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研究生： 張雅淳
Chang, Ya-Chuan
論文名稱： 小兒氣喘使用類固醇與長效乙二型擬交感神經作用劑複方吸入製劑之處方評估
Drug Utilization Evaluation of Inhaled Corticosteroid and Long-Acting Beta2 Adrenergic Agonist Combination Therapy in Asthma Children
指導教授： 高雅慧
Kao, Yea-Huei
許美英
Shu, May-Ying
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： 2011
畢業學年度： 99
語文別： 中文
論文頁數： 119
中文關鍵詞： 氣喘 、小兒 、適當性 、吸入式類固醇 、長效乙二型擬交感神經作用劑
外文關鍵詞： Asthma, pediatric, appropriateness, inhaled corticosteroid, long-acting beta2 adrenergic agonist
相關次數： 點閱：159  下載：33 
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    • 研究背景
    根據全球氣喘創議組織 (GINA, Global Initiative for Asthma)的氣喘診療指引，患有輕度氣喘的小兒病患，應給予ICS (Inhaled Corticosteroid)做為第一線治療，並依臨床氣喘控制情況做升階、降階調整藥物使用。美國FDA在2006年公佈LABA (Long-Acting Beta2 Adrenergic Agonist)可能會發生嚴重的氣喘發作，臺灣行政院衛生署也發布新聞稿，提醒使用含 LABA成分藥品之用藥安全，食品藥物管理局呼籲該等成分藥品可能會增加氣喘相關死亡風險。因此各國診療指引與FDA都建議當氣喘控制不佳而惡化成中、重度氣喘時，才加上LABA，以增進疾病控制。
    根據美國及加拿大的研究顯示，不到40%氣喘病患在開始使用ICS/LABA之複方吸入製劑之前，給予ICS做治療，顯示大於60%病患並未依照診療指引給予適當用藥。臺灣部分目前尚未有氣喘小兒使用ICS/LABA之類似研究。因此本研究旨在探討臺灣氣喘孩童使用ICS/LABA之處方型態分析，了解小兒氣喘使用ICS/LABA適當性，並探討影響藥品適當性的因素。
    研究方法
    以2006年至2007年的國內十八歲以下就醫資料之全民健康保險資料庫，研究對象為臺灣小兒氣喘族群，於2007/01/01至12/31曾接受過一次以上BFC或FSC處方者，以第一次使用BFC或FSC為指標日期，利用指標日期往前回推一年，以評估病患使用BFC或FSC是否適當，並探討影響適當性的因素。
    研究結果
    2007年有6,631人第一次使用BFC或FSC，平均年齡為7.3歲 (SD=4.31)，性別部分男生有4,118人 (62.10%)、女生有2,513人 (37.90%)，複方吸入製劑部分：使用BFC的有1,120人 (16.89%)、使用FSC的有5,511人 (83.11%)。經過適當性評估後，研究族群中有4,137人 (62.39%)屬於適當組、2,494人屬於不適當組 (37.61%)。若在「曾經處方過口服類固醇 (OCS, Oral Corticosteroid)」之適當性條件中增加氣喘診斷之條件，則本研究發現47.73%的研究族群屬於適當組，而有52.27%則屬於不適當組。
    適當性條件中，以口服類固醇使用情況最多，其次為曾經處方過吸入式類固醇，有1,189人 (17.93%)。不適當族群之處方型態以緩釋型xanthine為最常見的氣喘控制型用藥、其次為LTRA (Leukotriene Receptor Antagonist)。影響適當性之可能因素有年齡、科別、共病症的有無、區域和指標醫院層級。
    結論
    本研究發現62.39%的研究族群在使用ICS/LABA複方吸入製劑前的過去一年間，符合適當性條件，而有37.61%的研究族群在使用ICS/LABA複方吸入製劑前，沒有依照治療指引使用ICS，也沒有臨床中、重度氣喘的證據。
    若在曾經處方OCS之適當性條件中增加氣喘診斷之條件，則本研究發現47.73%的研究族群屬於適當組，而有52.27%則屬於不適當組。
    此結果和美國、加拿大研究結果相似，顯示ICS/LABA複方吸入製劑可能提前在使用輕度氣喘病人身上，與GINA或NAEPP (National Asthma Education and Prevention Program)等氣喘診療指引所建議不相同。
    臨床藥事服務
    因應院內自2月10日起舊品項Spiriva用罄後啟用新品Spiriva® Respimat®開方使用，配合胸腔科門診於內科診間進行臨床藥事服務，針對新使用tiotropium inhalation (Spiriva® Respimat®)病患做吸入器用藥衛教，包含使用方式、保養與更新。
    關鍵字：氣喘、小兒、適當性、吸入式類固醇、長效乙二型擬交感神經作用劑

