| Objective1.To observe the effect of modified Tongluo Recipe on acute ischemic stroke(ACI),High mobility group box 1(HMGB1)mediates toll like receptor4(TLR4)signaling pathway and related inflammatory factors in patients with ACI,and to further explore the mechanism of Jiawei Tongluo Recipe in the treatment of qi deficiency,yin deficiency and blood stasis.2.Objective evaluation on the efficacy and safety of modified Tongluo Recipe in the treatment of ACI patients with Qi deficiency,yin deficiency and blood stasis.3.To analyze the correlation between inflammatory factors and the scale,and to find more convenient and rapid indicators to evaluate the condition and prognosis of ACI.MethodThis study is a randomized controls,single-blind study.90 cases of ACI with Qi deficiency,yin deficiency and blood stasis,which met the inclusion criteria and did not meet the exclusion criteria were selected as the subjects.They were randomly divided into Jiawei Tongluo group(group Ⅰ),Tongluo Ⅳ group(group Ⅱ)and control group(group Ⅲ),with 30 cases in each group.Group Ⅰ was given Jiawei Tongluo prescription and conventional treatment.Group Ⅱ was given Tongluo Ⅳ prescription and conventional treatment.And group Ⅲ was given conventional treatment.The course of treatment was 14 days.NIHSS scale,Barthel Index and TCM symptom score were evaluated before and on the 14 th day of treatment.Serum HMGB1,TLR4 mRNA,C-reactive protein(CRP),white blood count(WBC),percentage of neutrophilic granulocyte(N%)and safety evaluation were detected before and on the 14 th day of treatment.Results1.Baseline comparisonThere was no significant difference in gender and age among the three groups(P>0.05).It is suggested that the baseline consistency is good and comparable.2.Comparison of inflammatory biomarkersBefore treatment,there were no significant differences in the serum HMGB1(P>0.05).The serum HMGB1 of the three groups decreased after treatment.Comparison between groups: there was significant difference in serum HMGB1 between group Ⅰ and group Ⅲ after treatment(P<0.01).There was significant difference in serum HMGB1 between group Ⅰ and group Ⅱ after treatment(P<0.01).There was significant difference in serum HMGB1 between group Ⅱ and group Ⅲ after treatment(P<0.05).The difference between groups before and after treatment: there was significant difference between group Ⅰ and groupⅡ(P<0.05),and there was significant difference between group Ⅰ and groupⅢ(P<0.01).There was significant difference between group Ⅱ and group Ⅲ(P<0.01).Intra group comparison: after treatment,serum HMGB1 of the three groups decreased compared with that before treatment,and the differences were statistically significant(P<0.01).Before treatment,there were no significant differences in the serum TLR4 mRNA(P>0.05).The serum TLR4 mRNA of the three groups decreased after treatment.Comparison between groups: there was significant difference in serum TLR4 mRNA between group Ⅰ and group Ⅲ after treatment(P<0.01).And there was significant difference in serum TLR4 mRNA between group Ⅰ and groupⅡ after treatment(P<0.01).There was significant difference in serum TLR4 mRNA between group Ⅱ and group Ⅲ after treatment(P<0.05).The difference between groups before and after treatment: There was significant difference between group Ⅰ and group Ⅲ(P<0.01).There was significant difference between group Ⅱ and group Ⅲ(P < 0.05).But there was no significant difference between group Ⅰ and group Ⅱ(P>0.05).Intra group comparison:after treatment,serum TLR4 mRNA in group Ⅰ,group Ⅱ and group Ⅲ decreased compared with that before treatment(P<0.01).Before treatment,there were no significant differences in CRP(P>0.05).CRP of the three groups decreased after treatment.Comparison between groups:there was significant difference in CRP between group Ⅰ and group Ⅲ after treatment(P<0.01).And there was significant difference in CRP between groupⅠand group Ⅱ after treatment(P<0.05).And there was significant difference in CRP between group Ⅱ and group Ⅲ after treatment(P<0.05).The difference between groups before and after treatment: There was significant difference between group Ⅰ and group Ⅱ(P<0.01),and there was significant difference between group Ⅰ and group Ⅲ(P < 0.01).But there was no significant difference between group Ⅱ and group Ⅲ(P>0.05).Intra group comparison:CRP in group Ⅰ decreased after treatment compared with that before treatment(P<0.01).CRP in group Ⅱ and group Ⅲ decreased after treatment,but the difference was not statistically significant(P>0.05).Before treatment,there