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静脉注射美洛昔康用于全膝关节置换术围手术期中重度疼痛管理的安全性和有效性:一项随机临床试验。

Safety and Efficacy of Perioperative Intravenous Meloxicam for Moderate-to-Severe Pain Management in Total Knee Arthroplasty: A Randomized Clinical Trial.

机构信息

University Orthopedic and Joint Replacement Center, Tamarac, Florida, USA.

Orthopaedic Center of Vero Beach, Vero Beach, Florida, USA.

出版信息

Pain Med. 2021 Jun 4;22(6):1261-1271. doi: 10.1093/pm/pnab016.

DOI:10.1093/pm/pnab016
PMID:33502533
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8185557/
Abstract

OBJECTIVE

To evaluate the effect of perioperative meloxicam IV 30 mg on opioid consumption in primary total knee arthroplasty (TKA).

DESIGN

Multicenter, randomized, double-blind, placebo-controlled trial.

SUBJECTS

In total, 181 adults undergoing elective primary TKA.

METHODS

Subjects received meloxicam 30 mg or placebo via an IV bolus every 24 hours, the first dose administered prior to surgery as part of a multimodal pain management protocol. The primary efficacy parameter was total opioid use from end of surgery through 24 hours.

RESULTS

Meloxicam IV was associated with less opioid use versus placebo during the 24 hours after surgery (18.9 ± 1.32 vs 27.7 ± 1.37 mg IV morphine equivalent dose; P < 0.001) and was superior to placebo on secondary endpoints, including summed pain intensity (first dose to 24 hours postdosing, first dose to first assisted ambulation, and first dose to discharge) and opioid use (48-72 hrs., 0-48 hrs., 0-72 hrs., hour 0 to end of treatment, and the first 24 hours after discharge). Adverse events (AEs) were reported for 69.9% and 92.0% of the meloxicam IV and placebo groups, respectively; the most common AEs were nausea (40% vs. 59%), vomiting (16% vs 22%), hypotension (14% vs 15%), pruritus (15% vs 11%), and constipation (11% vs 13%).

CONCLUSIONS

Perioperative meloxicam IV 30 mg as part of a multimodal analgesic regimen for elective primary TKA reduced opioid consumption in the 24-hour period after surgery versus placebo and was associated with a lower incidence of AEs typically associated with opioid use.

摘要

目的

评估围手术期静脉注射 30mg 美洛昔康对初次全膝关节置换术(TKA)患者阿片类药物消耗的影响。

设计

多中心、随机、双盲、安慰剂对照试验。

受试者

共 181 名择期行初次 TKA 的成年人。

方法

受试者接受静脉注射美洛昔康 30mg 或安慰剂,每 24 小时一次,首剂在手术前作为多模式疼痛管理方案的一部分给予。主要疗效参数是术后至 24 小时的总阿片类药物使用量。

结果

与安慰剂相比,静脉注射美洛昔康在术后 24 小时内的阿片类药物使用量更少(18.9±1.32 与 27.7±1.37mg 静脉注射吗啡等效剂量;P<0.001),且在次要终点方面优于安慰剂,包括总和疼痛强度(首次给药至 24 小时后、首次给药至首次辅助活动和首次给药至出院)和阿片类药物使用量(48-72 小时、0-48 小时、0-72 小时、0 小时至治疗结束和出院后 24 小时)。分别有 69.9%和 92.0%的静脉注射美洛昔康组和安慰剂组报告了不良事件(AE);最常见的 AE 是恶心(40%比 59%)、呕吐(16%比 22%)、低血压(14%比 15%)、瘙痒(15%比 11%)和便秘(11%比 13%)。

结论

围手术期静脉注射 30mg 美洛昔康作为择期初次 TKA 多模式镇痛方案的一部分,与安慰剂相比,可减少术后 24 小时内的阿片类药物消耗,并与阿片类药物使用相关的 AE 发生率较低相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc74/8185557/6a38a3959c5b/pnab016f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc74/8185557/9b72530e79a5/pnab016f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc74/8185557/6a38a3959c5b/pnab016f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc74/8185557/9b72530e79a5/pnab016f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc74/8185557/6a38a3959c5b/pnab016f2.jpg

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