奈多罗米钠滴眼液在春季角结膜炎的长期治疗中比色甘酸钠滴眼液更有效。

Nedocromil sodium eye drops are more effective than sodium cromoglycate eye drops for the long-term management of vernal keratoconjunctivitis.

作者信息

Verin P H, Dicker I D, Mortemousque B

机构信息

Centre Abadie, Bordeaux, France.

出版信息

Clin Exp Allergy. 1999 Apr;29(4):529-36. doi: 10.1046/j.1365-2222.1999.00501.x.

DOI:10.1046/j.1365-2222.1999.00501.x

PMID:10202368

Abstract

BACKGROUND

Vernal keratoconjunctivitis (VKC) is a severe though transient form of ocular allergy, predominant in young males, which requires careful management. Corticosteroids are effective but also cause serious topical side-effects in the eye, such as glaucoma and cataracts. The safer, mast cell stabilizing anti-inflammatories (commonly sodium cromoglycate) therefore have an important role. This parallel group study compared efficacy, tolerability and safety of sodium cromoglycate 2% with nedocromil sodium 2%, administered as one drop per eye four times daily for a period of 5 months.

METHODS

Children aged 4-17 years, with a diagnosis of mostly limbal VKC in the last 12 months, entered a 2-week baseline during which they used only artificial tears, and were then randomized to treatment, in groups of 18, on an investigator single-masked basis. Daily symptom diary cards were kept by patients/guardians, and VKC was assessed by the clinician at approximately monthly intervals. Dexamethasone was provided for rescue control of severe symptoms, if needed.

RESULTS

A total of 34 patients completed the study. Both trial treatments produced rapid improvements and many ocular signs and symptoms, including Trantas' dots, chemosis, itching, soreness and sticky discharge, were fully controlled by the end of the study. However, nedocromil sodium took effect more quickly, with a significant reduction compared to sodium cromoglycate for itching, grittiness, hyperaemia and keratitis within 6 weeks. In addition, nedocromil sodium was the more efficacious overall (significant vs sodium cromoglycate for hyperaemia, keratitis, papillae and pannus at 22 weeks). Both treatments were well tolerated and without serious adverse effects. Final opinions favoured nedocromil sodium, with full control of VKC recorded for 94% (patient opinion) and 100% (clinician opinion) of this treatment group, compared with 29% and 0%, respectively, in the sodium cromoglycate group.

CONCLUSIONS

Nedocromil sodium 2% eye drops is significantly more effective than sodium cromoglycate for treatment of VKC.

摘要

背景

春季角结膜炎（VKC）是一种严重但短暂的眼部过敏形式，主要发生在年轻男性中，需要谨慎管理。皮质类固醇有效，但也会在眼部引起严重的局部副作用，如青光眼和白内障。因此，更安全的肥大细胞稳定剂（通常为色甘酸钠）具有重要作用。这项平行组研究比较了2%色甘酸钠与2%奈多罗米钠的疗效、耐受性和安全性，两种药物均每日4次，每眼滴1滴，持续5个月。

方法

年龄在4至17岁之间、在过去12个月中大多被诊断为角膜缘型VKC的儿童进入为期2周的基线期，在此期间他们仅使用人工泪液，然后在研究者单盲的基础上，以每组18人的方式随机分组接受治疗。患者/监护人每天填写症状日记卡，临床医生大约每月评估一次VKC情况。如有需要，可提供地塞米松用于严重症状的抢救控制。

结果

共有34名患者完成了研究。两种试验治疗均使症状迅速改善，到研究结束时，许多眼部体征和症状，包括特兰塔小点、球结膜水肿、瘙痒、疼痛和粘性分泌物，均得到完全控制。然而，奈多罗米钠起效更快，在6周内，与色甘酸钠相比，其瘙痒、异物感、充血和角膜炎症状显著减轻。此外，总体而言奈多罗米钠更有效（在22周时，与色甘酸钠相比，其充血、角膜炎、乳头和血管翳症状有显著差异）。两种治疗耐受性均良好，且无严重不良反应。最终意见倾向于奈多罗米钠，该治疗组中94%（患者意见）和100%（临床医生意见）的患者VKC得到完全控制，而色甘酸钠组分别为29%和0%。