丁苯酞注射液治疗进展性脑卒中的疗效及安全性研究

Efficacy and Safety of Dl- 3- n- butylphthalide Injection for Progressive Stroke

目的观察和评价丁苯酞注射液治疗进展性脑卒中(PS)的有效性和安全性。方法选取2011—2014年于福建省立医院神经内科住院治疗符合纳入与排除标准的PS患者140例为研究对象。采用随机数字表法将患者分为丁苯酞组和对照组各70例。研究过程中失访6例,其中丁苯酞组2例,对照组4例,将其删除。丁苯酞组给予基础治疗+丁苯酞注射液治疗,对照组给予基础治疗。首诊时、进展后、治疗后14 d和治疗后90 d采用美国国立卫生研究院卒中量表(NIHSS)评分以及NIHSS评分进展幅度评估神经功能障碍程度;治疗后14 d和治疗后90 d采用NIHSS评分演变情况评估神经功能转归情况;治疗后14 d和治疗后90 d采用Barthel指数评估治疗后日常生活能力;治疗后90 d应用改良Rankin量表(mRS)评分评估神经功能障碍康复程度,将mRS评分≤2.0分定义为预后良好,mRS评分>2.0分定义为预后不良事件。对两组脑梗死病灶同侧颈内动脉系统的狭窄闭塞性病变患者的NIHSS评分、Barthel指数、mRS评分进行比较分析。观察有无皮疹等过敏反应及其他不良事件。结果两组治疗后14 d、治疗后90 d NIHSS评分均低于进展后,治疗后90 d NIHSS评分均低于治疗后14 d(P<0.05)。丁苯酞组治疗后14 d、治疗后90 d NIHSS评分降低率均高于对照组(P<0.05)。丁苯酞组治疗后14 d、治疗后90 d Barthel指数、预后良好率高于对照组,治疗后90 d mRS评分低于对照组(P<0.05)。共发现61例(45.5%)脑梗死病灶同侧颈内动脉系统的狭窄闭塞性病变,其中丁苯酞组29例(42.6%),对照组32例(48.5%)。丁苯酞组脑梗死病灶同侧颈内动脉系统的狭窄闭塞性病变患者治疗后14 d、治疗后90 d NIHSS评分低于进展后,治疗后90 d NIHSS评分低于治疗后14 d(P<0.05)。丁苯酞组脑梗死病灶同侧颈内动脉系统的狭窄闭塞性病变患者治疗后14 d Barthel指数、治疗后90 d Barthel指数、预后良好率均高于对照组(P<0.05)。两组不良事件发生率比较,差异无统计学意义(P>0.05)。结论丁苯酞注射液治疗能够促进PS患者神经功能和预后的改善,提高生活能力,是一种有效并安全的治疗方法。

Objective To assess the efficacy and safety of dl - 3 - n - butylphthalide injection on patients with progressive stroke （PS） . Methods Recruited 140 patients with PS who received treatment in Department of Neurology of Fujian Provincial Hospital from 2011 to 2014 and met inclusion and exclusion criteria. The patients were divided into dl - 3 - n - butylphthalide group and control group by random number table method. There were 70 cases in each group. In the research process, 6 patients were lost to follow up including 2 patients in dl - 3 - n - butylphthalide group and 4 patients in control group and they were excluded. The patients in dl - 3 - n - butylphthalide group were treated with dl - 3 - n - butylphthalide injection, and the patients in control group were not. The neurological deficits were assessed by NIHSS scores and the change range of NIHSS scores at first diagnosis, after progress and after 14 days and 90 days treatment; the outcome of the neurological function was assessed by the change of NIHSS scores after 14 days and 90 clays treatment; the ability of daily living was assessed by Barthel index after 14 days and 90 days treatment; the recovery of dysneuria was assessed by mRS scores after 90 days treatment. The mRS score ≤2. 0 indicates good prognosis and the mRS score 〉 2. 0 indicates bad prognosis. The NIHSS scores, Barthel index and mRS scores were compared and analyzed between two groups of patients with narrow occlusion lesions of the ipsilateral internalcarotid artery with the cerebral infarction lesions. Blood routine, hepatic and renal function, coagulation function and electrocardiography were detected and rash or other anaphylactic reaction and other adverse reactions were observed before treatment, after 14 days treatment and 30 days treatment. Results The NIHSS scores of two groups 14 days and 90 days after treatment were lower than those after progress; the NIHSS scores of two groups 90 days after treatment were lower than those 14 days after treatment （ P 〈 0. 05 ） . The reduction rate of NIHSS scores 14 days and 90 days after treatment in dl - 3 - n - butylphthalide group was greater than those in control group （ P 〈 0. 05 ） . D1 - 3 - n - butylphthalide group was higher in Barthel index 14 days and 90 days after treatment and favorable prognosis rate and was lower in mRS score 90 days after treatment than control group （P〈0. 05） . There were 61 （45.5%） patients with narrow occlusion lesions of the ipsilateral internal carotid artery with the cerebral infarction lesions, including 29 （42.6%） patients in the dl - 3 - n - butylphthalide group and 32 （48.5%） patients in the control group. The NIHSS scores 14 days and 90 days after treatment of patients with narrow occlusion lesions of the ipsilateral intemal carotid artery with cerebral infarction lesions were lower than after progress in dl - 3 - n - butylphthalide group ; the NIHSS scores 90 days after treatment of patients with narrow occlusion lesions of the ipsilateral intemal carotid artery with cerebral infarction lesions were lower than 14 days after treatment in dl - 3 - n - butylphthalide group （ P 〈 0. 05 ） . The Barthel index 14 days and 90 days after treatment and favorable prognosis rate of patients with narrow, occlusion lesions of the ipsilateral intemal carotid artery with the cerebral infarction lesions in dl - 3 - n - butylphthalide group were higher than those in control group （ P 〈 0. 05 ） . The two groups were not significantly different in the incidence rates of adverse reactions （P 〉 0. 05 ） . Conclusion D1 - 3 - n - butylphthalide injectibn can improve the neurologic function and prognosis of patients with progressive stroke and improve the ability of daily living. It is an effective and safe therapy.