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完整後設資料紀錄
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.advisor | 林慧玲(Fe-Lin Lin Wu),何藴芳(Yunn-Fang Ho) | |
dc.contributor.author | Jia-Wen Wu | en |
dc.contributor.author | 吳家雯 | zh_TW |
dc.date.accessioned | 2021-06-13T07:10:40Z | - |
dc.date.available | 2006-01-01 | |
dc.date.copyright | 2005-08-02 | |
dc.date.issued | 2005 | |
dc.date.submitted | 2005-07-26 | |
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dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/35797 | - |
dc.description.abstract | 3-Hydroxy-3-methylglutaryl coenzyme A reductase抑制劑(HMG-CoA reductase抑制劑,簡稱statins)臨床上用於降血脂與預防心血管疾病,一般而言,安全性高且病患耐受度佳。最常見的副作用為腸胃道不舒服、肝指數上升及肌肉酸痛或無力,這些副作用通常輕微,少有導致需停藥的情況。然而,橫紋肌溶解症(rhabdomyolysis)在被報告過的肌肉副作用中,發生率通常不高,但一旦發生卻相當嚴重,且其發生與否與statins類藥品劑量成正相關,這對大多透過Cytochrome P450(CYP)系統代謝的statins而言,容易與同由CYP系統代謝或易影響CYP活性的藥品間產生交互作用,使得statins血中濃度上升而引發橫紋肌溶解的危機。 本研究利用全民健康保險研究資料庫分析statins門診處方型態,及處方中具潛在藥品交互作用之開方情形,另外,在安全性之探討上,則針對橫紋肌溶解的危險率以及肌肉相關副作用發生率做分析。 研究中所使用的為2002年承保抽樣歸人檔,將四組共20萬人一起納入分析。在處方型態分析上有別於以往只著重在單張處方的藥品交互作用,本研究中的藥品交互作用含括同一病患的所有用藥,主要是以人次來表達,並且計算平均年使用日數、平均日劑量、具潛在交互作用藥品併用盛行率及併用時間。利用case-control方式分析有使用statins類藥品的病患發生橫紋肌溶解相對於沒有使用者的危險率。在肌肉相關副作用發生率上,分成五組來分析:無使用statins及fibrates、單用fibrates、單用statins、有併用交互作用藥品、單看併用statins及fibrates交互作用等,以發生副作用病患數為分子,藥品使用時間為分母,計算各組發生率並加以比較。 研究結果顯示,atorvastatin是門診中開方比例最高的藥品,所有statins的平均年使用日數大約120天,交互作用盛行率為18.5 %,有60 %的併用為同位醫師開出。最常被併用的藥品為diltiazem,其次是gemfibrozil,而平均併用時間最長的藥品為cyclosporine,在併用情形下statins的平均日劑量降低的幅度無臨床意義。在病患基本特性上,使用statins病患比起門診有就醫紀錄者年齡明顯偏高,在心血管及內分泌疾病上明顯較多(p < 0.05)。 在使用statins的病患中,並未偵測到發生橫紋肌溶解的病症。而肌肉相關副作用發生率的分析上,在控制了年齡、性別、藥品使用時間、糖尿病、甲狀腺功能低下的因素後,使用statins的病患是未使用者發生副作用的危險性之1.6倍(95 % CI 1.3,1.9;p < 0.0001),甚至使用fibrates的病患之危險性更高(OR 2.7;95 % CI 1.9,3.8;p < 0.0001)。 經由CYP3A代謝的藥品在多種藥品同時併用下容易產生藥品交互作用,本研究中使用率最高的atorvastatin及simvastatin,就是由CYP3A途徑代謝,而研究中所有交互作用,有四成比例非由同一醫師開出,這與病患到處就醫習慣相關,使得醫療人員在交互作用的偵測上更加困難。雖在本研究中未發現橫紋肌溶解的案例,但單獨使用statins類藥品即有增加肌肉相關副作用的危險性,因此在此類藥品的使用上,小心監測及適當衛教相當重要。 在藥品使用安全性的研究上,受限於樣本數太小及研究時距不夠長的問題,未來研究可考慮跨時性研究設計及建議國衛院擴增使用降血脂藥品族群為主題的資料庫。 | zh_TW |
dc.description.abstract | It’s known that 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins for short, are widely used for the treatment of hypercholesterolemia and have demonstrated efficacy for primary and secondary prevention of coronary heart disease (CHD). They are safe and usually well tolerated. The most frequently reported adverse events, including gastrointestinal disturbances, liver enzyme elevation, and muscle pain/weakness, are usually mild and there is almost no need to interrupt the therapy. Nevertheless, rhabdomyolysis is a quite severe adverse effect, though rare, and is related to the dosage of statins. Furthermore, statins are metabolized mainly by CYP system. The risk of rhabdomyolysis will be increased by drugs that share the same metabolic pathway. In this thesis, the prescribing patterns of statins and statin-drug interactions in outpatient are analyzed through the National Health Insurance Research Database in Taiwan. The