    Backgrounds
    Asthma is a problem worldwide. According to National Institutes of Health and GINA (Global Initiative for Asthma) guidelines, the preferred long-term control medications for persistent asthma are ICSs. Addition of a long acting beta 2-adrenergic agonist to an ICS is the preferred treatment option for patients with moderate or severe persistent asthma not adequately controlled on previous medications, with high impairment, or at high risk for an asthma exacerbation.
    FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma. Department of Health,Taiwan also issued a press release to remind the drug safety of pharmaceutical composition containing LABA, the Taiwan Food and Drug Administration also mentioned these ingredients may increase the risk of asthma-related death.
    Results from retrospective claims-based studies in the U.S. and Canada showed that less than 40% of patients started on ICS/LABA therapy had evidence of previous ICS use, in other words, ICS/LABA combination therapy was not used in accordance with guidelines in more than 60% of patients. The information about the appropriate use with ICS/LABA is unavailable in Taiwan. Therefore, this study was aimed to investigate utilization of ICS/LABA, examined the appropriateness of initiation of ICS/LABA combination therapy , and analyse the factors that affect the appropriateness.

    Methods
    We use National Health Insurance Research Database of about 1800,000 insurees. Data from January 1, 2006, to December 31, 2007, were used in the study. The study population included pediatric patients (<18 year-old) who initiated fluticasone/salmeterol (FSC)or budesonide/formoterol (BFC) combination therapy in 2007. Use was considered appropriate if patients met any of the criteria during a 1-year period before ICS/LABA initiation. Factors associated with appropriate initiation of ICS/LABA therapy were assessed.

    Results
    We identified 6,631 patients who met the inclusion criteria for the study in 2007, the mean age was 7.3 years (SD=4.31)and 4,118 (62.1%) patients were male. Of the 6,631 patients, 1,120 (16.9%) were assigned to the BFC therapy group, and 5,511 (83.1%) were assigned to the FSC therapy group. Based on the preindex indicators, 4,137 patients (62.4%) met ≧ 1 criterion for appropriate initiation of ICS/LABA therapy, and 2,494 (37.6%) were considered inappropriate candidates for initiating ICS/LABA combination therapy.
    With respect to the appropriate group, “≧1 pharmacy claim for OCS” (3,670 patients, 55.4%), “≧1 pharmacy claim for OCS with asthma” and ICS (1,189 patients, 17.9%) are the most frequently indicators, respectively. As for the inappropriate group, sustained-release theopylline and LTRA (Leukotriene Receptor Antagonist) were the most frequently monotherapy. Factors associated with appropriate use included age, prescriber specialty, comorbidity, region and hospital level.

    Conclusions
    Our study found out that ICS/LABA combination therapies are being prescribed appropriately in 62.39% of study population, and 37.61% of patients started on ICS/LABA therapy had no evidence of previous ICS use and moderate to severe asthma, consistent with the results from Canada and U.S. Results from our study revealed that ICS/LABA therapy is prescribed earlier, and ICS/LABA prescribing was inconsistent with GINA or NAEPP asthma guidelines.

    Key words：Asthma, pediatric, appropriateness, inhaled corticosteroid, long-acting beta2 adrenergic agonist.

