{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,30]],"date-time":"2026-08-30T03:31:55Z","timestamp":1788060715932,"version":"build-2784847793"},"reference-count":18,"publisher":"Wiley","license":[{"start":{"date-parts":[[2021,6,7]],"date-time":"2021-06-07T00:00:00Z","timestamp":1623024000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Construction of Clinical Evaluation Technology Platform for New Drugs","award":["2017ZX09304003"],"award-info":[{"award-number":["2017ZX09304003"]}]},{"name":"NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine","award":["2017ZX09304003"],"award-info":[{"award-number":["2017ZX09304003"]}]},{"name":"National Clinical Research Center","award":["2017ZX09304003"],"award-info":[{"award-number":["2017ZX09304003"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Evidence-Based Complementary and Alternative Medicine"],"published-print":{"date-parts":[[2021,6,7]]},"abstract":"<jats:p>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\u2009mg, 1 time\/day)\u2009+\u2009GXN tablets (0\u20136 months: 4 tablets\/time, 3 times\/day; 7\u201312 months, 4 tablets\/time, 2 times\/day), and the control group received oral aspirin (100\u2009mg, 1\u2009time\/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\u20135 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 <jats:inline-formula>\n                     <a:math xmlns:a=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M1\">\n                        <a:mi>P<\/a:mi>\n                     <\/a:math>\n                  <\/jats:inline-formula> 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 <jats:inline-formula>\n                     <c:math xmlns:c=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M2\">\n                        <c:mi>P<\/c:mi>\n                     <\/c:math>\n                  <\/jats:inline-formula> 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\u20135 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.<\/jats:p>","DOI":"10.1155\/2021\/6658704","type":"journal-article","created":{"date-parts":[[2021,6,9]],"date-time":"2021-06-09T05:49:55Z","timestamp":1623217795000},"page":"1-8","source":"Crossref","is-referenced-by-count":7,"title":["Clinical Study for Safety Evaluation of GXN Tablets Combined with Aspirin in Long-Term Treatment of Coronary Heart Disease"],"prefix":"10.1155","volume":"2021","author":[{"given":"Mingjie","family":"Zi","sequence":"first","affiliation":[{"name":"Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China"},{"name":"National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China"},{"name":"NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing 100091, 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