Division of Infectious Diseases, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC 27599, USA.
Trends Parasitol. 2010 Mar;26(3):119-24. doi: 10.1016/j.pt.2009.12.007. Epub 2010 Jan 18.
During follow-up in antimalarial drug trials, treated subjects can be newly infected. PCR correction is used to distinguish this re-infection from drug failure (recrudescence) and to adjust final drug efficacy estimates. The epidemiological, biological and technical limitations of PCR correction and how this can lead to misclassification in drug trial outcomes are underappreciated. This article considers these limitations and proposes a framework for reporting, interpreting and improving PCR correction of antimalarial trials.
在抗疟药物试验的随访过程中,治疗对象可能会被新感染。聚合酶链反应(PCR)校正用于区分这种再感染和药物失败(复发),并调整最终药物疗效估计。PCR 校正的流行病学、生物学和技术局限性以及这如何导致药物试验结果的错误分类尚未得到充分认识。本文考虑了这些局限性,并提出了一个报告、解释和改进抗疟试验中 PCR 校正的框架。