PMID- 34211572 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220424 IS - 1741-427X (Print) IS - 1741-4288 (Electronic) IS - 1741-427X (Linking) VI - 2021 DP - 2021 TI - Clinical Study for Safety Evaluation of GXN Tablets Combined with Aspirin in Long-Term Treatment of Coronary Heart Disease. PG - 6658704 LID - 10.1155/2021/6658704 [doi] LID - 6658704 AB - BACKGROUND: GXN tablets are composed of Danshen and Chuanxiong, with the functions of activating blood circulation, removing blood stasis, invigorating the pulse, and nourishing the heart, which are used for CHD patients with stable exertional angina Grade I or II (according to traditional Chinese medicine, it is a syndrome of heart and blood stasis with chest pain and dark purple lips and tongue). Clinical trials have shown satisfactory effects on coronary heart disease (CHD). 90.6% of Chinese patients with CHD use both Western medicine and Chinese medicine with the latter being thought to promote blood circulation and remove blood stasis. Some researchers doubt that the combination of Chinese medicine increases the risk of bleeding. The main objective of this study is to observe the safety of long-term use of Guanxinning (hereafter referred to as GXN) tablets combined with aspirin. METHODS: The study population is patients with CHD after percutaneous coronary intervention (PCI). Randomization was performed for patients with stable CHD who received dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel or ticagrelor for more than 12 months and then switched to the treatment with aspirin alone for 1 month. This study includes a total of 3,595 subjects in 63 hospitals. The experimental group took aspirin orally (100 mg, 1 time/day) + GXN tablets (0-6 months: 4 tablets/time, 3 times/day; 7-12 months, 4 tablets/time, 2 times/day), and the control group received oral aspirin (100 mg, 1 time/day). Major observation indicators are the incidence of bleeding events, adverse events (AEs), and adverse reactions. The primary endpoint indicators are the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) and the MACCE composite endpoint. RESULTS: A total of 31 cases of symptomatic bleeding were found in the two groups, including 21 cases (0.98%) in the experimental group and 10 cases (0.86%) in the control group; the difference between the two groups was not statistically significant. There were 29 cases (1.35%) of bleeding not reaching BARC type 1 in the experimental group. No attention was paid to the laboratory indicators in the control group during the trial process, so the bleeding as a laboratory indicator between the two groups was not comparable. For BARC type 3-5 bleeding events, there were 3 cases in the experimental group (0.139%) and 2 cases in the control group (0.172%); the difference between the two groups was not statistically significant and not clinically significant. During the trial period, there were a total of 255 cases of adverse reactions in 208 subjects with an incidence of 6.57% (141/2146) in the experimental group and 5.77% (67/1161) in the control group, and the P value was 0.5021; the difference between the two groups was not statistically significant. According to the analysis, the adverse reactions with a statistically significant difference between the two groups were gastrointestinal diseases, with the incidence in the experimental group being higher than that in the control group, and the main manifestations were gastrointestinal symptoms. There was no statistical difference in other types of adverse reactions between the two groups. In the trial period, there were 10 cases of serious adverse reactions, including 5 cases in the experimental group (5/2146, 0.23%) and 5 cases in the control group (5/ 1161, 0.43%), the P value was 0.3351; the difference in the incidence between the two groups was not statistically significant. CONCLUSION: For CHD patients with heart-blood stasis syndrome, the combination of aspirin and GXN tablets in the experimental group did not increase the incidence of bleeding events, nor did it increase the risk of bleeding of types 3-5 defined by BARC. Except for the increase in gastrointestinal symptoms, there was no increase in other adverse reactions in the experimental group. This trial is registered with Registration no. ChiCTR-IIR-17010688. CI - Copyright (c) 2021 Mingjie Zi et al. FAU - Zi, Mingjie AU - Zi M AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Li, Ruiqi AU - Li R AUID- ORCID: 0000-0002-2136-524X AD - Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China. AD - Cardiovascular Diseases Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. FAU - Lu, Fang AU - Lu F AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Li, Qingna AU - Li Q AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Zhao, Yang AU - Zhao Y AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Jia, Huijuan AU - Jia H AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Sun, Mingyue AU - Sun M AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Yang, Qiaoning AU - Yang Q AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Qiu, Panbo AU - Qiu P AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Wei, Eryang AU - Wei E AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Wang, Shuge AU - Wang S AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Li, Rui AU - Li R AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Zhang, Wantong AU - Zhang W AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Cao, Weiyi AU - Cao W AUID- ORCID: 0000-0001-9164-8643 AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Li, Yanling AU - Li Y AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. FAU - Xu, Hao AU - Xu H AUID- ORCID: 0000-0002-3139-4087 AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - Cardiovascular Diseases Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. FAU - Gao, Rui AU - Gao R AUID- ORCID: 0000-0003-2455-7615 AD - Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. AD - National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China. AD - NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, China. LA - eng PT - Journal Article DEP - 20210607 PL - United States TA - Evid Based Complement Alternat Med JT - Evidence-based complementary and alternative medicine : eCAM JID - 101215021 PMC - PMC8205569 COIS- The authors confirm that there are no known conflicts of interest associated with this research. EDAT- 2021/07/03 06:00 MHDA- 2021/07/03 06:01 PMCR- 2021/06/07 CRDT- 2021/07/02 06:38 PHST- 2020/12/24 00:00 [received] PHST- 2021/03/31 00:00 [revised] PHST- 2021/05/29 00:00 [accepted] PHST- 2021/07/02 06:38 [entrez] PHST- 2021/07/03 06:00 [pubmed] PHST- 2021/07/03 06:01 [medline] PHST- 2021/06/07 00:00 [pmc-release] AID - 10.1155/2021/6658704 [doi] PST - epublish SO - Evid Based Complement Alternat Med. 2021 Jun 7;2021:6658704. doi: 10.1155/2021/6658704. eCollection 2021.