中国烧伤医学领域临床试验现状和思考

吴军; 陈昭宏; 王玉振

doi:10.3760/cma.j.cn501120-20210909-00309

中国烧伤医学领域临床试验现状和思考

doi: 10.3760/cma.j.cn501120-20210909-00309

1.
深圳大学第一附属医院烧伤整形科，深圳　　518037
2.
福建医科大学附属协和医院烧伤与创面修复科，福建省烧伤研究所，福建省烧伤医学中心，福建省烧创伤重点实验室，福州　　350001

基金项目:

国家自然科学基金面上项目 82172214

详细信息

通讯作者:
吴军，Email：junwupro@126.com

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出版历程
- 收稿日期: 2021-09-09

Current situation and reflection of clinical trials in the field of burn medicine in China

1.
Department of Burns and Plastic Surgery, the First Affiliated Hospital of Shenzhen University, Shenzhen 518037, China
2.
Department of Burns and Wound Repair, Union Hospital, Fujian Medical University, Fujian Provincial Burn Institute, Fujian Burn Medical Center, Fujian Provincial Key Laboratory of Burn and Trauma, Fuzhou 350001, China

Funds:

General Program of National Natural Science Foundation of China 82172214

More Information

Corresponding author: Wu Jun, Email: junwupro@126.com

摘要

摘要: 临床试验对制订烧伤诊治指南或共识具有重要意义，然而我国烧伤医学领域开展临床试验的先天优势并没有转化为循证医学数据。该课题组分别统计中英文数据库里国内外烧伤/重症医学领域主要学术期刊2010—2020年发表的文献，了解到中文期刊发表烧伤医学领域临床试验的数量和比例普遍低于英文期刊，而且中文期刊中发表的烧伤医学领域临床试验文献数量和比例均低于重症医学领域。在此基础上，该课题组统计分析了2010—2020年烧伤医学领域临床试验注册情况，了解到我国烧伤医学领域临床试验的注册量和完成量不但低于美国烧伤医学领域，而且低于我国重症医学领域。烧伤医学领域临床试验开展不足的原因可能是烧伤发病率下降、烧伤专业医师数量下降且收入偏低、烧伤科研人才匮乏等。我国亟须整合烧伤医学领域临床资源优势，加强临床试验研究，提升国际话语权。
- 烧伤 /
- 临床试验 /
- 思考 /
- 国际临床试验注册平台
Abstract: Clinical trials are of great significance in formulating guidelines or consensus for the diagnosis and treatment of burns. However, the innate advantages of clinical trials in the field of burn medicine in China have not been translated into evidence-based medical data. Our research group counted the literature published in major academic journals in the field of burn medicine at home and abroad from 2010 to 2020 in Chinese and English databases, and found that the number and proportion of clinical trials in the field of burn medicine published in Chinese journals were generally lower than those in English journals. Moreover, the number and proportion of clinical trials in the field of burn medicine published in Chinese journals were lower than those in the field of critical care medicine. On this basis, our research group statistically analyzed the registration status of clinical trials in the field of burn medicine from 2010 to 2020, and found that the registration volume and completion volume of clinical trials in the field of burn medicine in China were not only lower than those in the field of burn medicine in the United States, but also lower than those in the field of critical care medicine in China. The reasons for insufficient clinical trials in the field of burn medicine may be the decrease in the incidence of burns, the decrease in the number of burn specialists and their low income, and the lack of burn research talents. It is necessary for China to integrate the advantages of clinical resources in the field of burn medicine, strengthen clinical trial research, and improve the discourse power in the international community.
- Burns /
- Clinical trial /
- Thinking /
- International Clinical Trial Registration Platform
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1 中国在2010—2020年每年注册的烧伤医学领域临床试验量

注：横坐标下a~k依次指示2010—2020中各年份

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表1 国内烧伤/重症医学领域主要中文学术期刊2010—2020年发表所有文献分类[篇（%）]

期刊名	文献篇数	烧伤/重症医学领域临床试验文献	有随机对照设计的非烧伤/重症医学领域临床试验文献	无随机对照设计研究文献
《中华烧伤杂志》	2 702	76（2.81）	313（11.58）	2 313（85.60）
《中华损伤与修复杂志（电子版）》	1 707	39（2.28）	233（13.65）	1 435（84.07）
《第三军医大学学报》	6 033	4（0.07）	803（13.31）	5 226（86.62）
《中华危重病急救医学》	4 128	159（3.85）	688（16.67）	3 281（79.48）
注：前3本期刊统计烧伤医学领域临床试验，最后1本期刊统计重症医学领域临床试验；有随机对照设计的非烧伤/重症医学领域临床试验文献主要包括烧伤/重症医学领域以外临床试验、观察性临床研究（包括横断面研究、病例对照研究、队列研究等）、动物实验、细胞实验等，无随机对照设计研究主要包括综述、荟萃分析、个案报道、流行病学调查等

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表2 国际烧伤医学领域主要英文学术期刊2010—2020年发表所有文献分类[篇（%）]

期刊名	文献篇数	烧伤医学领域临床试验文献	其他文献
《Burns & Trauma》	265	6（2.26）	259（97.74）
《Burns》	3 140	155（4.94）	2 985（95.06）
《Wound Repair and Regeneration》	1 140	71（6.23）	1 069（93.77）
注：《Burns & Trauma》杂志于2013年6月18日创刊

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表3 2010—2020年国际期刊中由不同国家发表的烧伤医学领域临床试验文献数量（篇）

期刊名	美国	中国	英国
《Burns & Trauma》	0	1	0
《Burns》	22	14	6
《Wound Repair and Regeneration》	20	2	18
注：《Burns & Trauma》杂志于2013年6月18日创刊

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表4 不同国家2010—2020年烧伤医学领域临床研究与临床试验注册与完成情况[项（%）]

国别	临床研究		临床试验
国别	注册情况	完成情况	注册情况	完成情况
美国	357（42.50）	159（41.19）	292（43.52）	132（43.14）
中国	104（12.38）	27（6.99）	74（11.03）	19（6.21）
英国	23（2.74）	13（3.37）	17（2.53）	11（3.59）
其他	356（42.38）	187（48.45）	288（42.92）	144（47.06）
合计	840（100）	386（100）	671（100）	306（100）
注：临床研究包括临床试验、观察性研究（如病例对照研究、队列研究、横断面研究）等，其他指表中国家之外的国家

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