阿仑膦酸钠对绝经后妇女骨密度影响的系统评价  

Systematic review on effects of alendronate on bone mineral density in postmenopausal women

作　　者：高颖[1] 房德敏[1] 张金红[1] 邢国胜[2] 崔爽爽[2] 冯鑫[1] 潘雪梅[1] 李帅[3] 

机构地区：[1]天津市天津医院药学部,300211 [2]天津市中西医结合骨科研究所 [3]天津医科大学临床医学院

出　　处：《中华老年医学杂志》2015年第9期1015-1020,共6页Chinese Journal of Geriatrics

基　　金：国家科技支撑计划-安全合理用药评价和干预技术研究与应用（2013BA106804）;阿仑膦酸钠的综合评价研究（2013BA106804Y023008）

摘　　要：目的系统评价阿仑膦酸钠对绝经后妇女骨密度的影响。方法计算机检索Cochrane图书馆、Pubmed、Embase数据库及中国生物医学文献数据库（CBM）、中文科技期刊全文数据库（cNKI）、维普、万方数据库，截止时间为2013年9月，检索语种为中文和英文。纳入以绝经后妇女为研究对象，比较阿仑膦酸钠与安慰剂疗效为目的随机对照试验，评价所纳入临床试验的研究质量，并用RevMan5．2软件进行数据分析，采用Statall．0软件构建Meta回归模型，探讨主要疗效指标产生异质性的来源。结果纳入12个随机对照试验的5466例患者。主要和次要疗效指标的Meta分析结果显示，服用阿仑膦酸钠10rag／1年、10mg／2～3年和5mg／2～3年对绝经后妇女腰椎、全髋、转子、股骨颈骨密度的升高程度均大于安慰剂对照组，腰椎骨密度的变化最大（加权均数差为5．39，95％CI：4．03～6．76；7．70，95％CI：6．96～8．43；5．99，95％CI：5．16～6．82），其次为转子和股骨颈，且骨密度随用药时间和用药剂量的增加呈正相关。结论阿仑膦酸钠治疗能有效改善绝经后妇女的骨量，建议阿仑膦酸钠治疗疗程至少2～3年。Objective To systematically assess the efficacy of alendronate in improving bone mineral density （BMD） in postmenopausal women. Methods The databases such as the Cochrane Library, PubMed, EMBASE, CBM, CNKI and VIP were electronically searched for all randomized controlled trials （RCTs）, with deadline of September 2013, without language restrictions. Women with postmenopausai osteoporosis were included as the research objects, the RCTs on the efficacy comparison between alendronate （tablets） and placebo were collected, and the quality of clinical trials were evaluated. RevMan5. 2 software was used for analysis. Meta regression models were established by using the Stata11. 0 software to discuss the source of heterogeneity of primaryindex for assessment of curative effect. Results Twelve studies with 5 466 patients were included. Meta analysis on primary and secondary curative effect index showed that compared with placebo, alendronate （10mg daily/1 year, 10mg daily/2-3 years and 5mg daily/2-3 years） significantly increased BMD at the lumbar spine, total hip, trochanter and femoral neck, and the changes oflumbar BMD were in maximum （WMD=5.39, 7.70 and 5.99, 9%CI： 4.03-6.76;6.96-8.43; 5.16-6.82;respectively）, followed by the trochanter and the femoral neck, and the BMD was increased with the medication time and dosage. Conclusions Alendronate could effectively increase BMD in postmenopausal women, and we recommend that the treatment course of alendronate should be 2-3 years at least.

关 键 词：阿仑膦酸钠 骨密度 绝经期 

分 类 号：R580[医药卫生—内分泌]