舌支撐下顎前突裝置及單體下顎前突裝置對於阻塞性睡眠呼吸中止症治療之比較

Abstract

目的： 舌支撐下顎前突裝置（Tongue-backing Mandibular Advancement Device，簡稱t-MAD）做為台大醫院睡眠牙醫學門診的常規治療項目，已行之多年，本論文的研究目的，即是期望能在其它變因受控制之下，單獨比較具有客製化上腭覆蓋（Customized Palatal Coverage）的t-MAD和早先的口內裝置（下顎單體前突裝置Monoblock），兩者對於阻塞性睡眠呼吸中止症是否具有治療成效上的差異，以期做為臨床上口內裝置的設計參考，提升阻塞性睡眠呼吸中止症使用口內裝置治療的成效。 實驗材料與方法： 實驗對象選自西元2015年12月至2016年06月間，於台大醫院胸腔內科或耳鼻喉科就診，經臨床檢查及多項睡眠生理檢查（PSG）測定後，判定為輕度以上（呼吸中止指數Apnea-Hypopnea Index，AHI≧5/h）之阻塞性睡眠呼吸中止症，並轉介至牙科部睡眠牙醫學門診尋求口內裝置治療之患者，實驗對象共計15位。上述患者皆為其製作一副客製化的口內裝置（t-MAD），而後隨機分配該患者配戴兩種不同口內裝置（t-MAD及Monoblock）的先後順序，兩者的差別僅在於客製化上腭覆蓋的保留或切除，每位患者都須佩戴兩種裝置各進行一次PSG檢查。此外，治療前後均記錄其基礎生理指數，並請患者填寫自覺症狀評量問卷。治療成功率之分類，是以AHI進步百分比>50%為Responder，若<50%則為Non-responder。 實驗結果： 總共有15位受試者接受Monoblock及t-MAD之治療，治療後PSG顯示：無論是Monoblock或t-MAD，在以下參數的改善上，皆與基期（Baseline）數值達到統計上的顯著差異：呼吸中止指數（AHI）、阻塞性呼吸中止次數（OA）、非快速動眼期呼吸中止指數（AHI-NREM）、快速動眼期呼吸中止指數（AHI-REM）、血氧去飽和事件（ODE）、最低血氧飽和度（Lowest O2）、血氧飽和度小於90%時間比率（O2< 90%）。此外，Monoblock在通氣降低（Hypopnea）及睡眠警醒指數（Arousal Index）也有顯著降低。而比較Monoblock及t-MAD，僅睡眠警醒指數（Arousal Index）具統計上的顯著差異。 總結： 研究結果顯示Monoblock及t-MAD皆為有效治療阻塞性睡眠呼吸中止症（OSA）的口內裝置，然而此兩裝置之間並無顯著差異，意即：客製化上腭覆蓋可能未如預期發揮其支撐舌頭之效果，未來研究將納入更多樣本數，並找出可能影響舌頭支撐成效差異的預測因子，做為新式口內裝置設計上的參考。

Objectives： The newly designed oral appliance, tongue-backing mandible advance device（t-MAD） which made with a customized palatal coverage has been used for years as a routine treatment for OSA patient in NTUH disordered sleep breathing dentistry clinic. The aim of this study is to compare the differences in the treatment outcomes between t-MAD and ther former, Monoblock, while other factors are under control. The results may give us some ideas to promote the effects of oral appliance in treating OSA paitents. Materials and Methods： Subjects recruided from patients whom referred from throatic medicine and ENT department in NTUH from December 2015 to June 2016. They were diagnosed as OSA by clinical symptoms and polysomnograpghy（Apnea Hypopnea Index, AHI≧5/h） and reffered to disorded breathing sleep dentistry clinic for oral appliance treatment. There were total 15 subjects included. The custom-made t-MAD was fabricated for each subject. The only difference between t-MAD and Monoblock is that keeping or removing the customized palatal coverage. Then a randomized-crossover clinical trail with these two oral appliances was conducted, followed by post-treatment PSG with each oral appliance. In the meanwhile, the basic physiologic data were recorded and the self-estimated questionnaires were filled before and after treatment. The subjects were divided into two groups on the basis of the degree of changes in AHI: responders（AHI reduction>50%） and non-responders（AHI reduction<50%）. Results： Total 15 subjects received Monoblock and t-MAD treatment, post-treatment PSG data show that no matter with Monoblock or t-MAD, there are statistically significant differences with baseline PSG in the following data：AHI, Obstructive Apnea, AHI-NREM, AHI-REM, Oxygen Desatuation Events, Lowest O2 Saturation, O2 Saturation＜90%. Besides, Hypopnea and Arousal Index decrease in patients with Monoblock treatment. Compare PSG data between Monoblock and t-MAD, significant difference only exists in Arousal Index. Conclusion： The results show that Monoblock and t-MAD are both effective oral appliances in treating OSA patients; however, there are no significant differences between these two devices, means that the customized palatal coverage may not function to support the tongue as we expected. We should include more samples in the future study and find out the predictive factors that affect the tongue-backing, for further designs of oral appliance.