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系統識別號 U0026-0108201617204500
論文名稱(中文) 老年糖尿病患藥事照護及低血糖風險評估
論文名稱(英文) Pharmaceutical care and detection of severe iatrogenic hypoglycemia risk in elderly patients with diabetes mellitus
校院名稱 成功大學
系所名稱(中) 臨床藥學與藥物科技研究所
系所名稱(英) Institute of Clinical Pharmacy and Pharmaceutical sciences
學年度 104
學期 2
出版年 105
研究生(中文) 陳俊宏
研究生(英文) Jyun-Hong Chen
學號 TB8981049
學位類別 博士
語文別 英文
論文頁數 74頁
口試委員 指導教授-高雅慧
口試委員-鄭靜蘭
口試委員-歐凰姿
口試委員-吳晉祥
召集委員-詹鼎正
口試委員-洪世昌
中文關鍵字 糖尿病  老年人  臨床試驗  藥事照護  低血糖  對稱分析法  Fibrate 
英文關鍵字 Diabetes  Elderly  Clinical Trials  Pharmaceutical Care  Hypoglycemia  Sequence Symmetry Analysis  Fibrate 
學科別分類
中文摘要 研究背景
老年糖尿病的高盛行率已經是全球性的問題,人口老化更是驅動老年糖尿病患急速上升的原因之一。許多研究顯示藥事照護可提供許多的益處,而藥物引起的低血糖更是對於老年糖尿病患照護上最需擔心的事情。對稱分析法(sequence symmetry analysis)是一種用於風險訊號偵測的案例式與個體內比較之分析方法,應可用於有效率地偵測引起低血糖的高風險藥物。
研究目的
本研究以隨機對照試驗(randomized controlled trial) 探討藥事照護改善老年糖尿病患醣化血色素(HbA1c)的實證結果及對於醫療花費的負擔評估。此外,對於降血糖藥物(antidiabetic drugs)和老年糖尿病患常用非降血糖藥物(non-antidiabetic drugs)引起低血糖的風險,本研究運用對稱分析法予以偵測,並使用巢式病例對照研究來驗證對稱分析法的結果。
研究方法
隨機對照試驗自2011年8月至2012年2月於衛生福利部南投醫院收案100位糖尿病共同照護網中醣化血色素≥9.0%的65歲以上老年糖尿病患進行隨機分派後由經過糖尿病照護相關訓練的藥師針對實驗組(50人)進行藥事照護,並與控制組進行醣化血色素及醫療花費的差異分析。對稱分析法及巢式病例對照研究則使用1999年至2012年健保資料庫糖尿病例抽樣歸人檔,篩選出65歲以上的老年糖尿病患資料進行降血糖藥物和非降血糖藥物引起低血糖的風險訊號偵測及分析。
研究結果
隨機對照試驗結果顯示,藥師提供血糖控制不佳的門診老年糖尿病患藥事照護可改善其醣化血色素,然而並未顯著提高醫療花費的負擔。對稱分析法分析結果偵測到7種降血糖藥物和14種非降血糖藥物顯著與低血糖具有相關性,而巢式病例對照研究則顯示由對稱分析法所偵測到具有低血糖風險的fibrate類降血脂藥物與低血糖確實呈現顯著相關。
結論
經由研究,我們認為經過糖尿病照護相關訓練的藥師加入糖尿病照護團隊並提供藥事照護,可改善老年糖尿病患醣化血色素,且不會顯著增加醫療花費負擔。使用對稱分析法來可有效率地偵測出可能引起老年糖尿病患低血糖之藥物,並進一步驗證fibrate類降血脂藥物與低血糖的相關性,提醒處方醫師評估使用這些具有潛在風險的藥物造成低血糖的可能性。
英文摘要 Background: Diabetes in older adults was a critical health problem regarding global diabetes prevalence and the aging of the overall population is a significant driver of the diabetes epidemic. Pharmaceutical care in diabetes management has shown benefits in this frail group. Meanwhile, drug-induced hypoglycemia was the most concerned complication in diabetes care of elderly patients. Sequence symmetry analysis (SSA) is a case-only and within individual comparisons tool for signal detection. Drugs with high hypoglycemia risk could be detected by this method efficiently.
Objective: This study aimed to investigate the effect of pharmaceutical care by conducting a randomized controlled trial to assess improvement of HbA1c levels and the change of medical expenses. Meanwhile, to assess hypoglycemia risk of drugs commonly used in elderly diabetic patients a sequence symmetry analysis was employed to detect the high risk non-antidiabetic drugs (hrNADDs), which were further verified by nested case control study.
