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目的探讨症状性脑动脉狭窄未行支架植入患者多类药物一体化治疗方案的效果、终点事件及安全性。方法初发的症状性脑动脉狭窄患者1 126例,随机分为治疗组787例,对照组339例。治疗组给予个体化分层血压调治技术,联合抗血小板及分层下调治血糖、血脂、纤维蛋白原的多类药物小剂量一体化协同治疗。对照组给予降压、单纯阿司匹林抗血小板、降糖、降脂、降纤的治疗方案。比较两组治疗后3年和5年健康功能水平、责任颈动脉狭窄区斑块内部回声特征、终点事件、不良反应、依从性情况。结果治疗组3年和5年脑梗死发生和复发、心脏事件、出血性表现、低血糖的发生率均明显低于对照组6.0%vs 13.3%、9.5%vs 19.2%、5.8%vs 12.4%、1.9%vs 6.2%、2.3%vs 7.1%(P<0.01)。治疗组3年和5年健康功能水平均高于对照组(P<0.05);超声复查斑块均较对照组稳定(P<0.05);治疗后5年病死率低于对照组4.2%vs 7.4%(P<0.05)。两组头痛发生率差异有统计学意义(P<0.05)。对照组退出率高于治疗组13.6%vs 5.3%(P<0.01)。结论症状性脑动脉狭窄未行支架植入患者多类药物一体化治疗方案显著降低了脑梗死发生和复发、心脏事件、出血性表现和低血糖的不良反应,极大提高了功能健康水平,效果显著,使用安全,患者依从性好。
Objective To investigate the efficacy, end point and safety of multi-drug therapy in patients with symptomatic cerebral arterial stenosis who underwent stent implantation. Methods A total of 1 126 symptomatic patients with symptomatic cerebral artery stenosis were randomly divided into treatment group (787 cases) and control group (339 cases). The treatment group was given individualized stratified blood pressure control technology, combined anti-platelet and stratified down regulation of blood glucose, blood lipids, fibrinogen multi-drug combination of low-dose treatment. The control group was given antihypertensive, aspirin anti-platelet alone, hypoglycemic, lipid-lowering, fibrinolytic treatment. The levels of health function of the two groups after 3 years and 5 years of treatment were compared, and the internal echo features, end point events, adverse reactions and compliance of the responsible carotid stenosis plaque area were compared. Results The incidence and recurrence of cerebral infarction at 3 years and 5 years in the treatment group were significantly lower than those in the control group (6.0% vs 13.3%, 9.5% vs 19.2%, 5.8% vs 12.4%, respectively) 1.9% vs 6.2%, 2.3% vs 7.1% (P <0.01). The levels of health function in the treatment group at 3 years and 5 years were higher than those in the control group (P <0.05). The plaques were more stable in the ultrasound group than those in the control group (P <0.05). The 5-year mortality rate was 4.2% vs 7.4 % (P <0.05). The incidence of headache between the two groups was statistically significant (P <0.05). The withdrawal rate of the control group was higher than that of the treatment group by 13.6% vs 5.3% (P <0.01). Conclusions Multi-drug therapy in patients with symptomatic cerebral arterial stenosis without stent implantation significantly reduces the incidence and recurrence of cerebral infarction, cardiac events, hemorrhagic manifestations and adverse reactions of hypoglycemia, which greatly improves the functional health level Significant, safe to use and patient-friendly.