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研究生:黃偉毅
研究生(外文):Huang, Wei-Yi
論文名稱:處方藥品臨床試驗多寡與健保給付後使用量之關係
論文名稱(外文):The Relationship of Volume of Clinical Studies and the Sales Volume of Prescription Drugs after NHIA Reimbursement
指導教授:謝錦堂謝錦堂引用關係
指導教授(外文):Shieh, Jiin-Tarng
口試委員:吳克梁世安謝錦堂
口試委員(外文):Wu, Ko,Liang, Shìh-AnShieh, Jiin-Tarng
口試日期:2017-06-07
學位類別:碩士
校院名稱:國立臺北大學
系所名稱:企業管理學系
學門:商業及管理學門
學類:企業管理學類
論文種類:學術論文
論文出版年:2017
畢業學年度:105
語文別:中文
論文頁數:56
中文關鍵詞:臨床試驗肺腺癌肺癌高血脂症銷售量表皮生長因子接受器酪胺酸激酶抑制劑史他汀
外文關鍵詞:Clinical TrialAdenocarcinomaLung CancerHyperlipidemiaSales VolumeEGFR-TKIsStatins
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本研究目的在於探討臨床試驗的數量與藥物健保給付後使用量的關係。硏究將處方藥物分為專科藥物及一般慢性病藥物,專科藥物選擇了用於治療死亡率最高的癌症-肺腺癌用藥表皮生長因子接受器酪胺酸激酶抑制劑Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor(EGFR-TKI)作為研究對象。一般慢性病藥物選擇了治療高血脂藥物使他作為探討對象。研究結果顯示,針對肺腺癌用藥,臨床試驗數量與健保給付後使用量呈顯著正相關(r=0.722, p=0.000)。降血脂藥物的臨床試驗數量與使用量並未呈現相關性(r=0.189, p=0.376)。本研究存在許多限制,例如可參考的相關文獻非常缺乏,亦未全面考量臨床治療的複雜性。然而,本硏究提供初步的實證,建議藥廠除了專注銷售及行銷外,針對處方用藥,尤其是專科用藥,應考慮投入更多的資源於藥品給付後的臨床試驗上,建立更多證據供臨床醫師處方行為的依據,識別更多病人使用該藥物,從而增加銷售量及營收。
The purpose of this research is to investigate the relationship between the volume of clinical studies and the volume of sales of specialty drugs and common chronic diseases drugs after NHIA (National Health Insurance Administration) reimbursement. For specialty drugs, two Epidermal Growth Factor Tyrosine Kinase Inhibitor(EGFR-TKIs), Iressa and Tarceva for Adenocarcinoma were selected and for common chronic disease, three Statins for hyperlipidemia were selected in this research. We analyzed the relationship between the volume of clinical studies published and their volume sales after reimbursement. The results showed that for specialty drugs, EGFR-TKIs, the volume of clinical studies was significantly correlated with the volume sales(r=0.722, p=0.000) but we found no correlation(r=0.189, p=0.376) for common chronic disease drug Statins .Although there are a lot of limitations of this research, our research suggested that pharmaceutical companies should continue to invest resources in conducting Phase IV clinical studies particularly for specialty drugs, not only for generating evidence for physicians to guide their clinical practices but also generate more consumptions and revenue by expanding more patients suitable for the medications with substantial evidence support.
第一章 緒論 1
第一節 研究背景及動機 1
第二節 研究目的 1
第三節 研究流程 2
第二章 文獻探討 5
第一節 臨床試驗之意義 5
第二節 臨床試驗的經濟效益 5
第三節 藥物臨床試驗的目的與分類 6
第四節 臨床試驗的結果發表 11
第五節 專科用藥及一般慢性病用藥 11
第六節 全民健康保險藥品給付制度 12
第七節 臨床試驗與藥物使用量的關係 12
第三章 研究方法 15
第一節 研究架構及假說 15
第二節 資料來源 16
第三節 硏究變數定義 31
第四節 資料蒐集 32
第五節 資料分析方法 34
第四章 實證分析 35
第一節 描述性分析 35
第二節 假說檢定:相關分析 41
第三節 研究假說結果之彙整 45
第五章 結論及硏究建議 47
第一節 結論 47
第二節 硏究建議 48
第三節 未來研究方向 51
參考文獻 53
著作權聲明 57

一、中文參考文獻
李玟瑾、林宗坤、王筱萍、張澶榮(2010)。血脂異常之藥物處理與降血脂藥物文獻回顧。臺灣臨床藥學雜誌,18,3,79-88。
彭姿蓉、李銘嘉、吳大圩(2015) 。EGFR-TKIs用於晚期非小細胞肺癌。藥學雜誌,31,2,32-37。
蔡佩娟、陳宣雅、張展維、鄭奕帝(2012)。高血脂症的防治觀念與用藥選擇。藥學雜誌,28,1,76-80。
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三、網路參考資料
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李育庭及劉嘉仁(2016)。癌症病人預後的評估工具簡介:存活期、反應率、無病存活期、疾病無惡化存活期是甚麼意思?取自http://cisc.twbbs.org/lib/addon.php?act=post&id=3682
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