目的:人口老龄化增加了绝经后骨质疏松症的发病率,威胁老年妇女的健康。Abaloparide是人甲状旁腺激素相关蛋白的合成肽类似物,最近已被批准用于治疗绝经后骨质疏松症。其疗效和安全性尚未得到系统评价。因此,对阿巴罗帕拉肽疗效和安全性的研究可为绝经后骨质疏松症的临床用药提供帮助。这项研究的目的是评估阿帕罗肽在绝经后骨质疏松症中的临床疗效和安全性。
方法:PubMed,科克伦图书馆,EMBASE,和WebofScience数据库从开始到2023年7月6日进行了电子搜索,以获取相关的随机对照试验。两位综述作者独立进行了这项研究筛选,质量评估(基于Cochrane手册中推荐的偏差风险评估工具),和数据提取。结果测量包括骨矿物质密度(BMD),骨转换和代谢标志物,骨折发生率,和不良事件。使用StataSE15处理数据分析。
结果:最终,8项随机对照试验,共有3705名绝经后妇女,包括在内。Meta分析显示,阿巴罗帕拉肽给药可显著增加腰椎的BMD(标准化均值差[SMD],1.28[95%CI,0.81-1.76);I2=78.5%]),股骨颈(SMD,0.70[95%CI,0.17-1.23;I2=75.7%]),和髋骨(SMD,与对照组相比,绝经后妇女为0.86[95%CI,0.53-1.20;I2=60.4%])。I型前胶原N-末端前肽,骨形成标记,阿巴罗帕拉肽给药后也升高。abaloparide组的椎体骨折发生率低于对照组(风险比,0.13;95%CI,0.06-0.26;I2=0%)。阿巴洛帕肽和安慰剂组之间的不良事件发生率没有显着差异(风险比,1.03;95%CI,0.99-1.06;I2=0%)。
结论:阿巴洛帕肽对绝经后妇女骨质疏松症有保护作用。它可以降低椎骨骨折的风险;增加腰椎的BMD,股骨颈,和髋关节;并减轻绝经后骨质疏松症的症状和并发症,具有相当的安全性。这项研究的局限性包括不搜索灰色文献和不进行亚组分析。PROSPERO注册号:CRD42022370944。
The aging of the population increases the incidence of postmenopausal osteoporosis, which threatens the health of elderly women. Abaloparatide is a synthetic peptide analogue of the human parathyroid hormone-related protein that has recently been approved for the treatment of postmenopausal osteoporosis. Its efficacy and safety have not been systematically evaluated. Therefore, studies on the efficacy and safety of abaloparatide could be of assistance in the clinical medication of postmenopausal osteoporosis. The aim of this study was to evaluate the clinical efficacy and safety of abaloparatide in postmenopausal osteoporosis.
PubMed, Cochrane Library, EMBASE, and Web of Science databases were electronically searched from inception to July 6, 2023, for relevant randomized controlled trials. Two review authors independently conducted the study screening, quality assessment (based on the Risk of Bias Assessment Tool recommended in the Cochrane handbook), and data extraction. Outcome measures included bone mineral density (BMD), bone turnover and metabolic markers, incidence of fractures, and adverse events. Data analyses were processed by using Stata SE15.
Ultimately, 8 randomized controlled trials, involving a total of 3705 postmenopausal women, were included. Meta-analysis showed that abaloparatide administration significantly increased the BMD of the lumbar vertebrae (standardized mean difference [SMD], 1.28 [95% CI, 0.81-1.76); I2 = 78.5%]), femoral neck (SMD, 0.70 [95% CI, 0.17-1.23; I2 = 75.7%]), and hip bone (SMD, 0.86 [95% CI, 0.53-1.20; I2 = 60.4%]) in postmenopausal women compared with the control group. Type I procollagen N-terminal propeptide, a bone formation marker, was also elevated after abaloparatide administration. The incidence of vertebral fracture was lower in the abaloparatide group than in the control group (risk ratio, 0.13; 95% CI, 0.06-0.26; I2 = 0%). There was no significant difference in the incidence of adverse events between the abaloparatide and the placebo groups (risk ratio, 1.03; 95% CI, 0.99-1.06; I2 = 0%).
Abaloparatide has a protective effect on women with postmenopausal osteoporosis. It could reduce their risk for vertebral fracture; increase their BMD of the lumbar spine, femoral neck, and hip; and alleviate symptoms and complications of postmenopausal osteoporosis with considerable safety. Limitations of this study include not searching the gray literature and not performing a subgroup analysis. PROSPERO Registration No.: CRD42022370944.