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研究生:黃郁棻
研究生(外文):Yu-Fen Huang
論文名稱:慢性阻塞性肺病之盛行率與用藥型態及吸入型類固醇與急性心肌梗塞相關性研究
論文名稱(外文):Prevalence, Drug Utilization Pattern, and Association between Inhaled Corticosteroids and Acute Myocardial Infarction among Patients with Chronic Obstructive Pulmonary Disease
指導教授:周月卿周月卿引用關係廖志飛廖志飛引用關係
指導教授(外文):Yueh-Ching ChouJyh-Fei Liao
學位類別:碩士
校院名稱:國立陽明大學
系所名稱:藥理學研究所
學門:醫藥衛生學門
學類:藥學學類
論文種類:學術論文
論文出版年:2014
畢業學年度:102
語文別:中文
論文頁數:120
中文關鍵詞:慢性阻塞性肺病台灣盛行率用藥型態趨勢吸入型類固醇全身性發炎反應急性心肌梗塞
外文關鍵詞:Chronic obstructive pulmonary diseaseCOPDTaiwanprevalencedrug utilization patterntrendinhaled corticosteroidssystemic inflammationacute myocardial infarctionAMI
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背景與目的: 慢性阻塞性肺病在2012年為全球第三大死因,儘管亞洲地區有更高的危險因子暴露情形,迄今包含台灣在內大多數國家的疾病負擔 (disease burden) 仍尚未被正確衡量。此外台灣亦無慢性阻塞性肺病用藥型態研究得以評估藥物治療合理性。而共病症不只增加慢性阻塞性肺病整體嚴重度,且增高住院率及死亡率,尤以冠狀動脈心臟病為主。基於發炎反應在慢性阻塞性肺病與粥狀動脈硬化病因皆扮演重要角色,因此慢性阻塞性肺病用藥中的吸入型類固醇可能藉由其抗發炎效果而產生額外的心肌梗塞保護效益,然而過去僅有少數相關研究且結論不一致。故本研究目的為 (1) 分析慢性阻塞性肺病盛行率趨勢與用藥型態趨勢,(2) 分析慢性阻塞性肺病病人使用吸入型類固醇是否對急性心肌梗塞具有保護效果。
方法: 本研究利用具全國代表性之健保資料庫進行以族群為基礎的回溯性研究。盛行率趨勢分析納入條件為2000年至2011年間30歲以上的慢性阻塞性肺病病人,分析項目包括總盛行率、性別盛行率與性別暨年齡別盛行率。另亦進行用藥型態趨勢分析且依照GOLD診治指引評估用藥合理性與診治指引依從性 (guideline adherence)。在慢性阻塞性肺病之吸入型類固醇與急性心肌梗塞相關性研究,採巢性病例對照研究法 (nested case-control study) 進行分析,納入2000年至2008年間30歲以上新確診之慢性阻塞性肺病病人作研究世代並追蹤至急性心肌梗塞發生、退保、死亡或研究結束 (2011年12月31日);研究世代中所有初次發生急性心肌梗塞的病人列為病例組,每位病例組病人再與同世代中未發生事件的病人進行1:4比例的隨機配對,配對條件為年齡、性別與納入日期;為控制慢性阻塞性肺病愈嚴重,愈容易發生急性心肌梗塞與使用吸入型類固醇之適應症干擾 (confounding by indication),藉由可模擬隨機分派試驗之傾向分數以校正疾病嚴重程度;並以條件式邏輯斯迴歸進行干擾因子與作用修飾因子 (effect modifier) 校正與估計急性心肌梗塞相對風險。
結果: 2000年至2011年間共納入53,815位研究對象,平均總盛行率為5.49%,平均男性盛行率 (6.32%) 高於女性 (4.67%),且年齡愈大,盛行率愈高 (30-39歲: 0.18%、40-64歲: 3.43%、≧65歲: 19.61%),顯示病人主要集中於65歲以上族群。而標準化總盛行率由2000年3.4%升高至2011年5.6%,盛行率成長主要在研究初期4至5年,之後即逐漸趨緩,值得注意的是女性盛行率成長較男性快速,使盛行率之性別差異逐漸縮小。用藥型態分析共納入53,379位研究對象,結果顯示台灣醫師治療慢性阻塞性肺病以口服型藥品為主,口服型藥品用藥率超過九成 (93.67%-98.30%),吸入型藥品用藥率僅約四成 (37.00%-41.53%),尤其單獨以茶鹼類藥品 (2000年64.74%;2011年60.20%) 或單獨以口服短效支氣管擴張劑 (2000年46.50%;2011年39.33%) 治療之情形最多,此情形與GOLD診治指引建議差距甚大。