Clinical Study Of Male Type 2 Diabetes Mellitus Patients With High Progesterone Treated With Qi Mai Bai Zhu Decoction

Research Objective1.To analyze the correlation of serum progesterone(PROG)level with several blood biochemical parameters,common traditional Chinese medicine(TCM)syndrome types,common complications and comorbidities in male patients with type 2 diabetes mellitus(T2DM),thus discussing the significance of PROG in the diagnosis and treatment of male T2DM patients.2.We observed the clinical efficacy and safety of Qi Mai Bai Zhu decoction treating with male T2DM patients with elevated PROG.Research Method1 Statistical analysis between clinical indicators,TCM syndrome types,common comlications and comorbidities grouped by different PROG levelsWe collected the clinical data of 251 male T2DM patients who were admitted in the department of endocrinology of Nanjing Hospital of Chinese Medicine between January 1st 2018 and December 31th 2019.Biochemical parameters and Clinical data such as age,duration,smoking history,waistline,hipline,waist-hip ratio(WHR),blood pressure(BP),body mass index(BMI),blood sugar(BG),C-peptide(CP),glycated hemoglobin(HbA1c),HOMA2-?,HOMA-IS,HOMA2-IR,five sex hormones,blood lipid,blood calcium(Ca2+)and common complications and comorbidities of DM were compared.And we also compared the correlation between PROG and pancreatic ?-cell function.2 Efficacy analysis using Qi Mai Bai Zhu decoction treating with male T2DM patients with elevated PROGWe collected altogether 70 male T2DM patients with elevated PROG and meanwhile belong to Qi and Yin deficiency and internal heat and blood stasis accumulated syndrome type in TCM.We then ranmomly assigned them into two groups,each group with 35 patients.Besides the basic therapy which include DM education and hypoglycemic agent western medicine,control group was administered vitamin E while treatment group was administered Qi Mai Bai Zhu decoction,finally we compared related efficacy and safety i?ndicators between the two groups.Research Result1.Comparison between related indicators grouped by different PROG levels?Compared with non-elevated PROG group,the elevated PROG group has lower BMI,Omin-CP,30min-CP,HOMA2-?,HOMA2-IR and higher HOMA-IS,estradiol(E2),testosterone(T)and Ca2+(P<0.05).?There is no significant difference in common complications and comorbidities between elevated PROG and non-elevated PROG group.? We divided all the cases into 6 groups according to TCM standard,namely Qi and Yin deficiency type 169 cases,damp and heat accumulated in the spleen type 114 cases,Qi obstruction and blood stasis type 29 cases,Yin deficiency and extreme heat type 39 cases,Yin and Yang deficiency type 0 case,Yang deficiency with blood stasis and water stopped type 0 case.We collected the most commonly seen syndrome types Qi and Yin deficiency type and damp and heat accumulated in the spleen type.By comparing the difference between them we found that,there is a statistic difference between Qi and Yin deficiency type and damp and heat accumulated in the spleen type in duration,waistline,WHR,BMI,DBP,Omin-CP,30min-CP,120min-CP,HOMA2-?,HOMA2-IR,HOMA-IS,PROG,T and FSH.?We divided those cases into four groups according to different PROG levels and TCM syndrome types,namely high PROG and Qi and Yin deficiency syndrome group,high PROG and damp and heat accumulated in the spleen syndrome group,non-elevated PROG and Qi and Yin deficiency syndrome group and non-elevated PROG and damp and heat accumulated in the spleen syndrome group.There is a statistic difference between hipline,BMI,Omin-CP,30min-CP,120min-CP,HOMA2-?,HOMA2-IR,HOMA-IS,PROG,E2,T and FSH.Among all the groups,the high PROG and Qi and Yin deficiency syndrome group has higher PROG level,lower CP level,HOMA2-(3,HOMA2-IR,and HOMA-IS(P<0.05).In addition,E2,T and FSH are also relatively higher with statistic difference.? There was a negative correlation between PROG level and HOMA-?(r=-0.158,P=0.031)2.Efficacy observation by using Qi Mai Bai Zhu Decoction treating with male T2DM patients with elevated PROGIn both control group and treatment group,post-treatment indexes including PROG,120min-BG,Omin-CP,120min-CP,HbAlc and HOMA-?all have varying degrees of improvement than those of pretreatment(P<0.05).In addition,FBG,30min-CP and HOMA-IS in the treatment group also have statistic difference between post-treatment and pretreatment.30min-BG in the control group also has statistic difference between post-treatment and pretreatment.Besides,30min-CP(76.46±34.82ng/ml VS 109.19±40.89ng/ml)and HOMA2-?(3.11±1.45%VS 4.04±1.51%)in treatment group is better improved compared with control group(P<0.05).In the comparison of TCM symptoms score,we found that both groups have significant improvement in the symptoms including dryness in the mouth and throat,fatigue,dysphoria,intolerant to the heat,numbness or pain in the extremities,lumbago,feeling of hungry and frequent urination.In addition,the treatment group has statistical improvment in constipation and forgetfulness.In the comparison between control group and treatment group,dryness,fatigue,dysphoria,intolerant to the heat,numbness or pain in the extremities and constipation in the treatment group are statisticlly different from in the control group(P<0.05).There is a significant difference in the TCM syndrome total score(6.14±2.62 VS 2.64±1.47)between the two groups.Total effective rate is also different between treatment group and control group(67.9%VS 92.0%).As to drug safety,both groups have good safety on the whole.ConclusionIn the group of male T2DM paitients,elevated PROG is associated with pancreatic ?-cell function and TCM syndrome types.The TCM pathogenesis of male T2DM with elevated PROG is Qi and Yin deficiency and internal heat and blood stasis.By using Qi Mai Bai Zhu Decoction,we acquired exact therapeutic effect including decreased PROG level,improvement pancreatic ?-cell function and TCM syndrome.Thus providing reference for the western and TCM treatment of DM.