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研究生:江怡蓉
研究生(外文):Yi-Jung Chiang
論文名稱:Fluoroquinolones於台灣地區結核病患者使用之處方型態分析
論文名稱(外文):The Prescribing Patterns of Fluoroquinolones in Patients with Tuberculosis in Taiwan
指導教授:林嘉音林嘉音引用關係高雅慧高雅慧引用關係
指導教授(外文):Chia-Yin LinYea-Huei Kao Yang
學位類別:碩士
校院名稱:國立成功大學
系所名稱:臨床藥學研究所
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:127
中文關鍵詞:處方型態分析結核病
外文關鍵詞:fluoroquinolonetuberculosisprescribing patterns
相關次數:
  • 被引用被引用:0
  • 點閱點閱:244
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  • 下載下載:31
  • 收藏至我的研究室書目清單書目收藏:0
研究背景
Fluoroquinolones (FQ)因具有使用方便及廣效殺菌等效果,容易被選擇做為經驗性抗生素,用於結核病發病初期不具特異性之感染症狀治療。然而FQ除了一般細菌外,也能有效的治療結核菌,故對於實際上是結核菌感染的患者使用FQ做為治療,即等同於單線藥品治療結核菌。然而這樣的處方行為,會造成結核病診斷延遲,抗藥性及預後不佳的狀況。此外,國內屬結核病流行區,FQ被處方於結核病患者的機率越高,很可能會造成抗藥性及診斷延遲比率增加,進而造成傳染率增加,因此有必要對於國內的處方情形進行研究。

研究方法
利用2000-2004全民健保資料庫門、住診檔,擷取出2003/01/01至12/31定義新確診結核病患(ICD9-code 010-018),分析FQ於結核病指標日期(首次被登記結核病診斷碼日期)前365天做為經驗性治療及指標日期後365天內之使用情形,研究處方適當性以及找出處方預測因子,以及經驗性fluoroquinolones的使用與診斷、治療及預後之間的關係,以提供臨床人員及抗生素管控決策之參考。

研究結果
本研究發現14,466位新確診結核病患者中,15.25%於首次被登記結核病診斷碼(指標日期)前曾使用過FQ的紀錄(FQ組),66.15%使用FQ以外之抗生素(Abx組)。年齡、女性、共病症、就診區域、醫師專科、醫院層級等皆為FQ處方之預測因子。而指標日期前處方抗生素之總就診次數中登記痰塗片及分枝桿菌培養醫令比率偏低(12.74%)。而FQ的使用除了造成診斷(30天)及治療延遲(24天)外,與死亡發生也有相關性(多變項分析OR=4.506),在指標日期後15.69%患者具有被處方FQ之記錄,而肝硬化、糖尿病、老年人、肺外結核、醫師專科及醫院層級等為處方之預測因子。

結論
本研究發現國內結核病患者在診斷前被處方抗生素(包括FQ)的次數及機率偏高,且FQ於診斷前的使用會導致診斷延遲,且與預後不佳有高度相關性。而於診斷之後,仍有一定比率患者被處方FQ,特別是對患有肝硬化或是年紀大的病患,然而詳細處方原因仍待進一步釐清。
Background
Due to its broad-spectrum antibaterial activity and convenient administration, FQ is likely to be widespread used as empirical therapy when TB patients present non-specific infectious symptoms. In addition to the anti-bacterial activity, FQ also has effective anti-TB activity. Several studies have demonstrated such empirical use of FQ can result in TB diagnosis delay, resistance and poor prognosis. Because of the TB prevalence and increasing resistance rate in Taiwan, there is a necessity to investigate the appropriateness FQ prescribing patterns in TB patients.

Method
We used the 2000-2004 National Health Insurance claims data base, to extract 2003 difinite new diagnosis TB patients (ICD-9 code 010-108). The objective is to investigate the antibiotics prescribing patterns (FQ and others), predictors in 365 days before and after their TB diagnosis date (index date) and the association between fluoroquinolones and prognosis.

