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研究生:毛乾泰
研究生(外文):MAO CHIEN TAI
論文名稱:藥物引起嚴重皮膚不良反應之相關因素及醫療耗用探討
論文名稱(外文):The Factors Associated with Severe Cutaneous Adverse Drug Reactions and the Subsequent Medical Consumptions
指導教授:許光宏許光宏引用關係
指導教授(外文):HSU KUANG HUNG
學位類別:碩士
校院名稱:長庚大學
系所名稱:醫務管理學研究所
學門:商業及管理學門
學類:醫管學類
論文種類:學術論文
論文出版年:2007
畢業學年度:95
語文別:中文
論文頁數:109
中文關鍵詞:嚴重皮膚不良反應醫療耗用高危險群
外文關鍵詞:Severe Cutaneous Adverse Drug ReactionsMedical
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藥物引起嚴重皮膚不良反應,如多形性紅斑、史帝芬-強生症候群及毒性表皮壞死溶解症,屬於急性嚴重的皮膚及黏膜不良反應,嚴重者會致命,不僅影響病人安全也增加醫療耗用,藉由此次研究結果,可做為醫護人員及醫院管理者之臨床治療及政策制定的參考。
本研究以回溯性分析臺灣北部某醫學中心西元2004-2005年間住院病患,總住院人次共255,219之健保申報檔案,符合ICD-9-CM 695.1之病人,共196例,其嚴重皮膚不良反應與藥物的關連性,以多變量模型分析其危險因子,並推論所導致的醫療耗用。
結果顯示,多形性紅斑的致病因素以感染為主,史帝芬-強生症候群及毒性表皮壞死溶解症的發生則以藥物為主。藥物分類以抗癲癇藥物最高,其次為抗生素類藥物;單一藥物以carbamazepine為最高,其次為phenytoin、allopurinol及phenobarbital。高風險群方面,未罹患腎臟疾病者使用carbamazepine發生史帝芬-強生症候群的機率,為未罹患腎臟疾病者且未使用carbamazepine的115倍,未罹患腦血管疾病者使用oxcarbazepine發生毒性表皮壞死溶解症的機率,為未罹患腦血管疾病者且未使用oxcarbazepine的372倍。醫療耗用方面,醫療總費用平均一年共343.8萬元,為全年住院健保申報總醫療費用的0.04%,嚴重皮膚不良反應每人每年平均費用與住院天數皆高於全院的平均。
對可能發生嚴重皮膚不良反應的危險族群,可透過建立藥物過敏電腦警示系統結合藥物不良反應之資訊系統,完整的電子病歷化,對民眾的用藥指導,以提高病患用藥安全及降低醫療耗用。
Severe cutaneous adverse drug reactions were found in many manifestations in the literatures, such as erythema multiforme, Stevens-Johnson syndrome, and the toxic epidermal necrolysis. These acute severe skin and mucous membrane adverse reactions could cause fatal consequence and high medical consumptions. As the natures of these adverse events have rigorously affected patient safety, the issue has been pursued seriously and has gathered more attentions by both hospital administrators and clinical practitioners.
This study collected historical medical records of in-patients in a medical center during 2004-2005. A total of 255,219 inpatient person-times were collected from claim database to National Health Insurance. One hundred and ninety six cases, which were matched with ICD-9-CM 695.1 diagnosis and checked with drug-related cutaneous adverse reactions, were analyzed by multivariable statistical models for their risk factors and related medical consumptions.
The analyses have demonstrated that the primary cause of erythema multiforme was from infections, however the occurrence of Stevens-Johnson syndrome and toxic epidermal necrolysis were found basically from medications. The likelihood of causing such severe cutaneous adverse drug reactions were high among patients using antiepileptic agents followed by antibiotic agents. Carbamazepine was found to be the one most likely to cause severe cutaneous adverse drug reactions while analyzed by brand name specific drug, followed by phenytoin, allopurinol, and phenobarbital. The high risk groups were found in patients with the following characteristics: 1) patients other than renal diseases but using carbamazepine (an elevated risk of 115 folds than patients other than renal diseases and not using carbamazepine); 2) patients other than cerebral vascular diseases but using oxcarbazepine (an elevated risk of 372 folds than patients other than cerebral vascular diseases but not using oxcarbazepine). The analysis of medical consumptions related to severe cutaneous adverse drug reactions has shown that 3,438 thousand NT dollars per year accounted for 0.04% of total inpatient medical consumptions. The average length of stay and medical consumptions were found to be higher in patients with severe cutaneous adverse drug reactions than patients otherwise.