Methods: We conducted a randomized controlled trial from August 2011 to February 2012 in Nantou Hospital, Ministry of Health and Welfare, Taiwan, R.O.C. 100 patients with type 2 diabetes with poor glycemic control (HbA1c levels of ≥9.0%) and aged ≥65 years were involved over 6 months. Participants were randomly assigned to a standard-care (control, n = 50) or pharmaceutical-care (intervention, n = 50) group. Pharmaceutical care was provided by a certified diabetes-educator pharmacist and HbA1c levels improvement and medical expenses were evaluated. SSA and nested case control study were conducted using Longitudinal Health Insurance Databases of diabetes datasets established by the NHRI from 1999 to 2012. To evaluate the clinically important hypoglycemia risk after exposure antidiabetic drugs (ADDs) or high risk non-antidiabetic drugs (hrNADDs) in elderly diabetic patients.
Results: Randomized controlled trial demonstrated that a pharmacist intervention program providing pharmaceutical care services to poorly-controlled, ambulatory elderly patients with DM could improve HbA1c levels, while medical expenses were not significantly increased. Drug-induced hypoglycemia in elderly diabetic patients could also be well-evaluated by SSA. Our study results indicated that severe hypoglycemia was observed in one antipyretic (acetylsalicylic acid), two -blockers (propranolol and labetalol), two antibacterials (sulfamethoxazole/trimethoprim and chloramphenicol), two tetracyclines (doxycycline and minocycline), two antifungals (ketoconazole and fluconazole), three lipid-lowering drugs (bezafibrate, gemfibrozil and fenofibrate) and two antidepressants (trazodone and venlafaxine) in elderly diabetic patients. The nested case control study provided evidence that exposure to fibrates (fenofibrate, bezafibrate, and gemfibrozil) was found to be associated with higher odds of hypoglycemia.
Conclusion: Including pharmacists in multidisciplinary diabetes care teams and provide pharmaceutical care for elderly diabetic patients would be helpful in poorly-controlled, ambulatory elderly patients with DM to improve control of HbA1c levels. Drug-induced hypoglycemia was detected clinical significantly in 7 ADDs and 14 hrNADDs by SSA. In population-based nested case-control study, fibrates were significantly associated with hypoglycemia. Prescribers should be cautious as severe hypoglycemia may occur after initiation of these high risk drugs to elderly diabetic patients.
論文目次 摘要 I
ABSTRACT III
誌謝 V
CHAPTER ONE-OVERVIEW 1
CHAPTER TWO- Pharmaceutical care in elderly diabetic patients 4
Section 1 – Background 4
Section 2 – Methods 5
Section 3 – Results 9
Section 4 – Discussion 11
Section 5 – Conclusion 14
CHAPTER THREE- Detection of severe iatrogenic hypoglycemia risk using sequence symmetry analysis 15
Section 1 – Background 15
Section 2 – Methods 17
Section 3 – Results 23
Section 4 – Discussion 25
Section 5 – Conclusion 35
CHAPTER FOUR- Risk of hypoglycemia in elderly patients with diabetes mellitus treated with fibrates: a Nested Case-Control Study 36
Section 1 – Background 36
Section 2 – Methods 37
Section 3 – Results 40
Section 4 – Discussion 41
Section 5 – Conclusion 44
CHAPTER FIVE - OVERALL CONCLUSION 45
REFERENCES 48
TABLES AND FIGURES 57
Table 1. Baseline characteristics of patients 57
Table 2. Comparison of HbA1c levels and payment points before and after intervention 58
Table 3. Comparison of medical expense (NTD) and pharmaceutical care cost before and after intervention 59
Table 4. Costs of pharmaceutical care 60
Table 5. Antidiabetic drugs (ADDs) for Sequence Symmetry Analysis (SSA) 61
Table 6. High risk non-antidiabetic drugs (hrNADDs) for Sequence Symmetry Analysis (SSA) 62
Table 7. SSA results of antidiabetic drugs (ADDs) 64
Table 8. SSA results of high risk non-antidiabetic drugs (hrNADDs) 65
Table 9. Characteristics of Patients with Hypoglycemia Compared with Controls 69
Table 10. Matched Conditional Logistic Regression Analysis of Hypoglycemic Risk in Case Patients versus Controls 70
Figure 1. Study flowchart of randomized controlled trial 71
Figure 2. Flowchart of study cohort selection in SSA 72
Figure 3. SSA results of OHA 73
Figure 4. A study flow diagram for the nested case control study 74
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