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与常规药物治疗慢性疼痛相比,脊髓刺激器在使用阿片类药物、非药物性疼痛干预和总费用方面的长期结果。

Long-term Outcomes in Use of Opioids, Nonpharmacologic Pain Interventions, and Total Costs of Spinal Cord Stimulators Compared With Conventional Medical Therapy for Chronic Pain.

机构信息

University of California, San Francisco School of Medicine, San Francisco.

Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, San Francisco.

出版信息

JAMA Neurol. 2023 Jan 1;80(1):18-29. doi: 10.1001/jamaneurol.2022.4166.

Abstract

IMPORTANCE

Spinal cord stimulators (SCSs) are increasingly used for the treatment of chronic pain. There is a need for studies with long-term follow-up.

OBJECTIVE

To determine the comparative effectiveness and costs of SCSs compared with conventional medical management (CMM) in a large cohort of patients with chronic pain.

DESIGN, SETTING, AND PARTICIPANTS: This was a 1:5 propensity-matched retrospective comparative effectiveness research analysis of insured individuals from April 1, 2016, to August 31, 2018. This study used administrative claims data, including longitudinal medical and pharmacy claims, from US commercial and Medicare Advantage enrollees 18 years or older in Optum Labs Data Warehouse. Patients with incident diagnosis codes for failed back surgery syndrome, complex regional pain syndrome, chronic pain syndrome, and other chronic postsurgical back and extremity pain were included in this study. Data were analyzed from February 1, 2021, to August 31, 2022.

EXPOSURES

SCSs or CMM.

MAIN OUTCOMES AND MEASURES

Surrogate measures for primary chronic pain treatment modalities, including pharmacologic and nonpharmacologic pain interventions (epidural and facet corticosteroid injections, radiofrequency ablation, and spine surgery), as well as total costs.

RESULTS

In the propensity-matched population of 7560 patients, mean (SD) age was 63.5 (12.5) years, 3080 (40.7%) were male, and 4480 (59.3%) were female. Among matched patients, during the first 12 months, patients treated with SCSs had higher odds of chronic opioid use (adjusted odds ratio [aOR], 1.14; 95% CI, 1.01-1.29) compared with patients treated with CMM but lower odds of epidural and facet corticosteroid injections (aOR, 0.44; 95% CI, 0.39-0.51), radiofrequency ablation (aOR, 0.57; 95% CI, 0.44-0.72), and spine surgery (aOR, 0.72; 95% CI, 0.61-0.85). During months 13 to 24, there was no significant difference in chronic opioid use (aOR, 1.06; 95% CI, 0.94-1.20), epidural and facet corticosteroid injections (aOR, 1.00; 95% CI, 0.87-1.14), radiofrequency ablation (aOR, 0.84; 95% CI, 0.66-1.09), or spine surgery (aOR, 0.91; 95% CI, 0.75-1.09) with SCS use compared with CMM. Overall, 226 of 1260 patients (17.9%) treated with SCS experienced SCS-related complications within 2 years, and 279 of 1260 patients (22.1%) had device revisions and/or removals, which were not always for complications. Total costs of care in the first year were $39 000 higher with SCS than CMM and similar between SCS and CMM in the second year.

CONCLUSIONS AND RELEVANCE

In this large, real-world, comparative effectiveness research study comparing SCS and CMM for chronic pain, SCS placement was not associated with a reduction in opioid use or nonpharmacologic pain interventions at 2 years. SCS was associated with higher costs, and SCS-related complications were common.

摘要

重要性

脊髓刺激器 (SCSs) 越来越多地用于治疗慢性疼痛。需要进行长期随访的研究。

目的

在患有慢性疼痛的大量患者中,确定 SCS 与常规医学管理 (CMM) 的比较效果和成本。

设计、设置和参与者:这是一项基于倾向评分匹配的回顾性比较有效性研究分析,涉及 2016 年 4 月 1 日至 2018 年 8 月 31 日期间美国商业和医疗保险优势计划中 18 岁及以上的参保个人。本研究使用来自 Optum Labs Data Warehouse 的行政索赔数据,包括纵向医疗和药房索赔,患者患有失败的背部手术综合征、复杂区域疼痛综合征、慢性疼痛综合征和其他慢性手术后背部和四肢疼痛的诊断代码。数据于 2021 年 2 月 1 日至 2022 年 8 月 31 日进行分析。

暴露

SCSs 或 CMM。

主要结果和措施

主要慢性疼痛治疗方式的替代指标,包括药物和非药物疼痛干预(硬膜外和关节突皮质类固醇注射、射频消融和脊柱手术),以及总成本。

结果

在倾向评分匹配的 7560 名患者人群中,平均(SD)年龄为 63.5(12.5)岁,3080 名(40.7%)为男性,4480 名(59.3%)为女性。在匹配的患者中,在最初的 12 个月内,与接受 CMM 治疗的患者相比,接受 SCS 治疗的患者使用慢性阿片类药物的可能性更高(调整后的优势比 [aOR],1.14;95%CI,1.01-1.29),但接受硬膜外和关节突皮质类固醇注射(aOR,0.44;95%CI,0.39-0.51)、射频消融(aOR,0.57;95%CI,0.44-0.72)和脊柱手术(aOR,0.72;95%CI,0.61-0.85)的可能性较低。在第 13 至 24 个月期间,慢性阿片类药物使用(aOR,1.06;95%CI,0.94-1.20)、硬膜外和关节突皮质类固醇注射(aOR,1.00;95%CI,0.87-1.14)、射频消融(aOR,0.84;95%CI,0.66-1.09)或脊柱手术(aOR,0.91;95%CI,0.75-1.09)与 CMM 相比,SCS 的使用没有显著差异。总体而言,在接受 SCS 治疗的 1260 名患者中,有 226 名(17.9%)在 2 年内出现与 SCS 相关的并发症,有 279 名(22.1%)进行了设备修订和/或移除,这些并不总是因并发症所致。在第一年,SCS 的治疗费用比 CMM 高出 39000 美元,而在第二年,SCS 与 CMM 的治疗费用相似。

结论和相关性

在这项比较慢性疼痛中 SCS 和 CMM 的大型、真实世界、比较效果研究中,与 CMM 相比,SCS 植入物的使用在 2 年内并没有降低阿片类药物的使用或非药物性疼痛干预。SCS 与更高的成本相关,并且 SCS 相关的并发症很常见。

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