Articaine hydrochloride: a study of the safety of a new amide local anesthetic
Articaine hydrochloride: a study of the safety of a new amide local anesthetic
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DOI：
10.14219/jada.archive.2001.0152
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发表时间：
2001-02-01
影响因子：
3.9
通讯作者：
Leblanc, D
中科院分区：
文献类型：
--
作者：
Malamed, SF;Gagnon, S;Leblanc, D
背景阿替卡因是一种酰胺类局部麻醉剂，1976年在德国引入临床，随后在欧洲、加拿大和2000年在美国引入临床。作者报告了3项相同的单次给药、随机、双盲、平行组、活性对照多中心研究，这些研究旨在比较阿替卡因（4%与肾上腺素1：100，000）与利多卡因（2%与肾上腺素1：100，000）的安全性和有效性。共有1，325例受试者参与这些研究，其中882例接受4%阿替卡因与肾上腺素1：100，000。在联合研究中，阿替卡因组和利多卡因组的不良事件总发生率分别为22%和20%。阿替卡因组最常报告的不良事件（不包括术后牙痛）为头痛（4%）、面部水肿、感染、牙龈炎和感觉异常（各1%）。这些事件的发生率与接受利多卡因的受试者报告的发生率相似。最常报告的与阿替卡因使用相关的不良事件为感觉异常（0.9%）、感觉减退（0.7%）、头痛（0.55%）、感染（0.45%）、皮疹和疼痛（各0.3%）。阿替卡因是一种耐受性良好、安全有效的局部麻醉剂，可用于临床牙科。
Background. Articaine is an amide local anesthetic introduced clinically in Germany in 1976 and subsequently throughout Europe, Canada and, in 2000, the United States.Methods. The authors report on three identical single-dose, randomized, double-blind, parallel-group, active-controlled multicenter studies that were conducted to compare the safety and efficacy of articaine (4 percent with epinephrine 1:100,000) with that of lidocaine (2 percent with epinephrine 1:100,000).Results. A total of 1,325 subjects participated in these studies, 882 of whom received articaine 4 percent with epinephrine 1:100,000. The overall incidence of adverse events in the combined studies was 22 percent for the articaine group and 20 percent for the lidocaine group. The most frequently reported adverse events in the articaine group, excluding postprocedural dental pain, were headache (4 percent), facial edema, infection, gingivitis and paresthesia (1 percent each). The incidence of these events was similar to that reported for subjects who received lidocaine. The adverse events most frequently reported as related to articaine use were paresthesia (0.9 percent), hypesthesia (0.7 percent), headache (0.55 percent), infection (0.45 percent), and rash and pain (0.3 percent each).Conclusions. Articaine is a well-tolerated, safe and effective local anesthetic for use in clinical dentistry.