| Objective:Mild Cognitive Impairment(MCI)is a high-risk disease for clinical screening of Alzheimer’s disease(AD).Early detection and timely intervention in the treatment of MCI can provide the best treatment time for delaying or blocking the formation of Alzheimer’s disease.This study was to investigate the effect of Modified Shuyu Pill combined with high-frequency(10Hz)repetitive transcranial magnetic stimulation on the clinical efficacy and safety of mild cognitive impairment.It is hoped that it will provide a new choice for the clinical treatment of MCI and delaying and preventing the conversion process of MCI to AD.Methods:1.Study design:This study adopts randomized and controlled principles.According to the criteria for inclusion of MCI,90 patients were randomly divided into three groups: control group,Chinese medicine group and comprehensive group,each group consisting of 30 people.2.Treatment methods:Three groups of patients were treated with basic treatment for the original disease.The control group only gave basic treatment.The Chinese medicine group on the basis oftreatment,to the Modified Shuyu Pill treatment with warm water half an hour after meals every morning and evening and 15 ml each time.The comprehensive group was given high-frequency repetitive transcranial magnetic stimulation on the basis of the Chinese medicine group every other day,the frequency was 10 Hz,and the location was DLPFC in the left side of the frontal lobes.The treatment course of the three groups was 4 weeks.3.Efficacy observation:Before the start of treatment and after the end of treatment,the MMSE score,MoCA score,ADL score,TCM syndrome score were evaluated in three groups of patients,Calculated the clinical efficacy of TCM,analyzed the above results by statistical software,assessed its safety by observing and recording adverse reactions simultaneously.Results:1.MMSE scale scores: At the end of the course of treatment,the comparison results of the same group before and after treatment was P>0.05 in the control group,P<0.05 in the TCM group and the comprehensive group.After treatment between groups,the comparison results was P<0.05 between the control group and the TCM group,P<0.01 between the control group and the comprehensive group,and the TCM group and the comprehensive group.The results suggested that the basic treatment had no significant improvement on the MMSE scale score,both of Modified Shuyu Pill and it’s combination of high-frequency rTMS treatment can improve the MMSE scale score,which is beneficial to the recovery of cognitive function in MCI patients.The treatment effect of the comprehensive group was better than that of the TCM group significantly,the TCM group better than the control group.2.MoCA scale scores:At the end of the course of treatment,the comparison results of the same group before and after treatment was P>0.05 in the control group,P<0.05 in the TCM group and the comprehensive group.After treatment between groups,the comparison results was P<0.05 between the control group and the TCM group,P<0.01 between the control group and the comprehensive group,and the TCM group and the comprehensive group.The results suggested that the basic treatment had no significant improvement on the MoCA scale score,both of Modified Shuyu Pill and it’s combination of high-frequency rTMS treatment can improve the MoCA scale score,which is beneficial to the recovery of cognitive function in MCI patients.The treatment effect of the comprehensive group was better than that of the TCM group significantly,the TCM group better than the control group.3.ADL scale scores:At the end of the course of treatment,the comparison results of the same group before and after treatment was P>0.05 in the control group,P<0.05 in the TCM group and the comprehensive group.After treatment between groups,the comparison results was P < 0.01 between the control group and the TCM group,control group and the comprehensive group,and the TCM group and the comprehensive group.The results suggest that basic treatment has no significant effect on the ability of daily living activities of MCI patients,both of Modified Shuyu Pill and it’s combination of high-frequency rTMS treatment can significantly reduce the ADL scale score,which is beneficial to the recovery of daily living activities of MCI patients.The treatment effect of the comprehensive group was better than that of the TCM group significantly,the TCM group better than the control groupsignificantly.4.TCM syndrome scale scores:At the end of the course of treatment,the comparison results of the same group before and after treatment was P>0.05 in the control group,P<0.05 in the TCM group and the comprehensive group.After treatment between groups,the comparison results was P<0.01 between the control group and the TCM group,the control group and the comprehensive group,and the TCM group and the comprehensive group.The results suggest that basic treatment has no significant improvement on the TCM syndrome of MCI patients.both of Modified Shuyu Pill and it’s combination of high-frequency rTMS treatment can significantly reduce the TCM syndrome scale,which is beneficial to the improvement of TCM syndrome in MCI patients.The treatment effect of the comprehensive group was better than that of the TCM group significantly,the TCM group better than the control group significantly.5.Efficacy of TCM syndromes:At the end of the course of treatment,the rank sum test of K independent samples showed P<0.05 and indicated that there was a difference in the overall clinical efficacy between the three groups.Further analysis and comparison showed that the comparison results was P < 0.0167 between the control group and the TCM group,the control group and the comprehensive group,and the TCM group and the comprehensive group.The results suggest that both of Modified Shuyu Pill and it’s combination of high-frequency rTMS treatment can significantly improve the clinical efficacy of TCM syndromes in MCI patients,and the treatment effect of the comprehensive group was better than that of the TCM group,the TCM group better than the control group.6.Safety evaluation:In this study,patients had fewer adversereactions during treatment,and there were no obvious abnormalities in the safety indicators before and after treatment.The result suggested that Modified Shuyu Pill combined with high-frequency rTMS was safe enough for the clinical treatment of MCI.Conclusion:Modified Shuyu Pill combined with high-frequency(10HZ)repetitive transcranial magnetic stimulation can effectively improve the cognition and daily living ability and safe enough in patients with Mild Cognitive Impairment,and the treatment effect is better than that of the TCM group,the TCM group better than the control group. |
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