摘要目的 观察玻璃体腔注射雷珠单抗(IVR)治疗早产儿视网膜病变(ROP)的安全性和有效性.方法 经ROP筛查并诊断为AP-ROP、阈值期ROP或高危阈值前期ROP的29例患儿57只眼纳入研究.其中,Ⅰ区病变9例18只眼,Ⅱ区病变20例39只眼.所有患儿在确诊后24 h内玻璃体腔注射10 mg/ml的雷珠单抗0.025 ml(含雷珠单抗0.25 mg).注射后第1个月每周随访1次,第2、3个月每两周随访1次,此后每一个月随访1次,至视网膜血管发育至Ⅲ区.随访时间16～52周,平均随访时间(28.1±11.7)周.对病情复发或对IVR治疗无反应者,给予重复IVR或激光光凝治疗.57只眼中,单次IVR治疗36只眼,占63.2％;重复IVR或补充激光光凝治疗21只眼,占36.8％.随访观察患儿视网膜血管变化情况及眼部或全身不良反应发生情况.结果 57只眼中,经单次IVR治疗病变完全消退36只眼,占63.2％;经重复IVR治疗病情改善11只眼,占19.3％;经补充激光光凝治疗病情稳定10只眼,占17.5％.单次IVR治疗的36只眼病变完全消退,视网膜血管发育至Ⅲ区.重复IVR或补充激光光凝治疗的21只眼中,病变复发18只眼,占所有患眼的31.6％;对IVR治疗无反应3只眼,占所有患眼的5.3％.病变复发的18只眼中,包括AP-ROP 14只眼,阈值期ROP 2只眼,阈值前期ROP 2只眼.其病变复发时间2～8周,平均复发时间(5.7±2.1)周.7只眼补充激光光凝治疗后病情稳定;11只眼给予再次IVR治疗后病情改善.对IVR治疗无反应3只眼,均为Ⅱ区病变高危阈值前期ROP,经激光光凝治疗后病情稳定.所有患儿随访期间均未发生眼部及全身不良反应.结论 单次IVR治疗大部分ROP患儿安全有效.部分治疗无反应或复发者,需重复IVR和(或)联合激光光凝治疗.

abstractsObjective To evaluate the efficacy and safety of intravitreal ranibizumab (IVR) for the treatment of retinopathy of prematurity(ROP).Methods A total of 57 eyes of 29 premature infants with diagnosis of high-risk pre-threshold,threshold ROP,or aggressive posterior ROP were reviewed and analyzed in the study.The lesions of 18 eyes were located in zone Ⅰ,39 eyes were located in zone Ⅱ.All infants in the study received IVR (10 mg/ml,0.025 ml) as the initial treatment within 24 hours after diagnosis.Follow-up examinations were performed after treatment,every week at the first month,every 2 weeks at the second and third month,every month afterward,until vascularization of zone Ⅲ was observed.Follow-up ranged from 16 weeks to 52 weeks,and the average follow-up time was (28.1±11.7) weeks.If the infants didn't respond positively to the treatment or the disease recurred,the additional treatments were applied.36 eyes (63.2％) received a single injection,whereas 21 eyes (36.8％) received additional treatments.The follow-up examinations included the development of retinal vessels,the ocular or systemic adverse events.Results Among the eyes,the development of peripheral retinal vessels could be observed in 36 eyes (63.2％) which received a single injection; clinical improvement in 11 eye (19.3％) which received repeat injection; stable disease in 10 eyes (17.5％) which received laser therapy.Among the eyes,18 eyes (31.6％) recurred,including ggressive posterior ROP (14 eyes),threshold ROP (2 eyes) and high-risk pre-threshold ROP (2 eyes).The mean time of recurrence was (5.7 ± 2.1) weeks (range 2.0-8.0 weeks).Three eyes (5.3％) of high-risk pre-threshold,threshold ROP lacked a positive response to the treatment.The lesions were controlled after additional laser given in these eyes.No serious ocular or systemic adverse events associated with the drug or the injection was observed during the follow-up period.Conclusion IVR is safe and effective for most ROP infants.In cases of recurrence or no response,conventional laser treatment or an additional IVR injection were needed.