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系統識別號 U0026-1102201919393200
論文名稱(中文) 非癌症患者長期使用鴉片類止痛藥後出現合併苯二氮平類藥物使用或死亡事件之危險因子
論文名稱(英文) The risk factors for concurrent use of benzodiazepines or death among non-cancer patients with long-term opioid analgesics use
校院名稱 成功大學
系所名稱(中) 公共衛生研究所碩士在職專班
系所名稱(英) Graduate Institute of Public Health(on the job class)
學年度 107
學期 1
出版年 108
研究生(中文) 李柏鋒
研究生(英文) Po-Feng Lee
學號 SB7041049
學位類別 碩士
語文別 中文
論文頁數 80頁
口試委員 指導教授-李中一
口試委員-鄭靜明
口試委員-莊佳蓉
口試委員-楊雅惠
中文關鍵字 處方鴉片類藥物  苯二氮平類藥物  死亡率  危險因子 
英文關鍵字 prescription opioids  benzodiazepine  mortality  risk factors 
學科別分類
中文摘要 研究背景:
過去20年以來,在許多北美與歐洲國家陸續出現鴉片類止痛藥物使用量大幅增加的現象,也衍生出許多社會和醫療問題,包括成癮者大量增加、以及中毒和死亡事件的增加等,相關問題也獲得國際間的重視。我國於2002至2014年期間鴉片類止痛藥物使用量上升41%,相比美國或澳洲呈倍數成長相比,顯得和緩許多,這是因為我國對該類藥物使用和開放上市的政策,較上述國家嚴格許多。然而,隨著鴉片類止痛藥物使用量增加,我國對相關問題的研究卻相當缺乏,本研究藉由分析我國全民健保申報資料,來了解我國非癌症患者中,長期鴉片類止痛藥使用者的流行病學特徵,以及後續出現合併苯二氮平類藥物使用、中毒、和死亡事件之發生情形與相關因素。
研究目的:
本研究將探討我國長期使用鴉片類止痛藥的非癌症患者∶(1)流行病學特徵; (2)合併苯二氮平類藥物使用之危險因子;(3)出現鴉片中毒事件之危險因子; (4)出現死亡事件之危險因子;(5)年齡與性別標準化死亡比(standardized mortality ratio, SMR);以及(6)原死因分佈。
材料和方法:
本研究採用世代研究法,資料來源為2000-2013年的全民健保承保抽樣檔;所選取的世代為2001-2012年間,非癌症而長期使用鴉片類藥物的成年個案(12,990人),長期使用的定義為連續使用鴉片類藥物>14天或90天內間歇使用>28天。統計方法上,本研究以Cox比例風險模式(Cox proportional hazards model)做存活分析,探討出現合併苯二氮平類藥物使用以及死亡之危險因子。本研究也以全人口為參考組,利用間接標準化方法,計算研究世代之年齡與性別標準化死亡比。
結果:
本研究的研究世代共12990人,其中7826人(60.2%)為男性,8715人(67.1%) 年齡介於45歲到64歲;2852人(22%)有合併苯二氮平類藥物使用,這些個案中有2327人(81.6%)在符合長期使用鴉片類止痛藥定義的一年內出現合併苯二氮平類藥物使用;合併苯二氮平類藥物使用之危險因子為女性、初次長期使用鴉片類止痛藥的年齡較高、低社經地位、CCI分數較高、思覺失調症、情感性精神病、焦慮症、以及酒精使用疾患。
在本研究追蹤期間,研究世代共有558人(4.3%)死亡,死亡率為11.6/每千人年,死亡的危險因子包括∶合併使用苯二氮平類藥物、男性、初次長期使用鴉片類止痛藥的年齡較高、投保地區都市化程度低、低薪、生理共病較多、情感性精神病、以及酒精使用疾患。與2006年全人口死亡率相較,研究世代在2001-2013之標準化死亡比為1.41(95%信賴區間為1.29-1.53),而女性的標準化死亡比高於男性。
結論:
長期使用鴉片類止痛藥以及合併使用苯二氮平類藥物的個案在2001年到2012年間皆呈現逐年增加的趨勢。本研究也發現社會人口學變項、共病、以及長期使用鴉片類止痛藥個案合併苯二氮平類藥物使用和死亡有顯著相關;而長期使用鴉片類止痛藥個案的標準化死亡略高於一般族群。另外,因為以健保資料庫登錄的疾病代碼並無法正確辨認出鴉片類藥物中毒事件,因此建議應考慮建立有效的鴉片類藥物中毒監控數據之蒐集機制。
關鍵字:處方鴉片類藥物;苯二氮平類藥物;死亡率;危險因子
英文摘要 Introduction
Over the past 20 years, the consumption of opioid analgesics has significantly increased in many countries of North America and Europe. There has been international concern over the rise in opioid analgesics addiction and black-marketing, as well as opioid intoxication and mortality. Although the average opioids consumption in Taiwan is still much lesser than U.S. and Australia, it rose by 41% between 2002 and 2014. This was because Taiwanese government implemented more strict policies on prescription of opioid analgesics, as well as the introduction of new opioid analgesics. However, there were only few articles conducted to address prescriptions of opioid analgesics in Taiwan. This study aimed to investigate the trend of long-term opioid analgesics use in Taiwan and the risk factors for subsequent intoxication or death among non-cancer patients with long-term opioid analgesics use.
Goal of study