were no significant differences in blood WBC(P>0.05).Blood WBC after treatment: there was significant difference in WBC between group Ⅰ and group Ⅲ(P<0.01),and there was statistical difference between group Ⅰ and group Ⅱ(P<0.05).However,there was no significant difference in blood WBC between group Ⅱ and group Ⅲ after treatment(P>0.05).The difference between groups before and after treatment: There was significant difference between group Ⅰ and group Ⅱ(P<0.01),and there was significant difference between group Ⅰ and group Ⅲ(P<0.01).But the difference was not statistically significant between group Ⅱ and group Ⅲ(P>0.05).Intra group comparison: after treatment,WBC in group Ⅰ decreased significantly(P<0.01).The WBC of group Ⅱ and group Ⅲ decreased slightly after treatment,but there was no statistical difference(P>0.05).Before treatment,there were no significant differences in blood N%(P>0.05).N% after treatment: there were significant differences between groupⅠ and group Ⅲ,group Ⅱ and group Ⅲ(P<0.05).But there was no significant difference in N% between group Ⅰ and group Ⅱ(P>0.05).The difference between groups before and after treatment: there was significant difference between group Ⅰ and group Ⅲ(P<0.01).There was significant difference between group Ⅱ and group Ⅲ(P < 0.05).But the difference was not statistically significant between group Ⅰ and group Ⅱ(P>0.05).Intra group comparison: after treatment,N% in group Ⅰ and group Ⅱ decreased significantly(P<0.01).N% of the group Ⅲ decreased after treatment,and there was statistical difference(P<0.05).3.Comparison of scale scoresBefore treatment,there were no significant differences in the scores of NIHSS(P > 0.05).NIHSS of the three groups decreased after treatment.Comparison between groups: there was significant difference in NIHSS between group Ⅰ and group Ⅲ after treatment(P<0.01).However,there was no significant difference in NIHSS between group Ⅱ and group Ⅲ,group Ⅰ and group Ⅱ after treatment(P>0.05).The difference between groups before and after treatment: there was significant difference between group Ⅰ and groupⅡ(P<0.01),and there was significant difference between group Ⅰ and groupⅢ(P<0.01).But there was no significant difference between group Ⅱ and group Ⅲ(P>0.05).Intra group comparison: NIHSS in group I and group Ⅱdecreased after treatment compared with that before treatment(P<0.01).NIHSS in group Ⅲ decreased slightly after treatment,but the difference was not statistically significant(P>0.05).Before treatment,there were no significant differences in the scores of BI(P>0.05).Comparison of BI scale score between groups after treatment:there were significant differences in BI between group Ⅰ and group Ⅲ,between group Ⅱ and group Ⅲ(P<0.01),but there was no significant difference between group Ⅰ and group Ⅱ(P>0.05).The difference between groups before and after treatment: there was significant difference between group Ⅰ and group Ⅱ(P<0.05),and there was significant difference between group Ⅰ and group Ⅲ(P<0.01).There was significant difference between group Ⅱ and groupⅡ(P<0.05).Intra group comparison: after treatment,BI in group Ⅰ and groupⅡ increased significantly(P < 0.01).The BI scale score of group Ⅲincreased slightly after treatment,but there was no statistical difference(P>0.05).Before treatment,there were no significant differences in the scores of Diagnosis and efficacy evaluation of strokes scale cores(P>0.05).After treatment,there was a significant difference in the Diagnosis and efficacy evaluation of strokes scale cores between group Ⅰ and group Ⅱ,group Ⅰ and group Ⅲ(P<0.01).There were significant differences between group Ⅱ and group Ⅲ(P<0.05).The difference between groups before and after treatment:There was no significant difference between the three groups before and after treatment.Intra group comparison: after treatment,the scale score of groupⅠ,group Ⅱ and group Ⅲ decreased significantly(P<0.01).Before treatment,there were no significant differences in the scores of stroke TCM syndrome score scale(P>0.05).Comparison of stroke TCM syndrome score scale between groups after treatment: there was significant difference between group Ⅰ and group Ⅱ(P<0.01),and there was also significant difference between group Ⅰ and group Ⅲ(P < 0.01).But there was no significant difference between groupⅡ and group Ⅲ(P>0.05).The difference between groups before and after treatment: There was no significant difference between the three groups before and after treatment.Intra group comparison:after treatment,the scores of stroke