丹参酚酸制剂辅助治疗冠心病、心绞痛及脑梗死相关疾病有效性及安全性的系统评价

doi:10.19803/j.1672-8629.20230583

摘要/Abstract

摘要： 目的评价注射用丹参多酚酸盐和注射用丹参多酚酸（简称“丹参酚酸制剂”）辅助治疗冠心病、心绞痛及脑梗死相关疾病的有效性及安全性。方法检索PubMed、Embase、Cochrane Library、中国知网、万方数据、维普网等数据库,自建库起至2023年2月1日,收集丹参酚酸制剂辅助治疗冠心病、心绞痛及脑梗死相关疾病不良心血管事件的随机对照试验研究,对纳入的研究进行质量评价和Meta分析。结果共纳入16项研究,2 018例患者。Meta分析结果显示,在随访180 d亚组中,丹参酚酸制剂辅助治疗冠心病、心绞痛相关疾病可显著降低主要不良心血管事件复合结局[相对危险度,RR=0.46,95%CI（0.31, 0.67）, P<0.001]、[NNT=12.19,95%CI（11.71, 12.68）]和心绞痛[RR=0.49,95%CI（0.33, 0.73）, P<0.001]、[NNT=14.44,95%CI（13.88,14.99）]的发生风险,但对降低心血管死亡、心肌梗死、脑卒中、血运重建的发生风险差异无统计学意义。药品不良反应发生风险差异无统计学意义（P=0.10）;不良反应主要表现为ALT/AST升高、腹胀、恶心、头晕/头痛、乏力等,各不良反应的发生风险差异无统计学意义（P=0.25）。结论在随访180 d亚组中,丹参酚酸制剂辅助治疗冠心病、心绞痛相关疾病可降低心绞痛的发生风险,且安全性良好,但尚需进一步证实。

关键词: 丹参酚酸, 辅助治疗, 主要不良心血管事件, 冠心病, 心绞痛, 脑梗死, 系统评价, Meta分析

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

中图分类号:

R972
R994.11

张静, 张恺, 易湛苗. 丹参酚酸制剂辅助治疗冠心病、心绞痛及脑梗死相关疾病有效性及安全性的系统评价[J]. 中国药物警戒, 2024, 21(8): 910-915.

ZHANG Jing, ZHANG Kai, YI Zhanmiao. Efficacy and safety of salvianolic acid preparations for adjuvant therapy on related diseases of coronary heart disease, angina and cerebral infarction: a systematic review[J]. Chinese Journal of Pharmacovigilance, 2024, 21(8): 910-915.

