| Objective:To explore the mechanism of buyanghuanwu decoction on white matter fiber in convalescent cerebral infarction.Methods:The research type is randomized controlled clinical trial.Using a third party center randomized method to recruit clinical subj ects,which are cerebral infarction patients in convalescence with qi deficiency and blood stasis syndrome.Subjects were randomly divided into control group and treatment group and each group use western medical treatment as basic support.The treatment group used buyanghuanwu decoction formula granule as intervention whereas the control group used placebos formula granule as intervention.The course of treatment is a total of 12 weeks.Each subj ect would be examined through diffusion tensor imaging(DTI)scanning respectively at the beginning of the trial and the 12th weeks after intervention.The obervation location is based on the region of interests(ROI)method,which includes the both sides of the anterior thalamic radiation(ATR.L,ATR.R),the corticospinal tract(CT.L,CT.R),cingulum(cingulate gyrus)(CCG.L,CCG.R),the cingulum(hippocampus)(CH.L,CH.R),Inferior.fronto-occipital.fasciculus(IFF.L,IFF.R),superior longitudinal fasciculus(SLF.L,SLF.R),superior.longitudinal.fasciculus.(temporal.part)(SLFT.L,SLFT.R),inferior longitudinal fasciculus(ILF.L,ILF.R),uncinate fasciculus(UF.L,UF.R),and forceps.major(FMA),forceps.minor(FMI).Extracting the corresponding "fraction anisotropy(FA)"," mean diffusitity(MD)"," axial diffusivity(λ1)"," radial diffusivity(λ23)" of all the above ROIs as technical analysis indicators.Using the general linear analysis method to make a comparision of the variation trend between the two groups before and after the intervention,and to explore the mechanism of buyanghuanwu decoction on white matter fiber in convalescent cerebral infarction.Results:In this study,a total of 20 patients were included in the full analysis set,including 10 patients in the control group and 10 patients in the treatment group.Apart from the dropouts and excluding patients,there were eventually 15 patients included in the per-protocol set,which were 6 patients in the control gr oup and 9 patients in the treatment group.Comparing the examining data of the two groups before and after treatment,we found the following results.There were 7 sites were proved changing in FA value,5 sites were proved changing in λ1,λ23 value and only 1 site was proved changing in MD value of all ROIs.Of the 7 ROIs of changed FA values,there were 6 sites in the treatment group,and in the other 3 indicators of changed sites,only 1 site of each reflected the changes of treatment group.Also,at the CT,the values of the 4 indicators are changed,and there were 3 indicators’ values were observed at the FMA and CCG as well.Examined the statistical differences of the two groups before and after treatment in FA,MD,λ1,λ23 based on the above findings,it was found that,at the CCG.R,the downward trend of FA value was more gentle in the treatment group than that of the control group,and the difference was statistically significant(F=6.380,P=0.025).The upward trend of λ23 value was more gentle in the treatment group than that of the control group,and the difference was statistically significant(F=7.794,P=0.015).Similarly,at the ATR.L,the upward trend of λ23 value was more gentle in the treatment group than that of the control group,and the difference was statistically significant(F=7.750,P=0.016).While in other ROIs,there was no statistically significant difference between the two groups in FA value and λ23 value(P>0.05).At the CCG.L,the trend of λ1 value in the treatment group was downward,but the appearance was opposite for the control group,and the difference was statistically significant(F=6.364,P=0.025).While in other ROIs,there was no statistically significant difference between the two groups in λ1 value(P>0.05).In all ROIs,there was no statistically significant difference between the two groups in MD value(P>0.05).Conclusion:To a certain extent,buyanghuanwu decoction can improve the compactness of local white matter fiber arrangement and enhance the integrity of myelin sheath in cerebral infarction patients convalescence with qi deficiency and blood stasis syndrome,and may have a certain repairing effect on the overall structure of white matter fiber.However,this conclusion is still in the exploratory stage,and this study can only preliminarily reveal the effective trend of buyanghuanwu decoction on the white matter fiber in the convalescent stage of cerebral infarction.Its reliability and generalizability still needs to be further demonstrated. |