Chinese Journal of Pharmacovigilance ›› 2024, Vol. 21 ›› Issue (8): 910-915.
DOI: 10.19803/j.1672-8629.20230583

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Efficacy and safety of salvianolic acid preparations for adjuvant therapy on related diseases of coronary heart disease, angina and cerebral infarction: a systematic review

ZHANG Jing1, ZHANG Kai2, YI Zhanmiao3,4,*   

  1. 1Department of Pharmacy, Beijing Yangfangdian Hospital, Beijing 100038, China;
    2Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China;
    3Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China;
    4Institute for Drug Evaluation, Peking University Health Science Center, BeiJing 100191, China
  • Received:2023-09-15 Online:2024-08-15 Published:2024-08-21

Abstract: Objective To evaluate the efficacy and safety of salvianolic acid salts for injection and salvianolic acid for injection (referred to as “salvianolic acid preparations”) for adjuvant therapy on related diseases of coronary heart disease, angina and cerebral infarction. Methods Randomized controlled trials of adverse cardiovascular events of salvianolic acid preparations for adjuvant treatment on related diseases of coronary heart disease, angina and cerebral infarction were collected by searching PubMed, Embase, Cochrane Library, CNKI, WanFang Data and VIP, et al. from the inception to February 1, 2023. The quality and Meta-analysis of the included studies were evaluated. Results A total of 16 RCTs involving 2 018 patients were included. The results of the Meta-analysis showed that salvianolic acid preparations for adjuvant therapy on related diseases of coronary heart disease and angina could significantly reduce the risk of the composite outcomes of MACEs [RR=0.46, 95%CI(0.31, 0.67), P<0.001], [NNT=12.19, 95%CI(11.71,12.68)] and angina [RR=0.49, 95%CI(0.33, 0.73),P<0.001], [NNT=14.44, 95%CI (13.88, 14.99)] in the 180 d follow-up subgroup, and there were no significant differences in the risk of cardiovascular death, myocardial infarction, stroke, revascularization between the intervention group and the control group. There was no statistical difference in the risk of adverse drug reactions between the intervention group and the control group (P=0.10). Major adverse drug reactions were elevated ALT/AST, abdominal distension, nausea, dizziness/headache, fatigue and so on. There was no statistical difference in the risk of various adverse drug reactions (P=0.25). Conclusion In the 180 d follow-up subgroup, salvianolic acid preparations for the adjuvant therapy on related diseases of coronary heart disease and angina could reduce the risk of angina, and were safe. But the above conclusions still need further confirmation.

Key words: salvianolic acid, adjuvant therapy, major adverse cardiovascular events(MACEs), coronary heart disease, angina, cerebral infarction, systematic review, Meta-analysis

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