前述不適當用藥型態有逐漸減少的情形且吸入型短效用藥亦逐漸減少 (33.93%→30.90%),吸入型長效固定劑量複方 (4.24%→18.58%) 與長效抗膽鹼藥品 (0.04%→5.89%) 用藥率逐年升高。顯示醫師逐漸注重維持型藥品 (maintenance) 之長期用藥效益,不僅求症狀緩解,亦可能因維持型藥品使疾病控制良好而減少緩解型 (resue) 藥品之使用需求,但醫師對診治指引之依從性仍然僅有微幅提高。在慢性阻塞性肺病之吸入型類固醇與急性心肌梗塞相關性分析中,共納入32,369位研究對象,其中共有980位病例組病人,配對的對照組病人共有3,912位,結果顯示目前使用 (距離指標日60天內) 中劑量吸入型類固醇 (相等於fluticasone 300-600 μg/day) 之急性心肌梗塞相對風險為0.45 (95%信賴區間0.25-0.82),P值為0.0091,具顯著差異,而停用中劑量類固醇超過60天則無保護效果。
結論: 本研究之三項結論分述如下:(1) 台灣慢性阻塞性肺病盛行率在亞洲國家居中間名次,盛行率趨勢變化為先逐漸增加再逐漸趨緩,疾病負擔以男性與老年病人為主,但有逐漸轉往女性之傾向。(2) 台灣醫師治療慢性阻塞性肺病以口服型藥品為主,尤其單獨以茶鹼類藥品治療為12年來主要用藥型態,此並不是最合理的治療方式但有微幅減少之趨勢,而吸入型長效固定劑量複方與長效抗膽鹼藥品則有逐漸增加之趨勢,但醫師對慢性阻塞性肺病診治指引之依從性仍有待快速提高。(3) 本研究發現目前使用 (current use) 中劑量吸入型類固醇 (相等於fluticasone 300-600 μg/day) 可顯著減少55%急性心肌梗塞風險,可能得以提供額外的重大心血管事件保護效果。本研究亦呼應慢性阻塞性肺病在全世界為一認知度不足 (under-recognition) 與治療不足(under-treatment) 的疾病,故建議臨床健康照護者應依診治指引治療病人,另建議政府政策制訂者仍須執行有效對策,以提升慢性阻塞性肺病之治療成效與管理。
Background and objectives: Chronic obstructive pulmonary disease (COPD) was the 3rd leading cause of death worldwide in 2012. Despite more hazardous exposure of COPD risk factors in Asia area than in Western countries, the disease burden remains unmeasured in most of the Asian countries, including Taiwan. Besides, there is also lack of drug utilization pattern of COPD in Taiwan to evaluate the rationality of drug use. Furthermore, comorbidities contribute to overall severity and increase mortality and hospitalization rates of COPD patients. Especially, coronary artery disease is the leading cause of morbidity and mortality. Because inflammation plays a major role in progression and initiation of COPD as well as atherosclerosis, it came out a question about whether inhaled corticosteroids (ICS), one of the drug choices in management of COPD, would reduce the risk of acute myocardial infarction (AMI) by anti-inflammatory effect. However, related studies are limited and have shown controversial conclusions about the impact of ICS on the risk of AMI. Hence, the aims of this study were (1) to examine the trend of prevalence and drug utilization pattern of COPD, and (2) to investigate whether ICS could protect COPD patients from AMI or not.
