Study on the clinical efficacy of Human Urinary Kalllikrein in the treatment of acute cerebral infarction according to TOAST classification.

To observe and evaluate the clinical efficacy of Human Urinary Kallikrein in the treatment of acute cerebral infarction (ACT) according to TOAST (The Trial of Org 10172 in Acute Stroke Treatment) classification. In accordance with randomized controlled trial, 110 patients with acute cerebral infarction were randomly assigned to kallikrein treatment group (55 cases) and control group (55 cases). TOAST classification and basic treatment were administrated on patients between two groups respectively. 0.15 PNA unit of Human Urinary Kallikrein injection plus 100 mL saline in intravenous infusion was performed in the kallikrein group, with once a day for 14 consecutive days. The National Institutes of Health Stroke Scale (NIHSS) scores in two groups were analyzed before and after the treatment. No difference was shown in the NIHSS scores before treatment among patients between two groups (P>0.05). While after the treatment, the NIHSS scores in both groups were reduced (P<0.05) and the NIHSS scores in the kallikrein treatment group were less than those in control group (P<0.05). Moreover, after the treatment, the NIHSS scores for large-artery atherosclerosis subtype (L) and small-artery occlusion lacunar subtype (S) as two subtypes of TOAST classification in the two groups were both reduced (P<0.05). After the treatment, NIHSS scores for L subtype in the kallikrein treatment were less than those in the control group (P<0.05). After the treatment, NIHSS scores for S subtype in the kallikrein treatment were less than those in the control group, without statistically significant difference. Comparisons on clinical efficacy indicated differences on the S subtype between two groups (P<0.05). The standardization effective rate was calculated, indicating 81.82% in the kallikrein treatment group and 54.55% in the control group, respectively. In TOAST classification, Human Urinary Kallikrein is able to remarkably improve the NIHSS scores for L subtype and S subtype patients with acute cerebral infarction and help to enhance the clinical efficacy.

RCT Entities:   Population Interventions Outcomes