在回答。

IF 0.8 2区 哲学 0 PHILOSOPHY
R. Hackenberg, K. Welle
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引用次数: 0

摘要

冠状动脉综合征(VIP试验)和高危PTCA (COURT试验),后者未被作者引用。两项研究都表明,在主要心脏事件(VIP试验)方面,与在COURT试验中使用离子介质(ioxaglate)相比,使用非离子造影剂(碘二醇)甚至减少了45%。这些差异可能是由于Scheller等人的研究中发现的一些方法缺陷造成的。实际上,在Scheller的研究中,随机化过程并没有得到充分的执行。报告提到,一个血管实验室使用一种造影剂,而另一个实验室使用另一种造影剂。即使两个血管实验室有相同的设备,我们也不能确定其中一个没有比另一个更老,病情更严重的病人在新的、更好的实验室接受治疗,或者最熟练、最有经验的操作员只在两个血管实验室中的一个工作。因此,我们不能相信这种“伪随机化”。因此,在研究人群的两组中存在重要的异质性,更严重的患者(ACS+CCS IV类患者)在非离子组。此外,它指出诊断冠状动脉造影是用非离子造影剂进行的。然而,在介入治疗过程中,患者接受非离子或依分配房间的每日可用性而定。因此,考虑到目前临时经皮冠状动脉介入治疗的实践,这意味着一半的患者最初接受离子造影剂,随后接受非离子造影剂。我们怎么能认真地比较这些条件下的结果呢?此外,离子造影剂与六种不同的非离子剂进行了比较:这些剂的剂量分别为5%至39%。最后,作者提到,与VIP研究相比,碘沙醇具有最高的亚急性支架闭塞率(5%),但只有5%(即90例患者)使用了该药物。这意味着他们中只有4人有亚急性闭塞,再一次,是否可能从这些有限的数据中得出任何结论?如前所述,Scheller等人的论文在概念和设计上存在一些缺陷。本研究不能挑战正确进行的随机研究,如VIP和COURT试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
In reply.
coronary syndromes (VIP trial) and high-risk PTCA (COURT trial), the latter not quoted by the authors. Both studies showed that there was no difference in terms of major cardiac events (VIP trial) or even a 45% reduction with a non-ionic contrast medium (iodixanol) when compared to an ionic medium (ioxaglate) in the COURT trial. These discrepancies could result from some methodological flaws noted in the study of Scheller et al. Actually, in the Scheller study, the randomization process was not really adequately performed. It mentioned that one angio-lab was working with one contrast medium when the other lab used the alternative agent. Even if both angio-labs have the same equipment, we cannot be sure that one is not older than the other, that the more seriously ill patients were treated in the new, better laboratory, or that the most skilled, experienced operators were working in only one of the two angiolabs. Thus, we cannot trust this ‘pseudo-randomization’. As a result, there was an important heterogeneity in the two arms of the study population, and more seriously ill patients (ACS+CCS Class IV patients) were in the non-ionic arm. In addition, it is stated that diagnostic coronary angiography was performed with non-ionic contrast media. However, in the interventional procedure, the patients received either non-ionic or ioxaglate, depending on the daily availability in the allocated room. Thus, taking into account the current practice of ad hoc percutaneous coronary intervention, this means that half the patients initially received ionic contrast medium followed by non-ionic contrast medium . . . How can we seriously compare the results in those conditions? Furthermore, the ionic contrast medium was compared to six different non-ionic agents: the respective administration of these agents ranged from 5 to 39% respectively. Finally, the authors mentioned that in contrast to the VIP study, iodixanol had the highest rate of subacute stent occlusion (5%), but only 5% (i.e. 90 patients) received this agent. This means that only four of them had subacute occlusion and, again, is it possible to draw any conclusions from these limited data? There are, as listed, several flaws in the concept and design of Scheller et al.’s paper. This study cannot challenge properly conducted, randomized studies, such as the VIP and COURT trials.
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来源期刊
PHILOSOPHY
PHILOSOPHY PHILOSOPHY-
CiteScore
1.40
自引率
0.00%
发文量
41
期刊介绍: Philosophy is the journal of the Royal Institute of Philosophy, which was founded in 1925 to build bridges between specialist philosophers and a wider educated public. The journal continues to fulfil a dual role: it is one of the leading academic journals of philosophy, but it also serves the philosophical interests of specialists in other fields (law, language, literature and the arts, medicine, politics, religion, science, education, psychology, history) and those of the informed general reader. Contributors are required to avoid needless technicality of language and presentation. The institutional subscription includes two supplements.
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