TCM syndrome score scale in the three groups were decreased compared with those before treatment,and there were significant differences(P<0.01).4.Efficacy comparisonAfter treatment,compared with group Ⅱ and group Ⅲ,the neurological function of group Ⅰ was significantly improved(P<0.01).Compared with groupⅢ,the neurological function of group Ⅱ was not improved(P>0.05).Compared with group Ⅲ,the activities of daily living were significantly improved in group Ⅰ,group Ⅱ(P<0.01).There was no difference in the activities of daily living between group Ⅰ and group Ⅱ(P>0.05).Compared with group Ⅲand group Ⅱ,TCM syndromes in group Ⅰ was significantly improved(P<0.01).There was no difference in the curative effect of TCM syndromes between groupⅡ and group Ⅲ(P>0.05).In group Ⅰ,the total effective rate of neurological function improvement was 73.3%,the total effective rate of the activities of daily living improvement was 36.7%,and the total effective rate of TCM syndrome improvement was 86.7%.Group Ⅰ was the best,group Ⅱ was the second,and group Ⅲ was the worst.5.Correlation analysisBefore treatment,there was a significant positive correlation between serum TLR4 mRNA and the score of NIHSS,BI,and Diagnosis and efficacy evaluation of strokes scale cores(r>0,P<0.01).The CRP was significantly positively correlated with N%(r>0,P<0.01).The WBC was significantly positively correlated with N%(r>0,P<0.01).The N% was significantly positively correlated with Diagnosis and efficacy evaluation of strokes scale cores(r>0,P<0.01).The scores of NIHSS was negatively correlated with BI score(r<0,P<0.05),and significantly positively correlated with Diagnosis and efficacy evaluation of strokes scale cores(r>0,P<0.01),positively correlated with the scores of stroke TCM syndrome score scale(r>0,P<0.05).After treatment,there was a significant positive correlation between serum HMGB1 and Diagnosis and efficacy evaluation of strokes scale cores(r>0,P<0.01).There was a significant positive correlation between the serum TLR4 mRNA and the scores of NIHSS,Diagnosis and efficacy evaluation of strokes scale cores(r>0,P<0.01).There was a positive correlation between serum TLR4 mRNA and CRP,Diagnosis and efficacy evaluation of strokes scale cores(r>0,P<0.05).The serum TLR4 mRNA was negatively correlated with BI score(r<0,P<0.05).The CRP was significantly positively correlated with N%,Diagnosis and efficacy evaluation of strokes scale cores and the scores of stroke TCM syndrome score scale after treatment(r>0,P<0.05).The WBC was significantly positively correlated with Diagnosis and efficacy evaluation of strokes scale cores after treatment(r>0,P<0.05).The N% was positively correlated with the scores of NIHSS(r>0,P<0.05).The N% was positively correlated with the scores of NIHSS after treatment(r>0,P<0.05).The scores of NIHSS was significantly positively correlated with Diagnosis and efficacy evaluation of strokes scale cores after treatment(r>0,P<0.01),and significantly negatively correlated with BI score(r<0,P<0.01).There was a significant negatively correlation between the scores of BI and Diagnosis and efficacy evaluation of strokes scale cores(r>0,P<0.01).There was a positive correlation between Diagnosis and efficacy evaluation of strokes scale cores and the scores of stroke TCM syndrome score scale after treatment(r>0,P<0.05).Before and after treatment,serum HMGB1,TLR4 mRNA,CRP,WBC,N%,NIHSS scale score,BI scale score,TCM syndrome score scale for stroke and stroke diagnosis and curative effect evaluation score were positively correlated(r>0,P<0.01).Conclusion1.Jiawei Tongluo Prescription can effectively reduce the levels of HMGB1 and TLR4 mRNA,inhibit the HMGB1/TLR4 Signal pathway,reduce the blood WBC,N% and CRP,and reduce the inflammatory reaction;2.Jiawei Tongluo Prescription can effectively improve the neurological function,activities of daily living and TCM Syndromes of ACI patients with Qi deficiency,yin deficiency and blood stasis;3.Jiawei Tongluo Prescription may protect the brain by inhibiting HMGB1/TLR4 signaling pathway and reducing the release of inflammatory factors.4.Serum TLR4 mRNA is closely related to neurological impairment,activities of daily living and TCM Syndromes of stroke in patients with ACI,which can be used as an index to judge the condition and prognosis of ACI.5.CRP and N% are consistent in reflecting the inflammation of ACI patients,which can be used as the detection indexes of ACI inflammation in daily clinical diagnosis and treatment. |
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