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研究生：	梁薰尹 Liang, Hsun-Yin
論文名稱：	巴金森氏病病人使用抗精神病藥物罹患身體疾病與死亡風險之比較 Comparative Physical Morbidity and Mortality Risks of Antipsychotics in Patients with Parkinson’s Disease
指導教授：	賴嘉鎮 Lai, Chia-Cheng Edward
學位類別：	碩士 Master
系所名稱：	醫學院 - 臨床藥學與藥物科技研究所 Institute of Clinical Pharmacy and Pharmaceutical sciences
論文出版年：	2018
畢業學年度：	106
語文別：	英文
論文頁數：	101
中文關鍵詞：	巴金森氏病、抗精神病藥物、身體疾病、死亡、風險比較
外文關鍵詞：	Parkinson’s disease, antipsychotic, physical morbidity, mortality, comparative risk
相關次數：	點閱：136 下載：1
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研究背景：巴金森氏病主要表現為運動症狀，且有較高的身體疾病風險，如骨折、肺炎、甚至是心血管疾病；亦可能引起精神病症狀如焦慮、憂鬱、認知功能與睡眠障礙等。巴金森氏病藥物雖能增加腦內多巴胺濃度緩解運動症狀，然而提高多巴胺濃度可能導致精神症狀發生。抗精神病藥物的使用雖可改善病患精神病症狀，但往往會惡化巴金森氏病病人的運動障礙。因此，巴金森氏病病人在使用抗精神病藥物控制時，需同時權衡病患精神與運動狀況。

研究目的：本研究之目的為比較巴金森氏病病人使用不同抗精神病藥物罹患身體疾病與死亡之風險。

研究方法：本研究採用回溯性世代研究法，資料來源為衛生福利部2001至2013年之健保資料。研究對象為40歲（含）以上診斷為原發性巴金森氏病並且新使用抗精神病藥之病人。依據藥物使用分組，分析病患使用不同抗精神病藥之身體疾病風險（即非精神疾病原因住院）、全死因死亡風險及全原因住院風險。以使用頻率最高的quetiapine作為參考藥物，使用多變項Cox比例風險模型校正干擾因子，評估抗精神病藥之相對風險。

結果：本研究共收錄10,232位新使用抗精神病藥物之巴金森氏病病人，平均年齡為76.31歲 (SD 8.97)，女性 (50.54%) 略多於男性 (49.46%)。最常使用之抗精神病藥物依序為quetiapine (44.41%)、risperidone (17.46%)、haloperidol (16.86%)、sulpiride (7.70%)、trifluoperazine (3.05%)。研究發現使用haloperidol (adjusted hazard ratio, 1.14; 95% CI, 1.05-1.24) 及risperidone (1.12; 1.04-1.21) 罹患身體疾病之風險顯著高於quetiapine；使用aripiprazole (0.56; 0.38-0.82) 之風險則是較quetiapine低。而olanzapine (1.32; 1.05-1.66)、risperidone (1.27; 1.16-1.40)、haloperidol (1.26; 1.13-1.41)，以及sulpiride (1.20; 1.04-1.38) 之死亡風險顯著高於quetiapine；使用aripiprazole (0.52; 0.29-0.92) 之風險則是顯著低於quetiapine。

結論： Risperidone、haloperidol、sulpiride及olanzapine被觀察到可能增加罹患身體疾病及死亡之風險，建議臨床上應避免使用。Aripiprazole在研究中被觀察到有較低的身體疾病與死亡風險，顯示其使用在巴金森氏病族群具有良好安全性。未來應能有相關研究，確認巴金森氏病人使用aripiprazole之經濟效果。

Background: Use of antipsychotics is a common treatment for psychosis in patients with Parkinson’s disease (PD). However, the decreased binding between dopamine and receptors caused by antipsychotics warrants attentions on worsening movement symptoms of PD.

Objectives: To compare the risks of physical morbidity and mortality in Taiwanese PD patients receiving different antipsychotics for controlling psychiatric symptoms.

Methods: We conducted a retrospective cohort study using the Taiwan’s National Health Insurance Research Database (NHIRD) from 2004-2012. Study population consisted of patients aged 40 years and older who diagnosed with PD newly receiving antipsychotic medications. The outcomes of interests were hospitalization due to physical morbidity (i.e., non-psychiatric hospitalization), all-cause mortality and all-cause hospitalization. Quetiapine was selected as reference group for comparisons because it was the most commonly used antipsychotics for patients with PD. We performed Cox proportional hazards models with adjustments of covariates such as age, sex and baseline PD treatments to compare the physical morbidity and mortality risks between antipsychotic groups.

