阿仑膦酸钠对糖皮质激素导致骨质疏松防治作用的Meta分析

A Meta-analysis of alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis

目的 评价阿仑膦酸钠防治糖皮质激素导致的骨质疏松（GIOP）的有效性和安全性.方法 检索PubMed、EMBASE、Cochrane Library、Web of Science、中国生物医学文献数据库（CBM）、万方数据库,收集有关阿仑膦酸钠与安慰剂比较防治GIOP的随机对照试验（RCT）,依据Jadad评分评价纳入RCT的质量,采用RevMan 5.1进行统计分析.结果 纳入7篇文献,共1111例患者.Meta分析显示,与安慰剂相比,阿仑膦酸钠治疗12个月可增加腰椎和股骨颈的骨密度（BMD）[均数差（MD）＝3.35,95％ CI（2.67 ～4.02）,P=0.000;MD=1.90,95％ CI（0.89 ～2.92）,P=0.000],治疗24个月增加腰椎BMD[MD＝3.91,95％ CI（2.37 ～5.45）,P＜0.000],但没有增加股骨颈BMD[MD=1.91,95％ CI（-1.15 ～5.02）,P＝0.22].在降低椎骨和非椎骨骨折风险方面与安慰剂相比差异无统计学意义[RR＝1.00,95％ CI （0.49 ～2.07）,P=0.99;RR=1.02,95％ CI （0.49～2.14）,P=0.95].阿仑膦酸钠与安慰剂相比不良事件发生率的差异无统计学意义[RR =0.97,95％CI （0.90～1.05）,P＝0.47].结论 阿仑膦酸钠能增加患者腰椎和股骨颈BMD,且不良反应低,还没有证据表明可以降低骨折风险.今后,尚需要开展大样本RCT观察阿仑膦酸钠对股骨BMD的影响是否与用药时间有关以及进一步探索其能否降低骨折发生率.

Objective To assess the efficiency and safety of alendronate for the prevention and treatment of glucoeorticoid-induced osteoporosis （ GIOP）. Methods The electronic databases of PubMed, EMBASE, Coehrane Library,Web of Science, Chinese BioMedical Literature Database （CBM） and Wanfang Data were searched for all randomized controlled trials （RCT） of alendronate vs. placebo. Two reviewers independently selected trials for inclusion, assessed trial quality using Jadad＇s scale and extracted the data. RevMan 5.1 software was used for data synthesis and Meta-analysis. Results Seven studies with 1111 patients were included. Compared with placebo, alendronate significantly increased bone mineral density （BMD） at the lumbar spine[MD =3.35, 95%CI （2. 67-4. 02） ,P =0. 0001 and the femoral neck[ MD = 1.90,95% CI （0. 89-2.92 ） , P = 0. 000 ] after 12 months of therapy. After 24 months of therapy, alendronate significantly increased BMD at the lumbar spine [ MD = 3.91, 95% CI （ 2. 37-5.45 ） , P = 0.000~, but not at the femoral neck[MD=l.91,95%Cl （-1.15-5.02）, P=0.22]. Compared with placebo, no significant reduction was found by the use of alendronate in the incidence of vertebral fi＇actures [RR = 1.00,95% C1 （0.49-2. 07） ,P =0. 991 or nonvertebral fractures[ RR = 1.02,95% C1 （0. 49-2. 14）, P =0. 95 1. No difference was shown with the adverse event between the two groups [ RR = 0. 97,95% C1 （0.90-1.05）, P = 0. 47 ] . Conclusions Alendronate is effective for the prevention and treatment of glueocorticoid-induced bone loss at the lmnbar spine and the femoral neck with relatively good safety profile. Yet, there is no significant difference between the two groups in reducing the incidence of vertebral fractures and non-vertebral fractures. Large-scale RCT designed to observe whether different lengths of alendronate therapy will influence the efficiency should be conducted in the future and to further explore whether it can reduce the incidence of fractures.