Mimura Osamu, Ishikawa Hitoshi, Kezuka Takeshi, Shikishima Keigo, Suzuki Tone, Nakamura Makoto, Chuman Hideki, Inoue Kenji, Kimura Akiko, Yamagami Akiko, Mihoya Maki, Nakao Yuzo
Department of Ophthalmology, Hyogo College of Medicine, Nishinomiya, Japan.
Department of Orthoptics and Visual Science, School of Allied Health Sciences, Kitasato University, Sagamihara, Japan.
Jpn J Ophthalmol. 2021 Jan;65(1):122-132. doi: 10.1007/s10384-020-00790-9. Epub 2021 Jan 20.
To evaluate the efficacy and safety of intravenous "freeze-dried sulfonated human normal immunoglobulin (GGS)" in patients with steroid-resistant optic neuritis (ON).
Multicenter, prospective, double-blind, parallel-group, randomized controlled trial.
Patients with steroid-resistant acute ON were randomly assigned to receive either intravenous GGS (GGS group) or intravenous methylprednisolone (steroid pulse [SP] group). Visual acuity (logarithm of the minimum angle of resolution [logMAR]), mean deviation (MD) value of the Humphrey Field Analyzer, and critical flicker fusion frequency were measured as efficacy endpoints; adverse events (AEs) were assessed as the safety endpoint.
Thirty-two patients (16 patients/group) received the study drugs. The primary endpoint, change in logMAR at week 2 compared to baseline, showed no statistically significant intergroup difference. However, compared with the SP group, change in the GGS group was increasingly indicative of visual improvement, with least squares mean difference of > 0.3 logMAR. On post-hoc analyses, the percentage of patients in the GGS and SP groups with improvement by ≥ 0.3 logMAR at week 2 were 75.0% and 31.3%, respectively. Changes in MD values at week 2 compared to baseline were 9.258 ± 8.296 (mean ± standard deviation) dB and 3.175 ± 6.167 dB in the GGS and SP groups, respectively. These results showed statistically significant intergroup differences (visual acuity improvement, P = 0.032; change in MD values, P = 0.030). No clinically significant AEs were observed.
Our results suggest that intravenous immunoglobulin could be a safe and efficacious therapeutic option for prompt treatment of steroid-resistant acute ON.
JapicCTI-132080.
评估静脉注射“冻干磺化人正常免疫球蛋白（GGS）”治疗激素抵抗性视神经炎（ON）患者的疗效和安全性。
多中心、前瞻性、双盲、平行组、随机对照试验。
将激素抵抗性急性视神经炎患者随机分为两组，分别接受静脉注射GGS（GGS组）或静脉注射甲泼尼龙（激素冲击[SP]组）。测量视力（最小分辨角对数[logMAR]）、Humphrey视野分析仪的平均偏差（MD）值和临界闪烁融合频率作为疗效终点；评估不良事件（AE）作为安全终点。
32例患者（每组16例）接受了研究药物治疗。主要终点，即第2周时logMAR相对于基线的变化，组间差异无统计学意义。然而，与SP组相比，GGS组的变化越来越显示出视力改善，最小二乘平均差异>0.3 logMAR。事后分析显示，第2周时GGS组和SP组中logMAR改善≥0.3的患者百分比分别为75.0%和31.3%。第2周时，GGS组和SP组相对于基线的MD值变化分别为9.258±8.296（平均值±标准差）dB和3.175±6.167 dB。这些结果显示组间差异有统计学意义（视力改善，P = 0.032；MD值变化，P = 0.030）。未观察到具有临床意义的不良事件。
我们的结果表明，静脉注射免疫球蛋白可能是迅速治疗激素抵抗性急性视神经炎的一种安全有效的治疗选择。
JapicCTI-132080。
