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系統識別號 U0026-0908201020393600
論文名稱(中文) 台灣精神分裂症疾患使用抗精神疾病藥物持續性之探討
論文名稱(英文) Antipsychotics Persistence of Patients with Schizophrenia in Taiwan
校院名稱 成功大學
系所名稱(中) 臨床藥學研究所
系所名稱(英) Institute of Clinical Pharmacy
學年度 98
學期 2
出版年 99
研究生(中文) 賴嘉鎮
研究生(英文) Chia-Cheng Lai
電子信箱 speedpopo@hotmail.com
學號 s6697403
學位類別 碩士
語文別 中文
論文頁數 137頁
口試委員 指導教授-高雅慧
口試委員-楊延光
口試委員-陳柏熹
指導教授-林嘉音
中文關鍵字 精神分裂症  抗精神疾病藥物  順服性  持續性  藥物成效 
英文關鍵字 schizophrenia  antipsychotics  adherence  persistence  effectiveness 
學科別分類
中文摘要 研究背景:精神分裂症為最嚴重的精神疾病之一,台灣的盛行率約佔0.3%,目前以抗精神疾病藥物為其最主要治療方式,因此選擇藥物成為重要的角色。藥物持續性為藥物本身特性包括:效果、安全性及病患忍受度之綜合結果,當藥物展現「良好持續性」時,代表病患能「穩定地」持續在某個療程之中。但目前何種藥物有最好持續性仍未知,且因族群、基因、環境與文化等不同,藥物持續性也會有所差異。因此,本研究旨在探討台灣精神分裂症之門診病患,各抗精神疾病藥物的持續性比較,以提供醫師與醫療政策之參酌。

研究方法:以全民健康保險研究資料庫2005年承保100萬人抽樣歸人檔,研究對象為2003年1月1日至2007年12月31日間,年齡大於18歲(含),診斷為精神分裂症 (ICD-9=295.XX),且具抗精神疾病藥物門診處方者,根據其所使用之抗精神疾病藥物進行分組。自2003年後第一筆抗精神疾病藥物門診處方起,追蹤一年時間,計算治療長度作為藥物持續性的測量。順服性強度以MPR (medication possession ratio) 及PDC (proportion of days covered) 計算之,作為輔助分析的依據,同時分析治療終止的原因,如:停藥、換藥、加藥、使用長效劑型與住院等。

結果:經過納入、排除與分組條件後,共1,532人進行藥物持續性測量,研究對象平均年齡約41歲 (SD=15.6)。發現非典型抗精神疾病藥物 (AA)比典型抗精神疾病藥物 (TA) 有較佳持續性 (AA,N=852人,99天;TA,N=680,86天;p=0.029)。其中,clozapine的持續性最好 (N=21,172天),且比起其他各組有顯著差異,sulpiride (N=323,117天) 次之,其他持續性較佳的藥物依降冪排序為quetiapine (N=121,105天),risperidone (N=471,100天),zotepine (N=33,97天),aripiprazole (N=19,94天)等;haloperidol (N=258,51天)與chlorpromazine (N=22,55天) 則持續性最差。所有藥物都有良好的順服性強度 (MPR及PDC > 0.9)。療程終止原因以停藥 (佔51%) 為主、其次為換藥 (34%),且二者發生時間在第一筆處方後30天以內 (約45%) 居多。

結論:本研究為提供台灣抗精神疾病藥物持續性比較相關資訊,整體而言AA雖比TA有較好持續性,但仍須考慮其臨床意義。clozapine 有最佳持續性,但臨床上仍有許多使用限制, haloperidol持續性最差。 Sulpiride歸類為TA,但其持續性並不亞於其他AA,又有相對較低價格,可能有經濟學之效益。持續性雖然為選擇藥物主要考量因素之一,但分析精神分裂症病患治療發現持續性皆偏低,臨床上仍須其他介入方式,以增進病患之治療結果。
英文摘要 Background:Schizophrenia is one of the most severe mental diseases. The prevalence is approximately 0.3% in Taiwan. Clinical guidelines suggest that antipsychotics is the main therapy of schizophrenia. The choice of antipsychotics plays a meaningful role in patients’ clinical outcome. Antipsychotics with good persistence may implicate that patients can stably stay on their treatment regimen. Therefore, this study was aimed to investigate the persistence of antipsychotics and provide some implications for practitioners or policy makers.

