1.广州中医药大学第一附属医院,广东省广州市白云区机场路16号,510405
2.广州中医药大学第八临床医学院
3.佛山市中医院
4.中国中医科学院西苑医院脾胃病研究所
txdly@sina.com
收稿:2025-06-25,
修回:2025-12-31,
纸质出版:2026-03-02
移动端阅览
刘凤斌,姚思梦,王萍等.症状、证候量表在脾胃病新药研发中的应用价值[J].中医杂志,2026,67(05):504-509.
LIU Fengbin,YAO Simeng,WANG Ping,et al.Application Value of Scales for Symptom & Syndrome Evaluation in Spleen-Stomach Diseases Related New Drug Research and Development[J].Journal of Traditional Chinese Medicine,2026,67(05):504-509.
刘凤斌,姚思梦,王萍等.症状、证候量表在脾胃病新药研发中的应用价值[J].中医杂志,2026,67(05):504-509. DOI: 10.13288/j.11-2166/r.2026.05.008.
LIU Fengbin,YAO Simeng,WANG Ping,et al.Application Value of Scales for Symptom & Syndrome Evaluation in Spleen-Stomach Diseases Related New Drug Research and Development[J].Journal of Traditional Chinese Medicine,2026,67(05):504-509. DOI: 10.13288/j.11-2166/r.2026.05.008.
症状、证候量表是中医临床疗效评价不可或缺的测评工具,在脾胃病新药研发各阶段中均具有重要价值,可为药物的临床定位、疗效评估和适应证拓展提供科学依据。通过分析当前症状、证候量表研究的热点,探讨症状、证候量表在脾胃病新药研发中的重要意义与应用难点,总结国内研究现状,并结合国际相关研究进行对比分析,展望未来发展趋势,以促进症状、证候量表在脾胃病新药研发中的应用,推动中医药现代化发展进程。
Symptom and syndrome efficacy evaluation scales are indispensable tools for clinical efficacy assessment in traditional Chinese medicine (TCM), and hold significant value at all stages of new drug research development for spleen and stomach diseases. These scales can provide scientific basis for clinical positioning, efficacy evaluation, and expansion of indications of new drugs. By analyzing the current hotspots and difficulties in research, this study aims to explore the important significance of these scales in the development of new drugs for spleen and stomach diseases, summarize the domestic research progress, and conduct comparative analyses with international studies. Future development trends are also discussed in order to promote the application of symptom and syndrome efficacy evaluation scales in the development of new drugs for spleen and stomach diseases and to advance the moder-nization process of TCM.
U.S. Department of Health and Human Services , Food and Drug Administration , Center for DrugEvaluation and Research (CDER) , Center for Biologics Evaluation and Research (CBER) , et al . Guidance for industry patient-reported outcome measures: use in medical product deve-lopment to support labeling claims [EB/OL]. ( 2009-12-01 ) [ 2025-05-01 ]. https://www.fda.gov/media/77832/download https://www.fda.gov/media/77832/download .
曾令烽 , 杨伟毅 , 梁桂洪 , 等 . 基于整合思维探讨患者临床报告结局问卷引进与中医临床效应测评 [J]. 中华中医药杂志 , 2022 , 37 ( 2 ): 611 - 617 .
LIU FB , HOU ZK , YANG YY , et al . Literature review and analysis of the development of health outcomes assessment instruments in Chinese medicine [J]. J Integr Med , 2013 , 11 ( 2 ): 80 - 89 .
程海波 , 张磊 , 付勇 , 等 . 2023年度中医药重大科学问题、工程技术难题和产业技术问题 [J]. 中医杂志 , 2023 , 64 ( 14 ): 1405 - 1421 .
国家药品监督管理局 . 国家药监局关于发布《中药注册管理专门规定》的公告 [EB/OL]. ( 2023-02-10 )[ 2025-04-10 ]. https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20230210173401120.html https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20230210173401120.html .
孙昱 , 文海若 , 汪祺 . 以患者为中心的药物研发策略 [J]. 药物评价研究 , 2020 , 43 ( 9 ): 1719 - 1727 .
童伟 . 基于中医证候积分联合IBS-SSS量表评价肠康方治疗腹泻型肠易激综合征的探讨 [D]. 南京 : 南京中医药大学 , 2024 .
MASON SF , DASGUPTA M , FLYNN KE , et al . Compa-rison of CAT and short forms for PROMIS pain and physical health domains in children with sickle cell disease [J]. J Patient Rep Outcomes , 2023 , 7 ( 1 ): 12 .
