Therapeutic hypothermia in neonatal hypoxic encephalopathy: A systematic review and meta-analysis.
Therapeutic hypothermia in neonatal hypoxic encephalopathy: A systematic review and meta-analysis.
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DOI：
10.7189/jogh.12.04030
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发表时间：
2022
影响因子：
7.2
通讯作者：
Dsouza JM
中科院分区：
文献类型：
--
作者：
Mathew JL;Kaur N;Dsouza JM
治疗性亚低温(TH)被认为是治疗新生儿缺氧性脑病最有效的方法。然而，以前系统审查的局限性和新数据的公布需要更新证据。我们进行了这项最新的系统回顾，以评估TH在新生儿脑病中对临床结果的影响。在这项系统回顾和荟萃分析中，我们检索了Medline、Cochrane Library、Embase、LIVO、Web of Science、Scope us、CINAHL、主要试验登记和灰色文献(从初始到2021年10月31日)，以寻找比较TH和常温治疗新生儿脑病的随机对照试验(RCT)。我们纳入了登记有围产期窒息和脑病的新生儿(妊娠≥35周)的RCT，他们接受了出生后6小时内开始的≤(34°C)48小时的≥，与不降温的比较。我们排除了非随机对照试验、延迟降温或降温至34°C的患者。两位作者独立评估了偏向风险，并提取了四个时间点的死亡率和神经功能障碍数据：新生儿(从随机分组到出院/死亡)、婴儿期(18-24个月)、儿童期(5-10岁)和长期(10岁)。其他结果包括癫痫发作、脑电异常和MRI表现。通过固定效应荟萃分析汇集已发表的随机对照试验的汇总数据。我们确定了36条 863条引文，包括39篇代表29篇随机对照试验的出版物，2,926名参与者。13项研究各有低、中、高偏倚风险。合并危险比(95%可信区间)：新生儿死亡率0.87(95%CI = 0.75，1.00)，n = 2434，I2 = 38%，18~24个月死亡率0.88(95%CI = 0.78，1.01)，n = 2042，I2 = 51%，5~10年死亡率0.81(95%CI = 0.62，1.04)，n = 515，I2 = 59%；5~10年伤残：0.68(95%CI = 0.52，0.90)，n = 442，I2 = 3%；18~24个月死亡率或伤残：0.78(95%CI = 0.72，0.86)，n = 1914，I2 = 54%；18~24月龄脑瘫：0.6 3(95%CI = 0.5 0，0.78)，n = 1136，I2 = 39%，儿童期脑瘫0.6 3(95%CI = 0.46，0.85)，n = 449，I2 = 0%。部分结果因研究环境不同而有显著差异；高收入国家18~24个月死亡的危险比(95%CI)为0.79(95%CI = 0.66，0.93)，n = 为1212，I2 = 为7%；中上收入国家为0.67(95%CI = 为0.41，1.09)，n = 为276，I2 = 为0；中低收入国家为1.18(95%CI = 为0.94，1.47)，n = 为554，I2 = 为75%。18~24个月死亡或残疾的合并危险比分别为0.77(95%CI = 0.69，0.86)，n = 1089，I2 = 0%；0.56(95%CI = 0.41，0.78)，n = 276，I2 = 30%；0.92(95%CI = 0.77，1.09)，n = 549，I2 = 86%。低偏差风险试验新生儿死亡的风险比为0.97(95%CI = 为0.80，1.16，n = 为1475，I2 = 为62%)，而高偏差风险试验为0.71(95%CI = 为0.55，0.91)，n = 为959，I2 = 为0%。同样，在低风险偏倚试验中，18-24个月死亡的风险比为0.96(95%CI = 为0.83，1.13)，n = 为1336，I2 = 为58%，而在高风险偏倚试验中，为0.72(95%CI = 为0.56，0.92)，n = 为706，I2 = 为0%。治疗新生儿脑病的低温可减少神经功能障碍和脑性瘫痪，但对新生儿、婴儿和儿童死亡率的影响尚不确定。它的实施环境会影响结果。低质量试验高估了TH的潜在益处。
Therapeutic hypothermia (TH) is regarded as the most efficacious therapy for neonatal hypoxic encephalopathy. However, limitations in previous systematic reviews and the publication of new data necessitate updating the evidence. We conducted this up-to-date systematic review to evaluate the effects of TH in neonatal encephalopathy on clinical outcomes. In this systematic review and meta-analysis, we searched Medline, Cochrane Library, Embase, LIVIVO, Web of Science, Scopus, CINAHL, major trial registries, and grey literature (from inception to October 31, 2021), for randomized controlled trials (RCT) comparing TH vs normothermia in neonatal encephalopathy. We included RCTs enrolling neonates (gestation ≥35 weeks) with perinatal asphyxia and encephalopathy, who received either TH (temperature ≤34°C) initiated within 6 hours