荷兰阿姆斯特丹OLVG医院Anne A.M.W. van Kempen研究团队取得一项新突破。他们比较了降低新生儿低血糖阈值与传统治疗阈值的结局。这一研究成果发表在2020年2月6日出版的国际学术期刊《新英格兰医学杂志》上。

全球许多早产、小于或大于胎龄、或母亲患有糖尿病的新生儿都要进行低血糖筛查，以预防脑损伤。然而，关于既安全又能避免过度治疗的血糖阈值尚未达成共识。

在一项多中心、随机、非劣效性试验中，研究组招募了689名在孕35周或更晚出生，且有低血糖风险的健康新生儿。将其随机分组，其中384名新生儿采用较低阈值（血糖低于2.0mmol/L），341名采用传统阈值（血糖低于2.6mmol/L）进行治疗。采用第三版贝利婴幼儿发展量表对发育程度进行评估，分数越高发育越好。

18个月时，低阈值组有82.5%、传统阈值组有86.5%的幼儿进行了贝利评分。低阈值组的认知和运动得分分别为102.9和104.6分，传统阈值组分别为102.2和104.9分，差异不显著。

低阈值组的平均血糖浓度为3.2mmol/L，传统阈值组为3.4mmol/L。传统阈值组严重低血糖事件较少发生，但该组的侵入性诊断和治疗干预较多。低阈值组的严重不良事件包括1例新生儿抽搐和1例新生儿死亡。

总之，在健康的无症状中度低血糖新生儿中，采用较低的血糖治疗阈值，18个月时的认知运动发育并不劣于传统阈值。

附：英文原文

Title: Lower versus Traditional Treatment Threshold for Neonatal Hypoglycemia

Author: Anne A.M.W. van Kempen, M.D., Ph.D.,, P. Frank Eskes, M.D.,, Debbie H.G.M. Nuytemans,, Johanna H. van der Lee, M.D., Ph.D.,, Lea M. Dijksman, Ph.D.,, Nicole R. van Veenendaal, M.D.,, Flip J.P.C.M. van der Hulst, M.D.,, Rob M.J. Moonen, M.D., Ph.D.,, Luc J.I. Zimmermann, M.D., Ph.D.,, Ellen P. van ’t Verlaat, M.Sc.,, Minouche van Dongen-van Baal, M.D.,, Ben A. Semmekrot, M.D., Ph.D.,, Hélène G. Stas, M.D.,, Ron H.T. van Beek, M.D., Ph.D.,, José J. Vlietman, M.D.,, Peter H. Dijk, M.D., Ph.D.,, Jacqueline U.M. Termote, M.D., Ph.D.,, Rogier C.J. de Jonge, M.D., Ph.D.,, Amerik C. de Mol, M.D., Ph.D.,, Marianne W.A. Huysman, M.D., Ph.D.,, Joke H. Kok, M.D., Ph.D.,, Martin Offringa, M.D., Ph.D.,, and Nicole Boluyt, M.D., Ph.D.

Issue&Volume: 2020-02-05

Abstract:

Background
Worldwide, many newborns who are preterm, small or large for gestational age, or born to mothers with diabetes are screened for hypoglycemia, with a goal of preventing brain injury. However, there is no consensus on a treatment threshold that is safe but also avoids overtreatment.

Methods
In a multicenter, randomized, noninferiority trial involving 689 otherwise healthy newborns born at 35 weeks of gestation or later and identified as being at risk for hypoglycemia, we compared two threshold values for treatment of asymptomatic moderate hypoglycemia. We sought to determine whether a management strategy that used a lower threshold (treatment administered at a glucose concentration of <36 mg per deciliter [2.0 mmol per liter]) would be noninferior to a traditional threshold (treatment at a glucose concentration of <47 mg per deciliter [2.6 mmol per liter]) with respect to psychomotor development at 18 months, assessed with the Bayley Scales of Infant and Toddler Development, third edition, Dutch version (Bayley-III-NL; scores range from 50 to 150 [mean {±SD}, 100±15]), with higher scores indicating more advanced development and 7.5 points (one half the SD) representing a clinically important difference). The lower threshold would be considered noninferior if scores were less than 7.5 points lower than scores in the traditional-threshold group.

Results
Bayley-III-NL scores were assessed in 287 of the 348 children (82.5%) in the lower-threshold group and in 295 of the 341 children (86.5%) in the traditional-threshold group. Cognitive and motor outcome scores were similar in the two groups (mean scores [±SE], 102.9±0.7 [cognitive] and 104.6±0.7 [motor] in the lower-threshold group and 102.2±0.7 [cognitive] and 104.9±0.7 [motor] in the traditional-threshold group). The prespecified inferiority limit was not crossed. The mean glucose concentration was 57±0.4 mg per deciliter (3.2±0.02 mmol per liter) in the lower-threshold group and 61±0.5 mg per deciliter (3.4±0.03 mmol per liter) in the traditional-threshold group. Fewer and less severe hypoglycemic episodes occurred in the traditional-threshold group, but that group had more invasive diagnostic and treatment interventions. Serious adverse events in the lower-threshold group included convulsions (during normoglycemia) in one newborn and one death.

Conclusions
In otherwise healthy newborns with asymptomatic moderate hypoglycemia, a lower glucose treatment threshold (36 mg per deciliter) was noninferior to a traditional threshold (47 mg per deciliter) with regard to psychomotor development at 18 months.

DOI: 10.1056/NEJMoa1905593

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1905593