| Objective: To observe the clinical effect of Gukang capsule in treating diabetic osteoporosis with kidney deficiency and blood stasis and its influence on IL-1、IL-6、TNF-α,to explore the etiology and pathogenesis of the disease and mechanism of the method of tonifying kidney and activating blood circulation,and to evaluate its safety in order to give play to the advantages of traditional Chinese medicine in the treatment of this disease.Methods:Choose 68 patients from October 2016 to March 2018 in the Weifang Hospital of Traditional Chinese Medicine who were diagnosed with Type 2Diabetic Osteoporosis of Kidney deficiency and Blood stasis,were divided into 2 groups randomly: treatment group and control group,34 cases in each group.On the premise of lifestyle intervention and hypoglycemic treatment,the control group was treated with calcium D and Alfa D3 capsules,and the treatment group was treated with Gukang capsule on the basis of the above treatment.Three months as a course of treatment,two groups were observed four courses of treatment.After two courses of treatment,the clinical efficacy and TCM symptom score of the two groups were compared.After the whole course of treatment,the blood glucose,glycosylated hemoglobin,bone mineral density,bone pain score,bone metabolism related biochemical indexes,cytokine levels,blood routine,liver and kidney function and other safetyindicators were compared before and after the treatment.All data were input by using Excel,SPSS 24.0 software system for statistics.Results: 2 cases were shedding in each group,and 32 cases were completed in the treatment group and the control group.After two courses of treatment,the total effective rate in the treatment group was 56.25% and that in the control group was 43.75%.There was no statistical difference between the two groups(P > 0.05).After four courses of treatment,the total effective rate was 87.50% in the treatment group and 53.13% in the control group.There was a significant difference between the two groups(P < 0.01).The curative effect of the treatment group was better than that of the control group,and the total effective rate increased with the prolongation of the course of treatment.The scores of TCM symptoms in the two groups were significantly improved compared with those before treatment(P < 0.01).The improvement in the treatment group was better than that in the control group,and the improvement of the symptoms in the treatment group was more obvious with the prolongation of the course of treatment.Both groups can reduce blood sugar and glycosylated hemoglobin,increase bone mineral density,alleviate bone pain,regulate bone metabolism and decrease the level of cytokines.There were significant differences between the treatment group and the control group(P < 0.05 or P < 0.01)in increasing bone density,alleviating bone pain,improving some indexes of bone metabolism and decreasing cytokines.During the treatment period,individual patients in the control group appeared abdominal distension,constipation and other uncomfortable symptoms.After the treatment,the patients were better and did not have a significant effect on the results.The blood routine examination,liver and kidney function and other safety observation indexes of the two groups were not obviously abnormal.Conclusion:The combination of Gukang capsule can improve the clinicalsymptoms of the kidney-deficiency and blood-stasis type diabetic osteoporosis patient,increase the bone density,reduce the bone pain,adjust the bone metabolism,reduce the level of the cytokineand have no obvious toxic and side effects,so it is safe and effective.It is worthy of clinical further research and application promotion. |
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