Purpose To evaluate the role of topical cyclosporine A 1% (CsA) as an adjuvant therapy in patients with acute Stevens-Johnson syndrome (SJS). Methods This is a randomised controlled trial in which 44 patients (88 eyes) with acute SJS, presenting within 3 months from the onset of the disease, were enrolled and randomised. Group A (n=44 eyes) patients received treatment with topical CsA 1% along with standard therapy consisting of topical corticosteroids, antibiotics and lubricants. Group B (n=44 eyes) patients received topical saline drops in combination with standard therapy. Various ocular surface parameters were assessed at baseline and the 6-month follow-up. Results The mean age of patients (years) was 23.9±15.1 in the CsA group and 26.0±18.7 in the control group (p=0.6840). The mean time from disease onset to presentation (days) was 17.0±14.0 and 12.9±11.3 in CsA and control groups, respectively (p=0.1568). At presentation, the mean grades of severity scores of various parameters were comparable. At 6 months, both groups showed a significant improvement in the mean severity grades of conjunctival hyperaemia (A, p=0.001; B, p=0.0001), mucocutaneous junction involvement (A, p=0.001; B, p=0.0001) and meibomian gland involvement (A, p=0.0471; B, p=0.006). Compared with baseline, the grades of corneal keratinisation (baseline, 0.48±0.7; 6 months, 1.02±0.8; p=0.0015) and neovascularisation (baseline, 1.07±1.2; 6 months, 1.57±1.0; p=0.0412) worsened after 6 months of CsA therapy. Intergroup comparison of grades of various parameters however did not reveal any significant difference at 6 months. Conclusions Adjuvant treatment with topical CsA is not superior to standard therapy, in cases of acute SJS. Data are available upon reasonable request. Data are available upon request.

中文翻译：

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外用 1% 环孢菌素在急性 Stevens-Johnson 综合征中的辅助作用评价：一项随机对照试验


目的 评价局部环孢素 A 1% （CsA） 作为急性 Stevens-Johnson 综合征 （SJS） 患者辅助治疗的作用。方法 这是一项随机对照试验，其中 44 例 （88 只眼） 急性 SJS 患者 （88 只眼） 在疾病发作后 3 个月内出现，被纳入并随机分组。A 组 （n=44 眼） 患者接受局部 CsA 1% 治疗以及由局部皮质类固醇、抗生素和润滑剂组成的标准治疗。B 组 （n=44 眼） 患者接受局部生理盐水滴剂联合标准治疗。在基线和 6 个月随访时评估各种眼表参数。结果 CsA 组患者平均年龄 （岁） 为 23.9±15.1 岁，对照组为 26.0±18.7 岁 （p=0.6840）。CsA 组和对照组从发病到就诊的平均时间 （天） 分别为 17.0±14.0 和 12.9±11.3 （p=0.1568）。在就诊时，各种参数的严重程度评分的平均等级具有可比性。6 个月时，两组结膜充血的平均严重程度等级均显著改善 （A，p=0.001;B，p=0.0001）、皮肤粘膜交界处受累 （A，p=0.001;B，p=0.0001）和睑板腺受累 （A，p=0.0471;B，p=0.006）。与基线相比，环孢素A 治疗 6 个月后角膜角化分级 （基线，0.48±0.7;6 个月，1.02±0.8;p=0.0015） 和新生血管形成 （基线，1.07±1.2;6 个月，1.57±1.0;p=0.0412） 恶化。然而，各种参数等级的组间比较在 6 个月时未显示任何显着差异。结论 在急性 SJS 病例中，局部 CsA 辅助治疗并不优于标准治疗。数据可根据合理要求提供。 可根据要求提供数据。