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O RI G I N A L A R T I C L E
RESUMO
ABSTRACT
Purpose: 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.
Methods: 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.
Results: 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.
Conclusions: 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
INTRODUO
A infeco ocular adenoviral um processo infeccioso autolimitado, altamente contagioso e muito frequente, podendo ocorrer
em surtos epidmicos(1-3). Pode se apresentar de trs formas clnicas
agudas: conjuntivite folicular aguda inespecfica, febre faringoconjuntival e ceratoconjuntivite epidmica(4,5) . O paciente tem
queixas de ardncia, dor, fotofobia, prurido, irritao e lacrimejamento(1-3). Na fase aguda da doena, observa-se em intensidades
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USO
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0,15%
418
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E T AL .
Tabela 1. Caractersticas dos pacientes antes do tratamento, expressos em mdia desvio padro ou em porcentual quando indicado
Idade
Sexo (% Masculino)
Cor (% Branco; Pardo; Negro)
Dias de sintomas
Lateralidade (% Unilateral)
Ardncia
Dor
Prurido
Fotofobia
Lacrimejamento
Secreo
Sensao de areia
Adenopatia (% Presena)
Edema
Quemose
Hiperemia
Hiposfagma
Petquias
Folculos
Infiltrados
Ceratite puntata
Pseudomembranas
Membranas
Todos (n=33)
Tratamento (n=19)
Controle (n=14)
31,23 10,30
33,3%
64,5%; 25,8%; 9,7%
2,18 1,26
51,5%
2,09 0,91
0,97 0,98
1,88 1,27
1,67 1,16
2,36 0,86
1,45 1,06
2,16 1,11
12,1%
1,18 1,07
0,21 0,55
1,61 0,61
0,12 0,33
1,76 0,83
0,33 0,48
-
30,78 12,28
26,3%
77,8%; 16,7%; 5,6%
1,89 0,87
47,4%
2,11 0,94
1,05 0,85
2,16 1,21
1,53 1,22
2,32 0,89
1,26 1,09
2,00 1,08
15,8%
1,00 0,88
0,26 0,65
1,63 0,59
0,11 0,32
1,63 0,76
0,42 0,51
-
31,84 8,84
42,9%
46,2%; 38,5%; 15,4%
2,57 1,60
57,1%
2,07 0,92
0,86 1,17
1,50 1,29
1,86 1,10
2,43 0,85
1,71 0,99
2,36 1,15
7,1%
1,43 1,28
0,14 0,36
1,57 0,65
0,14 0,36
1,93 0,92
0,21 0,43
-
0,79
0,32
0,07
0,32
0,58
0,87
0,33
0,13
0,43
0,70
0,19
0,23
0,45
0,36
0,81
1,00
0,74
0,24
0,22
-
Tabela 2. Resultados das graduaes dos sinais e sintomas em cada grupo, expressos em mdia desvio padro
Apresentao
Grupo tratamento
D6 (n=19)
D10 (n=14)
Apresentao
Grupo controle
D6 (n=14)
D10 (n=13)
2,11 0,94
1,05 0,85
2,16 1,21
1,53 1,22
2,32 0,89
1,26 1,09
2,00 1,08
1,00 0,88
0,26 0,65
1,63 0,59
0
0,11 0,32
1,63 0,76
0
0,42 0,51
0
0
0
1,11 1,10
0,26 0,56
0,63 1,01
0,79 1,08
0,68 1,16
0,42 0,51
0,37 0,76
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
0,79 1,19
0,21 0,58
0,79 1,12
0,64 1,01
0,57 1,02
0,43 0,85
0,14 0,36
0,14 0,53
0
0,14 0,36
0,14 0,53
0,07 0,27
0,71 0,73
0
0,21 0,43
0,07 0,27
0
0,07 0,27
2,07 0,92
0,86 1,17
1,50 1,29
1,86 1,10
2,43 0,85
1,71 0,99
2,36 1,15
1,43 1,28
0,14 0,36
1,57 0,65
0
0,14 0,36
1,93 0,92
0
0,21 0,43
0
0
0
0,57 0,94
0,21 0,43
1,14 0,95
1,07 1,00
0,86 1,03
0,64 0,84
0,43 0,94
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
0,58 0,90
0,08 0,29
0,75 0,87
0,92 0,90
0,25 0,62
0,17 0,39
0
0,23 0,44
0
0,31 0,48
0
0,08 0,28
0,92 0,76
0
0,23 0,44
0
0,08 0,28
0
Ardncia
Dor
Prurido
Fotofobia
Lacrimejamento
Secreo
Sensao de areia
Edema
Quemose
Hiperemia
Hiposfagma
Petquias
Folculos
Infiltrados
Ceratite puntata
Pseudomembranas
Membranas
Opacidade corneana
Os smbolos () e () indicam significncia estatstica entre a apresentao e o 6 dia de tratamento e entre a apresentao e o 10 dia, respectivamente
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