Qian Yujing, Qu Yi, Gao Fei, Pei Minghang, Liang Anyi, Xiao Junyan, Zhao Chan, Zhang Meifen
Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Ophthalmology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Front Pharmacol. 2021 Jul 19;12:699903. doi: 10.3389/fphar.2021.699903. eCollection 2021.
To evaluate and compare the efficacy and safety of interferon alpha-2a (IFN-α2a) and cyclosporine-A (CsA) in patients with refractory Behçet's uveitis (BU). In this 12-month randomized, controlled, prospective trial, 26 participants (44 eyes) completed the study. Patients were randomly allocated to the IFN-α2a or CsA groups. All patients in both groups received a standardized prednisone burst and tapering schedule as per protocol. The primary outcome measures were response rate, complete remission rate, and tolerance rate. The secondary outcome measures included time to achieve complete remission, the logarithm of the minimum angle of resolution (logMAR) of best-corrected visual acuity (BCVA), and Behçet's disease ocular attack score 24 (BOS24). T-tests and non-parametric tests were used to compare quantitative variables, and chi-square tests were performed to compare qualitative variables. The response and complete remission rates were 85.7% (12/14 patients) and 50.0% (7/14 patients) in the IFN-α2a group, compared with 66.7% (8/12 patients) and 25.0% (3/12 patients) in the CsA group, respectively ( > 0.05). Complete remission was achieved at 3.3 and 7.0 months after initiation of IFN-α2a and CsA ( = 0.023). LogMAR BCVA significantly improved 1 month after IFN-α2a initiation (23 eyes) ( = 0.002), and this beneficial effect remained statistically significant during the entire follow-up period ( < 0.05); however, this improvement was not observed in the CsA group (21 eyes). At the endpoint, LogMAR BCVA in the IFN-α2a group was significantly better (0.22 vs. 0.31, = 0.031) with a higher improvement rate (60.9 vs. 47.6%, > 0.05). Moreover, compared to the CsA group, more eyes in the IFN-α2a group had a lower BOS24 score (87.0 vs. 57.1%, = 0.042). None of the patients had any side effects that influenced the medication adherence. Compared to CsA plus corticosteroid, IFN-α2a plus corticosteroid appears to induce a better treatment response, a significantly greater improvement in visual acuity, and more stable remission of intraocular inflammation in a 12-month study period.
评估并比较干扰素α-2a（IFN-α2a）和环孢素A（CsA）治疗难治性白塞氏葡萄膜炎（BU）患者的疗效和安全性。在这项为期12个月的随机、对照、前瞻性试验中，26名参与者（44只眼）完成了研究。患者被随机分配到IFN-α2a组或CsA组。两组所有患者均按照方案接受标准化的泼尼松冲击和减量方案。主要结局指标为缓解率、完全缓解率和耐受率。次要结局指标包括达到完全缓解的时间、最佳矫正视力（BCVA）的最小分辨角对数（logMAR）以及白塞病眼部发作评分24（BOS24）。采用t检验和非参数检验比较定量变量，采用卡方检验比较定性变量。IFN-α2a组的缓解率和完全缓解率分别为85.7%（12/14例患者）和50.0%（7/14例患者），而CsA组分别为66.7%（8/12例患者）和25.0%（3/12例患者）（P>0.05）。IFN-α2a和CsA治疗开始后3.3个月和7.0个月达到完全缓解（P=0.023）。IFN-α2a治疗开始1个月后，23只眼的logMAR BCVA显著改善（P=0.002），且在整个随访期间这种有益效果在统计学上仍显著（P<0.05）；然而，CsA组（21只眼）未观察到这种改善。在终点时，IFN-α2a组的logMAR BCVA显著更好（0.22对0.31，P=0.031），改善率更高（60.9%对47.6%，P>0.05）。此外，与CsA组相比，IFN-α2a组更多的眼BOS24评分更低（87.0%对57.1%，P=0.042）。没有患者出现影响药物依从性的任何副作用。在为期12个月的研究期内，与CsA加皮质类固醇相比，IFN-α2a加皮质类固醇似乎能诱导更好的治疗反应、视力显著改善以及眼内炎症缓解更稳定。
