中西药联合应用下评价中药作用的模式探索＊

中西药合用是临床常用的干预策略和治疗手段,是在中西医两种医学体系相互取长补短的原则下实现二者的有机结合。如何真正将中医、西医两种医学进行结合,如何保证中药、西药叠加使用的效果是增效,实现两者优势互补,最大程度地提高临床治疗效果,保障人民身体健康,已成为当今社会极待解决的热点课题。目前的中西药联合模式研究仍存在诸多不足,如不良反应多,干预人群不明确,配伍不合理,机理不清楚,临床与基础研究脱节,同时仍缺乏高质量循证证据。鉴于目前中西医结合模式的局限性和评价中药作用模式的探索,我们提出COMTSM模式作为中西药联合应用的规范化研究方法,即结合（C: Combine）门诊数据挖掘（O: retrospective analysis of Outpatient cases）、Meta分析（M: Meta-analysis）、随机对照试验（T: randomized controlled Trial）、精准人群分析（S: Stratified analysis of clinical research）、机理机制研究（M: Mechanism research）。在COMTSM模式下研究津力达颗粒治疗糖尿病。中药津力达颗粒（JLD）在应用降糖西药基础上,可发挥出进一步的降糖、改善胰岛β细胞等作用,用高质量的循证证据表明中西药联合应用情况下中药有明显的增效作用。COMTSM模式评价中药作用成果显著,COMTSM模式主要用于中药的规范化研究,以获得高质量的循证证据,为其它中西药联合应用提供了规范化研究方法,也提出了新的适合中药应用的研究模式,为未来更多的中医药在COMTSM模式下研究提供了方向的引导,发挥中药防治疾病、改善临床症状,提高患者生活质量等积极作用。

Exploring the Mode of Evaluating the Role ofTraditional Chinese Medicine under the Combined Application of Chinese and Western Medicine

The combination of traditional Chinese medicine and Western medicine is an intervention strategy and treatment method commonly used in clinic. It realizes the organic combination of traditional Chinese medicine and Western medicine under the principle of complementing each other"s strengths and weaknesses.How to truly combine traditional Chinese medicine and Western medicine, how to ensure that the effect of superimposed use of traditional Chinese medicine and Western medicine is synergistic, to achieve complementary advantages, to maximize the clinical efficacy, and to protect people s health, is a hot topic to be solved in today"s society.At present, there are still many deficiencies in the study of the combined mode of Chinese and Western medicine, such as many adverse reactions, unclear intervention population, unreasonable compatibility, unclear mechanism, clinical and basic research disconnection, and lack of high-quality evidence-based evidence.In view of the limitations of the current mode of integrated Chinese and Western medicine and the exploration of evaluating the mode of action of traditional Chinese medicine, we propose COMTSM mode as a standardized research method of combined application of Chinese and Western medicine, i.e. O: Outpatient data analysis, M: Meta-analysis, and T: randomized controlled Tr. Ial), S: Stratified analysis of clinical research, and M: Mechanism research.The treatment of diabetes mellitus with Jinlida Granule(JLD) was studied under COMTSM mode. Based on the application of hypoglycemic western medicine, JLD can further reduce blood sugar and improve islet beta cells. High-quality evidence shows that the combination of traditional Chinese medicine and Western medicine has obvious synergistic effect.COMTSM model has achieved remarkable results in evaluating the role of traditional Chinese medicine. COMTSM model is mainly used in the standardized research of traditional Chinese medicine, in order to obtain high-quality evidence-based evidence, provide standardized research methods for the combined application of other traditional Chinese and Western medicine, and also put forward a new research model suitable for the application of traditional Chinese medicine, which provides direction guidance for more research of traditional Chinese medicine under COMTSM model in the future, and give full play to the prevention and treatment of diseases of traditional Chinese medicine. Disease, improve clinical symptoms, improve the quality of life of patients and other positive effects.