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Одна доза габапентина для приема внутрь при лечении острой послеоперационной боли у взрослых

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Background

Gabapentin is an antiepileptic drug, also used in the treatment of neuropathic pain, which is the subject of a Cochrane review, currently under revision. Its efficacy in treating established acute postoperative pain has not been demonstrated.

Objectives

To assess the efficacy and safety of single dose oral gabapentin compared with placebo in established acute postoperative pain using methods that permit comparison with other analgesics.

Search methods

We searched Cochrane CENTRAL, MEDLINE, EMBASE, and the Oxford Pain Relief Database. Additional studies were sought from reference lists of retrieved articles and reviews. Clinical trials databases were searched for unpublished studies; clinical trial reports of several unpublished studies have been made public following litigation in the US.

Selection criteria

Single oral dose, randomised, double‐blind, placebo‐controlled trials of gabapentin for relief of established moderate to severe postoperative pain in adults.

Data collection and analysis

Studies were assessed for methodological quality and data extracted by two review authors independently. Numbers of participants with at least 50% of maximum possible total pain relief (TOTPAR) or summed pain intensity difference (SPID) with gabapentin or placebo were calculated and used to derive relative benefit (RB) or risk (RR), and number‐needed‐to‐treat‐to‐benefit (NNT). Numbers of participants using rescue medication, and time to its use, were sought as additional measures of efficacy. Information on adverse events and withdrawals was collected.

Main results

Four unpublished studies met inclusion criteria; in three, participants had pain following dental surgery, and one followed major orthopaedic surgery; 177 participants were treated with a single dose of gabapentin 250 mg, 21 with gabapentin 500 mg, and 172 with placebo. At least 50% pain relief over 6 hours was achieved by 15% with gabapentin 250 mg and 5% with placebo; giving a RB of 2.5 (95% CI 1.2 to 5.0) and an NNT of 11 (6.4 to 35). Significantly fewer participants needed rescue medication within 6 hours with gabapentin 250 mg than with placebo; NNT to prevent use 5.8. About one third of participants reported adverse events with both gabapentin 250 mg and placebo. No serious adverse events occurred with gabapentin.

Authors' conclusions

Gabapentin 250 mg is statistically superior to placebo in the treatment of established acute postoperative pain, but the NNT of 11 for at least 50% pain relief over 6 hours with gabapentin 250 mg is of limited clinical value and inferior to commonly used analgesics. Gabapentin 250 mg is not clinically useful as a stand‐alone analgesic in established acute postoperative pain, though this is probably the first demonstration of analgesic effect of an antiepileptic in established acute pain.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Резюме на простом языке

Габапентин при острой послеоперационной боли у взрослых

Габапентин ‐ это лекарство, используемое в основном для лечения эпилепсии, а также боли, вызванной повреждением нервов (нейропатическая боль). Габапентин обычно не используют для лечения боли, возникающей после травмы или операции; вопрос относительно эффективности габапентина при этом виде боли остается спорным. Мы стремились выяснить, эффективен ли габапентин при лечении острой послеоперационной боли у взрослых. Мы нашли четыре неопубликованных клинических испытания с участием 370 человек, которые получали либо габапентин, либо плацебо (сахарные пилюли). Прием габапентина в дозе 250 мг приносит некоторое облегчение при острой послеоперационной боли. Однако он менее эффективен, чем другие лекарства, которые обычно используют в этой ситуации, особенно ибупрофен, диклофенак и напроксен, а также, возможно, парацетамол (ацетаминофен) как в виде отдельного лекарства, так и в сочетании со слабым опиоидом.

Тем не менее, с научной точки зрения интересно, что лекарство, первоначально разработанное для лечения эпилепсии, влияет на послеоперационную боль. Задачами для исследований, требующими решения в настоящее время, являются поиск оптимальной дозы, а также решение вопроса о том, может ли комбинация габапентина с обычными обезболивающими средствами быть лучше для лечения послеоперационной боли, чем обычные обезболивающие средства.