前言:與敗血症相關的急性呼吸窘迫症候群在臨床治療上仍是一個很困難的問題。本研究的目的是評估同時以基因重組人類活化C蛋白與體外膜氧合器治療與敗血症相關的急性呼吸窘迫症候群之療效及安全性。方法:我們以台大醫院中的前瞻性資料庫來做回溯性分析。我們收集了與敗血症相關的急性呼吸窘迫症候群並且使用體外膜氧合器的病人。符合本研究中基因重組人類活化C蛋白治療條件的病人接受該藥物治療,其他病人則接受傳統治療。初級終點為全部原因的在醫院死亡率,次級終點為嚴重出血併發症。結果:共有14位病人被收入本研究,其中5位接受基因重組人類活化C蛋白治療(研究組),其他9位接受傳統治療(對照組)。研究組中5位有2位死亡(40.0%),而對照組中9位有8位死亡(88.9%,p=0.095)。在嚴重出血併發症方面,在對照組中有2位發生(22.2%),在研究組中則無(p=0.505)。結論:在與敗血症相關的急性呼吸窘迫症候群並且使用體外膜氧合器的病人使用基因重組人類活化C蛋白治療,對於降低死亡率沒有顯著的成效,雖然在本研究中沒有發現與此藥物相關的嚴重出血併發症。
Introduction: Sepsis-related acute respiratory distress syndrome (S-ARDS) is a difficult problem for clinicians. The aim of this study was to evaluate the efficacy and safety of combined treatment with recombinant human activated protein C (rhAPC) and extracorporeal membrane oxygenation (ECMO) for S-ARDS.Methods: We retrospectively analyzed a prospective database in a single institution. Patients with S-ARDS requiring ECMO support were enrolled. RhAPC was given to the patients who met the criteria of our study. Other patients received conventional management. The primary endpoint was all-cause hospital mortality, and the secondary endpoint was serious bleeding complications.Results: A total of 14 patients were enrolled. Five patients received rhAPC and 9 underwent conventional treatments. Two of 5 patients in the rhAPC group (40.0%) and 8 of 9 patients in the control group (88.9%) died in the hospital (p=0.095). Two serious bleeding incidents occurred in patients in the control group (22.2%) and none in the rhAPC group (p=0.505).Conclusion: Our analyses suggested rhAPC has no significant effect on the reduction of all-cause mortality in patients with S-ARDS requiring ECMO support, although no increase in serious bleeding complications associated with rhAPC treatment was noted.