38%局部外用氨银氟化溶液在健康成年志愿者中的药代动力学。
Pharmacokinetics of 38% topical silver diamine fluoride in healthy adult volunteers.
出版信息
J Am Dent Assoc. 2019 Mar;150(3):186-192. doi: 10.1016/j.adaj.2018.10.018.
BACKGROUND
Silver diamine fluoride (SDF) is used topically to prevent or arrest caries. The authors' aim was to characterize the kinetics of silver and fluoride after topical application of SDF.
METHODS
Sixteen adults participated in a pharmacokinetics study after the application of 38% SDF to 5 teeth (approximately 50 microliters, estimated 4-11 milligrams per participant). Serum and urine samples were collected over 24 hours after application and were analyzed for silver and fluoride.
RESULTS
Silver serum peak was 0.67 (standard deviation [SD], 0.49) nanograms per milliliter; median time to peak was 3 hours. The estimated elimination half-life of silver was 46 (SD, 26) hours. No silver was recovered in urine. Baseline fluoride serum levels ranged from less than 10 through 50 ng/mL (< 0.01-0.05 parts per million) and fluctuated around baseline after SDF. The 24-hour urinary fluoride was 1.29 (SD, 0.81) mg.
CONCLUSIONS
SDF was well tolerated in this study, and no adverse events related to SDF were reported.
PRACTICAL IMPLICATIONS
This clinical study confirmed that topical application of 38% SDF, in growing use in the United States, is safe and well tolerated in healthy adults.
背景
银氟化物（SDF）被局部用于预防或控制龋齿。作者的目的是描述 SDF 局部应用后银和氟化物的动力学。
方法
16 名成年人在 5 颗牙齿上应用 38% SDF（约 50 微升，估计每位参与者 4-11 毫克）后参加了一项药代动力学研究。应用后 24 小时内采集血清和尿液样本，并分析银和氟化物。
结果
血清中银的峰值为 0.67（标准差 [SD]，0.49）纳克/毫升；中位数达峰时间为 3 小时。银的估计消除半衰期为 46（SD，26）小时。尿液中未回收银。氟化物血清基线水平范围从低于 10 到 50ng/ml（<0.01-0.05 百万分之一），SDF 后围绕基线波动。24 小时尿氟化物为 1.29（SD，0.81）毫克。
结论
本研究中 SDF 耐受性良好，未报告与 SDF 相关的不良事件。
实际意义
这项临床研究证实，在美国越来越多地使用的 38% SDF 的局部应用是安全的，在健康成年人中耐受性良好。
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