注射用丹参多酚酸盐与阿司匹林联用治疗冠心病心绞痛临床定位的四维度设计

现代中西药联合用药中,中医药一直有着其不可或缺的作用,对疾病有着不可替代的疗效,为了证明中药的精准定位,研究者应当采用多维度的设计,解决不同阶段不同需求的问题。本文以上市后药品注射用丹参多酚酸盐疗效评价精准定位为例,对四维度疗效评价及机制研究设计思路予以介绍,探索中医药在重大疾病治疗中不可或缺的治疗价值。首先,从HIS真实世界数据分析中发现了注射用丹参多酚酸盐常与阿司匹林联合使用治疗冠心病心绞痛,然后使用系统评价对注射用丹参多酚酸盐常与阿司匹林联合使用治疗冠心病心绞痛的疗效进行了验证,进一步采用网络药理学探索其疗效机制,发现二者联合用药对冠心病心绞痛的治疗有着共同的信号通路,有疗效增强和相加作用。最后,在前期3个维度的研究基础上,采用PRCT优效性试验设计,以血栓弹力图的检测作为客观评价指标,以验证注射用丹参多酚酸盐与阿司匹林联合用药治疗冠心病心绞痛的疗效。以期本范例为中药药品上市后疗效评价精准定位提供范例,供临床科研工作者参考和借鉴。

Four-dimensional Design of Clinical Localization of Salvianolate Injection Combined with Aspirin in the Treatment of Coronary Heart Disease Angina Pectoris

In modern times, traditional Chinese medicine(TCM)has always played an indispensable role in the combined use of traditional Chinese and western medicine, and has irreplaceable curative effects on diseases. To prove the accurate positioning of TCM, researchers should adopt multi-dimensional design to solve problems of different needs at different stages. In this paper, the precise positioning of the efficacy evaluation of Salvianolate Injection of post-marketing drugs was taken as an example to introduce the design ideas of the four-dimensional efficacy evaluation and mechanism research, in order to explore the indispensable therapeutic value of TCM in the treatment of major diseases. First of all, the HIS data analysis found in the real world for Salvianolate Injection is often associated with aspirin use in the treatment of coronary heart disease angina pectoris, and then the systematic evaluation was used for verifying the effects of Salvianolate Injection associated with aspirin in the treatment of coronary heart disease angina pectoris, further to explore the curative effect by using network pharmacology mechanism, which found common signaling pathways for the combination treatment of coronary heart disease angina pectoris and has efficacy enhancing and additive effect. Finally, on the basis of the previous three dimensional studies, PRCT optimal efficacy test design was adopted, and the detection of thrombus elasticogram was used as an objective evaluation index to verify the efficacy of Salvianolate Injection combined with aspirin in the treatment of coronary heart disease and angina pectoris. It is expected that this example will provide an example for the accurate positioning of the post-marketing efficacy evaluation of TCM drugs for the reference of clinical researchers.