地舒单抗治疗绝经后骨质疏松性骨折的效果及其对骨代谢标志物的影响

Treatment effect of denosumab on postmenopausal osteoporotic fractures and its influence on bone metabolic markers

目的分析地舒单抗治疗绝经后骨质疏松(PMOP)性骨折的临床效果及其对骨代谢标志物的影响。方法回顾性分析2021年5~11月北京大学深圳医院骨关节科收治的PMOP患者40例,其中20例有骨折病史。以上所有PMOP患者,给予地舒单抗60 mg,并予以碳酸钙及骨化三醇胶丸作为基础治疗。收集治疗前和治疗后6个月的腰椎和股骨颈的骨密度(BMD)、骨质疏松四项指标——前胶原Ⅰ型氨基端前肽(PⅠNP)、Ⅰ型胶原蛋白交联的C端末端肽(CTX)、维生素(V)D和骨钙素(Osteocalcin),并进行数据分析。此外,观察并记录地舒单抗治疗后药物不良反应。结果治疗6个月后,所有PMOP患者的腰椎及股骨颈BMD显著高于治疗前,血清中PⅠNP、CTX水平较治疗前明显降低(P<0.01,P<0.001)。根据是否曾有骨折进行亚组分析,骨折组与非骨折组PⅠNP、CTX、VD和Osteocalcin在治疗前、后均无统计学差异(P>0.05)。此外,药物不良反应发生率低(1/40,2.5%)。无骨折不愈合或延迟愈合情况出现。结论地舒单抗对PMOP的治疗安全有效,可以显著改善BMD及骨代谢异常。

Objective To investigate the efficacy of denosumab in the treatment of postmenopausal osteoporotic(PMOP)fracture and its influence on bone metabolic markers.Methods Forty PMOP patients admitted to the Department of Bone&Joint Surgery of Peking University Shenzhen Hospital from May to November 2021 were retrospectively reviewed.Twenty of these patients had a history of fracture.On the top of calcitriol and calcium carbonate,all PMOP patients were treated with denosumab 60 mg.Bone mineral density(BMD)of the lumbar spine and femoral neck,and four indicators of osteoporosis--the plasma level of procollagen typeⅠamino-terminal propeptide(PⅠNP),typeⅠcollagen cross-linked C-terminal telopeptide(CTX),Vitamin(V)D and Osteocalcin were collected before and 6 months after treatment.The data analysis was performed simultaneously.Furthermore,adverse drug reactions of denosumab during treatment were observed and recorded.Results All the PMOP patients after 6 months of treatment with denosumab,BMD of the lumbar spine and femoral neck were significantly higher than those before treatment,serum PⅠNP and CTX levels were significantly lower than those before treatment(P<0.01,P<0.001).Subgroup analysis was conducted according to whether there was any previous fracture,there were no significant differences in PⅠNP,CTX,VD and Osteocalcin between the fracture group and the non-fracture group before and after treatment(P>0.05).In addition,the incidence of adverse drug reactions was low(1/40,2.5%).There were no cases of nonunion or delayed union.Conclusions Denosumab is safe and efficacious for treating patients with PMOP,which could remarkably ameliorate BMD as well as abnormal bone metabolism.