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司美格鲁肽的使用与II型糖尿病患者单节段后路腰椎融合术后90天并发症的减少相关。

Semaglutide utilization associated with reduced 90-day postoperative complications following single-level posterior lumbar fusion for patients with type II diabetes.

作者信息

Seddio Anthony E, Gouzoulis Michael J, Vasudevan Rajiv S, Dhodapkar Meera M, Jabbouri Sahir S, Varthi Arya G, Rubio Daniel R, Grauer Jonathan N

机构信息

Department of Orthopaedics & Rehabilitation, Yale School of Medicine, New Haven, CT.

Department of Orthopaedics & Rehabilitation, Yale School of Medicine, New Haven, CT.

出版信息

Spine J. 2025 Mar;25(3):485-493. doi: 10.1016/j.spinee.2024.10.011. Epub 2024 Nov 2.

Abstract

BACKGROUND CONTEXT

Semaglutide (the active agent in medications such as Ozempic) has emerged as an increasingly popular medication in the management of diabetes due to its superior clinical efficacy compared with other medications. Patients undergoing surgery, such as posterior lumbar fusion (PLF), may be on these medications for type II diabetes mellitus (T2DM). While the correlation of T2DM with inferior PLF outcomes is known, considering the potential impact of semaglutide on the odds of postoperative complications has not previously been characterized.

PURPOSE

To investigate the potential correlation of semaglutide on 90-day postoperative adverse events following single-level PLF for those with T2DM who are or are not concurrently taking insulin.

STUDY DESIGN/SETTING: A retrospective cohort study utilizing the 2010 to Q2 2022 M161Ortho PearlDiver Mariner Patient Claims Database.

PATIENT SAMPLE

T2DM patients (with or without concurrent insulin use) undergoing single-level PLF (with or without interbody fusion) were identified using Current Procedural Terminology (CPT) codes. Exclusion criteria included: patients less than 18 years of age, those undergoing concurrent cervical, thoracic, anterior, or multilevel fusion procedures, and those with trauma, neoplasm, or infection diagnosed within three months of surgery.

OUTCOME MEASURES

Incidence of 90-day aggregated any, severe, and minor adverse events (AAE, SAE, and MAE, respectively), emergency department (ED) visits, and hospital readmissions.

METHODS

Patients with a prior diagnosis of T2DM not using insulin (T2DM-insulin) and T2DM concurrently using insulin (T2DM+insulin) undergoing PLF were identified. Patients within each group who utilized semaglutide in the year prior to surgery were identified and matched 1:4 with nonsemaglutide T2DM-insulin and nonsemaglutide T2DM+insulin patients, respectively, based on age, sex, Elixhauser Comorbidity Index (ECI), obesity, tobacco use, metformin use, and sodium-glucose transport protein 2 inhibitor (SGLT2i) use. The incidence of 90-day adverse events between groups was compared by univariate and multivariate analyses. Bonferroni correction was utilized to reduce the risk of type I error.

RESULTS

Of all T2DM patients undergoing PLF, semaglutide use was noted for 227 (0.73%) of T2DM-insulin patients, and 244 (2.17%) of T2DM+insulin patients. Once matched, there were 191 and 148 in the semaglutide groups, respectively. For the PLF T2DM-insulin analysis, those using semaglutide were at significantly lower odds of AAE (odds ratio [OR] 0.43), MAE (OR 0.45), and ED visits (OR 0.34) (p<.001 for all), but not of SAEs or readmissions. For the PLF T2DM+insulin analysis, those using semaglutide were at significantly lower odds of AAE (OR 0.40, p<.001), SAE (OR 0.43, p=.004), MAE (OR 0.34, p<.001), and ED visits (OR 0.26, p<.001), but not readmissions.

CONCLUSIONS

The current study found consistent reductions in aggregated 90-day adverse events, but similar odds of hospital readmission for T2DM patients undergoing PLF taking semaglutide preoperatively. These encouraging findings of reduced postoperative complications suggest further prospective analysis, as the observed findings suggest clinical benefit to semaglutide being utilized by the studied patient population.

摘要

背景

司美格鲁肽(如诺和泰等药物中的活性成分)因其相较于其他药物具有卓越的临床疗效,在糖尿病管理中已成为越来越受欢迎的药物。接受手术的患者,如后路腰椎融合术(PLF),可能因II型糖尿病(T2DM)而正在使用这些药物。虽然T2DM与PLF术后不良结果的相关性已为人所知,但司美格鲁肽对术后并发症几率的潜在影响此前尚未得到描述。

目的

探讨司美格鲁肽对接受单节段PLF手术的T2DM患者(无论是否同时使用胰岛素)术后90天不良事件的潜在相关性。

研究设计/设置:一项回顾性队列研究,使用2010年至2022年第二季度的M161Ortho PearlDiver Mariner患者索赔数据库。

患者样本

使用当前手术操作术语(CPT)代码识别接受单节段PLF(有或无椎间融合)的T2DM患者(无论是否同时使用胰岛素)。排除标准包括:年龄小于18岁的患者、同时接受颈椎、胸椎、前路或多节段融合手术的患者,以及在手术前三个月内被诊断患有创伤、肿瘤或感染的患者。

观察指标

90天汇总的任何不良事件、严重不良事件和轻微不良事件(分别为AAE、SAE和MAE)的发生率、急诊科就诊次数和再次入院率。

方法

识别术前诊断为未使用胰岛素的T2DM患者(T2DM-胰岛素组)和同时使用胰岛素的T2DM患者(T2DM+胰岛素组)且接受PLF手术的患者。根据年龄、性别、埃利克斯豪泽合并症指数(ECI)、肥胖、吸烟情况、二甲双胍使用情况和钠-葡萄糖转运蛋白2抑制剂(SGLT2i)使用情况,确定每组中在手术前一年使用司美格鲁肽的患者,并分别与未使用司美格鲁肽的T2DM-胰岛素组和未使用司美格鲁肽的T2DM+胰岛素组患者按1:4进行匹配。通过单因素和多因素分析比较各组90天不良事件的发生率。采用Bonferroni校正以降低I型错误的风险。

结果

在所有接受PLF手术的T2DM患者中,T2DM-胰岛素组有227例(0.73%)使用了司美格鲁肽,T2DM+胰岛素组有244例(2.17%)使用了司美格鲁肽。匹配后,司美格鲁肽组分别有191例和148例。对于PLF T2DM-胰岛素组分析,使用司美格鲁肽的患者发生AAE(优势比[OR] 0.43)、MAE(OR 0.45)和急诊科就诊(OR 0.34)的几率显著降低(所有p值均<0.001),但SAE或再次入院的几率没有降低。对于PLF T2DM+胰岛素组分析,使用司美格鲁肽的患者发生AAE(OR 0.40,p<0.001)、SAE(OR 0.43,p = 0.004)、MAE(OR 0.34,p<0.001)和急诊科就诊(OR 0.26,p<0.001)的几率显著降低,但再次入院的几率没有降低。

结论

本研究发现,术前使用司美格鲁肽的接受PLF手术的T2DM患者,90天汇总不良事件持续减少,但再次入院几率相似。这些关于术后并发症减少的令人鼓舞的发现表明需要进一步进行前瞻性分析,因为观察到的结果表明司美格鲁肽对所研究的患者群体具有临床益处。

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