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患者对周围神经性疼痛管理变化的总体印象:临床相关性及日常实践中的关联。

Patients' Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice.

机构信息

INSERM U987, Centre d'Evaluation et de Traitement de la Douleur, Hôpital Cochin, Assistance Publique des Hôpitaux de Paris (AP-HP), Université Paris Descartes, Paris, France.

Département d'Evaluation et Traitement de la Douleur, Centre Hospitalier Universitaire (CHU) de Nice, Fédération Hospitalo-Universitaire InovPain, Université Côte d'Azur, Nice, France.

出版信息

Eur J Pain. 2019 Jul;23(6):1117-1128. doi: 10.1002/ejp.1378. Epub 2019 Mar 18.

Abstract

BACKGROUND

Patient-Reported Outcome (PRO) instruments have been developed to evaluate pain management in daily practice; the Patients' Global Impression of Change (PGIC) is particularly recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials. The prospective non-interventional multicenter PRO-QURE study aimed at assessing correlations between PGIC and pain measurements and treatment effects in patients followed in French pain centres.

METHODS

Respectively, 495 and 379 patients with peripheral neuropathic pain initiating treatment with capsaicin 8% cutaneous patch(es) (female, 62.6%; mean age, 54.0 ± 14.8 years; post-surgical or traumatic pain, 52.7%; mean pain duration, 42.2 ± 54.1 months; DN4 score >4, 92.9%) completed the PGIC and several other PRO instruments before (baseline) and 3 months (M3) after treatment application.

RESULTS

At M3, improvement ("much improved" or "very much improved") was observed in 23.0% of patients, associated with decreases of -3.0 ± 2.2, -2.5 ± 2.4, and -23.1 ± 19.7 in BPI pain intensity, BPI pain interference and NPSI total scores, respectively. The highest Spearman's rank correlation coefficients with PGIC were found for pain intensity (BPI: r = -0.479, p < 0.001), satisfaction with current state (Patient Acceptable Symptomatic State: r = 0.455, p < 0.001), and treatment effectiveness (TSQM: r = 0.431, p < 0.001); correlation coefficients were lower for all NPSI scores, BPI pain interference score, HAD scores and EQ-5D-3L index.

CONCLUSIONS

In daily clinical practice, significant improvement in peripheral neuropathic pain, as assessed by PGIC scores, significantly correlated with changes in well-established measures of pain intensity, pain interference with activities of daily living, mood and quality of life, confirming its clinical interest as PRO measure in real-world conditions.

SIGNIFICANCE

Clinically important improvement in peripheral neuropathic pain, as assessed by PGIC scores, significantly correlated with well-established measures of pain intensity, pain interference in daily life and treatment efficacy. This result, associated with the ease of administration and scoring, encourages the widespread use of the PGIC in daily practice.

摘要

背景

患者报告结局(PRO)工具已被开发用于评估日常实践中的疼痛管理;方法、测量和临床试验中的疼痛评估倡议特别推荐使用患者整体印象变化(PGIC)。前瞻性非干预性多中心 PRO-QURE 研究旨在评估法国疼痛中心患者中 PGIC 与疼痛测量和治疗效果之间的相关性。

方法

分别有 495 名和 379 名患有周围神经性疼痛的患者开始使用 8%辣椒素贴剂(女性,62.6%;平均年龄 54.0±14.8 岁;术后或创伤性疼痛,52.7%;平均疼痛持续时间,42.2±54.1 个月;DN4 评分>4,92.9%)治疗,他们在治疗前(基线)和治疗后 3 个月(M3)完成了 PGIC 和其他几个 PRO 工具的评估。

结果

在 M3 时,23.0%的患者观察到改善(“明显改善”或“非常明显改善”),分别与 BPI 疼痛强度、BPI 疼痛干扰和 NPSI 总分降低 -3.0±2.2、-2.5±2.4 和 -23.1±19.7 相关。与 PGIC 相关性最高的斯皮尔曼等级相关系数为疼痛强度(BPI:r=-0.479,p<0.001)、对当前状态的满意度(患者可接受的症状状态:r=0.455,p<0.001)和治疗效果(TSQM:r=0.431,p<0.001);所有 NPSI 评分、BPI 疼痛干扰评分、HAD 评分和 EQ-5D-3L 指数的相关性系数较低。

结论

在日常临床实践中,PGIC 评分评估的周围神经性疼痛显著改善与疼痛强度、日常生活活动疼痛干扰、情绪和生活质量的既定措施的变化显著相关,证实了其在真实环境中作为 PRO 措施的临床意义。

意义

PGIC 评分评估的周围神经性疼痛的临床显著改善与疼痛强度、日常生活中的疼痛干扰和治疗效果的既定措施显著相关。这一结果,加上其易于管理和评分的特点,鼓励在日常实践中广泛使用 PGIC。

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