Department of Radiation Oncology, Marilia Medical School, Marília, São Paulo, Brazil.
Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):e507-11. doi: 10.1016/j.ijrobp.2011.06.1988.
To evaluate the effectiveness and safety of postoperative low single-dose of beta-irradiation (β-RT) in pterygium comparing conjunctival autograft (CAG) surgery with CAG plus adjuvant β-RT in a randomized clinical trial.
This trial was designed as a prospective, randomized, single-center study. Surgery was performed in all cases according to the CAG technique. One hundred and eight pterygia were postoperatively randomized to CAG + β-RT or CAG alone. In the case of β-RT, a (90) Sr eye applicator was used to deliver 10 Gy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test.
Between February 2008 and September 2008, 116 eyes with primary pterygium were operated on according to the trial protocol. Adjuvant treatment was performed within 24 h postoperatively. Eight patients were lost to follow-up, resulting in 108 patients who could be analyzed. At a mean follow-up of 18 months (range, 8-33), in the 54 eyes randomized to receive CAG + β-RT, 5 relapses occurred compared with 12 recurrences in the 54 eyes in CAG, for a crude control rate of 90.8 % vs. 78%; p = 0.032, respectively. The treatment complications as hyperemia, total dehiscence of the autograft and dellen were significantly more frequent in the CAG (p < 0.05). The arm of β-RT resulted in better cosmetic results and improves of symptoms than CAG.
A low single-dose of β-RT of 10 Gy after CAG surgery was a simple, effective, and safe treatment that reduced the risk of primary pterygium recurrence, improved symptoms after surgery, resulting in a better cosmetic effect than only CAG.
评价术后低剂量β射线（β-RT）治疗翼状胬肉的有效性和安全性，将结膜自体移植（CAG）手术与 CAG 联合辅助β-RT 进行随机临床试验。
本试验设计为前瞻性、随机、单中心研究。所有病例均按 CAG 技术进行手术。108 例翼状胬肉术后随机分为 CAG+β-RT 或 CAG 单独治疗组。在β-RT 治疗中，使用（90）Sr 眼敷贴器将 10Gy 施于巩膜表面，剂量率为 200-250cGy/min。治疗后，由眼科医生和放射肿瘤学家进行随访检查。使用分组序贯检验对累积数据进行分析。
2008 年 2 月至 2008 年 9 月，根据试验方案对 116 例原发性翼状胬肉眼进行手术。辅助治疗在术后 24 小时内进行。8 例患者失访，最终 108 例患者可进行分析。平均随访 18 个月（8-33 个月），在接受 CAG+β-RT 治疗的 54 只眼中，有 5 只复发，而在接受 CAG 治疗的 54 只眼中有 12 只复发，粗控制率分别为 90.8%和 78%，差异有统计学意义（p=0.032）。CAG 组的充血、自体移植物完全裂开和凹陷等治疗并发症明显更常见（p<0.05）。β-RT 组的美容效果和症状改善均优于 CAG 组。
CAG 术后 10Gy 低剂量单次β-RT 治疗是一种简单、有效、安全的治疗方法，可降低原发性翼状胬肉复发的风险，改善术后症状，美容效果优于单纯 CAG。
