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加巴喷丁预防急性带状疱疹后神经痛的疗效:一项双盲、随机对照试验。

Efficacy of gabapentin for the prevention of postherpetic neuralgia in patients with acute herpes zoster: A double blind, randomized controlled trial.

机构信息

Primary Care Research Unit of Mallorca, Balearic Health Service, Palma, Spain.

Balearic Islands Health Research Institute (IdISBa), Palma, Spain.

出版信息

PLoS One. 2019 Jun 5;14(6):e0217335. doi: 10.1371/journal.pone.0217335. eCollection 2019.

DOI:10.1371/journal.pone.0217335
PMID:31166976
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6550400/
Abstract

BACKGROUND

Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ). Previous trials have reported that gabapentin can relieve chronic neuropathic pain, but its effect on prevention of PHN is unclear.

OBJECTIVE

To assess the efficacy of a 5-week course of gabapentin on acute herpetic pain and on the prevention of PHN at 12 weeks in patients with acute HZ.

METHODS

This was a randomized, double blind, placebo-controlled trial conducted in 17 primary care health centers in Mallorca, Spain. All patients were older than 50 years, presented with HZ within 72 h of rash onset, and had moderate-severe pain (≥4 on a 10-point visual analogue scale [VAS]). Ninety-eight patients were randomized to receive gabapentin or placebo. All patients received valaciclovir for 7 days and analgesia if needed. The treatment period was 5 weeks, followed by 7 weeks of follow-up. Gabapentin was initiated at 300 mg/day and gradually titrated to a maximum of 1800 mg/day. The main outcome measure was pain at 12 weeks.

RESULTS

Seventy-five patients completed the study, 33 in the gabapentin group and 42 in the control group. A total of 18.2% of patients in the gabapentin group and 9.5% in the control group reported pain at 12 weeks (p = 0.144). Four patients in the gabapentin group (12.1%), but no patients in the placebo group, reported pain of 4 or more on a 10-point VAS. Patients taking gabapentin reported worse health-related quality of life and poorer sleep quality. Three patients discontinued the trial due to adverse effects from gabapentin.

CONCLUSION

Addition of gabapentin to the usual treatment of HZ within 72 h of rash onset provided no significant relief from acute herpetic pain or prevention of PHN.

TRIAL REGISTRATION

ISRCTN Registry identifier: ISRCTN79871784.

摘要

背景

带状疱疹后神经痛(PHN)是带状疱疹(HZ)最常见的并发症。先前的试验报告称,加巴喷丁可缓解慢性神经性疼痛,但它对预防 PHN 的效果尚不清楚。

目的

评估在出现皮疹后 72 小时内开始的 5 周加巴喷丁疗程对急性带状疱疹疼痛的缓解作用,以及对 12 周时 PHN 的预防作用。

方法

这是一项在西班牙马略卡岛的 17 个初级保健中心进行的随机、双盲、安慰剂对照试验。所有患者年龄均大于 50 岁,在皮疹出现后 72 小时内出现 HZ,且疼痛中度至重度(视觉模拟评分[VAS]上≥4 分)。98 名患者被随机分配接受加巴喷丁或安慰剂。所有患者均接受伐昔洛韦治疗 7 天,并按需给予镇痛。治疗期为 5 周,随后进行 7 周的随访。加巴喷丁起始剂量为 300mg/天,逐渐滴定至最大剂量 1800mg/天。主要结局测量指标为 12 周时的疼痛。

结果

75 名患者完成了研究,其中加巴喷丁组 33 名,对照组 42 名。加巴喷丁组和对照组中分别有 18.2%和 9.5%的患者在 12 周时报告有疼痛(p = 0.144)。加巴喷丁组有 4 名患者(12.1%),但安慰剂组没有患者报告 VAS 上的疼痛为 4 或以上。服用加巴喷丁的患者报告其健康相关生活质量更差,睡眠质量更差。由于加巴喷丁的不良反应,有 3 名患者退出了试验。

结论

在皮疹出现后 72 小时内将加巴喷丁添加到 HZ 的常规治疗中,不能显著缓解急性带状疱疹疼痛或预防 PHN。

试验注册

ISRCTN 登记号:ISRCTN79871784。

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