注射用鼠神经生长因子联合注射用重组人TNK组织型纤溶酶原激活剂治疗急性脑梗死患者的临床研究  

Clinical trial of mouse nerve growth factor injection combined with recombinant human TNK tissue-type plasminogen activator injection in the treatment of patients with acute cerebral infarction

作　　者：吴松[1] 金肇权[1] 孙丹[1] 朱明慧[1] WU Song;JIN Zhao-quan;SUN Dan;ZHU Ming-hui(Department of Emergency,Changzhou First People’s Hospital,Changzhou 213003,Jiangsu Province,China)

机构地区：[1]常州市第一人民医院急诊科,江苏常州213003

出　　处：《中国临床药理学杂志》2022年第3期199-202,共4页The Chinese Journal of Clinical Pharmacology

基　　金：江苏省自然科学基金面上基金资助项目(BK20131458)。

摘　　要：目的观察注射用鼠神经生长因子联合注射用重组人TNK组织型纤溶酶原激活剂(rhTNK-tPA)治疗急性脑梗死(ACI)患者的临床疗效及安全性。方法将122例ACI患者随机分为对照组和试验组,每组61例。对照组给予0.9 mg·kg^(-1) rhTNK-tPA,最大剂量≤90 mg,首先静脉推注总剂量的10%,在1 min内完成,将剩下90%剂量在60 min内静脉滴注完毕;24 h后对头颅进行计算机断层扫描技术(CT)复查,未见脑出血则给予阿司匹林肠溶片每次100 mg,qd,持续2周。试验组在对照组治疗的基础上,给予鼠神经生长因子18μg,qd,肌内注射,持续治疗2周。比较2组患者的临床疗效、血清可溶性细胞间黏附分子-1(sICAM-1)和髓鞘碱性蛋白(MBP)水平,药物不良反应及血管再通情况。结果试验过程中共脱落2例。治疗后,试验组和对照组的总有效率分别为93.33%(56例/60例)和80.00%(48例/60例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的sICAM-1分别为(292.46±16.24)和(316.85±17.95)μg·L^(-1),MBP分别为(2.19±0.35)和(2.63±0.37)μg·L^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有头晕、心律失常、颅内出血和皮肤黏膜出血,对照组的药物不良反应主要有头晕、心律失常和颅内出血。试验组和对照组的总药物不良反应发生率分别为11.67%和6.67%,差异无统计学意义(P>0.05)。试验组和对照组治疗后6个月的血管再通率分别为93.33%(56例/60例)和80.00%(48例/60例),差异有统计学意义(P<0.05)。结论注射用鼠神经生长因子联合rhTNK-tPA治疗ACI患者的临床疗效确切,其能显著改善血清sICAM-1和MBP水平,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of mouse nerve growth factor injection combined with recombinant human TNK tissue-type plasminogen activator injection(rhTNK-tPA)in the treatment of patients with acute cerebral infarction(ACI).Methods A total of 122 ACI patients were randomly divided into control and treatment groups with 61 cases per group.The control group was given 0.9 mg·kg^(-1) rhTNK-tPA,the maximum dose was≤90 mg.First,10%of the total dose was injected intravenously within 1 minute,and the remaining 90%of the dose was injected intravenously within 60 minutes.After 24 hours,the head was re-examined by computed tomography(CT),those without cerebral hemorrhage were given aspirin enteric-coated tablets 100 mg each time,qd,the treatment lasted for 2 weeks.On the basis of control group,the treatment group was additionally given 18μg,qd,intramuscular injection of rat nerve growth factor,and continued treatment for 2 weeks.The clinical efficacy,serum soluble intercellular adhesion molecule-1(sICAM-1),myelin basic protein(MBP)levels,adverse drug reactions and vascular recanalization were compared between the two groups of patients.Results A total of 2 cases fell off during the trial.After treatment,the total effective rates of treatment group and control group were 93.33%(56 cases/60 cases)and 80.00%(48 cases/60 cases),and the difference was statistically significant(P<0.05).After treatment,the sICAM-1 of the treatment group and control group were(292.46±16.24)and(316.85±17.95)μg·L^(-1),and the MBP were(2.19±0.35)and(2.63±0.37)μg·L^(-1),the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were dizziness,arrhythmia,intracranial hemorrhage and skin mucosal hemorrhage,while those in control group were dizziness,arrhythmia,and intracranial hemorrhage.The total adverse drug reaction rates of the treatment group and control group were 11.67%and 6.67%without significant difference(P>0.05).The vascular recanalization rates of the treatment

关 键 词：注射用重组组织型纤维蛋白溶酶原激活剂 注射用鼠神经生长因子 急性脑梗死 安全性评价 

分 类 号：R972[医药卫生—药品]