We aimed to investigate (1) sociodemographic characteristics; (2) risk factors of concurrent benzodiazepine use; (3) risk factors of opioid intoxication; (4) risk factors of death; (5) age and sex standardized mortality ratio (SMR); and (6) the distribution of cause of death, among non-cancer patients with long-term opioid analgesics use.
Material and methods
Our study design was a longitudinal and retrospective cohort study; and the database analyzed was all claim data, between 2000-2013, of a randomly selected population-based cohort (2-million people) provided by the Ministry of Health and Welfare. Our study cohort consisted of 12,990 adults with non-cancer diagnosis and long-term opioid analgesics use between 2001 and 2012. Long-term opioid analgesics use was defined as consecutive opioid analgesics use for more than 14 days, or intermittent opioid analgesics use more than 28 days in a 90 days period. We performed survival analysis (Cox regression model) to identify risk factors for subsequent concurrent benzodiazepine use and death. Defining the whole population as reference population, we also calculated age and sex standardized mortality ratio with indirect standardization method.
Results
We identified 12,990 beneficiaries to be our study cohort. In this cohort, 7,826 (60.2%) enrollees were male, and 8715 (67.1%) enrollees were aged between 45 and 64 years. Totally 2,852 (22%) enrollees were noted to have combined use of benzodiazepine, and 2,327 (81.6%) out of these 2,852 enrollees were identified within 1 year after the definition of long-term opioid analgesic were met. Risk factors of concurrent benzodiazepine use were female gender, middle age (45-64 years old), lower socioeconomic status, higher Charlson’s Comorbidity Index (CCI) score, and mental illness. We identified only 5 enrollees with opioid intoxication, and this is very likely to be under-estimated. There were 558 deaths (4.3%) noted in our cohort during follow-up, corresponding to a mortality rate of 11.6 / per 1,000 person-years. The risk factors of death included male gender, older age, combined benzodiazepine use, higher CCI score, living in rural area, lower income, affective disorder, and alcohol use disorder. Compared with the whole population in 2006, the all-cause SMR of our cohort between 2001 and 2013 is 1.41 (95% confidence interval=1.29-1.53). The sex-specific SMR was higher in female enrollees than in male enrollees.
Conclusion
The number of enrollees with long-term opioid analgesics use and combined benzodiazepine use, respectively, was increasing between 2001 and 2012. We also found that sociodemographic characteristics, comorbidity, and concurrent benzodiazepine in enrollees with long-term opioid analgesics use were significantly associated with death. Our cohort had a higher all-cause SMR compared with general population. Moreover, since it is difficult to identify opioid intoxication events correctly by International Classification of Disease codes in the claim data of National Health Insurance, establishing other valid surveillance systems to minitor intoxication events are needed and should be considered.

