Yabiku Simone Tiemi, Yabiku Mariann Midori, Bottós Kátia Mantovani, Araújo Aline Lutz, Freitas Denise de, Belfort Rubens
Departamento de Oftalmologia, Universidade Federal de São Paulo -UNIFESP - São Paulo (SP), Brazil.
Arq Bras Oftalmol. 2011 Nov-Dec;74(6):417-21. doi: 10.1590/s0004-27492011000600007.
To evaluate the efficacy and the toxicity of 0.15% ganciclovir gel in the treatment of adenoviral conjunctivitis and in preventing ocular complications after adenoviral conjunctivitis, such as corneal infiltrates and pseudomembranes.
Double blind, interventional and randomized clinical trial. Thirty-three patients with clinical diagnosis of adenoviral conjunctivitis with onset of symptoms for five or less days were randomized in two groups: Group 1 (treatment) with 19 patients used ganciclovir gel and Group 2 (control) with 14 patients used artificial tears without preservative. Patients answered a questionnaire of signs and symptoms and were submitted to an ophthalmologic exam. On the 6th and 10th days of treatment they answered the same questions and were re-examined by the same ophthalmologist. Signs and symptoms were compared. T Student, Mann-Whitney e Wilcoxon tests were used to statistical analysis.
Trend of better response in the treatment group in relation of patients' perception, besides faster improvement of this group compared to the control group (p=0.26). There were lower transmission to the fellow eye (p=0.86) and to people living together (p=0.16) in the treatment group. No statistical difference related to signs and symptoms of conjunctivitis were found comparing both groups. We observed statistical difference in pain, itch and photophobia only in the treatment group, comparing each group alone. No toxicity and more tolerance of the ganciclovir were observed. There was no statistical difference in the ocular complications after conjunctivitis between both groups.
This study showed trend of better and faster response of the signs and symptoms of the patients treated with ganciclovir compared with the control group, but with no statistical significant. These results need to be confirmed by additional studies, with more patients and longer follow-up. Clinical Trails.gov: NCT01349452.
评估0.15%更昔洛韦凝胶治疗腺病毒性结膜炎以及预防腺病毒性结膜炎后眼部并发症（如角膜浸润和假膜）的疗效和毒性。
双盲、干预性随机临床试验。33例临床诊断为腺病毒性结膜炎且症状出现5天及以内的患者被随机分为两组：第1组（治疗组）19例患者使用更昔洛韦凝胶，第2组（对照组）14例患者使用无防腐剂的人工泪液。患者回答症状和体征问卷，并接受眼科检查。在治疗的第6天和第10天，他们回答相同问题，并由同一位眼科医生再次检查。比较症状和体征。采用t检验、曼-惠特尼检验和威尔科克森检验进行统计学分析。
与对照组相比，治疗组患者自我感觉好转趋势更明显，且改善速度更快（p = 0.26）。治疗组中患眼向对侧眼的传播率较低（p = 0.86），向同住者的传播率也较低（p = 0.16）。两组在结膜炎症状和体征方面未发现统计学差异。仅在治疗组中，单独比较每组时，疼痛、瘙痒和畏光方面存在统计学差异。未观察到更昔洛韦的毒性，且耐受性更好。两组在结膜炎后眼部并发症方面无统计学差异。
本研究表明，与对照组相比，使用更昔洛韦治疗的患者症状和体征有更好、更快的改善趋势，但无统计学显著性差异。这些结果需要通过更多患者和更长随访时间的进一步研究来证实。Clinical Trails.gov：NCT01349452。
