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العنوان
A comparative study between low dose and standard dose intravenous alteplase in acute ischemic stroke in an Egyptian sample /
المؤلف
El-Shanawany, Basma Gamal Abd El-Maksoud.
هيئة الاعداد
باحث / بسمة جمال عبد المقصود الشنوانى
مشرف / وفيق محمود الشيخ
مشرف / جيلان محمود سالم
مشرف / خالد حاتم عفيفي
مناقش / وفيق محمود الشيخ
الموضوع
Neuropsychiatry. Cerebrovascular stroke.
تاريخ النشر
2019.
عدد الصفحات
140 p. :
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
الطب النفسي والصحة العقلية
تاريخ الإجازة
24/12/2019
مكان الإجازة
جامعة المنوفية - كلية الطب - الامراض العصبية والطب النفسي
الفهرس
Only 14 pages are availabe for public view

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from 152

Abstract

Cerebrovascular stroke is a leading cause of death and disability worldwide. Tissue-Type plasminogen activator (Alteplase) is the only Food and Drug Administration (FDA) approved medication for treatment of acute ischemic stroke within 4.5 hours with a recommended dose of 0.9 mg/kg.
However, intravenous thrombolytic therapy has not been widely adopted, stringent time window restriction, risk of ICH and high costs are major obstacles that prevent its broad application.
Many neurologists in Asia consider that lower doses of IV tPA are better for Asian patients with ischemic stroke because of the racial difference in coagulation and fibrinolysis responses which increase the risk of SICH.
Upon these concerns, many observational and registry studies had been conducted in order to prove the efficacy and safety of lower doses of intravenous rt-PA in Asia. One of them led Japanese in 2006 to approve use the dose (0.6 mg/kg) of intravenous rt-PA in its stroke care guidelines after confirming its safety and efficacy.
Despite the high prevalence rate of ischemic stroke among Egyptian population, only Less than 1% of stroke patients in Egypt receive intravenous thrombolysis. A major reason is the high cost of alteplase.
Lowering the dose of alteplase and thus lowering its economic burden will greatly promote the implementation of this therapy and improve the neurologic recovery in Egyptian patients with AIS.
The aim of the current study was to evaluate if low-dose alteplase treatment is as effective and safe as standard-dose regimen in the treatment of Egyptian patients with acute ischemic stroke.
The current study was non-randomized clinical trial, recruited 80 Egyptian patients with acute ischemic stroke from the neurology department of EL-Mataria Teaching Hospital and Menoufia University Hospital. Patients were subdivided into two groups (40 patients in each group). A group was thrombolysed at a dose of 0.6 mg/kg and the other group was thrombolysed at a dose of 0.9 mg/kg.
The two groups were compared regarding safety and efficacy. Safety outcome was assessed by the occurrence of symptomatic intracerebral hemorrhage (SICH) within the first 24 hours post treatment & 90-day mortality. We defined SICH according to ECASS ᴨstudy definition (any hemorrhage plus a neurological deterioration of ≥4 points on the NIHSS baseline or from the lowest NIHSS value after baseline to 7 days or leading to death). Efficacy outcome was assessed by favourable outcome at 90 days (defined as mRS of 0-2)
The study revealed that the two groups were matched together regarding their demographic data with a mean age of 61 years and male predominance (65%) & vascular risk factors with hypertension was the most common risk factor among the studied sample.
Time to treatment was the most prevalent difference between the two groups with 90% of low dose group were thrombolysed between 3-4.5 hours versus 2.5% of standard dose group were thrombolysed within the same time window.