Zhou Yu, Chen Qiaming, Meng Wenxia, Jiang Lu, Wang Zhi, Liu Jie, Lin Mei, Zhou Hongmei, Chen Xiaofang, Zhao Man, Zeng Xin
State Key Laboratory of Oral Disease, West China College of Stomatology, Sichuan University, Sichuan, China.
Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Apr;109(4):561-6. doi: 10.1016/j.tripleo.2009.11.006. Epub 2010 Feb 26.
The aim of this study was to explore the effectiveness and safety of topical application of 50 mg penicillin G potassium troches in the treatment of minor recurrent aphthous ulcerations (MiRAU) in a Chinese cohort.
A randomized, double-blinded, placebo and no-treatment-controlled, multicenter clinical trial was performed. Troches were consecutively applied 4 times per day for 4 days. The size and pain level of ulcers were measured and recorded on days 0, 3, 4, 5, and 6.
A total of 258 subjects with minor recurrent aphthous ulcerations (86 subjects in penicillin G potassium group, 88 subjects in placebo control group, and 84 subjects in no-treatment control group) fulfilled the study. Penicillin G potassium significantly reduced ulcer size (P < .00001 for days 3, 4, 5, and 6) and alleviated ulcer pain (P < .00001 for days 3, 4, 5, and 6). No severe adverse reactions were observed. Only 4 subjects experienced mild adverse reaction.
Penicillin G potassium troches are effective in reducing ulcer size and alleviating ulcer pain of the patients in the treatment of a single episode of MiRAU in this Chinese cohort. Few adverse effects were observed with this therapeutic approach.
本研究旨在探讨50毫克青霉素G钾含片局部应用于中国人群复发性轻型阿弗他溃疡（MiRAU）治疗的有效性和安全性。
进行一项随机、双盲、安慰剂和无治疗对照的多中心临床试验。含片连续4天每天应用4次。在第0、3、4、5和6天测量并记录溃疡的大小和疼痛程度。
共有258例复发性轻型阿弗他溃疡患者（青霉素G钾组86例，安慰剂对照组88例，无治疗对照组84例）完成研究。青霉素G钾显著减小溃疡大小（第3、4、5和6天P <.00001）并减轻溃疡疼痛（第3、4、5和6天P <.00001）。未观察到严重不良反应。仅4例受试者出现轻度不良反应。
在该中国人群中，青霉素G钾含片在治疗单次发作的MiRAU时，可有效减小患者溃疡大小并减轻溃疡疼痛。该治疗方法观察到的不良反应较少。
