Wang Zongze, Li Ying, Zhou Fengxin, Piao Zhe, Hao Jian
From the Department of Orthopedics, Tianjin Nankai Hospital (ZW, FZ, ZP, JH); and Renal Department of Internal Medicine, The Second Hospital of Tianjin Medical University (YL), Tianjin, China.
Medicine (Baltimore). 2016 May;95(22):e3042. doi: 10.1097/MD.0000000000003042.
Although observational studies have identified the protective effect of statins on bone health, the effects remain controversial in randomized controlled trials (RCTs). We conducted a meta-analysis of RCTs to evaluate the effects of statins on bone mineral density (BMD) and fracture risk among adults.We searched electronic databases of Medline, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) and conducted a bibliography review to identify articles published until May, 2015.Studies included in this meta-analysis should be randomized controlled trials conducted in adults, using statins in the intervention group. Information on changes in BMD or odds ratio, relative risk or hazard ratio (HR) for fracture risk with the corresponding 95% confidence interval (CI) was provided.Two investigators independently reviewed the title or abstract, further reviewed the full-texts and extracted information on study characteristics and study outcomes. Net change estimates of BMD and pooled HR of fracture risk comparing the intervention group with the control group were estimated across trials using random-effects models.Of the relevant 334 citations, 7 trials (including 27,900 randomized participants in total) meeting the eligibility criteria were included. Of the 7 trials, 5 were conducted to assess the association of statins use with BMD change and 2 with fracture risk. Compared with the control group, statins use was associated with significant increase in BMD of 0.03 g/cm (95% CI: 0.006, 0.053; I = 99.2%; P < 0.001), but null association with fracture risk, with the pooled HR of 1.00 (95% CI: 0.87, 1.15; I = 0; P = 0.396). Sensitivity analyses revealed that the associations were consistent and robust.The effect of statins use on bone health among subpopulation could not be identified due to limited number of trials.These findings provide evidence that statins could be used to increase BMD other than decreasing fracture risk in participant with dyslipidemia. In addition, further trials with the primary outcome of bone health-related measurements in subpopulation are warranted to ensure the effect of statins use.
尽管观察性研究已证实他汀类药物对骨骼健康具有保护作用,但在随机对照试验(RCT)中,其效果仍存在争议。我们对RCT进行了一项荟萃分析,以评估他汀类药物对成年人骨密度(BMD)和骨折风险的影响。我们检索了Medline、Embase和Cochrane对照试验中央注册库(CENTRAL)的电子数据库,并进行了文献综述,以确定截至2015年5月发表的文章。纳入该荟萃分析的研究应为针对成年人开展的随机对照试验,干预组使用他汀类药物。需提供BMD变化信息或骨折风险的比值比、相对风险或风险比(HR)及相应的95%置信区间(CI)。两名研究人员独立审查标题或摘要,进一步审查全文,并提取有关研究特征和研究结果的信息。使用随机效应模型在各试验中估计干预组与对照组相比BMD的净变化估计值和骨折风险的合并HR。在334条相关引文中,有7项试验(总共包括27900名随机参与者)符合纳入标准。在这7项试验中,5项旨在评估他汀类药物使用与BMD变化的关联,2项评估与骨折风险的关联。与对照组相比,使用他汀类药物与BMD显著增加0.03 g/cm相关(95%CI:0.006,0.053;I² = 99.2%;P < 0.001),但与骨折风险无关联,合并HR为1.00(95%CI:0.87,1.15;I² = 0;P = 0.396)。敏感性分析表明,这些关联是一致且稳健的。由于试验数量有限,无法确定他汀类药物在亚组人群中对骨骼健康的影响。这些发现提供了证据,表明他汀类药物可用于增加血脂异常参与者的BMD,而非降低骨折风险。此外,有必要进一步开展以亚组人群骨骼健康相关测量为主要结局的试验,以确保他汀类药物使用的效果。