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研究生:姜采玲
研究生(外文):Tsai-Ling Chiang
論文名稱:以台灣全民健保資料庫分析門診新癲癇個案診斷率與藥物處方趨勢
論文名稱(外文):Newly-Diagnosed Rates of Epilepsy and Trends of Antiepileptic Drug Prescribing Pattern in Outpatient Setting in Taiwan
指導教授:簡淑真簡淑真引用關係
學位類別:碩士
校院名稱:臺北醫學大學
系所名稱:藥學研究所
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:2008
畢業學年度:96
語文別:中文
論文頁數:140
中文關鍵詞:癲癇新診斷病人抗癲癇藥物處方趨勢健保資料庫
外文關鍵詞:Epilepsynewly diagnosed patientsantiepileptic drugs prescribing patternNational Health Insurance Research Database
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研究目的: 研究台灣2002年至2005年門診新癲癇個案診斷率及抗癲癇藥物使用趨勢。
研究方法: 以台灣國家衛生研究院所提供的健保資料庫歸人檔(200,432人, 約1%台閩人口)及基本資料檔作為研究材料。擷取診斷碼為345.xx之新診斷病人以估算2002年至2005年新癲癇個案診斷率,並估算每年新診斷病人於初診斷時各種抗癲癇藥物及各種藥物組合的處方率,進而評估2002年至2005年初診斷抗癲癇藥物使用趨勢。追蹤2002年新發生並於初診斷開始用藥病人,估算從2002年至2005年各種抗癲癇藥物及各種藥物組合的處方率並評估藥物使用趨勢、估算自初診斷至停藥的中位時間;針對2002年新診斷但未於初診斷用藥的病人,於2005年12月31日前有用藥者,估算第一次用藥的中位時間。
研究結果: 新癲癇個案診斷率自2002年的131.8/每十萬人年降至2005年的110.0/每十萬人年。大於等於65歲的族群發生率最高,46至64歲的族群次之,19至45歲的族群最低;整體而言,男性高於女性。每年約有50%新診斷病人於初診斷時即開始用藥,多以傳統型抗癲癇藥物為優先選擇(開立率>90%),且以單方使用為主;傳統抗癲癇藥物的使用趨勢逐年遞減(p<0.05)、新型抗癲癇藥物逐年遞增(p<0.05)。從2002年至2004年,phenytoin、carbamazepine和 valproic acid是最常於初診斷時開立;但至2005年clonazepam則取代carbamazepine成為最優先使用之前三項藥物之ㄧ;clonazepam的處方趨勢往上(p<0.05)、carbamazepine則是往下(p<0.05)。追蹤用藥的型態中,4年來仍是以單方傳統抗癲癇藥物的使用為主,其中以phenytoin、carbamazepine和valproic acid為最常開立的藥物;各種成分及處方的使用趨勢皆無統計上的顯著性。32.4%新診斷病人在被診斷為癲癇之後至少3年仍未使用抗癲癇藥物,而在初診斷未用藥病人中,於觀察期間有用藥者,半數於4.5個月開始用藥(95% 信賴區間為0.0-14.7個月)。新診斷且在初診斷開始用藥者,半數於6.8個月後停藥(95% 信賴區間為2.2-11.3個月),16.8%的病人會持續使用藥物至少達3年。
結論: 新癲癇個案診斷率約為104.6~133.9/每十萬人年。雖然傳統抗癲癇藥物的使用趨勢逐年遞減、新型抗癲癇藥物逐年遞增,但是多以單方傳統型抗癲癇藥物為優先選擇,新型抗癲癇藥物多以輔助性的方式給予。在初診斷未用藥病人中,於觀察期間有用藥者,半數於4.5個月開始用藥。新診斷且在初診斷開始用藥者,半數的病人約於7個月後停藥。
Objective: To estimate the newly-diagnosed rates of epilepsy in outpatient setting from 2002 to 2005 in Taiwan. The trends of initial and followup antiepileptic drugs (AEDs) prescribing pattern were also evaluated.
Method: Data set of a randomly sampled cohort with 200,432 people from the registry for beneficiaries in Taiwan, about 1% of the population, was provided by the National Health Research Institutes. The data set consisted of outpatient and inpatient visit, diagnosis, and prescription drug records. Newly-diagnosed epilepsy patients were identified by the ICD-9-CM diagnostic criteria 345.xx coding. The newly-diagnosed rates of epilepsy were estimated and adjusted by coverage rate (about 97.0%). The trends of AEDs prescribing pattern of newly-diagnosed patients each year from 2002 to 2005 were evaluated and compared if they also were prescribed AED in the same visit. In addition, the newly-diagnosed patients in 2002 were followed as a fixed cohort to evaluate the trends of AEDs prescribing pattern over time. The median time of initiation and withdrawing AEDs therapy of this fixed cohort were evaluated as well.
