Department of Endocrinology, Jinling Hospital, Affiliated Hospital of Medical College of Nanjing University.
Department of Endocrinology, Taikang Xianlin Drum Tower Hospital, Nanjing, Jiangsu Province, China.
Eur J Endocrinol. 2021 Feb;184(2):277-287. doi: 10.1530/EJE-20-0857.
Tripterygium glycosides (TG) has been used to treat a spectrum of inflammatory and autoimmune diseases. Our preliminary studies have shown that TG is effective in the treatment of active Graves' ophthalmopathy (GO).
We aimed to compare the efficacy and tolerability of TG with intravenous methylprednisolone (iv.MP) in patients with active moderate-to-severe GO.
This study was an observer-masked, single-centre, block-randomised trial. Patients with active moderate-to-severe GO were randomly assigned to receive iv.MP (500 mg once per week for 6 weeks followed by 250 mg per week for 6 weeks) or with TG (20 mg tablet three times per day for 24 weeks). The primary endpoints were the overall response rate and the patients' quality of life at 12 and 24 weeks.
In this study, 161 patients were enrolled and randomised from 2015 to 2019. A total of 79 were randomly assigned to receive iv.MP and 82 to receive TG. A greater overall response rate was found in the TG group compared with the iv.MP group at week 24 (90.2% vs 68.4%, P = 0.000). Similarly, the patients' quality of life of the TG group showed a significantly higher response than the iv.MP group at week 24 (89.02% vs 72.15%, P = 0.001). The TG therapy showed a better CAS response than the iv.MP (91.5% vs 70.9% improved, P < 0.05), and up to 91.2% of patients were inactive. Also, the TG group showed a significantly higher improved rate of diplopia, proptosis, visual acuity, soft tissue involved and the decrease of eye muscle motility than the iv.MP group at week 24. Significantly more patients in the iv.MP group than the TG group experienced adverse events.
Compared with iv.MP treatment, TG therapy is more effective and safer for patients with active moderate to severe GO.
雷公藤多苷（TG）已被用于治疗一系列炎症和自身免疫性疾病。我们的初步研究表明，TG 治疗活动期格雷夫斯眼病（GO）有效。
我们旨在比较 TG 与静脉注射甲基强的松龙（iv.MP）治疗活动期中重度 GO 患者的疗效和耐受性。
这是一项观察者设盲、单中心、区组随机试验。活动期中重度 GO 患者被随机分为 iv.MP 组（500mg/周，共 6 周，然后 250mg/周，共 6 周）或 TG 组（20mg 片剂，每天 3 次，共 24 周）。主要终点是治疗 12 周和 24 周时的总缓解率和患者生活质量。
这项研究于 2015 年至 2019 年共纳入 161 例患者，并进行随机分组。其中 79 例患者被随机分配至 iv.MP 组，82 例患者被随机分配至 TG 组。治疗 24 周时，TG 组的总缓解率明显高于 iv.MP 组（90.2% vs 68.4%，P=0.000）。同样，TG 组患者的生活质量在 24 周时的缓解率也明显高于 iv.MP 组（89.02% vs 72.15%，P=0.001）。与 iv.MP 相比，TG 治疗的 CAS 反应更好（91.5% vs 70.9%改善，P<0.05），高达 91.2%的患者处于非活动状态。此外，TG 组在 24 周时复视、眼球突出、视力、软组织受累和眼外肌运动度改善的发生率明显高于 iv.MP 组。与 TG 组相比，iv.MP 组发生不良反应的患者明显更多。
与 iv.MP 治疗相比，TG 治疗活动期中重度 GO 患者更有效且更安全。
