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中成药治疗2型糖尿病的临床研究总结及评价
王丹蕾, 季昭臣, 胡海殷, 冯超男, 强晓钰, 吴晓蕾, 彭德慧, 曹璐佳, 张俊华
天津中医药大学循证医学中心, 天津 301617
摘要:
[目的] 对中成药治疗2型糖尿病的临床随机对照试验(RCT)的基本情况和方法学质量进行全面总结与分析,为临床研究的开展、政策及指南的制定提供循证证据与合理建议。[方法] 基于中医药循证研究证据库系统(EVDS)旗下中成药临床证据数据库的收录,补充检索中国知网(CNKI)、万方数据库、中国生物医学文献数据库(CBM)等,检索时间为建库至2020年12月31日,纳入中成药治疗2型糖尿病的RCTs作为临床证据来源,对研究的发表信息、样本量、干预及对照措施、疗程、结局指标、方法学质量等内容进行分析和评价。[结果] 纳入中成药治疗2型糖尿病的RCTs研究377篇,其中样本量>200例的RCTs研究26篇,占6.90%。涉及中成药79种,其中口服中成药54种(68.35%),注射液25种(31.65%);干预vs对照设置以“中成药+西药vs西药”应用最多,涉及93篇RCTs占总纳入文献量的24.67%;疗程以31~90d为主(194篇,51.46%);评价指标中,理化检测指标(81.70%)和症状/体征指标(10.00%)应用最多。[结论] 已发表的中成药治疗2型糖尿病RCTs在设计和实施方面存在缺陷,多数研究分配序列的保存、受试者盲法被评为中高风险;研究关键环节如试验注册、伦理审批等报告不足。建议后续开展大样本、高质量的RCT研究,在试验设计方面邀请方法学专家提供专业技术支撑,并遵守试验注册、伦理审批等关键环节要求,严格按照临床试验报告规范(CONSORT)声明报告结果,进一步提升证据可靠性。
关键词:  中成药  2型糖尿病  随机对照试验  循证医学
DOI:10.11656/j.issn.1672-1519.2023.01.12
分类号:R587.1
基金项目:天津市高等学校创新团队(TD12-5032)。
Summary and evaluation of clinical research on the treatment of type 2 diabetes mellitus with Chinese patent medicine
WANG Danlei, JI Zhaochen, HU Haiyin, FENG Chaonan, QIANG Xiaoyu, WU Xiaolei, PENG Dehui, CAO Lujia, ZHANG Junhua
Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Abstract:
To summarize and analyze the basic situation and methodological quality of the randomized controlled trials (RCT) of Chinese patent medicine for type 2 diabetes mellitus (T2DM),the databases of EVDS,CNKI,WanFang and CBM were retrieved. The time of screening was from database inception to December 31,2020. RCTs were included in the research type. The intervention and control measures,course of treatment,outcome indicators and methodological quality were analyzed and evaluated. There were 377 RCTs studies involving Chinese patent medicine in the treatment of T2DM,of which 26 were include patients more than 200,accounting for 6.90%. 79 kinds of Chinese patent medicines were involved,including 54 kinds of oral Chinese patent medicines(68.35%) and 25 kinds of injection (31.65%);The intervention vs control setting was “Chinese patent medicine+western medicine vs western medicine”,involving 93 RCTs,accounting for 24.67% of the total included literature;The main course of treatment was 31 to 90 days (194 articles,51.46%). Among the evaluation outcomes,physical and chemical test outcomes (81.70%) and symptom/sign outcomes (10.00%) were the most used. The published Chinese patent medicine has some defects in the design and implementation of RCTs for T2DM. Most of the patients studied were saved by the allocation sequence,and the blindness of subjects was rated as high risk. The reports of key research links such as trial registration and ethical approval are insufficient. It is suggested to carry out large sample and high-quality RCT research in the follow-up,invite methodological experts to provide professional and technical support in the test design,comply with the requirements of key links such as test registration and ethical approval,and report the results in strict accordance with the consort reporting specification,so as to further improve the reliability of evidence.
Key words:  Chinese patent medicine  type 2 diabetes mellitus  randomized controlled trial  evidence based medicine
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