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参考文献

[1] JI GW, CHENG CX, YIN KW, et al.Artemisinin, the magic drug discovered from Traditional Chinese Medicine[J]. Engineering, 2019, 5(1): 32-39.
[2] NHC. Diagnosis and treatment of novel coronavirus infection (trial 10th edition)[EB/OL]. (2023-01-06)[2024-03-02]. http://www.nhc.gov.cn/ylyjs/pqt/202301/32de5b2ff9bf4eaa88e75bdf7223a65a.shtml.
[3] HAN S, ZHAO XZ, SHI LW, et al.Comprehensive pharmacological evaluation of salvia miltiorrhiza depside salts for injection[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2021, 56(5): 422-428.
[4] National Pharmacopoeia Committee.Pharmacopoeia of the people’s Republic of China volume I (中华人民共和国药典一部)[M]. Beijing: China Medical Science and Technology Press, 2020: 415-416.
[5] JULIAN H, JAMES T, JACQUELINE C, et al. Cochrane handbook for systematic reviews of interventions version 6.3[EB/OL]. (2022-11-14)(2023-10-25). https://training.cochrane.org/handbook.
[6] CHENG F, LIU XF, FENG YY.Effect and the mechanism of salvianolate on platelet activation in patients with ACS[J]. Journal of Tropical Medicine(热带医学杂志), 2016, 16(8): 1012-1015.
[7] LIU TZ, CAO GY, WANG WZ, et al.Effects of salvianolate on oxidative stress, cardiac function and vascular endothelial function in patients with emergency PCI[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine(现代中西医结合杂志), 2020, 29(10): 1089-1092.
[8] ZHANG ZP, LI J, LIU YM, et al.The clinical study of salvianolate with intervention bioinformatics of patients with non-ST-segment elevation myocardial infarction[J]. International Journal of Traditional Chinese Medicine(国际中医中药杂志), 2021, 43(1): 27-31.
[9] ZHU GL, WANG DL.Effect of salvianolate injection combined with rosuvastatin in the treatment of elderly acute myocardial infarction and its effect on NF-κB inflammatory signaling pathway[J]. Chinese Journal of Gerontology(中国老年学杂志), 2021, 41(16): 3400-3404.
[10] XING JF, CUI HM, LIU HQ, et al.Study on the efficacy and safety of salvia miltiorrhiza polyphenolate in patients with non-ST-elevation acute coronary syndrome after PCI[J]. Chinese Journal of Difficult and Complicated Cases(疑难病杂志), 2021, 20(1): 13-21.
[11] OU Y, SUN SJ, SHI HM, et al.Protective effects of salvianolate on myocardial injury or myocardial infarction after elective percutaneous coronary intervention in NSTE-ACS patients: a randomized placebo-controlled trial[J]. Chinese Journal of Integrative Medicine, 2020, 26(9): 656-662.
[12] XU XY, WANG CG, ZHANG XM.Observation on efficacy and safety of salvianolic acids for injection in treatment of anterior circulation acute cerebral infarction[J]. Chinese Journal of practical Nervous Diseases(中国实用神经疾病杂志), 2020, 23(2): 108-113.
[13] CUI H, LI XY, GAO XW, et al.A prospective randomized multicenter controlled trial on salvianolate for treatment of unstable angina pectoris in a Chinese elderly population[J]. Chinese Journal of Integrative Medicine, 2019, 25(10): 728-735.
[14] ZHANG YF, XU BX, ZHAO Y, et al.Effects of salvianolate on vascular endothelial function and MACE in young and middle-aged patients with acute coronary syndrome after PCI[J]. Chinese Journal of Integrative Medicine on Cardio-cerebrovascular Disease(中西医结合心脑血管病杂志), 2020, 18(20): 3422-3424.
[15] SHI XH.Effects of salvianolate injection on cardiac function, renal function, myocardial injury in percutaneous coronary intervention postoperative patients with coronary heart disease[J]. Shaanxi Journal of Traditional Chinese Medicine(陕西中医), 2019, 40(5): 568-571.
[16] HOU LF, SHOU YF.Effects of salvianolate injection on myocardial injury, nerve endocrine hormones, vascular endothelial function and cardiac function associated with PCI[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine(现代中西医结合杂志), 2018, 27(23): 2573-2576.
[17] WU DX, ZHU J, CAI WY, et al.Effects of salvianolate on oxidative stress and vascular endothelial function in patients with acute myocardial infarction by treatment of PCI[J]. Journal of Clinical Medicine in Practice(实用临床医药杂志), 2016, 20(19): 16-19.
[18] GAO LL, LI YH, LI FX, et al.The effects of Danshen polyphenolic acid combined with dual antiplatelet drugs on patients with CYP2C19 gene mutation after intracranial and extracranial stenting[J]. Stroke and Nervous Diseases(卒中与神经疾病), 2019, 26(2): 206-213.
[19] LIN JY, WANG HQ.A preliminary study on the reduction of PCI associated myocardial infarction by salvianolate[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2018, 35(6): 884-887.
[20] LIU Y, DENG B, XU JH, et al.Effect of polydanshinolate on myocardial reperfusion after percutaneous coronary interventions in patients with acute myocardial infarction[J]. Clinical Medicine of China(中国综合临床), 2010, 26(2): 121-126.
[21] LI CL, CHEN ZL, CHEN GC.Effect of salvianolate on perioperative myocardial injury in patients with angina pectoris of coronary heart disease treated with PCI[J]. Journal of Emergency in Traditional Chinese Medicine(中国中医急症), 2015, 24(7): 1235-1237.
[22] SUN G, LI X, WEI J, et al.Pharmacodynamic substances in Salvia miltiorrhiza for prevention and treatment of hyperlipidemia and coronary heart disease based on lipidomics technology and network pharmacology analysis[J]. Biomedicine & Pharmacotherapy, 2021, 141: 111846.
[23] BOHAN L, TIAN A, TINGYE W, et al.Effects of salvianolic acid B on glycometabolism and lipid metabolism in rodents: Meta-analysis[J]. Traditional Medicine and Modern Medicine, 2020, 3(3): 175-183.
[24] LAN Y, RENJIE Z, SHIYANG H, et al. Effects of salvianolic acid A and salvianolic acid B in renal interstitial fibrosis via PDGF-C/PDGFR-α signaling pathway[J]. Phytomedicine, 2022, 106: 154414.
[25] YAO XH, XIAO HB, BIAN JQ, et al.New progress in mechanism of salviae miltiorrhizae radix et rhizoma in treatment of diabetes and its complications[J]. Chinese Journal of Experimental Traditional Medical Formulae(中国实验方剂学杂志), 2021, 27(7): 209-218.
[26] HAN L, SU Y, CHEN B, et al.Association of coronary slow flow with the risk of major adverse cardiovascular and cerebrovascular events[J]. Journal of Qingdao University(Medical Sciences)(青岛大学学报医学版), 2020, 56(3): 318-322.
[27] SUN JJ, HE Y.A case of neutropenia induced by salvianolate for injection[J]. Herald of Medicine(医药导报), 2022, 41(1): 125-126.
[28] LIU YF, CAO XH, ZHANG XM.Effect of salvianolic acids for injection combined with tirofiban on NIHSS and mRS scores in patients with acute progressive cerebral infarction[J]. Drug Evaluation Research(药物评价研究), 2020, 43(8): 1635-1638, 1650.
[29] CHENG JQ, SHI QP, JIANG XD, et al.Meta-analysis of incidence rates and influencing factors of adverse drug reactions related to salvianolate injection[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2020, 37(11): 1355-1364.