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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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A Study on the Safety Profile, Clinical Outcomes and Adverse Events in Patients taking Recombinant Tissue Plasminogen Activator (r-tPA) in Acute Ischaemic Stroke in a Tertiary Care Hospital

Author: BERIL MATHEWS, MATHEW GEORGE, LINCY JOSEPH, SANGEETH JOHNS, PRIYA JOSEPH, REETHU MAMMEN
Abstract: Background: Stroke is the 2nd largest cause of death and 4th largest cause of disability in India. Medical treatment with Recombinant Tissue Plasminogen Activator (r-tPA) is an approved thrombolytic therapy for Acute Ischaemic Stroke (AIS). Objective: To evaluate the efficacy, clinical outcomes and adverse reactions of using r-tPA in patients who are admitted to the hospital diagnosed with Acute Ischaemic Stroke. Methodology: This is a Prospective – Retrospective study which involved 39 patients admitted between 0 - 4.5 h. The clinical outcomes were measured using National Institute of Health Stroke Scale (NIHSS) and Barthel Index score scale. Statistical Analysis was done using Tukey’s test and ANOVA using the Instat Software. Results: The patients were categorized into 4 groups based on the time window. The therapy was found to be effective in patients whose time window is between 2 – 3 h. The r-tPA treated patients were more likely to have a very favourable outcome on the basis of the NIHSS score (=1) and Barthel Index (100%, P < 0.001) after 1 month. It was observed that Headache, Drowsiness, Bleeding and Shortness of Breath were the major Adverse Events in the study which were corrected by appropriate therapy. Conclusion: From the results obtained it can be stated that the clinical outcome obtained after r-tPA therapy were safe, effective and can be recommended for the Acute Ischaemic Stroke patients who were admitted in the hospital within the time window.
Keyword: Recombinant Tissue Plasminogen Activator, Time Window, NIHSS, Barthel Index, Clinical outcome.
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