Key words: prescription opioids; benzodiazepine; mortality; risk factors
論文目次 目錄
中文摘要(I)
英文延伸摘要(Abstract)(III)
目錄(V)
圖目錄(VIII)
表目錄(VIII)
第一章、前言(1)
第二章、文獻探討(3)
第一節、疼痛治療原則(3)
第二節、鴉片類止痛藥物分類(4)
第三節、世界各國鴉片類止痛藥的使用趨勢(5)
一、全球趨勢(5)
二、美國(5)
三、歐洲(6)
四、英國(7)
五、澳洲(7)
六、台灣(7)
第四節、鴉片類止痛藥的中毒與死亡(9)
一、美國(9)
二、加拿大(10)
三、英國(11)
四、澳洲(11)
第五節、使用鴉片類止痛藥的主要適應症(11)
第六節、鴉片類藥物使用個案出現中毒或死亡的危險因子(12)
一、社會人口學因素(12)
二、鴉片類藥物相關因素(13)
三、合併其他藥物(14)
四、重複就醫取藥或藥物替代行為(14)
五、生理或精神疾患共病(15)
第三章、材料與方法(16)
第一節、資料來源與研究設計(16)
第二節、研究架構(16)
第三節、長期使用鴉片類藥物合併使用苯二氮平類藥物之危險因子分析(16)
一、研究設計(16)
二、研究世代(17)
三、潛在危險因子(18)
四、統計分析(21)
第四節、長期使用鴉片類藥物死亡之危險因子分析(22)
一、研究設計(22)
二、研究世代(22)
三、潛在危險因子(22)
四、統計分析(23)
第五節、長期使用鴉片類藥物者之死因分析及標準化死亡比(23)
一、死因資料來源(23)
二、標準人口及各死因死亡人數(23)
三、統計分析方法(23)
第四章 結果(25)
第一節、長期使用鴉片類藥物合併使用苯二氮平類藥物之危險因子分析(25)
一、長期使用鴉片類藥物之定義與相對應之中毒、死亡風險(25)
二、2001-2012年期間初次長期使用鴉片類止痛藥的非癌症成年個案之流行病學特徵(26)
三、長期使用鴉片類藥物樣本合併使用苯二氮平類藥物之危險因子分析(27)
第二節、長期使用鴉片類藥物死亡之危險因子分析(29)
第三節、長期使用鴉片類藥物死亡之死因分析與標準化死亡比(31)
第五章 討論(32)
第一節、研究問題討論(32)
一、我國長期使用鴉片類止痛藥的非癌症個案之流行病學特徵(32)
二、我國長期使用鴉片類止痛藥的非癌症個案,在長期使用鴉片類止痛藥物之後,合併苯二氮平類藥物使用之比率為何?而影響此合併使用的危險因子為何?(33)
三、我國長期使用鴉片類止痛藥的非癌症個案,死亡之危險因子為何?(34)
四、我國長期使用鴉片類止痛藥的非癌症個案死亡風險之年齡、性別標準化死亡比以及死亡個案之死因分布為何?(35)
第二節、其他相關問題討論(36)
一、本研究中因研究世代出現鴉片類藥物中毒個案過少,故無法進行鴉片類藥物中毒之存活分析,鴉片類藥物中毒個案很少是否代表台灣中毒人數真的很少?(36)
二、本研究不納入65歲以上個案,會不會影響結果?(37)
第三節、本研究的優勢與研究限制(38)
一、本研究的優勢(38)
二、本研究的研究限制(38)
第六章 結論(39)
參考文獻(40)
附錄(74)
附錄一: 論文比較(74)
附錄二:長期使用鴉片類藥物和合併苯二氮平類藥物的定義比較(76)
附錄三:死因別之標準化死亡比(與2001年全人口比較)(77)
附錄四:死因別之標準化死亡比(與2011年全人口比較)(78)
附錄五:標準化死亡比(與2001年全人口比較)(79)
附錄六:標準化死亡比(與2011年全人口比較)(80)
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