芪参益气滴丸联合西药治疗对经皮冠状动脉介入术后不良心血管事件及生活质量影响的Meta分析Meta-analysis of effect of Qishen Yiqi Dripping Pills combined with Western medicine on adverse cardiovascular events and quality of life after percutaneous coronary intervention
代倩倩;石兆峰;胡嘉元;韩松洁;钟长鸣;关曼柯;田贵华;商洪才;
DAI Qian-qian;SHI Zhao-feng;HU Jia-yuan;HAN Song-jie;ZHONG Chang-ming;GUAN Man-ke;TIAN Gui-hua;SHANG Hong-cai;Dongzhimen Hospital,Beijing University of Chinese Medicine;
摘要(Abstract):
系统评价芪参益气滴丸联合西药治疗对经皮冠状动脉介入(PCI)术后不良心血管事件及生活质量的影响。计算机检索中国期刊全文数据库(CNKI)、万方数据库(Wanfang)、维普数据库(VIP)、中国医学文献数据库(SinoMed)、PubMed、Cochrane Library和Web of Science共7个中英文数据库,收集芪参益气滴丸联合常规西药治疗冠心病患者PCI术后的随机对照试验(RCT),检索时限从建库至2020年4月1日。2名研究人员独立进行文献筛选、资料提取与偏倚风险评价后,采用RevMan 5.3软件进行Meta分析。共纳入31项RCTs, 3 537例患者。Meta分析结果显示,在PCI术后主要不良心血管事件(MACE)方面,联用芪参益气滴丸可显著减少心绞痛复发、心律失常、心力衰竭以及再次血运重建事件的发生,优于常规西药治疗;而在改善非致死性心肌梗死、心源性死亡、支架内再狭窄、脑卒中等其他不良心血管事件方面,2组无明显差异。在改善左室射血分数(LVEF)、6 min步行试验(6MWT)、高敏C反应蛋白(hs-CRP)和西雅图心绞痛量表(SAQ)方面,联用芪参益气滴丸较常规西药治疗有明显优势,可升高LVEF,6MWT,SAQ,降低hs-CRP水平,差异均有统计学意义。2组患者发生不良反应较少,差异无统计学意义,主要表现为胃肠道反应、皮疹、牙龈等小出血,无严重不良反应,停药或对症处理后可消失。应用芪参益气滴丸联合西药治疗PCI术后患者可减少MACE的发生,提高临床疗效,改善生活质量和预后,且安全可靠。受纳入研究数量和质量的限制,仍需开展更多规范、严谨、高质量的临床研究进一步验证上述结论。
To systemically evaluate the effect of Qishen Yiqi Dripping Pills combined with Western medicine on adverse cardiovascular events and quality of life after percutaneous coronary intervention(PCI). A total of 7 Chinese and English databases including CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library and Web of Science were searched by computer to collect the randomized controlled trials(RCTs) on Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients with coronary heart disease after PCI with the retrieval time from the database establishment to April 1, 2020. Two researchers independently conducted li-terature screening, data extraction and bias risk assessment. Then, Meta-analysis was performed by using RevMan 5.3 software. A total of 31 RCTs were included, involving 3 537 patients. The results of Meta-analysis showed that in terms of major adverse cardiovascular events(MACE) after PCI, the combination of Qishen Yiqi Dripping Pills could significantly reduce the recurrence of angina pectoris, incidence of arrhythmia, heart failure and re-revascularization, and the effect was better than that of Western medicine treatment alone. However, there was no significant difference between the two groups in the improvement of non-fatal myocardial infarction, cardiac death, stent restenosis, stroke and other adverse cardiovascular events. In terms of improving left ventricular ejection fraction(LVEF), 6 min walking test(6 MWT), high-sensitivity C-reactive protein(hs-CRP) and Seattle angina pectoris scale(SAQ), the combination of Qishen Yiqi Dripping Pills and Western medicine treatment had obvious advantages over Western medicine treatment alone in increasing LVEF, 6 MWT and SAQ, and reducing the level of hs-CRP, with statistically significant differences. There were few adverse reactions in both groups, and there was no significant difference between the two groups. The main manifestations were gastrointestinal reactions, rash, gingiva and other small bleeding, and no serious adverse reactions occurred. The above reactions could disappear after drug withdrawal or symptomatic treatment. The application of Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients after PCI could reduce the occurrence of MACE, improve the clinical efficacy, quality of life and prognosis in a safe and reliable manner. However, due to the quantity and quality limitations of included studies, more standardized, rigo-rous and high-quality clinical studies are still needed to further verify the above conclusions.
