利⽤用全民健康保險資料庫分析台灣地區⼝腔黏膜下纖維化症惡性轉化成口腔癌的情形

口腔黏膜下纖維化症，是眾所週知的口腔癌前病變，本研究的目的在於探討台灣地區口腔黏膜下纖維化症惡性轉化成口腔癌的情形。本篇文章透過全民健康保險研究資料庫，選取出被診斷為口腔黏膜下纖維化症的實驗組別，剩下不曾被診斷出纖維化的群體，再根據年紀、性別及指標日期配對出對照組別，比較兩個組別之間的差異性。同時將口腔白斑列入分析，評估是否造成口腔黏膜下纖維化症惡性轉化協同效果。結果顯示，在778個纖維化症患者中有71人 ( 9.13% ) 觀察到惡性轉化成口腔癌。經過校正後，發現纖維化症的組別中，惡性轉化的風險比率為對照組別的29.26倍 ( 95%信賴區間為20.55-41.67 )。而同時罹患口腔白斑與口腔黏膜下纖維化症的患者，有更高的惡性轉化風險( 52.46倍 ; 95%信賴區間為 34.88-78.91 )。存活分析 ( The Kaplan-Meier plot ) 的結果顯示出，在觀察的期間，兩個組別之間有顯著性差異 ( log-rank test, p<0.001 )。平均發生惡性轉化的時間如下：非纖維化症組別為5.1年、纖維化症組別為2.7年、同時罹患口腔白斑與纖維化症組別為2.2年。綜合以上結果我們發現，台灣地區的口腔黏膜下纖維化症患者比起非纖維化症患者來說，有較高的風險發生惡性轉化成口腔癌。同時口腔白斑可能會提高黏膜下纖維化症患者發生惡性轉化的風險。

Background : Oral submucous fiﾞbrosis ( OSF ) is one of the well-recognized oral potentially malignant disorders. In this study, we investigated the malignant transformation of OSF in a Taiwanese population. Methods : A retrospective cohort study was analyzed from Taiwan’s National Health Insurance Research Database.A comparison cohort was randomly frequency matched with the OSF cohort according to age, sex, and index year. Oral leukoplakia ( OL ) was further stratifiﾞed to evaluate for the possible synergistic effects of OSF-associated malignant transformation. Results : In this cohort, 71 ( 9.13% ) of 778 cases of OSF were observed to transform into oral cancer. The malignant transformation rate was29.26-fold in the OSF cohort than in the comparison cohort after adjustment ( 95% confiﾞdence intervals 20.55-41.67 ). To further stratify with OL, OSF with OL( 52.46%; 95% confiﾞdence intervals 34.88-78.91 ) had higher risk of malignant transformation rate than OSF alone ( 29.84%; 95% confiﾞdence intervals 20.99-42.42 ). The Kaplan-Meier plot revealed the rate free of malignant transformation was signifiﾞcant over the 13-year follow-up period ( log-rank test, P<.001 ). The mean duration of malignant transformation was 5.1, 2.7, and 2.2 years for non-OSF, OSF alone, and OSF with OL, respectively. Conclusion : Oral submucous fiﾞbrosis patients exhibited a signifiﾞcantly higher risk of malignant transformationthan those without OSF. OL could enhance malignant transformation in patients with OSF.