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研究生:周千瀅
研究生(外文):Chian-Ying Chou
論文名稱:Statin類藥物在台灣慢性病患之療效比較
論文名稱(外文):Comparative Effectiveness of Statin Therapy in Patients with Chronic Conditions in Taiwan
指導教授:黃心苑黃心苑引用關係
指導教授(外文):Nicole Huang
學位類別:博士
校院名稱:國立陽明大學
系所名稱:公共衛生研究所
學門:醫藥衛生學門
學類:公共衛生學類
論文種類:學術論文
論文出版年:2017
畢業學年度:105
語文別:英文
論文頁數:173
中文關鍵詞:比較效果研究史坦丁效力癡呆憂鬱症性功能障礙
外文關鍵詞:comparative effectiveness researchstatinpotencydementiaerectile dysfunctiondepression
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  • 下載下載:22
  • 收藏至我的研究室書目清單書目收藏:1
“比較效果研究”(comparative effectiveness research,簡稱CER)是一種臨床實效研究,評價不同的治療方案或藥物對特定患者的療效差異,針對不同患者找出最好的治療方法,並減少不必要的醫療開支,已被廣泛應用於評估藥物益處和危害。基於statin類藥物是最強效的降血脂藥物,且能有效改善心血管疾病患者預後、併發症與死亡率,是全球最受歡迎的降血脂藥,但對於其可能發生少見不良反應如癡呆症、憂鬱症或性功能障礙等的疑慮可能影響患者對statin類藥物治療順從性,從而影響療效,因此需要對statin類藥物之益處與危害做深入評估研究。
在本論文中,我們試圖研究statin類藥物對三種主要慢性疾病的影響:癡呆、憂鬱症和性功能障礙。第一部分和第二部分研究採用回溯性傾向配對世代研究設計,使用台灣國民健康保險研究數據庫作為主要資料來源,研究國人statin類藥物使用與癡呆症或性功能障礙發生風險關聯性,並深究此關聯性是否受到患者個人特質(如年齡、性別等)、statin類藥物類別差異(如親脂性、效力)、statin類藥物使用累積狀態等因素所影響。第三部分研究應用meta-analysis研究方式,彙整現有相關文獻,分析statin類藥物使用與憂鬱症發生風險關聯性,並探討此關聯性是否受到statin類藥物類別差異或使用累積狀態等因素影響。
歸結本系列研究有幾個重要發現,分述如下:
1. 回溯性傾向配對世代研究結果顯示statin類藥物使用與癡呆症或器質性性功能障礙的風險降低有關。而在meta-analysis研究中,結果發現statin類藥物使用與研究觀察期超過一年以上之憂鬱症風險降低有關。
2. Statin類藥物的效力可能在癡呆症、憂鬱症和性功能障礙的預防作用中至為關鍵。藥物使用累積持續時間亦為重要的一環。
3. Statin類藥物對癡呆症的保護作用在女性中比在男性中更為明顯,但不受年齡影響。
4. 在世代研究中,statin類藥物的親脂性與否與對癡呆症或性功能障礙的保護作用並無關聯性。然而,在meta-analysis研究中顯示高親脂性statin類藥物可以顯著降低憂鬱症發生風險。
我們的研究結果顯示statin類藥物使用可降低癡呆症、憂鬱症和器質性性功能障礙的發生風險。另一方面,此研究結果也帶出爾後的研究值得關注的幾個議題,如性別差異與藥物基因遺傳多樣性對療效或副作用之影響,及statin類藥物使用與神經障礙、精神疾病或發炎性疾病之間的關係,有助於進一步了解statin類藥物在其他疾病中的應用,並探討其經濟比較。
Comparative effectiveness research (CER) has been widely applied in evaluating the benefits and harms of medicines. It not only impact market demand of patients and doctors, but may also affect payer coverage policy. Since statins are the most popular lipid-lowering agents in the world, occasional negative case reports or anecdotes of statin associated adverse drug reactions on public media may also influent patient’s behavior on statin therapy adherence. Concerns have been raised about the balance between harms and benefits of statin use.
In present dissertation, we aimed to investigate the effects of statin use on three major chronic conditions of diseases: dementia, ED, and depression. In the first part of the dissertation, we investigated the relationship between prescribing patterns of statins and the incidence of incident dementia among the elderly population in Taiwan, and determined whether this relationship was moderated by age, gender and pharmacokinetic characteristics of statins. In the second part of the dissertation, we evaluated the association between statin use and the risk of incident ED, and determined whether class effects existed. These two studies adopted the Taiwan’s National Health Insurance Research Databases as main data source by using a retrospective propensity-matched cohort study design. In the third part of this dissertation, we conducted a meta-analysis of cohort studies in analyzing the relationship between statin use and the incidence of incident depression, and explored the roles of class effects on this relationship. Our studies yielded several important findings and summarized as fallowing:
1. Our population based propensity-matched cohort studies demonstrated that statin use was associated with reduced risks of dementia and organic ED. In the meta-analysis study, we found that statin use was associated with the reduced risk of depression in a follow-up period longer than one year.
2. The potency of statins may play an important role in yielding protective effects of statins on dementia, ED, and depression. The cumulative duration of statin utilization also play a critical role in these effects.
3. The protective effects of statins for incident dementia were more apparent in female than in male, but were not moderated by age.
