普瑞巴林和度洛西汀治疗痛性糖尿病周围神经病变（PDPN）患者的疗效：一项多中心IV期临床试验——BLOSSOM

Efficacy of Pregabalin and Duloxetine in Patients with Painful Diabetic Peripheral Neuropathy (PDPN): A Multi-Centre Phase IV Clinical Trial-BLOSSOM.

作者信息

Rakusa Martin, Marolt Iris, Stevic Zorica, Rebrina Sandra Vuckovic, Milenkovic Tatjana, Stepien Adam

机构信息

Division of Neurology, University Medical Centre Maribor, 2000 Maribor, Slovenia.

Faculty of Medicine, University of Maribor, 2000 Maribor, Slovenia.

出版信息

Pharmaceuticals (Basel). 2023 Jul 18;16(7):1017. doi: 10.3390/ph16071017.

DOI:10.3390/ph16071017

PMID:37513930

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10386018/

Abstract

INTRODUCTION

Our trial (ClinicalTrials.gov Identifier: NCT04246619) evaluates the efficacy of two generic medications, pregabalin and duloxetine, for treating pain in PDPN patients.

METHODS

The patients were randomised either into the pregabalin (99) or the duloxetine (102) arm. Pain was evaluated using the DN-4 questionnaire, and visual analogue scales (VASs, 0-100 mm) were used to measure the average pain intensity (API), worst pain intensity (WPI) in the last 24 h and current pain intensity (CPI).

RESULTS

The proportion of patients with a clinically significant improvement in the API at Week 12 was 88.3% [CI 81.7%, 94.8%] in the pregabalin arm and 86.9% [CI 76.7%, 97.1%] in the duloxetine arm. After 12 weeks, the CPI, API, and WPI decreased by -35.3 [-40.5, -30.0], -37.0 [-41.4, -32.6], and -41.6 [-46.6, -36.5] in the pregabalin arm, and by -35.0 [-39.2, -30.7], -36.9 [-41.5, -32.3], and -40.0 [-44.8, -35.2] in the duloxetine arm (all in mm, all < 0.001).

CONCLUSION

Our results demonstrate that pregabalin and duloxetine are effective medications for treating pain in PDPN in more than 86% of all randomised patients.

摘要

引言

我们的试验（ClinicalTrials.gov标识符：NCT04246619）评估了两种通用药物普瑞巴林和度洛西汀治疗糖尿病周围神经病变（PDPN）患者疼痛的疗效。

方法

将患者随机分为普瑞巴林组（99例）或度洛西汀组（102例）。使用DN-4问卷评估疼痛，并使用视觉模拟量表（VAS，0-100mm）测量平均疼痛强度（API）、过去24小时内最严重疼痛强度（WPI）和当前疼痛强度（CPI）。

结果

在第12周时，普瑞巴林组API有临床显著改善的患者比例为88.3%[CI 81.7%，94.8%]，度洛西汀组为86.9%[CI 76.7%，97.1%]。12周后，普瑞巴林组的CPI、API和WPI分别下降了-35.3[-40.5，-30.0]、-37.0[-41.4，-32.6]和-41.6[-46.6，-36.5]，度洛西汀组分别下降了-35.0[-39.2，-30.7]、-36.9[-41.5，-32.3]和-40.0[-44.8，-35.2]（均以mm为单位，均P<0.001）。