基于终点事件的冠心病心衰中医防治方案循证优化思路和方法
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摘要
目的:分析目前中医药治疗冠心病心衰临床研究存在的问题,探讨和提出冠心病心衰中医防治方案循证优化的思路和方法。方法:系统检索PubMed、EMBASE、Cochrane Library、CNKI、WanFang、VIP和CBM数据库,筛选中医药治疗冠心病心衰的临床研究,评价研究的风险偏倚和结局指标,与慢性心衰的Cochrane系统综述的结局指标进行比较分析,以发现目前研究存在的问题,并针对问题提出改进方法。结果:纳入32篇中医药治疗冠心病心衰的临床研究,各研究的方法学质量普遍偏低,且研究对病死率、再入院率的终点事件结局报道很少,与Cochrane系统综述所关注的结局指标存在较大差距。在冠心病心衰的中医防治方案中,应加强完善临床研究设计和方法,选择冠心病心衰的终点事件作为研究的主要结局指标。结论:在冠心病心衰中医防治方案循证优化中,提高试验的方法学质量和终点事件结局指标的选择至关重要,更有价值的研究证据才能为冠心病心衰患者提供更佳的治疗方案。
Objective: This paper analyzed the present clinical researches of traditional Chinese medicine(TCM) in the treatment of heart failure caused by coronary heart disease and discusses the ideas and methods of evidence-based optimization. Methods: PubMed, EMBASE, Cochrane Library, CNKI, WanFang, VIP and CBM were searched to screen the clinical studies of TCM for treating heart failure caused by coronary heart disease. The problems and solutions were discussed by evaluating the risk of bias of the studies and analyzing the outcomes compared with the Cochrane systematic reviews of chronic heart failure. Results: A total of 32 clinical researches were included and the methodological quality of the studies was generally low. In addition, few studies assessed the endpoint events, mortality and readmission, as the primary outcomes in their trials, which is significantly different from the outcomes concerned in the Cochrane systematic reviews. Conclusion: It is really critical to improve the methodological quality of the trials and to choose the endpoint events as the primary outcomes in the evidence-based optimization of the prevention and treatment of TCM for heart failure caused by coronary heart disease Chinese medicine.
Objective: This paper analyzed the present clinical researches of traditional Chinese medicine(TCM) in the treatment of heart failure caused by coronary heart disease and discusses the ideas and methods of evidence-based optimization. Methods: PubMed, EMBASE, Cochrane Library, CNKI, WanFang, VIP and CBM were searched to screen the clinical studies of TCM for treating heart failure caused by coronary heart disease. The problems and solutions were discussed by evaluating the risk of bias of the studies and analyzing the outcomes compared with the Cochrane systematic reviews of chronic heart failure. Results: A total of 32 clinical researches were included and the methodological quality of the studies was generally low. In addition, few studies assessed the endpoint events, mortality and readmission, as the primary outcomes in their trials, which is significantly different from the outcomes concerned in the Cochrane systematic reviews. Conclusion: It is really critical to improve the methodological quality of the trials and to choose the endpoint events as the primary outcomes in the evidence-based optimization of the prevention and treatment of TCM for heart failure caused by coronary heart disease Chinese medicine.
引文
1中华医学会心血管病学分会,中华心血管病杂志编辑委员会.中国心力衰竭诊断和治疗指南2014.中华心血管病杂志, 2014(2):98-122.
2 Ambrosy A P, Fonarow G C, Butler J, et al. The global health and economic burden of hospitalizations for heart failure:lessons learned from hospitalized heart failure registries. J Am Coll Cardiol, 2014, 63(12):1123-1133.
3 张鹏,陈婵,王娟,等.基于两种研究结果的冠心病心力衰竭症状、证和证素分布特点的比较研究.中华中医药杂志, 2016(12):4969-4973.
4 黄峻.中国心力衰竭流行病学特点和防治策略.中华心脏与心律电子杂志, 2015(2):2-3.
5 曹雅旻,胡大一,王宏宇,等.我国基层医院慢性心力衰竭药物治疗现状调查.中华内科杂志, 2006(11):907-909.
6 程康安,吴宁.国部分地区1980、1990、2000年慢性心力衰竭住院病例回顾性调查.中华心血管病杂志, 2002(8):5-9.
7 郑筱萸.中药新药临床研究指导原则.北京:中国医药科技出版社,2002:77-85.
8 张占锋.中西医结合治疗冠心病重度心力衰竭临床观察.光明中医,2018, 33(4):561-563.
9 张松雨,李纲,李燕,等.稳心颗粒联合倍他乐克对冠状动脉粥样硬化性心脏病心力衰竭合并室性早搏患者血浆N-末端B型利钠肽原水平的影响.中医学报, 2018(5):865-869.
