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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2023.28239

摘要内容如下：

重要性

依赖透析的患者骨折的发病率很高，但几乎没有关于最佳治疗策略的证据。慢性肾脏病-矿物质和骨骼疾病在依赖透析的患者中几乎普遍存在，使骨骼脆性的诊断和治疗复杂化。

目的

在依赖透析治疗的骨质疏松症患者中，与口服双膦酸盐相比，狄诺塞麦治疗严重低钙血症的发生率和相对风险。

设计、设置和参与者

对2013年至2020年开始接受狄诺塞麦或口服双膦酸盐治疗的65岁或以上女性透析医疗保险患者进行回顾性队列研究。通过与网络数据库中的合并肾脏手术的链接，获得包括每月血清钙在内的临床表现指标。

曝光

狄诺塞麦，60毫克，或口服双膦酸盐。

主要成果和措施

严重低钙血症定义为经白蛋白校正的血清总钙低于7.5 mg/DL（1.88 mmol/L）或一级医院或急诊科诊断为低钙血症（急诊）。还评估了非常严重的低钙血症（血钙低于6.5 mg/DL[1.63 mmol/L]或紧急护理）。在前12个治疗周内，计算治疗加权累积发病率的逆概率、加权风险差异和加权风险比。

结果

在未加权队列中，1523名接受狄诺舒马治疗的患者中有607名和1281名接受口服双膦酸盐治疗的患者中有23名出现严重低钙血症。12周重度低钙血症的加权累积发生率，狄诺塞麦组为41.1%，口服双膦酸盐组为2.0%（加权风险差，39.1%[95%可信区间，36.3%-41.9%]；加权风险比，20.7[95%CI，13.2-41.2]）。狄诺塞麦组（10.9%）与口服双膦酸盐组（0.4%）相比，12周内极重度低钙血症的加权累积发生率也有所增加（加权风险差异，10.5%[95%CI，8.8%-12.0%]；加权风险比，26.4[95%CI，9.7-449.5]）。

结论和相关性

与口服双膦酸盐相比，狄诺塞麦与65岁及以上女性透析依赖患者严重和极严重低钙血症的发生率显著升高相关。考虑到诊断透析依赖患者潜在骨病理生理学的复杂性、狄诺塞麦在该人群中的高风险以及监测和治疗严重低钙血症所需的复杂策略，狄诺塞麦应在仔细选择患者并制定频繁监测计划后给药。

英文原文如下：

Abstracts

Importance  Dialysis-dependent patients experience high rates of morbidity from fractures, yet little evidence is available on optimal treatment strategies. Chronic kidney disease-mineral and bone disorder is nearly universal in dialysis-dependent patients, complicating diagnosis and treatment of skeletal fragility.

Objective  To examine the incidence and comparative risk of severe hypocalcemia with denosumab compared with oral bisphosphonates among dialysis-dependent patients treated for osteoporosis.

Design, Setting, and Participants  Retrospective cohort study of female dialysis-dependent Medicare patients aged 65 years or older who initiated treatment with denosumab or oral bisphosphonates from 2013 to 2020. Clinical performance measures including monthly serum calcium were obtained through linkage to the Consolidated Renal Operations in a Web-Enabled Network database.

Exposures  Denosumab, 60 mg, or oral bisphosphonates.

Main Outcomes and Measures  Severe hypocalcemia was defined as total albumin-corrected serum calcium below 7.5 mg/dL (1.88 mmol/L) or a primary hospital or emergency department hypocalcemia diagnosis (emergent care). Very severe hypocalcemia (serum calcium below 6.5 mg/dL [1.63 mmol/L] or emergent care) was also assessed. Inverse probability of treatment-weighted cumulative incidence, weighted risk differences, and weighted risk ratios were calculated during the first 12 treatment weeks.

Results  In the unweighted cohorts, 607 of 1523 denosumab-treated patients and 23 of 1281 oral bisphosphonate-treated patients developed severe hypocalcemia. The 12-week weighted cumulative incidence of severe hypocalcemia was 41.1% with denosumab vs 2.0% with oral bisphosphonates (weighted risk difference, 39.1% [95% CI, 36.3%-41.9%]; weighted risk ratio, 20.7 [95% CI, 13.2-41.2]). The 12-week weighted cumulative incidence of very severe hypocalcemia was also increased with denosumab (10.9%) vs oral bisphosphonates (0.4%) (weighted risk difference, 10.5% [95% CI, 8.8%-12.0%]; weighted risk ratio, 26.4 [95% CI, 9.7-449.5]).

Conclusions and Relevance  Denosumab was associated with a markedly higher incidence of severe and very severe hypocalcemia in female dialysis-dependent patients aged 65 years or older compared with oral bisphosphonates. Given the complexity of diagnosing the underlying bone pathophysiology in dialysis-dependent patients, the high risk posed by denosumab in this population, and the complex strategies required to monitor and treat severe hypocalcemia, denosumab should be administered after careful patient selection and with plans for frequent monitoring.

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