Chen Zheng, Shrestha Niti, Zhao Chunmei, Fan Bifa, Luo Fang
Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.
Trials. 2020 Dec 9;21(1):1012. doi: 10.1186/s13063-020-04919-6.
Postherpetic neuralgia (PHN) is the most common complication attributed to herpes zoster, which involves the reactivation of residual varicella zoster virus. It has been reported previously that pre-emptive amitriptyline following acute herpes zoster has shown latent positive effects in the prevention of PHN. In this study, by interfering with the same targets, norepinephrine and serotonin, we aim to evaluate whether pre-emptive duloxetine may proactively prevent PHN development.
This is a nationwide multicentric, randomized, open-label, blinded-endpoint study that will recruit 750 participants from 18 primary centres in China. Patients aged more than 50 years who are diagnosed with uncomplicated HZ, present with vesicles within 72 h of their emergence, and have an average pain score of at least 40/100 mm on a visual analogue scale (VAS, 0 mm = no pain, 100 mm = worst possible pain, at opposite ends of a 100-mm line) will be recruited for this study. Participants will be randomized into a duloxetine arm and a control arm. Participants allocated to the duloxetine arm will be given antivirals, analgesics and duloxetine, while those allocated to the control arm will receive antivirals and analgesics but no duloxetine. The primary outcome of this study is preventive efficacy against PHN, which will be evaluated based on a 100 mm VAS. Any pain scores other than 0 mm on the VAS 12 weeks after HZ onset will be defined as PHN. The secondary outcomes will consist of the average weekly VAS score, the average weekly consumption of each analgesic, weekly feature of the pain, patients' quality of life based on the 12-item Short-Form Health Survey, Patient Global Impression of Change Scale, sleep quality as evaluated by the Pittsburgh Sleep Quality Index and adverse events during the study period.
This study will investigate a prophylactic approach for reducing the prevalence of postherpetic neuralgia with duloxetine and will add significant new knowledge on the preventive effects of duloxetine on PHN.
Clinicaltrials.gov NCT04313335 . Registered on 18 March 2020.
带状疱疹后神经痛（PHN）是带状疱疹最常见的并发症，它涉及残留水痘-带状疱疹病毒的重新激活。此前有报道称，急性带状疱疹后预防性使用阿米替林对预防PHN显示出潜在的积极效果。在本研究中，通过干扰相同靶点去甲肾上腺素和5-羟色胺，我们旨在评估预防性使用度洛西汀是否可主动预防PHN的发生。
这是一项全国多中心、随机、开放标签、盲终点研究，将从中国18个基层中心招募750名参与者。年龄超过50岁、被诊断为无并发症的HZ、在水疱出现后72小时内出现水疱且视觉模拟量表（VAS，0mm = 无疼痛，100mm = 可能的最严重疼痛，在100mm线的两端）平均疼痛评分至少为40/100mm的患者将被纳入本研究。参与者将被随机分为度洛西汀组和对照组。分配到度洛西汀组的参与者将给予抗病毒药物、镇痛药和度洛西汀，而分配到对照组的参与者将接受抗病毒药物和镇痛药，但不接受度洛西汀。本研究的主要结局是对PHN的预防效果，将基于100mm VAS进行评估。HZ发作12周后VAS上除0mm以外的任何疼痛评分将被定义为PHN。次要结局将包括平均每周VAS评分、每种镇痛药的平均每周消耗量、疼痛的每周特征、基于12项简短健康调查问卷的患者生活质量、患者总体变化印象量表、匹兹堡睡眠质量指数评估的睡眠质量以及研究期间的不良事件。
本研究将调查一种用度洛西汀降低带状疱疹后神经痛患病率的预防方法，并将为度洛西汀对PHN的预防作用增添重要的新知识。
Clinicaltrials.gov NCT04313335。于2020年3月18日注册。
