A randomized, placebo-controlled trial of oxycodone and of gabapentin for acute pain in herpes zoster

被引:60
作者
Dworkin, Robert H. [1 ,2 ]
Barbano, Richard L. [2 ]
Tyring, Stephen K. [3 ,4 ]
Betts, Robert F. [5 ]
McDermott, Michael P. [2 ,6 ,7 ]
Pennella-Vaughan, Janet [1 ]
Bennett, Gary J. [8 ]
Berber, Erhan [9 ]
Gnann, John W. [10 ,11 ,12 ,13 ]
Irvine, Carrie [14 ]
Kamp, Cornelia [2 ]
Kieburtz, Karl [2 ]
Max, Mitchell B. [15 ]
Schmader, Kenneth E. [16 ,17 ]
机构
[1] Univ Rochester, Sch Med & Dent, Dept Anesthesiol, Rochester, NY 14642 USA
[2] Univ Rochester, Sch Med & Dent, Dept Neurol, Rochester, NY 14642 USA
[3] Univ Texas Hlth Sci Ctr, Dept Dermatol, Houston, TX USA
[4] Ctr Clin Studies, Houston, TX USA
[5] Univ Rochester, Sch Med & Dent, Dept Med, Rochester, NY 14642 USA
[6] Univ Rochester, Sch Med & Dent, Dept Biostat, Rochester, NY 14642 USA
[7] Univ Rochester, Sch Med & Dent, Dept Computat Biol, Rochester, NY 14642 USA
[8] McGill Univ, Dept Anesthesiol, Montreal, PQ, Canada
[9] Nova Pharmaceut Corp, E Hanover, NJ USA
[10] Univ Alabama Birmingham, Dept Med, Birmingham, AL 35294 USA
[11] Univ Alabama Birmingham, Dept Pediat, Birmingham, AL 35294 USA
[12] Univ Alabama Birmingham, Dept Microbiol, Birmingham, AL 35294 USA
[13] Birmingham Vet Adm Med Ctr, Birmingham, AL USA
[14] Univ Rochester, Sch Med & Dent, Dept Biostat & Computat Biol, Rochester, NY 14642 USA
[15] Univ Pittsburgh, Dept Anesthesiol, Pittsburgh, PA USA
[16] Duke Univ, Dept Geriatr Med, Durham, NC USA
[17] Durham VA Med Ctr, GRECC, Durham, NC USA
关键词
Herpes zoster; Acute pain; Randomized clinical trial; Oxycodone; Gabapentin; Postherpetic neuralgia; POSTHERPETIC NEURALGIA; CLINICAL-TRIALS; NEUROPATHIC PAIN; VARICELLA; VACCINE; EPIDEMIOLOGY; MECHANISMS; ACYCLOVIR; INTENSITY; IMPACT;
D O I
10.1016/j.pain.2008.12.022
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
Although acute pain in patients with herpes zoster can be severe and has a Substantial impact on health-related quality of life, there have. been no randomized clinical trials of oral medications specifically for its ongoing treatment. A randomized clinical trial was conducted in which 87 subjects >= 50 years of age with herpes zoster within 6 calendar days of rash onset and with worst pain in the past 24 h >= 3 on a 0-10 rating scale initiated 7 clays of treatment with famciclovir in combination with 28 days of treatment with either controlled-release (CR) oxycodone, gabapentin, or placebo. Subjects were evaluated for adverse effects of treatment, acute pain, and health-related quality of life. The results showed that CR-oxycodone and gabapentin were generally safe and were associated with adverse events that reflect well-known effects of these medications. Discontinuing participation in the trial, primarily associated with constipation, occurred more frequently in subjects randomized to CR-oxycodone (27.6%) compared with placebo (6.9%). Treatment with CR-oxycodone reduced the mean worst pain over days 1-8 (p = 0.01) and days 1 - 14 (p = 0.02) relative to placebo but not throughout the entire 28-day treatment period as pain resolved in most subjects. Gabapentin did not provide significantly greater pain relief than placebo, although the data for the first week were consistent with a modest benefit. By demonstrating that CR-oxycodone is safe, generally adequately tolerated, and appears to have efficacy for relieving acute pain, the results of this clinical trial provide a foundation for evidence-based treatment for acute pain in herpes zoster. (C) 2008 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
引用
收藏
页码:209 / 217
页数:9
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