Gabapentin for the treatment of postherpetic neuralgia - A randomized controlled trial
Gabapentin for the treatment of postherpetic neuralgia - A randomized controlled trial
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DOI：
10.1001/jama.280.21.1837
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发表时间：
1998-12-02
影响因子：
120.7
通讯作者：
Magnus-Miller, L
中科院分区：
文献类型：
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作者：
Rowbotham, M;Harden, N;Magnus-Miller, L
背景.-带状疱疹后神经痛 (PHN) 是一种在疱疹测试仪（带状疱疹）后出现的顽固性神经性疼痛综合征，许多患者无法得到有效治疗。目的.-确定抗惊厥药物加巴喷丁在减轻 PHN 疼痛方面的功效和安全性。设计.-多中心、随机、双盲、安慰剂对照、平行设计、从 1996 年 8 月到 7 月进行的为期 8 周的试验1997 年。设置。-16 个美国门诊临床中心。参与者。-总共 229 名受试者被随机分配。干预。-4 周的滴定期，最大剂量为 3600 mg/d 加巴喷丁或匹配的安慰剂。以最大耐受剂量继续治疗 4 周。如果治疗在研究开始前稳定并在整个研究过程中保持不变，则继续联合使用三环类抗抑郁药和/或麻醉药。主要结果指标。-主要疗效指标是从基线周到治疗最后一周基于 Ii 点李克特量表（0，无疼痛；10，可能最严重的疼痛）的平均每日疼痛评分的变化，次要指标包括平均每日睡眠评分、简式麦吉尔疼痛问卷 (SF-MPQ)、受试者总体变化印象和研究者评定的临床总体变化印象、简表 36 (SF-36) 生活质量问卷和情绪状态概况 (POMS)。安全措施包括不良事件的发生频率和严重程度。 结果 - 113 名患者接受加巴喷丁治疗，其中 89 名 (78.8%) 完成了研究； 116 人接受了安慰剂，95 人 (81.9%) 完成了研究。通过意向治疗分析，接受加巴喷丁的受试者的平均每日疼痛评分从 6.3 分显着降低至 4.2 分，而随机接受安慰剂的受试者则从 6.5 分降至 6.0 分（P
Context.-Postherpetic neuralgia (PHN) is a syndrome of often intractable neuropathic pain following herpes tester (shingles) that eludes effective treatment in many patients.Objective.-To determine the efficacy and safety of the anticonvulsant drug gabapentin in reducing PHN pain.Design.-Multicenter, randomized, double-blind, placebo-controlled, parallel design, 8-week trial conducted from August 1996 through July 1997.Setting.-Sixteen US outpatient clinical centers.Participants.-A total of 229 subjects were randomized.Intervention.-A 4-week titration period to a maximum dosage of 3600 mg/d of gabapentin or matching placebo. Treatment was maintained for another 4 weeks at the maximum tolerated dose. Concomitant tricyclic antidepressants and/or narcotics were continued if therapy was stabilized prior to study entry and remained constant throughout the study.Main Outcome Measures.-The primary efficacy measure was change in the average daily pain score based on an Ii-point Likert scale (0, no pain; 10, worst possible pain) from baseline week to the final week of therapy, Secondary measures included average daily sleep scores, Short-Form McGill Pain Questionnaire (SF-MPQ), Subject Global Impression of Change and investigator-rated Clinical Global Impression of Change, Short Form-36 (SF-36) Quality of Life Questionnaire, and Profile of Mood States (POMS). Safety measures included the frequency and severity of adverse events.Results.-One hundred thirteen patients received gabapentin, and 89 (78.8%) completed the study; 116 received placebo, and 95 (81.9%) completed the study. By intent-to-treat analysis, subjects receiving gabapentin had a statistically significant reduction in average daily pain score from 6.3 to 4.2 points compared with a change from 6.5 to 6.0 points in subjects randomized to receive placebo (P