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[摘要]
【目的】 探讨蛭龙活血通瘀胶囊联合依达拉奉治疗缺血性脑血管病(ICVD)气虚血瘀证患者的疗效及其对血清可溶性细 胞表面分化抗原40配体(sCD40L)、脂蛋白磷脂酶A2(Lp-PLA2)、糖化白蛋白(GA)的影响。【方法】 将2022年3月至2023年 10月在邯郸市中医院接受治疗的117例ICVD气虚血瘀证患者随机分为对照1组、对照2组和研究组,每组各39例。3组均给 予利尿、调节血脂、抗血小板、降压等基础治疗,在此基础上,对照1组给予依达拉奉治疗,对照2组给予蛭龙活血通瘀胶 囊治疗,研究组给予蛭龙活血通瘀胶囊联合依达拉奉治疗,疗程均为14 d。观察3组患者治疗前后神经功能美国国立卫生研 究院脑卒中量表(NIHSS)评分、日常生活能力改良Barthel指数(MBI)评分、脑血流动力学指标[收缩期峰流速(PSV)、舒张期 末流速(EDV)、平均流速(Vm)、血管搏动指数(PI)、阻力指数(RI)]、神经因子[神经元特异性烯醇化酶(NSE)、S100β 蛋白 (S100β)、人脑髓鞘碱性蛋白(MBP)]、血管内皮功能指标[血管性血友病因子(vWF)、内皮素 1(ET-1)、一氧化氮(NO)] 以及血清sCD40L、Lp-PLA2、GA水平的变化情况,比较3组患者的临床疗效及不良反应发生率。【结果】(1)疗效方面,治疗 14 d后,研究组的总有效率为94.87%(37/39),明显高于对照1组的71.79%(28/39)和对照2组的76.92%(30/39),差异均有统 计学意义(P < 0.05);而对照1组与对照2组比较,差异无统计学意义(P > 0.05)。(2)脑血流动力学指标方面,治疗后,3组患 者大脑中动脉(MCA)的PSV、EDV、Vm、PI均较治疗前升高(P < 0.05),RI均较治疗前下降(P < 0.05),且研究组对MCA的 PSV、EDV、Vm、PI的升高幅度及对RI的下降幅度均明显优于对照1组和对照2组(P < 0.05);而对照1组与对照2组治疗后 MCA的 PSV、EDV、Vm、PI、RI比较,差异均无统计学意义(P > 0.05)。(3)血清sCD40L、Lp-PLA2、GA水平方面,治疗后, 3组患者的血清sCD40L、Lp-PLA2、GA水平均较治疗前下降(P < 0.05),且研究组对血清 sCD40L、Lp-PLA2、GA水平的下降 幅度均明显优于对照1组和对照2组(P < 0.05);而对照1组与对照2组治疗后血清sCD40L、Lp-PLA2、GA水平比较,差异 均无统计学意义(P > 0.05)。(4)神经因子方面,治疗后,3 组患者的血清 NSE、S100β、MBP 水平均较治疗前下降(P < 0.05),且研究组对血清NSE、S100β、MBP水平的下降幅度均明显优于对照 1 组和对照 2 组;而对照 1 组与对照 2 组治疗后 血清 NSE、S100β、MBP 水平比较,差异均无统计学意义(P > 0.05)。(5)血管内皮功能方面,治疗后,3组患者的血清vWF、 ET-1水平均较治疗前下降(P < 0.05),血清NO水平均较治疗前升高(P < 0.05),且研究组对血清vWF、ET-1水平的下降幅度及 对血清NO水平的升高幅度均明显优于对照1组和对照2组(P < 0.05);而对照1组与对照2组治疗后血清vWF、ET-1、NO水平比 较,差异均无统计学意义(P > 0.05)。(6)神经功能和日常生活能力方面,治疗后,3 组患者的 NIHSS 评分均较治疗前下降 (P < 0.05),MBI评分均较治疗前升高(P < 0.05),且研究组对NIHSS评分的下降幅度及对MBI评分的升高幅度均明显优于对 照1组和对照2组(P < 0.05);而对照1组与对照2组治疗后的NIHSS、MBI评分比较,差异均无统计学意义(P > 0.05)。(7)不 良反应方面,研究组的不良反应发生率为15.38%(6/39),对照1组为7.69%(3/39),对照2组为12.82%(5/39),组间比较,差 异无统计学意义(P > 0.05)。【结论】 蛭龙活血通瘀胶囊联合依达拉奉治疗ICVD气虚血瘀证患者疗效显著,能改善血液循环, 恢复神经功能,提高日常活动能力,且具有较高的安全性,其机制可能与改善血管内皮功能,下调血清NSE、S100β、MBP 等神经因子以及血清sCD40L、Lp-PLA2、GA表达水平有关。
[Key word]
[Abstract]
Objective To investigate the therapeutic efficacy of Zhi Long Huoxue Tongyu Capsules combined with Edaravone in the treatment of patients with ischemic cerebrovascular disease(ICVD)of qi deficiency and blood stasis syndrome, and to explore their effect on serum levels of soluble cluster of differentiation 40 ligand (sCD40L), lipoprotein phospholipase A2(Lp-PLA2), and glycated albumin(GA). Methods A total of 117 patients with ICVD of qi deficiency and blood stasis syndrome were randomly divided into control group 1, control group 2,and study group,with 39 patients in each group. The three groups were all given basic treatment with agents of diuretic,lipid regulation,antiplatelet,and antihypertensive,and additionally,control group 1 was given Edaravone,control group 2 was given Zhi Long Huoxue Tongyu Capsules,and the study group was given Zhi Long Huoxue Tongyu Capsules combined with Edaravone. The course of treatment for the three groups covered 14 days. Before and after treatment,the three groups were observed in the changes of National Institutes of Health Stroke Scale(NIHSS)scores for neurological function,modified Barthel Index(MBI)scores for activities of daily living(ADL),cerebral hemodynamics indicators [peak systolic velocity(PSV),end-diastolic velocity (EDV),mean velocity(Vm),pulsatility index(PI),and resistance index(RI)],neurofactors [neuron-specific enolase(NSE), S100β protein(S100β), and myelin basic protein(MBP)], vascular endothelial function indicators [von Willebrand factor(VWF), endothelin 1(ET-1), and nitric oxide(NO)], and levels of serum sCD40L,Lp-PLA2,and GA. After treatment,the clinical efficacy and the incidence of adverse reactions among the three groups of patients were compared. Results(1)After 14 days of treatment,the total effective rate of the study group was 94.87%(37/39),which was significantly higher than that of control group 1 [71.79%(28/39)] and control group 2 [76.92%(30/39)],the differences being statistically significant(P < 0.05). No statistically significant difference was shown between control group 1 and control group 2(P > 0.05).