4. The lipophilicity did not seem to be associated with protective effects of statins on dementia and ED. However, our meta-analysis results demonstrated that the high lipophilicity statins could significantly reduced the risk of depression.
Our findings suggest that statin treatment is associated with a reduction in risk of incident dementia, organic ED, and depression. On the other hand, the findings have suggested several potential topics that worth to pay close attention in future researches such as gender difference, genetic diversities, and the relationship between statin and neurological disorders, psychiatric disorders, or inflammatory disease, which may help to further understand risks and benefits of statins.
<Table of Contents>
Acknowledgement……………………………………………………… i
摘要…………………………………………………………………..……... ii
Abstract…………………………………………………………………...... iv
Table of Contents……………………………………………………..... vii
List of Figures…………………………………………………………….. ix
List of Tables……………………………………………………………… x
Chapter one: Introduction
I. Background………………………………………………………… 2
II. Significance……………………………………………………… 10
III. Specific Aims………………………………………………... 12
Chapter two: Literature review
I. Comparative effectiveness research…….…………… 14
II. Review of statin………………………………………………… 18
III. Review of statin and incident dementia…………… 22
IV. Review of statin and incident erectile dysfunction…26
V. Review of statin and incident depression……………28
Chapter three: Material and Methods
I. Statin and incident dementia………………………………32
II. Statin and incident erectile dysfunction……………39
III. Statin and incident depression………………………… 46
Chapter four: Results
I. Statin and incident dementia…………………………… 52
II. Statin and incident erectile dysfunction......…66
III. Statin and incident depression………………………… 74
Chapter five: Discussion and Conclusion
I. Statin and incident dementia……………………………. 83
II. Statin and incident erectile dysfunction……………90
III. Statin and incident depression……………………………98
IV. Conclusion and Policy Implications……………………103
V. Future perspectives……………………………………………106
References………………………………………………………………………108
Appendix
A. Sensitivity analysis results……………………………136
B. Abbreviations……………………………………………………149
C. Diagnosis code of diseases and injuries……………151
D. NHI drug code………………………………………………………153
E. Published papers………………………………………………161

<List of Figures>
Fig. 1 Flow chart of criteria used to select participants for the study……………………………………………38
Fig. 2 Participant selection criteria employed in the study………………………………………………………………………………45
Fig. 3 Flow diagram of included studies………………………50
Fig. 4 Hazard Ratios for incident dementia stratified by gender………………………………………………………………………………63
Fig. 5 Hazard Ratios for ED according to cumulative use of individual statins………………………………………………....72
Fig. 6 Forest plot of pooled effect of the association between statin use and risk of depression…………………...77
Fig. 7 Subgroup analyses on the association between statin use and risk of depression stratified by study follow-up period………………………………...…………………………78
Fig. 8 Subgroup analyses on the association between specific types of statin use and risk of depression stratified by statin potency………………………………………79
Fig. 9 Subgroup analyses on the association between specific types of statin use and risk of depression stratified by statin lipophilicity…..…………........80
Fig. 10 Funnel plot of publication bias in the studies investigating risk of depression associated with use of statins…………………………………………………………………………81
Fig A-1. Flow chart of criteria used to select participants for the study……………………………………………137
Fig A-2. Estimated survival curves for time to dementia in patients treated with statins with respect to those not treated with statins…………………………….........…………141
Fig A-3. Dose-response relationship of incident ED and statin therapy……………………………………...……………………148

<List of Tables>
Table 1. Pharmacologic and pharmacokinetic properties of the statins……20
Table 2. CASP cohort study checklists............47
Table 3. Baseline characteristics of the study population………………………………………………………………………55
Table 4. Baseline characteristics of the study population stratified by gender………………………………………57
Table 5. Temporal association of Incident dementia among statin users and nonusers stratified by gender………………………………………………………………………………58
Table 6. HRs and 95% CIs for the association between statin use and dementia, stratified by the socioeconomic status and the presence of comorbidity …………………………59
Table 7. HRs and 95% CIs for the association between statin use and dementia……………………………………………………60
Table 8. HRs and 95% CIs for the association between statin use and dementia in men…………………………………………61
Table 9. HRs and 95% CIs for the association between statin use and dementia in momen………………………………………62
Table 10. Sensitivity test for the relation between statins use and dementia..………………………………………………64
Table 11. HRs and 95% CIs for the association between statin use and dementia/AD from different study design………………………………………………………………………………65
Table 12. Baseline characteristics of participants……………………………………………………………………69
Table 13. IRs and HRs of ED associated with statin use……………………………………………………………………………………71
Table 14. Sensitivity analyses for the relationship between statin use and ED…………………………………………………73
Table 15. Summary of included studies……………………76
Table A-1. Baseline characteristics……………………………………………………………… 138
Table A-2. Risk of incident dementia for statin users and nonusers……………………………………………………………………139
Table A-3. Temporal association of incident dementia among statin users and nonusers stratified by gender and age…………………………………………………………………………………140
Table A-4. HRs and 95% CIs for the variables and dementia……………….…………………………………………………………142
Table A-5. HRs and 95% CIs for the association between statin use and dementia stratified according to demographic status and presence of medical conditions…………………… 143
Table A-6. HRs and 95% CIs for the association between statin use and dementia according to medication status for patients…………………………………………………………………………144
Table A-7. HRs of ED associated with statin use - stratified by cumulated dose…………………………………………146
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