中药联合辛伐他汀治疗急性脑梗死的临床疗效

Clinical curative effect of integrated traditional Chinese medicine combined with simvastatin treatment on acute cerebral infarction

目的观察中药联合辛伐他汀治疗急性脑梗死的近期及远期效果。方法 150例急性脑梗死患者随机分为对照组、辛伐他汀组和联合治疗组,每组50例。对照组采用脑梗死规范药物治疗,包括抗血小板积聚、调整血糖和血压、改善循环、保护神经细胞、降低脑水肿及相关营养支持治疗,并给予健康教育及早期综合康复治疗,出院后常规口服药物治疗;辛伐他汀组在对照组治疗基础上每日1次加用辛伐他汀40 mg口服,出院后在常规药物治疗的基础上继续坚持每日1次口服辛伐他汀40 mg;联合治疗组在辛伐他汀组治疗的基础上,按中医辨证论治加用中草药方剂。3组患者于入组时和治疗4、8、24周后分别进行美国国立卫生院神经功能缺损评分(NIHSS)及生活质量评分(BI),并比较血总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白(LDL)及高密度脂蛋白(HDL)水平。3组患者均定期随访,共随访4 a,观察比较再发急性脑梗死、心肌梗死、脑出血及死亡情况。结果治疗前3组患者的血脂水平、NIHSS和BI比较差异均无统计学意义(P>0.05)。治疗4、8、24周后,与治疗前比较,对照组患者血脂水平无明显变化(P>0.05),NIHSS明显降低(P<0.05),BI明显提高(P<0.05);辛伐他汀组和联合治疗组患者TC、TG、LDL水平和NIHSS与治疗前及对照组的同时间点相比较均明显降低(P<0.05),而BI均明显提高(P<0.05);联合治疗组患者的TC、LDL水平明显低于辛伐他汀组(P<0.05)。治疗8、24周后,联合治疗组患者的NIHSS显著低于辛伐他汀组(P<0.05),BI均显著高于辛伐他汀组(P<0.05)。随访4 a,辛伐他汀组和联合治疗组患者心肌梗死的发病率和脑梗死再发病率均低于对照组(P<0.05);辛伐他汀组患者心肌梗死发病率和脑梗死再发病率与联合治疗组比较差异无统计学意义(P>0.05);3组患者的脑出血发病率及病死率比较差异无统计学意义(P>0.05)。联合治疗组与辛伐他汀组不良反应比较差异无统计学意义(P>0.05)。结论中药联合辛伐他汀防治急性脑梗死更有利于降低血脂水平,改善患者预后并提高其生活质量,联合治疗安全有效。

Objective To observe the short-term and long-term effect of integrated traditional Chinese medicine combined with simvastatin on acute cerebral infarction patients. Methods A total of 150 patients with acute cerebral infarction were randomly divided into control group（ n = 50）, simvastatin group（ n = 50） and integrated treatment group （n = 50）. The patients in control group were treated with standardized drug including anti-platelet aggregation, adjusting blood sugar and blood pressure, improving cerebral blood circulation, protecting the nerve cells, reducing brain edema and other related nutritional support treatment,and were given health-education and ear｜y comprehensive rehabilitation, who were given routine oral drug treatment after discharge. On the basis of the treatment of control group, the patients in the simvastatin group had received simvastatin （40 mg, once a day）. Patients in the integrated treatment group additionally took Chinese medicine apart from receiving the same treatment as the simvastatin group. The rating scales such as National Institutes of Health Stroke Scale（NIHSS） and barthel index （BI） were used to evaluate all patients at pre-therapy, after 4,8 and 24 weeks of treatment. At the same time, the levels of total cholesterol （ TC ）, triglyceride （ TG）, low density lipoprotein （LDL） and high density lipoprotein （HDL） were measured and compared among the three groups. All patients were followed up for 4 years on a regular basis, and the incidence of the cerebral infarction, the myocardial infarction, intracerebral hemorrhage and deathy were observed and compared. Results There were no statistically significance difference about lipid levels and the scores of NIHSS and BI among the three groups before treatment（P 〉 0.05 ）. After 4,8 and 24 weeks of treatment, the lipid levels in the control group had no obvious change compared with those before treatment （ P 〉 0.05 ）, while the scores of NIHSS were significantly lower （ P 〈 0.05 ）, and the scores of BI were increased significantly（ P 〈 0.05 ）. In the simvastatin group and the integrated treatment group, the levels of TC, TG, LDL-C and the scores of NIHSS were significantly lower than before treatment and the same time of the control group （P 〈 0.05 ） ,but the scores of BI were increased significantly（P 〈 0.05 ）. In the integrated treatment group,the levels of TC and LDL-C were obviously lower than those in the simvastatin group（P 〈 0.05 ）. After 8 and 24 weeks of treatment, the scores of NIHSS of the integrated treatment group were significantly lower and the scores of BI were increased obviously than those of the simvastatin group（P 〈 0.05）. After 4 years, the incidence of cerebral infarction and myocardial infarction in the two treatment groups were obviously lower than those of the control group （P 〈 0.05 ）, but there was no obviously difference between the two treatment groups（P 〉 0.05 ）;and there was no obviously difference in the intracerebral hemorrhage and deathy event rate among the three groups（ P 〉 0.05 ）. There was no obviously difference comparing the adverse reaction between the simvastatin group and the integrated treatment group （P 〉 0.05 ）. Conclusion Integrated traditional Chinese medicine and simvastatin can significantly reduce the blood lipid level and perfect the prognosis, improve the life qualities of stroke patients, and the integrated treatment is safety.