Effect Of Jiawei Erxian Granule Combined With Alendronate In Patients With Osteoporosis

ObjectiveThe clinical efficacy and safety of Jiawei Erxian Granules in combination with bisphosphonates and the use of bisphosphonates alone in the treatment of osteoporosis with liver and kidney yin deficiency was investigated by comparing the symptoms and signs,bone mineral density(BMD)and bone turnover index levels of patients with osteoporosis.The clinical efficacy and safety of Jiawei Erxian Granules were investigated by statistical analysis to provide data to support the clinical efficacy of Chinese patent medicine in the treatment of osteoporosis(OP).MethodsBy collecting patients with liver and kidney yin deficiency type of osteoporosis who met the diagnostic criteria in our outpatient clinic from January 2022 to June 2022.The same clinician was fixed to take the patients’ medical history and record their general information(gender,age,height,weight,etc.),and to test their BMD bone metabolism biochemical indexes,including liver and kidney function,serum 25-hydroxyvitamin D[25(OH)-D],serum osteocalcin(OST),type Ⅰ collagen cross-linked carboxy-terminal peptide(β-CTX),type Ⅰ collagen amino-terminal elongation peptide(P1NP),blood calcium and phosphorus levels.Patients were randomly divided into 2 groups and both were given lifestyle modification and calcium supplementation.In the control group,alendronate VD3 tablets(Ⅱ)were used as the treatment drug of choice;in the treatment group,bisphosphonates were used in combination with Jiawei Erxian granules taken orally.Pain assessment and TCM symptom determination were performed and recorded for both groups before treatment and after 2 weeks,12 weeks and 24 weeks of treatment,respectively.OST,P1NP,blood calcium and phosphorus levels,β-CTX,25(OH)-D were repeated in both groups 12 weeks after treatment.24 weeks after treatment,bone mineral density was rechecked and recorded.Statistical methods SPSS 26.0 system software was used to analyse the differences in BMD and bone metabolic indexes between the two groups and the correlation between Chinese medicine evidence scores and bone metabolic indexes in the treatment group.Before statistical analysis of all measures,a normality test was performed and measures tested to conform to a normal distribution were statistically described by "x±s" using the independent samples t-test;measures that did not conform to a normal distribution were statistically described by R(P25,P50,P75)[median(quartiles)]were described statistically using the rank sum test;all count data were tested using the x2 test.The test level was α=0.05,and differences were considered statistically significant at P<0.05.Total effective rate=number of siqnificant cases+number of effective cases/total number of casesResultsThis study eventually included 60 patients,including 25 males and 35 females.After 12 weeks of treatment,the pain degree and symptoms of traditional Chinese medicine in the control group were improved to a certain extent,and the pain degree and symptoms of traditional Chinese medicine in the treatment group were significantly improved.25(OH)-D and OST were increased in both groups,and the increase degree was more serious in the treatment group.β-CTX decreased in both groups,and the decrease was more obvious in the treatment group.PINP decreased in both groups,but there was no significant difference between the two groups.After 12 weeks of treatment,BMD improved in both groups,and the improvement was greater in the treatment group.Except for one patient who voluntarily withdrew from the study after complaining of dry stool after taking alendronate sodium and vitamin D3 tablets(Ⅱ),no abnormal safety indicators were found in other patients during the study period.ConclusionOur research group found that patients with liver and kidney yin deficiency type OP achieved relatively significant clinical efficacy after a full course of treatment with Jiawei Erxian Granules combined with Alendronate Sodium Vitamin D3(Ⅱ)Tablets,which has the advantages of high safety,low side effects and convenient application,and can dialectically replace the use of some traditional Chinese medicine tonics in clinical application,and has high promotion value.