Method: The retrospective population-based survey was conducted using the nationally representative dataset, the National Health Insurance Research Database (NHIRD). COPD patients over 30 years old in 2000-2011 were included in the trend of prevalence analysis. The overall, gender-specific prevalence, gender and age-specific prevalence were assessed during the study period. Furthermore, the studied population, who had COPD medications prescribed in 2000-2011, was analyzed to evaluate the rationality of drug use patterns and physicians’ adherence to the GOLD guideline. The second part of this study was a nested case-control study. A cohort of incident COPD patients between January 2000 and December 2008 were included and followed up to diagnosis of AMI, termination of health coverage, death or end of the study period (December 2011), which ever came first. Within the COPD cohort, each case with first AMI was identified, and matched on age, gender and cohort entry date with up to 4 non-AMI controls randomly selected from the same COPD cohort. To avoid bias attributing to confounding by indication, in other words, the much poorer prognosis of COPD indicated much higher AMI risk and is also the indication for ICS intervention, the technique named propensity score was used to control the COPD severity by imitation of randomized control trial. The conditional logistic regression was used to estimate the relative risk of AMI and adjust for several confounders and effect modifiers. Results: 53,815 studied subjects were identified in 2000-2011. The mean overall prevalence of COPD in Taiwan was 5.49%, and mean male prevalence (6.32%) was higher than mean female prevalence (4.67%). The prevalence increased with age (30-39 years of age, 0.18%; 40-64 years of age, 3.43%; ≧65 years of age, 19.61%). The result showed that the majority of COPD patients were over 65 years old. The standardized overall prevalence went from 3.4% to 5.6% in 2000-2011, which revealed that the prevalence grew mainly in the initial 4-5 years but leveled off over time. It was noted that the growth of female prevalence was faster than that of male resulting in gradually diminished gender difference. There were 53,379 studied subjects in the analysis of the drug utilization pattern. It demonstrated that the COPD treatment was predominated by oral form medications with the use rate of oral medications more than 90% (93.67%-98.30%) whereas the use rate of inhaled medications was about 40% only (37.00%-41.53%). In addition, the most frequently used regimen was monotherapy of the alternatives─xanthines (in 2000: 64.74%; in 2011: 60.20%) or monotherapy of oral short-acting β2-agonists (SABA) (in 2000: 46.50%; in 2011: 39.33%), which was inconsistent with the GOLD recommendation. The above mentioned inappropriate phenomenon decreased over the years, so did the use of short-acting bronchodilators (33.93%→30.90%). On the other hand, the use of inhaled long-acting fixed-dose combination (FDC) and long-acting muscarinic antagonists (LAMA) increased from 4.24% to 18.58% and from 0.04% to 5.89% respectively. It demonstrated that physicians in Taiwan gradually paid more attention on the long-term benefits of the maintenance therapy rather than mere symptom relief or the need of rescue therapy was decreased as the disease was well controlled by maintenance therapy. However, physicians’ adherence to the GOLD guideline only improved slightly. There were 32,369 patients in the COPD cohort of the nested case-control study. Among them, 980 cases having incident AMI were matched with 3912 controls. The relative risk of AMI for current user (within 60 days before index date) with medium dose of ICS (equivalent to fluticasone 300-600 μg/d) was 0.45 (95% CI 0.25-0.82, p =0.0091). There was no further protective benefit for patients withdrawal ICS more than 60 days.
Conclusion: The three conclusions of this study are as follows: (1) the disease burden of COPD in Taiwan was in the middle rank among Asian countries. The trend of prevalence began with a gradual rise then leveled off in the last decade. While the disease burden tended to shift from men to female. (2) Physicians in Taiwan preferred to management COPD with oral form medications, particularly monotherapy of xanthines, which was predominated in the COPD regimens through the 12 years, and the irrational pattern of drug use slightly decreased as times goes by; Moreover, the use of fixed-dose combination (FDC) and long-acting muscarinic antagonist (LAMA) were increased. After all, the adherence to GOLD guideline was still unsatisfactory and needed to facilitate the improvement. (3) Current user of medium dose ICS (equivalent of fluticasone 300-600 μg/d) was found to be associated with a significant reduction of 55% AMI risk, which confer additional benefit of ICS to protect COPD patients against one of the major acute cardiac events. COPD is an under-recognition and under-treatment disease in the world. As the results, healthcare givers and the health policy makers still need to conduct effective strategies to improve COPD management.

