Stiebel-Kalish Hadas, Robenshtok Eyal, Hasanreisoglu Murat, Ezrachi David, Shimon Ilan, Leibovici Leonard
Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel.
J Clin Endocrinol Metab. 2009 Aug;94(8):2708-16. doi: 10.1210/jc.2009-0376. Epub 2009 Jun 2.
Graves' ophthalmopathy (GO) is a common cause of morbidity in patients with Graves' disease. Optimal treatment of GO remains unclear, and an evidence-based approach may improve patients' outcome.
A systematic review and metaanalysis of randomized, controlled trials comparing treatment modalities for GO vs. placebo, no intervention, or other treatments. Primary outcome was the clinical activity score (CAS).
Thirty-three trials evaluating 1367 patients fulfilled inclusion criteria. In patients with moderate to severe GO, iv pulse corticosteroids were significantly better than oral corticosteroids in reducing CAS [standardized mean difference -0.64, 95% confidence interval (CI) -1.11 to -0.17, chi(2) 7.91, I(2) 62%, random effect], with lower rate of adverse events. Somatostatin analogs showed a minor but statistically significant advantage over placebo (mean difference -0.63, 95% CI -0.98 to -0.28). There was no advantage of orbital radiotherapy over sham radiation in CAS, but radiotherapy was superior for response rates of diplopia (odds ratio 4.88, 95% CI 1.93-12.34, two trials). Treatment with combination of orbital radiotherapy and corticosteroids was significantly better than with either treatment alone (standardized mean difference -1.05, 95% CI -1.62 to -0.48).
Current evidence demonstrates the efficacy of iv corticosteroids in decreasing CAS in patients with moderate to severe GO. Intravenous pulse corticosteroids therapy has a small but statistically significant advantage oral therapy and causes significantly fewer adverse events. Somatostatin analogs have marginal clinical efficacy. The efficacy of orbital radiotherapy as single therapy remains unclear, whereas the combination of radiotherapy with corticosteroids has better efficacy than either radiotherapy or oral corticosteroids alone.
格雷夫斯眼病(GO)是格雷夫斯病患者发病的常见原因。GO的最佳治疗方法尚不清楚,循证医学方法可能会改善患者的治疗效果。
对比较GO治疗方式与安慰剂、无干预或其他治疗的随机对照试验进行系统评价和荟萃分析。主要结局指标为临床活动评分(CAS)。
33项评估1367例患者的试验符合纳入标准。在中度至重度GO患者中,静脉注射脉冲式皮质类固醇在降低CAS方面显著优于口服皮质类固醇[标准化均数差-0.64,95%置信区间(CI)-1.11至-0.17,χ² 7.91,I² 62%,随机效应],不良事件发生率更低。生长抑素类似物与安慰剂相比显示出较小但具有统计学意义的优势(均数差-0.63,95%CI -0.98至-0.28)。在CAS方面,眼眶放疗与假放疗相比无优势,但放疗在复视缓解率方面更优(比值比4.88,95%CI 1.93 - 12.34,两项试验)。眼眶放疗与皮质类固醇联合治疗显著优于单独使用任何一种治疗(标准化均数差-1.05,95%CI -1.62至-0.48)。
现有证据表明静脉注射皮质类固醇对降低中度至重度GO患者的CAS有效。静脉注射脉冲式皮质类固醇疗法比口服疗法有小但具有统计学意义的优势,且不良事件明显更少。生长抑素类似物具有边缘临床疗效。眼眶放疗作为单一疗法的疗效仍不明确,而放疗与皮质类固醇联合使用比单独放疗或口服皮质类固醇疗效更好。