Result: The newly-diagnosed rates of epilepsy decreased gradually from 131.8 per 100,000 person-years in 2002 to 110.0 per 100,000 person-years in 2005. The highest age-specific newly-diagnosed rate was found in the group aged 65 years or older and the lowest in the group aged 19 to 45 years. Overall, the male patients had higher rate of diagnosis than the female patients. Each year, between 47.5% and 56.0% of newly-diagnosed patients were prescribed AEDs at first visit. Contrary to the downward trend found in the prescribing pattern of conventional AEDs (p< 0.05), there was a significant increase in prescribing newer AEDs in these new cases of epilepsy (p< 0.05). However, there were more than 90% of the newly-diagnosed patients prescribed with conventional AEDs as monotherapy at first visit in 2005. The top three prescribed AEDs consistently included phenytoin, carbamazepine and valproic acid from 2002 to 2004, whereas carbamazepine was replaced by clonazepam in the top three list in 2005. The trend of clonazepam prescribing pattern increased (p< 0.05), whereas the trend of carbamazepine prescribing pattern decreased (p< 0.05). Concerning the newly-diagnosed patients in 2002, conventional AEDs as monotherapy was most prescribed. The top three prescribed AEDs consistently included phenytoin, carbamazepine and valproic acid from 2002 to 2005. The median time to start AEDs therapy was 4.5 (95% CI=0.0-14.7) months. The median time of withdrawing AEDs therapy was 6.8 (95% CI=2.2-11.3) months.
Conclusion: The newly-diagnosed rates of epilepsy patients were in the range of 104.6 to 133.9 per 100,000 person-years. At first visit, the trend of conventional AEDs prescribing pattern decreased while the trend of newer AEDs prescribing pattern increased. However, conventional AEDs as monotherapy was prescribed most frequently from 2002 to 2005. The median time of starting AEDs therapy was 4.5 months. The median time of withdrawing AEDs therapy was about 7 months.
致謝………………………………………………………………….. I
中文摘要…………………………………………………………….. II
英文摘要…………………………………………………………….. IV
內容目錄…………………………………………………………….. VI
表目錄………………………………………………………………. VIII
圖目錄………………………………………………………………. XI
第一章 前言………………………………………………………… 1
第二章 文獻回顧…………………………………………………… 3
第一節 名詞解釋………………………………………………… 3
第二節 分類……………………………………………………… 5
第三節 癲癇流行病學…………………………………………… 8
第四節 癲癇機轉及病因學……………………………………… 10
第五節 癲癇診斷及評估………………………………………… 13
第六節 癲癇治療………………………………………………… 15
第七節 抗癲癇藥物治療………………………………………… 16
第八節 以automated database之抗癲癇藥物使用研究………… 35
第九節 台灣全民健康保險研究資料庫簡介…………………… 47
第三章 研究目的…………………………………………………… 49
第四章 研究方法…………………………………………………… 50
第一節 研究設計………………………………………………… 50
第二節 研究對象………………………………………………… 50
第三節 研究參數定義…………………………………………… 51
第四節 研究資料收集…………………………………………… 52
第五節 統計分析………………………………………………… 57
第五章 研究結果…………………………………………………… 58
第一節 新診斷率………………………………………………… 58
第二節 初診斷用藥率、藥物使用處方率及趨勢……………… 63
第三節 2002年新發生癲癇病人追蹤…………………………… 110
第六章 討論……………………………………………………….. 124
第一節 新診斷率………………………………………………… 124
第二節 初診斷用藥率、藥物使用處方率及趨勢……………… 126
第三節 2002年新發生癲癇病人追蹤…………………………… 129
第七章 研究限制…………………………………………………… 133
第八章 結論………………………………………………………… 134
第九章 未來展望………………………………………………….. 135
第十章 參考文獻…………………………………………………… 136

表目錄
表2-1 局部發作……………………………………………………... 6