    目錄 中文摘要 i Abstract iii 誌謝 vi 目錄 viii 表目錄 xiii 圖目錄 xv 縮寫名稱與全名對照表 xvi 第一篇、小兒氣喘使用類固醇與長效乙二型擬交感 神經作用劑複方吸入製劑之處方評估 1 第一章 、研究背景 1 第二章 、文獻回顧 2 第一節 、氣喘 2 一 、定義 2 二 、臺灣流行病學研究 2 三 、診斷與嚴重程度分級[4, 5, 27, 28] 5 第二節 、氣喘的治療[29] 7 一 、以噴霧方式 (Aerosol delivery)給藥 7 二 、氣喘的藥物藥理分類[29] 8 三 、氣喘的治療概念[4, 5, 27] 13 第三節 、氣喘使用類固醇與長效乙二型擬交感神經作用劑複方吸入製劑之處方評估 17 一 、類固醇與長效乙二型擬交感神經作用劑複方吸入製劑使用建議 17 二 、長效乙二型擬交感神經作用劑 18 三 、類固醇與長效乙二型擬交感神經作用劑複方吸入製劑之使用適當性相關研究 22 四 、結論 24 第三章 、研究目的及重要性 26 一 、研究目的 26 二 、重要性 26 第四章 、研究方法 27 第一節 、研究設計 27 一 、研究類型 27 二 、研究材料及工具 27 三 、納入條件 29 四 、排除條件 29 五 、基本資料、分組、處方型態 30 六 、研究流程 31 第二節 、研究變相與操作定義 34 一 、研究對象與研究藥品之定義 34 二 、研究族群基本資料之定義 36 三 、適當性與處方型態之定義 37 第三節 、資料處理流程 42 第四節 、統計資料分析 43 一 、統計工具 43 二 、統計模式設定 43 三 、統計資料分析 43 第五章 、研究結果 44 第一節 、研究對象納入、排除 44 第二節 、研究族群基本資料 46 第三節 、臨床嚴重程度與適當性評估 51 一 、適當性評估結果 51 二 、適當條件的符合情況 52 三 、不適當族群之處方分析 52 四 、適當組與不適當組之基本資料比較 53 第四節 、影響適當性之因素 61 一 、單變項分析 61 二 、多變項分析 63 第六章 、研究討論 67 第一節 、研究對象的納入、排除及分組討論分析 67 一 、資料庫與指標前期間的設定 67 第二節 、研究對象基本資料之分析 68 一 、年齡與性別 68 二 、指標藥品被處方情況 70 三 、指標藥品之劑量 72 第三節 、適當性之分析 73 一 、ICS使用情況 73 二 、ICS/LABA使用適當性 73 三 、不適當組之藥品分析 77 第四節 、影響適當性的因素 79 一 、年齡 79 二 、指標藥品 79 三 、就診科別 80 四 、共病 81 五 、醫院層級 82 第五節 、研究限制 83 第七章 、結論與建議 84 第八章 、未來研究方向 85 第二篇 臨床藥事服務 86 第一章 、前言 86 第二章 、服務目的與服務方法 88 第一節 、服務目的 88 第二節 、服務方法 88 一 、篩選病人方式 88 二 、衛教地點 88 三 、衛教時間 89 四 、衛教工具 89 五 、工具與資料來源 89 第三節 、照會方式與衛教流程 90 第三章 、衛教內容 91 第四章 、衛教結果 96 第一節 、病患基本資料 96 第二節 、Spiriva® Respimat®吸入器使用後病人常見問題 100 一 、裝填 100 二 、使用前準備 101 三 、使用方式 102 四 、保養與更換 103 五 、其他問題 104 第三節 、其他吸入器衛教 105 第五章 、心得與感想 106 參考資料 108 附錄一、吸入器正確使用方式 114 附錄二、Fenoterol (Berotec®)衛教單張 115 附錄三、FSC (Seretide® 50,250 Evohaler)衛教單張 116 附錄四、FSC (Seretide® 250 Accuhaler)衛教單張 117 附錄五、BFC (Symbicort® Turbuhaler®)衛教單張 118 作者簡介 119 表目錄 第一篇、小兒氣喘使用類固醇與長效乙二型擬交感神經作用劑複方吸入製劑之處方評估 Table 2-1-1 Self-reported prevalence