Ophthalmology. 2020 Apr;127(4S):S5-S18. doi: 10.1016/j.ophtha.2020.01.037.
To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal keratitis.
The authors performed a randomized, double-masked, placebo-con- trolled, multicenter clinical trial of 106 patients with active herpes simplex stromal keratitis who had not received any corticosteroids for at least 10 days before study enrollment. Patients were assigned to the placebo group (n = 49) or the steroid group (topical prednisolone phosphate; n = 57); both regimens were tapered over 10 weeks. Both groups received topical trifluridine. Visual acuity assessment and slit-lamp biomicroscopy were performed weekly for 10 weeks, every other week for an additional 6 weeks or until removal from the trial, and at 6 months after randomization.
The time to treatment failure (defined by specific criteria as persistent or progressive stromal keratouveitis or an adverse event) was significantly longer in the steroid group compared with the placebo group. Compared with placebo, corticosteroid therapy reduced the risk of persistent or progressive stromal keratouveitis by 68%. The time from randomization to resolution of stromal keratitis and uveitis was significantly shorter in the steroid group compared with the placebo group even though both groups included patients who were removed from the study and treated with topical corticosteroids according to best medical judgment. Nineteen (33%) of the steroid-treated patients and 11 (22%) of the placebo-treated patients completed the 10 weeks of protocol therapy and had stable, noninflamed corneas after 16 weeks. At 6 months after randomization, no clinically or statistically significant differences in visual outcome or recurrent herpetic eye disease were identified between the steroid and placebo groups.
The topical corticosteroid regimen used in this study was significantly better than placebo in reducing persistence or progression of stromal inflammation and in shortening the duration of herpes simplex stromal keratitis. Postponing steroids during careful observation for a few weeks delayed resolution of stromal keratitis but had no detrimental effect as assessed by visual outcome at 6 months.
评估局部皮质类固醇治疗单纯疱疹性基质角膜炎的疗效。
作者对 106 例活动性单纯疱疹性基质角膜炎患者进行了一项随机、双盲、安慰剂对照、多中心临床试验，这些患者在研究入组前至少 10 天未接受任何皮质类固醇治疗。患者被分配到安慰剂组（n=49）或激素组（局部磷酸泼尼松龙；n=57）；两组方案均在 10 周内逐渐减少。两组均接受三氟尿嘧啶治疗。视力评估和裂隙灯生物显微镜检查每周进行 10 周，之后每两周进行一次，持续 6 周或直至退出试验，以及随机分组后 6 个月。
激素组治疗失败（根据具体标准定义为持续性或进行性基质角膜炎或不良事件）的时间明显长于安慰剂组。与安慰剂相比，皮质类固醇治疗将持续性或进行性基质角膜炎的风险降低了 68%。尽管两组均包括根据最佳医学判断退出研究并接受局部皮质类固醇治疗的患者，但激素组从随机分组到基质角膜炎和虹膜炎消退的时间明显短于安慰剂组。19 名（33%）接受激素治疗的患者和 11 名（22%）接受安慰剂治疗的患者完成了 10 周的方案治疗，在 16 周后角膜稳定，无炎症。随机分组后 6 个月，激素组和安慰剂组在视力结果或复发性疱疹性眼病方面无临床或统计学显著差异。
与安慰剂相比，本研究中使用的局部皮质类固醇方案在减少基质炎症的持续或进展以及缩短单纯疱疹性基质角膜炎的病程方面明显更好。在仔细观察数周后推迟使用类固醇会延迟基质角膜炎的消退，但在 6 个月时通过视力评估没有不利影响。
