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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >Safety of withdrawing inhaled nitric oxide therapy in persistent pulmonary hypertension of the newborn (see comments)
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Safety of withdrawing inhaled nitric oxide therapy in persistent pulmonary hypertension of the newborn (see comments)

机译：在新生儿持续性肺动脉高压中退出吸入一氧化氮治疗的安全性（请参阅评论）

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OBJECTIVE: Because of case reports describing hypoxemia on withdrawal of inhaled nitric oxide (I-NO), we prospectively examined this safety issue in newborns with persistent pulmonary hypertension who were classified as treatment successes or failures during a course of I-NO therapy. METHODS: Randomized, placebo-controlled, double-masked, dose-response clinical trial at 25 tertiary centers from April 1994 to June 1996. Change in oxygenation and outcome (death and/or extracorporeal membrane oxygenation) during or immediately after withdrawing I-NO were the principal endpoints. Patients (n = 155) were term infants, <3 days old at study entry with echocardiographic evidence of persistent pulmonary hypertension of the newborn. Exclusion criteria included previous surfactant treatment, high-frequency ventilation, or lung hypoplasia. Withdrawal from treatment gas (0, 5, 20, or 80 ppm) started once treatment success or failure criteria were met. Withdrawal of treatment gas occurred at 20% decrements at <4 hours between steps. RESULTS: The patient profile was similar for placebo and I-NO groups. Treatment started at an oxygenation index (OI) of 25 +/- 10 (mean +/- SD) at 26 +/- 18 hours after birth. For infants classified as treatment successes (mean duration of therapy = 88 hours, OI <10), decreases in the arterial partial pressure of oxygen (PaO(2)) were observed only at the final step of withdrawal. On cessation from 1, 4, and 16 ppm, patients receiving I-NO demonstrated a dose-related reduction in PaO(2) (-11 +/- 23, -28 +/- 24, and -50 +/- 48 mm Hg, respectively). For infants classified as treatment failures (mean duration of therapy = 10 hours), no change in OI occurred for the placebo group (-13 +/- 36%, OI of 31 +/- 11 after the withdrawal process); however a 42 +/- 101% increase in OI to 46 +/- 21 occurred for the pooled nitric oxide doses. One death was possibly related to withdrawal of I-NO. CONCLUSION: For infants classified as treatment successes, a dose response between the I-NO dose and decrease in PaO(2) after discontinuing I-NO was found. A reduction in I-NO to 1 ppm before discontinuation of the drug seems to minimize the decrease in PaO(2) seen. For infants failing treatment, discontinuation of I-NO could pose a life-threatening reduction in oxygenation should extracorporeal membrane oxygenation not be readily available or I-NO cannot be continued on transport.
机译：目的：由于病例报告描述了吸入一氧化氮（I-NO）停用时的低氧血症，因此我们对患有持续性肺动脉高压的新生儿进行了前瞻性检查，该新生儿被归类为在I-NO治疗过程中治疗成功或失败。方法：1994年4月至1996年6月在25个三级中心进行的随机，安慰剂对照，双掩蔽，剂量反应临床试验。在撤出I-NO期间或之后，氧合和预后的改变（死亡和/或体外膜氧合）是主要终点。患者（n = 155）为足月婴儿，在研究进入时小于3天，并有超声心动图证据表明新生儿持续存在肺动脉高压。排除标准包括先前的表面活性剂治疗，高频通气或肺发育不全。一旦满足治疗成功或失败标准，便开始从治疗气体（0、5、20或80 ppm）中抽出气体。在步骤之间的少于4小时内，以20％的减量抽出处理气体。结果：安慰剂和I-NO组的患者资料相似。出生后26 +/- 18小时，治疗开始于25 +/- 10（平均+/- SD）的氧合指数（OI）。对于分类为治疗成功的婴儿（平均治疗时间= 88小时，OI <10），仅在停药的最后一步观察到了动脉血氧分压（PaO（2））的降低。在停止1、4和16 ppm时，接受I-NO的患者表现出与剂量相关的PaO（2）降低（-11 +/- 23，-28 +/- 24和-50 +/- 48 mm汞）。对于被分类为治疗失败的婴儿（平均治疗时间= 10小时），安慰剂组的OI没有发生变化（-13 +/- 36％，戒断后OI为31 +/- 11）;但是，合并一氧化氮剂量的OI增加了42 +/- 101％，达到46 +/- 21。一例死亡可能与撤回I-NO有关。结论：对于被分类为治疗成功的婴儿，发现I-NO剂量与中断I-NO后PaO（2）降低之间的剂量反应。在停药前将I-NO降低至1 ppm似乎可以最大程度地减少PaO（2）的降低。对于未通过治疗的婴儿，如果无法随时获得体外膜氧合或无法继续运输I-NO，则中断I-NO可能会危及生命，减少氧合。

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