and divided into two groups: pretreatment and post-treatment group. The observed endpoints are cardiovascular death, nonfatal myocardio infarction, target vessel revascularization, stroke, unstable angina, during one year follow-up. Also, the bleeding complications were recorded.
Results: There were no significant differences between regimens neither in 30-day nor 1 year follow-up. But it had the trend towarding lower cardiac events in the pretreatment clopidogrel loading group, especially in the ST elevation myocardial infarction patients (when compared with post-treatment clopidogrel loading dose group). Parameters included in the Cox proportional hazard regression model that independently associated with any cardiovascular events in 30 days was the duration of clopidogrel after stent implantation (HR 0.892, CI 0.822-0.969, p=0.0006), the longer the duration, the lower the risk, either in bare metal stent or drug eluting stent pateints. And parameters that independently associated with any cardiovascular events in 1 year, was the Killip classification IV (All regimen: HR 17.825, CI 5.054-62.864, p<0.001; only loading dose included: HR 68.629, CI 6.394-736.632, p<0.001).
Conclusion: In this study, there was no statistically significant risk reduction in the pretreatment loading dose group, but it has the trend towarding the lower event rate while other regimens had similar outcomes. We also recommend that stent-implanted patients, either bare metal stent or drug eluting stent patients, should complete the usage of 1-month clopidogrel.
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校內：2010-08-09公開校外：2010-08-09公開