Ozturk Mehmet Adnan, Korkmaz Levent
Division of Neonatology, Department of Pediatrics, Erciyes University Medical Faculty, Kayseri, Turkey.
Int Ophthalmol. 2019 Sep;39(9):1921-1930. doi: 10.1007/s10792-018-1018-8. Epub 2018 Sep 18.
Retinopathy of prematurity (ROP), a proliferative vitreoretinopathy resulting from the vascular disorder of the retina, is the most frequent cause of blindness in childhood. In our time, ROP in advanced stage, a serious problem in premature infants, has no other treatment more effective and with fewer side effects than laser photocoagulation (LPC) treatment, which narrows visual field. The search for methods with fewer side effects than LPC has increased in recent times for the treatment of ROP. We aimed to investigate the effects in question of propranolol on ROP in various stages (stages 1, 2, and 3 ROP).
This study is designed as a randomized, placebo-controlled, single-centered, double-blind clinical trial with parallel groups. A total of 126 very preterm infants, followed up in our unit from April 2011 to January 2013, were randomly selected and included in our study. They were separated into the groups of 0, 1, and 2 depending on their stage of ROP. In addition, all the patients were divided into control group (CG) and propranolol treatment group (PTG). While the cases in the CG were administered physiological saline solution, the cases in the PTG were administered propranolol (2 mg/kg/day) in the neovascularization phase (second phase) of the ROP.
Propranolol given to the group of stage 0-1 ROP was observed to have had no effect on the level of statistical significance between the CG and PTG in terms of increase in ROP stages (p > 0.05). However, propranolol was found to be more useful in patients with stage 2 ROP (p < 0.05).
When given in the neovascularization phase of the ROP, propranolol was found to be effective in the stage 2 (advanced stage) ROP patients but in stage 0-1 (early-stage) ROP patients, its efficacy was not sufficient.
早产儿视网膜病变(ROP)是一种因视网膜血管紊乱导致的增生性玻璃体视网膜病变,是儿童失明的最常见原因。在我们这个时代,晚期ROP是早产儿面临的一个严重问题,除了会缩小视野的激光光凝(LPC)治疗外,没有其他更有效且副作用更少的治疗方法。近年来,人们一直在寻找比LPC副作用更少的ROP治疗方法。我们旨在研究普萘洛尔对不同阶段(1期、2期和3期ROP)ROP的影响。
本研究设计为一项随机、安慰剂对照、单中心、双盲的平行组临床试验。2011年4月至2013年1月在我们科室接受随访的126名极早产儿被随机选取并纳入本研究。根据ROP阶段将他们分为0组、1组和2组。此外,所有患者被分为对照组(CG)和普萘洛尔治疗组(PTG)。CG组患者给予生理盐水溶液,PTG组患者在ROP的新生血管形成期(第二阶段)给予普萘洛尔(2mg/kg/天)。
观察发现,给予0 - 1期ROP组的普萘洛尔在ROP阶段增加方面,CG组和PTG组之间在统计学意义水平上没有影响(p>0.05)。然而,发现普萘洛尔对2期ROP患者更有用(p<0.05)。
在ROP的新生血管形成期给予普萘洛尔时,发现其对2期(晚期)ROP患者有效,但对0 - 1期(早期)ROP患者,其疗效不足。