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双膦酸盐使用与全髋关节置换术后翻修风险的关联:来自美国全关节置换登记处的结果

Association of Bisphosphonate Use and Risk of Revision After THA: Outcomes From a US Total Joint Replacement Registry.

作者信息

Khatod Monti, Inacio Maria C S, Dell Richard M, Bini Stefano A, Paxton Elizabeth W, Namba Robert S

机构信息

Department of Orthopaedic Surgery, Southern California Permanente Medical Group, 6041 Cadillac Avenue, Los Angeles, CA, 90034, USA.

Surgical Outcomes and Analysis, Kaiser Permanente, San Diego, CA, USA.

出版信息

Clin Orthop Relat Res. 2015 Nov;473(11):3412-20. doi: 10.1007/s11999-015-4263-4.

Abstract

BACKGROUND

Total hip arthroplasty (THA) is often performed in patients who are older and may take bisphosphonates to treat a variety of conditions, most commonly osteoporosis. However, the clinical effects of bisphosphonate use on patients who have undergone THA are not well described.

QUESTIONS/PURPOSES: (1) Is bisphosphonate use in patients with osteoarthritis undergoing primary THA associated with a change in the risk of all-cause revision, aseptic revision, or periprosthetic fracture compared with patients not treated with bisphosphonates? (2) Does the risk of bisphosphonate use and revision and periprosthetic fracture vary by patient bone mineral density and age?

METHODS

A retrospective cohort study of 12,878 THA recipients for the diagnosis of osteoarthritis was conducted; 17.8% of patients were bisphosphonate users. Data sources for this study included a joint replacement registry (93% voluntary participation) and electronic health records and an osteoporosis screening database with complete capture of cases as part of the Kaiser Permanente integrated healthcare system. The endpoints for this study were revision surgery for any cause, aseptic revision, and periprosthetic fracture. The exposure of interest was bisphosphonate use; patients were considered users if prescriptions were continuously refilled for a period equal to or longer than 6 months. Bone quality (based on dual-energy x-ray absorptiometery ordered based on the National Osteoporosis Foundation's clinical guidelines taken within 5 years of the THA) and patient age (< 65 versus ≥ 65 years) were evaluated as effect modifiers. Patient, surgeon, and hospital factors were evaluated as confounders. Cox proportional hazards models were used. Hazard ratios (HRs) and 95% confidence intervals (CIs) were determined.

RESULTS

Age- and sex-adjusted risks of all-cause (HR, 0.50; 95% CI, 0.33-0.74; p < 0.001) and aseptic revision (HR, 0.53; 95% CI, 0.34-0.81; p = 0.004) was lower in bisphosphonate users than in nonusers. The adjusted risk of periprosthetic fractures in patients on bisphosphonates was higher than in patients not on bisphosphonates (HR, 1.92; 95% CI, 1.13-3.27; p = 0.016). Lower risks of all-cause revision and aseptic revision were observed in patients with osteopenia (HR, 0.49; 95% CI, 0.29-0.84; and HR, 0.53; 95% CI, 0.29-0.99, respectively) and osteoporosis (HR, 0.22; 95% CI, 0.08-0.62; and HR, 0.33; 95% CI, 0.11-0.99, respectively).

CONCLUSIONS

Patients considered bisphosphonate users who underwent THA had a lower risk for revision surgery. Bisphosphonate use was associated with a higher risk of periprosthetic fractures in younger patients with normal bone quantity. Evaluation of bone quality and bisphosphonate use for the diagnosis of osteoporosis is encouraged in patients with osteoarthritis who are candidates for primary THA. Further research is required to determine the optimal duration of therapy because long-term bisphosphonate use has been associated with atypical femur fractures.

LEVEL OF EVIDENCE

Level III, therapeutic study.

摘要

背景

全髋关节置换术(THA)常用于老年患者,这些患者可能因多种病症,最常见的是骨质疏松症而服用双膦酸盐类药物。然而,双膦酸盐类药物对接受THA患者的临床影响尚无充分描述。

问题/目的:(1)与未接受双膦酸盐类药物治疗的骨关节炎患者相比,接受初次THA的骨关节炎患者使用双膦酸盐类药物是否会改变全因翻修、无菌性翻修或假体周围骨折的风险?(2)双膦酸盐类药物使用、翻修和假体周围骨折的风险是否因患者骨密度和年龄而异?

方法

对12878例诊断为骨关节炎的THA接受者进行了一项回顾性队列研究;17.8%的患者使用双膦酸盐类药物。本研究的数据来源包括一个关节置换登记处(93%自愿参与)、电子健康记录以及一个骨质疏松症筛查数据库,该数据库完整收录了作为凯撒医疗集团综合医疗系统一部分的病例。本研究的终点是因任何原因进行的翻修手术、无菌性翻修和假体周围骨折。感兴趣的暴露因素是双膦酸盐类药物的使用;如果处方连续 refill 时间等于或超过6个月,则患者被视为使用者。根据双能X线吸收法(基于美国国家骨质疏松基金会临床指南在THA后5年内进行检测)评估骨质量,将患者年龄(<65岁与≥65岁)作为效应修饰因素进行评估。将患者、外科医生和医院因素作为混杂因素进行评估。使用Cox比例风险模型。确定风险比(HRs)和95%置信区间(CIs)。

结果

双膦酸盐类药物使用者的全因(HR,0.50;95%CI,0.33 - 0.74;p < 0.001)和无菌性翻修(HR,0.53;95%CI,0.34 - 0.81;p = 0.004)的年龄和性别调整风险低于未使用者。使用双膦酸盐类药物的患者假体周围骨折的调整风险高于未使用双膦酸盐类药物的患者(HR,1.92;95%CI,1.13 - 3.27;p = 0.016)。骨量减少(HR,0.49;95%CI,0.29 - 0.84)和骨质疏松(HR,0.22;95%CI,0.08 - 0.62)患者的全因翻修和无菌性翻修风险较低(分别为HR,0.53;95%CI,0.29 - 0.99)。

结论

接受THA的双膦酸盐类药物使用者翻修手术风险较低。双膦酸盐类药物的使用与骨量正常的年轻患者假体周围骨折风险较高相关。对于拟行初次THA的骨关节炎患者,鼓励评估骨质量并使用双膦酸盐类药物诊断骨质疏松症。由于长期使用双膦酸盐类药物与非典型股骨骨折相关,因此需要进一步研究以确定最佳治疗持续时间。

证据水平

III级,治疗性研究。

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