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企业和非公企业科协,面向广大科技工作者征集“2019重大前沿科学问题与工程技术难题”,中华中医药学会征集了相关问题并分类、凝练,经专家论证后遴选出中医药领域3项重大科学问题和3项工程技术难题,并于2019年6月发布[24]。
其中,中醫临床研究方法学,特别是中医临床疗效评价创新方法与技术是中医药当前的工程技术难题,是影响中医药核心竞争力的关键。其中有一些亟待解决的关键问题,如:中医证候最小化核心症状的筛选、中医药个体化动态诊疗与现代临床流行病学中序贯试验等相结合的适用性评价、中医所关注的结局与国际公认结局的差异和对其可能的补充、中药安慰剂的制作、针刺手法的客观化呈现和评价、安慰针刺的制作和理论论证、中医药诊疗过程中的人文关怀作用,以及中医药临床试验质量评价技术(如中医诊断、辨证质控和评价、中医药干预措施质控和合理性评价、试验数据质控和合理性评价、中医四诊信息采集质控)等。
如何解决这些问题,目前并没有标准的、公认的方法,但已有研究者尝试通过SWAT和ROR研究来寻找证据。如专家提出,中医所关注的结局与国际公认结局的差异和对其可能的补充是当前需要解决的关键问题之一,对此,国内研究者已开展了相关的SWAT和ROR研究,如研究者提出中医临床研究核心指标集的构建方法,包括中医核心证候指标集[9],并以非瓣膜性房颤为例,验证了该方法的可行性[30-31]。在该项研究中,研究者针对核心指标集研究方法中存在的不确定因素嵌入了方法学研究,如采用不同方法评估德尔菲调查中可能影响核心指标集研究结果的因素,丰富了核心指标集研究的方法学。
4 总结
在当前中医临床研究水平低下、中医质量不高的情况下,通过证据而非经验来发现问题并找到解决问题的方法,不仅能丰富和完善中医临床研究方法学,也有助于提高临床研究质量和水平、减少研究浪费。将SWAT和ROR 2种研究模式引入到中医临床研究中,可能会为中医临床研究的设计与实施提供证据,促进循证中医药学的实践与发展。
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(2019-09-10收稿 责任编辑:徐颖)
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