Brown R S, Di Stanislao P T, Beaver W T, Bottomley W K
Department of Oral Diagnostic Sciences, University of Texas Health Science Center, Houston.
Oral Surg Oral Med Oral Pathol. 1991 May;71(5):565-8. doi: 10.1016/0030-4220(91)90363-h.
Twenty severely retarded institutionalized epileptic adults with phenytoin-induced gingival hyperplasia were divided into two groups and received a daily 3 mg capsule of either folic acid or lactose for 16 weeks in a randomized, double-blind, parallel study. Serum folate and phenytoin levels were recorded at baseline and on completion of the study. Twelve areas of the gingiva on each patient were graded at 4-week intervals for 16 weeks with respect to the three indexes: hyperplasia, gingival health, and plaque index. There were no significant differences between treatment groups for any of the three indexes over time. The poststudy serum folate levels were three times baseline levels for the active drug group (p less than 0.001) but unchanged in the placebo group. Phenytoin blood levels that began within the therapeutic window (10 to 20 micrograms/ml) tended to remain within the therapeutic window for both groups, with no reported seizure activity. A single daily oral 3 mg capsule of folic acid did not show efficacy as the sole therapeutic agent in the reduction of phenytoin-induced gingival hyperplasia.
在一项随机、双盲、平行研究中，20名患有苯妥英钠所致牙龈增生的重度智障成年癫痫患者被分为两组，分别每日服用3毫克叶酸胶囊或乳糖胶囊，为期16周。在基线期和研究结束时记录血清叶酸和苯妥英钠水平。在16周内，每隔4周对每位患者牙龈的12个部位就增生、牙龈健康和菌斑指数这三个指标进行分级。随着时间推移，治疗组在这三个指标中的任何一个方面均无显著差异。研究结束后，活性药物组的血清叶酸水平是基线水平的三倍（p小于0.001），而安慰剂组则无变化。两组开始时处于治疗窗（10至20微克/毫升）内的苯妥英钠血药浓度均倾向于保持在治疗窗内，且均未报告有癫痫发作活动。每日单次口服3毫克叶酸胶囊作为单一治疗药物，在减轻苯妥英钠所致牙龈增生方面未显示出疗效。
