State University of Campinas (UNICAMP), Campinas, Brazil.
State University of Campinas (UNICAMP), Campinas, Brazil; Federal University of Pernambuco (UFPE), Recife, Brazil.
Am J Ophthalmol. 2020 May;213:195-202. doi: 10.1016/j.ajo.2019.12.025. Epub 2020 Jan 9.
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.
Randomized, double-masked clinical trial.
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.
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.
TMP-SMZ may be used safely for prophylaxis of recurrent toxoplasmic retinochoroiditis and may provide long-term benefits.
比较 1 年的甲氧苄啶-磺胺甲噁唑（TMP-SMZ）治疗与安慰剂在 6 年随访期间降低弓形虫性视网膜炎复发风险的效果。
随机、双盲临床试验。
本队列纳入了巴西坎皮纳斯招募的 141 名受试者。纳入标准为单侧活动性复发性弓形虫性视网膜炎。所有受试者均接受 1 剂 TMP-SMZ（160mg/800mg），每日 2 次，共 45 天，所有病变均在治疗后愈合。在初始治疗后，受试者被随机分为第 1 组（1 剂 TMP-SMZ 每隔 1 天服用 311 天）或第 2 组（1 片含有无活性成分淀粉的相同安慰剂每隔 1 天服用 311 天）。在第二次至第六年的随访期间，除非出现新的复发，否则所有受试者均未接受治疗。主要结局为随访第 1 年和第 6 年的复发性弓形虫性视网膜炎。
初次感染后第 1、2、3、4、5 和 6 年的累积复发概率分别为安慰剂组 13.0%（9/69）、17.4%（12/69）、20.3%（14/69）、23.2%（16/69）、26.1%（18/69）和 27.5%（19/69），TMP-SMZ 组为 0%、0%、0%、0%、0%和 1.4%（1/72）（P<0.001；对数秩检验）。安慰剂组中有 3 例（3/69；4.3%）同一患者出现多次复发。两组均未观察到治疗相关的毒性或不良反应。女性患者的新发复发更为频繁。
TMP-SMZ 可安全用于预防复发性弓形虫性视网膜炎，并可提供长期获益。
