口腔医学研究

口腔医学研究 ›› 2021, Vol. 37 ›› Issue (2): 167-172.DOI: 10.13701/j.cnki.kqyxyj.2021.02.017

• 口腔黏膜病学研究 • 上一篇    下一篇

石辛含片治疗复发性口疮(胃火上炎证)的随机双盲安慰剂对照多中心临床试验研究

田媛1, 周刚2, 关晓兵3, 谭劲4, 刘关键5, 隋秋丽1,6, 李佳7, 林梅1*, 周红梅1*   

  1. 1. 国家口腔疾病临床医学研究中心 四川大学华西口腔医院口腔黏膜病科 四川 成都 610041;
    2.武汉大学口腔医院口腔黏膜科 湖北 武汉 430079;
    3.首都医科大学附属北京口腔医院口腔黏膜科 北京 100050;
    4.湖南中医药大学第一附属医院口腔科 湖南 长沙 410007;
    5.四川大学华西医院中国循证医学中心 四川 成都 610041;
    6.郑州市口腔医院牙周黏膜科 河南 郑州 450000;
    7.四川大学华西口腔医院国家药物临床试验机构 四川 成都 610041
  • 收稿日期:2020-08-25 发布日期:2021-02-11
  • 通讯作者: 林梅,E-mail:linmei2k@163.com
    周红梅,E-mail:zhouhm@scu.edu.cn
  • 作者简介:田媛(1993~ ),女,山东德州人,硕士在读,研究方向:口腔黏膜病学。

Shixin Buccal Tablets on Recurrent Aphthae with Syndrome of Flaring Up of the Stomach-fire: A Randomized Double-blind Placebo-controlled Multicenter Clinical Trial

TIAN Yuan1, ZHOU Gang2, GUAN Xiaobing3, TAN Jin4, LIU Guanjian5, SUI Qiuli1,6, LI Jia7, LIN Mei1*, ZHOU Hongmei1*   

  1. 1. National Clinical Research Center for Oral Diseases ＆ Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China;
    2. Department of Oral Medicine,School and Hospital of Stomatology, Wuhan University, Wuhan 430079, China;
    3. Departmentof Oral Medicine, Beijing Stomatological Hospital, Capital Medical University, Beijing 100050, China;
    4. Department of Stomatology, The First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410000, China;
    5. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;
    6. Department of Periodontal Mucosa, Zhengzhou Stomatological Hospital, Zhengzhou 450000, China;
    7. State Institute of Drug Clinical Trial, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
  • Received:2020-08-25 Published:2021-02-11

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摘要： 目的:评价石辛含片治疗复发性口疮(胃火上炎证)的有效性与安全性。方法:采用优效性检验、进行随机双盲单模拟、安慰剂平行对照、多中心临床试验设计。试验组和对照组分别给予石辛含片和安慰剂,疗程为5 d。主要疗效评价指标为疼痛初始缓解时间,次要疗效评价指标为全部溃疡愈合率、目标溃疡愈合率、目标溃疡存在时间、溃疡总数、疼痛指数、溃疡面积及中医症候量化指标;记录不良反应和实验室检查结果进行安全性评价。结果:共纳入234例,试验组和对照组各117例,试验组的疼痛初始缓解时间(主要疗效指标)优效于安慰剂对照组(P<0.05)。次要疗效指标,试验组均显示出比对照组更好的改善数据,差异具有统计学意义(P<0.01)。发生临床症状不良事件21例,与药物相关者8例(试验组6例,对照组2例),主要表现为轻~中度腹痛、腹泻等,多数为轻度,可自行缓解;未发生严重不良事件。两组不良事件及不良反应发生率比较差异无统计学意义。结论:石辛含片用于治疗复发性口疮(胃火上炎证)可有效缓解疼痛、促进愈合,改善胃火上炎中医症候,并有良好的安全性。

关键词: 石辛含片, 复发性阿弗他溃疡, 胃火上炎证, 多中心药物临床试验, 疼痛缓解, 溃疡愈合

Abstract: Objective: To study the efficacy and safety of Shixin buccal tablets on the treatment of recurrent aphthae with syndrome of flaring up of the stomach-fire. Methods: A randomized, double-blind, placebo controlled, parallel-group, and multicenter study with single simulation was conducted. The patients in experimental group and the control group were given Shixin buccal tablets and placebo respectively for 5 days. The clinical outcomes consisted of the primary outcome (onset time of pain relief) and the secondary outcomes (rate of ulcer healing, days for ulcer healing, numbers of ulcers, pain scores,size of ulcers and the traditional Chinese medicine(TCM)symptoms of measurements). Adverse events and laboratory results were recorded to evaluate the safety of the agent. Results: 234 patients were enrolled and randomly divided into the experimental group and the control group, with 117 cases each. The primary outcome,namely,onset time of pain relief in experimental group was shorter than that in the control group (P<0.05). For all secondary outcomes,the experimental group showed significantly better efficacy than that in the control group (P<0.01). The main adverse reactions were mild gastrointestinal symptoms such as stomachache or diarrhea,which could be relieved without any treatment. No severe adverse events were observed. The incidence of adverse events and adverse reactions was similar between two groups. Conclusion:Shixin buccal tablets is effective and safe on the treatment of recurrent aphthae with syndrome of flaring up of the stomach-fire.

Key words: Shixin buccal tablets, recurrent aphthous ulcer, syndrome of flaring up of the stomach-fire, multi-center clinical trail pain relief, ulcer healing