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研究生:黃尹韻
研究生(外文):Yin-Yun Huang
論文名稱:Thiazolidinediones門診處方不適當用於第二型糖尿病合併嚴重心衰竭患者之實證研究
論文名稱(外文):Study of Inappropriate Thiazolidinediones Prescribing among Patient with Type Two Diabetes and Heart Failure
指導教授:黃文鴻黃文鴻引用關係蔡憶文蔡憶文引用關係
指導教授(外文):Weng-Foung HuangYi-Wen Tsai
學位類別:碩士
校院名稱:國立陽明大學
系所名稱:醫務管理研究所
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:2009
畢業學年度:97
語文別:中文
論文頁數:89
中文關鍵詞:thiazolidinediones潛在不適當處方糖尿病心衰竭
外文關鍵詞:thiazolidinedionespotentially inappropriate prescriptionsdiabetes mellitusheart failure
相關次數:
  • 被引用被引用:1
  • 點閱點閱:196
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  • 下載下載:0
  • 收藏至我的研究室書目清單書目收藏:0
研究背景:
用藥安全一直是病人安全與醫療品質非常重要的一環,對於必須長期藥物治療之慢性疾病患者來說,不適當的處方不但可能增加相關不良反應,增加醫療上的耗用外,嚴重會造成住院更甚是死亡。治療糖尿病之口服降血糖藥品thiazolidinediones是備受注目與爭議之藥品。國內、外文獻顯示,服用thiazolidinediones後因體液滯留問題,會增加心衰竭之風險。目前,衛生主管機關核准的thiazolidinediones類藥品仿單上明示,該類藥品不建議使用於心臟疾病分級第3、4級(NYHA分級)之嚴重心衰竭患者身上。但國外文獻指出,該類藥品仍不適當用於嚴重心衰竭患者身上,且違反藥品指示使用的比例有逐漸增加的趨勢。因此,國內是否有相同狀況,值得探討。

研究目的:
研究目的主要分為兩點:(一)瞭解國內第二型糖尿病合併嚴重心衰竭住院患者,其出院後門診TZD處方開立情形;(二)分析出院後一年內門診曾被開立TZD處方之第二型糖尿病合併嚴重心衰竭患者,其不同病患特質、疾病史及過去藥品使用經驗與出院後一年內門診所有TZD開立頻次、劑量多寡的差異。

研究方法:
本研究採回溯性世代研究,利用全民健康保險資料庫,針對2005年當中首次因心衰竭住院並已於該年出院,且入院前一年內已有第二型糖尿病病史但無心衰竭住院病史之嚴重心衰竭患者。以Cox proportional hazard model分析不同病患特質、疾病史、過去藥品使用經驗下,患有第二型糖尿病合併嚴重心衰竭患者於出院後一年內門診開立TZD處方之危險比。再針對出院後一年內門診曾被開立TZD處方之第二型糖尿病合併嚴重心衰竭患者,利用複迴歸分析自出院後一年內,門診所有TZD開立頻次與劑量多寡,是否受到其病患特質、疾病史及過去藥品使用經驗的不同影響。
研究結果:
1. 在849位研究對象中,77人於心衰竭出院後一年內門診曾被開立TZD類藥品,潛在不適當處方率為8.48%。而過去曾使用過TZD者相較於過去未曾使用過TZD者有較高的風險門診被開立TZD處方(HR=6.554,95%CL=3.903-11.004);此外,但當次住院天數≧14天者相較於<7天者,其門診被開立TZD處方之風險較低(HR=0.336,95%CL=0.132-0.854)。
2. 針對心衰竭出院後一年內門診曾被開立TZD類藥品者,追蹤其心衰竭出院後一整年TZD處方,發現TZD處方開立頻次共計559筆,平均每人一年有7.76筆TZD處方,對照其一年內門診所有口服降血糖藥品張數,潛在不適當處方率為45.56%。平均每人一年所有TZD處方DDD總量為136.75個DDD,換算成平均每人每日劑量為0.79個DDD。此外,過去有TZD使用經驗者,相較於沒有使用經驗者來說,其TZD平均每日開立劑量會減少10.2%(β=-0.102,t=-2.002,p=0.049);而Charlson comorbidity index(簡稱CCI)≧3者相較於其他人來說,其TZD平均每日開立劑量會減少13.1%(β=-0.131,t=-2.247,p=0.028)。

結論:
於本研究發現,國內TZD類藥品仍有不適當用於第二型糖尿病合併嚴重心衰竭患者身上。且過去曾使用過該類藥品者,其心衰竭出院後門診被開立風險相對較高,顯示醫師在用藥選擇上,仍較以病患過去藥品使用經驗為依據。另外,本研究發現,高開立風險者,其一年內之頻次與劑量並非成正比,顯示在探討潛在不適當處方時,頻次與劑量皆須同時納入考量。

