首次评估在鞘内混合药物治疗癌症疼痛时，从罗哌卡因切换到高浓度布比卡因。

First Evaluation Switching From Ropivacaine to Highly Concentrated Bupivacaine in Intrathecal Mixtures for Cancer Pain.

机构信息

Department of Anesthesiology and Pain Medicine, Institut de Cancerologie de l'Ouest, Angers, France.

Department of Epidemiology and Biostatistics, Institut de Cancerologie De l'Ouest, Angers, France.

出版信息

Neuromodulation. 2021 Oct;24(7):1215-1222. doi: 10.1111/ner.13469. Epub 2021 Jun 28.

DOI:10.1111/ner.13469

PMID:34181790

Abstract

BACKGROUND

Intrathecal drug delivery is widely used for intractable cancer pain treatment. A combination of drugs with morphine and bupivacaine is recommended in first line therapy. In France, we use ropivacaine 10 mg/mL instead of bupivacaine 5 mg/mL, the only concentration available. Bupivacaine 40 mg/mL has been available in France only since July 2020 under temporary authorization of use.

OBJECTIVES

The main objective of the study was to evaluate the safety, efficacy by pain assessment, to analyze drug dosage changes, to report adverse events (AEs) and conversion ratios switching from ropivacaine to bupivacaine. Secondary objective was to evaluate costs differences.

MATERIALS AND METHODS

We conducted this retrospective follow-up monocentric study within the Institut de Cancérologie de l'Ouest (ICO) Pain Department in Angers, France. We included 14 patients aged 18 years and above, implanted with an Intrathecal Drug Delivery Systems (IDDS) for cancer pain treatment and followed up at ICO from July 2020 to February 2021 after switching from ropivacaine to bupivacaine. We used a continuous infusion mode and Bolus could be added through Personal Therapy Manager (PTM).

RESULTS

The median conversion ratio between ropivacaine and bupivacaine was 0.68 (0.65; 0.69) and resulted in no significant change in numeric rating scale evaluation (p = 0.10). We observed moderate and rapidly reversible AEs such as clinical hypotension (29%) and motor block after bolus (21%). The estimated median hospital cost per day was significantly lower (p = 0.05) for the bupivacaine refills than for the last ropivacaine pump refill, decreasing from US$ 61.7 (49.6; 70.5) to US$ 50.4 (45.9; 60.4). The median reimbursement per day from the National Health Insurance (NHI) was three times lower for bupivacaine pump refill when compared to the last ropivacaine pump refill (p < 0.01), decreasing from US$ 179.10 (156.79; 182.91) to US$ 64.59 (59.85; 71.89).

CONCLUSION

Switching from ropivacaine to bupivacaine in IDDS appears more efficacious while remaining just as secure, and at lower cost.

摘要

背景

鞘内药物输送广泛用于治疗难治性癌症疼痛。在一线治疗中，推荐使用吗啡和布比卡因联合药物。在法国，我们使用 10mg/mL 的罗哌卡因代替 5mg/mL 的布比卡因，这是唯一可用的浓度。40mg/mL 的布比卡因仅在 2020 年 7 月获得临时使用授权后在法国上市。

目的

本研究的主要目的是评估安全性、疼痛评估的疗效，分析药物剂量变化，报告不良事件（AE）和从罗哌卡因转换为布比卡因的转换比。次要目标是评估成本差异。

材料和方法

我们在法国昂热的 ICO 疼痛科进行了这项回顾性单中心研究。我们纳入了 2020 年 7 月至 2021 年 2 月期间，在 ICO 接受鞘内药物输送系统（IDDS）治疗癌症疼痛的年龄在 18 岁及以上的 14 名患者，在切换到布比卡因后进行随访。我们使用连续输注模式，通过个人治疗管理器（PTM）可以添加推注。

结果

罗哌卡因与布比卡因的中位数转换比为 0.68（0.65；0.69），数字评分量表评估无显著变化（p=0.10）。我们观察到中度和快速可逆的 AE，如临床低血压（29%）和推注后的运动阻滞（21%）。布比卡因 refill 的估计每日平均住院费用明显低于最后一次罗哌卡因泵 refill（p=0.05），从 61.7 美元（49.6；70.5）降至 50.4 美元（45.9；60.4）。与最后一次罗哌卡因泵 refill 相比，布比卡因 refill 的国家健康保险（NHI）每日报销金额低三倍（p<0.01），从 179.10 美元（156.79；182.91）降至 64.59 美元（59.85；71.89）。