巴曲酶注射液治疗急性缺血性脑卒中的临床研究

Clinical trial of batroxobin injection in the treatment of acute ischemic stroke

目的比较不同治疗时间使用巴曲酶注射液治疗急性缺血性脑卒中的临床疗效及安全性。方法将146例急性缺血性脑卒中患者随机分为对照组和试验组,每组73例。对照组于入院24 h后给予巴曲酶注射液10 BU,静脉滴注1 h,第2天开始,改为5 BU,隔日1次,静脉滴注;试验组于入院后立即给予巴曲酶注射液治疗,用法用量与对照组相同。2组患者均治疗4周。比较2组患者的临床疗效、美国国立卫生研究院卒中量表(NHISS)评分、颅内水肿面积和血肿体积,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为87. 67%(64例/73例)和73. 97%(54例/73例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的NHISS评分分别为(7. 94±1. 06)和(12. 58±1. 24)分,颅内水肿面积分别为(1. 56±0. 21)和(3. 14±0. 36) cm2,血肿体积分别为(4. 89±0. 57)和(9. 23±1. 25) m L,差异均有统计学意义(均P <0. 05)。2组患者的药物不良反应均以恶心呕吐、头晕、耳鸣和眼痛为主。试验组和对照组的总药物不良反应发生率分别为8. 22%和9. 59%,差异无统计学意义(P>0. 05)。结论巴曲酶注射液早期用于治疗急性缺血性脑卒中的临床疗效确切,其能有效减轻神经功能缺损程度,缩小病灶,且不增加药物不良反应的发生率。

Objective To compare the clinical efficacy and safety of batroxobin injection in different treatment time in the treatment of acute ischemic stroke. Methods A total of 146 patients with acute ischemic stroke were randomly divided into control and treatment groups with 73 cases per group. Control group was given batroxobin injection 10 BU 24 h after hospitalization,intravenous drip for 1 h,and starting from the second day,it was changed to 5 BU,once every other day,intravenous drip. Treatment group was treated with batroxobin injection immediately after hospitalization,the dosage and usage were the same as those of control group. Two groups were treated for 4 weeks. The clinical efficacy, national institutes of health stroke scale ( NHISS) score,intracranial edema area and hematoma volume,and adverse reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 87. 67%( 64 cases / 73 cases) and 73. 97%( 54 cases /73 cases) with significant difference ( P < 0. 05). After treatment,the main indexes of treatment and control groups were compared: the NHISS scores were ( 7. 94 ± 1. 06) and ( 12. 58 ± 1. 24),intracranial edema area were( 1. 56 ± 0. 21) and ( 3. 14 ± 0. 36) cm2,hematoma volume were ( 4. 89 ± 0. 57) and ( 9. 23 ± 1. 25) mL,the differences were statistically significant ( all P < 0. 05). The adverse drug reactions of two groups were nausea and vomiting,dizziness,tinnitus and eye pain. The total incidences of adverse drug reactions in the treatment and control groups were 8. 22% and 9. 59% without significant difference ( P > 0. 05). Conclusion Batroxobin injection has a definitive clinical efficacy in the treatment of acute ischemic stroke at the early stage,which can effectively alleviate the degree of neurological deficit and reduce the focus,without increasing the incidence of adverse drug reactions.