關鍵字:thiazolidinediones、潛在不適當處方、糖尿病、心衰竭
Background
Medication safety is a very important part of patient safety and medical quality at all times. For the patients with chronic diseases and need long-term medication treatment, potentially inapplicable prescriptions not only bring adverse drug reaction, increase the use of medical care, but also result in hospitalization or even death in the worst scenario. Thiazolidinediones is a kind of oral medicine category for anti-hyperglycemic indication and with certain controversies. At present, most available literature showed that the fluid retention problem occurred after taking thiazolidinediones will increase the risk of heart failure. Health authorities also issued warnings of use on type II diabetes mellitus patients who experienced heart attack or had latent heart disease and heart failure. The package insert of thiazolidinediones indicates it is not recommended for patients with serious heart failure with heart disease classification III and IV (NYHA Functional Classification). However, some foreign literature pointed out that it is still applicable to patients with serious heart failure; and the rate of such situation is gradually increasing. Therefore, it is worthy to explore whether there are similar situations in Taiwan.
Objectives
The objectives of this study are two folded: (A) To find out the use of TZD in outpatient services of type II diabetes mellitus patients who were hospitalized for serious heart failure after being discharged from the hospital. (B) To analyze the differences between patient characteristics, disease history, the previous TZD medication, as well as the frequency and the volume of TZD dose within one year of hospital discharge.
Methods
This study is a retrospective cohort study by using National Health Insurance claims data. The study subjects were patients who were diagnosed with type II diabetes mellitus, yet without heart failure in the previous year, and was first hospitalized for serious heart failure in 2005 and discharged in the same year. The risk ratio of study subjects getting TZD prescription from outpatient services after being discharged from the hospital within one year were analyzed for different patients’ characteristics, disease history, and the previous medication experiences by Cox proportional hazard model. Further analysis with multiple-regression-analysis was used to explore whether the frequency and the volume of dose are affected by patients’ characteristics, disease history, and the previous medication experience.
Results
The main findings of this study are summarized as the followings:
1. 77 of the 849 study subjects had doctors issued TZD type prescription after hospitalized for heart failure, discharged, and follow-up for one year of outpatient visit. The rate of potentially inapplicable prescription is 8.48%. Comparing to patients who have never taken TZD, the patients who had TZD taking history have higher risk of getting the TZD prescription during follow-up outpatient services (HR=6.554, 95% CI=3.903-11.004); Furthermore, patients who were hospitalized for 14 days or more than 14 days have lower risk of getting TZD prescription in comparison to patients who were hospitalized less than 7 days (HR=0.336, 95%CI=0.132-0.854).

2. For patients whom TZD prescription were issued to during one year follow-up after discharged form heart failure hospitalization, the total counts of doctor TZD prescription writing is 559, i.e. an average of 7.76 TZD prescriptions per year for each patient. When compare to all oral medicine for hypoglycemic medicines from outpatient services, the potentially inappropriate prescription rate is 45.56%. There was an average of 136.75 DDD TZD in total per year for each patient, i.e. the dose per day for each patient is 0.79 DDD. The daily dose of the TZD prescription for patients who had previous TZD taking history will be decreased for 10.2% (β=-0.102,t=-2.002,p=0.049) when compared to TZD non-taking subjects; however, the TZD dose for patients with Charlson comorbidity index (CCI) 3 or more will be decreased for 13.1% per day when compared to patients with CCI <3.
Conclusions
In this study, we found that TZD prescribing for type II diabetes mellitus patients who also complicated by serious heart failure are still in existence. Furthermore, patients who had previous TZD taking history have higher risk of receiving TZD prescription after being discharged form heart failure hospitalization. It may reflect a phenomenon that physicians’ choice of medication still related to patients’ previous medication. This research also found that the yearly frequency among high risk ratio TZD taking patients is not proportional to the amount of doses; it may show that frequency and the amount of doses should be taken into consideration when exploring potentially inappropriate prescriptions.

Keywords: thiazolidinediones, potentially inappropriate prescriptions, diabetes mellitus, heart failure
中文摘要 I
英文摘要 Ш
目錄 V
表目錄 VI
第一章 緒論 1
第一節 研究動機與背景 1
第二節 研究目的 4
第三節 研究問題 4
第二章 文獻探討 5
第一節 糖尿病的介紹 5
第二節 心衰竭的介紹 12
第三節 Thiazolidinediones之介紹 17
第四節 潛在不適當處方 30
第三章 研究方法 35
第一節 研究設計與架構 35
第二節 資料來源及樣本選取 37
第三節 變項名稱及定義 41
第四節 統計分析 45
第四章 研究結果 48
第一節 心衰竭出院後一年內TZD潛在不適當處方開立情形 49
第二節 追蹤期間曾被開立TZD處方者出院後一年內門診TZD開立頻次分析 56
第三節 追蹤期間曾被開立TZD處方者出院後一年內門診 63
TZD開立劑量分析 63
第四節 追蹤期間曾被開立TZD處方者出院後一年內門診 67
TZD平均每日開立劑量分析 67
第五章 討論 71
第一節 研究結果之討論 71
第二節 研究方法之討論 76
第三節 研究限制 77
第六章 結論與建議 79
第一節 結論 79
第二節 建議 80
參考文獻 81
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