唑来膦酸治疗类风湿关节炎合并骨量减少或骨质疏松患者的疗效和安全性研究OA北大核心CSTPCD

Objective To investigate the efficacy and safety of zoledronic acid in the treatment of rheumatoid ar-thritis(RA)patients combined with osteopenia or osteoporosis(OP).Methods The study was a 48-week prospective,multicenter,randomized,open-controlled trial.Treatment was 5 mg zoledronic acid intravenous infusion once.The 136 RA patients in the RA group were divided into 4 groups:40 patients with RA combined with OP in the RA-OP-ZOL group were treated with zoledronic acid,33 patients with RA combined with OP in the RA-OP group were untreated,30 patients with RA combined with osteopenia in the RA-osteopenia-ZOL group were treated with zoledronic acid,and 33 patients with RA combined with osteopenia in the RA-osteopenia group were untreated.The control group of 130 non-RA patients was also divided into 4 groups:32 OP patients in the CG-OP-ZOL group were treated with zoledronic acid,36 OP patients in the CG-OP group were untreated,32 osteopenia patients in the CG-osteopenia-ZOL group were treated with zoledronic acid,and 30 osteopenia patients in the CG-osteopenia group were untreated.After 48 weeks,the change from baseline and rate of change in lumbar spine 1-4(L1-L4),femoral neck,and total hip BMD,as well as the safety of therapy were ob-served in RA patients and control patients.Results After 48 weeks of zoledronic acid treatment,L1-L4,femoral neck,and total hip BMD were significantly increased in the RA-OP-ZOL,RA-osteopenia-ZOL,CG-OP-ZOL,and CG-osteope-nia-ZOL groups compared with baseline(P＜0.05).There was no significant difference in the rate of change in L1-L4,femoral neck,and total hip BMD between the RA-OP-ZOL and CG-OP-ZOL groups(P＞0.05).The difference in the rate of change in L1-L4,femoral neck,and total hip BMD between the RA-osteopenia-ZOL and CG-osteopenia-ZOL groups was also not significant(P＞0.05).After 48 weeks of follow-up,L1-L4,femoral neck,and total hip BMD were signifi-cantly reduced in the untreated RA-osteopenia group compared with baseline(P＜0.05).Fever after receiving zoledronic acid treatment was improved after symptomatic treatment.The difference in the incidence of new fractures after zoledronic acid treatment was not statistically significant compared with that of untreated patients(P＞0.05).No renal impairment,osteonecrosis of the jaw,or atypical femur fracture was found in all patients treated with zoledronic acid.Conclusion Zoledronic acid treatment significantly improves L1-L4,femoral neck,and total hip BMD in patients with RA combined with OP or osteopenia and has fewer adverse effects.Stable RA patients with osteopenia or OP have similar response to pa-tients with osteopenia or OP.