The Ethox Centre, Department of Public Health and Primary Health Care, The University of Oxford, Headington, Oxford, UK.
Arch Dis Child Fetal Neonatal Ed. 2011 Jan;96(1):F75-8. doi: 10.1136/adc.2010.184689. Epub 2010 Nov 10.
In intensive care settings in the developed world, therapeutic hypothermia is established as a therapy for term infants with moderate to severe neonatal encephalopathy due to perinatal asphyxia. Several preclinical, pilot and clinical trials conducted in such settings over the last decade have demonstrated that this therapy is safe and effective. The greatest burden of birth asphyxia falls, however, in low- and middle-income countries; it is still unclear whether therapeutic hypothermia is safe and effective in this context. In this paper, the issues around treatments that may be proven safe and effective in the developed world and the caution needed in translating these into different settings and populations are explored. It is argued that there are strong scientific and ethical reasons supporting the conduct of rigorous, randomised controlled trials of therapeutic hypothermia in middle-income settings. There also needs to be substantial and sustainable improvements in all facets of antenatal care and in the basic level of newborn resuscitation in low income countries. This will reduce the burden of disease and allow health workers to determine rapidly which infants are most eligible for potential neuroprotection.
在发达国家的重症监护环境中，亚低温治疗已被确立为围产期窒息导致的中重度新生儿脑病足月婴儿的治疗方法。过去十年中，在这些环境中进行的几项临床前、试点和临床试验表明，这种治疗方法是安全有效的。然而，出生窒息的最大负担落在中低收入国家；在这种情况下，亚低温治疗是否安全有效仍不清楚。本文探讨了在发达国家已被证明安全有效的治疗方法在不同环境和人群中应用时需要谨慎的问题。有人认为，有强有力的科学和伦理理由支持在中等收入国家进行严格的、随机对照的亚低温治疗试验。在低收入国家，还需要在产前护理的各个方面以及新生儿基本复苏水平方面进行实质性和可持续的改进。这将减轻疾病负担，并使卫生工作者能够迅速确定哪些婴儿最有资格接受潜在的神经保护。
