摘要
目的:对钙联合维生素D3预防老年人骨质疏松性骨折的随机对照试验(RCTs)进行Meta分析,旨在评估其有效性及安全性。方法:系统检索PubMed、Embase、Cochrane Library、ClinicalTrials.gov、CBM、CNKI、万方、维普数据库,收集相关RCTs研究。筛选文献并提取数据。使用Cochrane偏倚风险评估工具对纳入研究的质量进行评定,利用RevMan 5.3软件进行Meta分析。结果:纳入23项研究,共计78966例患者。Meta分析结果显示,在骨折预防方面,钙联合维生素D3相比于安慰剂或未治疗组显著降低总体骨折、髋部骨折的发生。在影响骨密度方面,钙联合维生素D3相比于安慰剂或未治疗组显著增加全身骨密度、股骨颈骨密度、腰椎L2-4骨密度,并增加血清25(OH)D浓度。在安全性方面,钙联合维生素D3不良反应发生高于安慰剂或未治疗组。结论:钙联合维生素D3能够有效预防老年人骨质疏松骨折,并提高老年人群骨密度水平和血清25(OH)D浓度,但相较于安慰剂或未治疗增加了不良反应的发生。
Objective:To evaluate the efficacy and safety for the prevention osteoporosis-related fractureeffect of calcium and vitamin D3 in the elderly.Methods:The RCTs ofcalciumand vitamin DweresearchedfromPubMed,Embase,Cochrane Library,ClinicalTrials.gov,CBM,CNKI,Wanfang and VIP Database.The literature was screened and extracted.The Cochrane bias risk assessment tool was used to assess the quality of the included studies.Meta analysis was performed using RevMan 5.3 software.Results:A total of 23 studies were included with 78966 patients.In terms of fracture,compared with placebo and nontreatment group,the combination of calcium and vitamin D3 reduced the happen of any fracture and hip fracture.In terms of bone mineral density,compared with placebo and nontreatment group,the combination of calcium and vitamin D3 increased total bone mineral density,femoral neck bone mineral density,lumbar spine L2-4 bone mineral density,serum 25(OH)D concentration.In terms of safety,compared with placebo and nontreatment group,the combination of calcium and vitamin D3 increased the incidence of adverse reactions.Conclusion:Compared with placebo and nontreatment group,calcium and vitamin D3 can effectively prevent osteoporotic fracture in the elderly with increasing the incidence of adverse reactions.
作者
耿娜
杨娜娜
丁庆明
冯婉玉
GENG Na;YANG Na-na;DING Qing-ming;FENG Wan-yu(Department of Pharmacy Peking University People′s Hospital,Beijing 100044,China;Department of Life Sciences and Biopharmaceutics,Shenyang Pharmaceutical University,Liaoning Shenyang 110016,China)
出处
《中国药物评价》
2022年第4期291-303,共13页
Chinese Journal of Drug Evaluation
