| Objective: To observe the clinical efficacy and safety of Yishen Tianjing Recipe in the treatment of type 2 diabetes patients with osteoporosis of kidney essence deficiency type,so as to provide clinical basis for the treatment of this disease with traditional Chinese medicine.Methods: From January 2022 to December 2022,60 patients with type 2 diabetes mellitus osteoporosis of kidney essence deficiency type who met the inclusion criteria and signed the informed consent form were selected from the outpatient and inpatient departments of the diabetes Department and Osteoporosis Department of the First Affiliated Hospital of Gansu University of Traditional Chinese Medicine.According to the random number table,they were divided into the control group of 30 cases and the observation group of 30 cases.The control group was given basic treatment with calcitriol capsules,while the observation group was given Yishen Filling Essence Formula on the basis of the control group for 12 consecutive weeks.Observe the changes in blood calcium,blood phosphorus,parathyroid hormone,osteocalcin,alkaline phosphatase,bone density,fasting blood glucose,2-hour postprandial blood glucose,glycated hemoglobin,estradiol,testosterone,visual analogue score,traditional Chinese medicine syndrome score,and safety indicators before and after treatment.The results were statistically analyzed using SPSS 26.0software.Result:(1)In this clinical study,there were no dropout or termination patients in the two groups.Before treatment,the general situation,observation indicators and safety indicators of the two groups of patients were statistically analyzed.The results showed that the control group and the observation group had significant differences in age,gender,duration of type 2 diabetes,duration of type 2 diabetes osteoporosis,patient body mass index,glucose metabolism indicators,bone metabolism indicators,sex hormones There was no statistically significant difference in visual simulation score and liver and kidney function(P>0.05),which can be compared.(2)Comparison of Traditional Chinese Medicine Syndrome Score: The TCM syndrome score of the two groups of patients significantly decreased compared to before treatment(P<0.01),and the observation group showed a better decrease than the control group(P<0.01).(3)Comparison of single Chinese medicine symptoms: Both groups of patients showed improvement in single Chinese medicine clinical symptoms compared to before treatment(P<0.05);After treatment,the observation group showed better improvement in lower back pain,lower limb weakness,thirst,excessive drinking,dizziness,and fatigue compared to the control group(P<0.05),but there was no statistically significant difference in tinnitus,tinnitus,and decreased memory compared to before treatment(P>0.05).(4)Blood glucose comparison: The fasting blood glucose,2-hour postprandial blood glucose,and glycated hemoglobin levels of the two groups of patients decreased compared to before treatment,but the difference was not statistically significant(P>0.05);After treatment,there was no statistically significant difference between the groups(P>0.05).(5)Comparison of bone metabolism indicators: After treatment,the control group and observation group showed varying degrees of increase in blood calcium,blood phosphorus,alkaline phosphatase,and osteocalcin compared to before treatment(P<0.05),while parathyroid hormone significantly decreased compared to before treatment(P<0.05);After treatment,the increase of alkaline phosphatase and osteocalcin in the observation group was greater than that in the control group(P<0.01),and the decrease of parathyroid hormone was greater than that in the control group(P<0.05).However,there was no statistically significant difference in blood calcium and phosphorus(P>0.05).(6)Comparison of bone density: There was no statistically significant difference in bone density between the control group and the observation group before and after treatment in lumbar spine L1,L2,L3,L4(P>0.05);After treatment,there was no statistically significant difference between the groups(P>0.05).(7)Comparison of sex hormones: After treatment,the E2 value of two groups of female patients significantly increased(P<0.05),while the T value significantly decreased(P<0.05);After treatment,the E2 value in the observation group increased significantly compared to the control group(P<0.01),and there was no statistically significant difference in T value(P>0.05).After treatment,the T value of the observation group significantly increased compared to before treatment(P<0.01),while the T value of the control group showed no significant difference compared to before treatment(P>0.05),and the E2 value of both groups showed no statistical significance;After treatment,the increase in T value in the observation group was greater than that in the control group(P<0.01),and there was no statistically significant difference in E2 value(P>0.05).(8)Visual simulation score: The visual simulation score of the control group and the observation group decreased significantly after treatment compared to before treatment(P<0.01);After treatment,the observed group showed a greater decrease compared to the control group(P<0.01).(9)Comparison of traditional Chinese medicine efficacy and clinical efficacy: The total effective rate of traditional Chinese medicine syndrome efficacy in the control group was 70.00%,while the total effective rate of traditional Chinese medicine syndrome efficacy in the observation group was 86.67%.The total effective rate in the observation group was higher than that in the control group(P<0.01).The total effective rate of clinical efficacy after treatment in the control group was 63.33%,while the total effective rate of clinical efficacy after treatment in the observation group was 76.67%.The total effective rate in the observation group was higher than that in the control group(P<0.01).(10)Safety evaluation: Both groups of patients showed no significant abnormalities in general vital signs(body temperature,respiration,pulse,blood pressure),blood routine,urine routine,fecal routine,liver function,kidney function,urinary calcium,and electrocardiogram before and after treatment.No allergic or other discomfort symptoms were observed.Conclusion: Yishen Tianjing Recipe can significantly improve the clinical symptoms and syndromes of type 2 diabetes patients with osteoporosis,effectively regulate bone metabolism and sex hormone levels,and its overall clinical efficacy is better than that of the control group,with high safety performance. |
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