阿加曲班注射液治疗静脉溶栓后24h内进展性卒中患者的临床研究

Clinical trial of argatroban injection in the treatment of patients with progressive stroke within 24 h after intravenous thrombolysis

目的观察阿加曲班注射液治疗静脉溶栓后24 h内进展性卒中患者的临床疗效及安全性。方法将100例静脉溶栓后24 h内进展性卒中患者随机分为对照组和试验组,每组50例。对照组给予调脂、降糖、降压及溶栓24 h后抗血小板聚集等常规治疗;试验组在对照组治疗的基础上,给予阿加曲班每次20 mg,q8 h,静脉泵入,48 h后改为每次10 mg,bid,静滴连续5 d。比较2组患者的临床疗效,美国国立卫生院卒中量表(NIHSS)和改良Rankin量表(MRS)评分,凝血功能,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94.00%(47例/50例)和70.00%(35例/50例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的NIHSS评分分别为(3.22±2.22)和(5.36±4.69)分,MRS评分分别为(1.36±1.32)和(1.96±1.62)分,差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有牙龈出血和呕吐,对照组发生的药物不良反应有呕吐。试验组和对照组的总药物不良反应发生率分别为4.00%和2.00%,差异无统计学意义(P>0.05)。结论阿加曲班注射液治疗静脉溶栓后24 h内进展性卒中患者的临床确切,其可显著改善患者的神经功能,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of argatroban injection in the treatment of patients with progressive stroke within 24 h after intravenous thrombolysis.Methods A total of 100 patients with progressive stroke within 24 h after intravenous thrombolysi were randomly divided into control and treatment groups with 50 cases per group.Control group was treated with routine therapy such as lipid regulation,hypoglycemia,blood pressure and anti-platelet aggregation after thrombolysis for 24 hours.Treatment group was given argatroban 20 mg per time,q8 h,intravenous pumping,48 hours later,the dose was adjusted to argatroban 10 mg per time,bid,and continued for 5 days,on the basis of control group.The clinical efficacy,national institute of health stroke scale(NIHSS),modified rankin scale(MRS)and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 94.00%(47 cases/50 cases)and 70.00%(35 cases/50 cases)with significant difference(P<0.05).After treatment,the NIHSS scores of treatment and control groups were(3.22±2.22)and(5.36±4.69),the MRS scores were(1.36±1.32)and(1.96±1.62),the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were gingival bleeding and vomiting,while those in control group were vomiting.The incidences of total adverse drug reactions in treatment and control groups were 4.00%and 2.00%without significant difference(P>0.05).Conclusion Argatroban injection has a definitive clinical efficacy in the treatment of patients with progressive stroke within 24 h after intravenous thrombolysis,which can significantly improve the neurological function,without increasing the incidence of adverse drug reactions.