背景:接受血液透析的患者发生骨折的风险较高;然而,缺乏在该人群中治疗骨质疏松症的大量证据。我们探索了denosumab的功效,一种靶向核因子κB配体受体激活剂的抗IgG2抗体,降低血液透析患者的骨折发生率和全因死亡率。
方法:这项回顾性队列研究于2013年12月至2022年12月进行,评估了denosumab对骨折发生率和全因死亡率的影响。在研究期间开始denosumab治疗的患者被定义为denosumab组,而那些没有denosumab用药史的人被定义为非denosumab组。Kaplan-Meier曲线和对数秩检验用于评估生存和骨折/死亡风险。分别。Cox比例风险模型用于分析骨折和全因死亡率。
结果:在214例血液透析患者中,52(24.3%)接受了denosumab。中位年龄为73.0±11.5岁,92名(43.0%)女性,中位透析时间为59个月(四分位距,6-126).在研究期间,37例未经denosumab治疗的患者发生骨折,而denosumab组有8例.在未调整模型中没有观察到显著差异(HR,0.53;95%置信区间(CI),0.24-1.14)。调整竞争性死亡率和临床因素,HR保持在0.64(95%CI,0.27-1.51)。关于全因死亡率,我们发现未调整模型(HR,0.61[95%CI,0.38-0.98])。在调整后的模型中观察到死亡率显著降低(HR,0.46[95%CI,0.26-0.80])。值得注意的是,denosumab组的死亡率显着下降,特别是在心血管疾病相关病例中(HR,0.33[95%CI,0.14-0.78])。
结论:Denosumab可以降低血液透析患者的全因死亡率,尤其是那些有心血管并发症的患者。这一发现为血液透析患者的骨质疏松症治疗提供了有希望的方向。
BACKGROUND: Patients undergoing hemodialysis are at an elevated risk of fractures; however, substantial evidence for osteoporosis treatment in this population is lacking. We explored the efficacy of denosumab, an anti-IgG2 antibody that targets the receptor activator of nuclear factor-kappa B ligand, in reducing fracture incidence and all-cause mortality in patients undergoing hemodialysis.
METHODS: This retrospective cohort
study-conducted from December 2013 to December 2022-evaluated the effects of denosumab on fracture incidence and all-cause mortality. Patients who initiated denosumab treatment during the
study period were defined as the denosumab group, while those without a history of denosumab administration were defined as the non-denosumab group. Kaplan-Meier curves and log-rank tests were used to assess survival and fracture/mortality risks, respectively. Cox proportional hazards models were used to analyze both fractures and all-cause mortality.
RESULTS: Among 214 patients undergoing hemodialysis, 52 (24.3%) received denosumab. The median age was 73.0 ± 11.5 years, with 92 (43.0%) females, and the median dialysis duration was 59 months (interquartile range, 6-126). During the
study, thirty-seven non-denosumab-treated patients had fractures compared to eight in the denosumab group. No significant differences were observed in the unadjusted model (HR, 0.53; 95% confidence interval (CI), 0.24-1.14). Adjusting for competing mortality and clinical factors, the HR remained at 0.64 (95% CI, 0.27-1.51). Regarding all-cause mortality, we found a statistically significant difference in the unadjusted model (HR, 0.61 [95% CI, 0.38-0.98]). A significant reduction in mortality was observed in the adjusted model (HR, 0.46 [95% CI, 0.26-0.80]). Notably, the denosumab group showed a significant decrease in mortality, particularly in cardiovascular disease-related cases (HR, 0.33 [95% CI, 0.14-0.78]).
CONCLUSIONS: Denosumab may reduce all-cause mortality in patients undergoing hemodialysis, particularly in those with cardiovascular complications. This finding offers a promising direction for osteoporosis treatment in patients undergoing hemodialysis.