| Objective:To systematically study and analyze the clinical efficacy and safety of Zhuanggu Tongbi pills in the treatment of diabetic osteoporosis(DOP),objectively evaluate its effectiveness and safety,and provide reference for the clinical treatment of DOP.Methods:Patients with diabetic osteoporosis syndrome of liver and kidney deficiency were selected and treated in the outpatient Department of Endocrinology and Nephrology,Hospital of Traditional Chinese Medicine,Dianjiang Chongqing from December 2021 to November 2022.They were numbered according to the inclusion order and divided into control group and treatment group by random number table method.The two groups were based on blood sugar control,and the control group was given calcium carbonate D3 tablets orally.The treatment group was given Zhuanggu Tongbi Pills orally.After 12 weeks of treatment,the changes of bone mineral density(BMD),blood phosphorus(P),blood calcium(Ca),glycated hemoglobin(HbA1c),fasting venous blood glucose(FPG),2 hours post-meal venous blood glucose(2hPG)and TCM syndrome score before and after treatment were evaluated in both groups.Results:①Comparison of BMD:The BMD values of the two groups after treatment were higher than those before treatment(P<0.05),and there was no significant difference between the two groups(P>0.05).②Comparison of blood calcium and phosphorus:After treatment,blood calcium was increased in both groups(P<0.05),but there was no significant change in blood phosphorus(P>0.05),and there was no significant difference between the two groups after treatment(P>0.05).③Comparison of blood sugar:After treatment,HbAlc,FPG and 2hPG were decreased in both groups(P<0.05),but there were no significant changes in Hb A1c,FPG and 2hPG between groups(P>0.05).④Comparison of traditional Chinese medicine syndrome score:The traditional Chinese medicine syndrome scores of both groups showed improvement before and after treatment(P<0.05).The total effective rate was 90.00%in the treatment group and 73.33%in the control group,indicating that Zhuanggu Tongbi pills were more effective in improving symptoms such as dry throat,lower back pain,and hot palms and soles.⑤Safety evaluation:There were no significant abnormalities in the safety indicators of both groups during the study.Conclusion:① Zhuanggu Tongbi Pills has a more significant curative effect in the treatment of DOP liver and kidney deficiency syndrome,which can effectively improve the clinical symptoms of patients,improve bone metabolism indicators such as bone density,improve bone function,and improve the quality of life of patients.②Zhuanggu Tongbi Pills have been proven to be safe and effective during the research process,and can be applied clinically. |