Effects of Urinary Kallidinogenase in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism

Recruitment & Eligibility

Inclusion Criteria

Aged 18-75 years (male or female)
Patients were admitted to hospital within 72h of stroke onset
Diagnosis of acute ischemic stroke according to the criteria stated in the Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China (2010), and patients were confirmed as acute ischemic cerebrovascular disease by head computed tomography (CT) or magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI)
NIHSS score ranged from 3-21 points
Patients were previously diagnosed with type 2 diabetes, in which they were in line with the 2006 WHO diagnostic criteria for diabetes, or they had fasting blood glucose of 6.1-6.9mmol/L and glycosylated hemoglobin (HbA1C) of>6.1%
Patients could cooperate with the test and evaluation of relevant indicators in the trial.

Exclusion criteria:

Pregnant or lactating women
Patients with severe heart, liver and kidney dysfunction
Patients with a history of cerebrovascular disease and who still suffered from serious neurological dysfunction that had an influence on the trial
Patients with physical disabilities, joint deformities or muscle lesions
Patients were confirmed with intracranial hemorrhage by CT
Patients were allergic to the study drug
Patients suffering from severe systemic infection
Patients who had participated in other clinical trials within 1 month
For any reason, the researchers believed that the subject was unlikely to complete the study (such as cerebral infarction caused by cerebral embolism, intracranial arteritis, cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) and moyamoya disease; patients undergoing thrombolysis or thrombectomy after admission; patients and their families were unable to cooperate with follow-up.)

Exclusion Criteria

Not provided

Study & Design

Arm && Interventions

Group	Intervention	Description
HUK group	Urinary Kallidinogenase	On the basis of routine treatment for cerebral infarction, patients in the HUK group were also given Urinary Kallidinogenase at 0.15 PNA unit/day, for a 10-day course.

Primary Outcome Measures

Name	Time	Method
NIHSS Score at 90 Days	at 90 days after admission	Comparison of NIHSS score between the control and HUK group at 90 days

Secondary Outcome Measures

Name	Time	Method
Factors related to Non-General Recovery (90-day NIHSS was reduced by <90%)	at 90 days after admission	Based on NIHSS score，multivariate analysis was performed to evaluate the factors related to non-general recovery (90-day NIHSS was reduced by \<90%) for all patients. Evaluation of NIHSS score: General recovery was when NIHSS score was reduced by 90%-100%; Non-general recovery referred to when NIHSS score was reduced by \<90%.
mRS Score	10 days, 30 days, and 90 days after admission	The mRS score of 10 days after admission was taken as the baseline.Comparison of mRS score between the control and HUK group at 30days、90days. Based on mRS，multivariate analysis was also performed to evaluate the factors related to poor curative effect (90-day mRS ≥3) for all patients. Evaluation of mRS score: mRS score of 0-2 points referred to a good curative effect, and 3-5 points referred to a poor curative effect.
fasting glucose levels	at admission and 10 days after admission	Comparison of the change in fasting glucose levels between the control and HUK group at admission and 10days.
NIHSS Score at 10 Days、30 Days	at 10 days, 30 days after admission	Comparison of NIHSS score between the control and HUK group at 10days、30days.

Recruitment & Eligibility