雷珠单抗与视网膜光凝治疗Ⅱ区早产儿视网膜病变1年期疗效分析

One-year outcomes of intravitreal ranibizumab and laser photocoagulation for zone Ⅱ retinopathy of prematurity

  • 摘要:
      背景  雷珠单抗已成为治疗早产儿视网膜病变(retinopathy of prematurity,ROP)的一线用药,其治疗Ⅰ区病变的效果明显优于激光治疗,但对Ⅱ区病变的长期治疗效果,尤其是屈光状态报道较少。
      目的  比较玻璃体腔注射雷珠单抗(intravitreal ranibizumab,IVR)与视网膜光凝治疗(retinal photocoagulation,RP) Ⅱ区 ROP 1年后的复发情况、视网膜结构和屈光变化。
      方法  回顾性分析2018年1月 - 2019年12月解放军总医院第七医学中心NICU收治的Ⅱ区1型病变达阈值期或阈值前期ROP患儿,根据治疗方式分为IVR治疗组和RP治疗组,ROP自发消退病例作为对照组。术后定期随诊,比较两组ROP病变消退、复发及出生1年时屈光状态和眼轴等。
      结果  总计66例132眼,中位胎龄29.00(IQR: 27.00 ~ 31.00)周,男40例纳入分析,IVR治疗24例48眼,中位胎龄28.00 (IQR: 26.00 ~ 30.00)周,男14例,RP治疗22例44眼,中位胎龄28.50(IQR: 28.00 ~ 31.00)周,男13例,对照组(ROP自发消退) 20例40眼,中位胎龄27.50(IQR: 27.00 ~ 30.75)周,男13例,三组基线资料差异无统计学意义(P均>0.05)。随访1年后,IVR组中5例(9眼,18.75%),RP组中1例(2眼,4.54%)复发,差异有统计学意义(P=0.029)。RP治疗组平均等效球镜(spherical equivalent,SE)明显低于IVR组和对照组Md(IQR):-0.06(-1.47 ~ 1.00) D vs -0.75(-2.50 ~ 0.75) D和0.50(-1.00 ~ 1.19) D (P=0.034);RP组散光(>1 D)发生率明显高于IVR组和对照组(59.09% vs 31.25%和15.00%,P<0.001),三组间眼轴、高度近视(<-5.00 D)发生率差异无统计学意义(P>0.05)。
      结论  IVR和RP治疗Ⅱ区1型ROP均有效,IVR治疗后复发率高,再次注射依然有效,同时IVR矫正出生后52周近视和散光的发生率低,远期安全性有待进一步评估。

     

    Abstract:
      Background  Intravitreal ranibizumab (IVR) has become the first-line drug for treatment of retinopathy of prematurity (ROP). At present, IVR is significantly better than retinal photocoagulation (RP) in zone I ROP, and there is no obvious difference in zone Ⅱ ROP between them. However, there are few reports on the long-term effect in zone Ⅱ, especially the refractive status.
      Objective  To compare the recurrence, anatomical and refractive outcomes of intravitreal ranibizumab (IVR) with laser photocoagulation for zone Ⅱ type 1 retinopathy of prematurity (ROP) at 1-year corrected age.
      Methods  Totally 48 eyes of 24 infants with type 1 ROP in Zone Ⅱ that received IVR and 44 eyes of 22 infants that received laser photocoagulation from January 2018 to December 2019 were followed-up at the corrected age of 1 year. Another 20 infants with spontaneously regressed ROP were enrolled in the study as the control group. Fundus examination was performed at baseline and each follow-up. ROP recurrence, anatomical and refractive outcomes were assessed at 1 year corrected age.
      Results  Totally 66 infants (132 eyes, median gestation age 29.0027.00-31.00 weeks, 40 males) were followed up. There were 24 cases (48 eyes, median gestation age 28.00 IQR: 26.00-30.00 weeks, 14 males) in the IVR group, 22 cases (44 eyes, median gestation age 28.50 IQR: 28.00-31.00 weeks, 13 males) in the RP group, and 20 cases (40 eyes, median gestation age 27.50 IQR: 27.00-30.75 weeks, 13 males) in the control group with spontaneously resolved ROP. ROP recurred in 9 eyes of 5 infants (18.75%) in the IVR group and 2 eyes of 1 infant (4.54%) in the laser therapy group (P= 0.029). And after 2 or 3 injection, ROP regressed. At 1 year corrected age, the differences in axial length were not significant between the two groups. The median spherical equivalent refraction (SE) was significantly lower in eyes treated with laser (MdIQR: -0.75 -2.50, -0.75D) than the IVR group (MdIQR:-0.06-1.47, 1.00D) and control group (MdIQR:0.50-1.00, 1.19D). The frequencies of high myopia (>1.00 D) in the laser group (59.09%) was significantly higher then that in the IVR group (31.25%) and the control group (15.0%)(P<0.001). There was no significant difference in the axial length and the incidence of high myopia (< -5.00 D) among the three groups (P >0.05).
      Conclusion  Both IVR and RP are effective in the treatment of type 1 ROP in zone II. Though the recurrence rate is high after IVR treatment, reinjection is still effective. At the same time, the incidence of myopia and astigmatism corrected by IVR at 52 weeks after birth is low, but the long-term safety needs to be further evaluated.

     

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