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奥利司他在急性术后疼痛中的疗效、安全性和副作用的系统评价和荟萃分析方案。

Efficacy, safety, and side effects of oliceridine in acute postoperative pain, a protocol for a systematic review and meta-analysis.

机构信息

Institute of Anatomy and Clinical Morphology, University Witten/Herdecke, Witten, Germany.

Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Knappschaftskrankenhaus Bochum and Ruhr University Bochum, Bochum, Germany.

出版信息

PLoS One. 2024 Feb 29;19(2):e0299320. doi: 10.1371/journal.pone.0299320. eCollection 2024.

DOI:10.1371/journal.pone.0299320
PMID:38422105
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10903901/
Abstract

This will be the first meta-analysis on the efficacy, safety, and side effects of oliceridine on postoperative pain. Our aim with this work is to evaluate the clinical utility of this relatively new substance in a broad postoperative context. Oliceridine is a new so-called bias opioid that is approved for severe pain requiring an opioid. Due to its biased agonism, it is said to have fewer side effects than conventional opioids. This systematic review and meta-analysis will analyze the efficacy, safety, and side effects of oliceridine compared to placebo or morphine in acute postoperative pain for up to 72 hours. In January 2024, an extensive search in various databases will be performed without restrictions for randomized controlled trials with at least single blinding. After data extraction, data will be pooled and meta-analytic calculations performed. A random-effects model will be used. Dichotomous data will be presented as risk ratio and continuous data as standardized mean difference. Dose-dependent side effects will be evaluated with meta-regression. Heterogeneity will be assessed via the Q statistic and prediction interval in case of a sufficient number of included studies. Publication bias will be examined using funnel plot and Duval and Tweedie's trim and fill method.

摘要

这将是第一篇关于奥利塞定在术后疼痛中的疗效、安全性和副作用的荟萃分析。我们的目的是在广泛的术后背景下评估这种相对较新的物质的临床实用性。奥利塞定是一种新的所谓偏向阿片类药物,已被批准用于需要阿片类药物的严重疼痛。由于其偏向激动作用,据称它比传统阿片类药物的副作用更少。这项系统评价和荟萃分析将分析奥利塞定与安慰剂或吗啡在急性术后疼痛中的疗效、安全性和副作用,时间长达 72 小时。2024 年 1 月,将在各种数据库中进行广泛搜索,不受限制地纳入至少有单盲的随机对照试验。在提取数据后,将对数据进行汇总并进行荟萃分析计算。将使用随机效应模型。二项数据将表示为风险比,连续数据将表示为标准化均数差。将使用元回归评估剂量依赖性副作用。如果纳入的研究数量足够,将通过 Q 统计量和预测区间评估异质性。将使用漏斗图和 Duval 和 Tweedie 的修剪和填充方法检查发表偏倚。

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本文引用的文献

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In a meta-analysis, the I-squared statistic does not tell us how much the effect size varies.在一项荟萃分析中,I² 统计量并未告诉我们效应量的变化程度。
J Clin Epidemiol. 2022 Dec;152:281-284. doi: 10.1016/j.jclinepi.2022.10.003. Epub 2022 Oct 9.
2
Multimodal Analgesia.多模式镇痛。
Anesthesiol Clin. 2022 Sep;40(3):455-468. doi: 10.1016/j.anclin.2022.04.002. Epub 2022 Aug 2.
3
Worst pain intensity and opioid intake during the early postoperative period were not associated with moderate-severe pain 12 months after total knee arthroplasty - a longitudinal study.一项纵向研究表明,全膝关节置换术后早期的最严重疼痛强度和阿片类药物摄入量与术后12个月时的中重度疼痛无关。
Scand J Pain. 2022 Aug 8;23(2):364-371. doi: 10.1515/sjpain-2022-0007. Print 2023 Apr 25.
4
Characteristics and outcomes of unplanned intensive care unit admission after general anesthesia.全麻后非计划性转入重症监护病房的特征和结局。
BMC Anesthesiol. 2022 Jun 20;22(1):191. doi: 10.1186/s12871-022-01729-y.
5
Budget impact and pharmacy costs with targeted use of oliceridine for postsurgical pain in patients at high risk of opioid-related adverse events.阿片类药物相关不良事件高危患者术后疼痛靶向使用oliceridine的预算影响和药房成本
Expert Rev Pharmacoecon Outcomes Res. 2022 Jun;22(4):671-681. doi: 10.1080/14737167.2022.2038137. Epub 2022 Mar 15.
6
Estimating Risk Ratios and Risk Differences: Alternatives to Odds Ratios.估计风险比和风险差异:比值比的替代方法。
JAMA. 2020 Sep 15;324(11):1098-1099. doi: 10.1001/jama.2020.12698.
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Clin Pharmacol Drug Dev. 2020 Jul;9(5):639-650. doi: 10.1002/cpdd.750. Epub 2019 Nov 7.
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