The findings have suggested that actions can be made for high risk groups with information assisted systems and internal controls. With the development of electronic medical records, the incorporation of medication guideline and safety management system into physician prescription and patient directions will improve the safety levels and cost containment of health care settings.
指導教授推薦書
口試委員會審定書
授權書 iii
誌謝 iv
中文摘要 v
英文摘要 vi
目錄 vii
圖表目錄 ix
第一章 緒論 1
第一節 研究背景與動機 1
第二節 研究目的 5
第二章 文獻探討 6
第一節 嚴重皮膚藥物不良反應的定義 6
第二節 嚴重皮膚藥物不良反應的評估方式 15
第三節 國內外有關藥物引起嚴重皮膚不良反應的實證研究 18
第四節 國內外藥物引起嚴重皮膚不良反應之醫療耗用分析 37
第三章 研究方法 41
第一節 研究架構 41
第二節 研究材料 43
第三節 研究假說 44
第四節 研究變項及方法 45
第四章 研究結果 50
第一節 嚴重皮膚不良反應之樣本特性 51
第二節 嚴重皮膚不良反應之危險因子探討 68
第三節 嚴重皮膚不良反應之醫療耗用分析 72
第五章 討論 81
第一節 嚴重皮膚藥物不良反應的探討 81
第二節 醫療產業之醫療耗用影響 94
第三節 嚴重皮膚不良反應的預防策略 95
第四節 研究限制 97
第六章 結論與建議 99
第一節 結論 99
第二節 建議 102
參考文獻 104
英文部份 104
中文部份 108

圖表目錄
圖3-1-1、研究架構 42
表2-1-1、多形性紅斑的定義 12
表2-1-2、史帝芬-強生症候群的定義 13
表2-1-3、毒性表皮壞死溶解症的定義 14
表2-2-1、Naranjo不良反應與藥物相關性之評估 17
表2-3-1、嚴重皮膚不良反應各類型疾病之百分比 22
表2-3-2、嚴重皮膚不良反應的發生率 23
表2-3-3、嚴重皮膚不良反應的致死率 24
表2-3-2、嚴重皮膚不良反應就醫的科別關係 31
表2-4-1、藥物不良反應引起的每人平均住院天數及醫療費用 39
表3-4-1、各研究變項之操作型定義 48
表3-4-2、慢性疾病狀態之疾病名稱及對照之ICD-9-CM-Code 49
表4-1-1、引起嚴重皮膚不良反應個案特性描述 59
表4-1-2、非藥物引發的致病因素別之嚴重皮膚不良反應發生率 60
表4-1-3、Naranjo評估法之內部一致性的判定 61
表4-1-4、確認藥物引起嚴重皮膚不良反應發生率的分佈狀況 62
表4-1-5、年齡與性別之嚴重皮膚不良反應發生率 63
表4-1-6、疾病別之嚴重皮膚不良反應發生率 64
表4-1-7、抗癲癇藥物之嚴重皮膚不良反應發生率 65
表4-1-8、抗生素藥物之嚴重皮膚不良反應發生率 66
表4-1-9、非類固醇類消炎藥與其他藥物之嚴重皮膚不良反應發生率 67
表4-2-1、嚴重皮膚不良反應之疾病及藥物的危險因子 70
表4-2-2、嚴重皮膚不良反應之高風險群 71
表4-3-1、醫療費用指標分佈現況 78
表4-3-2、嚴重皮膚不良反應之醫療費用指標分佈 79
表4-3-2、嚴重皮膚不良反應之醫療費用指標分佈(續) 80
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