关键词(KeyWords):
芪参益气滴丸;冠心病;经皮冠状动脉介入术;主要不良心血管事件;Meta分析
Qishen Yiqi Dropping Pills;coronary heart disease;percutaneous coronary intervention;major adverse cardiovascular events;Meta-analysis
基金项目(Foundation): 中共中央组织部第二批国家“万人计划”(2016)项目(W02020052)
作者(Author):
代倩倩;石兆峰;胡嘉元;韩松洁;钟长鸣;关曼柯;田贵华;商洪才;
DAI Qian-qian;SHI Zhao-feng;HU Jia-yuan;HAN Song-jie;ZHONG Chang-ming;GUAN Man-ke;TIAN Gui-hua;SHANG Hong-cai;Dongzhimen Hospital,Beijing University of Chinese Medicine;
Email:
DOI: 10.19540/j.cnki.cjcmm.20200618.501
参考文献(References):
- [1] 杨光,何浩强,陈光,等.中药调节肠道菌群干预冠心病及其危险因素的研究进展[J].中国中药杂志,2020,45(1):29.
- [2] 中华医学会心血管病学分会介入心脏病学组,中国医师协会心血管内科医师分会血栓防治专业委员会,中华心血管病杂志编辑委员会,等.中国经皮冠状动脉介入治疗指南 (2016) [J].中华心血管病杂志,2016,44(5):382.
- [3] 史利锋,林平.经皮冠状动脉介入治疗患者术后心脏不良事件的发生情况及影响因素[J].中华护理杂志,2015,50(12):1449.
- [4] 林飞,王阶,郭丽丽,等.中医药对冠心病经皮冠状动脉介入术后治疗现状研究[J].中华中医药杂志,2015,30(4):1181.
- [5] 季昭臣,胡海殷,杨丰文,等.益气活血类中成药治疗冠心病心绞痛的网状Meta分析[J].中国中药杂志,2019,44(9):1927.
- [6] 李郁春.益气活血法对冠心病PCI术后患者心血管不良事件发生影响的Meta分析[D].合肥:安徽中医药大学,2017.
- [7] 中华中医药学会心血管病分会.冠心病心绞痛介入前后中医诊疗指南[J].中国实验方剂学杂志,2018,24(15):4.
- [8] 颜红兵.临床冠心病诊断与治疗指南[M].北京:人民卫生出版社,2010.
- [9] 王显.经皮冠状动脉介入治疗(PCI)术后胸痛中医诊疗专家共识[J].中医杂志,2014,55(13):1167.
- [10] 国家卫生计生委合理用药专家委员会,中国药师协会.冠心病合理用药指南(第2版)[J].中国医学前沿杂志(电子版),2018,10(6):1.
- [11] 何战斌,冯雁,樊旺祥,等.芪参益气滴丸联合曲美他嗪治疗冠心病经皮冠状动脉介入术后的临床研究[J].中西医结合心脑血管病杂志,2018,16(7):886.
- [12] 冯志博.射血分数与ACS介入术后中医证型的相关性及中药干预研究[D].北京:中国中医科学院,2016.
- [13] 刘敏.芪参益气滴丸联合心脉通贴散对不稳定型心绞痛PCI术后心绞痛的临床研究及对炎症因子的影响[D].南京:南京中医药大学,2017.
- [14] 宋思洋.芪参益气滴丸联合尼可地尔对急诊PCI术后左室射血分数保留性心力衰竭患者血清NT-proBNP、hs-CRP、Hcy和CysC的影响[J].现代中西医结合杂志,2020,29(5):514.
- [15] 宋红星,张杰,鲁召辉,等.芪参益气滴丸对老年急性心肌梗死患者PCI术后心脏康复的影响[J].齐齐哈尔医学院学报,2017,38(22):2649.
- [16] 崔源源.中药防治冠状动脉介入后血管损伤的研究[D].北京:中国中医科学院,2015.
