| 中药治疗慢性萎缩性胃炎临床试验方案设计关键因素思考 |
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| 引用本文： | 王天园,李博,赵国桢,胡晶,王宏,冯硕,张会娜.中药治疗慢性萎缩性胃炎临床试验方案设计关键因素思考[J].中国全科医学,2022,25(20):2519-2524. |
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| 作者姓名： | 王天园 李博 赵国桢 胡晶 王宏 冯硕 张会娜 |
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| 作者单位： | 1100010 北京市，首都医科大学附属北京中医医院2100010 北京市中医药研究所3100010 北京市，北京中医药循证医学中心4100029 北京市，北京中医药大学 |
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| 基金项目： | 国家自然科学基金资助项目(81973694) |
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| 摘 要： | 中医药治疗慢性萎缩性胃炎具有一定的优势，但缺乏大样本、高质量的相关临床研究。本文通过阐述中药治疗慢性萎缩性胃炎的临床试验方案设计、评价等方面的技术要点，为中药治疗慢性萎缩性胃炎的临床试验方案设计提供方法学参考，促进相关临床研究质量的提升，并根据中药及慢性萎缩性胃炎临床试验的特点和实际需求，对临床研究设计基本要素进行讨论分析，尤其是对结局指标的选择研究，为中医临床疗效综合评价提供思路。
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| 关 键 词： | 胃炎，萎缩性 中药 临床试验 研究设计 影响因素分析 |
| 收稿时间： | 2022-02-17 |
Thoughts on Key Factors of Clinical Trial Protocol Design for Chronic Atrophic Gastritis Treated with Traditional Chinese Drugs |
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| Tianyuan WANG,Bo LI,Guozhen ZHAO,Jing HU,Hong WANG,Shuo FENG,Huina ZHANG.Thoughts on Key Factors of Clinical Trial Protocol Design for Chronic Atrophic Gastritis Treated with Traditional Chinese Drugs[J].Chinese General Practice,2022,25(20):2519-2524. |
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| Authors: | Tianyuan WANG Bo LI Guozhen ZHAO Jing HU Hong WANG Shuo FENG Huina ZHANG |
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| Institution: | 1Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China2Beijing Institute of Traditional Chinese Medicine, Beijing 100010, China3Beijing Evidence-based Chinese Medicine Center, Beijing 100010, China4Beijing University of Chinese Medicine, Beijing 100029, China |
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| Abstract: | Traditional Chinese Drugs has proven to have unique merits in treating chronic atrophic gastritis (CAG) , but needs to be verified further by high-quality large-sample clinical studies. We detailed the technique essentials of clinical trial protocol design and assessment for CAG treated with Traditional Chinese Drugs, which may be used as a methodological reference for clinical trial protocol design for CAG treated using Traditional Chinese Drugs, promoting the quality improvement of relevant studies. Then we discussed the essentials of relevant clinical trial protocol design, especially the selection of outcome indicators, in accordance with the attributes of Traditional Chinese Drugs, and features and actual needs of such trials, providing ideas for comprehensive evaluation of efficacy of Traditional Chinese Drugs in treating CAG. |
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| Keywords: | Gastritis atrophic Traditional Chinese Drugs Clinical trial Research design Root cause analysis |
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