[Clinical assessment of oral ganciclovir capsules on the treatment of herpes simplex keratitis].

Objective: To evaluate the clinical values of oral ganciclovir on the treatment of herpes simplex keratitis (HSK).

Methods: A randomized, controlled, single-blind and prospective study was carried out from May in 2008 to June in 2009 at Department of Ophthalmology, Eye Ear Nose and Throat Hospital of Fudan University. 60 patients (60 eyes) with HSK, including stromal keratitis and corneal endotheliitis, were enrolled in the study and were randomly arranged into two groups in average. Oral ganciclovir was orally administered 1000 mg 3 times per day for 8 weeks, 0.15% ganciclovir ophthalmic gel, 4 times per day, and 0.1% fluorometholone eye drops, 3 times per day, in the test group, meanwhile, the control group was adopted the same ophthalmic gel and eye drops without the oral capsules. The symptoms and signs were evaluated before and after the therapy 1st week, 2nd week, 4th week, 6th week and 8th day respectively with the side effects observed.

Results: There was no significant difference between the control and test group in the mean scores of symptoms (control 10.70 ± 3.61, test 11.87 ± 3.47) and signs (control 13.83 ± 3.74, test 15.27 ± 3.83) respectively before the treatment (Z = -1.269 and -1.419; P > 0.05). After the administration, the total scores of symptoms and signs in the test group were 8.37 ± 4.31, 2.70 ± 2.65, 0.70 ± 1.44, 0.33 ± 0.92 and 0.17 ± 0.65 respectively at each follow-up time point, which were obviously lower than those in the control group, 13.63 ± 7.64, 10.53 ± 7.18, 7.83 ± 6.49, 5.37 ± 5.33 and 4.37 ± 5.11 respectively (Z = -2.801, -4.895, -5.260, -4.758, and -4.292; P < 0. 05). The efficacy rates in the test group were all 100.0% after the administration, but those in the control group were 50.0%, 73.3%, 86.7%, 93.3% and 96.6%. Furthermore, the cure rates in the test group were 0.0%, 36.7%, 76.7%, 90.0% and 93.3% respectively at each follow-up time point, which were significantly higher than those in the control group with 0.0%, 3.3%, 16.7%, 30.0% and 43.3% respectively (χ(2) = 20.00, 16.433, 22.571, 22.636 and 17.330; P < 0. 001). There was no obvious discomfortableness and adverse reaction observed in the test group. Unfortunately, 5 patients in the control group and 3 patients in the test group underwent the recurrence of HSK after the course of treatment, but there was no significant difference between the groups in the recurrence rate.

Conclusions: Oral ganciclovir can effectively assist to relieve the symptoms and signs and shorten the pathogenesis of herpes simplex stromal keratitis and corneal endotheliitis. And short-term oral ganciclovir has confirmed good safety.