地舒单抗与唑来膦酸治疗绝经后骨质疏松症的疗效对比研究

Comparison of Clinical Efficacy between Denosumab and Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis

目的对比地舒单抗(denosumab,DEN)与唑来膦酸(zoledronic acid,ZOL)对绝经后骨质疏松症(postmenopausal osteoporosis,PMO)的治疗效果。方法回顾性分析2020年10月~2021年6月徐州医科大学附属医院收治的86例PMO患者的病例资料,根据使用药物的不同将其分为两组,即DEN组(n=40)和ZOL组(n=46)。DEN组患者给予皮下注射DEN 60mg,2次/年;ZOL组患者给予静脉滴注ZOL 5mg,1次/年。比较两组患者的基本信息、骨代谢标志物[骨源性碱性磷酸酶(bone alkaline phosphatase,BAP)、Ⅰ型前胶原氨基端延长肽(total procollagen typeⅠamino-terminal propeptide,TP1NP)、β-胶原特殊序列(β-cross laps,β-CTX)、骨钙素(bone gla protein,BGP)、甲状旁腺激素(parathyroid hormone,PTH)、25羟基维生素D(25OHD)等]、骨密度值、骨痛视觉模拟量表(visual analogue scale,VAS)评分。结果治疗1年后,两组患者腰椎及髋部骨密度值较治疗前均显著升高(P<0.05),DEN组患者腰椎(L_(1~4))、股骨颈、全髋等部位骨密度值高于ZOL组,且差异有统计学意义(P<0.05);两组患者的TP1NP、β-CTX、BAP、BGP及ALP水平较治疗前均显著降低(P均<0.05),25OHD水平较治疗前显著升高(P<0.05),且DEN组患者的β-CTX水平显著低于ZOL组(P<0.05);两组患者骨痛症状均较前缓解,VAS评分均显著降低(P均<0.05),同时DEN组患者的骨痛VAS评分显著低于ZOL组(P<0.05)。结论DEN和ZOL治疗PMO均效果显著且安全,能够有效提高骨密度值,改善骨代谢指标。本研究初步证实DEN较ZOL在增加腰椎(L_(1~4))、股骨颈、全髋等部位骨密度值及减轻患者疼痛方面更有优势。

Objective To compare the efficacy of denosumab(DEN)and zoledronic acid(ZOL)on postmenopausal osteoporosis(PMO).Methods The case data of 86 patients with PMO admitted to the Affiliated Hospital of Xuzhou Medical University from October 2020 to June 2021 were retrospectively analyzed and divided into two groups according to the different drugs used:DEN group(n=40)and ZOL group(n=46).The patients of DEN group were given subcutaneous injection of 60mg DEN,twice a year,the patients of ZOL group were given 5mg ZOL,once a year.The basic information and bone metabolism markers[bone alkaline phosphatase(BAP),total procollagen typeⅠamino-terminal propeptide(TP1NP),β-cross laps(β-CTX),bone gla protein(BGP),parathyroid hormone(PTH),25-hydroxyvitamin D(25OHD)],bone mineral density,visual analogue scale(VAS)for bone pain in the two groups were compared.Results After 1 year of treatment,the BMD of lumbar spine and hip in both groups were significantly increased compared with before treatment(P<0.05).The BMD of lumbar spine(L_(1-4)),femoral neck and total hip in the DEN group were higher than those in ZOL group,and the difference was statistically significant(P<0.05);the values of TP1NP,β-CTX,BAP BGP and ALP were significantly decreased compared with before treatment(P<0.05);the level of 25OHD was significantly increased compared with before treatment(P<0.05);the level ofβ-CTX in DEN group was significantly lower than that in ZOL group(P<0.05).The symptoms of bone pain were relieved in both groups,and the VAS score was significantly decreased(P<0.05),while the VAS score of bone pain in DEN group was significantly lower than that in ZOL group(P<0.05).Conclusion Both DEN and ZOL are effective in the treatment of PMO,which can effectively improve bone mineral density and bone metabolism indexes.This study preliminarily confirmed that DEN has more advantages than ZOL in increasing bone mineral density of lumbar spine(L_(1-4)),femoral neck,total hip and alleviating patients pain.