Clinical Efficacy Of Zoledronic Acid In The Treatment Of Primary Biliarycholangitis With Secondary Osteoporosis

Objective:The incidence of secondary osteoporosis(OP)in primary biliary cholangitis(PBC)and the therapeutic effect of zolephonic acid have not been systematically studied in China.On the one hand,this study aims to explore the prevalence,influence factors,bone minaral density(BMD)and serum bone metabolic markers of PBC with osteoporosis by comparing with the normal population of the same age and same sex.On the other hand,by comparing the changes of visual simulation score(VAS),BMD and bone metabolic markers before and after 6 months of treatment,the therapeutic effect of zoledronic acid on patients of different ages was explored.Methods:A total of 100 PBC patients admitted to the Rheumatology Department of the Affiliated Hospital of Qingdao University from October 2012 to October 2019 were selected as the PBC group,and 100 healthy subjects matched by age and gender were selected as the control group.General condition,clinical indicators such as BMD and serum bone metabolic markers were collected and compared between the two groups.82 postmenopausal PBC women were grouped according to age,body mass index(BMI)and menopause time,and the incidence of osteoporosis and bone mass loss in each group were calculated and compared.40 cases with osteoporosis were treated by intravenous injection of 5mg(100ml)zoledronic acid(migoda)once,supplemented with vitamin D3 and calcium simultaneously.VAS,BMD,serum total N-terminal propeptide of typeΙprocollagen(t-P1NP),beta collagen specific sequences(β-CTX)and 25-OH-VD3 were reviewed 6 months after theatment.The results were also compared and analyzed in different age groups(51-60 years old,61-70 years old and over 70 years old).At the same time,the side effects of zoledronic acid were monitored.Results:BMD in lumbar and left femoral neck,serum 25-OH-VD3 and t-P1 NP levels in PBC patients were significantly lower than those in the control group,while serum β-CTX were significantly higher,and the differences were statistically significant.Among the 82 postmenopausal women in the PBC group,14(17%)cases had normal BMD,BMD of 28(34%)cases were confirmed as bone loss,and 40(49%)cases was diagnosed with osteoporosis.While in the control group,BMD of 46(56%)cases were normal,21(26%)cases was bone loss,and 15(18%)had osteoporosis.The number of patients with OP in the PBC group was significantly higher than that in the control group.The 82 postmenopausal women with PBC were divided into four groups according to age,and 2 patients were less than 50 years old with normal BMD.There were 35 cases aged51-60,including 13 cases with osteoporosis(37.14%).36 cases were aged 61-70,including 21 cases with osteoporosis(58.33%).There were 9 cases more than 70 years old,including 6 cases of osteoporosis,accounting for 66.67%.The 82 postmenopausal PBC women were divided into 3 groups according to BMI,including 4 patients in the lean group(< 18.5)and 2 patients with osteoporosis(50%).There were 42 cases in the normal group(18.5-23.9),among which 24 cases(57.14%)had osteoporosis.There were36 patients in the overweight and obese group(≥ 24.0),and 13 patients with osteoporosis,accounting for 36.11%.A total of 82 postmenopausal PBC women were divided into 3 groups according to the time of menopause.There were 10 cases of menopause for less than 5 years,of which 2 were with osteoporosis,accounting for 20%;23 cases were postmenopausal for 5-9 years,including 9 cases of osteoporosis(39.13%).There were 49 patients with menopause more than 10 years,including 29 patients with osteoporosis,accounting for 59.18%.After 6 months of treatment with zoledronic acid,symptoms of low back pain were significantly improved and VAS scores were significantly reduced compared with that before treatment(P < 0.001).Besides,the lumbar BMD and serum 25-OH-VD3 levels in patients with PBC were significantly higher(P < 0.05),the serum t-P1 NP and β-CTX levels were significantly lower(P < 0.05),while the left femoral neck BMD was not significantly improved(P > 0.05).After 6 months of treatment,lumbar BMD,serum t-P1 NP and β-CTX levels were significantly improved in patients aged 51-60 years,61-70 years and over 70 years(P < 0.05).Serum 25-OH-VD3 levels were significantly higher in patients aged 51-60 years and 61-70 years than before treatment(P < 0.05),serum 25-OH-VD3 levels were also increased in patients older than 70 years,but the difference was not statistically significant(P > 0.05).No serious side effects were found in 40 patients treated with zoledronic acid.There were only 5 cases of fever(12.5%),2cases of myalgia(5%)and 1 case of nausea(2.5%),the total incidence of side effects was20%.Conclusion:1.Compared with the normal population of the same age and same sex,PBC patients had lower BMD and serum t-P1 NP levels,while β-CTX levels were higher.The incidence of OP in PBC patients was significantly higher than that in the normal population.2.Age,BMI and menopausal time are all influence factors for postmenopausal female patients with PBC combined with OP.The older the age,the lower the BMI and the longer the menopause time,the more likely it is that OP occurs on PBC patients.3.Zoledronic acid can improve the symptoms of low back pain in patients with OP secondary to PBC,reduce the VAS scores,improve the lumbar spine BMD,and reduce the level of serum bone turnover markers.It is effective in patients aged 51-60 years,61-70 years and over 70 years.