| 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 |
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| 引用本文： | 田媛,周刚,关晓兵,谭劲,刘关键,隋秋丽,李佳,林梅,周红梅. 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[J]. 口腔医学研究, 2021, 37(2): 167-172. DOI: 10.13701/j.cnki.kqyxyj.2021.02.017 |
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| 作者姓名： | 田媛 周刚 关晓兵 谭劲 刘关键 隋秋丽 李佳 林梅 周红梅 |
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| 作者单位： | 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;武汉大学口腔医院口腔黏膜科 湖北武汉 430079;首都医科大学附属北京口腔医院口腔黏膜科 北京 100050;湖南中医药大学第一附属医院口腔科 湖南长沙 410007;四川大学华西医院中国循证医学中心 四川成都 610041;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;郑州市口腔医院牙周黏膜科 河南郑州 450000;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;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;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 |
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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、...
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| 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 |
Shixin Buccal Tablets on Recurrent Aphthae with Syndrome of Flaring Up of the Stomach-fire: A Randomized Doubleblind Placebo-controlled Multicenter Clinical Trial. |
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| TIAN Yuan,ZHOU Gang,GUAN Xiaobing,TAN Jin,LIU Guanjian,SUI Qiuli,LI Jia,LIN Mei,ZHOU Hongmei. Shixin Buccal Tablets on Recurrent Aphthae with Syndrome of Flaring Up of the Stomach-fire: A Randomized Doubleblind Placebo-controlled Multicenter Clinical Trial.[J]. Journal of Oral Science Research, 2021, 37(2): 167-172. DOI: 10.13701/j.cnki.kqyxyj.2021.02.017 |
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| Authors: | TIAN Yuan ZHOU Gang GUAN Xiaobing TAN Jin LIU Guanjian SUI Qiuli LI Jia LIN Mei ZHOU Hongmei |
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| Affiliation: | (National Clinical Research Center for Oral Diseases & Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China;Department of Oral Medicine,School and Hospital of Stomatology, Wuhan University, Wuhan 430079, China;Departmentof Oral Medicine, Beijing Stomatological Hospital, Capital Medical University, Beijing 100050, China;Department of Stomatology, The First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410000, China;Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;Department of Periodontal Mucosa, Zhengzhou Stomatological Hospital, Zhengzhou 450000, China;State Institute of Drug Clinical Trial, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China) |
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| 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. |
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| Keywords: | Shixin buccal tablets recurrent aphthous ulcer syndrome of flaring up of the stomach-fire multi-center clinical trail pain relief ulcer healing |
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