- [17] 左玉琴.用不同的西医疗法联合芪参益气滴丸对老年急性心肌梗死患者进行治疗的效果分析[J].当代医药论丛,2016,14(22):2.
- [18] 廉滋鑫.芪参益气滴丸对于冠心病介入术后气虚血瘀型患者干预疗效的临床观察[D].太原:山西中医药大学,2017.
- [19] 张晓云,魏万林,田国祥,等.芪参益气滴丸对冠状动脉介入术后炎症因子及心脏不良事件的影响[J].中国循证心血管医学杂志,2013,5(2):167.
- [20] 张武宁,彭雪梅,高晓东,等.芪参益气滴丸对永久性房颤合并冠心病PCI术后患者Hcy水平及短期心功能的影响[J].中国保健营养,2016,26(32):104.
- [21] 成玲,孟根托娅,梁俊国.芪参益气滴丸对PCI术后患者心肌保护作用及不良心血管事件的防治[J].中国实验方剂学杂志,2019,25(16):78.
- [22] 景强强,姚龙.芪参益气滴丸对PCI术后近期炎症因子的影响[J].湖北中医药大学学报,2016,18(5):38.
- [23] 李建.芪参益气滴丸对急性心肌梗死患者治疗作用观察[D].新乡:新乡医学院,2018.
- [24] 李成伟,袁峰,李晓娟.芪参益气滴丸干预PCI术后急性前壁心肌梗死患者冠脉血流和左室功能的研究[J].中西医结合心脑血管病杂志,2014,12(12):1441.
- [25] 李斌.芪参益气滴丸对冠心病支架术后支架内再狭窄的影响[J].中国保健营养,2014(5):2877.
- [26] 汤丽芬,戴小华,许祖建.芪参益气滴丸对冠心病PCI术后患者心功能及营养状况的影响[J].中西医结合心血管病电子杂志,2019,7(9):159.
- [27] 王慧.芪参益气滴丸对急性冠脉综合征患者PCI术疗效的影响[D].天津:天津医科大学,2013.
- [28] 王效浣,高奋堂,郭朝霞,等.芪参益气滴丸对急性心肌梗死PCI术后内皮功能的影响[J].光明中医,2020,35(2):151.
- [29] 王昆.芪参益气滴丸对冠心病PCI术后患者(气虚血瘀型)心功能及心绞痛疗效观察[D].合肥:安徽中医药大学,2019.
- [30] 王正斌,孙国举,秦小飞.芪参益气滴丸对冠状动脉介入术后炎症因子及心脏不良事件的影响[J].现代诊断与治疗,2019,30(19):3320.
- [31] 王计亮,薛静.芪参益气滴丸联合替格瑞洛对急性冠脉综合征PCI术后血小板功能、炎性细胞因子及预后的影响[J].现代中西医结合杂志,2019,28(19):2134.
- [32] 田福利,魏万林,张二箭,等.芪参益气滴丸联合阿托伐他汀对冠状动脉内支架再狭窄的干预[J].中国循证心血管医学杂志,2012,4(3):224.
- [33] 苗建波.芪参益气滴丸在冠心病合并糖尿病患者经PCI术后的应用研究[C].北京:基层医疗机构从业人员科技论文写作培训会,2016.
- [34] 苗建波.芪参益气滴丸在经皮冠状动脉介入术后的冠心病患者中的应用研究[C].北京:基层医疗机构从业人员科技论文写作培训会,2016.
- [35] 许文渤.芪参益气滴丸对急性冠脉综合征患者及大鼠急性心梗后左室重构及心功能的影响[D].长春:吉林大学,2019.
- [36] 许祖建,戴小华,汤丽芬,等.芪参益气滴丸对冠心病PCI术后患者心功能及心绞痛疗效的影响[J].时珍国医国药,2019,30(9):2208.
- [37] 谷丰,杨巧宁,白瑞娜,等.芪参益气滴丸治疗冠心病介入术后合并高血压患者的预后研究[J].世界中医药,2018,13(10):2396.
- [38] 赵云,陈晓瑞.芪参益气滴丸对老年急性心肌梗死患者超敏C反应蛋白和心脏功能的影响[J].重庆医学,2016,45(10):1379.
