复元活血汤加减联合吡拉西坦治疗老年性痴呆肾虚血瘀证的临床观察

Clinical Observation of Modified Fuyuan Huoxue Decoction Combined with Piracetam on Alzheimer’s Disease of Shenxuxueyu(肾虚血瘀) Syndrome

目的:探讨复元活血汤加减联合吡拉西坦治疗老年性痴呆(AD)肾虚血瘀证的临床疗效。方法:240例患者随机分为中药组、西药组和联合组,分别给予复元活血汤加减、吡拉西坦、复元活血汤加减联合吡拉西坦,疗程均为12 w。观察各组治疗前后简易智能状态检查量表(MMSE)、长谷川痴呆量表(HDS)、老年痴呆患者生活质量量表(QOL-AD)、中医症状评分。检测各组血流变指标[高切全血粘度(HBV)、低切全血粘度(LBV)、红细胞压积(HCT)、纤维蛋白原(Fg)],血脂[高密度脂蛋白(HDL-c)、低密度脂蛋白(LDL-c)、三酰甘油(TG)、载脂蛋白a(Apo-a)]水平,蛋白[神经元特异性烯醇化酶(NSE)、高迁移率族蛋白B;(HMGB;)、微管相关蛋白(Tau)、髓鞘碱性蛋白(MBP)]水平。比较各组临床疗效及安全性。结果:联合组总有效率96.2%(75/78),高于中药组的77.6%(56/74)和西药组的75.6%(59/76)(P<0.05)。与治疗前比较,中药组和联合组MMSE、HDS、QOL-AD、HDL-c明显升高(P<0.05),中医症状评分、HBV、LBV、HCT、Fg、LDL-c、TG、Apo-a、NSE、HMGB;、Tau、MBP值明显降低(P<0.05);西药组MMSE、QOL-AD明显升高(P<0.05),HBV、LBV、Fg、LDL-c、TG、Apo-a、NSE、HMGB;、Tau、MBP值明显降低(P<0.05)。联合组治疗后MMSE、HDS、QOL-AD、HDL-c值较中药组和西药组升高(P<0.05);中医症状评分、HBV、LBV、HCT、Fg、LDL-c、TG、Apo-a、NSE、HMGB;、Tau、MBP值较中药组和西药组降低(P<0.05)。结论:复元活血汤加减联合吡拉西坦可有效改善AD肾虚血瘀证患者的临床症状,其作用机制可能与影响蛋白生成有关。

Objective:To observe the clinical efficacy of modified Fuyuan Huoxue Decoction combined with piracetam in the treatment of Alzheimer’s disease(AD)differentiated into Shenxuxueyu(肾虚血瘀)syndrome.Methods:Two hundred and forty patients were randomly divided into the traditional Chinese medicine(TCM)group,western medicine(WM)group,and combined medication group,and separately treated with the modified Fuyuan Huoxue Decoction,piracetam,and modified Fuyuan Huoxue Decoction combined with piracetam for 12 weeks.The mini-mental state examination(MMSE),Hasegawa dementia scale(HDS),quality of life in Alzheimer’s disease(QOL-AD),and TCM symptom score before and after treatment were observed.Then the hemorheological indexes[high whole blood viscosity(HBV),low whole blood viscosity(LBV),hematocrit(HCT),and fibrinogen(Fg)],blood lipids[high-density lipoprotein-cholesterol(HDL-c),low-density lipoprotein-cholesterol(LDL-c),triglyceride(TG),and apolipoprotein a(Apo-a)],and proteins[neuron specific enolase(NSE),high mobility group box B1(HMGBl),microtubule-associated protein(Tau),and myelin basic protein(MBP)]were detected.The clinical efficacy and safety were compared in each group.Results:The total effective rate in the combined medication group was 96.2%(75/78),which was higher than 77.6%(56/74)in the TCM group and 75.6%(59/76)in the WM group(P<0.05).Compared with the situations before treatment,the MMSE,HDS,QOL-AD,and HDL-c levels in the TCM and combined medication groups were significantly increased(P<0.05),while the TCM symptom score,HBV,LBV,HCT,Fg,LDL-c,TG,Apo-a,NSE,HMGB1,Tau,and MBP were significantly decreased(P<0.05),In the WM group,the MMSE and QOL-AD were significantly elevated(P<0.05),while the HBV,LBV,Fg,LDL-c,TG,Apo-a,NSE,HMGB1,Tau,and MBP were significantly lowered(P<0.05).After combined medication,the MMSE,HDS,QOL-AD,and HDL-c levels were higher than those in the TCM group and WM group(P<0.05),whereas the TCM symptom score,HBV,LBV,HCT,Fg,LDL-c,TG,Apo-a,NSE,HMGB1,Tau,and MBP were lower(P<0.05).Conclusion:The modified Fuyuan Huoxue Decoction combined with piracetam effectively improves the clinical symptoms of patients with AD differentiated into Shenxuxueyu(肾虚血瘀)syndrome,which may be related to its influence on protein production.