[1]徐培丽戎杰杨一帆张钧华郭成莲张慧闫咏梅.我国中医药防治帕金森病临床试验注册现状分析[J].陕西中医药大学学报,2024,(01):007-13.[doi:10.13424/j.cnki.jsctcm.2024.01.002]
　U PeiliRONG JieYANG YifanZHANG Junhua?GUO ChenglianZHANG HuiYAN Yongmei.Analysis of the Current Status of Clinical Trial Registration for Traditional Chinese Medicine in the Prevention and Treatment of Parkinson’s Disease in China[J].Journal of Shaanxi University of Traditional Chinese Medicine,2024,(01):007-13.[doi:10.13424/j.cnki.jsctcm.2024.01.002]
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我国中医药防治帕金森病临床试验注册现状分析()
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《陕西中医药大学学报》[ISSN:2096-1340/CN:61-1501/R]

卷:
期数:
2024年01期
页码:
007-13
栏目:
出版日期:
2024-01-20

文章信息/Info

Title:
Analysis of the Current Status of Clinical Trial Registration for Traditional Chinese Medicine in the Prevention and Treatment of Parkinson’s Disease in China
文章编号:
2096-1340(2024)01-0007-07
作者:
徐培丽1戎杰2杨一帆2张钧华1郭成莲2张慧2闫咏梅2
1.陕西中医药大学，陕西 咸阳 712000；
2.陕西中医药大学附属医院，陕西 咸阳 712046
Author(s):
U Peili1RONG Jie2YANG Yifan2ZHANG Junhua1?GUO Chenglian2ZHANG Hui2YAN Yongmei2
1.Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712000,China;
2.Affiliated Hospital of Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712046,China
关键词:
关键词：帕金森病; 中医药治疗; 临床试验; 中国临床试验注册中心
Keywords:
Key words： Parkinsons disease; Traditional Chinese medicine treatment; Clinical trials; China Clinical Trial Registration Center
分类号:
R277.7
DOI:
10.13424/j.cnki.jsctcm.2024.01.002
文献标志码:
A
摘要:
摘要：目的 探讨当前我国帕金森病相关中医药临床试验在中国临床试验注册中心（Chinese Clinical Trial Register，ChiCTR）注册的特点及发展趋势。方法 检索ChiCTR数据库注册的中医药防治帕金森病相关的临床试验，检索时间从建库日期到2023年6月10日，选用Access建立数据库获取相关数据，选用Excel对数据进行归纳分析，探索其临床试验特征。 结果 共纳入当前我国帕金森病相关中医药临床试验共62项，涉及14个省级行政区，41个临床试验单位（机构）。注册地区前3位的是上海（16项，25.8%），北京（13项，21.0%）和广东（9项，14.5%），共计占比61.3%。试验机构以上海中医药大学附属龙华医院注册数量最多，为5项，占比8.0%。经费来源排名顺序列在第一位的是地方财政资助；其次为单位资助和国家财政资助。研究类型以干预性研究为主，共58项（93.5%），研究方法采用随机法56项（96.6%），盲法23项（37.0%）。干预手段包括中药经方，中成药，针灸以及传统功法等。结论 我国中医药治疗帕金森病的临床试验注册研究数量逐年上升，研究者临床试验规范性意识不断提升。但存在中医药防治帕金森病临床试验注册认识不足、临床试验局限于单中心、地域及机构分布不平衡、RCT研究质量不高、临床试验研究设计欠规范、标准操作规程和质量控制有待加强、临床试验研究报告不规范等问题。中医药治疗帕金森病手段多样，疗效明显，因此建议研究者增强科研意识，优化设计方案，重视临床试验的规范化管理。
Abstract:
Abstract： Objective To explore the characteristics and development trends of clinical trials of traditional Chinese medicine related to Parkinsons disease in China registered at the Chinese Clinical Trial Registry (ChiCRT).Methods Retrieve clinical trials related to the prevention and treatment of Parkinsons disease using traditional Chinese medicine registered in the ChiCRT database.The search was conducted from the database establishment date to June 10,2023.Access was used to establish the database to obtain relevant data,and Excel was used to summarize and analyze the data,exploring its clinical trial characteristics.Results The results included a total of 62 clinical trials of traditional Chinese medicine related to Parkinsons disease in China,involving 14 provinciallevel administrative regions and 41 clinical trial units (institutions).The top three registered regions are Shanghai (16,25.8%),Beijing (13,21.0%),and Guangdong (9,14.5%),accounting for a total of 61.3%.Among the experimental institutions,Longhua Hospital affiliated with Shanghai University of Traditional Chinese Medicine has the highest number of registrations,with 5 items accounting for 8.0%.The top ranked source of funding is local financial assistance;Next are unit funding and national financial support.The research type is mainly intervention research,with a total of 58 items (93.5%).The research method adopts random method in 56 items (96.6%) and blind method in 23 items (37.0%).Interventions include traditional Chinese medicine,traditional Chinese patent medicines and simple preparations,acupuncture and moxibustion and traditional exercises.Conclusion The number of registered clinical trials of traditional Chinese medicine for the treatment of Parkinsons disease in China has been increasing year by year,and the awareness of standardization in clinical trials among researchers is constantly improving.However,there are problems such as insufficient understanding of clinical trial registration for traditional Chinese medicine in the prevention and treatment of Parkinsons disease,limited clinical trials to single centers,uneven distribution of regions and institutions,low quality of RCT research,lack of standardization in clinical trial design,need to strengthen standard operating procedures and quality control,and nonstandard clinical trial research reports.Traditional Chinese medicine has various methods for treating Parkinsons disease and significant therapeutic effects.Therefore,it is recommended that researchers enhance their research awareness,optimize design plans,and attach importance to the standardized management of clinical trials.

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备注/Memo

备注/Memo:
基金项目：国家中医药管理局中医药科学技术研究专项课题（GZY-KJS-2021-001）；陕西省重点研发计划项目（2020ZDLSF05-14）；陕西省中医药管理局中西医结合临床协作创新项目（2020-ZXY-002）；陕西中医药大学附属医院科研课题（2020LCJD003；2020LCJD007）
更新日期/Last Update: 2024-01-24