Bührer Christoph, Bassler Dirk
Department of Neonatology, Charité University Medical Center, Berlin, Germany.
Neonatology. 2015;108(1):49-52. doi: 10.1159/000381659. Epub 2015 May 9.
Oral propranolol has improved the treatment of infantile hemangiomas, and a pediatric oral solution of propranolol has recently been licensed in the USA and Europe. In very preterm infants, infantile hemangiomas are associated with the occurrence of retinopathy of prematurity (ROP), and both diseases share a peculiar time course, featuring a lag phase after birth followed by rapid growth and then gradual regression.
To identify clinical studies evaluating the use of oral propranolol in preterm infants with ROP.
Two small bicentric, pilot, randomized controlled trials found a nonsignificant reduction of ROP requiring intervention by laser treatment or bevacizumab injection of similar magnitude. Together, 6 of 35 (17%) infants who had been receiving oral propranolol underwent ROP intervention, as opposed to 14 of 36 (39%) controls (relative risk 0.42, 95% CI: 0.15-1.16). Randomized controlled trials are ongoing that investigate early preventive oral propranolol starting at 1 week of age and propranolol eye drops in preterm infants with stage 2 ROP.
Further, large interventional studies are required to determine the clinical benefit-risk ratio of oral propranolol to prevent vision-threatening ROP in very preterm infants.
口服普萘洛尔改善了婴儿血管瘤的治疗，一种儿科用普萘洛尔口服溶液最近已在美国和欧洲获批。在极早产儿中，婴儿血管瘤与早产儿视网膜病变（ROP）的发生有关，这两种疾病都有一个特殊的病程，其特点是出生后有一个延迟期，随后快速生长，然后逐渐消退。
确定评估口服普萘洛尔用于ROP早产儿的临床研究。
两项小型双中心、试点、随机对照试验发现，需要通过激光治疗或注射贝伐单抗进行干预的ROP有类似程度的非显著性减少。接受口服普萘洛尔治疗的35名婴儿中有6名（17%）接受了ROP干预，而36名对照组婴儿中有14名（39%）接受了干预（相对风险0.42，95%置信区间：0.15 - 1.16）。正在进行随机对照试验，研究从1周龄开始早期预防性口服普萘洛尔以及用于2期ROP早产儿的普萘洛尔滴眼液。
需要进一步开展大型干预性研究，以确定口服普萘洛尔预防极早产儿发生威胁视力的ROP的临床效益风险比。
