| 1 ObjectiveUnder the guidance of traditional Chinese medical theory,this study applies the method of invigorating spleen and kidney and promoting blood circulation to treat diabetic osteoporosis patients with spleen and kidney deficiency and blood stasis.It observes the clinical efficacy of this method in treating DOP patients and evaluates its medication safety.It also analyzes the bone metabolism conversion indexes(serum PINP,serumβ-CTX),bone mineral density(BMD)of the patients treated with the method of invigorating spleen,tonifying kidney and promoting blood circulation.The influence of biochemical indexes(mainly Ca,P,PTH)and whether they have related influence on blood sugar(FPG,PBG,Hb A1c)and the improvement of clinical symptoms and TCM syndrome scores of patients are observed to provide reference for clinical medication.Digging up and giving full play to the advantages and characteristics of traditional Chinese medicine in the prevention and treatment of chronic diseases are conducive to bringing better curative effects and providing more choices for clinical treatment of DOP patients.2 MethodsAccording to the diagnostic criteria recommended by WHO in the latest clinical guidelines for type 2 diabetes mellitus and primary osteoporosis in China and the inclusion criteria and exclusion criteria established in this study,62 eligible diabetic osteoporosis patients were randomly divided into two groups,31 in the control group and 31 in the experimental group.On the basis of routine diet,exercise guidance and hypoglycemic treatment,the control group was treated with western medicine(alendronate sodium vitamin D3 tablets(Ⅱ)70 mg:5600 IU*1,orally,once a week),while the experimental group was treated with Jianpi Yishen Huoxue Huayu Recipe(composed of 12g of Herba Epimedii,12g of Radix Cyathulae,10g of Fructus Psoraleae,12g of Radix Rehmanniae Preparata,15g of Saviae Miltiorrhizae Radix,20g of Radix Astragali,20g of Poria,20g of Concha Ostreae,12g of Herba Taxilli,12g of Radix Angelicae Sinensis,etc.)The two groups were treated for 6 months respectively.During the medication period,the patient’s three routine indexes,liver and kidney function,electrocardiogram and other safety indexes were monitored,and the clinical therapeutic effect and improvement of TCM syndrome scores before and after treatment in the two groups were observed and compared.The blood glucose(fasting blood glucose,2h postprandial blood glucose and glycosylated hemoglobin),bone mineral density(BMD),blood calcium(Ca),blood phosphorus(P),parathyroid hormone(PTH),serum PINP,β-CTX and other index values before and after treatment were recorded.After 6 months of treatment,they were sorted out and analyzed with statistical software.SPSS23.0 statistical software was used in this study.For the measurement data,the patients in the same group were compared and analyzed by paired T test before and after treatment.The comparison of the experimental group and the control group before and after treatment respectively adopts two independent sample T tests.The results are all expressed as?x±s.For counting data,?~2tests were used for analysis.Other measurement data,such as grade data and those that do not conform to normal and variance,are analyzed by rank sum test.Results the difference was P<0.05,which was statistically significant.3 Results(1)62 cases of diabetic osteoporosis with spleen and kidney deficiency and blood stasis syndrome conforming to the standard were included in the study.There were 31 cases in the experimental group and 31 cases in the control group.The actual effective follow-up was 60 cases,and 1 case in the control group was excluded due to irregular medication.One case in the treatment group was rejected because it could not be effectively followed up.The sex,age,course of disease,body mass index and other data of the two groups before treatment were comparable(P>0.05).(2)Comparison of the clinical effects of the two groups before and after treatment:The total effective rates of the control group and the experimental group are 63.3%and 86.7%respectively,and the comparison of the two groups before and after treatment was statistically significant(P<0.05 or P<0.01);Compared between the two groups,the comparison before treatment is comparable(P>0.05).The comparison after treatment has statistical significance(P<0.05).The curative effect of the experimental group is more obvious than that of the control group.(3)Comparison of TCM syndrome scores between the two groups before and after treatment:After treatment,the two groups all have statistically significant differences compared with before treatment(P<0.05 or P<0.01).Compared between the two groups,the comparison before treatment is comparable(P>0.05).The comparison after treatment has statistical significance(P<0.05).The improvement of TCM syndrome points in the experimental group is more significant than that in the control group.(4)Comparison of blood glucose levels before and after treatment between the two groups:After treatment,fasting blood glucose(FPG),2h postprandial blood glucose(PBG)and Hb Alc levels of patients in the experimental group and the control group were significantly reduced,with significant differences compared with those before treatment(P<0.05 or P<0.01);There was no statistical difference between the two groups before treatment(P>0.05).The improvement degree of FPG,PBG and Hb Alc in the experimental group are better than that in the control group after treatment(P<0.05 or P<0.01).(5)Comparison of bone mineral density before and after treatment between the two groups:the bone mineral density of each part(lumbar L1-4,femoral neck,femoral trochanter and Ward triangle)of the two groups after treatment is significantly higher than that before treatment(P<0.05 or P<0.01).Compared between the two groups,the comparison of each part before treatment iscomparable(P>0.05).The comparison after treatment in all parts has statistical significance(P<0.05 or P<0.01).The improvement of bone mineral density in all parts of the experimental group was more significant than that in the control group.(6)Comparison of biochemi Cal indexes of serum Ca,serum p and serum PTH before and after treatment between the two groups:After treatment,serum Ca and serum P in the two groups are higher than before treatment,but P>0.05,with no difference and no statistical significance;Compared between the two groups,the comparison before treatment is comparable(P>0.05).The comparison after treatment has no statistical significance(P>0.05).Before and after treatment,the serum PTH of the experimental group and the control group were significantly improved,and there were significant differences between the two groups(P<0.05 or P<0.01).Compared between the two groups,the comparison before treatment is comparable(P>0.05).The comparison after treatment has statistical significance(P<0.05 or P<0.01).The improvement degree of the experimental group is better than that of the control group.(7)Comparison of serum PINP andβ-CTX between the two groups before and after treatment:the serum PINP andβ-CTX of the two groups decreased significantly after treatment(P<0.05 or P<0.01);Compared between the two groups,the comparison before treatment was P>0.05,with no difference and comparability.After treatment,the experimental group was significantly lower than the control group(P<0.05 or P<0.01).the improvement degree of the experimental group was better than that of the control group.(8)Safety observation before and after treatment of the two groups of patients:During the treatment of the two groups of patients,there is no abnormality in monitoring the three major conventions of the patients,liver and kidney function is normal,and electrocardiogram is bnormal as well.There was no allergic reaction or other physical discomfort.4 ConclusionsThe compound prescription of traditional Chinese medicine based on the therapeutic principle of invigorating spleen and kidney and promoting blood circulation and removing blood stasis can effectively improve the clinical symptoms of patients with diabetic osteoporosis,reduce TCM syndrome scores,control blood sugar level,significantly improve the bone mineral density and bone metabolism indexes of patients.This method is safe and has no liver and kidney damage.So it is worthy of clinical promotion and application. |
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