Clinical Observation On Treatment Of Postmenopausal Osteoporosis Of Kidney Deficiency And Blood Stasis Type With Gushukang Formula

Objective: To evaluate the effect of Gushukang Formula on postmenopausal osteoporosis(POMP)of kidney deficiency and blood stasis type.Methods: The patients with PMOP of kidney deficiency and blood stasis type admitted to the outpatient and inpatient department of Department of Orthopedics and Traumatology of Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from September 2020 to June 2022 were recruited as the study objects.By meeting the inclusion criteria and exclusion criteria,60 patients meeting the requirements were finally selected for this clinical study.The patients were randomly divided into control group(Caltrate D group)and treatment group(Gushukang Formula group)by double-blind method,30 cases in each group.The Gushukang group was treated with Gushukang formula on the basis of the same treatment with Caltrate D in the control group,and the treatment cycle was 6 months.The main outcome measurement indexes were TCM syndrome score,clinical efficacy,bone mineral density(BMD),Determination of serum estradiol E2,cytokines(tumor necrosis factor,TNF-α)and bone turnover markers(osteocalcin,BGP).The results were collected before intervention and at the end of treatment(6 months).Results: Before the treatment,the baseline data of the two groups,such as age,BMI,menopause years,TCM syndrome score,BMD,estrogen,TNF-beta,osteocalcin and so on,had no statistical difference and were comparable.After the end of the course of drug treatment in each group,the changes of various indicators in the two groups of patients are as follows:1.TCM syndrome score: After 6 months of treatment,the clinical symptoms of patients in Gushukang group were significantly improved and the TCM syndrome score was significantly reduced(P<0.05);The control group after 6 months of treatment in the TCM syndrome score in the statistical level of difference(P<0.05),but the clinical symptoms of improvement effect is limited;after treatment,there was significant difference between Gushukang group and control group in TCM syndrome score.That is,the clinical symptoms of patients were significantly improved after the intervention of Gushukang Formula.2.Clinical efficacy: In Gushukang group,15 cases were markedly effective,13 effective and 2 ineffective,the total effective rate was 93.3%(28/30).In the control group,4 cases were markedly effective,14 cases were effective,and 12 cases were ineffective.The total effective rate was 60%(18/30).There was significant difference between the two groups(P<0.05).That is to say,the clinical curative effect of Gushukang Formula is higher than that of the control group.3.Bone mineral density(BMD): There was significant difference in the change of lumbar BMD between the two groups after 6-month treatment(P<0.05).The BMD values of the two groups increased,and the increase range of BMD in Gushukang Formula group was higher than that in the control group with significant difference(P<0.05),that is,Gushukang Formula group could significantly increase the BMD values of patients,and was superior to that in the control group.4.Blood bone metabolism index: After 6 months of treatment,the level of E2 in Gushukang group was significantly higher than that before treatment(P<0.05);In the control group,there was no significant difference in E2 level before and after intervention.After treatment,the level of E2 in Gushukang group was significantly higher than that in control group(P<0.05).After 6 months of treatment,the levels of TNF-α and BGP in Gushukang group were significantly lower than those before treatment(P<0.05).In the control group,there was no significant difference in the levels of TNF-α and BGP before and after intervention.At the end of treatment,the levels of TNF-α and BGP in Gushukang group were lower than those in control group(P<0.05).The results showed that the control group had no significant effect on the levels of E2,TNF-α and BGP in the patients.On the contrary,Gushukang could increase the level of E2 and decrease the level of TNF-α and BGP.5.Safety evaluation: During the whole treatment and follow-up,no significant adverse drug reactions(musculoskeletal symptoms,rash,nausea,anorexia and vomiting)occurred in the subjects in both groups,and routine examinations such as blood routine,liver and kidney function,electrolyte and ECG showed no significant changes and no significant abnormalities,indicating the safety and reliability of the treatment regimen of Gushukang Formula.Conclusion: Gushukang Formula has significant clinical efficacy in the treatment of PMOP.It can effectively relieve the related clinical symptoms of patients with PMOP of kidney deficiency and blood stasis type,increase the level of estrogen E2 to promote bone formation,reduce the level of cytokine tumor necrosis factor to inhibit bone resorption,reduce the level of osteocalcin to inhibit bone turnover and promote bone formation,improve the high bone turnover state of postmenopausal body,maintain the balance of bone metabolism,increase the bone density of patients,and has good safety.Therefore,Gushukang Formula is recommended to be popularized as the treatment scheme of PMOP.