摘要
目的通过Meta分析,评估阿法骨化醇治疗骨质疏松症的有效性和安全性。方法检索PubMed、CNKI和万方数据库,选择符合标准的阿法骨化醇治疗骨质疏松症的随机对照试验(randomized controlled trials,RCT)。按Jadad评价标准结合Cochrane简单评价方法严格评价文献质量,对入选文献进行Meta分析。结果检索文献截至2020年6月,共纳入14个RCT,1315例骨质疏松症患者。Meta分析结果显示,骨质疏松症患者经阿法骨化醇治疗,与对照组相比腰椎骨密度明显升高,加权均数差(weighted mean difference,WMD)为0.08 g/cm^(2)(95%CI:0.04~0.11 g/cm^(2),P<0.001),阿法骨化醇0.5μg/d组(WMD=0.07 g/cm^(2),95%CI:0.01~0.13 g/cm^(2),P=0.02)和1.0μg/d组(WMD=0.10 g/cm^(2),95%CI:0.03~0.17 g/cm^(2),P=0.006)提高腰椎骨密度更加显著。阿法骨化醇治疗后股骨颈骨密度明显升高,WMD为0.07 g/cm^(2)(95%CI:0.03~0.11 g/cm^(2),P=0.001)。在新发骨折方面,与对照组相比,阿法骨化醇治疗后骨折风险明显下降(RR=0.61,95%CI:0.47~0.80,P=0.0003)。阿法骨化醇治疗组血钙水平与对照组比较,差异无统计学意义,高钙血症或高尿钙症少见。结论相对小样本RCT进行的Meta分析显示,阿法骨化醇(0.5μg/d和1.0μg/d)治疗骨质疏松症,能够明显增加骨密度,有效降低骨折发生风险。
Objective To evaluate the efficacy and safety of alfacalcidol in the treatment of osteoporosis.Methods The randomized controlled trials(RCTs)of alfacalcidol treatment in osteoporosis were searched in PubMed,CNKI,and Wanfang database.Literature quality was strictly evaluated according to Jadad and Cochrane evaluation,and Meta-analysis was carried out.Results We included 14 RCTs(1315 patients)until June,2020.Meta-analysis showed that alfacalcidol increased BMD at lumbar spine[weighted mean difference(WMD)=0.08 g/cm^(2),95%CI:0.04-0.11 g/cm^(2),P<0.001],especially in 0.5μg/d(WMD=0.07 g/cm^(2),95%CI:0.01-0.13 g/cm^(2),P=0.02)and 1.0μg/d group(WMD=0.10 g/cm^(2),95%CI:0.03-0.17 g/cm^(2),P=0.006).Alfacalcidol increased BMD at femoral neck(WMD=0.07 g/cm^(2),95%CI:0.03-0.11 g/cm^(2),P=0.001)compared with the control group.Alfacalcidol significantly reduced the risk of fracture than the control group(RR=0.61,95%CI:0.47-0.80,P=0.0003).There was no significant difference in serum calcium level between alfacalcidol group and control group.Hypercalcemia and hypercalciuria were seldom seen.Conclusions The systematic evaluation shows that alfacalcidol(0.5μg/d and 1.0μg/d)can increase bone mineral density and reduce the fracture risk in treatment of osteoporosis.There is no significant difference in safety profiles between alfacalcidol and the control groups.
作者
姜艳
邢小平
李梅
王鸥
夏维波
JIANG Yan;XING Xiao-ping;LI Mei;WANG Ou;XIA Wei-bo(Department of Endocrinology,Key Laboratory of Endocrinology of National Health Commission,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China)
出处
《中华骨质疏松和骨矿盐疾病杂志》
CSCD
北大核心
2021年第3期221-229,共9页
Chinese Journal Of Osteoporosis And Bone Mineral Research
基金
国家自然科学基金(81970757)
中国医学科学院医学与健康科技创新工程项目(2020-I2M-C&T-B-016)。
