Silva-Fernández Lucía, Rosario María Piedad, Martínez-López Juan Antonio, Carmona Loreto, Loza Estibaliz
Rheumatology Unit, Hospital Universitario de Guadalajara, Guadalajara, Spain.
Reumatol Clin. 2013 Jan-Feb;9(1):42-52. doi: 10.1016/j.reuma.2012.06.007. Epub 2012 Sep 1.
To determine the efficacy and safety of denosumab in osteoporosis.
A systematic search was performed in MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (1950 to July 2010), meeting abstracts (2009-2010), trial registries, and reference lists. The selection criteria were as follows: (population) osteoporosis patients of any age; (intervention) treatment with denosumab; (outcome) efficacy and safety; (study design) randomized clinical trials (RCTs); no language restrictions. Two reviewers independently screened titles and abstracts and subsequently extracted data from the selected studies including quality items, and on outcomes of interest. A meta-analysis was performed for safety issues.
A total of 25 studies were included. Denosumab reduces the risk of new radiographic vertebral fracture in a 68% compared with placebo (p<0.001) and increases bone mineral density (BMD) at lumbar spine, total hip, and one-third radius more than alendronate and placebo. A single subcutaneous dose of denosumab resulted in a dose-dependent, rapid, profound, and sustained decrease bone turnover markers (BTMs). Denosumab was in general well tolerated. A meta-analysis has shown an increase in the incidence of urinary infections (p=0.012) and eczema (p<0.001) in the patients treated with denosumab. Meta-analysis of efficacy was complicated due to the study features.
Denosumab given subcutaneously twice yearly is associated with a reduction in the risk of vertebral, nonvertebral, and hip fractures in women with osteoporosis. Denosumab is associated with greater and sustained increases in BMD and reductions in BTMs compared with placebo and/or alendronate and with a risk of urinary infections and eczema.
确定地诺单抗治疗骨质疏松症的疗效和安全性。
在MEDLINE、EMBASE和Cochrane对照试验中央注册库（1950年至2010年7月）、会议摘要（2009 - 2010年）、试验注册库及参考文献列表中进行系统检索。选择标准如下：（研究对象）任何年龄的骨质疏松症患者；（干预措施）用地诺单抗治疗；（观察指标）疗效和安全性；（研究设计）随机临床试验（RCT）；无语言限制。两名研究者独立筛选标题和摘要，随后从选定的研究中提取数据，包括质量项目及感兴趣的观察指标。对安全性问题进行荟萃分析。
共纳入25项研究。与安慰剂相比，地诺单抗使新的影像学椎体骨折风险降低68%（p<0.001），并且在腰椎、全髋和桡骨远端三分之一处增加骨矿物质密度（BMD）的幅度大于阿仑膦酸钠和安慰剂。单次皮下注射地诺单抗可导致骨转换标志物（BTMs）呈剂量依赖性、快速、显著且持续下降。地诺单抗总体耐受性良好。荟萃分析显示，接受地诺单抗治疗的患者尿路感染（p = 0.012）和湿疹（p<0.001）发生率增加。由于研究特点，疗效的荟萃分析较为复杂。
每年皮下注射两次地诺单抗可降低骨质疏松症女性发生椎体、非椎体和髋部骨折的风险。与安慰剂和/或阿仑膦酸钠相比，地诺单抗可使BMD更大幅度且持续增加，BTMs降低，并伴有尿路感染和湿疹风险。
