Division of Endocrinology, Mayo Clinic, Rochester, Minnesota.
Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.
Ophthalmology. 2020 Apr;127(4S):S160-S171. doi: 10.1016/j.ophtha.2020.01.031.
Although widely used for more than 85 years, the efficacy of radiotherapy for Graves' ophthalmopathy (GO) has not been established convincingly.
To evaluate the efficacy of radiotherapy for GO.
Prospective, randomized, internally controlled, double-blind clinical trial in a tertiary care academic medical center.
The patients were ethnically diverse males and females over age 30 seen in a referral practice. The patients had moderate, symptomatic Graves' ophthalmopathy (mean clinical activity score, 6.2) but no optic neuropathy, diabetes, recent steroid treatment, previous decompression, or muscle surgery. Forty-two of 53 consecutive patients were enrolled after giving informed consent and fulfilling study entry criteria. Eleven eligible patients declined to participate because of inconvenience, desire for alternative therapy, or concern about radiation.
One randomly selected orbit was treated with 20 Gy of external beam therapy; sham therapy was given to the other side. Six months later, the therapies were reversed.
Every 3 months for 1 year, we measured the volume of extraocular muscle and fat, proptosis, range of extraocular muscle motion, area of diplopia fields, and lid fissure width. Effective treatment for GO will modify one or more of these parameters.
No clinically or statistically significant difference between the treated and untreated orbit was observed in any of the main outcome measures at 6 months. At 12 months, muscle volume and proptosis improved slightly more in the orbit that was treated first.
In this group of patients, representative of those for whom radiotherapy is frequently recommended, we were unable to demonstrate any beneficial therapeutic effect. The slight improvement noted in both orbits at 12 months may be the result of natural remission or of radiotherapy, but the changes are of marginal clinical significance.
尽管放射性治疗格雷夫斯眼病（GO）已经使用了 85 多年，但它的疗效并未得到令人信服的确证。
评估放射性治疗 GO 的疗效。
在一家三级保健学术医疗中心进行的前瞻性、随机、内部对照、双盲临床试验。
患者为在一个转诊诊所就诊的不同种族的男女，年龄均超过 30 岁。这些患者患有中度、有症状的格雷夫斯眼病（平均临床活动评分 6.2），但无视神经病变、糖尿病、近期类固醇治疗、既往减压术或肌肉手术史。42 例符合连续纳入标准的患者在知情同意并符合研究纳入标准后被纳入。11 例符合条件的患者因不便、希望采用替代疗法或担心辐射而拒绝参与。
一侧随机选择的眼眶接受 20Gy 的外照射治疗；另一侧给予假治疗。6 个月后，治疗方案逆转。
在 1 年的每 3 个月，我们测量眼外肌和脂肪体积、突眼度、眼外肌运动范围、复视区面积和睑裂宽度。GO 的有效治疗将改变这些参数中的一个或多个。
在 6 个月时，任何主要观察指标均未观察到治疗眼和未治疗眼之间存在临床或统计学显著差异。在 12 个月时，治疗首先进行的眼眶中的肌肉体积和突眼度略有改善。
在我们这组患者中，他们代表了那些经常推荐接受放射治疗的患者，我们未能证明任何有益的治疗效果。在 12 个月时两个眼眶中观察到的轻微改善可能是自然缓解或放射治疗的结果，但这些变化具有边缘的临床意义。