of birth for ≥48 hours, vs no cooling. We excluded non-RCTs, those with delayed cooling, or cooling to >34°C. Two authors independently appraised risk-of-bias and extracted data on mortality and neurologic disability at four time points: neonatal (from randomization to discharge/death), infancy (18-24 months), childhood (5-10 years), and long-term (>10 years). Other outcomes included seizures, EEG abnormalities, and MRI findings. Summary data from published RCTs were pooled through fixed-effect meta-analysis. We identified 36 863 citations and included 39 publications representing 29 RCTs with 2926 participants. Thirteen studies each had low, moderate, and high risk-of-bias. The pooled risk ratios (95% confidence interval, CI) were as follows: neonatal mortality: 0.87 (95% CI = 0.75, 1.00), n = 2434, I2 = 38%; mortality at 18-24 months: 0.88 (95% CI = 0.78, 1.01), n = 2042, I2 = 51%; mortality at 5-10 years: 0.81 (95% CI = 0.62, 1.04), n = 515, I2 = 59%; disability at 18-24 months: 0.62 (95% CI = 0.52, 0.75), n = 1440, I2 = 26%; disability at 5-10 years: 0.68 (95% CI = 0.52, 0.90), n = 442, I2 = 3%; mortality or disability at 18-24 months: 0.78 (95% CI = 0.72, 0.86), n = 1914, I2 = 54%; cerebral palsy at 18-24 months: 0.63 (95% CI = 0.50, 0.78), n = 1136, I2 = 39%; and childhood cerebral palsy: 0.63 (95% CI = 0.46, 0.85), n = 449, I2 = 0%. Some outcomes showed significant differences by study-setting; the risk ratio (95% CI) for mortality at 18-24 months was 0.79 (95% CI = 0.66,0.93), n = 1212, I2 = 7% in high-income countries, 0.67 (95% CI = 0.41, 1.09), n = 276, I2 = 0% in upper-middle-income countries, and 1.18 (95% CI = 0.94, 1.47), n = 554, I2 = 75% in lower-middle-income countries. The corresponding pooled risk ratios for ‘mortality or disability at 18-24 months’ were 0.77 (95% CI = 0.69, 0.86), n = 1089, I2 = 0%; 0.56 (95% CI = 0.41, 0.78), n = 276, I2 = 30%; and 0.92 (95% CI = 0.77, 1.09), n = 549, I2 = 86% respectively. Trials with low risk of bias showed risk ratio of 0.97 (95% CI = 0.80, 1.16, n = 1475, I2 = 62%) for neonatal mortality, whereas trials with higher risk of bias showed 0.71 (95% CI = 0.55, 0.91), n = 959, I2 = 0%. Likewise, risk ratio for mortality at 18-24 months was 0.96 (95% CI = 0.83, 1.13), n = 1336, I2 = 58% among low risk-of-bias trials, but 0.72 (95% CI = 0.56, 0.92), n = 706, I2 = 0%, among higher risk of bias trials. Therapeutic hypothermia for neonatal encephalopathy reduces neurologic disability and cerebral palsy, but its effect on neonatal, infantile and childhood mortality is uncertain. The setting where it is implemented affects the outcomes. Low(er) quality trials overestimated the potential benefit of TH.
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发表时间：
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