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全国依托考昔注射液临床经验(NICE)2.0:评估依托考昔注射液在住院和门诊环境中急性疼痛管理的真实世界有效性和耐受性。

Nationwide Etoricoxib Injection Clinical Experience (NICE) 2.0: Assessing Real-World Effectiveness and Tolerability of Etoricoxib Injection in Acute Pain Management in Both Inpatient and Outpatient Settings.

作者信息

Kumar Sb Uday, Mehrotra Shubh, Singh Amulya, Prabhoo Tanay, Muchhala Sameer, Natarajan Vidhya

机构信息

Orthopedics, Parmanand Deepchand (PD) Hinduja Sindhi Hospital, Bangalore, IND.

Orthopedics, Lovee Shubh Hospital, Lucknow, IND.

出版信息

Cureus. 2025 Aug 14;17(8):e90116. doi: 10.7759/cureus.90116. eCollection 2025 Aug.

Abstract

BACKGROUND

Effective acute pain management remains a challenge. Etoricoxib, a selective COX-2 inhibitor, is known for its favorable safety profile compared to traditional NSAIDs. While oral etoricoxib is well-established for pain management, the intramuscular (IM) formulation remains underrepresented in the published literature and warrants further clinical investigation.

OBJECTIVES

This study aims to assess the effectiveness of IM etoricoxib (90 mg/mL) in reducing acute pain severity in inpatient and outpatient settings and to evaluate its tolerability.

MATERIALS AND METHODS

In this retrospective, multicenter, observational cohort study, medical records of 1,018 patients treated at the discretion of doctors across 296 centers in India were reviewed. Pain was assessed on the 10-point Visual Analog Scale (VAS). In outpatient settings, VAS score recordings were taken at baseline and at 30- and 60-minute post-injection intervals. In inpatient settings, recordings were taken at baseline, 30 minutes, 60 minutes, 6 hours, 12 hours, and 24 hours. Adverse events were documented.

RESULTS

The study included 1,018 patients, 229 (22.5%) inpatients and 789 (77.5%) outpatients. The primary indication for IM etoricoxib injection was acute back pain (272, 26.7%). Pain reduction, measured via VAS, showed significant results. In outpatients, VAS scores reduced by 61.6% at 60 minutes post-injection (p < 0.001). In inpatients, pain reduction was sustained over 24 hours, with a cumulative reduction of 69.45% at 24 hours (p < 0.001). The need for rescue analgesics was minimal (2.9%). Safety analysis revealed no adverse events in 992 (97.4%) of patients, with mild pain at the injection site in 338 (33.2%).

CONCLUSION

IM etoricoxib demonstrated rapid and sustained pain relief with excellent tolerability across diverse patient populations.

摘要

背景

有效的急性疼痛管理仍然是一项挑战。依托考昔是一种选择性环氧化酶-2(COX-2)抑制剂,与传统非甾体抗炎药相比,其安全性良好。虽然口服依托考昔在疼痛管理方面已得到充分确立,但肌肉注射(IM)剂型在已发表的文献中仍未得到充分体现,值得进一步进行临床研究。

目的

本研究旨在评估肌肉注射依托考昔(90毫克/毫升)在减少住院和门诊患者急性疼痛严重程度方面的有效性,并评估其耐受性。

材料与方法

在这项回顾性、多中心、观察性队列研究中,对印度296个中心的1018例由医生酌情治疗的患者的病历进行了回顾。采用10分视觉模拟量表(VAS)评估疼痛。在门诊环境中,在基线以及注射后30分钟和60分钟记录VAS评分。在住院环境中,在基线、30分钟、60分钟、6小时、12小时和24小时进行记录。记录不良事件。

结果

该研究纳入了1018例患者,其中229例(22.5%)为住院患者,789例(77.5%)为门诊患者。肌肉注射依托考昔的主要适应证为急性背痛(272例,26.7%)。通过VAS测量的疼痛减轻显示出显著效果。在门诊患者中,注射后60分钟时VAS评分降低了61.6%(p<0.001)。在住院患者中,疼痛减轻持续24小时,24小时时累积减轻69.45%(p<0.001)。使用急救镇痛药的需求极少(2.9%)。安全性分析显示,992例(97.4%)患者未发生不良事件,338例(33.2%)患者注射部位出现轻度疼痛。

结论

肌肉注射依托考昔在不同患者群体中均表现出快速且持续的疼痛缓解以及出色的耐受性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3867/12433326/665b52928e24/cureus-0017-00000090116-i01.jpg

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