国内外针刺治疗抑郁症临床研究文献的对比研究与思考

Literature regarding clinical research of acupuncture for depression in the worldwide:comparison and discussion

收集万方、维普、中国期刊全文数据库(CNKI)、PubMed数据库2004年1月至2015年3月期间发表的关于针刺治疗抑郁证的临床研究文献,采用Jadad标准对符合纳入标准的随机对照研究(RCT)文献的质量进行评价,按照2010版的CONSORT和STRICTA条目对所有研究的设计方案(研究对象、干预措施、效应评价等)进行对比与分析。有57篇文献纳入对比研究,其中46篇为RCT(国内核心期刊36篇,国内研究国外期刊发表6篇,国外研究4篇)。研究发现,国内发表的研究文献重视针灸辨证,针灸干预方式及生物学效应指标更丰富,国外发表的研究文献在RCT质量评分上占优,基线评估及效应评价体系方面更全面,并且更重视诊疗参数的量化设计。国内外针刺治疗抑郁症临床研究之间的差异不利于循证研究评价,整体研究质量需要进一步提升。今后的研究应参照统一标准设计与报道并重视临床试验注册,促进融合国内外研究成果并提升整体研究水平,这一过程可引入真实世界研究模式以激发针灸临床研究新的发展动力。

The literature regarding clinical research of acupuncture for depression published in Wanfang database,VIP database,CNKI database and PubMed from January of 2004 to March of 2005 was collected,and the quality of randomized controlled trial（RCT）that met the inclusive criteria was evaluated with Jadad.The research designs（research objective,intervention,effect assessment）were compared and analyzed by using the 2010 version of Consolidated Standards of Reporting Trials（CONSORT）and Standards for Reporting Interventions in Clinical Trials of Acupuncture（STRICTA）.As a result,a total of 57 articles were included in the comparative study,46 of which were RCTs（36articles were published in China core journals,6articles written by China were published in foreign countries,and 4articles were foreign researches）.It was found the literature of Chinese researches attached great importance to the syndrome differentiation of acupuncture,and various types of acupuncture intervention and biological effect indicators were applied;the literature of foreign researches presented advantages on RCT quality,and the baseline evaluation and effect evaluation systems were more comprehensive,in addition,more attention was paid to quantitative design of clinical parameters.It was concluded the differences between Chinese and foreign clinical research of acupuncture for depression were unfavorable for the evidence-based research,and the overall quality of researches was in need of improvement.It was recommended the future researchers should be designed and reported in accord with unified criteria,and the registration of acupuncture clinical trial should be valued,which could promote the integration of research results and improve the overall researches level.In this process,the research model of real world might be introduced to stimulate new development trends of acupuncture clinical research.