Methods:We used systemic sampling cohort database in year 2005 of 1,000,000 insurees. The study population included adult patients (≥18 year-old) with schizophrenia diagnosed (ICD-9=295.XX), and had ambulatory prescriptions of antipsychotics from 1 Jan 2003 through 31 Dec 2007. Eligible patients were grouped according to their medications, and were followed up one year. Their treatment duration measured as persistence. Calculated their MPR (medication possession ratio) and PDC (proportion of days covered) as adherence intensity. We also assessed the reasons of treatment termination, such as discontinuation, switching, augmentation, long-acting agent user and hospitalization.

Results:There were 1,532 eligible patients, with average age 41 years old (SD=15.6). Atypical antipsychotics (AA) showed better persistence than typical antipsychotics (TA) (AA:N=852, 99 days;TA:N=680, 86 days;p=0.029). Clozapine showed the best persistence compared with all other antipsychotics (N=21,172 days), which was statistical significant. Sulpiride showed second best in persistence (N=323,117days). Other better persistence antipsychotics in descending order:quetiapine (N=121,105 days),risperidone (N=471,100 days),zotepine (N=33,97days),aripiprazole (N=19,94 days);haloperidol (N=258,51 days) and chlorpromazine (N=22,55 days) showed the poorest persistence. All antipsychotics had good adherence intensity (MPR and PDC > 0.9). The main reasons of treatment termination were discontinuation (51%) and switching (34%), and most of them (approximately 45%) happened within 30 days.

Conclusion:This study could provide antipsychotics persistence information in Taiwan. Overall AA had better persistence than overall TA, but clinical significance should be further investigated. Clozapine showed the best persistence, and haloperidol showed the worst persistence. Sulpiride, one of the TA, showed as good as AA’s persistence, and may have economical benefit because of its relatively lower price. Though antipsychotics persistence is one of the key factors to regimen decision making, the results showed that all patients had relatively poor persistence. Patients with schizophrenia still need other interventions for enhancing adherence (and persistence) for improving their treatment outcome.
論文目次 中文摘要 I
Abstract III
誌謝 V
目錄 VII
表目錄 X
第一篇、抗精神疾病藥物持續性的探討 1
第一章、研究背景 1
第二章、文獻回顧 2
第一節、精神分裂症 2
一、精神分裂症的流行病學 2
二、精神分裂症之特性 4
三、精神分裂症之診斷 4
四、精神分裂症之分類 5
五、精神分裂症之治療方式 6
第二節、抗精神疾病藥物 8
一、藥理基礎與機轉與臨床作用 8
二、 抗精神疾病藥物副作用 10
三、抗精神疾病藥物之分類與各類特性 15
四、藥物動力學比較 20
五、藥物臨床試驗之比較 22
第三節、抗精神疾病藥物服藥順服性 27
一、抗精神疾病藥物順服性不佳之盛行率與原因 27
二、抗精神疾病藥物順服性之重要性 30
三、研究藥物持續性與順服性強度之方法 31
四、抗精神疾病藥物持續性與順服性強度之比較 35
第三章、研究目的與重要性 40
第四章、研究方法 41
第一節、研究設計 41
一、研究類型 41
二、研究材料與工具 41
三、研究對象與排除條件 43
四、分組 44
五、觀察時間與測量結果 44
六、研究流程 45
第二節、研究名詞、研究變項與操作定義 47
第三節、資料處理流程 55
第四節、統計方法 56
一、 統計工具 56
二、 統計模式設定 56
三、 統計資料分析 56
第五章、研究結果 57
第一節、研究對象收入、排除與分組 57
第二節、研究對象基本資料分析 60
第三節、各組藥物持續性與順服性強度 69
第四節、研究對象發生療程終止之分析 72
第六章、研究討論 75
第一節、研究對象收入、排除情況之分析 75
一、研究間期設定與資料庫分析 75
二、收入條件與結果之探討 75
三、排除條件與結果之探討 77
第二節、研究對象基本資料與人口特性分析 78
一、人口特性分析 78
二、研究對象之基本資料分析 80
第三節、藥物持續性之分析 86
一、典型與非典型抗精神疾病藥持續性分析 88
二、抗精神疾病藥物個別之持續性比較 91
第四節、研究對象發生療程終止之分析 96
第五節、研究限制 98
第七章、結論與建議 100
第八章、未來研究方向 101
第二篇、臨床藥事服務-精神科護理人員用藥相關知識衛教 102
第一章、目的 102
第二章、方法 103
第三章、衛教方式、題目與重點 105
第一節、衛教方式 105
第二節、衛教題目與重點 105
第三節、前測與後測問卷 106
第四節、滿意度問卷 107
第四章、衛教結果 109
第一節、抗精神疾病藥物整理與探討 109
第二節、鎮靜與安眠藥物整理與探討 110
第三節、抗精神疾病藥物藥品交互作用 111
第四節、綜合三次衛教滿意度 112
第五章、討論與建議 122
參考文獻 127

