关键词: Denosumab Monoclonal antibodies Osteoporosis Renal insufficiency Romosozumab

来  源:   DOI:10.1016/j.afos.2024.05.004   PDF(Pubmed)

Abstract:
UNASSIGNED: There are challenges for the treatment of osteoporosis in patients with kidney failure and monoclonal antibodies (MAb) might be a suitable therapy. However, the efficacy and safety of MAb among patients with osteoporosis and renal insufficiency remains unclear.
UNASSIGNED: We systematically searched PubMed, Embase, and Cochrane Central for studies evaluating the efficacy and safety of the use of MAb in patients with osteoporosis and renal insufficiency. We pooled risk ratios (RR) and 95% confidence intervals (CI) for binary outcomes. Mean difference (MD) was used for continuous outcomes.
UNASSIGNED: We included 5 studies with 33,550 patients. MAb therapy decreased the risk of vertebral fractures (RR 0.32; 95% CI 0.26-0.40; P < 0.01) when compared to placebo and no statistical difference was found when comparing to bisphosphonate (RR 0.71; 95% CI 0.49-1.03; P = 0.07). MAb therapy also decreased the risk of nonvertebral fractures (RR 0.79; 95% CI 0.69-0.91; P = 0.0009). Lumbar spine bone mineral density (BMD) was higher in the MAb therapy when compared to both placebo (MD 10.90; 95% CI 8.00-13.80; P < 0.01) and bisphosphonate (MD 7.66; 95% CI 6.19-9.14; P < 0.01). There was no statistically significant difference in the change of estimated glomerular filtration rate and in the incidence of hypocalcemia and serious adverse events between groups.
UNASSIGNED: There were reductions in both vertebral and nonvertebral fracture risks, alongside improvements in BMD among patients with renal insufficiency treated with MAb.
摘要:
肾衰竭患者骨质疏松症的治疗存在挑战,单克隆抗体(MAb)可能是合适的治疗方法。然而,MAb在骨质疏松症和肾功能不全患者中的疗效和安全性尚不清楚.
我们系统地搜索了PubMed,Embase,和CochraneCentral用于评估骨质疏松症和肾功能不全患者使用MAb的有效性和安全性的研究。我们汇总了二元结果的风险比(RR)和95%置信区间(CI)。平均差(MD)用于连续结果。
我们纳入了5项研究,共33,550名患者。与安慰剂相比,MAb治疗降低了椎体骨折的风险(RR0.32;95%CI0.26-0.40;P<0.01),与双膦酸盐相比无统计学差异(RR0.71;95%CI0.49-1.03;P=0.07)。MAb治疗也降低了非椎骨骨折的风险(RR0.79;95%CI0.69-0.91;P=0.0009)。与安慰剂(MD10.90;95%CI8.00-13.80;P<0.01)和双膦酸盐(MD7.66;95%CI6.19-9.14;P<0.01)相比,MAb治疗的腰椎矿物质密度(BMD)更高。两组间估计肾小球滤过率的变化以及低钙血症和严重不良事件的发生率无统计学差异。
椎骨和非椎骨骨折的风险均降低,此外,MAb治疗肾功能不全患者的BMD也有改善。
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