KRASKA J , BELL K , COSTELLO S . Graded response model analysis and computer adaptive test simulation of the depression anxiety stress scale 21: evaluation and validation study [J]. J Med Internet Res , 2023 , 25 : e45334 . doi: 10.2196/45334 http://dx.doi.org/10.2196/45334 .
GAO X , XIA L , WANG F , et al . Applying item response theory to the student adaptation to college questionnaire: examining psychometric characteristics and developing computerized adaptive testing version [J]. J Pers Assess , 2023 , 105 ( 6 ): 797 - 806 .
OTTENHOF MJ , GEERARDS D , HARRISON C , et al . Applying computerized adaptive testing to the FACE-Q skin cancer module: individualizing patient-reported outcome measures in facial surgery [J]. Plast Reconstr Surg , 2021 , 148 ( 4 ): 863 - 869 .
侯政昆 . 基于计算机自适应测试的胃痞患者报告结局量表研制 [D]. 广州 : 广州中医药大学 , 2012 .
李筱颖 . 胃痛PRO计算机自适应试验的初步构建研究 [D]. 广州 : 广州中医药大学 , 2011 .
张晓雨 , 田思超 , 尤良震 , 等 . 大数据时代中医症状疗效评价存在的问题与解决对策 [J]. 中医杂志 , 2024 , 65 ( 8 ): 792 - 795 .
CARROZZINO D , PATIERNO C , GUIDI J , et al . Clinimetric criteria for patient-reported outcome measures [J]. Psychother Psychosom , 2021 , 90 ( 4 ): 222 - 232 .
ZHANG Y , WANG X , CARROZZINO D , et al . Clinimetric properties of the Chinese version of the Euthymia Scale [J]. Clin Psychol Psychother , 2022 , 29 ( 1 ): 360 - 366 .
MARSHALL J , GOSA MM , DODRILL P . Patient-reported outcome measures that describe the feeding skills domain for pediatric feeding disorder: a clinimetric review [J]. J Pediatr Gastroenterol Nutr , 2023 , 77 ( 1 ): 137 - 145 .
HASSETT MJ , DIAS S , CRONIN C , et al . Strategies for implementing an electronic patient-reported outcomes-based symptom management program across six cancer centers [J]. BMC Health Serv Res , 2024 , 24 ( 1 ): 1386 .
HETTIARACHCHI SENARATH GM , DELIR HAGHIGHI P , BAI L , et al . Barriers and facilitators to the uptake of electronic collection and use of patient-reported measures in routine care of older adults: a systematic review with qualitative evidence synthesis [J]. JAMIA Open , 2024 , 7 ( 3 ): ooae068 .
BRUSCO NK , MYLES PS , ATKINSON V , et al . Deve-lopment of the ‘AusPROM’ recommendations for elective surgery patients [J]. Aust Health Rev , 2022 , 46 ( 5 ): 621 - 628 .
KRISTENSEN S , HOLMSKOV J , PØLUND K , et al . Using patient-reported outcome measures in psychiatric hospital care: an observational study describing an iterative implementation process in Denmark [J]. Int J Qual Health Care , 2022 , 34 ( Supplement_1 ):ii40-ii48.
郑筱萸 . 中药新药临床研究指导原则(试行) [M]. 北京 : 中国医药科技出版社 , 2002 .
国家中医药管理局 . 中医内科病证诊断疗效标准 [EB/OL]. ( 1994-06-28 )[ 2025-05-01 ]. https://ndls.org.cn/ standard/detail/e427980802f34bc876dcab00e66024c5 https://ndls.org.cn/standard/detail/e427980802f34bc876dcab00e66024c5 .
梁茂新 , 王雪峰 . 中医疗效评价指标和方法研究需要解决的认识问题 [J]. 世界科学技术 , 2006 , 8 ( 1 ): 31 - 35 .
刘凤斌 . 胃肠疾病患者生存质量研究的探索 [J]. 广州中医药大学学报 , 1997 , 14 ( 4 ): 10 - 13 .
刘凤斌 , 王维琼 . 中医脾胃系疾病PRO量表的研制与条目筛选 [J]. 世界科学技术-中医药现代化 , 2009 , 11 ( 4 ): 527 - 531 .
黄尧达 . 中医脾胃系疾病PRO量表之慢性胃炎模块的研制和考核 [D]. 广州 : 广州中医药大学 , 2009 .
