State Key Laboratory of Oral Diseases, West China School of Stomatology, Sichuan University, Chengdu, China.
Am J Med. 2012 Mar;125(3):292-301. doi: 10.1016/j.amjmed.2011.09.011.
Recurrent aphthous ulceration is the most common oral mucosal lesion and may be associated with many systemic diseases. Topical corticosteroids are used frequently for recurrent aphthous ulceration; however, the number of high-quality clinical experiments available is insufficient, and no reports exist on the blood level of corticosteroids after topical usage in the oral mucosa. The objective was to determine the efficacy and safety of dexamethasone ointment in the treatment of recurrent aphthous ulceration and detect serum dexamethasone concentrations in the patients.
A randomized, double-blinded, placebo-controlled, parallel, multicenter clinical trial was conducted in 5 centers to compare the efficacy and safety of dexamethasone ointment with placebo. There were 810 patients with minor recurrent aphthous ulcerations screened for study eligibility, and 240 patients were enrolled at 5 centers from March 1, 2009 to April 30, 2010; 120 were assigned randomly to the treatment group and 120 to a control group. Patients were instructed to apply the given agent to the identified ulcer 3 times a day (after meals) for 5 days. The size, pain level, healing ratio, and average duration of ulcers and the safety of the agents were evaluated. The serum concentration of dexamethasone was detected using a high-performance liquid chromatography/mass spectrometry assay.
The results showed that baseline characteristics were similar (P>.5). At day 6 ± 2 after treatment, there was significant difference in the variation of ulcer size between the treatment group (7.167 ± 6.3415 mm(2)) and the control group (4.346 ± 7.0666 mm(2); P = .000); and in the variation of pain level between the treatment group (5.623 ± 1.9570) and the control group (4.940 ± 2.2449; P = .001). The healing ratio was 83.33% in the treatment group and 54.70% in the control group (P = .000). No severe adverse reactions were observed. No serum dexamethasone was detected before or after the use of the agents (<0.502 ng/mL).
Dexamethasone ointment was efficient in the treatment of recurrent aphthous ulceration and was safe as evaluated using clinical assessment and serum level detection.
复发性阿弗他溃疡是最常见的口腔黏膜病变，可能与许多系统性疾病有关。局部皮质类固醇常被用于治疗复发性阿弗他溃疡；然而，可用的高质量临床试验数量不足，且尚无关于口腔黏膜局部使用皮质类固醇后血药水平的报告。本研究旨在确定地塞米松软膏治疗复发性阿弗他溃疡的疗效和安全性，并检测患者的血清地塞米松浓度。
在 5 个中心进行了一项随机、双盲、安慰剂对照、平行、多中心临床试验，比较了地塞米松软膏与安慰剂的疗效和安全性。共有 810 例复发性阿弗他溃疡患者符合研究入选标准，2009 年 3 月 1 日至 2010 年 4 月 30 日，5 个中心共纳入 240 例患者，其中 120 例随机分配至治疗组，120 例分配至对照组。患者被指示在饭后每日 3 次（共 5 天）将所给药物涂于所识别的溃疡处。评估溃疡大小、疼痛程度、愈合率、平均溃疡持续时间和药物安全性。使用高效液相色谱/质谱联用测定法检测血清地塞米松浓度。
结果显示，两组患者的基线特征相似（P＞.5）。治疗后第 6 ± 2 天，治疗组（7.167 ± 6.3415 mm2）和对照组（4.346 ± 7.0666 mm2）的溃疡大小变化差异具有统计学意义（P=.000）；治疗组（5.623 ± 1.9570）和对照组（4.940 ± 2.2449）的疼痛程度变化差异也具有统计学意义（P=.001）。治疗组的愈合率为 83.33%，对照组为 54.70%（P=.000）。未观察到严重不良反应。用药前后均未检测到血清地塞米松（＜0.502 ng/mL）。
地塞米松软膏治疗复发性阿弗他溃疡有效，且临床评估和血清水平检测均显示其安全性良好。