- [39] 邓伟,赵季红.芪参益气滴丸对ACS患者冠脉介入治疗后无复流的疗效观察[J].医学信息,2016,29(16):153.
- [40] 陈伟国,朱萧玲,常盼,等.芪参益气滴丸对急性心肌梗死PCI术后患者血清学指标及预后的影响[J].陕西中医,2020,41(1):20.
- [41] 陈爽.芪参益气滴丸对急性心肌梗死再灌注后心功能及心室重构的临床疗效观察[D].南京:南京中医药大学,2015.
- [42] 胡盛寿,高润霖,刘力生,等.《中国心血管病报告2018》概要[J].中国循环杂志,2019,34(3):209.
- [43] 韩雅玲.经皮冠状动脉介入术相关并发症的诊治现状与思考[J].中国实用内科杂志,2010,30(7):589.
- [44] 荣杰,许颖智,张军平.冠心病患者介入术前后中医证候演变规律分析[J].中医杂志,2012,53(23):2027.
- [45] 杨萍,周玉平,常秀春,等.黄芪甲苷调控Nrf2/Bach1/HO-1信号通路抑制缺氧复氧诱导的H9c2心肌细胞损伤[J].中国中药杂志,2019,44(11):2331.
- [46] 马婧,陈茜,边亚倩,等.基于系统中药学的丹参活血化瘀功效标志物研究[J].中国中药杂志,2020,45(14):3259.
- [47] HAN J Y,LI Q,PAN C S,et al.Effects and mechanisms of Qishen Yiqi Pills and major ingredients on myocardial microcirculatory disturbance,cardiac injury and fibrosis induced by ischemia-reperfusion[J].Pharmacol Res,2019,147:104386.
- [48] 卫靖靖,朱明军,王永霞,等.心脉隆注射液治疗冠心病心力衰竭有效性与安全性的系统评价[J].中国中药杂志,2020,45(19):4756.
- [49] 黎美欢,李颖,陈铭泰,等.脂必泰胶囊联合他汀调节冠心病患者血脂水平的Meta分析[J].中国中药杂志,2020,45(12):2966.
- [50] 王智,邱林,龚艳君,等.冠心病患者冠状动脉介入治疗前后血浆高敏C反应蛋白水平的变化及其与主要不良心血管事件的关系[J].中国动脉硬化杂志,2016,24(11):1104.
- [51] 李静,常改.西雅图量表测量冠心病患者生活质量的评价[J].中国公共卫生,2004(5):86.
- [52] 卓小媛,郑景辉,陈家坤,等.中药联合常规西药治疗冠心病经皮冠状动脉介入治疗术后心血管不良事件的Meta分析[J].河北中医,2019,41(7):1079.
- [53] 白洋,车方远,易文慧,等.加载口服中成药对PCI术后长期主要不良心脑血管事件影响的Meta分析[J].中医杂志,2018,59(12):1024.
- [54] MOHER D,HOPEWELL S,SCHULZ K F,et al.CONSORT 2010 explanation and elaboration:updated guidelines for reporting parallel group randomised trials[J].Int J Surg,2012,10(1):28.
- 芪参益气滴丸
- 冠心病
- 经皮冠状动脉介入术
- 主要不良心血管事件
- Meta分析
Qishen Yiqi Dropping Pills - coronary heart disease
- percutaneous coronary intervention
- major adverse cardiovascular events
- Meta-analysis
- 代倩倩
- 石兆峰
- 胡嘉元
- 韩松洁
- 钟长鸣
- 关曼柯
- 田贵华
- 商洪才
DAI Qian-qian- SHI Zhao-feng
- HU Jia-yuan
- HAN Song-jie
- ZHONG Chang-ming
- GUAN Man-ke
- TIAN Gui-hua
- SHANG Hong-cai
- Dongzhimen Hospital
- Beijing University of Chinese Medicine
- 代倩倩
- 石兆峰
- 胡嘉元
- 韩松洁
- 钟长鸣
- 关曼柯
- 田贵华
- 商洪才
DAI Qian-qian- SHI Zhao-feng
- HU Jia-yuan
- HAN Song-jie
- ZHONG Chang-ming
- GUAN Man-ke
- TIAN Gui-hua
- SHANG Hong-cai
- Dongzhimen Hospital
- Beijing University of Chinese Medicine