Effect of Tongxinluo Capsules on TCM Syndrome Elements in Patients with Chronic Coronary Syndrome of Qi Deficiency and Blood Stasis Type： A Multicenter and Prospective Cohort Study
10.13422/j.cnki.syfjx.20251396
- VernacularTitle:通心络胶囊对气虚血瘀型慢性冠脉综合征患者中医证素的影响： 一项多中心、前瞻性队列研究
- Author:
Jia WANG
1
;
Xilun TAN
2
;
Xuesen WANG
1
;
Xiaohe YANG
1
;
Meili GAO
1
;
Yiying LIU
1
;
Chenhao ZHANG
1
Author Information
1. Wangjing Hospital of China Academy of Chinese Medical Sciences，Beijing 100102，China
2. Chongqing Medical University，Chongqing 400016，China
- Publication Type:Journal Article
- Keywords:
Tongxinluo capsule;
chronic coronary syndrome;
traditional Chinese medicine syndrome element;
major adverse cardiovascular event;
prospective cohort study
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(13):170-177
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo investigate the effects of Tongxinluo capsules on traditional Chinese medicine （TCM） syndrome elements and major adverse cardiovascular events （MACEs） in patients with chronic coronary syndrome of Qi deficiency and blood stasis type. MethodsA multicenter and prospective cohort study was conducted. The intervention of Tongxinluo Capsules was used as the exposure factor， and the patients were divided into an exposure group （integrated traditional Chinese and western medicine treatment group） and a non-exposure group （western medicine treatment group）. The patients were followed up for one year. The TCM syndrome element scores were assessed by using a syndrome element diagnosis scale on the day of enrollment and in the third， sixth， and twelfth months， and the incidence of MACE within one year was recorded. ResultsA total of 186 patients were included， with 128 patients in the exposure group and 58 patients in the non-exposure group. There was no significant difference in baseline data between the two groups. Compared with those in the pretreatment period for each group， the Qi deficiency and blood stasis syndrome scores in the treatment and follow-up period were significantly improved （P<0.05）. Compared with the non-exposure group， the exposure group exhibited significantly decreased Qi deficiency syndrome scores in the treatment and follow-up period （P<0.01） and significantly reduced blood stasis syndrome scores in the sixth month （P<0.05）. In the remaining follow-up period， there was no statistically significant difference between the two groups. Compared with that of the non-exposure group， during the treatment period （the third month）， the difference in Qi deficiency and blood stasis syndrome scores of the exposure group was statistically significant （P<0.05， P<0.01）. At the end of the follow-up period， patients in the non-exposure group had a MACE probability of 6.90% （4/58）， higher than 3.13% in the exposure group （4/58）. Compared with patients with angina pectoris who used conventional medicine， patients administered with Tongxinluo Capsules had a relative risk（RR） of 0.45 ［95%confidence interval（95%CI） 0.12-1.75， P=0.26］. There was no significant difference in the incidence of MACE within one year between the two groups. ConclusionTongxinluo capsules can improve the degree of Qi deficiency in patients with chronic coronary syndrome in the short term， and the improvement effect of blood stasis syndrome appears in the medium and long term. They can better improve the Qi deficiency syndrome in the long term. Within one year， the incidence of MACE in the exposure group was lower than that in the non-exposure group.
