| Objective: By detecting the number of microbleeds,blood lipid levels,homocysteine levels,coagulation function,and consulting room blood pressure levels before and after treatment,the MMSE score and traditional Chinese medicine syndrome integral were measured to explore the mechanism of action and clinical efficacy of Naotaifang Capsule in treating hypertensive cerebral small vessel disease patients with cerebral microbleeds(Qi Deficiency and Blood Stasis Syndrome,Wind and Phlegm Blocking Collateral Syndrome),Evaluate the clinical efficacy and safety of Naotaifang capsule in the treatment of hypertensive cerebral small vessel disease patients with cerebral microbleeding(Qi Deficiency and Blood Stasis Syndrome,Wind and Phlegm Blocking Collateral Syndrome).Methods: This study adopts a multicenter,randomized,double-blind,simulated parallel controlled trial design.Collect patients from the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine,the First Affiliated Hospital of Shaoyang College,Changde First Traditional Chinese Medicine Hospital,and Wuyi Traditional Chinese Medicine Hospital of Jiangmen City,Guangdong Province,who met the inclusion criteria from July 2020 to April 2022.After the introduction period,all subjects were randomly divided into an experimental group and a control group,with the experimental group receiving Naotaifang capsules and the control group receiving simulated agents,The intervention period is 6 months.The efficacy analysis was conducted on 66 patients who completed the visit,with the main efficacy indicator being the number of microbleeds;Secondary efficacy indicators include blood lipid levels,homocysteine levels,coagulation function,MMSE scores,traditional Chinese medicine syndrome scores,and consulting room blood pressure levels;Liver and kidney function,myocardial enzyme spectrum,etc.are used as safety indicators.Conduct efficacy and safety indicators testing before enrollment,at the 3rd and 6th months,and use SPSS software for statistical analysis of the test data.Results: 1.Analysis of patient s basic data: This study included 66 patients with hypertension cerebral small vessel disease complicated with CMBs who completed follow-up,and there was no statistical difference in gender or age between the two groups(P>0.05),indicating comparability.2.Comparison of the number of CMBs: There was no statistically significant difference in the number of CMBs between the experimental group and the control group,but it was found that the total effective rate in the experimental group was higher than that in the control group.The number of CMBs in the experimental group decreased compared to before treatment.3.LDL-C comparison: There was no statistically significant difference between the control group and the experimental group in the difference(visit 1-introduction period),but there was an increase in the LDL-C difference between the experimental group’s visit 1-introduction period and the control group’s visit 1-introduction period;There was no statistically significant difference in the difference between the control group and the experimental group(visit 2-introduction period),but the difference in visit 2-introduction period between the experimental group and the control group increased less.4.Comparison of HCY: There was no statistically significant difference between the control group and the experimental group(visit1-introduction period),but in this sample,the experimental group showed a decrease in HCY compared to the control group;There was no statistically significant difference in the difference between the control group and the experimental group(visit 2-introduction period),but the HCY difference between the experimental group and the control group was relatively low in this sample.5.APTT comparison: There was no statistically significant difference in the difference between the control group and the experimental group(visit 1-introduction period);There was no statistically significant difference in the difference between the control group and the experimental group(visit 2-introduction period),but there was a decrease in the difference between the visit 2-introduction period in the experimental group and the control group.The difference between the visit 2-introduction period and the visit 1-introduction period in the experimental group decreased more.6.Comparison of MMSE scores: There was no statistically significant difference between the control group and the experimental group(visit1-introduction period);There was no statistically significant difference in the difference between the control group and the experimental group(visit 2-introduction period),but in this sample,the MMSE score of the experimental group during visit 2-introduction period increased compared to visit 1-introduction period.7.Comparison of Traditional Chinese Medicine Syndrome Score Differences: There was no statistically significant difference between the control group and the experimental group(visit 1-introduction period).However,in this sample,the TCM syndrome score of the experimental group decreased compared to the control group,and the TCM syndrome score of the experimental group decreased more compared to the control group;There was no statistically significant difference in the difference between the control group and the experimental group(visit 2-introduction period).However,in this sample,the experimental group showed a decrease in traditional Chinese medicine syndrome scores.8.Comparison of Traditional Chinese Medicine Syndrome Score Efficacy: There was no statistically significant difference in the efficacy of traditional Chinese medicine syndrome during the introduction period compared to visit 1,but the total effective rate of the experimental group was higher than that of the control group;There was no statistically significant difference in the efficacy of traditional Chinese medicine syndromes during the introduction period compared to visit 2.9.Comparison of blood pressure levels in the consultation room:Systolic blood pressure: There was no statistically significant difference between the control group and the experimental group(visit1-introduction period),but there was a decrease in the difference between the experimental group’s visit 1-introduction period and the control group’s visit 1-introduction period;There was no statistically significant difference in the difference between the control group and the experimental group(visit 2-introduction period).However,there was a greater decrease in the difference in systolic blood pressure between the experimental group visit and the control group visit during the 2-introduction period.Diastolic blood pressure: There was no statistically significant difference in the difference between the control group and the experimental group(visit 1-introduction period),but the difference in visit 1-introduction period between the experimental group and the control group decreased more;There was no statistically significant difference in the difference between the control group and the experimental group(visit 2-introduction period).There was an increase in the difference in diastolic blood pressure between the experimental group’s visit 2-introduction period and the control group’s visit 2-introduction period.10.Analysis of safety indicators: Both groups of patients showed no significant abnormalities in liver and kidney function,myocardial enzyme spectrum,etc.Conclusion: 1.Naotaifang Capsule may be effective in reducing the number of CMBs,reducing LDL-C and HCY levels,shortening APTT,and controlling blood pressure elevation.2.Naotaifang Capsule may improve cognitive function by increasing MMSE scores and promoting the recovery of traditional Chinese medicine clinical syndromes.3.Naotaifang Capsule has no obvious adverse reactions or side effects,and has high safety. |
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