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目的探讨预防脑梗死再发联合治疗方案的效果、终点事件发生及安全性的对照研究。方法初发性脑梗死患者978例,随机分为治疗组626例,对照组352例,治疗组给予个体化血压调治技术,联合抗血小板治疗及危险分层下小剂量辛伐他汀达标,三大类药物构成一体化的治疗方案。对照组给予降压、单纯阿司匹林抗血小板及危险分层下小剂量辛伐他汀达标的治疗方案。比较两组3年和5年后脑梗死再发率、终点事件发生率、不良反应及依从性情况。结果治疗组治疗后3年和5年脑梗死再发率、心脏事件发生率均明显低于对照组,5.4%vs 13.6%、7.8%vs21.0%、5.8%vs 11.6%(P<0.01),治疗后5年总病死率低于对照组,4.2%vs 7.1%(P<0.05)。治疗组治疗后3年和5年功能健康水平均高于对照组(P<0.05)。治疗组头痛发生率高于对照组(P<0.05)。两组脑出血、肝酶升高、消化道出血、癌症的发生率差异均无统计学意义(P>0.05)。对照组退出率高于治疗组,13.6%vs 5.3%(P<0.01)。结论预防脑梗死再发联合治疗方案,在脑梗死二级预防中能显著降低脑梗死再发率、心脏事件发生率和病死率,极大的提高了功能健康水平。患者对药物依从性好,而且安全性也好。
Objective To explore the effect of prevention and treatment of recurrent cerebral infarction and the occurrence and safety of end-point events. Methods A total of 978 patients with primary cerebral infarction were randomly divided into treatment group (626 cases) and control group (352 cases). The treatment group was given individualized blood pressure control technique. Combined with antiplatelet therapy and low-dose simvastatin under risk stratification, Drugs constitute an integrated treatment program. Control group was given antihypertensive, anti-aspirin platelets and risk stratification of low-dose simvastatin standard treatment. The incidence of recurrent cerebral infarction, the incidence of end point events, adverse reactions and compliance were compared between the two groups after 3 years and 5 years. Results The incidence of recurrent cerebral infarction and cardiac events at 3 years and 5 years after treatment in the treatment group were significantly lower than those in the control group (5.4% vs 13.6%, 7.8% vs21.0% vs 5.8% vs 11.6%, P <0.01) The overall mortality after 5 years of treatment was lower than that of the control group (4.2% vs 7.1%, P <0.05). Three and five years after treatment in the treatment group, the functional health level was higher than that in the control group (P <0.05). The incidence of headache in the treatment group was higher than that in the control group (P <0.05). There was no significant difference in the incidence of cerebral hemorrhage, elevated liver enzymes, gastrointestinal bleeding and cancer between the two groups (P> 0.05). The withdrawal rate of the control group was higher than that of the treatment group, 13.6% vs 5.3% (P <0.01). Conclusion Prevention of recurrent cerebral infarction combined with regimens can significantly reduce the incidence of recurrent cerebral infarction, cardiac events and mortality in the secondary prevention of cerebral infarction, and greatly improve the functional health. Patient compliance with the drug is good and safe.