[1]成舟 陈丽芳 谭登 闵文△.中药熏洗治疗跟痛症的临床试验质量评价[J].中国中医骨伤科杂志,2018,26(02):76-80.
　CHENG Zhou CHEN Lifang TAN Deng MIN Wen.Quality Assessment of Clinical Trials of TCM Fumigation Treating Heel Pain[J].Chinese Journal of Traditional Medical Traumatology & Orthopedics,2018,26(02):76-80.
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中药熏洗治疗跟痛症的临床试验质量评价()
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《中国中医骨伤科杂志》[ISSN:1005-0205/CN:42-1340/R]

卷:
第26卷
期数:
2018年02期
页码:
76-80
栏目:
文献研究
出版日期:
2018-01-15

文章信息/Info

Title:
Quality Assessment of Clinical Trials of TCM Fumigation Treating Heel Pain
文章编号:
1005-0205(2018)02-0076-05
作者:
成舟1 陈丽芳2 谭登1 闵文1; 2△
1南京中医药大学第一临床医学院(南京,210029) 2南京中医药大学国际教育学院
Author(s):
CHENG Zhou1 CHEN Lifang2 TAN Deng1 MIN Wen1; 2△
1The First Clinical Medical College of Nanjing University of Chinese Medicine Nanjing 210029,China; 2College of International Education,Nanjing University of Chinese Medicine,Nanjing 210029,China.
关键词:
中药熏洗;  跟痛症;  临床试验;  CONSORT-中药复方;  改良Jadad评分量表;  质量评价
Keywords:
Keywords: TCM steam wash;  heel pain;  clinical trials;  CONSORT-CHM formulas;  improved Jadad scale;  quality assessment
分类号:
R681.8
文献标志码:
A
摘要:
目的:采用国际公认的CONSORT-中药复方和改良Jadad评分量表对近10年相关文献进行回顾分析,初步探讨中药熏洗治疗跟痛症随机对照试难(RCT)的质量状况,为今后进行中医药临床试验提供借鉴和思路。方法:计算机检索中国知网、万方、维普三方数据库,对纳入文献中的中药熏洗治疗跟痛症随机对照试验采用CONSORT-中药复方和改良Jadad评分量表进行质量评价。结果:检索得410篇文献,经筛选后共纳入43篇文献。参照CONSORT-中药复方中25条标准,仅有1篇在篇名及关键词中提及随机对照试验,3篇提及盲法,无文献描述样本量的计算,11篇提及随机分配的方法。此次纳入文献的研究结论均为阳性,但均未介绍效应大小及精度,亦无文献进行意向性分析(ITT)。据改良Jadad评分量表,纳入的43篇文献均在0～3分之间。结论:国内近10年中药熏洗治疗跟痛症的随机对照试验质量普遍较低,研究者在参考及引用此类结果时需谨慎考量其真实性和准确性,并在今后中医药临床研究中高度重视和认真参照CONSORT-中药复方和改良Jadad评分量表,提高中医药临床试验质量。
Abstract:
Abstract Objective:To assess related literature retrospectively in recent 10 years by internationally recognized CONSORT-CHM formulas & improved jadad scale and to explore the quality of RCT of TCM fumigation treating heel pain,providing reference and ideas for the future clinical trials of traditional Chinese medicine.Methods:The literature retrieved from CNKI,WANFANG,WEIPU(VIP)Websites was presented using CONSORT-CHM formulas & improved jadad scale for quality evaluation.Results:A total of 43 articles screened from the preliminary 410 articles are included.With reference to the 25 standards in the CONSORT-CHM formulas,only one referred to randomized controlled trials in the title and abstract.3 articles are referred to blindness; No literature is used to describe the sample size; 11 articles refer to the random allocation method.The results of this study are positive,but none of the effects of size and accuracy were introduced,and there was no intention-to-treat analysis(ITT).According to Improved Jadad Scale,43 articles were included between 0 and 3 points.Conclusion:In recent 10 years,the quality of randomized controlled trial of TCM steam & wash treating HeelPain is generally low in China.Researchers need to carefully consider its authenticity and accuracy when referring to and referencing such results,and in the future attach great importance to and seriously refer to CONSORT-CHM formulas and improved jadad scale,and effectively improve the quality of clinical trials of Chinese medicine.

参考文献/References:

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备注/Memo

备注/Memo:
基金项目:江苏省基础研究计划(自然科学基金)-面上研究 项目(BK20151357) 南京大学计算机软件新技术国家重点实验室资助 项目(KFKT2014B20) △通信作者 E-mail:wenge1977@126.com
更新日期/Last Update: 2018-02-15