表2-2 癲癇或癲癇發作病因(依年齡分)…………………………… 12
表2-3 台灣抗癲癇藥物的健保給付日期…………………………... 18
表2-4 抗癲癇藥物機轉……………………………………………... 19
表2-5 抗癲癇藥物對各種癲癇發作之臨床療效…………………... 21
表2-6 抗癲癇藥物的重要藥物動力學性質………………………... 24
表2-7 抗癲癇藥物和相關cytochrome P450 isoenzyme的關係…… 25
表2-8 抗癲癇藥物之間有臨床意義的交互作用…………………... 27
表2-9 初診斷藥物選擇建議(成人)………………………………… 30
表2-10 初診斷藥物選擇建議(孩童和青少年)……………………… 31
表2-11 Refractory epilepsy之新型AEDs藥物選擇建議…………… 32
表2-12 接受治療的癲癇病患之盛行率和發生率的研究-英國…….. 36
表2-13 以抗癲癇藥物的使用進行癲癇盛行和發生的研究-荷蘭...... 37
表2-14 抗癲癇藥物使用情形的研究-傳統和新型AEDs-義大利...... 39
表2-15 抗癲癇藥物使用情形的研究-傳統和新型AEDs-英國…...... 40
表2-16 抗癲癇藥物使用情形的橫斷面研究-丹麥……….................. 41
表2-17 抗癲癇藥物使用情形的縱貫性研究-丹麥……..…………… 42
表2-18 台灣癲癇盛行率和抗癲癇藥物使用的研究………………... 43
表2-19 以automated database之抗癲癇藥物使用研究比較表 -盛行個案…………………………………………………….. 45
表2-20 以automated database之抗癲癇藥物使用研究比較表 -新發生個案………………………………………………….. 46
表2-21 台灣全民健康保險研究資料庫之優缺點…………………... 48
表5-1 新診斷率…………………….……………………………….. 59
表5-2 詳細診斷碼的人數分佈…..…………………………………. 59
表5-3 新診斷率-不分組和性別分組…………….............................. 60
表5-4 新診斷率-不分組和年齡分組…………….............................. 61
表5-5 初診斷用藥率………………………………………………... 63
表5-6 初診斷用藥率-性別分組…………………………………….. 64
表5-7 初診斷用藥率-年齡分組…………………………………….. 65
表5-8 初診斷用藥率-醫療層級分組……………………………….. 66
表5-9 初診斷用藥率-地區分組…………………………………….. 67
表5-10 初診斷用藥率-科別分組…………………………………….. 68
表5-11 初診斷藥品成分處方率……………………………………... 71
表5-12 傳統AEDs初診斷處方率-性別分組....................................... 73
表5-13 傳統AEDs初診斷處方率-年齡分組....................................... 74
表5-14 傳統AEDs初診斷處方率-醫療層級分組………………...... 76
表5-15 新型AEDs初診斷處方率-醫療層級分組………………….. 78
表5-16 傳統AEDs初診斷處方率-地區分組...................................... 80
表5-17 新型AEDs初診斷處方率-地區分組....................................... 83
表5-18 傳統AEDs初診斷處方率-科別分組....................................... 85
表5-19 不分組及次分組初診斷藥品成分使用趨勢關係表………... 88
表5-20 初診斷藥物組合型態處方率………………………………... 89
表5-21 初診斷藥物組合型態處方率-性別分組…………………….. 91
表5-22 初診斷藥物組合型態處方率-年齡分組…………………….. 92
表5-23 初診斷藥物組合型態處方率-醫療層級分組……………….. 94
表5-24 初診斷藥物組合型態處方率-地區分組…………………….. 96
表5-25 初診斷常見藥物組合處方率………………………………... 99
表5-26 初診斷常見藥物組合處方率-性別分組…………………….. 101
表5-27 初診斷常見藥物組合處方率-年齡分組………...................... 103
表5-28 初診斷常見藥物組合處方率-醫療層級分組……………….. 105
表5-29 初診斷常見藥物組合處方率-科別分組…………………….. 107
表5-30 不分組及次分組之初診斷藥物組合型態及常見藥物組合使用趨勢關係表……………………………………………... 109
表5-31 用藥追蹤:藥品成分處方率……............................................ 112
表5-32 用藥追蹤:藥物組合型態處方率……………………............ 114
表5-33 用藥追蹤:常見藥物組合處方率……………….................... 116
表5-34 何時停藥-性別分組………………………………………….. 119
表5-35 何時停藥-年齡分組………………………………………….. 120
表5-36 何時開始用藥-性別分組…………………………………….. 122
表5-37 何時開始用藥-年齡分組…………………………………….. 123
表6-1 癲癇發生率/新診斷率.............................................................. 125
表6-2 新使用AEDs病人之處方趨勢............................................... 128

圖目錄
圖2-1 癲癇診斷及評估…………………………………………... 14
圖2-2 抗癲癇藥物發展時間序…………………………………... 17
圖4-1 新診斷率、初診斷用藥之資料處理流程圖……………… 55
圖4-2 2002新診斷癲癇病人追蹤之資料處理流程圖………….. 56
圖5-1 新診斷率-不分組和性別分組…………………………….. 60
圖5-2 新診斷率-年齡分組……………………………………….. 62
圖5-3 2002年新發生癲癇病人追蹤…………………………….. 110
圖5-4 何時停藥…………………………………………………... 118
圖5-5 何時停藥-性別分組……………………………………….. 119
圖5-6 何時停藥-年齡分組……………………………………….. 120
圖5-7 何時開始用藥……………………………………………... 121
圖5-8 何時開始用藥-性別分組………………………………….. 122
圖5-9 何時開始用藥-年齡分組………………………………….. 123
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