雷珠单抗单次玻璃体腔注射对1型阈值前期和阈值期早产儿视网膜病变的疗效和安全性比较

Comparative study on the effect and safety of single intravitreal injection of ranibizumab for type 1 prethreshold and threshold retinopathy of prematurity

目的比较早产儿视网膜病变(ROP)的1型阈值前期和阈值期经单次玻璃体腔注射雷珠单抗(IVR)治疗后的疗效、复发率及安全性。方法采用回顾性队列研究方法,将2016年1月至2019年12月在徐州医科大学附属徐州市立医院接受IVR治疗的ROP患儿51例100眼资料纳入研究。经Retcam眼底照相及间接检眼镜检查确诊1型阈值前期ROP 39例70眼、阈值期ROP 18例30眼。于确诊后24~36 h玻璃体腔注射0.25 mg/0.025 ml雷珠单抗。术后1 d观察有无眼压升高、眼内出血及眼内炎症反应,术后1周用Retcam眼底照相检查眼底病灶是否消退,每间隔2~4周复查1次,直至视网膜血管化,观察有无全身及眼部并发症。比较单次IVR治疗后1型阈值前期和阈值期ROP治愈率、视网膜血管化发生时间及复发率。结果单次IVR治疗后ROP治愈率为86%(86/100),均未见全身不良反应,1型阈值前期组、阈值期组ROP治愈率分别为85.71%(60/70)和86.67%(26/30),2个组比较差异无统计学意义(χ2=0.09,P=0.65)。1型阈值前期组和阈值期组视网膜血管化时间分别为(11.86±8.60)周和(14.45±10.01)周,2个组比较差异无统计学意义(t=0.88,P=0.22)。ROP复发10眼,其中1型阈值前期组复发率为5.71%(4/70),明显低于阈值期组的20.00%(6/30),差异有统计学意义(χ2=4.76,P=0.03)。10眼ROP复发,其中6眼再次行1次IVR治疗,4眼行1次激光光凝治疗。单次IVR治疗后5眼出现视网膜前出血,未行干预,出血自行吸收。结论单次玻璃体腔注射雷珠单抗治疗1型阈值前期及阈值期ROP均安全、有效,阈值期组ROP复发率高于1型阈值前期组,经再次治疗可以显著提高治愈率。

Objective To compare the efficacy,recurrence rate and safety of a single intravitreal injection of ranibizumab between type 1 prethreshold and threshold retinopathy of prematurity(ROP).Methods A retrospective cohort study was conducted.A total 100 eyes from 51 ROP patients in Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University from January 2016 to December 2019 were enrolled.Retcam and indirect ophthalmoscope were used to confirm the diagnosis of 39 cases of type 1 prethreshold ROP(70 eyes)and 18 cases of threshold ROP(30 eyes).All the subjects were given a single intravitreal injection of ranibizumab(IVR)0.25 mg/0.025 ml as the initial treatment within 24-36 hours after diagnosis.Events such as increased intraocular pressure,intraocular bleeding and endophthalmitis were observed and recorded 1 day after IVR.Retcam photography was used to check whether the fundus lesions was subsided 1 week after IVR.Regular follow-up was conducted once every 2-4 weeks until retinal vascularization.Systemic and ocular complications were recorded.The cure rate,the time of retinal vascularization and the recurrence rate of single IVR for type 1 prethreshold disease and threshold disease were compared.This study was approved by the Ethics Committee of Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University.Results After a single IVR,86 of 100 eyes(86.00%)were cured,among which 60 of 70 type 1 prethreshold ROP eyes(85.71%)and 26 of 30 threshold ROP eyes(86.67%)were cured,with no significant difference between the two groups(χ2=0.09,P=0.65).No systemic adverse reactions were observed after a single IVR treatment.The final retinal vascularization time was(11.86±8.60)weeks in the type 1 prethreshold ROP group and(14.45±10.01)weeks in the threshold ROP group,with no statistically significant difference between the two groups(t=0.88,P=0.22).Recurrence of ROP appeared in 10 eyes after a single IVR,including 4 eyes(5.71%)in the type 1 prethreshold ROP group and 6 eyes(20.00%)in the threshold ROP group,the recurrent rate was significantly different between the two groups(χ2=4.76,P=0.03).Six recurrent eyes were treated with IVR for the second time,and 4 recurrent eyes were treated with laser photocoagulation.Five eyes presented with preretinal hemorrhage after IVR treatment,and were recovered without intervention.Conclusions The treatment of type 1 prethreshold ROP and threshold ROP with single IVR in vitreous cavity is safe and effective.The recurrence rate of threshold ROP is higher than type 1 prethreshold ROP.Retreatment can significantly improve the cure rate.