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Clinical study of Bushen Huayu Prescription combined with Western medicine in the treatment of cerebral small vessel disease |
LIANG Fang1 HUO Qingping1 CHEN Xu2 ZHAO Yuwu3 |
1.Department of Traditional Chinese Medicine, Shanghai Sixth People′s Hospital, Shanghai 200233, China;
2.Department of Neurology, Shanghai Eighth People′s Hospital, Shanghai 200233, China;
3.Department of Neurology, Shanghai Sixth People′s Hospital, Shanghai 200233, China |
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Abstract 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.
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