表目錄
第一篇、抗精神疾病藥物持續性的探討
Table 2.2-1 Receptor potencies of selected antipsychotic agents 13
Table 2.2-2 Benefits and risks of modern and conventional antipsychotic agents 14
Table 2.2-3目前台灣上市之抗精神疾病藥物依化學結構分類 16
Table 2.2-4目前台灣抗精神疾病藥物上市時間與分類 19
Table 2.2-5抗精神疾病藥物藥物動力學比較 21
Table 2.3-1藥物順服性不佳的原因 29
Table 2.3-2各研究計算順服性強度的定義比較 34
Table 2.3-3 Medication Adherence by Drug for Simple Drug Use 38
Table 4.2-1抗精神疾病藥物定義與ATC/DDD對照 52
Table 4.2-2本研究相關疾病定義與診斷碼(ICD-9-CM) 53
Table 4.2-3本研究藥品定義與ATC-code對照 54
Table 5.1-1納入條件與排除條件 59
Table 5.2-1 Baseline characteristics of patients in each groups 63
Table 5.2-2 Subtype of Schizophrenia (in%) for patients in each antipsychotics group 64
Table 5.2-3 Co-morbidity (in%) for patients in each antipsychotics group 65
Table 5.2-4 Co-medication (in%) for patients in each antipsychotics group 66
Table 5.2-5 Co-medication (in%) for patients in each antipsychotics group 67
Table 5.2-6 Combination medication (in%) for patients in each antipsychotics group 68
Table 5.3-1 Persistence and intensity of each antipsychotics group 70
Table 5.3-2 Statistical analysis of persistence comparisons of each antipsychotics group 71
Table 5.4-1 Disposition of patient in each antipsychotics group at treatment termination 73
Table 5.4-2 Interval of patient in each antipsychotics group at treatment termination 74
Table 6.2-1 Comparisons of DDD/unit of each dosage with patient average daily dose 84
第二篇、臨床藥事服務-精神科護理人員用藥相關知識衛教
Table 3.3-1 衛教前測與後測題目 108
Table 3.4-1 滿意度問卷項目 108
Table 4.1-1 滿意度調查表 (總院) 113
Table 4.1-2 滿意度調查表 (斗六分院) 114
Table 4.2-1 滿意度調查表 (總院) 115
Table 4.2-2 滿意度調查表 (斗六分院) 116
Table 4.3-1 滿意度調查表 (總院) 117
Table 4.3-2 滿意度調查表 (斗六分院) 118
Table 4.4-1 前後測之結果 (總院) 119
Table 4.4-1 前後測之結果 (斗六分院) 120
Table 4.5-1 三次衛教總體滿意度 (總院) 121
Table 4.5-2 三次衛教總體滿意度 (斗六分院) 121


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