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Human urinary kallidinogenase in treating acute ischemic stroke patients: analyses of pooled data from a randomized double-blind placebo-controlled phase IIb and phase III clinical trial
- Source :
- Neurological research. 42(4)
- Publication Year :
- 2020
-
Abstract
- Objectives: Intravenous thrombolysis and thrombectomy are recommended for patients whose stroke onsets are within first 6 h, and very few options are available for patients whose stroke onset is more than 6 h, which includes most ischemic stroke patients. Human urinary kallidinogenase (HUK) showed potential clinical benefits in acute ischemic stroke patients. This study aims to investigate the safety and clinical benefits of HUK in ischemic stroke patients.Patients and methods: Patients were recruited for a multicenter double-blind, placebo-controlled phase II b and phase III trial. Neurophysiological outcomes were assessed by the European Stroke Scale (ESS) and the functional outcomes were assessed by the activity of daily living scale (ADL). Safety was monitored by recording adverse events.Results: The improvements in ESS scores and ADL scores in the HUK group were significantly greater than that in patients receiving placebo. Furthermore, HUK treatment was also associated with a lower rate of disable, according to ADL. HUK-related adverse events occurred at a low rate, in 1.73% of HUK-treated patients.Conclusion: HUK is safe and provides potential clinical benefits as a treatment for acute ischemic stroke. Further large post-marketing observational studies are needed.
- Subjects :
- 0301 basic medicine
Adult
Data Analysis
Male
medicine.medical_specialty
Activities of daily living
Adolescent
medicine.medical_treatment
Urinary system
Placebo
Brain Ischemia
03 medical and health sciences
Young Adult
0302 clinical medicine
Double-Blind Method
Internal medicine
medicine
Humans
Prospective Studies
Adverse effect
Stroke
Aged
Ischemic Stroke
business.industry
Coagulants
General Medicine
Thrombolysis
Middle Aged
medicine.disease
Clinical trial
030104 developmental biology
Treatment Outcome
Neurology
Observational study
Female
Kallikreins
Neurology (clinical)
business
030217 neurology & neurosurgery
Subjects
Details
- ISSN :
- 17431328
- Volume :
- 42
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Neurological research
- Accession number :
- edsair.doi.dedup.....a958a93d4be9b09f7f5e196199d5800d