Jürgenliemk-Schulz Ina M, Hartman Lidy J C, Roesink Judith M, Tersteeg Robbert J H A, van Der Tweel Ingeborg, Kal Henk B, Mourits Maarten P, Wyrdeman Harm K
Department of Radiation Oncology, University Medical Centre Utrecht, Heidelberglaan 100, NL-3584 CX Utrecht, The Netherlands.
Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1138-47. doi: 10.1016/j.ijrobp.2003.12.021.
To affirm the effectiveness and complication rate of postoperative single-dose beta-irradiation (RT) with (90)Sr in the case of primary pterygium in a clinical trial. Pterygium is a benign disease of the supporting orbital tissue that can cause impairment of visual function. Depending on the technique used for surgery, recurrence is described in up to 70% of cases-a reason to combine the initial treatment with radiotherapy or chemotherapy.
This trial was designed as a prospective, randomized, multicenter, double-blind study. Surgery was performed in all cases according to the bare sclera technique. Ninety-one patients with 96 pterygia were postoperatively randomized to either beta-RT or sham RT. In the case of beta-RT, a (90)Sr eye applicator was used to deliver 2500 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. Sham RT was given using the same type of applicator without the (90)Sr layer. 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 1998 and September 2002, 96 eyes with primary pterygium were operated on according to the trial protocol. Additional treatment was performed within 24 hours postoperatively. Ten patients were lost to follow-up, resulting in 86 patients who could be analyzed. In the 44 eyes randomized to receive beta-RT, 3 relapses occurred compared with 28 recurrences in the 42 eyes that received sham RT, for a crude control rate of 93.2% vs. 33.3%, respectively. At a mean follow-up of 18 months, major treatment complications had not been observed.
Single-dose beta-RT after bare sclera surgery is a simple, effective, and safe treatment that reduces the risk of primary pterygium recurrence.
在一项临床试验中，证实原发性翼状胬肉病例术后单次剂量锶-90β射线照射（放疗）的有效性和并发症发生率。翼状胬肉是一种支持性眼眶组织的良性疾病，可导致视功能损害。根据所采用的手术技术，高达70%的病例会出现复发，这也是将初始治疗与放疗或化疗相结合的一个原因。
本试验设计为一项前瞻性、随机、多中心、双盲研究。所有病例均根据裸巩膜技术进行手术。91例患有96只翼状胬肉的患者术后被随机分为β射线放疗组或假放疗组。在β射线放疗组中，使用锶-90眼部敷贴器以200至250 cGy/分钟的剂量率向巩膜表面给予2500 cGy剂量。假放疗使用相同类型的敷贴器，但没有锶-90层。治疗后，眼科医生和放射肿瘤学家都进行了随访检查。使用序贯检验分析累积数据。
1998年2月至2002年9月期间，96只原发性翼状胬肉眼根据试验方案进行了手术。术后24小时内进行了额外治疗。10例患者失访，最终86例患者可供分析。在随机接受β射线放疗的44只眼中，出现3例复发，而接受假放疗的42只眼中有28例复发，粗控制率分别为93.2%和33.3%。平均随访18个月时，未观察到主要治疗并发症。
裸巩膜手术后单次剂量β射线放疗是一种简单、有效且安全的治疗方法，可降低原发性翼状胬肉复发风险。
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