超声引导下椎间孔注射干扰素1b治疗带状疱疹后神经痛的疗效和安全性:一项随机、双盲、安慰剂对照、多中心临床试验的研究方案

IF 2.7 3区 医学 Q2 CLINICAL NEUROLOGY Frontiers in Neurology Pub Date : 2025-01-06 eCollection Date: 2024-01-01 DOI:10.3389/fneur.2024.1516262
Hui-Min Hu, Wen-Hui Liu, Chen Li, Qing Shi, Chun-Hua Liu, An-Xiang Liu, Yi-Fan Li, Yi Zhang, Peng Mao, Bi-Fa Fan
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引用次数: 0

摘要

目的:带状疱疹后神经痛(PHN)是一种难治性神经性疼痛,可引起严重的痛苦、残疾、经济损失和医疗负担。在本研究中,我们旨在评估干扰素(IFN)-α1b椎间孔注射治疗PHN患者的有效性和安全性。患者和方法:这是一项随机、双盲、安慰剂对照的多中心临床试验研究方案。共招募来自11家医院的200名PHN患者,按1:1的比例随机分配到IFN-α1b治疗组和安慰剂对照组。两组均给予普瑞巴林150mg口服,每日2次,同时椎间孔注射利多卡因作为常规治疗。该试验包括筛选期、2周干预和3个月随访。主要结果将包括视觉模拟量表评分和疼痛缓解持续时间。次要结果将包括36项简表、服用止痛药的剂量和持续时间、水痘-带状疱疹病毒DNA的病毒载量、体液细胞因子水平以及抢救药物的剂量和频率。所有不良事件和严重不良事件将在研究期间进行评估。结论:本研究有望为椎间孔注射IFN-α1b治疗PHN患者的有效性和安全性提供依据。临床试验注册:https://www.chictr.org.cn/indexEN.html,标识符ChiCTR240008996。
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Efficacy and safety of interferon-alpha 1b injection into the intervertebral foramen with ultrasonic guidance in patients with postherpetic neuralgia: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial.

Purpose: Postherpetic neuralgia (PHN) is a type of refractory neuropathic pain that causes significant suffering, disability, economic loss, and medical burden. In this study, we aim to evaluate the efficacy and safety of interferon (IFN)-α1b injection into the intervertebral foramen of patients with PHN.

Patients and methods: This is a study protocol for a randomized, double-blind placebo-controlled multicenter clinical trial. A total of 200 participants with PHN from 11 hospitals will be recruited and randomly assigned to the treatment group administered with IFN-α1b and control group treated with placebo in a 1:1 ratio. Both groups will also receive oral pregabalin 150 mg twice daily and lidocaine injection into the intervertebral foramen as conventional therapy. This trial will involve a screening period, a 2-week intervention, and a 3-month follow-up. The primary outcomes will include the visual analog scale score and duration of pain relief. The secondary outcomes will include the 36-item short-form, dosage and duration of painkillers taken, viral load of varicella-zoster virus DNA, humoral cytokine level, and dosage and frequency of rescue medication. All adverse events and severe adverse events will be assessed during the study.

Conclusion: This study is expected to provide evidence for the efficacy and safety of IFN-α1b injection into the intervertebral foramen in patients with PHN.

Clinical trial registration: https://www.chictr.org.cn/indexEN.html, identifier ChiCTR240008996.

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来源期刊
Frontiers in Neurology
Frontiers in Neurology CLINICAL NEUROLOGYNEUROSCIENCES -NEUROSCIENCES
CiteScore
4.90
自引率
8.80%
发文量
2792
审稿时长
14 weeks
期刊介绍: The section Stroke aims to quickly and accurately publish important experimental, translational and clinical studies, and reviews that contribute to the knowledge of stroke, its causes, manifestations, diagnosis, and management.
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