在急性疼痛治疗中使用静脉注射奥利司定与静脉注射氢吗啡酮或芬太尼的胃肠道不良反应比较,采用调整后的间接治疗比较方法。

IF 1.9 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES
Joseph Biskupiak, Gary Oderda, Diana Brixner, Todd L Wandstrat
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引用次数: 0

摘要

背景:在缺乏来自随机对照试验的头对头比较数据的情况下,间接治疗比较(ITC)可用于比较治疗方法与共同参照物(安慰剂或活性治疗)的相对效果。在急性疼痛治疗方面,临床试验已将奥利司定的效果与吗啡进行了比较,但未将其与芬太尼或氢吗啡酮进行比较。目的:通过 ITC 分析评估奥利司定与相关比较药(芬太尼和氢吗啡酮)之间的安全性比较(特别是恶心、呕吐和阿片类药物引起的呼吸抑制 [OIRD] 发生率的差异)。研究方法系统性文献综述确定了奥利司定与吗啡、吗啡与芬太尼或氢吗啡酮的随机临床试验。ITC 分析采用了共同的活性比较物吗啡。结果:共确定了六项随机对照试验(奥立克定-2 项;氢吗啡酮-3 项;芬太尼-1 项)的数据可用于 ITC 分析。两项研究(整形外科和矫形外科)报告了奥利司定的数据,一项汇总分析也报告了奥利司定的数据。由于 OIRD 的数据有限,ITC 将重点放在恶心和呕吐方面。在 ITC 分析中将奥利司定与氢吗啡酮进行比较时,与氢吗啡酮相比,奥利司定可显著降低需要止吐药的恶心和/或呕吐发生率(整形外科和汇总数据),而整形外科的结果在统计学上并不显著。当利用来自 Hong 的数据将奥利司定与氢吗啡酮进行比较时,ITC 仅显示出奥利司定可降低恶心和呕吐风险的趋势,但在所有三项比较中(骨科手术、整形外科和综合),该趋势均无统计学意义。利用奥利司他骨科手术数据和骨科与整形外科合并数据对奥利司他与芬太尼研究进行的 ITC 比较显示,奥利司他有降低风险的趋势,但无统计学意义。结论在 ITC 分析中,与氢吗啡酮相比,奥利凯里定可显著降低骨科手术中恶心和/或呕吐的发生率或止吐药需求,与芬太尼相比,奥利凯里定有降低风险的非显著趋势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Gastrointestinal adverse effects associated with the use of intravenous oliceridine compared with intravenous hydromorphone or fentanyl in acute pain management utilizing adjusted indirect treatment comparison methods.

Background: In the absence of head-to-head comparative data from randomized controlled trials, indirect treatment comparisons (ITCs) may be used to compare the relative effects of treatments versus a common comparator (either placebo or active treatment). For acute pain management, the effects of oliceridine have been compared in clinical trials to morphine but not to fentanyl or hydromorphone. Aim: To assess the comparative safety (specifically differences in the incidence of nausea, vomiting and opioid-induced respiratory depression [OIRD]) between oliceridine and relevant comparators (fentanyl and hydromorphone) through ITC analysis. Methods: A systematic literature review identified randomized clinical trials with oliceridine versus morphine and morphine versus fentanyl or hydromorphone. The ITC utilized the common active comparator, morphine, for the analysis. Results: A total of six randomized controlled trials (oliceridine - 2; hydromorphone - 3; fentanyl - 1) were identified for data to be used in the ITC analyses. The oliceridine data were reported in two studies (plastic surgery and orthopedic surgery) and were also reported in a pooled analysis. The ITC focused on nausea and vomiting due to limited data for OIRD. When oliceridine was compared with hydromorphone in the ITC analysis, oliceridine significantly reduced the incidence of nausea and/or vomiting requiring antiemetics compared with hydromorphone (both orthopedic surgery and pooled data), while results in plastic surgery were not statistically significant. When oliceridine was compared with hydromorphone utilizing data from Hong, the ITC only showed a trend toward reduced risk of nausea and vomiting with oliceridine that was not statistically significant across all three comparisons (orthopedic surgery, plastic surgery and combined). An ITC comparing oliceridine with a study of fentanyl utilizing the oliceridine orthopedic surgery data and combined orthopedic and plastic surgery data showed a trend toward reduced risk that was not statistically significant. Conclusion: In ITC analyses, oliceridine significantly reduced the incidence of nausea and/or vomiting or the need for antiemetics in orthopedic surgery compared with hydromorphone and a non-significant trend toward reduced risk versus fentanyl.

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来源期刊
Journal of comparative effectiveness research
Journal of comparative effectiveness research HEALTH CARE SCIENCES & SERVICES-
CiteScore
3.50
自引率
9.50%
发文量
121
期刊介绍: Journal of Comparative Effectiveness Research provides a rapid-publication platform for debate, and for the presentation of new findings and research methodologies. Through rigorous evaluation and comprehensive coverage, the Journal of Comparative Effectiveness Research provides stakeholders (including patients, clinicians, healthcare purchasers, and health policy makers) with the key data and opinions to make informed and specific decisions on clinical practice.
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