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曲丽娜,卢富,曾堃,陈建钢,田平林,谭劲.荆门上清丸治疗复发性口腔溃疡上焦实热证的临床研究[J].湖南中医药大学学报英文版,2023,43(2):283-288.[Click to copy
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| 荆门上清丸治疗复发性口腔溃疡上焦实热证的临床研究 |
| 曲丽娜,卢富,曾堃,陈建钢,田平林,谭劲 |
| (中国中医科学院广安门医院, 北京 100053;湖北中医药大学附属医院, 湖北 武汉 430060;武汉大学中南医院, 湖北 武汉 430071;湖北齐进药业有限公司, 湖北 荆门 448000;湖南中医药大学第一附属医院, 湖南 长沙 410007) |
| 摘要: |
| 目的 评价荆门上清丸治疗复发性口腔溃疡上焦实热证的有效性及安全性。方法 纳入中国中医科学院广安门医院、湖北中医药大学附属医院、武汉大学中南医院、湖南中医药大学第一附属医院2014年3月至2015年5月共240例受试者，将其随机均分为试验组和对照组。试验组予以荆门上清丸含服，对照组予以荆门上清丸模拟剂（安慰剂）含服，每次4粒，每日4次，早、中、晚饭后及睡前各一次。观察两组患者的靶溃疡愈合率、靶溃疡愈合时间、靶溃疡激惹痛评分、靶溃疡面积、口腔溃疡静息痛及中医证候疗效并进行安全性评价。结果 治疗后，试验组靶溃疡愈合率77.31%，高于对照组的31.03%（P<0.05）；试验组靶溃疡愈合时间短于对照组（P<0.05）；试验组中医证候有效率94.96%，高于对照组的81.03%（P<0.05）。第3、第5天，试验组靶溃疡激惹痛评分、靶溃疡面积、口腔溃疡静息痛评分均低于对照组（P<0.05）。本次试验发生13例19例次不良事件，试验组不良事件发生率为5.88%，低于对照组的10.26%，但差异无统计学意义（P>0.05）。结论 荆门上清丸治疗复发性口腔溃疡上焦实热证具有较好的疗效，能够改善溃疡疼痛、促进溃疡愈合、缩短溃疡病程，并且在中医证候疗效及改善溃疡面积、溃疡疼痛、口渴欲饮、口咽灼干而热、口黏腻、口臭等单项中医症状上具有优势，同时具有较好的安全性。 |
| 关键词: 复发性口腔溃疡 荆门上清丸 多中心临床试验 临床研究 上焦实热证 |
| DOI：10.3969/j.issn.1674-070X.2023.02.017 |
| Received:October 16, 2022 |
| 基金项目:湖北齐进药业有限公司资助课题（2014003）。 |
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| Clinical trial of Jingmen Shangqing Pill in the treatment of recurrent oral ulcer with upper energizer excess-heat pattern |
| QU Lina,LU Fu,ZENG Kun,CHEN Jiangang,TIAN Pinglin,TAN Jin |
| (Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing 100053, China;The Hospital of Hubei University of Chinese Medicine, Wuhan, Hubei 430060, China;Zhongnan Hospital of Wuhan University, Wuhan, Hubei 430071, China;Hubei Qijin Pharmaceutical Co., Ltd, Jingmen, Hubei 448000, China;The First Hospital of Hunan University of Chinese Medicine, Changsha, Hunan 410007, China) |
| Abstract: |
| Objective To evaluate the efficacy and safety of Jingmen Shangqing Pill in the treatment of recurrent oral ulcer with upper energizer excess-heat pattern. Methods A total of 240 patients admitted into Guang'anmen Hospital of China Academy of Chinese Medical Science, the Hospital of Hubei University of Chinese Medicine, Zhongnan Hospital of Wuhan University, and the First Hospital of Hunan University of Chinese Medicine from March 2014 to May 2015 were selected and were randomly ivided into test group and control group. The test group sucked Jingmen Shangqing Pill, the control group sucked Jingmen Shangqing Pill simulant, 4 pills each time, 4 times a day (in the morning, after lunch, after dinner and before bed). The target ulcer healing rate, target ulcer healing time, target ulcer irritability pain score, target ulcer area, oral ulcer rest pain and TCM pattern efficacy were observed in the two groups, and finally the safety was evaluated based on the results of the examination. Results After treatment, the target ulcer healing rate in the test group was 77.31%, higher than 31.03% in the control group (P<0.05); the total effective rate of the treatment group was 94.96%, higher than 81.03% in the control group (P<0.05); the healing time of target ulcer in the test group was shorter than that in the control group (P<0.05). On 3 and 5 d, the target ulcer irritation score, the target ulcer area and the oral ulcer resting pain score in the test group were lower than those in the control group (P<0.05). There were 13 cases of 19 adverse events in this trial. The incidence of adverse events in the test group was 5.88%, lower than 10.26% in the control group, but the difference was not statistically significant (P>0.05). Conclusion Jingmen Shangqing Pill has good curative effects in the treatment of recurrent oral ulcers with upper energizer excess-heat pattern. It can improve ulcer pain, promote ulcer healing, and shorten the course of ulcer disease. It has a curative effect in TCM pattern and it can safely reduce ulcer area, ulcer pain, thirst, desire to drink, hot and dry oropharynx, sticky mouth and bad breath. |
| Key words: recurrent oral ulcer Jingmen Shangqing Pill multicenter clinical trial clinical research upper energizer excess-heat pattern |
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