未经证实:治疗性低温(TH)被认为是新生儿缺氧性脑病最有效的治疗方法。然而,以前的系统评价和新数据的发布存在局限性,因此需要更新证据.我们进行了这项最新的系统评价,以评估TH在新生儿脑病中对临床结局的影响。
未经评估:在本系统综述和荟萃分析中,我们搜索了Medline,科克伦图书馆,Embase,LIVIVIVO,WebofScience,Scopus,CINAHL,主要的审判登记处,和灰色文学(从开始到2021年10月31日),用于比较新生儿脑病中TH与正常体温的随机对照试验(RCT)。我们纳入RCT纳入新生儿(妊娠≥35周)围产期窒息和脑病,在出生后6小时内开始接受TH(温度≤34°C)≥48小时,vs没有冷却。我们排除了非RCT,那些延迟冷却的人,或冷却至>34°C。两位作者独立评估了偏倚风险,并提取了四个时间点的死亡率和神经残疾数据:新生儿(从随机到出院/死亡),婴儿期(18-24个月),童年(5-10年),和长期(>10年)。其他结果包括癫痫发作,脑电图异常,和MRI检查结果。通过固定效应荟萃分析汇总已发表的随机对照试验的数据。
UNASSIGNED:我们确定了36863篇引文,包括39篇出版物,代表29项RCT,共有2926名参与者。13项研究每个研究都很低,中度,和高风险的偏见。合并风险比(95%置信区间,CI)如下:新生儿死亡率:0.87(95%CI=0.75,1.00),n=2434,I2=38%;18-24个月的死亡率: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%;18-24个月时的残疾:0.62(95%CI=0.52,0.75),n=1440,I2=26%;5-10年的残疾:0.68(95%CI=0.52,0.90),n=442,I2=3%;18-24个月时的死亡率或残疾:0.78(95%CI=0.72,0.86),n=1914,I2=54%;18-24个月的脑瘫:0.63(95%CI=0.50,0.78),n=1136,I2=39%;儿童脑瘫:0.63(95%CI=0.46,0.85),n=449,I2=0%。一些结果显示不同的研究设置有显著差异;18-24个月死亡率的风险比(95%CI)为0.79(95%CI=0.66,0.93),在高收入国家,n=1212,I2=7%,0.67(95%CI=0.41,1.09),在中高收入国家,n=276,I2=0%,和1.18(95%CI=0.94,1.47),在中低收入国家,n=554,I2=75%。18-24个月死亡率或残疾的相应合并风险比为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%。低偏倚风险的试验显示,新生儿死亡率的风险比为0.97(95%CI=0.80,1.16,n=1475,I2=62%)。而偏倚风险较高的试验显示0.71(95%CI=0.55,0.91),n=959,I2=0%。同样,18-24个月死亡风险比为0.96(95%CI=0.83,1.13),在低偏倚风险试验中,n=1336,I2=58%,但0.72(95%CI=0.56,0.92),n=706,I2=0%,在偏倚试验的高风险中。
UNASSIGNED:治疗性低温治疗新生儿脑病可减少神经残疾和脑瘫,但是它对新生儿的影响,婴儿和儿童死亡率是不确定的。实施的设置会影响结果。低(呃)质量试验高估了TH的潜在益处。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.