新生儿缺氧缺血性脑病药物治疗临床证据

Clinical evidence for the pharmacological therapy in newborn infants with hypoxic-is-chemic encephalopathy

摘要:

目的：药物治疗是缺氧缺血性脑病（hypoxic-ischemic encephalopathy，HIE）治疗的重要组成部分，以循证医学方法为基础的系统评价和临床随机对照试验为判定药物干预疗效提供了最可靠的证据。该研究检索了近年来的HIE药物治疗的临床证据，并探讨其临床应用价值。方法：检索MEDLINE、EMBASE、Oxford围产新生儿组资料库和Cochrane图书馆关于HIE药物治疗的随机（或半随机）对照研究（randomized or quasi-randomized controlled trials, RCT）和系统评价，并进行分析。结果：4个系统评价和13个RCT涉及HIE的药物治疗临床试验。治疗药物包括巴比妥类药物、别嘌呤醇、硫酸镁、甘露醇、纳络酮和多巴胺。上述药物均不能显著降低HIE患儿新生儿期和婴儿期死亡率以及严重神经发育残疾率和惊厥发生率。结论：目前尚未有临床证据表明某种药物能明显降低HIE患儿死亡率及改善神经系统预后。现有HIE药物治疗的临床试验存在规模小，疗效判定方法不统一等问题，需大规模的临床协作试验证实现有药物的有效性。［中国当代儿科杂志，2009，11（9）：740-744］

Abstract:

OBJECTIVE: Pharmacological intervention is an important means for the treatment of hypoxic-ischemic encephalopathy (HIE). As meta-analyses and randomized controlled clinical trials based on evidence-based medicine are able to provide the most reliable evidence for clinical practice, this study searched several databases in order to find the clinical evidence for the pharmacological treatment of neonatal HIE. METHODS: Meta-analyses and randomized (or quasi-randomized) controlled trials (RCT) for pharmacological therapy of HIE in term or late preterm newborn infants were searched from the databases of MEDLINE, EMBASE, Oxford Neonatal Group and Cochrane Library. The relevant literatures were statistically analyzed. RESULTS: Four Meta-analyses and thirteen RCTs were found to be involved in barbiturate, allopurinol, magnesium sulfate, mannitol, naloxone and dopamine therapy. None of the drugs could significantly decrease the mortality and the incidence of seizure or severe neurodevelopmental disabilities in newborn infants with HIE. CONCLUSIONS: Current clinical evidence indicates that no individual drug could decrease mortality and improve the neurodevelopmental outcomes in infants with HIE. Problems such as small scale in sampling and discrepancy in the identification of drug efficacy which exist in the clinical trials might lead to the uncertain effect of the drugs, and large sized and collaborative clinical trials are needed in the future.［Chin J Contemp Pediatr, 2009, 11 (9):740-744］