Clinical Study On The Treatment Of Type 2 Diabetes With Lower Limb Neuropathy (Upper Heat And Lower Cold Type) With Modified Wumei Pill

Objective: To observe the clinical curative effect of Wumei pill flavored formula in the treatment of type 2 diabetes mellitus(T2DM)with lower limb neuropathy(upper hot and lower cold type),and to offer rationale and clinical basis support for the treatment of T2 DM with lower limb neuropathy(upper hot and lower cold type)by objective estimate of its efficacy and safety.Methods: 60 patients who met the inclusion criteria in Jinan Hospital of Traditional Chinese Medicine from 2021.12 to 2022.12 were stochastically divided into observation group and control group with 30 patients in each group.The control group was given blood glucose control,diabetes(DM)education,and mecobalamin tablet orally.The observation group was given Wumei pill flavored formula on the basis of blood glucose control,diabetes education,and mecobalamin tablet orally.Record the TCM syndrome score,TCM syndrome efficacy,Toronto score,blood glucose(including FBG,2h FBG),glycosylated hemoglobin(Hb Alc%),fasting plasma insulin(FINS),2h insulin after meal(2h INS),insulin resistance index HOMA-IR(HOMA-IR=FBG * FINS/22.5),blood lipids(TC,TG,LDC-C),vibration sense threshold measurement,ankle reflex,temperature sense,vibration sense,pressure sense,pain sense,and compare relevant indicators.During the treatment,closely observe the vital signs of patients,observe adverse reactions,and take corresponding intervention measures,and observe their safety.Results: 1.There was no remarkable divergence(P>0.05)among two groups in terms of VPT,blood glucose level(FBG,2H FBG),TCSS score and TCM syndrome score before treatment(P>0.05),and there was comparability between the two groups.After treatment,the decline range of neuropathy related score(VPT),blood glucose level(FBG,2H FBG),TCSS score and TCM syndrome score of patients in the observation group was remarkable higher than that in the control group.After statistical treatment,there was a significant difference(P<0.05),which was statistically significant and comparable.2.Safety analysis: No significant adverse effects were observed in the two groups,and safety testing indicators were not outside the normal range.Conclusion: 1.The modified formula of Wumei pill is better than western medicine in reducing the vibration sensation threshold of T2 DM patients with lower limb neuropathy,which is beneficial to improve the patients’ neuropathy.2.The modified Wumei Pill has a significant effect on improving the syndrome of TCM in patients with upper heat and lower cold type,providing clinical basis for the treatment of T2 DM related diseases by syndrome differentiation of six meridians.