relative risk of rhabdomyolysis and the incidence rate of mild muscular side effects are also examined. All cohort datasets within year 2002, total 200,000 patients, are included. The statin-drug interactions are analyzed not only on the same prescription but among different prescriptions of a person. The prescribing patterns are expressed in terms of person-time, cumulative using days per year, prescribed daily doses (PDD), the prevalence of potentially severe statin-drug interactions, and the duration of combination use. Using persons not taking statins as a control, a case-control study was performed to exam the relative risk of rhabdomyolysis in patients on statins. As for the incidence rates of mild muscular side effects, five different groups are selected and compared with each other. The rates are calculated by using case numbers as the numerator and time interval of drug used as the denominator. The study shows that atorvastatin was the most frequently prescribed statin. The average cumulative using days per year of statins are about 120 days. The prevalence of statin-drug interactions is 18.5 %, and 60 % of the total interactions are prescribed by the same doctors. Diltiazem and gemfibrozil were the two most frequently prescribed drugs that combined with statins, and cyclosporine is the drug that has the longest duration of combination. PDDs of statins in combination was not significant different from those in single use. Patients on statin therapy are much older than the general population and have higher incidence of underlying circulatory and endocrine diseases (p < 0.05). In this study, no of rhabdomyolysis was detected in statin users. After controlling the predisposing factors such as age, gender, duration for exposing to drug, DM and hypothyroidism, the incidence of mild muscular side effects for statin users was 1.6 times (95 % CI 1.3, 1.9; p < 0.0001) of those not using statins, and the odds ratio in fibrate users was even higher (OR 2.7; 95 % CI 1.9, 3.8; p < 0.0001). Drug-drug interactions easily occur for drugs metabolized via CYP3A isoenzyme under polypharmacy. Atorvastatin and simvastatin that are metabolized by CYP3A, are the two most frequently prescribed statins in our research. Around 40 % of interactions are difficult to detect due to patients’ habits of doctor shopping. Although there is no rhabdomyolysis was detected in our study in patients using statins, statin’s monotherapy increased the risk of muscular side effects. It is important to monitor the use of statins and provide proper patient education. Small sample size and short duration to follow up are the limitations of this study. That National Health Research Institutes (NHRI) set a new database of patients on lipid lowering drugs and further longitudinal studies on the use of statins are recommended. | en |
dc.description.provenance | Made available in DSpace on 2021-06-13T07:10:40Z (GMT). No. of bitstreams: 1 ntu-94-R92451007-1.pdf: 765059 bytes, checksum: d8884c63172fba891b2ac8d2e083e7ca (MD5) Previous issue date: 2005 | en |
