| ObjectiveThis study is to observe the clinical efficacy of Huoxue Jiangtangyin formula combined with epalrestat tablets in the treatment of diabetic peripheral neuropathy(DPN)with qi and yin deficiency and stasis syndrome,and to investigate its potential mechanisms of regulation of blood glucose and anti-inflammatory agsinst DPN,which provides evidence for the therapeutic effect and mechanism researches of Traditional Chinese Medicine in the treatment and prevention of DPN.MethodsAccording to the case-control method,90 patients with DPN who met the inclusion criteria were divided into control group and treatment group according to the principle of random control.All patients were given basic diabetic treatment,the treatment group were treated with Huoxue Jiangtang decoction combined with Epalrestat,while the control group were treated with Epalrestat alone,both with a course of 8 weeks.Before and after treatment,the scores of TCM symptoms and clinical signs were recorded,Serum Fasting blood-glucose(FPG),2-hour postprandial blood glucose(2hPG),glycosylated hemoglobin(HbA1c),high mobility group protein B1(HMGB1),toll-like receptor 2(TLR2),toll like receptor 4(TLR4),myeloid differentiation protein 88(MyD88),interleukin-6(IL-6)and tumor necrosis factor a(TNF-α)were detected,and double down median nerve current perception threshold(CPT)were measured.Statistical analysis was performed to compare the differences between the two groups in the end.ResultsTCM syndrome score:It had no significantly statistical difference before treatment among two groups(P>0.05).The score of TCM syndrome in both groups significantly decreased compared with that before(P<0.05).And compared with the control group,the treatment group was significantly lower(P<0.05).Score of difference before and after treatment of the treatment group was significantly higher compared with the control group(P<0.05).Clinical signs score:It had no significantly statistical difference before treatment among two groups(P>0.05).The score of clinical signs in both groups were significantly decreased compared with that before(P<0.05).And compared with the control group,the treatment group was significantly lower(P<0.05).Score of difference before and after treatment was significantly higher compared with the control group(P<0.05).Glucose metabolism:There was no significantly statistical difference in FPG and 2hPG among two groups before treatment(P>0.05).The level of FPG and 2hPG of both groups were significantly decreased compared with that before(P<0.05).And compared with the control group,FPG and 2hPG of the treatment one significantly decreased(P<0.05).The difference of FPG and 2hPG before and after treatment in the two groups was significantly larger in the treatment group than in the control one(P<0.05).There was no significantly statistical difference in HbAlc both before and after treatment among two groups(P>0.05).The difference of HbAlc before and after treatment between the two groups met no statistical significant difference(P>0.05).Serum HMGB1,TLR2,TLR4,MyD88,IL-6,INF-α:It had no significantly statistical difference in HMGB1 among two groups(P>0.05).After treatment,HMGB1 in the treatment groups significantly decreased compared with that before(P<0.05),but the control group didn’t(P>0.05).And compared with the control group,HMGB1 of treatment one significantly decreased(P<0.05).The difference of HMGB1 before and after treatment among two groups showed that the treatment group was significantly larger than the control one(P<0.05).Before treatment,there was no significantly statistical difference in TLR2 and TLR4 among two groups(P>0.05).After treatment,The TLR2 and TLR4 in the two groups decreased significantly compared with those before(P<0.05).And compared with the control group,TLR2 and TLR4 of the treatment one was decreased more significantly(P<0.05).The difference of TLR2 and TLR4 before and after treatment in the two groups was significantly larger in the treatment group than in the control one(P<0.05).The difference of HMGB1 between the two groups before and after treatment was positively correlated with the difference of TLR2 and TLR4(r>0,P<0.05).It had no significantly statistical difference in MyD88 among two groups before treatment(P>0.05).After treatment,there was a decrease in MyD88 in both groups compared with that before,and there was a significant difference in the treatment group(P<0.05),but not among the controls(P>0.05).And compared with the control group,MyD88 of the treatment one was decreased more significantly(P<0.05).The difference of MyD88 before and after treatment in the two groups showed that the treatment group was significantly larger than the controls(P<0.05).It had no significantly statistical difference in IL-6 and TNF-α among two groups before treatment(P>0.05).After treatment,The IL-6 and TNF-αlevels in both groups decreased significantly compared with those before(P<0.05).And compared with the control group,IL-6 and TNF-α of the treatment one decreased more significantly(P<0.05).The differences of IL-6 and TNF-α before and after treatment in the two groups were significantly larger in the treatment group than in the control one(P<0.05).The CPT:Before treatment,median nerve CPT in both lower limbs of the two groups at different frequencies shows no significant difference(P>0.05).After treatment,at 5Hz level,the CPT in both the treatment group and the control group decreased significantly before and after treatment(P<0.05).Compared with the control group,the right median nerve CPT decreased more significantly in the treatment group(P<0.05).At 250Hz,the CPT in both the treatment group and the control group(right limb)decreased significantly before and after treatment(P<0.05).Compared with the control group,right CPT decreased significantly in the treatment group(P<0.05).At 2000Hz,It had no significant difference before and after treatment in bilateral CPT in both groups(P>0.05),in addition,it had no significant difference in bilateral CPT among two groups(P>0.05).ConclusionIn the treatment of Qi and Yin deficiency and blood stasis type of DPN,Huoxuejiangtang decoction combined with Epalrestat is superior to Epalrestat alone in decreasing clinical symptoms,lowering blood glucose and alleviating nerve injury.It may reduce nerve injury in DPN by regulating related factors in TLR2/TLR4-MyD88 pathway by regulating the expression of HMGB1.Meanwhile,Huoxue Jiangtang decoction has no obvious adverse reactions and toxic side effects in clinical use,and it is safe in clinical application. |
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