IONSYS™与吗啡PCA:使用贝叶斯方法分析当前文献

Edgard Engelman, Jean-Corentin Salengros
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引用次数: 2

摘要

在四项非劣效性研究中发现,提供透皮芬太尼的IONSYS™装置不逊于静脉吗啡PCA;可接受的疗效损失必须低于治疗成功率下降10%。贝叶斯分析允许计算与任何选择的治疗成功率差异有关的可能性,并且不限于基于任意阈值的结论。方法通过4项对比研究的数据,探讨静脉吗啡PCA的优越性。我们对这四项研究进行了贝叶斯分析,根据这四项研究中报告的共同主要结果,按照与它们发表日期平行的顺序进行分析。在第一个分析中,我们使用了一个无信息的先验,在第二个分析中,我们使用了一个适度怀疑的先验。结果在无先验概率的情况下,吗啡PCA有75%的概率存在一定(0%)的成功率提高。在适度怀疑的前提下,这种可能性仍在69%左右。治疗失败的相对风险降低(10%)的概率,在初始无信息先验的情况下为14.8%,在怀疑先验的情况下为3.7%。相对风险降低20%的可能性实际上是不存在的。结论芬太尼透皮系统虽然治疗成功率会有所下降,但似乎是静脉注射吗啡PCA的可行替代品,因为治疗成功率不太可能出现大的差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
IONSYS™ versus morphine PCA: Analysis of the current literature using a Bayesian approach

Background

The IONSYS™ device, providing transdermal fentanyl, has been found as non-inferior to intravenous morphine PCA in four non-inferiority studies; the accepted loss of efficacy had to be lower than a 10% decrease of therapeutic success. Bayesian analysis allows to compute likelihoods pertaining to any chosen difference in therapeutic rate of success, and is not limited to conclusions based on arbitrary thresholds.

Methods

We try to show the superiority of intravenous morphine PCA, using the data of the four comparative studies. We have subjected the four studies to a Bayesian analysis, with respect to the common primary outcome reported in the four studies, in a sequence that parallels their dates of publication. In a first analysis we used an uninformative prior, and in a second analysis a moderately sceptical prior.

Results

With an uninformative prior probability, there is a 75% probability that some (>0%) increased rate of success exists with morphine PCA. With a moderately sceptical prior the probability is still around 69%. The probability of a relative risk reduction of treatment failure >10% of difference, is 14.8% with an initial uninformative prior and 3.7% with a sceptical prior. The probability of a relative risk reduction >20% is virtually non-existent.

Conclusions

Although, some decrease in the rate of therapeutic success can be expected, the fentanyl transdermal system seems a viable substitute to intravenous morphine PCA, as a large difference in the rate of therapeutic success is unlikely.

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