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Однократная доза лумиракоксиба для приема внутрь при послеоперационной боли у взрослых

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Background

Lumiracoxib is a selective cyclooxygenase‐2 (COX‐2) inhibitor. COX‐2 inhibitors were developed to avoid COX‐1‐related gastrointestinal (GI) problems while maintaining the analgesic and anti‐inflammatory activity of traditional non‐steriodal anti‐inflammatory drugs (NSAIDs).

Objectives

To review the analgesic efficacy, duration of analgesia, and adverse effects of a single oral dose of lumiracoxib for moderate to severe postoperative pain in adults.

Search methods

We searched Cochrane CENTRAL, MEDLINE, and EMBASE to February 2010.

Selection criteria

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

Data collection and analysis

Studies were assessed for methodological quality and the data extracted by two review authors independently. Summed total pain relief over six hours (TOTPAR 6) was used to calculate the number of participants achieving at least 50% pain relief. These derived results were used to calculate, with 95% confidence intervals, the relative benefit compared to placebo, and the number needed to treat (NNT) for one participant to experience at least 50% pain relief over six hours. Numbers of participants using rescue medication, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals was collected.

Main results

In this updated review four studies met the inclusion criteria. In total 366 participants were treated with lumiracoxib 400 mg, 51 with lumiracoxib 100 mg, and 212 with placebo. Active comparators were naproxen 500 mg, rofecoxib 50 mg, celecoxib 200 mg, celecoxib 400 mg, and ibuprofen 400 mg. With lumiracoxib 400 mg 50% of participants had at least 50% pain relief over six hours, compared with 8% given placebo; RB 6.9 (95% CI 4.1 to 12), NNT 2.4 (2.1 to 2.8).

Median time to onset of analgesia was shorter for lumiracoxib 400 mg (0.6 to 1.5 hours) than placebo (>12 hours). Fewer participants needed rescue medication with lumiracoxib (64%) than with placebo (91%) over 12 to 24 hours; NNT to prevent remedication 3.7 (2.9 to 5.0). The weighted median time to use of rescue medication was 9.4 hours for lumiracoxib 400 mg and 1.7 hours for placebo.

Adverse events were generally mild to moderate in severity, with one serious event reported in a placebo patient.

Authors' conclusions

Lumiracoxib 400 mg given as a single oral dose is an effective analgesic for acute postoperative pain, and has a relatively long duration of action. Adverse events with lumiracoxib did not differ from placebo.

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

Однократная доза лумиракоксиба (Prexige®) для приема внутрь при острой послеоперационной боли у взрослых

Послеоперационная боль часто плохо контролируется. Обезболивающие средства группы ингибиторов циклооксигеназы (ЦОГ‐2) были разработаны с целью уменьшения побочных эффектов нестероидных противовоспалительных средств (НПВС) со стороны желудочно‐кишечного тракта. Лумиракоксиб 400 мг обеспечил быстрое, эффективное и длительное облегчение послеоперационной боли в четырех исследованиях в стоматологической и ортопедической хирургии. Из 366 участников, получавших лумиракоксиб в дозе 400 мг, половина отметили высокий уровень обезболивания (по меньшей мере 50% облегчения боли в течение шести часов) по сравнению с 8% получавшими плацебо. Продолжительность анальгезии была относительно длительной и составляла 9 часов, меньшее число участников нуждалось в дополнительном использовании обезболивающих препаратов в группе лумиракоксиба, чем в группе плацебо. Сведения о неблагоприятных событиях были противоречивыми, но серьезных неблагоприятных событий не произошло ни у одного пациента, принимающего лумиракоксиб в этих исследованиях.