骨化三醇预防和治疗骨质疏松症的快速卫生技术评估

Rapid Health Technology Evaluation of Calcitriol in the Prevention and Treatment of Osteoporosis

目的:基于快速卫生技术评估的方法,评价骨化三醇预防和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、中国期刊全文数据库、中国生物医学文献服务系统、万方数据库和卫生技术评估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,并对文献进行质量评价与定性分析。结果:共纳入8篇文献,包括系统评价和荟萃分析(Meta分析)7篇、经济学研究1篇。骨化三醇单药治疗能改善患者的骨密度,显著降低骨转换标志物水平,降低跌倒的发生风险;骨化三醇联合双膦酸盐治疗能改善患者的骨痛症状,骨化三醇与钙剂联合应用能改善患者的肌肉力量。但是,骨化三醇单药或与其他药物联合治疗降低骨折风险方面,目前尚未得出一致的结论。骨化三醇常见不良反应为高钙血症、高钙尿症,但其程度比较温和;与阿法骨化醇单药治疗方案相比,骨化三醇单药治疗为劣势方案,不经济;与阿法骨化醇联合钙剂方案相比,骨化三醇联合钙剂方案预防骨质疏松骨折效果较好,但成本也更高。结论:骨化三醇单药治疗在改善患者的骨密度、降低骨转换标志物水平和降低跌倒风险方面有较好的有效性;骨化三醇与其他药物联合治疗能改善患者的骨痛症状、肌肉力量。但骨化三醇单药或与其他药物联合治疗降低骨折风险方面,目前尚未得出一致的结论。骨化三醇的安全性较好;经济学评价还需要更深入的研究。

OBJECTIVE:To evaluate the efficacy,safety and economy of calcitriol in the prevention and treatment of osteoporosis by rapid health technology evaluation.METHODS:PubMed,EMBase,the Cochrane Library,CNKI,SinoMed,Wangfang database and HTA related websites and databases were systematically retrieved to extract the data according to the inclusion and exclusion criteria,and quality evaluation and qualitative analysis of literature were evaluated.RESULTS:A total of 8 literature were included,including 7 systematic reviews and meta-analysis(Meta-analysis),and 1 economic research.Calcitriol monotherapy can improve the bone density of patients,significantly decreasing the levels of bone turnover markers,and reduce the risks of falling.Calcitriol combined with bisphosphonate therapy can improve the symptoms of bone pain,and the combination of calcitriol and calcium can improve the muscle strength of patients.However,no consistent conclusion had been reached regarding the reduction of fracture risk with calcitriol monotherapy or in combination with other drugs.Common adverse drug reactions of calcitriol were hypercalcemia and hypercalciuria,but the degree was relatively mild.Compared with alfacalcidol monotherapy,calcitriol monotherapy was inferior and uneconomical.Compared wit alfacalcidol combined with calcium regimen,calcitriol combined with calcium regimen was more effective in preventing osteoporotic fractures,but its cost was also higher.CONCLUSIONS:Calcitriol monotherapy is effective in improving the bone density of patients,decreasing the levels of bone turnover markers and reducing the risk of falling.Calcitriol combined with other drugs can improve the symptoms of bone pain and muscle strength.However,no consistent conclusion have been reached regarding the reduction of fracture risk with calcitriol monotherapy or in combination with other drugs.The safety of osteotriols is good,yet the economic evaluation needs more in-depth study.