■这篇综述考虑了与解释过去三十年中发表的300篇关于人体和动物组织暴露于射频电磁场(RF-EMF)可能的遗传毒性影响的论文的混合遗产有关的问题。主要论文回顾了遗传毒性测试共识指南的演变,以及对评估用于健康风险评估的科学研究的系统评价的日益重视。附录通过检查采用彗星测定的遗传毒性出版物的子集,考虑了评估生物效应文献中的一些问题。虽然大多数研究发现暴露没有统计学上显著的影响,相当少的研究(主要是,体内研究)报告了暴露的统计学显着影响。研究的质量是高度可变的;虽然一些研究是精心完成和记录,这些研究均不符合目前公认的准则,例如经济合作与发展组织(OECD)的准则.使用偏倚风险(RoB)标准对研究的评估表明,在这个研究样本中,与低质量的研究相比,较高质量的研究不太可能发现有统计学意义的结果.
■作者得出结论,统计显著性应该只是评估生物效应研究的一个考虑因素。在评估暴露的健康风险时,简单地列出使用零假设测试和统计显著性标准p<0.05确定的“统计”显著效应是误导和无信息的。需要仔细综合证据,包括研究效度的评估,报道的影响的生物学意义,以及研究结果与其他相关研究的一致性。作者建议,未来所有用于人类健康风险评估和文献评估的射频遗传毒性研究应按照公认的质量指南进行。即OECD或类似的基因毒性筛选研究指南和PRISMA或其他公认的文献综述指南。该组中的积极研究应该通过更严格的质量控制来重新进行,以建立结果的可靠性。
This review considers issues related to interpreting the mixed legacy of >300 papers published during the past three decades on possible genotoxic effects of exposure of human and animal tissues to radiofrequency electromagnetic fields (RF-EMF). The main paper reviews the evolution of
consensus guidelines for genotoxicity testing and the increasing emphasis on systematic reviews for evaluation of scientific studies for use in health risk assessments. An Appendix considers some issues in assessing the bioeffects literature by examining a subset of genotoxicity publications that employed the comet assay. While most studies found no statistically significant effects of exposure, a significant minority of studies (chiefly, in vivo studies) reported statistically significant effects of exposure. The quality of the studies was highly variable; while several studies were meticulously done and documented, none of these studies were compliant with currently accepted
guidelines such as those of the Organization for Economic Cooperation and Development (OECD). Evaluation of the studies using risk of bias (RoB) criteria showed that, in this sample of studies, higher quality studies were less likely to find statistically significant results than those of lower quality.
The authors conclude that statistical significance should be only one consideration in evaluation of bioeffects studies. Simply listing \'statistically\' significant effects identified using null hypothesis testing and the criterion p < 0.05 for statistical significance is misleading and uninformative in assessing health risks of exposure. A careful synthesis of evidence is needed, including assessment of study validity, biological significance of reported effects, and coherence of study results with those of other related studies.The authors recommend that all future RF genotoxicity studies intended for use in human health risk assessments and evaluations of the literature should be done in compliance with accepted quality
guidelines, i.e. OECD or equivalent
guidelines for genotoxicity screening studies and PRISMA or other accepted
guideline for reviews of the literature. The positive studies in this group should be redone with tighter quality control to establish the reliability of the findings.