Zhao Xiaojing, Zhou Changcheng, Chen Han, Ma Jingjing, Zhu Yunjuan, Wang Peixue, Zhang Yi, Ma Haiqin, Zhang Hongjie
Department of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.
Medicine (Baltimore). 2017 Mar;96(11):e6378. doi: 10.1097/MD.0000000000006378.
Low bone mineral density (BMD) is a frequent complication of inflammatory bowel disease (IBD), particularly in patients with Crohn disease (CD). The aim of our study is to determine the efficacy and safety of different drugs used to treat low BMD in patients with CD.
PUBMED/MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched for eligible studies. A random-effects model within a Bayesian framework was applied to compare treatment effects as standardized mean difference (SMD) with their corresponding 95% credible interval (CrI), while odds ratio (OR) was applied to compare adverse events with 95% CrI. The surface under the cumulative ranking area (SUCRA) was calculated to make the ranking of the treatments for outcomes.
Twelve randomized controlled trials (RCTs) were eligible. Compared with placebo, zoledronate (SMDs 2.74, 95% CrI 1.36-4.11) and sodium-fluoride (SMDs 1.23, 95% CrI 0.19-2.26) revealed statistical significance in increasing lumbar spine BMD (LSBMD). According to SUCRA ranking, zoledronate (SUCRA = 2.5%) might have the highest probability to be the best treatment for increasing LSBMD in CD patients among all agents, followed by sodium-fluoride (27%). For safety assessment, the incidence of adverse events (AEs) demonstrated no statistical difference between agents and placebo. The corresponding SUCRA values indicated that risedronate (SUCRA = 77%) might be the most safe medicine for low BMD in CD patients and alendronate ranked the worst (SUCRA = 16%).
Zoledronate might have the highest probability to be the best therapeutic strategy for increasing LSBMD. For the safety assessment, risedronate showed the greatest trend to decrease the risk of AEs. In the future, more RCTs with higher qualities are needed to make head-to-head comparison between 2 or more treatments.
低骨矿物质密度(BMD)是炎症性肠病(IBD)的常见并发症,尤其是在克罗恩病(CD)患者中。我们研究的目的是确定用于治疗CD患者低BMD的不同药物的疗效和安全性。
检索PUBMED/MEDLINE、EMBASE和Cochrane对照试验中央注册库以获取符合条件的研究。在贝叶斯框架内应用随机效应模型,以标准化均数差(SMD)及其相应的95%可信区间(CrI)比较治疗效果,而应用比值比(OR)及95%CrI比较不良事件。计算累积排名曲线下面积(SUCRA)以对治疗结局进行排名。
12项随机对照试验(RCT)符合条件。与安慰剂相比,唑来膦酸(SMD为2.74,95%CrI为1.36 - 4.11)和氟化钠(SMD为1.23,95%CrI为0.19 - 2.26)在增加腰椎骨密度(LSBMD)方面具有统计学意义。根据SUCRA排名,唑来膦酸(SUCRA = 2.5%)可能是所有药物中增加CD患者LSBMD的最佳治疗方法的概率最高,其次是氟化钠(27%)。对于安全性评估,各药物与安慰剂之间不良事件(AE)的发生率无统计学差异。相应的SUCRA值表明,利塞膦酸钠(SUCRA = 77%)可能是CD患者低BMD最安全的药物,而阿仑膦酸钠排名最差(SUCRA = 16%)。
唑来膦酸可能是增加LSBMD的最佳治疗策略的概率最高。对于安全性评估,利塞膦酸钠降低AE风险的趋势最大。未来,需要更多高质量的RCT来对两种或更多治疗方法进行直接比较。