唑来膦酸治疗骨质疏松症的快速卫生技术评估

Rapid Health Technology Assessment of Zoledronic acid in the Treatment of Osteoporosis

目的评价唑来膦酸治疗骨质疏松症的有效性、安全性和经济性。方法系统检索PubMed、Embase、the Cochrane Library、Web of Science、CNKI、VIP、万方数据库和卫生技术评估(HTA)相关的网站及数据库,根据纳入和排除标准筛选文献,提取数据和评价文献质量,对文献的结果进行定性综合比较与分析。结果共纳入22篇文献,包括3篇HTA报告、9篇SR/Meta、11篇经济学研究(其中1篇文献同时包含Meta分析和经济学研究)。唑来膦酸能提高患者的骨密度,降低骨转换标志物浓度,显著改善患者的骨痛症状。唑来膦酸对骨密度的改善作用不弱于阿仑膦酸钠。唑来膦酸的常见不良反应发生率高于安慰剂组;但严重不良反应的发生率与安慰剂组无显著差别。相较于基础治疗,唑来膦酸具有成本效果优势;与其他类型的双膦酸类药物相比,在大多数情况下唑来膦酸具有较好的经济性。结论唑来膦酸治疗骨质疏松症具有较好的有效性、安全性和经济性。

OBJECTIVE To evaluate the efficacy,safety,and pharmacoeconomic of Zoledronic acid in the treatment of osteoporosis by rapid health technology assessment,and to provide evidence support for rational drug use and health care policymakers.METHODS PubMed,Embase,the Cochrane Library,Web of Science,CNKI,VIP,CNKI,Wangfang database,and HTA related websites and databases were systematically retrieved to screen the literature as per the inclusion and exclusion criteria.HTA reports,systematic reviews/Meta-analysis,and pharmacoeconomic studies comparing Zoledronic acid with other drugs for osteoporosis treatment were included.The data were extracted,the quality of the included literature was evaluated,and the results of the included literature were qualitatively and descriptively analyzed.RESULTS A total of 22 studies were included,including three HTA reports,nine systematic reviews/Meta-analyses,and 11 economic research(one systematic review/Meta-analysis also carried out pharmacoeconomic research).Zoledronic acid could increase bone density,reduce the concentrations of bone metabolism markers,and alleviate the symptoms of bone pain.The efficacy of Zoledronic acid was comparable to Alendronate in the improvement of bone density.In terms of safety,common adverse reactions of Zoledronic acid included fever,headache,muscle pain,joint pain,and fatigue,but the degree of these common adverse reactions was relatively mild,and all of these symptoms could be resolved with symptomatic treatment.The incidence of common adverse reactions of Zoledronic acid was significantly higher than basic treatments(e.g.,calcium supplements,vitamin D,et al.).While there was no significant difference in the incidence of severe adverse reactions between Zoledronic acid and basic treatments.In terms of pharmacoeconomic,Zoledronic acid therapy was more cost-effective compared with the basic treatment.Similarly,Zoledronic acid was more economical than other bisphosphonates in most cases.CONCLUSION Zoledronic acid is safe and effective in the treatment of osteoporosis,not inferior to alendronate,and has economic advantages compared with basic treatments and alendronate.