研究限制

第五章討論

第三節研究限制

T2DM 為一個病因複雜且多因性的慢性疾病，牽涉遺傳、環境及生活型態、

肥胖等多重因素，本論文利用健保資料庫進行失眠與T2DM 風險相關性分析，但因健保資料庫的限制，缺乏研究對象有關生活型態的資訊，例如飲食、運動、抽

菸、喝酒等生活習慣的資料，或相關臨床檢驗值，因此對於許多可能影響結果的干擾因子，無法進行控制，現就將針對研究對象、研究設計、變項控制之研究限制描述於下:

一、研究對象

(一)、本研究推估失眠盛行率及發生率，無法排除會有低估的誤差存在。若罹患失眠未就診，亦不會出現在資料庫的就診紀錄上，可能造成失眠罹病人數的低估。

(二)、個案因失眠到醫療院所求診，推論其失眠狀態通常較為嚴重或影響生活品質較大，有可能伴隨較多生理、心理健康問題，無法排除本身已具有較多與T2DM 相關的危險因子。

(三)、因為健保資料庫給付的特性，有可能因為給付程度的不同而排擠門診診斷碼

的呈現，可能患者有失眠問題，但因門診的診斷碼只能呈現3 個，因此優先呈現

給付較高的診斷碼，而可能排除失眠診斷碼，上述因素皆可能影響結果的推論。

二、研究設計

(一)、本論文採取回溯性世代研究法(Retrospective cohort study)，雖屬縱貫性研究設計之一，但對因果關係(causal effect)的推論強度仍不如前瞻性研究(Prospective cohort study)，儘管我們納入失眠研究族群及參考族群時，當下已排除研究族群先前已罹患失眠及T2DM 者，建議未來研究在人力、財力等資源可充分提供下，仍以前瞻性研究設計為佳。

(二)、本論文收案 2000-2005 期間符合失眠定義條件的研究族群，6 年內共收案 94,535 位失眠患者，建議未來可將收案期間延伸至 2009.12.31，觀察最後一年 T2DM 發生事件，可增加研究樣本及觀察時間。

三、相關干擾因子

(一)、儘管本研究已進行相關干擾因子的控制(年齡、性別)，但仍有大部分重要變項無法取得，例如血糖值、身體質量指數、總膽固醇、高密度脂蛋白、低密度脂蛋白、三酸甘油脂、抽菸或飲酒、身體活動量等相關檢驗數值或生活習慣等變項，

無法排除這些重要干擾因子可能影響研究結果推論。

(二)、失眠主要來自於臨床醫師的診斷，具有高度的有效性及一致性，但缺乏來自於研究對象睡眠品質的主觀感受或睡眠時數的客觀測量。

(三)、對於失眠族群真正使用安眠藥行為無法確切掌握，基於健保資料庫限制，若

患者自費安眠藥處方，健保資料庫並不會呈現給付紀錄，可能造成安眠藥使用率低估。

(四)、本研究發現，失眠的研究對象，超過 99%研究對象皆有使用至少一種安眠藥，

這似乎與先前的研究有些出入，推論本研究結果呈現失眠患者高比例接受藥物治療現象可能與研究資料是利用健保資料進行分析，當個案因為失眠到醫院就診時才會在健保資料庫門診檔留下紀錄，因此可能造成高估失眠患者接受治療的比例。

(五)、各類安眠藥使用劑量在本論文並無深入探討，先前研究指出，安眠藥劑量的大小與增加疾病風險有關，例如胰臟炎(Lai, Lin, & Liao, 2015)、Complex Sleep Behaviors(Hwang, Ni, Chen, Lin, & Liao, 2010)；但另外也有研究指出，zolpidem 累積劑量 540mg，反而增加 T2DM 發生風險，機轉不明 (Lin et al ., 2015)，顯示結果仍有不一致處，未來可再進一步探討，而本論文亦無法排除各類安眠藥劑量的差異可能影響結果的推論。

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在文檔中失眠與第二型糖尿病風險之觀察性研究 (頁 80-123)

第五章 討論

第三節 研究限制