(2)After treatment,the cerebral hemodynamics indicators of PSV,EDV,Vm,and PI of the middle cerebral artery(MCA)in the three groups were increased compared with those before treatment(P < 0.05),and the RI was decreased compared with that before treatment(P < 0.05). The increase of PSV,EDV,Vm,and PI of the MCA and the decrease of RI in the study group were significantly superior to those in control group 1 and control group 2(P < 0.05). No statistically significant differences in PSV,EDV,Vm,PI,and RI of MCA were shown between control group 1 and control group 2 after treatment(P > 0.05).(3)After treatment,the serum sCD40L,Lp-PLA2,and GA levels in the three groups were decreased compared with those before treatment(P < 0.05),and the decrease in the study group was significantly superior to that in control group 1 and control group 2(P < 0.05). However,the differences of the serum levels after treatment between control group 1 and control group 2 were not statistically significant(P > 0.05).(4)After treatment,the serum levels of neurofactors of NSE,S100β,and MBP in the three groups were all decreased compared with those before treatment(P < 0.05),and the decrease of the serum levels in the study group was significantly superior to that in control group 1 and control group 2, while the differences of the serum levels after treatment between control group 1 and control group 2 were not statistically significant(P > 0.05).(5)After treatment,the vascular endothelial function indicators of serum vWF and ET-1 levels in the three groups were decreased compared with those before treatment(P < 0.05),and the serum NO level was increased compared with that before treatment(P < 0.05). The decrease of serum vWF and ET-1 levels and the increase of serum NO level in the study group were significantly superior to those in control group-1 and control group-2(P < 0.05),while the difference of serum vWF, ET-1 and NO levels after treatment between control group 1 and control group 2 were not statistically significant(P > 0.05).(6)After treatment,the NIHSS scores for neurological function in the three groups were decreased(P < 0.05)and the MBI scores for ADL were increased(P < 0.05)compared with those before treatment,and the decrease of the NIHSS scores and the increase of the MBI scores in the study group was significantly superior to those in control group 1 and control group 2(P < 0.05),while and the differences of NIHSS and MBI scores after treatment between control group 1 and control group 2 were not statistically significant(P > 0.05).(7)The incidence rate of adverse reactions was 15.38%(6/39) in the study group,7.69%(3/39)in the control group 1,and 12.82%(5/39)in the control group 2,and the pairwise comparison between groups showed that the difference was not statistically significant (P > 0.05). Conclusion Zhi Long Huoxue Tongyu Capsules combined with Edaravone exert certain efficacy in the treatment of patients with ICVD of qi deficiency and blood stasis syndrome,and the combined therapy is effective on improving blood circulation, restoring neurological function, enhancing the ADL, with higher safety. Its therapeutic mechanism may be related to the improvement of the vascular endothelial function,and the down-regulation of serum levels of neurofactors of NSE,S100 β,MBP,and serum expression levels of sCD40L,Lp-PLA2,and GA.
[中图分类号]
R277.7
[基金项目]
河北省重点研发计划项目(编号:22010382048D);邯郸市科学技术研究与发展计划项目(编号:19422083019-2)