Subject(s)
Chorioretinitis , Toxoplasma , Toxoplasmosis, Ocular , Chorioretinitis/diagnosis , Chorioretinitis/drug therapy , Chorioretinitis/prevention & control , Humans , Toxoplasmosis, Ocular/diagnosis , Toxoplasmosis, Ocular/drug therapy , Trimethoprim, Sulfamethoxazole Drug Combination/therapeutic useABSTRACT
PURPOSE: To compare the effects of 1 year of treatment with trimethoprim-sulfamethoxazole (TMP-SMZ) vs placebo in reducing the risk of recurrence of toxoplasmic retinochoroiditis during a 6-year follow-up period. DESIGN: Randomized, double-masked clinical trial. METHODS: This cohort included 141 subjects recruited in Campinas, Brazil. The inclusion criterion was unilateral active recurrent toxoplasmic retinochoroiditis. All subjects were treated with 1 dose of TMP-SMZ (160 mg/800 mg) twice daily for 45 days, and all lesions healed after this treatment. After this initial treatment, subjects were randomly assigned to group 1 (1 TMP-SMZ dose every other day for 311 days) or group 2 (1 identical placebo tablet containing starch with no active ingredients every other day for 311 days). Between the second and sixth years of follow-up appointments, none of the subjects received treatment unless a new recurrence episode had occurred. The primary outcomes were recurrent toxoplasmic retinochoroiditis within the first year of follow-up and recurrent toxoplasmic retinochoroiditis in the 6 years of follow-up. RESULTS: The cumulative probability of recurrence 1, 2, 3, 4, 5, and 6 years after the initial infection was, respectively, 13.0% (9/69), 17.4% (12/69), 20.3% (14/69), 23.2% (16/69), 26.1% (18/69), and 27.5% (19/69) in the placebo group and 0%, 0%, 0%, 0%, 0%, and 1.4% (1/72) in the TMP-SMZ group (P < .001; log-rank test). There were 3 cases (3/69; 4.3%) of multiple recurrences in the same individual in the placebo group. No treatment-limiting toxicity or side effects were observed in either group. New recurrences were more frequent among female subjects. CONCLUSIONS: TMP-SMZ may be used safely for prophylaxis of recurrent toxoplasmic retinochoroiditis and may provide long-term benefits.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Chorioretinitis/prevention & control , Eye Infections, Parasitic/prevention & control , Toxoplasmosis, Ocular/prevention & control , Trimethoprim, Sulfamethoxazole Drug Combination/therapeutic use , Adult , Chorioretinitis/diagnosis , Chorioretinitis/parasitology , Double-Blind Method , Eye Infections, Parasitic/diagnosis , Eye Infections, Parasitic/parasitology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Recurrence , Secondary Prevention , Toxoplasmosis, Ocular/diagnosis , Toxoplasmosis, Ocular/parasitology , Visual Acuity/physiology , Young AdultABSTRACT
PURPOSE: To compare the effects of 1 year of treatment with trimethoprim/sulfamethoxazole (TMP-SMZ) vs a placebo in reducing the risk of toxoplasmic retinochoroiditis recurrences during a 3-year follow-up period. DESIGN: Randomized, double-masked clinical trial. METHODS: This cohort included 141 volunteers recruited in Campinas, Brazil. Inclusion criterion was unilateral active recurrent toxoplasmic retinochoroiditis. All volunteers were treated with 1 tablet of TMP-SMZ (160 mg/800 mg) twice daily for 45 days, and all lesions healed after this treatment. After this initial treatment, the volunteers were randomly assigned to Group 1 (1 TMP-SMZ tablet every 2 days for 311 days) or Group 2 (1 identical placebo tablet containing starch with no active ingredients every 2 days for 311 days). At the second- and third-year follow-up appointments, none of the volunteers received treatment unless a new recurrence episode had occurred. The primary outcomes were recurrent toxoplasmic retinochoroiditis within the first year of follow-up and recurrent toxoplasmic retinochoroiditis within the third year of follow-up. RESULTS: The cumulative probability of recurrence at 1, 2, and 3 years of follow-up were, respectively, 13.0% (9/69), 17.4% (12/69), and 20.3% (14/69) in the placebo group and 0% (0/72) in the TMP-SMZ group (P < .001, log-rank test). There was no case of multiple recurrences in the same individual. No treatment-limiting toxicity or side effects were observed in either group. New recurrences were more frequent among female volunteers. CONCLUSIONS: TMP-SMZ may be used safely for prophylaxis of recurrent toxoplasmic retinochoroiditis, with long-term benefits.
