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[摘要]
目的:比较玻璃体腔注射康柏西普和雷珠单抗治疗1型早产儿视网膜病变(ROP)的有效性和安全性。方法:回顾性收集2018-08/2020-01于西京医院眼科确诊为1型ROP,并进行玻璃体腔注射康柏西普(IVC组,46例91眼)或雷珠单抗(IVR组,55例109眼)治疗的患儿临床资料,比较治疗后两组患儿ROP病变消退、复发及再治疗情况,不良预后及眼部和全身并发症情况。结果:纳入患儿101例200眼中急进型后极部ROP(AP-ROP)20眼,阈值期ROP 86眼,阈值前期1型ROP 94眼。两组患儿基线资料及治疗前ROP严重程度均无差异(P>0.05)。IVC组和IVR组一次治愈率无差异(93.4% vs 87.2%,P>0.05)。一次治疗后IVC组复发6眼(6.6%),平均复发时间为11.7±4.13wk,其中2眼再次行IVC治疗,4眼行视网膜激光光凝治疗,治疗后病变均消退; IVR组复发11眼(10.1%),平均复发时间9.82±4.02wk,其中4眼再次行IVR治疗,7眼行视网膜激光光凝治疗,治疗后病变均退行; 两组复发率及复发时间均无显著差异(P>0.05)。IVC组一次治疗后未见病变进展; IVR组一次治疗后3眼病情进展,其中2眼视网膜增殖加重伴出血,行视网膜激光光凝治疗,1眼进展为牵拉性视网膜脱离,行玻璃体切除术治疗。两组患儿治疗后均未出现与药物或玻璃体腔注射相关的眼部及全身并发症,IVR组3眼出现颞侧视网膜皱褶,视网膜血管牵拉致血管弓夹角变小等不良预后。结论:IVC和IVR均为1型ROP治疗的有效手段,两者一次治愈率、复发率无显著差异,但IVR治疗的部分病情严重患儿有出现病变进展或不良预后的可能,需长期严密观察随访。
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[Abstract]
AIM:To compare the effectiveness and safety of intravitreal injection of conbercept(IVC)and intravitreal injection of ranibizumab(IVR)for type 1 retinopathy of prematurity(ROP).METHORDS: A retrospective case series observation was carried out. Clinical data of patients with type 1 ROP treated with IVC(46 cases, 91 eyes)or IVR(55 cases, 109 eyes)from August 2018 to January 2020 in Xijing Hospital were collected. Regression, progression, recurrence, retreatment of ROP, the proportion of adverse outcomes and ocular and systemic complications were all analyzed.RESULTS:All the 101 infants(200 eyes)with type 1 ROP treated with intravitreal injection of anti-vascular endothelial growth factor(VEGF)were enrolled, in which 20 eyes with aggressive posterior ROP(AP-ROP), 86 eyes with threshold ROP, and 94 eyes with type 1 pre-threshold ROP were included. There were no statistical differences in the basic conditions and the severity of ROP between the two groups before treatment(P>0.05). There was no difference in the primary cure rate between IVC and IVR groups(93.4% vs 87.2%, P>0.05). A total of 6 eyes(6.6%)developed ROP recurrence in the IVC group, in which 2 eyes received a second IVC, and 4 eyes were treated with laser photocoagulation(LP). In the IVR counterpart, 11 eyes(10.1%)developed ROP recurrence, among them 4 eyes underwent another IVR, and 11 eyes were treated with LP. The recurrence interval was 11.7±4.13wk and 9.82±4.02wk in the IVC and IVR groups. All these results of recurrence showed no significant statistical difference between these two groups(P>0.05). There was no progression of ROP appeared in IVC group. The progression of ROP developed in 3 eyes after initial ranibizumab injection, among them retinal fibrous proliferation and hemorrhage treated with LP in 2 eyes, and tractional retinal detachment treated with vitrectomy in 1 eye. No drug or injection related side effect was observed in infants of both groups. There were some adverse prognosis, such as temporal retinal folds, smaller angle between upper and lower temporal retinal vessel trunks caused by retinal vascular traction in 3 eyes in IVR group during the long-term follow up.CONCLUSION: Both IVC and IVR are effective and safety choices for the treatment of ROP. There was no significant difference between the first cure rate and the recurrence rate. Some of the most severe cases treated by IVR were at risk for progression or poor prognosis that need to be followed up for a long time.
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[基金项目]
国家自然科学基金项目(No.81770936); 陕西省重点研发计划项目(No.2021SF-159)