ABSTRACT
Objective:To observe the effects of adjuvant therapy of Huayu pills on neurological recovery of patients with acute cerebral infarction (ACI) and syndrome of Qi deficiency and blood stasis, and to investigate its mechanism of action for antioxidation, anti-inflammation and improvement of microcirculation. Method:One hundred and forty patients were randomly divided into control group (70 cases) and observation group (70 cases) by random number table. During the study period, there were 3 drop-out cases, 2 excluded cases, and 65 completed cases in the control group. There were 1 drop-out cases, 4 excluded case, and 65 completed cases in the observation group. Western medicine was given in both groups. Patients in control group additionally got oral administration of Xiaoshuang Tongluo tablets, 6 tablets/time, 3 times/day. The patients in observation group got oral administration of Huayu pills, 5 g/time, 2 times/days. The treatment course was 4 weeks in both groups. Before the treatment, and at the second and fourth week after treatment, scores of national institute of health stroke scale (NIHSS) were graded. Before and after treatment, scores of functional independent measures (FIM) scale, fugl-meyer assessment of motor function (FMA), Qi deficiency and blood stasis syndrome were graded. Disability/mortality and safety were discussed after treatment. Levels of the whole blood viscosity (BV), plasma viscosity (PV), platelet aggregation rate (PAG), fibrinogen (FIB), P-selectin (CD62p), D-dimer (D-D), superoxide dismutase (SOD), malondialdehyde (MDA), nitric oxide (NO), lipid peroxide (PLO), homocysteine (Hcy), tumor necrosis factor -α (TNF-α), serum cystatin C (Cys-C) and hypersensitive C-reactive protein (hs-CRP) were detected both before and after treatment. Result:In the analysis of rank sum test, clinical efficacy in observation group was better than that in control group (Z=2.131, P<0.05). At the second and fourth week after treatment, scores of NIHSS, Qi deficiency and blood stasis, as well as levels of NO, PLO, MDA, Hcy, Cys-C, hs-CRP, TNF-α, BV, PV, PAG, FIB, CD62 p and D-D in observation group were lower than those in control group (P<0.01), while levels of FIM, FMA and SOD were all higher than those in control group (P<0.01). Conclusion:Based on the comprehensive treatment of Western medicine, adjuvant therapy of Huayu pills can improve the degree of nerve function defect, improve the ability of exercise and daily life, reduce the degree of disability, improve the microcirculation and hemorheology, reduce the inflammatory reaction, eliminate oxygen free radicals, and relieve the oxidative stress injury in patients with ACI and Qi deficiency and blood stasis syndrome, and the clinical efficacy is better than that of Western medicine alone.
ABSTRACT
Objective:To establish the quality standard for Huayu pills. Methods:TLC was adopted to identify salvia miltiorrhi-za, rhubarb charcoal and panax notoginseng; the contents of tanshinoneⅡA , chrysophanol and physcion in Huayu pills were deter-mined by RP-HPLC with Wondasil C18 (250 mm × 4. 6 mm,5μm) as the analytical column, the mobile phase was composed of metha-nol-0. 1% phosphoric acid solution (85 ∶15), the flow rate was 1. 0 ml·min-1,the detection wavelength was 254 nm, the column temperature was 35℃, and injection volume was 10 μl. Results:The TLC spots were clear and well-separated without any negative in-terference; the calibration curve of tanshinoneⅡA , chrysophanol and physcion was linear over the range of 0. 212-2. 12 μg ( r =0. 999 9),0. 159-1. 59 μg(r=0. 999 9) and 0. 072 6-0. 726 μg(r=0. 999 9), the average recovery was 99. 55 %, 99. 56% and 100. 60%, and RSD was 1. 57%,2. 26% and 2. 28%(n=6), respectively. Conclusion: The method is fast and accurate with good specificity, and can be used for the quality control of Huayu pills.