Results: We identified a cohort of 10,232 patients with the mean age of 76.31 years (SD 8.97) and 50.54% female. Quetiapine (44.41%) was the most frequently used antipsychotics, followed by risperidone (17.46%), haloperidol (16.86%), sulpiride (7.70%), and trifluoperazine (3.05%). We found the risks of physical morbidity hospitalization were higher in haloperidol (adjusted hazard ratio, 1.14; 95% CI, 1.05-1.24) and risperidone (1.12; 1.04-1.21) compared with quetiapine. We found patients receiving aripiprazole (0.56; 0.38-0.82) had significantly lower risks compared with quetiapine users. In addition, we found the mortality risks were higher in olanzapine (1.32; 1.05-1.66), risperidone (1.27; 1.16-1.40), haloperidol (1.26; 1.13-1.41), and sulpiride (1.20; 1.04-1.38) while lower in aripiprazole (0.52; 0.29-0.92) compared with quetiapine.

Conclusions: The findings indicated risperidone, haloperidol, sulpiride, and olanzapine should not be used for psychosis in patients with PD because of the increased risks of physical morbidity and mortality. We found aripiprazole posed lower physical morbidity and mortality risks, which could be a good potential drug of choice for psychosis in PD patients. The study could be a strong ground for future research evaluating cost-effectiveness of aripiprazole for the patients with PD.

摘要	I
SUMMARY	III
誌謝	V
CONTENT	VII
CONTENT OF TABLES	XI
CONTENT OF FIGURES	XII
EPISODE I	COMPARATIVE PHYSICAL MORBIDITY AND MORTALITY RISKS OF ANTIPSYCHOTICS IN PATIENTS WITH PARKINSON’S DISEASE	1
BACKGROUND INFORMATION	1
1	Introduction	1
RELEVANT LITERATURE	1
1	Epidemiology of PD in Taiwan	1
2	Psychosis in PD	2
2.1	Development of psychosis in PD	2
2.2	Pathophysiology of psychosis in PD	2
3	Antipsychotics prescription and the therapeutic dilemma	3
3.1	The need of antipsychotics	3
3.2	Therapeutic dilemma	4
3.3	Recommendation drug	6
3.4	Prescribing pattern in domestic and abroad	7
4	Safety concerns in antipsychotics use	8
4.1	Increased morbidity and mortality risks of AP use in dementia	8
4.2	Special features of PD	9
4.3	Knowledge gap	10
STUDY OBJECTIVES AND CLINICAL RELEVANCE	12
1	Study objectives	12
2	Clinical relevance	12
STUDY METHOD	13
1	Study design	13
2	Data sources	13
3	Study population	14
3.1	Inclusion criteria	14
3.2	Exclusion criteria	15
4	Study duration and follow-up	15
4.1	Censored points	15
5	Outcome measures	16
5.1	Primary endpoints	16
5.2	Secondary endpoints	16
6	Analytic variables and definition	17
6.1	Exposure definitions	17
6.2	Variables for patient characterization	18
7	Study scheme	23
8	Statistical analysis	24
8.1	Data management	24
8.2	Analytical approach	24
9	Sensitivity analysis	25
RESULTS	27
1	Cohort characteristics	27
2	Utilization of AP	38
3	Primary outcome: comparative physical morbidity risk	44
4	Secondary outcome: comparative mortality risk	47
5	Secondary outcome: comparative all-cause hospitalization risk	50
6	Sensitivity analysis	53
DISCUSSION	60
1	Rationale for cohort selection	60
2	Taiwanese AP users with PD	61
3	Prescribing pattern of AP among Taiwanese PD patients	65
3.1	AP selection through 2004 to 2012	65
3.2	Dosage and physician specialty	66
4	The risk of physical morbidity, mortality, and all-cause hospitalization in AP users with PD	69
4.1	Incidence of non-psychiatric hospitalization	69
4.2	Incidence of death	69
4.3	Incidence of all-cause hospitalization	70
4.4	Quetiapine: the standard treatment for psychosis in PD	70
4.5	Clozapine: the AP recommended by AAN while rarely used in Taiwan	71
4.6	Risperidone, haloperidol, sulpiride and olanzapine: AP should not be used in PD	………………………………………………………………………………71
4.7	Aripiprazole: a good potential drug of choice	74
5	Sensitivity analysis	74
6	Strength and limitation	75
FUTURE DIRECTION	77
CONCLUSIONS	78
EPISODE II  CLINICAL SERVICE 巴金森氏病衛教手冊編撰	79
第一章	前言	79
第二章	服務目的	80
第三章	服務方法及材料	80
第四章	服務結果	81
第五章	討論	90
REFERENCE	91
Appendix 1 Physical morbidity outcome of antipsychotics users with Parkinson’s disease using covariate and propensity score adjustment	99
Appendix 2 Mortality outcome of antipsychotics users with Parkinson’s disease using covariate and propensity score adjustment	100
Appendix 3 All-cause hospitalization outcome of antipsychotics users with Parkinson’s disease using covariate and propensity score adjustment	101
                                    

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