Result
We have found 14,466 consistent with the definitions of definite TB diagnosis patients in 2003. 15.25% (FQ group) was prescribed with FQ before TB index date, and 66.15% was prescribes with other antibiotics (Abx group). Age, sex, comorbidity, and the geographic area, the level and the physician specialist were the predictors for FQ prescription. FQ was also associated with poor prognosis, and can result in 30 days delay diagnosis and 24 days treatment delay compared with Abx group. The sputum smear test was also infrequent (12.74% of total visits). 15.69% patient were prescribed with FQ after index date.The predictors of FQ prescribing after index date included liver cirrhosis,elder,extrapulmonpary TB,and DM.

Conclusion
Antibiotics were frequently prescribed in TB patients before TB diagnosis.FQ use can lead to delay of TB diagnosis and associate with poor prognosis. FQ prescribing after TB diagnosis was also common, especially in elder or patients with liver cirrhosis.
目錄
第一章 研究背景 1

第二章 文獻回顧 3
第一節 結核疾病簡介 3
2.1.1 國內外疫情概況 3
2.1.2 政府現行防疫措施及瓶頸 3

第二節 Fluoroquinolones簡介 10
2.2.1 藥物特性 10
2.2.2 Fluoroquinolones用於結核病治療所扮演的角色 16

第三節 Fluoroquinolones經驗性治療對結核病診斷及預後之影響 24
2.3.1 可能延遲結核病治療以及造成死亡率提高 24
2.3.2 可能使acid fast bacillus(AFB)呈陰性的機會增加 25
2.3.3 可能使結核菌對fluoroquinolones敏感性降低 26
2.3.4 結核病患在診斷前使用fluoroquinolones的情形-國外保險資料庫研究 26

第四節 Fluoroquinolones之抗藥性問題及現階段專家學者意見 27
2.4.1 全球廣泛性抗藥性結核菌株(XDR-TB)的發生 27
2.4.2 結核菌對於fluoroquinolones產生抗藥性的情形 28
2.4.3 專家學者意見 30

第三章 研究目的及方法 31
第一節 研究目的 31

第二節 研究型態 31

第三節 研究材料 31
3.3.1 全民健保資料庫 31
3.3.2 國際疾病傷害及死因分類標準ICD-9-CM 1992年版 32
3.3.3 健保給付藥品Anatomical Therapeutic Chemical (ATC) classification代碼對照檔(高雅慧、郭垂文、洪榮輝、郭士禎所編訂) 32

第四節 研究對象 32

第五節 操作變項定義 33
3.5.1 研究對象定義 33
3.5.2 指標日期前fluoroquinolones之處方型態分析部分 34
3.5.3 指標日期後365天內之fluoroquinolones處方型態分析部分 37
3.5.4 處方預測因子分析 37
3.5.5 對於診斷及治療預後的影響分析 39

第六節 資料處理 41
3.6.1 資料處理流程 41
3.6.2 指標日期前fluoroquinolones之處方型態分析 42
3.6.3 診斷後fluoroquinolones之處方型態分析 43
3.6.4 Fluoroquinolones之處方行為預測因子分析: 43
3.6.5 Fluoroquinolones對於結核病診斷及治療預後影響 44

第四章 統計分析 46
第一節 資料分析方法 46
4.1.1 敘述型統計 46
4.1.2 推論型統計 46

第二節 統計模式設定 47

第三節 統計工具 47

第五章 研究結果 48
第一節 病患基本特性分佈 48

第二節 指標日期前fluoroquinolones之處方型態分析 50
5.2.1 定義新確診結核病患者其抗生素組別與基本特質分佈 50
5.2.2 患者使用fluoroquinolones或其他抗生素之比率與次數 52
5.2.3 指標日期前痰塗片及分枝桿菌培養之監測情形 54
5.2.4 Fluoroquinolones及其他類抗生素處方情形 56

