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研究生:羅珮嘉
研究生(外文):Pei-Chia Lo
論文名稱:台灣小兒氣喘中西藥交互作用之世代研究
論文名稱(外文):The Herb-Drug Interaction among Children with Asthma in Taiwan: A Population-Based Nationwide Cohort Study
指導教授:賴榮年賴榮年引用關係傅淑玲傅淑玲引用關係
指導教授(外文):Jung-Nien LaiShu-Ling Fu
學位類別:碩士
校院名稱:國立陽明大學
系所名稱:傳統醫藥研究所
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:2016
畢業學年度:104
語文別:中文
論文頁數:87
中文關鍵詞:小兒氣喘非固醇類解熱鎮痛抗發炎藥物中醫中西藥交互作用健保資料庫
外文關鍵詞:Childhood AsthmaNSAIDsTraditional Chinese MedicineHerb-Drug InteractionNational Health Insurance Research Database
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前言:
全球18歲以下氣喘兒的盛行率約佔12.0%,而台灣地區18歲以下氣喘兒的盛行率自2002年的13.0% 逐年增加到2008年的16.9%。在過去的研究發現,某些藥物會誘導氣喘發作,屬於氣喘發作的危險因子,例如西藥阿斯匹靈 (aspirin)、非固醇類解熱鎮痛抗發炎劑 (NSAIDs) 等等。同時,某些氣喘兒的家長除了使用西藥外,亦會尋求中醫治療,而中藥對於治療氣喘的安全性目前尚未建立完整的評估,因此,本研究之目的即在(一)探討氣喘兒使用非固醇類解熱鎮痛抗發炎藥物與氣喘發作之相關性,以及(二)探討中藥與西藥合併治療氣喘兒與氣喘住院風險之相關性。

研究方法:
本研究為使用國家衛生研究院所釋出的全民健康保險資料庫中,2005年百萬歸人檔為研究對象。本研究分為兩部分,均為使用回溯性世代研究之方法,研究門診有三次以上氣喘診斷碼之小於等於18歲以下氣喘人口族群。在研究部分(一)使用此族群之1997-2012年期間所有門診、住院病歷及藥物使用記錄,並將族群分為合併使用治療氣喘藥物與非固醇類解熱鎮痛抗發炎藥物族群 (研究組),與單純使用治療氣喘藥物族群 (參考組),使用相對危險 (Relative Risk, RR) 計算方式,研究這兩個族群在研究期間的氣喘住院風險,以及使用邏輯式迴歸分析計算氣喘住院前1-2天內最常使用之非固醇類解熱鎮痛抗發炎藥物。在研究部份(二)中,使用此族群之2000-2012年期間所有門診、住院及藥物使用記錄,並且將族群分為曾使用中藥大於等於30天以上之族群 (traditional Chinese menicine users, TCM users) 以及未曾或使用中藥小於30天以內族群 (Non TCM users) 後,並經過校正兩組之年齡、性別、投保地區、共病型態和使用治療氣喘藥物種類後,研究兩組在觀察期間其氣喘住院風險的風險比 (adjusted Hazard Ratio, aHR)。

研究結果
在研究部份(一)當中發現,共有29,484位符合條件之患者,合併使用非固醇類解熱鎮痛抗發炎藥物與治療氣喘藥物的族群 (研究組) 共有9,862位 (33.4%),而單純使用治療氣喘藥物的族群 (參考組) 共有19,622位 (66.6%)。研究結果亦發現,研究組比起參考組,有顯著較高氣喘住院率 (RR: 1.35, 95% CI: 1.30–1.41)。經校正所有NSAIDs藥物後,發現與氣喘住院相關之前三名非固醇類解熱鎮痛抗發炎藥物分別為aspirin (阿斯匹靈)、ibuprofen以及diclofenac這三個藥物。其中又以ibuprofen累積使用7-365天與氣喘住院風險有正相關 (aOR: 1.53-1.54, 95% CI:1.01-2.33)。
在研究部份(二)當中發現,共有33,865名符合條件之患者,其中曾使用中藥的患者 (TCM users) 為14,783位 (43.6%),未曾使用中藥的患者 (Non TCM users) 為19,082位 (56.4%)。使用TCM患者的族群型態分布為:性別以女生居多,年齡層較大,地區則以中台灣、高雄縣市、南台灣使用中藥的比例較多。共病部分,氣喘合併有過敏性鼻炎、急性支氣管炎、或急性鼻竇炎、或胃食道逆流、或蕁麻疹的患者使用中藥的比例較高。治療氣喘藥物方面,TCM users組使用較多種治療氣喘藥物。經校正性別、年齡、共病和使用西藥氣喘藥物的種類後,TCM組有較低的氣喘住院風險 (aHR:0.90, 95% CI:0.83-0.95),且初次診斷氣喘年齡為6歲以上的患者使用中藥累積達180天以上,可降低後續氣喘住院風險達29% (aHR: 0.71, 95% CI:0.51-0.98)。

