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詹姆斯·A·兰德青年研究者奖:全膝关节置换术后大剂量开具阿片类药物是不必要的:一项随机对照试验。

The James A. Rand Young Investigator's Award: Large Opioid Prescriptions Are Unnecessary After Total Joint Arthroplasty: A Randomized Controlled Trial.

机构信息

Adult Reconstruction Division, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.

Department of Anesthesiology, Rush University Medical Center, Chicago, IL.

出版信息

J Arthroplasty. 2019 Jul;34(7S):S4-S10. doi: 10.1016/j.arth.2019.01.065. Epub 2019 Feb 4.

DOI:10.1016/j.arth.2019.01.065
PMID:30799266
Abstract

BACKGROUND

The purpose of this randomized controlled trial is to determine whether the quantity of opioid pills prescribed at discharge is associated with the number of opioid pills consumed or unused by patients after primary hip and knee arthroplasty within 30 days after discharge.

METHODS

A total of 304 opioid-naïve patients were randomized to receive either 30 or 90 5-mg oxycodone immediate-release (OxyIR) pills at discharge. Daily opioid consumption, number of unused pills, and pain scores were calculated for 30 days with a patient-completed medication diary. Statistical analysis involved t-test, rank-sum, chi-squared tests, and multiple linear regression with alpha = 0.05.

RESULTS

Of the 304 patients randomized, 161 patients were randomized to receive 30 pills and 143 to receive 90. In the first 30 days after discharge, the median number of unused pills was 15 in the 30 group vs 73 in the 90 group (P < .001). Within 90 days of discharge, 26.7% of the 30 group and 10.5% of the 90 group requested a refill (P < .001), leading to a mean of 777.1 ± 414.2 morphine equivalents vs 1089.7 ± 536.4 prescribed (P < .0001). There was no difference between groups in mean morphine equivalents consumed. Regression analysis demonstrated that being prescribed 90 OxyIR pills was independently associated with taking more OxyIR pills (P = .028). There was no difference in pain scores within the first 30 days and in patient-reported outcome scores at 6 weeks postoperatively.

CONCLUSION

Prescribing fewer OxyIR pills is associated with a significant reduction in unused opioid pills and decreased opioid consumption with no increase in pain scores and no difference in patient-reported outcomes.

LEVEL OF EVIDENCE

Level I. Randomized controlled trial.

摘要

背景

本随机对照试验旨在确定在初次髋关节和膝关节置换术后 30 天内出院时开具的阿片类药物丸剂数量是否与患者出院后 30 天内消耗或未使用的阿片类药物丸剂数量相关。

方法

共纳入 304 名阿片类药物初治患者,随机分为出院时接受 30 或 90 片 5mg 盐酸羟考酮即时释放(OxyIR)片。通过患者完成的用药日记计算 30 天内的每日阿片类药物消耗、未使用药丸数量和疼痛评分。统计分析包括 t 检验、秩和检验、卡方检验和多重线性回归,α 值为 0.05。

结果

在随机分组的 304 名患者中,161 名患者被随机分配到 30 片组,143 名患者被分配到 90 片组。在出院后的前 30 天内,30 片组未使用药丸的中位数为 15 粒,90 片组为 73 粒(P<0.001)。在出院后 90 天内,30 片组的 26.7%和 90 片组的 10.5%要求续药(P<0.001),导致平均消耗的 777.1±414.2 吗啡当量与处方的 1089.7±536.4 吗啡当量相比(P<0.0001)。两组消耗的吗啡当量平均值无差异。回归分析表明,开 90 片 OxyIR 药丸与服用更多 OxyIR 药丸独立相关(P=0.028)。在出院后前 30 天内的疼痛评分和术后 6 周的患者报告结局评分无差异。

结论

开较少 OxyIR 药丸与显著减少未使用阿片类药物丸剂以及减少阿片类药物消耗相关,而不会增加疼痛评分或对患者报告结局产生影响。

证据水平

I 级,随机对照试验。

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