尤瑞克林治疗急性前循环脑梗死的近期疗效和安全性研究

Short-term therapeutic efficacy and safety of kallikrein in patients with acute anterior circulation cerebral infarction

目的评价尤瑞克林治疗急性前循环脑梗死的近期疗效和安全性。方法采用随机、单盲、对照设计，纳入珠江医院神经内科自2006年10月至2009年4月收治的61例急性前循环脑梗死患者，并按随机数字表法分为尤瑞克林组（31例）和对照组（30例）。两组患者根据病情给予相同的基础治疗，尤瑞克林组在此基础上予以每天0．15PNA单位尤瑞克林（以100mL生理盐水稀释，30qO滴／min静脉滴注，每天1次，连续14d）。在治疗前及治疗后第21天分别观察两组患者神经功能缺损程度（NIHSS评分）及日常生活能力（mRS评分），并进行血尿常规、肝肾功能、血糖、血脂及心电图等检查，监测血压和脉率，必要时复查头颅CT，观察药物相关的出血性事件及不良反应。结果与对照组相比．尤瑞克林能明显改善患者NIHSS评分和提高mRS评分，差异有统计学意义（P=0．022，P=0．032）。依据平均秩次（尤瑞克林组23．86，对照组35．93）判断，尤瑞克林组疗效优于对照组。除尤瑞克林组2例有哮喘病史患者因治疗期间诱发哮喘发作而退出试验外，其他患者未见不良反应。尤瑞克林组用药前后血尿常规、肝肾功能、血糖、血脂及心电图等检查无异常变化，用药后头颅CT检查未见药物相关的出血性事件。结论应用尤瑞克林治疗急性前循环脑梗死患者安全、有效，能显著改善患者神经功能缺损症状和提高日常生活能力。

Objective To evaluate the short-term therapeutic efficacy and safety of kallikrein in patients with acute anterior circulation cerebral infarction. Methods Sixty-one patients with anterior circulation cerebral infarction, admitted to our hospital from October 2006 to April 2009, were enrolled in the randomized single-blind control trail. These patients were assigned to kallikrein treatment group （n=31） and control group （n=30）. They were both treated by identical basis therapy, such as antiplatelet, dilute blood viscosity, neurotrophy therapy and symptomatic treatment. The patients in the treatment group were treated by intravenous infusion administration of 0.15 PNA kallikrein diluted in 100 mL 0.9% saline at 30-40 drops/min once daily for 14 consecutive days. On the pretherapy and 21~ post-treatment day, the National Institutes of Health Stroke Scale （NIHSS）, activity of daily living （ADL） of modified Rankin Scale （mRS） in these patients were performed; blood routine examinations and urinalysis, hepatorenal function, levels of blood glucose and lipid, and ECG were assessed; blood pressure and pulse rate were monitored. CT scan was employed for ICH if necessary. Drug relative hemorrhage and adverse drug reaction （ADR） were recorded in detail. Results As compared with those in the control group, significantly reduced NIHSS scores and obviously improved ADL scores in the kallikrein treatment group were noted （P=0.022, P=-0.032, respectively）. According to the mean rank （kallikrein treatment group： 23.86, control group： 35.93）, the efficacy in the treatment group was better than that in the control group. Except that asthmatic attack happened to 2 patients （having the history of asthma） during treatment period, no other ADRs were noted in all the patients. No abnormal changes of blood routine examinations, urinalysis, hepatorenal function, levels of blood glucose and lipid, and ECG and head CT features in the kallikrein treatment group were detected before and after the treatment; no drug relative hemorrhage was noted either. Conclusion Kallikrein is safe and effective in treating patients with acute anterior circulation cerebral infarction, through reducing the neurologic function impairment and improving ADL.