Yang Lin, Tian Jin-hui, He Zhi-yu, Tang Xu-lei, Yang Ke-hu
Department of Endocrinology, the First Hospital of Lanzhou University, Lanzhou 730000, China. Email:
Zhonghua Nei Ke Za Zhi. 2013 Oct;52(10):838-43.
To assess the efficiency and safety of alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis (GIOP).
The electronic databases of PubMed, EMBASE, Cochrane 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.
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 = 0.000] 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 = 1.91, 95%CI (-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 fractures [RR = 1.00, 95%CI (0.49-2.07), P = 0.99] or nonvertebral fractures [RR = 1.02, 95%CI (0.49-2.14), P = 0.95]. No difference was shown with the adverse event between the two groups[RR = 0.97, 95%CI (0.90-1.05), P = 0.47].
Alendronate is effective for the prevention and treatment of glucocorticoid-induced bone loss at the lumbar 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.
评估阿仑膦酸钠预防和治疗糖皮质激素性骨质疏松症（GIOP）的有效性和安全性。
检索PubMed、EMBASE、Cochrane图书馆、Web of Science、中国生物医学文献数据库（CBM）和万方数据的电子数据库，查找所有阿仑膦酸钠与安慰剂对照的随机对照试验（RCT）。两名研究者独立选择纳入试验，使用Jadad量表评估试验质量并提取数据。采用RevMan 5.1软件进行数据合成和Meta分析。
纳入7项研究，共1111例患者。与安慰剂相比，治疗12个月后，阿仑膦酸钠显著提高腰椎骨密度[MD = 3.35，95%CI（2.67 - 4.02），P = 0.000]和股骨颈骨密度[MD = 1.90，95%CI（0.89 - 2.92），P = 0.000]。治疗24个月后，阿仑膦酸钠显著提高腰椎骨密度[MD = 3.91，95%CI（2.37 - 5.45），P = 0.000]，但未显著提高股骨颈骨密度[MD = 1.91，95%CI（-1.15 - 5.02），P = 0.22]。与安慰剂相比，使用阿仑膦酸钠后椎体骨折发生率[RR = 1.00，95%CI（0.49 - 2.07），P = 0.99]和非椎体骨折发生率[RR = 1.02，95%CI（0.49 - 2.14），P = 0.95]均未显著降低。两组不良事件发生率无差异[RR = 0.97，95%CI（0.90 - 1.05），P = 0.47]。
阿仑膦酸钠对预防和治疗糖皮质激素引起的腰椎和股骨颈骨质流失有效，安全性相对较好。然而，两组在降低椎体骨折和非椎体骨折发生率方面无显著差异。未来应开展大规模RCT，观察不同疗程的阿仑膦酸钠治疗是否会影响疗效，并进一步探索其是否能降低骨折发生率。
