羊膜移植联合干扰素滴眼液治疗原发性翼状胬肉效果评估

Clinical evaluation of outcome of amniotic membrane transplantation combine with interferon eye drops for primary pterygium

目的评估羊膜移植联合应用重组人干扰素α2b滴眼液(简称干扰素滴眼液)治疗原发性翼状胬肉的临床效果。方法采用随机对照临床试验方法,纳入于2018年6—12月在北京同仁眼科中心就诊并按时完成随访的原发性翼状胬肉患者49例55眼,采用随机数字表法将受试者分为试验组23例25眼和对照组26例30眼。试验组采用翼状胬肉切除联合羊膜移植术+干扰素滴眼液进行治疗,对照组采用翼状胬肉切除术联合自体结膜移植术。试验组于术后第3天采用干扰素滴眼液点眼,连续用药3个月,分别于术后3 d、7 d、1个月、3个月以及半年对患者进行随访,观察患者的最佳矫正视力(BCVA)、角膜上皮缺损修复情况以及翼状胬肉复发率。结果术后6个月,2个组BCVA下降、稳定和提高的眼数分布比较,差异无统计学意义(P=0.259)。术后2个组术眼均有1眼在14 d内角膜上皮完全修复,其余术眼角膜上皮均在7 d内完全修复,2个组间不同角膜上皮愈合时间眼数分布比较,差异无统计学意义(P=1.000)。术后6个月,2个组患眼均未出现翼状胬肉真性复发,2个组结膜增生1、2、3级眼数比较,差异无统计学意义(Z=0.461,P=0.497)。试验组与对照组中出现纤维血管组织增生者分别占12.0%(3/25)和6.7%(2/30),但纤维血管组织增生均仅处于结膜与植片交界处,未到达植片中央及角膜缘。结论与传统翼状胬肉切除联合自体结膜移植术比较,羊膜移植联合干扰素滴眼液点眼治疗原发性翼状胬肉复发率无升高,对健康结膜组织损伤小。

Objective To observe the clinical effect of the biological amniotic membrane transplantation combined with interferonα2b eye drops(interferon eye drops)in the treatment of primary pterygium.Methods A randomized controlled clinical trial was used,49 patients(55 eyes)of primary pterygium were selected in Beijing Tongren eye center from June to December,2018,and all the subjects finished the follow up on time.The patients were randomly divided into two groups by random number table method,with 25 eyes of 23 patients in the experimental group and 30 eyes of 26 patients in the control group.The experimental group was treated with pterygium resection combined with amniotic membrane transplantation and interferon eye drops,while the control group was treated with pterygium resection combined with conjunctival autograft transplantation.Meanwhile the experimental group was treated with interferon eye drops on the 3rd day after surgery for 3 months.Follow up was done on the 3rd day,7th day,1st month,3rd month and half a year after the surgery.The best corrected visual acuity(BCVA),heal of corneal epithelial defect and pterygium recurrence rate were observed.Written informed consent was obtained from each subject prior to entering the study cohort.The study protocol was approved by the Ethics Committee of Beijing Tongren Hospital(No.TRECKY2018-043).Results At 6 months after surgery,there was no significant difference in number of eyes with decrease,stable or increase of BCVA between the two groups(P=0.259);Cornea epithelium of one eye in each group was healed within 14 days,and the cornea epithelia were healed within 7 days in all rest cases of the two groups,and there was no significant difference in the healing time of corneal epithelium between the two groups(P=1.000);At 6 months after the surgery,there was no true recurrence in the two groups,and there was no significant difference between the two groups of grade 1,2 and 3 patients with conjunctival hyperplasia(Z=0.461,P=0.497).There were three eyes(3/25,12.0%)and two eyes(2/30,6.7%)had fibrovascular tissue hyperplasia in the experimental group and control group,respectively,but fibrovasular tissue hyperplasia was only appeared at the junction of conjunctiva and graft,and did not reach the center of the and graft or the limbus of cornea.Conclusions Compared with the traditional conjunctival autograft transplantation,amniotic membrane transplantation combined with interferon eye drops has no higher recurrence rate for the treatment of primary pterygium,while it is getting less damage to the healthy conjunctival tissue.