Gao Ge, Cui Jian, Xie Yuanyuan, Dong Jing
Central Hospital Affiliated to Shandong First Medical University, Jinan, China.
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Mountain Hospital), Jinan, China.
Front Med (Lausanne). 2024 Aug 14;11:1440948. doi: 10.3389/fmed.2024.1440948. eCollection 2024.
Postmenopausal osteoporosis (PMOP) increases fracture risk in women. Though traditional treatments are slow to act, combining romosozumab with conventional therapy shows promise. Despite its growing use, studies on effectiveness are limited. This study aims to systematically evaluate the combined therapy's impact on pain relief, disease progression, and adverse reactions in PMOP patients.
Databases including PubMed, EMBASE, ScienceDirect, and the Cochrane Library were searched from their inception to September 2023 to identify randomized controlled trials (RCTs) evaluating the role of romosozumab in PMOP. Random or fixed effect models were employed for statistical analysis. Two reviewers independently assessed the quality of the included studies and extracted the data. The meta-analysis was conducted using RevMan 5.4 software.
Six RCTs with a total sample size of 17,985 cases were included. The incidence of vertebral fractures was compared and analyzed after 12 and 24 months of treatment. Romosozumab significantly reduced the incidence of vertebral fractures at 24 months (OR = 0.36; 95% CI: 0.35-0.52) but not at 12 months (OR = 0.39; 95% CI: 0.14-1.05). It was also associated with a decreased incidence of nonvertebral fractures (OR = 0.79; 95% CI: 0.66-0.94) and clinical fractures at 24 months (OR = 0.70; 95% CI: 0.59-0.82) compared to standard therapy. Romosozumab demonstrated a significant improvement in percentage change in bone mineral density (BMD) [mean difference (MD) = 10.38; 95% CI: 4.62-16.14] and in hip joint BMD (MD = 4.24; 95% CI: 2.92-5.56). There was no notable difference in adverse reactions compared to standard care ( > 0.05). Funnel plots displayed a predominantly symmetrical pattern, suggesting no evidence of publication bias in the selected literature.
Combining romosozumab with conventional therapy effectively treats PMOP, significantly reducing vertebral, non-vertebral, and clinical fractures while increasing BMD in the hip, femoral neck, and lumbar spine. However, further high-quality studies are needed for validation.
绝经后骨质疏松症(PMOP)会增加女性骨折风险。尽管传统治疗起效缓慢,但将罗莫佐单抗与传统疗法联合使用显示出前景。尽管其使用越来越广泛,但关于有效性的研究有限。本研究旨在系统评估联合治疗对PMOP患者疼痛缓解、疾病进展及不良反应的影响。
检索包括PubMed、EMBASE、ScienceDirect和Cochrane图书馆在内的数据库,从建库至2023年9月,以识别评估罗莫佐单抗在PMOP中作用的随机对照试验(RCT)。采用随机或固定效应模型进行统计分析。两名 reviewers 独立评估纳入研究的质量并提取数据。使用RevMan 5.4软件进行荟萃分析。
纳入6项RCT,总样本量为17985例。比较并分析治疗12个月和24个月后的椎体骨折发生率。罗莫佐单抗在24个月时显著降低椎体骨折发生率(OR = 0.36;95% CI:0.35 - 0.52),但在12个月时未降低(OR = 0.39;95% CI:0.14 - 1.05)。与标准治疗相比,它还与24个月时非椎体骨折发生率降低(OR = 0.79;95% CI:0.66 - 0.94)和临床骨折发生率降低(OR = 0.70;95% CI:0.59 - 0.82)相关。罗莫佐单抗在骨密度(BMD)百分比变化[平均差(MD)= 10.38;95% CI:4.62 - 16.14]和髋关节BMD(MD = 4.24;95% CI:2.92 - 5.56)方面显示出显著改善。与标准治疗相比,不良反应无显著差异(> 0.05)。漏斗图显示出主要对称的模式,表明所选文献中无发表偏倚的证据。
罗莫佐单抗与传统疗法联合可有效治疗PMOP,显著降低椎体、非椎体和临床骨折发生率,同时增加髋部、股骨颈和腰椎的BMD。然而,需要进一步的高质量研究进行验证。