中文摘要 i
英文摘要 iv
圖表索引 viii
縮寫表 ix
第一章 緒論 10
第一節 研究背景與動機 10
第二節 研究目的 34
第二章 文獻探討 35
第一節 慢性阻塞性肺病盛行率趨勢相關研究 35
第二節 慢性阻塞性肺病用藥型態趨勢相關研究 39
第三節 吸入型類固醇與急性心肌梗塞相關研究 43
第三章 研究設計與方法 47
第一節 研究項目與研究假設 47
第二節 研究設計與研究工具 48
第三節 統計方法 68
第四章 研究結果 70
第一節 慢性阻塞性肺病盛行率趨勢 70
第二節 慢性阻塞性肺病用藥型態趨勢 80
第三節 慢性阻塞性肺病之吸入型類固醇與急性心肌梗塞相關性 91
第五章 討論 101
第一節 慢性阻塞性肺病盛行率趨勢討論 101
第二節 慢性阻塞性肺病用藥型態趨勢討論 109
第三節 慢性阻塞性肺病之吸入型類固醇與急性心肌梗塞相關性討論 114
第四節 研究限制 118
第六章 結論與建議 120
參考文獻 122

圖1-1-1 慢性支氣管炎、肺氣腫與氣喘於病理學及臨床特質重疊……… 25
圖1-1-2 GOLD 2001-2003分級與藥物治療…………………… 31
圖1-1-3 GOLD 2006-2010分級與藥物治療……………………………… 31
圖3-2-1 研究架構…………………………………………………………… 50
圖3-2-2 慢性阻塞性肺病之吸入型類固醇與急性心肌梗塞相關性研究族群 57
圖3-2-3 吸入性類固醇使用者……………………………………………… 62
圖3-2-4 資料處理流程……………………………………………………… 69
圖4-1-1 慢性阻塞性肺病盛行率趨勢變化………………………………… 78
圖4-1-2 慢性阻塞性肺病平均年齡別盛行率……………………………… 81
圖4-1-3 慢性阻塞性肺病性別盛行率趨勢變化…………………………… 81
圖4-2-1 口服型與吸入型藥品用藥率趨勢圖……………………………… 88
圖4-2-2 口服型長短效藥品、吸入型長短效藥品與替代品項用藥率趨勢圖 88
圖4-2-3 吸入型各類藥品用藥率趨勢圖…………………………………… 90
表1-1-1 新版GOLD分級方式……………………………………………… 32
表1-1-2 新版GOLD藥物治療方式………………………………………… 32
表3-2-1 資料檔名稱、年代與擷取變項 (2000-2011)……………………… 52
表3-2-2 本研究之慢性阻塞性肺病用藥分類表…………………………… 54
表3-2-3 臨床效果可比性之估算劑量表…………………………………… 63
表3-2-4 操作型定義表……………………………………………………… 68
表4-1-1 慢性阻塞性肺病病人數 …………………………………………… 74
表4-1-2 慢性阻塞性肺病之粗盛行率及標準化盛行率…………………… 77
表4-1-3 慢性阻塞性肺病之年齡別及性別盛行率………………………… 80
表4-2-1 慢性阻塞性肺病各類藥品用藥率及用藥率變化量……………… 83
表4-2-2 口服型與吸入型藥品用藥率……………………………………… 87
表4-2-3 在2000年及2011年前5名處方開立型態及用藥率…………… 92
表4-3-1 病人基本特質表…………………………………………………… 97
表4-3-2 使用吸入型類固醇與急性心肌梗塞風險之相關性……………… 100
表4-3-3 吸入型類固醇平均每日劑量與急性心肌梗塞風險之相關性…… 102
表5-1-1 各國盛行率趨勢比較表…………………………………………… 110
表5-1-2 各國用藥趨勢比較表……………………………………………… 115


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