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低剂量局部用丝裂霉素C治疗重度春季角结膜炎的随机试验

A randomized trial of low-dose, topical mitomycin-C in the treatment of severe vernal keratoconjunctivitis.

作者信息

Akpek E K, Hasiripi H, Christen W G, Kalayci D

机构信息

Ocular Immunology Service, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, USA.

出版信息

Ophthalmology. 2000 Feb;107(2):263-9. doi: 10.1016/s0161-6420(99)00096-2.

Abstract

OBJECTIVE

To evaluate the efficacy and safety of low-dose, topical mitomycin-C in patients with severe vernal keratoconjunctivitis.

DESIGN

Placebo-controlled, double-masked, randomized clinical trial.

PARTICIPANTS

Twenty-six patients with vernal keratoconjunctivitis refractory to combination of steroid and mast-cell stabilizer treatment.

INTERVENTION

Patients were randomly assigned (2:1) to treatment with topical 0.01% mitomycin-C eye drops (n = 17) or placebo (n = 9) three times daily for 2 weeks.

MAIN OUTCOME MEASURES

Symptoms (itching, tearing, photophobia, ropy mucous discharge, foreign body sensation) and signs (conjunctival hyperemia, epithelial punctate keratitis, Trantas' dots, limbal edema, and palpebral conjunctival giant papillae) of vernal keratoconjunctivitis recorded on the day of enrollment and at the end of the treatment period.

RESULTS

There was a statistically significant decrease in ropy mucous discharge, photophobia, conjunctival hyperemia, and limbal edema in the mitomycin-C treated group compared with the placebo group at the end of the 2-week treatment period. In addition, none of the 17 treated patients, but all 9 of the placebo patients, required medication during the 4-week posttreatment follow-up period. No adverse effects of treatment with mitomycin-C were observed.

CONCLUSIONS

Short-term, low-dose, topical mitomycin-C may be considered in the acute exacerbation periods of patients with severe vernal keratoconjunctivitis refractory to conventional treatment.

摘要

目的

评估低剂量局部应用丝裂霉素-C治疗重度春季角结膜炎患者的疗效和安全性。

设计

安慰剂对照、双盲、随机临床试验。

参与者

26例对类固醇和肥大细胞稳定剂联合治疗无效的春季角结膜炎患者。

干预措施

患者按2:1随机分组,分别接受局部应用0.01%丝裂霉素-C滴眼液治疗(n = 17)或安慰剂治疗(n = 9),每日3次,共2周。

主要观察指标

在入组当天和治疗期结束时记录春季角结膜炎的症状(瘙痒、流泪、畏光、丝状黏液分泌物、异物感)和体征(结膜充血、上皮点状角膜炎、Trantas点、角膜缘水肿和睑结膜巨大乳头)。

结果

在2周治疗期结束时,与安慰剂组相比,丝裂霉素-C治疗组的丝状黏液分泌物、畏光、结膜充血和角膜缘水肿有统计学意义的显著减少。此外,在4周的治疗后随访期内,17例接受治疗的患者均未需要用药,而9例安慰剂组患者均需要用药。未观察到丝裂霉素-C治疗的不良反应。

结论

对于传统治疗无效的重度春季角结膜炎患者的急性加重期,可考虑短期、低剂量局部应用丝裂霉素-C。

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