結論:
本研究發現在氣喘兒使用非固醇類解熱鎮痛抗發炎藥物,與氣喘住院風險有正相關性。短期使用aspirin (阿斯匹靈)、ibuprofen以及diclofenac這三個藥物增加氣喘兒住院的風險,而進一步分析發現,長期使用ibuprofen大於7-365天更有增加氣喘兒氣喘住院之風險;此外,中西藥合併使用在治療氣喘兒無增加氣喘住院風險,具有安全性。且分層分析顯示,中西藥合併使用治療6歲以上氣喘兒有降低後續氣喘住院之風險。


Introduction
The prevalence of childhood asthma under 18 years old is 12% worldwide, and the prevalence rate of childhood asthma in Taiwan increased year by year from 13.0% in 2002 to 16.9% in 2008. According to the past research, a proportion of medication induced asthma exacerbation, such as aspirin or NSAIDs. On the other hand, some parents seek traditional Chinese medicine (TCM) to help their children to relieve asthma symptoms. The safety and efficacy of TCM in treating childhood asthma has not been established, therefore, the aim of the study is to (1) investigate the relationship between NSAIDs and asthma exacerbation in children (2) investigate the relationship between integration of Western medicine and TCM and asthma-related hospitalization in children with asthma.

Methods
The study population included one million randomized people enrolled in the year 2005 from the National Health Insurance Research Database (NHIRD) in Taiwan. The research contains two parts. Both the study designs were conducted retrospective cohort study, and population aged less than 18 years old and having at least three times confirmed diagnosis by physicians were enrolled. In the research Part 1, all the medical records from 1997 to 2012 were researched, and the study populations were divided into groups of concurrently using NSAIDs with anti-asthmatic drugs (index group), and only using anti-asthmatic drugs (reference group). The start of the observation date was the first diagnosis date of asthma and the endpoint was either the date that patients were hospitalized with asthma initially or the date of last medical visit before December 31, 2012. The Relative Risk was used to estimate the risk of asthma-related hospitalization in the two groups, and logistic regression model was used to ananlyze the most frequently prescribed NSAIDs in 1-2 days prior to asthma-related hospitalization. In the research Part 2, we conducted a retrospective cohort study with the population who was diagnosed with asthma at the age less than 18 years old, indeed, at least three times confirmed diagnosis by physicians were enrolled. The medical records from 2000 to 2012 were researched, and we divided the study population into group of using TCM more than 30 days (traditional Chinese medicine, TCM users), and group of using TCM less than 30 days or without using TCM (Non TCM users). After adjustment for gender, age, comorbidities and types of asthma medication, the risk of asthma-related hospitalization in the two groups were estimated by using Cox proportional hazards model.

Results
In research Part1, among total 29,484 patients, 19,622 (66.6%) patients used anti-asthmatic agents alone (reference group), while 9,862 (33.4%) patients used anti-asthmatic agents concurrently with NSAIDs (index group). Index group had more asthma-related hospitalization (RR: 1.35, 95% CI: 1.30–1.41). After adjusting for NSAIDs, we found that aspirin, ibuprofen, and diclofenac posed certain risks with regard to asthma-related hospitalization, and exposure to ibuprofen in 7 to 365 days had positive correlation to asthma-related hospitalization (aOR: 1.53-1.54, 95% CI:1.01-2.33). In research Part2, among the total 33,685 patients, 14,783 (43.6%) were TCM users, and 19,082 (56.4%) patients were non-TCM users. The TCM users were mostly girls in gender, and the age distribution were older than non-TCM users, and higher percentage was found living in central Taiwan, Kaohsiung city, and southern Taiwan. In the aspect of cormobidity, patients combined with allergic rhinitis, acute bronchitis, sinusitis, gastroesophageal reflux disease, or urticaria are prone to use TCM combination therapy. After adjustment for gender, age, cormobidities and types of asthma medication, TCM therapy had a lower risk of asthma-related hospitalization in comparison with non-TCM therapy (aHR:0.90,95% CI: 0.83-0.95). Moreover, children older than 6 years of age using TCM therapy more than 180 days had a 29% reduction in the asthma-related hospitlaization consequently (aHR:0.71,95% CI:0.51-0.98).

