脊髓刺激与靶向药物输送治疗慢性疼痛的选择：一种结果预测公式的验证。

The Choice of Spinal Cord Stimulation Versus Targeted Drug Delivery in the Management of Chronic Pain: Validation of an Outcomes Predictive Formula.

机构信息

Evidence-Based Pain Management Research, Cleveland Clinic, Cleveland, OH, USA.

出版信息

Neuromodulation. 2023 Aug;26(6):1218-1225. doi: 10.1016/j.neurom.2023.02.083. Epub 2023 Apr 14.

DOI:10.1016/j.neurom.2023.02.083

PMID:37061895

Abstract

OBJECTIVE

In 2020, Mekhail et al published a formula that predicted the likelihood of a successful outcome for those who undergo spinal cord stimulation (SCS) for long-term pain management, based on retrospectively collected clinical and demographic data from one major medical center. The aim of this study is to validate such a predictive formula, prospectively, in a cohort of patients from multiple medical practices that are more representative of real-life clinical practice.

MATERIALS AND METHODS

For the study, 939 patients who underwent successful SCS or targeted drug delivery (TDD) trials at multiple independent medical centers in the USA were enrolled into the Medtronic product surveillance registry data base before they underwent SCS or TDD device implantation, from 2018 to 2020. The registry data were collected prospectively but not specifically for this study. The data examined included demographic information, pain diagnosis, pain scores (visual analog scale [VAS]), Oswestry Disability Index scores, and quality-of-life scores at baseline and six months after implant. Because our goal is to validate the previously published predictive formula, in addition to the outcomes data previously mentioned, we collected the variables necessary for such a task: sex, age, depression, the presence of neuropathic pain, spine-related pain diagnosis, and persistent spinal pain syndrome "post laminectomy syndrome." Spine-related pain diagnosis included subjects with chronic spine pain who never had back surgery and whose pain was not radicular nor neuropathic.

RESULTS

Of 619 patients with SCS, 138 (22%) achieved ≥ 50% reductions of the baseline VAS at six months. The logistic model predicts SCS success with an area under the receiver operating characteristic curve (AUC) of 80% in the current validation data set. Of 320 patients with TDD, 147 (46%) achieved ≥ 50% reduction of the baseline VAS at six months. The logistic model predicts TDD success with an AUC of 78% in the current validation data set.

CONCLUSION

The study provides real life validation of the previously published predictive formula(4).

摘要

目的

2020 年，Mekhail 等人发表了一个公式，该公式基于一家主要医疗中心回顾性收集的临床和人口统计学数据，预测那些接受脊髓刺激（SCS）进行长期疼痛管理的人成功的可能性。本研究的目的是在来自多个医疗实践的患者队列中前瞻性验证该预测公式，这些患者更能代表现实临床实践。

材料和方法

在这项研究中，2018 年至 2020 年期间，在美国多家独立医疗中心接受过成功的 SCS 或靶向药物输送（TDD）试验的 939 名患者在接受 SCS 或 TDD 设备植入前被纳入美敦力产品监测注册数据库。该注册数据是前瞻性收集的，但不是专门为这项研究收集的。检查的数据包括人口统计学信息、疼痛诊断、疼痛评分（视觉模拟评分[VAS]）、Oswestry 残疾指数评分和植入后 6 个月的生活质量评分。因为我们的目标是验证之前发表的预测公式，除了之前提到的结果数据外，我们还收集了完成此项任务所需的变量：性别、年龄、抑郁、存在神经病理性疼痛、脊柱相关疼痛诊断和持续性脊柱疼痛综合征“椎板切除术后综合征”。脊柱相关疼痛诊断包括患有慢性脊柱疼痛的患者，这些患者从未接受过背部手术，其疼痛不是神经根性或神经病理性的。

结果

在 619 名接受 SCS 的患者中，138 名（22%）在 6 个月时 VAS 基线降低≥50%。在当前验证数据集中，逻辑模型预测 SCS 成功率的受试者工作特征曲线（ROC）下面积（AUC）为 80%。在 320 名接受 TDD 的患者中，147 名（46%）在 6 个月时 VAS 基线降低≥50%。在当前验证数据集中，逻辑模型预测 TDD 成功率的 AUC 为 78%。