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Внутривенный или внутримышечный парекоксиб при острой послеоперационной боли у взрослых

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Background

Parecoxib was the first COX‐2 available for parenteral administration, and may, given intravenously or intramuscularly, offer advantages over oral medication when patients have nausea and vomiting or are unable to swallow, such as in the immediate postoperative period.

Objectives

Assess the efficacy of single dose intravenous or intramuscular parecoxib in acute postoperative pain, the requirement for rescue medication, and any associated adverse events.

Search methods

We searched Cochrane CENTRAL, MEDLINE, EMBASE in November 2008.

Selection criteria

Randomised, double‐blind, placebo‐controlled clinical trials of parecoxib compared with placebo for relief of acute postoperative pain in adults.

Data collection and analysis

Two review authors independently assessed trial quality and extracted data. The area under the “pain relief versus time” curve was used to derive the proportion of participants with parecoxib and placebo experiencing at least 50% pain relief over 6 hours, using validated equations. The number‐needed‐to‐treat‐to‐benefit (NNT) was calculated using 95% confidence intervals (CI). The proportion of participants using rescue analgesia over a specified time period, and time to use of rescue analgesia, were sought as additional measures of efficacy. Information on adverse events and withdrawals were also collected.

Main results

Seven studies (1446 participants) were included. There was no significant difference between doses, or between intravenous and intramuscular administration for 50% pain relief over 6 hours: NNTs compared with placebo were 3.1 (2.4 to 4.5), 2.4 (2.1 to 2.8), and 1.8 (1.5 to 2.3) for 10, 20, and 40 mg parecoxib respectively. Fewer participants required rescue medication over 24 hours with parecoxib than placebo: parecoxib 40 mg was significantly better than parecoxib 20 mg (NNTs to prevent use of rescue medication 7.5 (5.3 to 12.8) and 3.3 (2.6 to 4.5) respectively; P < 0.0007). Median time to use of rescue medication was 3.1 hours, 6.9 hours and 10.6 hours with parecoxib 10 mg, 20 mg and 40 mg respectively, and 1.5 hours with placebo. Adverse events were generally mild to moderate, rarely led to withdrawal, and did not differ in frequency between groups. No serious adverse events were reported with parecoxib or placebo.

Authors' conclusions

A single dose of parecoxib 20 mg or 40 mg provided effective analgesia for 50 to 60% of those treated compared to about 15% with placebo, and was well tolerated. Duration of analgesia was longer, and significantly fewer participants required rescue medication over 24 hours with the higher dose.

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

Парекоксиб для внутримышечного или внутривенного введения (инъекции в мышцу или вену) при острой послеоперационной боли у взрослых

Самым распространенным путем введения лекарств для послеоперационного обезболивания является прием внутрь (через рот), но некоторые пациенты в раннем послеоперационном периоде не могут глотать, иногда возникает тошнота или рвота, и у таких пациентов может быть предпочтительным внутривенное или внутримышечное введение. В этом обзоре оценили семь исследований парекоксиба, инъекционного ингибитора ЦОГ‐2, для облегчения острой послеоперационной боли. Однократные дозы 20 мг или 40 мг обеспечивали эффективное уменьшение боли у 50–60% человек, получавших лечение, по сравнению с 15%, получавшими плацебо. При более высокой дозе продолжительность уменьшения боли была дольше (10,6 часа для 40 мг по сравнению с 6,9 часа для 20 мг), и значимо меньше людей, получавших более высокую дозу, нуждались в лекарствах для немедленного облегчения боли в течение 24 часов (66% в сравнении с 81%). Неблагоприятные события, как правило, были легкой или средней степени тяжести, о них сообщали чуть более половины человек, получавших лечение как в группе парекоксиба, так и в группе плацебо.