Indigenous recombinant streptokinase vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial.
Indian J Med Sci
;
2005 May; 59(5): 200-7
Article
in English
| IMSEAR
| ID: sea-66389
ABSTRACT
BACKGROUND:
Streptokinase is the most widely used thrombolytic agent and can now be made using recombinant DNA technology. The present trial was initiated to assess an indigenous recombinant streptokinase (Shankinase, r-SK).AIM:
To compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK) and natural streptokinase (Streptase, n-SK). SETTINGS ANDDESIGN:
Double blind, randomized, non-inferiority, multicentric, parallel study. MATERIALS ANDMETHODS:
Patients of AMI < 6 hours of chest pain and 2 mm ST elevation in 2 contiguous chest leads V(1)-V(6) or 1 mm in limb leads were randomized to receive 1.5 miu of either r-SK or n-SK. CK Peaking and decrease of > or = 50% ST segment were used to assess reperfusion. STATISTICALANALYSIS:
Difference in the groups was assessed by chi-square or paired t test as required. Probability value < 0.05 was considered significant with 95% confidence interval.RESULTS:
Overall 150 patients were recruited (96 r-SK group and 54 in n-SK group) and demographic and clinical profile of the groups was comparable. Reperfusion was seen in 68.2% (58) and 69.4% (34) patients in r-SK and n-SK groups respectively. Commonly seen adverse events were fever in 7 (8.5%), hypotension in 3 (3.6%), nausea in 2 (2.4%) patients. Minor bleeding were seen in 4 (4.8%) of patients.CONCLUSION:
Indigenous recombinant Streptokinase (r-SK) is as efficacious as natural streptokinase (n-SK) in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile.
Full text:
Available
Index:
IMSEAR (South-East Asia)
Main subject:
Streptokinase
/
Recombinant Proteins
/
Female
/
Humans
/
Male
/
Thrombolytic Therapy
/
Retrospective Studies
/
Follow-Up Studies
/
Treatment Outcome
/
Electrocardiography
Type of study:
Observational study
/
Prognostic study
Language:
English
Journal:
Indian J Med Sci
Year:
2005
Type:
Article
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