and severity of asthma in Taiwan. [3, 24, 26] 4 Table 2-1-2 Classify Asthma Severity[4] 6 Table 2-2-1 GINA Recommended medication by level of severity(1) 15 Table 2-2-2 GINA Recommended medication by level of severity(2) 16 Table 2-3-1 SMART Results 20 Table 2-3-2 美國FDA與臺灣衛生署核可，含有LABA之吸入劑藥品 21 Table 2-3-3 ICS/LABA複方吸入製劑之處方分析[8, 10] 24 Table 2-3-4 ICS/LABA複方吸入製劑之使用適當性相關研究 (皆為美國發表) 25 Table 4-1-1 各檔案間串檔變項說明 27 Table 4-2-1 本研究相關疾病診斷碼 (ICD-9-CM) 38 Table 4-2-2 臺灣各縣市所屬區域 39 Table 4-2-3 氣喘相關藥品與ATC代碼對照 40 Table 5-2-1 研究族群基本資料 48 Table 5-2-2 指標藥品使用情況 50 Table 5-3-1 適當性評估與結果 54 Table 5-3-2 適當性評估與結果 (伴有氣喘診斷) 54 Table 5-3-3 不適當組之氣喘處方分析 56 Table 5-3-4 適當組與不適當組之基本資料比較 (不含氣喘診斷) 57 Table 5-3-5 適當組與不適當組之基本資料比較 (含氣喘診斷) 59 Table 5-4-1 影響適當性之因素 (不含氣喘診斷) 65 Table 5-4-2 影響適當性之因素 (含氣喘診斷) 66 Table 6-2-1 本研究與Friedman, 2009適當性研究之平均年齡比較 69 Table 6-2-2 本研究與其他適當性研究之性別比較 69 Table 6-2-3本研究與其他適當性研究之指標藥品處方情況 71 Table 6-2-4 指標藥品在各國上市時間 71 Table 6-2-5 指標藥品的吸入劑劑型選擇 71 Table 6-3-1本研究與其他適當性研究之ICS處方情況 75 Table 6-3-2本研究與其他適當性研究結果比較 75 Table 6-3-3 Frideman等人與本研究之適當性條件結果比較 76 Table 6-3-4 Frideman等人與本研究之不適當組之藥品分析結果比較 78 Table 6-4-1 美國研究各科別影響適當性結果之比較 80 第二篇、臨床藥事服務 Table 1-1-1 各種吸入器外觀 87 Table 2-1-1 成大醫院胸腔內科門診時間表 89 Table 3-1-1 藥品衛教單張 (Spiriva® Respimat®) 92 Table 3-1-2 Spiriva® Respimat®衛教記錄表 95 Table 4-1-1 病患基本資料 97 Table 4-1-2 吸入器學名與商品名對照 97 Table 4-2-1 衛教後病人常發生問題之次數 (以步驟分類) 100 Table 4-3-1 其他吸入器衛教記錄表 105 圖目錄 第一篇、小兒氣喘使用類固醇與長效乙二型擬交感神經作用劑複方吸入製劑之處方評估 Figure 4-1-1 研究流程 32 Figure 4-2-1 指標前期間 39 Figure 4-2-2 指標前期間之醫院層級分類方式 39 Figure 5-1-1 研究對象納入、排除情況 45 Figure 5-3-1 處方SABA之累積劑量與人數分佈 55 Figure 5-3-2 適當條件數與符合人數 55 第二篇、臨床藥事服務 Figure 2-3-1 胸腔科門診衛教照會單 90 Figure 4-1-1 病人教育程度 98 Figure 4-1-2 衛教對象 98 Figure 4-1-3 同使使用其他吸入器品項與人數 99 Figure 4-1-4 每週衛教人數趨勢圖 99

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