Effects of Urinary Kallidinogenase on NIHSS Score, mRS Score, and Fasting Glucose Levels in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 主要终点
- NIHSS Score at 90 Days
研究概览
简要总结
Urinary kallidinogenase may assist recovery acute ischemic stroke. This study evaluated the impact of urinary kallidinogenase on NIHSS score, modified Rankin scale (mRS) score and fasting glucose levels in patients with AIS combined with diabetes mellitus and impaired fasting glucose.
详细描述
Patients with AIS and abnormal glucose metabolism were enrolled in this prospective cohort study and divided into two groups. The HUK group were treated with urinary kallidinogenase and standard treatment, the control group received standard treatment. NIHSS scores, mRS scores and fasting blood glucose were evaluated and compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- 未提供
研究组 & 干预措施
HUK group
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.
干预措施: Urinary Kallidinogenase (Drug)
结局指标
主要结局
NIHSS Score at 90 Days
时间窗: at 90 days after admission
Comparison of NIHSS score between the control and HUK group at 90 days
次要结局
- Factors related to Non-General Recovery (90-day NIHSS was reduced by <90%)(at 90 days after admission)
- mRS Score(10 days, 30 days, and 90 days after admission)
- fasting glucose levels(at admission and 10 days after admission)
- NIHSS Score at 10 Days、30 Days(at 10 days, 30 days after admission)