中医食疗证型适用性的证据分级方法构建

An Approach for Grading Syndrome Suitability of Dietary Therapy in Traditional Chinese Medicine

明确中医食疗方案对不同证型的适用性(适用或忌用)是中医食疗合理应用和安全性的保障。构建了一套综合考虑古籍、现代研究和专家经验证据的中医食疗证型适用性分级系统(GRADE-SSD)。GRADESSD根据当前可得最高质量证据,将中医食疗对各中医证型的适用性分为2类4级:“确定”适用/忌用(A级)、“很可能”适用/忌用(B级)、“可能”适用/忌用(C级)、证据不足无法确定(D级)。应用时,首先系统检索当前可用的古籍和临床研究证据,针对不同证据(中医古籍、随机对照试验、观察性研究和meta分析)采用规定工具评价证据质量,再以质量“就高”原则确定食疗的中医证型适用性级别。若缺乏直接证据,GRADE-SSD支持基于“类方”间接证据的降级评价。当缺乏古籍和临床研究时,可采用GRADE-SSD方案评价行业共识或专家意见证据质量,用于食疗的中医证型适用性级别。基于中医食疗对安全性的要求,当“适用”和“忌用”证据同时存在时应考虑为“忌用”证据。GRADE-SSD还提供了基于未来新证据的证据确定性更新方案。GRADE-SSD评价结果可为中医食疗临床试验设置纳入/排除标准和食疗产品标签中声明各证型适用性提供依据。

Clarifying the applicability(indications or contraindications)of traditional Chinese medicine(TCM)dietary regimens to different syndromes is a guarantee for the rational application and safety of TCM dietary therapy.By considering evidence from ancient literature,modern research and experts'experience,the Grading System for Syndrome Suitability of Dietary Therapy in TCM(GRADE-SSD)has been constructed.According to the currently available highest-quality evidence,GRADE-SSD classified the applicability of TCM dietary therapy to various TCM syndromes into 2 categories and 4 grades:"definitely"applicable/contradicted(Grade A),"very likely"applicable/contradicted(Grade B),"possibly"applicable/contradicted(Grade C),and insufficient evidence to determine(Grade D).When applying,first,systematically search the currently available ancient books and clinical research evidence.For different types of evidence(ancient TCM books,randomized controlled trials,observational studies,and meta-analyses),use the prescribed tools to evaluate the quality of the evidence,and then determine the applicability level of TCM syndromes of dietary therapy based on the principle of"taking the highest"quality.If there is a lack of direct evidence,GRADE-SSD supports a downgraded evaluation based on indirect evidence of"similar prescriptions".When there is a lack of ancient books and clinical research,the GRADE-SSD plan can evaluate the quality of evidence from peer consensus or expert opinions for the applicability level of TCM syndromes of dietary therapy.Based on the requirements for the safety of TCM dietary therapy,when there is both"applicable"and"contradicted"evidence,it should be considered as"contradicted"evidence.GRADE-SSD also provides an evidence certainty update plan based on new evidence in the future.The evaluation results of GRADE-SSD can provide a basis for setting inclusion/exclusion criteria in clinical trials of TCM dietary therapy and stating the applicability of each syndrome in the labels of dietary therapy products.