玻璃体内注射雷珠单抗治疗早产儿视网膜病变疗效观察

Efficacy and safety of intravitreal injection of ranibizumab for retinopathy of prematurity

目的观察玻璃体内注射雷珠单抗治疗早产儿视网膜病变(retinopathy of prematurity,ROP)的疗效及安全性。方法将2014年6月至2015年8月在我院确诊并首次进行抗VEGF治疗的连续性Ⅰ、Ⅱ区ROP患儿49例95眼纳入研究。将患儿依据病变分区分为Ⅰ区组和Ⅱ区组,主要比较2组患儿出生体质量、孕周、治疗时矫正胎龄、治疗好转、复发及再治疗时间之间的差异。用30G 1 m L注射器抽取10 mg·m L-1的雷珠单抗0.025 m L(含雷珠单抗0.25 mg)于患儿角膜缘后1.5 mm穿刺注射。注射结束时妥布霉素地塞米松眼膏包眼。注药后3 d运用手持裂隙灯及眼压计观察患眼有无眼压增高、眼内新鲜出血及眼内炎情况,治疗后1周间接检眼镜观察视网膜血管迂曲扩张及病变嵴消退情况。同时观察有无与治疗相关的其他全身不良反应。结果本研究病例首次治疗后血管迂曲、扩张消失或程度减轻,新生血管及嵴消退93眼,占95.9%。其中,Ⅰ区组58眼,Ⅱ区组35眼。两组ROP好转率比较,差异无统计学意义(P>0.05)。随访期间复发22眼。其中,Ⅰ区组17眼,占Ⅰ区ROP消退患眼的29.3%;Ⅱ区组5眼,占Ⅱ区ROP消退患眼的14.3%。两组复发率比较,差异有统计学意义(P<0.05)。复发后再次行雷珠单抗或激光光凝治疗。复发至再次治疗时间为(6.50±2.54)周。Ⅰ区组和Ⅱ区组复发至再次治疗时间分别为(6.44±2.74)周、(6.67±2.31)周,两组差异无统计学意义(P>0.05)。末次随访时,可观察到继续血管化。随访期间和末次随访时,未见与治疗方式和药物相关的其他眼部并发症和全身不良反应发生。结论雷珠单抗治疗Ⅰ、Ⅱ区ROP疗效较好,但ROP复发率较高。未见明确与药物有关的局部和全身并发症。

Objective To observe the efficacy and safety of intravitreal injection of ranibizumab in the treatment of retinopathy of prematurity（ROP）.Methods Data from 49 consecutive ROP patients（95 eyes） including type I pre-threshold,threshold and aggressive posterior ROP who had received anti-VEGF treatment for the first time in our hospital from June 2014 to August 2015 were collected.60 eyes from the 95 eyes were confined as the zone I disease group,while the remaining 35 eyes as zone Ⅱ disease group.The difference of birth weight,gestational age,corrected gestational age,treatment effects,recurrence and re-treatment time between two groups were compared.0.025 mL ranibizumab（10 mg · mL^（-1）） was injected through 1.5mm puncture after corneal limbus by using 30 G 1 mL injection syringe.At the end of the injection,tobramycin and dexamethasone ophthalmic ointment eye bag was used.After the injection of3 days,the portable slit lamp and tonometer were used to observe the intraocular pressure,intraocular hemorrhage and endophthalmitis.The indirect ophthalmoscope was used to observe the retinal vascular tortuosity and ridge regression of lesion expansion at 1 week after treatment.At the same time,the systemic adverse reactions related to treatment were observed.Results After receiving ranibizumab treatment for the first time,93 eyes（95.9%） exhibited ROP regression after single injection,including 58 eyes in zone I disease group,35 eyes in zone Ⅱ disease group.There was no statistical difference between two groups（P〉 0.05）.22 eyes required additional anti-VEGF injection or laser treatment for ROP recurrence,including 17 eyes in zone I disease group 5 eyes in zone Ⅱ disease group.There was statistical difference between two groups（P〉0.05）.The time from recurrence to re-treatment was（6.50 ±2.54） weeks,which in zone I disease group was（6.44 ±2.74） weeks and in zone II disease group was（6.67 ±2.31） weeks,there was no statistical difference between two groups（P〉0.05）.No local or systemic adverse events associated with the treatment or drug was observed within the following period.Conclusion Intravitreal injection of ranibizumab is an effective and well tolerated method for zone I and zone II ROP,but the recurrence rate is high.There Is no local or systemic adverse events associated with the treatment or drug.