dc.description.tableofcontents | 目錄 目錄 I 表目錄 XIII 圖目錄 XVII 第一章 前言 1 第二章 文獻探討 3 第一節 HMG-CoA Reductase抑制劑之臨床用途及療效 3 第二節 HMG-CoA Reductase抑制劑之不良反應 9 第三節 Statins類藥品之藥動學特性 15 第四節 藥品交互作用 17 第五節 肌肉毒性發生率 21 第三章 研究目的 27 第四章 研究材料及方法 28 第一節 研究材料 28 第二節 研究藥物選擇流程 30 第三節 欲研究之藥品交互作用組合 33 第四節 分析方法及流程 34 第五節 資料處理與分析 46 第五章 研究結果 47 第一節 含潛在不良藥品交互作用組合之Statins處方分析 47 第二節 Statins類藥品與橫紋肌溶解相關性分析 66 第三節 使用Statins患者之肌肉痛或肌炎發生率探討 67 第六章 討論 69 第一節 研究限制 69 第二節 Statins類藥品與其他具潛在不良交互作用藥品併用盛行率之研究比較 73 第三節 藥品併用合理性探討及相關建議 78 第四節 病患就醫行為 84 第五節 Statins使用安全性探討 85 第六節 肌肉相關副作用發生率 91 第七章 未來研究方向 95 參考文獻 96 附錄 106 表目錄 表2-1-1 Statins用於初級預防心血管疾病上的臨床試驗 7 表2-1-2 Statins用於次級預防心血管疾病上的臨床試驗 8 表2-2-1 Statins主要副作用的位置與臨床表現 9 表2-2-2 Statins肌肉及肝臟副作用發生率 10 表2-2-3 肌肉不良反應的臨床分類 12 表2-2-4增加Statins引起肌肉毒性危險性的因素 13 表2-3-1 Statins類藥品之藥品動態學特性比較 16 表2-4-1 與Statins類藥品代謝有交互作用的藥品 19 表2-5-1 美國因使用Statins造成的橫紋肌溶解症的回報率(每百萬張處方) 24 表2-5-2 使用降血脂藥物造成橫紋肌溶解症的發生率(/10,000人-年) 25 表2-5-3 FDA通報橫紋肌溶解案例併用藥品名稱和比例 26 表4-2-1 Drug Interaction Facts交互作用顯著性定義 30 表4-3-1 欲研究之藥品交互作用組合 33 表5-1-1 2002年Statins門診處方型態比較 48 表5-1-2 Statins處方中含潛在不良藥品交互作用組合之分析 48 表5-1-3 各個具潛在性交互作用藥品所佔的比例 52 表5-1-4 各種藥品交互作用組合所佔的比例 53 表5-1-5 各個具潛在性交互作用藥品平均併用時間 54 表5-1-6 併用兩種以上具交互作用可能性的藥品組合 55 表5-1-7 併用交互作用藥品或交互作用藥品為同醫師開方情形下的Statin日平均開方劑量 56 表5-1-8 各群體間病患的性別-年齡分佈 58 表5-1-9 各群體間病患的診斷比較(1) 60 表5-1-10 各群體間病患的診斷比較(2) 61 表5-1-11 各群體間病患的診斷比較(3) 62 表5-1-12 無使用Statins對照組與使用Statins者的診斷差異 64 表5-1-13 單獨使用Statins與DDI使用者的診斷差異 65 表5-3-1 各組別肌肉相關副作用發生率 67 表6-2-1 本研究與R auml;tz Bravo研究之設計與研究藥品比較 73 表6-2-2 本研究與R auml;tz Bravo之研究結果比較 75 表6-3-1 Statins與Fibrates併用治療的優劣分析 79 表6-3-2 Statins及Fibrates宜避免併用的臨床狀態 81 表6-3-3 本身生理狀態容易造成肌肉不良反應暫時不適合使用Statins 83 表6-5-1 Statins類藥品的使用時距與劑量:本研究與美國FDA通報系統資料比較 88 圖目錄 圖2-1-1 Statins類藥品的作用機轉 4 圖2-1-2 Statins降低膽固醇合成誘導肝臟LDL受體表現及合成增加 5 圖4-2-1 與Statins類藥品具潛在不良交互作用之藥品選擇流程 32 圖4-4-1 Statins處方型態研究流程 36 圖4-4-2 使用潛在會發生不良反應的藥品交互作用對的資料庫分析流程 38 圖4-4-3 橫紋肌溶解案例的選取流程 42 圖4-4-4 控制組選取流程 43 圖5-1-1 2002年各Statins門診處方張數佔率及使用人次佔率 51 圖5-1-2 各Statins交互作用人次數及盛行率 51 圖5-1-3 各個具潛在性交互作用藥品所佔的比例 52 圖5-1-4 各群體間病患的年齡分佈圖 59 圖5-1-5 各群體間病患的性別比例圖 59 圖5-2-1 橫紋肌溶解案例選取結果 66 | |
dc.language.iso | zh-TW | |
dc.title | 全民健康保險研究資料庫HMG-CoA Reductase Inhibitors處方型態及用藥安全性分析:自藥品交互作用觀點探討 | zh_TW |
dc.title | Prescribing Patterns and Safety of HMG-CoA Reductase Inhibitors Usage within National Health Insurance Research Database: A Drug-Interaction Approach | en |
dc.type | Thesis | |
dc.date.schoolyear | 93-2 | |
dc.description.degree | 碩士 | |
dc.contributor.advisor-orcid | ,何藴芳(yfho@ntu.edu.tw) | |
dc.contributor.oralexamcommittee | 于明暉,高雅慧 | |
dc.subject.keyword | 全民健康保險研究資料庫,健保資料庫,處方型態,藥品交互作用,交互作用,降血脂, | zh_TW |
dc.subject.keyword | HMG-CoA reductase inhibitors,statins,prescribing patterns,National Health Insurance Research Database,drug interactions, | en |
dc.relation.page | 109 | |
dc.rights.note | 有償授權 | |
dc.date.accepted | 2005-07-27 | |
dc.contributor.author-college | 醫學院 | zh_TW |
dc.contributor.author-dept | 臨床藥學研究所 | zh_TW |
顯示於系所單位: | 臨床藥學研究所 |
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