Conclusion
NSAIDs have positive correlation with asthma-related hospitalization in children, especially ibuprofen, diclofenac, and aspirin. Furthermore, long-term exposure to ibuprofen of 7 to 365 days increased the risk for asthma-related hospitalization. On the other hand, integration of Western medicine and TCM in treating children with asthma was safe and did not increase the risk of asthma-related hospitalizaion. Moreover, using TCM combination therapy in children older than 6 years of age decreased the risk of subsequent asthma-related hospitalization.


目錄
誌謝 i
中文摘要 iii
Abstract vi
目錄 x
圖目錄 xii
表目錄 xiii
第一章 小兒氣喘之文獻探討 1
第一節 小兒氣喘的流行病學 1
第二節 小兒氣喘的定義、病理及分類 2
第三節 小兒氣喘的西醫診斷與治療 4
第四節 小兒氣喘的中醫典籍文獻回顧與治療 9
第五節 台灣使用健保資料庫研究小兒氣喘之文章彙整與分析 13
第二章 小兒氣喘與西藥非固醇類解熱鎮痛抗發炎藥物危險因子的探討 16
第一節 研究動機與目的 16
第二節 研究方法 18
第三節 資料處理及步驟 23
第四節 研究結果 29
第五節 討論 40
第三章 小兒氣喘使用中藥之族群分析及與氣喘住院之相關性分析 46
第一節 研究動機與目的 46
第二節 研究方法 47
第三節 資料處理及步驟 50
第四節 研究結果 56
第五節 討論 70
第四章 結論與建議 77
第一節 氣喘兒童使用西藥NSAIDs安全性之建議 77
第二節 氣喘兒童使用中藥之建議 78
參考文獻 81
附錄 86
附錄一 投稿北台灣中醫醫學雜誌 86
附錄二 2015亞洲藥學院校聯合大會(AASP)壁報論文 87

圖目錄
圖 1 小兒氣喘與非固醇類解熱鎮痛抗發炎藥物危險因子的探討之研究流程 19
圖 2 小兒氣喘使用中藥之族群分析及與氣喘住院之相關性分析之研究流程 48
圖 3 年齡6-18歲氣喘兒使用中藥累積天數與氣喘住院風險之相關性 67

表目錄
表 1 五歲以內臨床診斷為小兒氣喘的特徵 5
表 2 氣喘症狀的控制程度 6
表 3 小於五歲孩童氣喘的升降階梯治療 7
表 4 大於五歲孩童及成人氣喘的升降階梯治療 8
表 5 近5年健保資料庫研究兒童氣喘使用中醫藥情形之論文 14
表 6 本研究所使用之所有國際疾病分類號(ICD-9 code) 20
表 7 本研究治療氣喘藥物以及非固醇類解熱鎮痛抗發炎藥物(NSAIDs)清單 21
表 8 研究組與參考組之族群型態分布 30
表 9 研究組與參考組之氣喘住院相對風險 32
表 10 研究組與參考組之氣喘住院及氣喘急診之相對風險(分層) 33
表 11 所有氣喘住院兒童住院前最常使用之NSAIDs藥物排名 34
表 12 研究組與對照組之氣喘住院兒童住院前使用NSAIDs情況 36
表 13 研究組中有氣喘住院患者與非氣喘住院患者累積使用NSAIDs情況 38
表 14 含有麻黃成份之單方及複方中藥品項 54
表 15 中藥組與非中藥組之族群型態分布及校正後之勝算比 57
表 16 中藥組與非中藥組之氣喘分類和氣喘用藥及校正之勝算比 58
表 17 中藥組與非中藥組之共病型態及校正之勝算比 59
表 18 氣喘兒童使用中醫之診斷分類 60
表 19 氣喘兒就診中醫最常被開立之中藥複方 61
表 20 兒童性別、年齡、共病總數、氣喘藥種類總數和氣喘住院風險相關性 63
表 21 氣喘兒使用氣喘藥物與使用中藥和氣喘住院風險之相關性 64
表 22 氣喘兒性別年齡分布與使用中藥和氣喘住院風險之相關性 65
表 23 氣喘兒童使用中藥之累積天數和氣喘住院風險之相關性 66
表 24 氣喘兒使用麻黃類中藥藥物和氣喘住院風險之相關性 68
表 25 氣喘兒使用麻黃類中藥藥物不同劑量和氣喘住院風險之相關性 69


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