文章摘要
洪寿海,张盈盈,徐福.近7年高影响因子SCI期刊针灸RCT研究分析与探讨[J].浙江中医药大学学报,2021,45(7):718-725.
近7年高影响因子SCI期刊针灸RCT研究分析与探讨
Analysis and Discussion of Acupuncture-related RCT Studies in High Impact Factor SCI Journals in Recent Seven Years
DOI:10.16466/j.issn1005-5509.2021.07.006
中文关键词: 针灸  临床研究  随机对照  高影响因子  SCI  探讨与分析
英文关键词: acupuncture  clinical research  randomized control  high impact factor  SCI  discussion and analysis
基金项目:国家自然科学基金青年项目(81804182、81603677);浙江省自然科学基金/探索项目Y(LY20H270008);浙江省中医药科技计划项目(2016ZA081)
作者单位
洪寿海 浙江中医药大学附属第一医院 杭州 310006 
张盈盈 浙江中医药大学 
徐福 浙江中医药大学附属第一医院 杭州 310006 
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中文摘要:
      [目的]通过对科学引文索引(science citation index,SCI)期刊收录的高影响因子针灸随机对照试验(randomized controlled trial,RCT)研究进行总结,了解高影响因子期刊发表针灸相关研究的现状,为今后针灸临床研究提供一定的参考。[方法]通过对Pubmed、Web of Science、Science Direct、Embas、Cochrane Library以及护理累积索引和联合卫生文献(Cumulative Index to Nursing and Allied Health Literature,CINAHL)数据库中影响因子大于10的针灸临床RCT研究文献进行检索,检索年限为2014年1月至2020年7月,对获得的文献进行总结与分析。[结果]共获得17篇高影响因子RCT研究的文献,国内发表的文献数量占总文献数量的41%。文献中涉及病种以疼痛类为主,占总文献病种的41%。研究中假针刺对照组设置越来越多,占总文献的76%,其中关于假针刺设计,以假穴位加假针灸针、不透皮针刺加假电针应用最多。在临床研究开展之前,有15篇文献的临床研究方案进行了注册,其中选择最多的注册平台为ClinicalTrials.gov(www.clinicaltrials.gov);并且有10篇提前进行了方案发表。对于试验研究中样本量、针刺治疗方案、针刺治疗选穴辨证等问题,都需要有前期预试验或别人的前期研究为基础,并在文献中详细说明。对于试验观察指标处理多采用意向性分析(intention-to-treat,ITT)原则。此外,试验研究中假针刺组得气与设盲问题、试验研究结果报告不规范问题等,需在今后研究中更加注意。[结论]高影响因子针灸临床RCT研究具有较严谨的试验设计和研究思路,通过对其进行分析与总结,可为今后针灸临床疗效及安全性评价提供更好的研究思路。
英文摘要:
      [Objective]To summarize the high-impact factor acupuncture and moxibustion randomized controlled trials(RCT) research included in science citation index(SCI) journals, in order to understand the current status of acupuncture-related research published in high-impact journals, and provide a certain reference for future acupuncture clinical research. [Methods] Through searching Pubmed, Web of Science, Science Direct, Embas, Cochrane Library, and Cumulative Index to Nursing and Allied Health Literature(CINAHL) database with an impact factor greater than 10 in clinical RCT research literature on acupuncture and moxibustion, the search period was from January 2014 to July 2020, and the literatures were summarized and analyzed.[Results] A total of 17 literatures on RCT research with high impact factors were obtained. After analysis, it was found that the number of published literature in China accounted for 41% of the total. The disease mentioned in the literature was mainly pain, accounting for 41% of the total diseases in the literature. In the study, more and more sham acupuncture control groups were set up, accounting for 76% of the total literature. Among them, sham acupuncture design with sham acupuncture points and sham acupuncture needles, non-permeable acupuncture and sham electric acupuncture were mostly used. Before the start of clinical research, clinical research protocols of 15 articles were registered, and the most selected registration platforms were ClinicalTrials.gov(www.clinicaltrials.gov); and 10 articles were published in advance. For the problems of sample size, acupuncture treatment plan, acupuncture treatment selection and differentiation of symptoms and signs in the experimental research, it is necessary to have preliminary pre-test or other people‘s preliminary study as the basis, and explain in detail in the literature. For the treatment of experimental observation indicators, the principle of intention-to-treat(ITT) is mostly used. In addition, the sham acupuncture group‘s problems of getting Qi and blinding, and the problems of non-standardized report of the experimental research results in the experimental research need to be paid more attention to in future research. [Conclusion] The high impact factor acupuncture clinical RCT research has more rigorous trial design and research ideas. Through continuous analysis and summary, it can provide better research ideas for the future clinical efficacy and safety evaluation of acupuncture.
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