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认知功能障碍髋部骨折患者的骨折预防:来自 HORIZON 复发性骨折试验的二次数据分析。

Fracture prevention in patients with cognitive impairment presenting with a hip fracture: secondary analysis of data from the HORIZON Recurrent Fracture Trial.

机构信息

Oxford NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road, Headington, OX, OX3 7LD, UK.

出版信息

Osteoporos Int. 2014 Jan;25(1):77-83. doi: 10.1007/s00198-013-2420-8. Epub 2013 Jun 28.

Abstract

UNLABELLED

Patients with cognitive impairment (CI) often do not receive secondary fracture prevention. Use of zoledronic acid led to a similar reduction in re-fracture risk but the survival benefit was limited to those without CI.

INTRODUCTION

We tested whether the effects of zoledronic acid (Zol) on re-fracture and mortality differed in patients presenting with a hip fracture by cognitive status.

METHODS

We used data from the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly Recurrent Fracture Trial, of yearly intravenous 5 mg Zol vs. placebo in patients presenting with a hip fracture. Primary outcome was new fracture and secondary outcome mortality. Short Portable Mental Status Questionnaire (SPMSQ) with a cut-point of >2 was used to identify CI. Fine-Gray models for competing events were fitted to study the effect of Zol on re-fracture and Cox regression for death. A multiplicative term was introduced to study a potential interaction between treatment and cognitive status on outcomes.

RESULTS

Baseline SPMSQ of 1,966/2,127 (92.4%) patients was measured. Three hundred fifty (17.8%) had CI, balanced between treatment arms. In the placebo arm, there was similar fracture incidence between those with and without CI (15.4 vs. 12.3%, p = 0.26). There was no significant interaction for the effect of CI on Zol and re-fracture (p = 0.66). CI was associated with higher 1-year mortality (12.6 vs. 4.3%, p < 0.001) and the interaction was bordering significance (interaction, p = 0.066). Zol prolonged survival only in patients with normal cognitive status [HR 0.56 (95% CI 0.40-0.80)] and not in those with CI [HR 0.90 (95% CI 0.59-1.38)].

CONCLUSIONS

While these results require confirmation, the findings support the use of bisphosphonates in patients with osteoporotic fracture and CI expected to live for more than 6 months.

摘要

背景

认知障碍(CI)患者常得不到二级骨折预防。唑来膦酸的应用可降低再骨折风险,但生存获益仅限于无 CI 的患者。

目的

我们检测了认知状态不同的髋部骨折患者使用唑来膦酸(Zol)对再骨折和死亡率的影响是否存在差异。

方法

我们使用了每年静脉注射 5mg Zol 与安慰剂治疗髋部骨折患者的骨质疏松性骨折复发预防研究(HORIZON-RFT)的数据。主要结局是新发骨折,次要结局是死亡率。采用简短精神状态问卷(SPMSQ),截断值>2 分来识别 CI。竞争风险的 Fine-Gray 模型用于研究 Zol 对再骨折的影响,Cox 回归用于研究死亡。引入一个乘积项来研究治疗和认知状态对结局的潜在交互作用。

结果

共纳入 2127 例患者的基线 SPMSQ 评分,其中 1966 例(92.4%)患者的评分可评估。350 例(17.8%)患者有 CI,两组间平衡。安慰剂组,有 CI 和无 CI 的患者骨折发生率相似(15.4%比 12.3%,p=0.26)。CI 对 Zol 和再骨折影响的交互作用无统计学意义(p=0.66)。CI 与较高的 1 年死亡率相关(12.6%比 4.3%,p<0.001),且交互作用有显著趋势(p=0.066)。Zol 仅在认知状态正常的患者中延长生存时间[HR 0.56(95%CI 0.40-0.80)],而在有 CI 的患者中无生存获益[HR 0.90(95%CI 0.59-1.38)]。

结论

虽然这些结果需要进一步证实,但研究结果支持在预期生存时间超过 6 个月的骨质疏松性骨折合并 CI 的患者中使用双膦酸盐。

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