补肾化瘀方联合西药治疗脑小血管病的临床研究

Clinical study of Bushen Huayu Prescription combined with Western medicine in the treatment of cerebral small vessel disease

目的观察补肾化瘀方联合西药干预脑小血管病(CSVD)患者的临床疗效。方法收集252例CSVD受试者,病例来源于上海市第六人民医院、上海市第八人民医院,研究时限为2015年3月~2017年12月。将所有患者分为补肾化瘀干预组、安慰剂对照组,每组126例。疗程24周,分别于干预0、12、24周检测:24h动态血压;血清总胆固醇(TC)、三酰甘油(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、空腹血糖(FBG)、餐后2h血糖(2hPBG)、糖化血红蛋白(HbA1c),比较两组干预前后上述各指标的变化水平,同时比较两组干预0、24周记忆与执行筛查量表(MES)的评分变化。结果两组干预前24h平均收缩压、24h平均舒张压、TC、TG、LDL-C、HDL-C、FBG、2hPBG、HbA1c比较,差异均无统计学意义(P>0.05);干预后,两组24h平均收缩压、24h平均舒张压、TC、TG、LDL-C、FBG均较干预前显著下降,HDL-C均较干预前显著升高,补肾化瘀干预组干预后HbA1c显著低于干预前,差异有统计学意义(P<0.05或P<0.01);两组干预后2hPBG与干预前比较差异均无统计学意义(P>0.05);两组干预后上述各指标比较差异均无统计学意义(P>0.05)。干预后,两组MES评分均较治疗前显著提高,且补肾化瘀干预组MES评分显著高于安慰剂对照组,差异有高度统计学意义(P<0.01)。全分析集统计结果与符合方案集统计结果一致。结论补肾化瘀方联合西药基础治疗干预CSVD可降低血压、血脂、HbA1c,提高MES评分,有助于延缓或阻断CSVD患者从轻度认知障碍到严重认知障碍、最终发展为痴呆的演变过程。

Objective To observe the curative effect of Bushen Huayu Prescription combined with Western medicine for intervenion of cerebral small vessel disease(CSVD).Methods Total 252 subjects with CSVD were collected,the patients were from Shanghai Sixth People′s Hospital and Shanghai Eighth People′s Hospital,the time limit was from March 2015 to December 2017.All patients were divided into Bushen Huayu intervention group and placebo control group,with 126 cases in each group.The course was 24 weeks,the indices were detected at 0,12,24 weeks after intervention:24 h ambulatory blood pressure;serum total cholesterol(TC),triglyceride(TG),high density lipoprotein cholesterol(HDL-C),low density lipoprotein cholesterol(LDL-C),fasting blood glucose(FBG),2-hour post-meal blood glucose(2hPBG),glycosylated hemoglobin(HbA1c),the changes of all indices above between two groups were compared before and after intervention,at the same time,and the changes of memory and executive screening scale(MES)of the two groups were compared at 0,24 weeks after intervention.Results Before intervention,there were no statistically significant differences of the mean systolic blood pressure in 24 hours,mean diastolic blood pressure in 24 hours,TC,TG,LDL-C,HDL-C,FBG,2hPBG and HbA1c between the two groups(P>0.05);after intervention,the systolic blood pressure in 24 hours,mean diastolic blood pressure in 24 hours,TC,TG,LDL-C,FBG in the two groups were significantly lower than those before intervention,HDL-C were significantly higher than those before intervention,the level of HbA1c in the Bushen Huayu intervention group was lower than that before intervention,with statistically significant differences(P<0.05 or P<0.01);there was no statistically signifcant difference of 2hPBG in the two groups after intervention compared with those before intervention(P>0.05);there were no statistically significant differences of the indices above between the two groups after intervention(P>0.05).After intervention,the scores of MES in the two groups were all higher than those before intervention,and the score of MES in Bushen Huayu intervention group was higher than that in placebo control group,the differences were highly statistically signifcant(P<0.01).The statistical results of full analysis set were consistent with per protocol set.Conclusion Bushen Huayu Prescription combined with basci Western medicine for intervenion of CSVD can decrease blood pressure,blood lipid,HbA1c,and increase MES scores,which is helpful to delay or block the evolution process of CSVD patients from mild cognitive impairment to severe cognitive impairment,and to dementia finally.