Kan Shun-Li, Yuan Zhi-Fang, Li Yan, Ai Jie, Xu Hong, Sun Jing-Cheng, Feng Shi-Qing
Department of Orthopedics, Tianjin Medical University General Hospital School of Nursing, Tianjin Medical University, Heping, Tianjin, China.
Medicine (Baltimore). 2016 Jun;95(25):e3990. doi: 10.1097/MD.0000000000003990.
Glucocorticoid-induced osteoporosis (GIOP) is a serious problem for patients with rheumatic diseases requiring long-term glucocorticoid treatment. Alendronate, a bisphosphonate, has been recommended in the prevention of GIOP. However, the efficacy and safety of alendronate in preventing GIOP remains controversial. We performed a meta-analysis to investigate the efficacy and safety of alendronate in preventing GIOP in patients with rheumatic diseases.We retrieved randomized controlled trials from PubMed, EMBASE, and the Cochrane Library. Two reviewers extracted the data and evaluated the risk of bias and quality of the evidence. We calculated the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes, and the mean difference (MD) with a 95% CI for continuous outcomes using Review Manager, version 5.3.A total of 339 studies were found, and 9 studies (1134 patients) were included. Alendronate was not able to reduce the incidence of vertebral fractures (RR = 0.63, 95% CI: 0.10-4.04, P = 0.62) and nonvertebral fractures (RR = 0.40, 95% CI: 0.15-1.12, P = 0.08). Alendronate significantly increased the percent change in bone mineral density (BMD) at the lumbar spine (MD = 3.66, 95% CI: 2.58-4.74, P < 0.05), total hip (MD = 2.08, 95% CI: 0.41-3.74, P < 0.05), and trochanter (MD = 1.68, 95% CI: 0.75-2.61, P < 0.05). Significant differences were not observed in the percent change in BMD at the femoral neck (MD = -0.33, 95% CI: -2.79 to 2.13, P = 0.79) and total body (MD = 0.64, 95% CI: -0.06 to 1.34, P = 0.07). No significant differences in the adverse events were observed in patients treated with alendronate versus the controls (RR = 1.00, 95% CI: 0.94-1.07, P = 0.89). The odds of gastrointestinal adverse events were significantly reduced (RR = 0.77, 95% CI: 0.62-0.97, P < 0.05).Our analysis suggests that alendronate can increase the percent change in BMD at the lumbar spine, total hip, and trochanter, and is not associated with an increased incidence of gastrointestinal adverse events; however, the vertebral and nonvertebral fractures cannot be reduced. However, the results should be interpreted with caution due to the poor statistical power.
糖皮质激素性骨质疏松症（GIOP）是需要长期糖皮质激素治疗的风湿病患者面临的一个严重问题。阿仑膦酸钠，一种双膦酸盐，已被推荐用于预防GIOP。然而，阿仑膦酸钠预防GIOP的疗效和安全性仍存在争议。我们进行了一项荟萃分析，以研究阿仑膦酸钠在预防风湿病患者GIOP方面的疗效和安全性。我们从PubMed、EMBASE和Cochrane图书馆检索了随机对照试验。两名评价员提取数据并评估偏倚风险和证据质量。我们使用Review Manager 5.3版本计算二分类结局的风险比（RR）及其95%置信区间（CI），以及连续结局的平均差（MD）及其95%CI。共检索到339项研究，纳入9项研究（1134例患者）。阿仑膦酸钠未能降低椎体骨折的发生率（RR = 0.63，95%CI：0.10 - 4.04，P = 0.62）和非椎体骨折的发生率（RR = 0.40，95%CI：0.15 - 1.12，P = 0.08）。阿仑膦酸钠显著增加了腰椎（MD = 3.66，95%CI：2.58 - 4.74，P < 0.05）、全髋（MD = 2.08，95%CI：0.41 - 3.74，P < 0.05）和大转子（MD = 1.68，95%CI：0.75 - 2.61，P < 0.05）骨密度（BMD）的变化百分比。在股骨颈（MD = -0.33，95%CI： - 2.79至2.13，P = 0.79）和全身（MD = 0.64，95%CI： - 0.06至1.34，P = 0.07）的BMD变化百分比方面未观察到显著差异。与对照组相比，接受阿仑膦酸钠治疗的患者在不良事件方面未观察到显著差异（RR = 1.00，95%CI：0.94 - 1.07，P = 0.89）。胃肠道不良事件的发生率显著降低（RR = 0.77，95%CI：0.62 - 0.97，P < 0.05）。我们的分析表明，阿仑膦酸钠可增加腰椎、全髋和大转子的BMD变化百分比，且与胃肠道不良事件发生率增加无关；然而，不能降低椎体和非椎体骨折的发生率。然而，由于统计效力不足，对结果的解释应谨慎。
