| Objective: To explore the clinical efficacy of Yiqi Tongluo prescription in the treatment of elderly patients with type 2 diabetes mellitus combined with osteoporosis(Qi deficiency blood stasis),and to explore its mechanism.Methods:A total of 60 cases of elderly patients with type 2 diabetes mellitus combined with osteoporosis(Qi deficiency blood stasis)from Sep.2016 to Sep.2017 were selected,and they were divided into control group and treatment group according to randomized single-blind control method,30 cases were for each group.Patients in 2 groups were treated with basic treatment,the control group was given Galci D film treatment,600 mg/time,2 times/d,the treatment group was given traditional Chinese medicine(TCM)Yiqi Tongluo prescription treatment on the basis of the control group,3 months were 1 treatment course for 2 groups,and 2groups were treated for 2 courses.The patients gender,age,duration and other major baseline datas,the clinical curative effect of the 2 groups were statisticsed andcompared;The scores of TCM syndromes,blood glucose,biochemical markers of bone metabolism,indexes of bone metabolism,parathyroid hormone,blood lipid,sex hormone and Lumbar bone mineral density(BMD)of patients in 2 groups were compared before and after treatment;Record and compared the occurrence of related adverse reactions in the 2 groups of patients during treatment.Results:(1)After statistical analysis,there was no significant difference between the 2 groups in terms of sex,age and duration(P>0.05);and the 2 groups were comparable;(2)Compared with before treatment,the score of TCM syndromes in 2 groups significantly decreased after treatment(P<0.01),and the score in the treatment group was significantly lower than that in the control group,the difference was statistically significant(P<0.01);The effective rate was as high as 86.67% in the treatment group,which was significantly higher than that 63.33% of the control group,the difference was statistically significant(P<0.01);(3)Compared with before treatment,the levels of fasting plasma glucose(FPG),postprandial 2h blood glucose(2h PG),glycosylated hemoglobin(Hb A1c)decreased significantly in the 2 groups after treatment(P< 0.05 or P<0.01),and postprandial 2h blood glucose(2h PG),glycosylated hemoglobin(Hb A1c)of the treatment group was significantly lower than those in the control group,and the difference was statistically significant(P<0.05);(4)Compared with before treatment,the levels of calcium(Ca),Osteocalcin(OC),N-terminal procollagen I propeptide(PINP)N-MID and PINP content in the 2 groups were significantly increased after treatment(P<0.05 or P<0.01),and the treatment group was significantly higher than those in the control group,the difference was statistically significant(P<0.05);(5)Compared with before treatment,the level of parathyroid hormone(PTH)level in treatment group was significantly decreased after treatment(P<0.01),and which was significantly lower than that in the control group,the difference was statistically significant(P<0.05);(6)Compared with before treatment,the serum Estradiol(E2)level and serum testosterone(T)level of male patients in the 2 groups significantly increased after treatment(P<0.05 or P<0.01),and the treatment group was significantly higher than the control group,the difference was statistically significance(P<0.05 or P<0.01);(7)Compared with before treatment,the BMD in the treatment group significantly increased after treatment(P<0.01),and the treatment group was significantly higher than the control group after treatment,the difference was statistically significant(P<0.05);(8)Compared with before treatment,The serum levels of triglyceride(TG)decreased significantly in the 2 groups after treatment,the levels of high-density lipoprotein(HDL)increased significantly in the treatment group after treatment,and the difference was statistically significant(P<0.01);The serum levels of total cholesterol(TC),low density lipoprotein(LDL)decreased in the 2 groups after treatment,the levels of high-density lipoprotein(HDL)increased in the control group after treatment,but there was no significant difference between the 2 groups after treatment(P>0.05);and the above indexes in 2 groups after treatment had no significant difference(P>0.05);(9)The patients in 2 groups in the clinical observation did not appear related adverse reactions,which indicated that the clinical application of 2 groups of drugs safe and reliable.Conclusion:Yiqi Tongluo prescription can effectively decrease blood sugar levels of elderly patients with type 2 diabetes mellitus combined with osteoporosis,and i 2 diabetes mellitus;regulate its parathyroid hormone and sex hormones and which can improve the bone metabolism and bone mineral density,and relieve its clinical symptoms,with significantly efficacy,and it has good security at the same time. |