早产儿视网膜病变患儿中双相与静态氧饱和度目标的比较。
Comparison of Biphasic vs Static Oxygen Saturation Targets Among Infants With Retinopathy of Prematurity.
机构信息
Department of Pediatrics, Division of Neonatology, Cleveland Clinic, Cleveland, Ohio.
Department of Pediatrics, Case Western Reserve Institute-Metro Health Medical Center, Cleveland, Ohio.
出版信息
JAMA Ophthalmol. 2019 Apr 1;137(4):417-423. doi: 10.1001/jamaophthalmol.2018.7021.
IMPORTANCE
The Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) demonstrated that static low oxygen saturation decreased retinopathy of prematurity (ROP) but increased mortality compared with static high oxygen saturation cohorts.
OBJECTIVE
To compare outcomes of a biphasic oxygen protocol with static targets recommended by SUPPORT.
DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study comparing biphasic vs static standards 41 months prior to and 42 months after a change from biphasic to static SUPPORT standards at a level III neonatal intensive care unit (Fairview Hospital, Cleveland, Ohio). The study included infants born at a corrected gestational age (CGA) of 31 weeks or younger or birth weight 1500 g or less. Data were analyzed between August 2010 and July 2017.
INTERVENTIONS
The pre-SUPPORT group underwent biphasic protocol target saturations of 85% to 92% at younger than 34 weeks' CGA and greater than 95% at 34 weeks' CGA or older. The post-SUPPORT group underwent a constant 91% to 95% target.
MAIN OUTCOMES AND MEASURES
Primary outcome was incidence of type 1 ROP. Secondary outcomes were incidence of any ROP, time to full vascularization, and mortality.
RESULTS
Of 596 eligible infants, 562 were included in ophthalmic analysis. Three hundred three patients were boys (54%); 399 were white (71%), 87 were black (15%), and 76 were of other or unknown race/ethnicity (14%). Mean (SD) CGA and birth weight were 29 (2) weeks and 1151 (346) g, respectively. Any ROP overall increased (53 [20%] pre-SUPPORT vs n = 86 [28%] post-SUPPORT; absolute difference, 8%; 95% CI, 1%-15%; odds ratio, 1.6; 95% CI, 1.05-2.3; P = .03). Type 1 ROP increased in the post-SUPPORT era (n = 6 [2%] pre-SUPPORT vs n = 18 [6%] post-SUPPORT; absolute difference, 4%; 95% CI, 0.4%-7%; odds ratio, 2.7; 95% CI, 1.05-6.9; P = .03). There was a delay in vascularization in the post-SUPPORT group (n = 6 [2%] pre-SUPPORT vs n = 18 [6%] post-SUPPORT; absolute difference, 4%; 95% CI, 0.4%-7%; P = .03).
CONCLUSIONS AND RELEVANCE
Compared with static oxygen standards, biphasic oxygen targets are associated with decreased incidence and severity of ROP without increasing mortality.
重要性
Surfactant、Positive Pressure、and Pulse Oximetry Randomized Trial (SUPPORT) 研究表明，与高氧饱和度的静态 cohort相比，低氧饱和度的静态可降低早产儿视网膜病变（ROP）的发生率，但会增加死亡率。
目的
比较两相氧方案与 SUPPORT 推荐的静态目标的结果。
设计、地点和参与者：这是一项回顾性队列研究，在一项三级新生儿重症监护病房（克利夫兰的 Fairview 医院）从两相改为静态 SUPPORT 标准的 41 个月前和 42 个月后，比较两相与静态标准，纳入校正胎龄（CGA）为 31 周或更小或出生体重为 1500 g 或更小的婴儿。数据于 2010 年 8 月至 2017 年 7 月进行分析。
干预措施
在小于 34 周 CGA 时，前 SUPPORT 组接受 85%至 92%的两相方案目标饱和度，在 34 周 CGA 或更大时接受 95%以上的目标饱和度。后 SUPPORT 组接受恒定的 91%至 95%的目标饱和度。
主要结局和测量指标
主要结局是 1 型 ROP 的发生率。次要结局包括任何 ROP 的发生率、完全血管化的时间和死亡率。
结果
在 596 名符合条件的婴儿中，有 562 名进行了眼科分析。303 名男婴（54%）；399 名白人（71%），87 名黑人（15%），76 名其他或未知种族/民族（14%）。平均（SD）CGA 和出生体重分别为 29（2）周和 1151（346）g。总体任何 ROP 发生率增加（前 SUPPORT 组 53[20%]例，后 SUPPORT 组 86[28%]例；绝对差异，8%；95%CI，1%-15%；比值比，1.6；95%CI，1.05-2.3；P=0.03）。在后 SUPPORT 时代，1 型 ROP 发生率增加（前 SUPPORT 组 6[2%]例，后 SUPPORT 组 18[6%]例；绝对差异，4%；95%CI，0.4%-7%；比值比，2.7；95%CI，1.05-6.9；P=0.03）。在后 SUPPORT 组中，血管化时间延迟（前 SUPPORT 组 6[2%]例，后 SUPPORT 组 18[6%]例；绝对差异，4%；95%CI，0.4%-7%；P=0.03）。
结论和相关性
与静态氧标准相比，两相氧目标与 ROP 的发生率和严重程度降低相关，而不会增加死亡率。
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