使用組織胞漿素原活化劑靜脈注射治療急性缺血性腦中風之初期經驗

Preliminary Experience of Treating Acute Ischemic Stroke with Intravenous Tissue Plasminogen Activator

組織胞漿素原活化劑（Tissue Plasminogen Activator, t-PA）於1996年經美國食品藥物衛生管理局（FDA）核准使用於3小時內的缺血性腦中風。本研究是為瞭解美國家神經疾病及中風研究中心（NINDS）對急性缺血性腦中風使用t-PA的治療準則是否適用於台灣地區民眾。在新光醫院回溯性收集1年半內因急性缺血性腦中風接受靜脈注射t-PA的25病例。三個月的死亡率32%，三個月的巴氏量表指數（BI）≧95分者有32%。症狀性腦出血及死亡性腦出血的比率分別為20%和12%，若選取完全沒有違反NINDS治療流程的12病例，則症狀性腦出血及死亡性腦出血的比率分別降為8.3%和8.3%。違反NINDS治療準則的比率是52%，主要是超過3小時的治療期限（40%）或t-PA注射24小時內使用肝素（24%）。統計結果發現發生症狀性腦出血與超過3小時的治療期限而又於24小時內使用肝素（p=0.01），或治療前電腦斷層中大腦動脈灌注區低密度區大於三分之一（p=0.024）有關。治療後三個月時有較佳預後（BI≧75分）的預測因素是治療前的NIHSS分數。自中風發生到急診所花的平均時間是44±30分，而入急診到做完頭部電腦斷層平均時間是34±10分，自進入急診到開始注射t-PA的平均時間是105±39分，和德州休士頓地區t-PA治療經驗相比，相差不大。因此我們的結論是：（l）NINDS的急性缺血性腦中風t-PA治療準則是實際可行的；（2）不違反NINDS治療準則下，病人發生症狀性腦出血比例和NINDS t-PA研究結果類似；（3）違反NINDS治療流程會導致較高比率的症狀性腦出血，所以完全遵守NINDS治療準則是必需的。

We evaluate the feasibility and safety of t-PA (tissue plasminogen activator) therapy for acute ischcmic stroke by using the NINDS (National Institute of Neurological Disorders and Stroke) protocol in northern Taiwan. We retrospectively collected 25 cases who were treated with intravenous t-PA for acute ischemic stroke in a teaching hospital during 1.5 years period. The rates of symptomatic intracerebral hemorrhage (ICH) and fatal ICH are 20% and 12% respectively in all patients. Those among patients without protocol violations (12 patients) were 8.3% and 8.3% respectively. The mortality rate is 32%. The rate of nearly neurological recovery (Barthel index, BI≧95) is 32%. The rate of any violation to NINDS protocol is 52%. Common violations include initiation of t-PA beyond 3 hours (40%) and use of heparin within 24 hours (24%). Double violations as t-PA beyond 3 hours also use of heparin within 24 hours (P=0.01) or low density greater than 1/3 middle cerebral artery territory in early computed tomography scan (CT)(P=0.024) can predict symptomatic ICH. Baseline NIHSS (National Institute of Health Stroke Scale) score can predict good clinical outcomc (BI≧75) in 3 months after treatment. The mean time from stroke onset to emergency department arrival was 44±30 minutes; emergency department arrival to CT was 34±10 minutes; and emergency department arrival to start of t-PA was 105土39 minutes. We conclude: (1) NINDS protocol for acute ischemic stroke is feasible; (2) the incidence of symptomatic ICH among patients without protocol violations was similar to that of NINDS t-PA stroke study; (3) protocol violations would lead to a higher rate of symptomatic ICH. Therefore strict adherence to NINDS protocol is necessary.