阿加曲班注射液联合高压氧治疗急性缺血性脑卒中的临床研究

Clinical trial of argatroban injection combined with hyperbaric oxygen in the treatment of acute ischemic stroke

目的观察阿加曲班注射液联合高压氧治疗急性缺血性脑卒中(AIS)的临床疗效及安全性。方法将78例AIS患者随机分为对照组39例和试验组39例。对照组前1~2 d予以阿加曲班60 mg持续静脉泵入,第3天开始予以阿加曲班每次10 mg,bid,静脉滴注3 h;试验组在对照组治疗的基础上,予以高压氧治疗,压力0.2 MPa,氧浓度为纯氧,每天1次,每次60 min。2组患者均治疗10d。比较2组患者的临床疗效、炎症因子水平、和肽素(CPP)和N末端脑钠肽前体(NT-proBNP)水平、中国脑卒中临床神经功能缺损程度量表(NDS)和欧洲卒中量表(ESS)评分、梗死面积,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84.62%(33例/39例)和71.79%(28例/39例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的CPP分别为(2.78±0.36)和(4.19±0.57)pmol·L^(-1),NT-proBNP分别为(127.34±18.08)和(214.54±30.16)pmol·L^(-1),NDS评分分别为(12.84±1.77)和(18.28±2.42)分,ESS评分分别为(68.44±9.74)和(62.18±8.62)分,差异均有统计学意义(均P<0.01)。2组患者治疗期间均未发生药物不良反应。结论阿加曲班注射液联合高压氧治疗AIS的临床疗效确切,且安全性较好。

Objective To observe the clinical efficacy and safety of argatroban injection combined with hyperbaric oxygen in the treatment of acute ischemic stroke（ AIS）. Methods A total of 78 patients with AIS were randomly divided into control and treatment groups with 39 cases per group. Control group received argatroban injection 60 mg per time,continuous intravenous infusion for day 1 to 2,and on the third day,adagiban was given 10 mg per time,bid,intravenous drip for 3 hours. Treatment group was treated with hyperbaric oxygen for 60 min with the pressure was 0. 2 MPa,oxygen concentration was pure oxygen,once a day,on the basis of control group. Two groups were treated for 10 days. The clinical efficacy,levels of inflammatory cytokines,copeptin（ CPP） and N terminal pro brain natriuretic peptide（ NT-proBNP）,Chinese stroke clinical neurological deficit scale（ NDS） and European stroke scale（ ESS） score,and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 84. 62%（ 33 cases/39 cases） and 71. 79%（ 28 cases/39 cases） with significant difference（ P〈0. 05）. After treatment,the main indexes in treatment and control groups were compared： CPP were（ 2. 78 ± 0. 36） and（ 4. 19 ± 0. 57） pmol · L^-1, NT-pro BNP were（ 127. 34 ± 18. 08） and（ 214. 54 ± 30. 16） pmol·L^-1,NDS scores were（ 12. 84 ± 1. 77） and（ 18. 28 ± 2. 42）points,ESS scores were（ 68. 44 ± 9. 74） and（ 62. 18 ± 8. 62） points,the differences were statistically significant（ all P〈0. 01）. There were no significant adverse drug reactions occurred in two groups during the treatment. Conclusion Argatroban injection combined with hyperbaric oxygen has a definitive clinical efficacy and safety in the treatment of AIS.