Shi Chang Gui, Zhang Ying, Yuan Wen
Department of Orthopaedics, Changzheng Hospital, Second Military Medical University of China, Shanghai, China.
Am J Ther. 2016 May-Jun;23(3):e894-904. doi: 10.1097/MJT.0000000000000236.
Epidemiological evidence suggests that bisphosphonates are the most promising drugs for patients with osteogenesis imperfecta (OI). However, data on this issue are controversial. We conducted a meta-analysis to assess the efficacy of bisphosphonates on bone mineral density (BMD) and fracture rate in patients with OI. Electronic databases were searched to find relevant studies. Two reviewers independently identified relevant randomized controlled trials, which evaluated the efficacy of bisphosphonates in patients with OI. Outcome measures were fracture incidence and BMD changes in different skeletal sites. A total of 9 randomized controlled trials including 557 patients were identified. Meta-analysis demonstrated a beneficial effect of bisphosphonates on spine BMD Z-score and area BMD (in grams per square centimeter) %. Patients treated with bisphosphonates had a lower risk of fracture [risk ratio (RR) = 0.80; 95% confidence interval (CI): 0.66-0.97] compared with those in control groups. In children, bisphosphonates were efficacious in reducing fractures (RR = 0.80; 95% CI: 0.66-0.97), where in adults, bisphosphonates seemed equivalent to placebo in that respect (RR = 0.82; 95% CI: 0.42-1.59), although no significant difference was noted between these 2 RRs (test of interaction, z = -0.07; P = 0.94). There was also no significant difference in reducing fractures between oral and intravenous bisphosphonates (P = 0.23). This study showed that bisphosphonates could increase the BMD and reduce the risk of facture in patients with OI. There was no enough evidence to identify any differences in efficacy between oral and intravenous bisphosphonates on fracture reduction, as well as between children and adults.
流行病学证据表明，双膦酸盐类药物是治疗成骨不全症（OI）患者最有前景的药物。然而，关于这个问题的数据存在争议。我们进行了一项荟萃分析，以评估双膦酸盐类药物对OI患者骨密度（BMD）和骨折发生率的疗效。通过检索电子数据库来查找相关研究。两位评审员独立识别相关的随机对照试验，这些试验评估了双膦酸盐类药物对OI患者的疗效。结局指标是不同骨骼部位的骨折发生率和BMD变化。共识别出9项包括557例患者的随机对照试验。荟萃分析表明，双膦酸盐类药物对脊柱BMD Z评分和面积BMD（每平方厘米克数）%有有益影响。与对照组相比，接受双膦酸盐类药物治疗的患者骨折风险较低[风险比（RR）=0.80；95%置信区间（CI）：0.66 - 0.97]。在儿童中，双膦酸盐类药物在降低骨折发生率方面有效（RR = 0.80；95% CI：0.66 - 0.97），而在成人中，双膦酸盐类药物在这方面似乎与安慰剂相当（RR = 0.82；95% CI：0.42 - 1.59），尽管这两个RR之间未发现显著差异（交互作用检验，z = -0.07；P = 0.94）。口服和静脉注射双膦酸盐类药物在降低骨折发生率方面也没有显著差异（P = 0.23）。这项研究表明，双膦酸盐类药物可以提高OI患者的BMD并降低骨折风险。没有足够的证据来确定口服和静脉注射双膦酸盐类药物在降低骨折发生率方面的疗效差异，以及儿童和成人之间的疗效差异。