第三節 指標日期後患者使用fluoroquinolones之情形 59
5.3.1 特定fluoroquinolones處方情形 59

第四節 Fluoroquinolones處方之預測因子 60
5.4.1 於指標日期前fluoroquinolones之使用 60
5.4.2 於指標日期後特定fluoroquinolones之使用 60

第五節 Fluoroquinolones使用對於結核病診斷及治療預後之影響 66
5.5.1 診斷及治療延遲方面 66
5.5.2 住院天數方面 68
5.5.3 結核病用藥治療天數方面 68
5.5.4 指標日期之後住院比率方面 68
5.5.5 死亡率方面 68

第六章 研究討論 72
第一節 研究族群人口特性 72

第二節 指標日期前之經驗性抗生素使用狀況 75
6.2.1 使用抗生素之比率 75
6.2.2 痰塗片及分枝桿菌培養之監測情形 76
6.2.3 指標日期前fluoroquinolones之處方情形與預測因子 77

第三節 指標日期後fluoroquinolones之處方情形及處方預測因子 80

第四節 經驗性抗生素使用對於結核病診斷及治療延遲之影響 82
6.4.1 Fluoroquinolones之影響 82
6.4.2 其他類抗生素之影響 83
6.4.3 其他可能造成診斷延遲的因素 83

第五節 經驗性抗生素對於結核病患者預後之影響 85
6.5.1 患者住院天數影響與指標日期後住院之比率 85
6.5.2 死亡率之影響 85

第七章 研究限制 87

第八章 未來研究方向 89

第九章 結論與建議 90

臨床藥事服務 92

參考文獻 118

作者簡介 127


表目錄
表5-1 新確診結核病患之基本特徵 51
表5-2 於指標日期前患者被處方抗生素之門診次數 53
表5-3 於指標日期前,對於具呼吸道感染相關診斷之就診記錄(不論是否處方抗生素),登記痰塗片及分枝桿菌培養監測情形 55
表5-4 於指標日期前,對於具呼吸道感染相關診斷且具抗生素處方之就診登記痰塗片及分枝桿菌培養監測情形 55
表5-5 Fluoroquinolones於”指標日期前”處方之預測因子 (FQ組vs.Abx組) 61
表5-6 Fluoroquinolones於”指標日期前”處方之預測因子 (FQ組vs.控制組) 63
表5-7 結核病於”指標日期後”fluoroquinolones處方之預測因子 (FQ組 vs. Non-FQ組) 64
表5-8比較FQ vs. Abx組門診診斷患者診斷延遲天數 66
表5-9 針對指標日期前曾接受過痰塗片或分枝桿菌培養之門診診斷患者,分析醫令檢測時間、診斷及藥物治療時間之延遲天數比較 67
表5-10 死亡之危險因子-14,466位患者(1,434人於開始用藥/指標日期後180天內死亡) 70
表5-11 死亡之危險因子-無共病症8,743人(550人於開始用藥/指標日期後180天內死亡) 71

附錄1 Fluoroquinolone全民健康保險給付規定 99
附錄2 WHO(2003)、International standard care of TB(2006)及國內2006出版肺結核病診治指引建議之診斷流程-經驗性抗生素使用時機 (改編) 100
附錄3 抗生素適應症之ICD9-CM (1992) 101
附錄4 Fluoroquinolones使用於結核病治療效果之相關大型研究結果整理 108
附錄5 臨床藥事服務 112


圖目錄
圖5-1 研究結果-定義新確診結核病患者篩選過程 49
圖5-2 FQ組於指標日期前各類fluoroquinolones處方筆數分佈 57
圖5-3 於指標日期前Fluoroquinolones處方適應症、醫院層級以及醫師專科分佈 57
圖5-4 於指標日期前非fluoroquinolones之抗生素品項處方筆數分佈 58
圖5-5 於指標日期前Abx組患者使用抗生素之處方適應症、醫院層級以及醫師專科分佈 58
圖5-6 於指標日期後特定fluoroquinolones處方之醫院層級及科別分佈 59
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