梁炳君 . 中医脾胃系疾病PRO量表之肠易激综合征量表的研制与考核 [D]. 广州 : 广州中医药大学 , 2010 .
余纯梓 . 脾胃系疾病PRO量表之胃食管病模块的研制与考核 [D]. 广州 : 广州中医药大学 , 2011 .
唐旭东 , 卞立群 , 王凤云 , 等 . 功能性胃肠病症状重叠现象与中医药治疗思路 [J]. 中医杂志 , 2010 , 51 ( 3 ): 271 - 273 .
唐旭东 , 王萍 , 刘保延 , 等 . 基于慢性胃肠疾病患者报告临床结局测量量表的编制及信度、效度分析 [J]. 中医杂志 , 2009 , 50 ( 1 ): 27 - 29 .
唐旭东 , 王萍 , 赵迎盼 , 等 . 《基于慢性胃肠疾病患者报告的临床结局评价量表》应用于功能性胃肠病疗效评价适用性专家问卷调查 [J]. 中国中西医结合杂志 , 2018 , 38 ( 2 ): 182 - 185 .
王凤云 , 吕咪 . 从中医药治疗胃食管反流病的优势环节解读《中药新药用于胃食管反流病的临床疗效评价指导原则》 [J]. 中国中西医结合消化杂志 , 2023 , 31 ( 7 ): 493 - 496 .
卞立群 , 王凤云 , 陈婷 , 等 . 《中药新药用于慢性胃炎的临床疗效评价技术指导原则(试行)》内容解读 [J]. 中国中西医结合消化杂志 , 2024 , 32 ( 11 ): 961 - 965 .
罗辉 , 廖星 , 王茜 . 中医证候积分在疗效评价中的应用:基于240项随机对照试验的比较研究 [J]. 中国中西医结合杂志 , 2015 , 35 ( 10 ): 1261 - 1266 .
史钊 , 窦蕾 , 李顺平 . 国内外患者报告结局的应用现状与研究进展 [J]. 中国全科医学 , 2023 , 26 ( 4 ): 401 - 408 .
GNANASAKHTHY A , MORDIN M , EVANS E , et al . A review of patient-reported outcome labeling in the United States(2011—2015) [J]. Value Health , 2017 , 20 ( 3 ): 420 - 429 .
GNANASAKHTHY A , NORCROSS L , DEMURO ROMANO C , et al . A review of patient-reported outcome labeling of FDA-approved new drugs (2016—2020): counts, categories, and comprehensibility [J]. Value Health , 2022 , 25 ( 4 ): 647 - 655 .
NAISMITH RT , WUNDES A , ZIEMSSSEN T , et al . Diroximel fumarate demonstrates an improved gastrointestinal tolerability profile compared with dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: results from the randomized, double-blind, phase Ⅲ EVOLVE-MS-2 study [J]. CNS Drugs , 2020 , 34 ( 2 ): 185 - 196 .
方碧陶 . 国家药品监督管理局印发《真实世界证据支持药物研发与审评的指导原则(试行)》 [J]. 中医药管理杂志 , 2020 , 28 ( 2 ): 107 .
国家药品监督管理局 . 用于产生真实世界证据的真实世界数据指导原则(试行) [EB/OL]. ( 2021-04-13 ) [ 2025-05-01 ]. https://www.cde.org.cn/attachmentout. do?mothed=list&id=0e208b282a448d40 https://www.cde.org.cn/attachmentout.do?mothed=list&id=0e208b282a448d40 .
唐凌 , 艾星 , 赵田 , 等 . 对“以患者为中心”的罕见疾病药物研发的审评考虑 [J]. 罕见病研究 , 2024 , 3 ( 2 ): 168 - 174 .
国家药品监督管理局药品审评中心 . 患者报告结局在药物临床研究中应用的指导原则(试行) [EB/OL].( 2021-12-01 )[ 2023-04-21 ]. https://www.cde.org.cn/main/news/viewInfoCommon/c2f79c22e8678241b030c71523eb300c https://www.cde.org.cn/main/news/viewInfoCommon/c2f79c22e8678241b030c71523eb300c .
严华美 , 江云 , 胡薏慧 , 等 . 治疗症状类中药新药临床试验疗效指标设计的关键问题 [J]. 药物评价研究 , 2023 , 46 ( 9 ): 1833 - 1840 .
0
浏览量
0
下载量
0
CSCD
关联资源
相关文章
相关作者
相关机构
京公网安备11010102007558号