地舒单抗注射液对比唑来膦酸注射液治疗绝经后骨质疏松症的系统评价及成本-效果分析

Systematic Review and Cost-Effectiveness Analysis of Denosumab Injection and Zoledronic Acid Injection in the Treatment of Postmenopausal Osteoporosis

目的:系统评价地舒单抗注射液对比唑来膦酸注射液治疗绝经后骨质疏松症的有效性及安全性,并基于成本-效果分析探讨两者的经济性。方法:检索中国知网、中国生物医学文献数据库、万方数据库和维普数据库等中文数据库,以及PubMed、Embase和the Cochrane Library等英文数据库,搜索地舒单抗注射液对比唑来膦酸注射液治疗绝经后骨质疏松症的随机对照试验(研究组患者使用地舒单抗注射液;对照组患者使用唑来膦酸注射液),检索时间为各数据库创建至2022年5月。经过文献筛选与资料,对两种方案的疗效进行Meta分析。并从医疗保健系统的角度,采用成本-效果分析法比较两者的经济性。结果:经过筛选最终纳入3项研究,共1163例患者。Meta分析结果显示,与唑来膦酸注射液比较,地舒单抗注射液能显著提高绝经后骨质疏松症患者腰椎、髋骨的骨密度变化百分比(腰椎:MD=1.07,95%CI=0.23~1.91,P=0.01;髋骨:MD=0.89,95%CI=0.13~1.65,P=0.02),差异均有统计学意义;但并未显著降低骨折风险(OR=0.52,95%CI=0.23~1.17,P=0.11),差异无统计学意义。安全性方面,两种方案的药品不良反应发生率总体均较低,均未发生严重的药品不良反应。成本-效果分析结果显示,地舒单抗注射液的成本-效果比低于唑来膦酸注射液(492.03 vs.834.34)。结论:治疗绝经后骨质疏松症,地舒单抗注射液在提高骨密度方面优于唑来膦酸注射液,两者降低骨折风险的效果相当;在经济性方面,地舒单抗注射液较唑来膦酸注射液更具有成本-效果优势。

OBJECTIVE:To systematically review the efficacy and safety of denosumab injection versus zoledronic acid injection in the treatment of postmenopausal osteoporosis,so as to explore the economics by cost-effectiveness method.METHODS:Chinese databases such as CNKI,CBM,Wanfang Data,and VIP and English databases such as PubMed,Embase and the Cochrane Library were retrieved to collect the randomized controlled trial of denosumab injection versus zoledronic acid injection in the treatment of postmenopausal osteoporosis(study group was treated with denosumab injection,control group was given zoledronic acid injection).The retrieval time was from the establishment of the database to May 2022.After literature screening and data analysis,efficacy of the two regimens was analyzed by Meta-analysis.Cost-effectiveness analysis was used to compare the economics of the two regimens from the perspective of health care system.RESULTS:Totally 3 studies were enrolled,including 1163 patients.Meta-analysis showed that compared with zoledronic acid injection,desuzumab injection could significantly improve the percentage change of bone mineral density of lumbar spine and hip bone in postmenopausal osteoporosis(lumbar spine:MD=1.07,95%CI=0.23-1.91,P=0.01;hip:MD=0.89,95%CI=0.13-1.65,P=0.02),with statistically significant difference;yet did not significantly reduce the risk of fracture(OR=0.52,95%CI=0.23-1.17,P=0.11),and the difference was not statistically significant.In terms of safety,the incidence of adverse drug reactions in both regimens was low,and no particularly severe adverse drug reactions occurred.Cost-effectiveness analysis showed that the cost-effectiveness ratio of dizumab injection was lower than that of zoledronic acid injection(492.03 vs.834.34).CONCLUSIONS:Desumumab is superior to zoledronic acid in increasing bone mineral density in the treatment of postmenopausal osteoporosis,yet there is no difference in reducing fracture risk.In terms of economics,desumumab injection has more cost-effectiveness advantages over zoledronic acid injection.