10 王永智,浦奎.自拟益气祛瘀方辅助西药治疗冠心病心衰疗效及对心功能、炎症相关细胞因子水平的影响.中国中医急症, 2018, 27(6):1053-1056.
11 屈历涛,张万里,王贺毅.三仙强心汤治疗冠心病合并慢性心力衰竭60 例临床观察.光明中医, 2017(8):1116-1118.
12 吕俊芳,朱明军.加味三仁汤治疗冠心病慢性心力衰竭三焦湿热证临床研究.陕西中医, 2018(5):596-598.
13 邹清,邓桂兰,彭桂元,等.参芪强心汤治疗冠心病心力衰竭50例临床观察.湖南中医杂志, 2012, 28(6):6-9.
14 周志天,李翊卫,祝红明.参附注射液对冠心病心力衰竭患者血浆C反应蛋白浓度的影响.天津中医药, 2005(3).
15 周华,杨婧.鹿红方治疗充血性心力衰竭合并心绞痛的临床研究.中西医结合心脑血管病杂志, 2007, 5(4):286-288.
16 赵德语.三参益心汤对老年冠心病心力衰竭患者左室功能的影响.新中医, 2011, 43(9):11-13.
17 张为,鲁卫星.养心氏片治疗冠心病慢性心力衰竭气虚血瘀证临床研究.辽宁中医药大学学报, 2010, 12(3):115-118.
18 杨震,李蜜蜂,于连云.益气温阳活血利水中药治疗冠心病心力衰竭的疗效观察.光明中医, 2016, 31(13):1910-1911.
19 许杰.益肾舒心丸改善冠心病左室舒张功能障碍的临床研究.中西医结合心脑血管病杂志, 2005(3).
20 王冬,王岩.芪参益气滴丸治疗冠心病心力衰竭的临床观察.吉林医学, 2010, 31(16):2418-2419.
21 任兰芳,李冰,何开莉.芪参益气滴丸治疗心肌梗死后慢性心衰100例临床观察.疾病监测与控制杂志, 2017, 11(6):503-504.
22 祁俊仙,袁如玉,李广平,等.冠心病慢性心力衰竭患者血清脂联素水平及芪参益气滴丸对其影响.陕西医学杂志, 2010(12).
23 牛新萍,王霞,杨林.益气养阴方对心肌梗死后心力衰竭患者心功能影响的研究.中国实用医药, 2015(22).
24 马友合.强心汤治疗胸痹心水68例临床观察.河北中医, 2001(9).
25 卢军利,芦桂云,吴艳杰,等.保元汤对冠心病心力衰竭患者血管内皮依赖性舒张功能的影响.河北中医, 2012, 34(9):1304-1306.
26 刘元,王亚红,赵悦茹,等.益气活血对冠心病左室功能不全的影响.北京中医药大学学报, 1996(6).
27 刘海涛.中西医结合治疗冠心病慢性心力衰竭76例.四川中医,2003(2).
28 刘东敏,赵明君.加味苓桂术甘汤治疗冠心病心衰34例.陕西中医,2011, 32(9):1190-1192.
29 林娜,高积慧.平喘固本汤治疗慢性心力衰竭心肺气虚证50例临床观察.湖南中医杂志, 2017, 33(3):44-46.
30 李鹤,刘亚洋,汪再舫.益气升陷法治疗冠心病左室舒张功能不全的临床研究.四川中医, 2013, 31(2):66-67.
31 赖仁奎,盛小刚,潘光明.暖心胶囊治疗冠心病心力衰竭临床疗效及对左室功能的影响.新中医, 2015, 47(5):32-33.
32 黄浩.益气通络利水方治疗冠心病心衰气虚血瘀证临床观察.吉林中医药, 2006, 26(1):10-11.
33 顾旭,尚树忠,郭锐.黄芪注射液辅助治疗充血性心力衰竭68例.医药导报, 2003(8).
34 宫丽鸿,张艳.中医药干预慢性心衰的治疗方案研究.世界中西医结合杂志, 2012, 07(2):166-168.
35 程运友,朱秋灵,杨进玉,等.冠心康胶囊联合西药治疗冠心病慢性心力衰竭60例.中医研究, 2012, 25(7):23-25.
36 Yuan C L, D S. Efficacy of Yi Qi Fu Mai injection on heart failure complicated with angina pectoris in patients with coronary heart disease.Chinese journal of new drugs, 2012, 21(15):1774-1777.
37 Xian S, Yang Z, Lee J, et al. A randomized, double-blind, multicenter,placebo-controlled clinical study on the efficacy and safety of Shenmai injection in patients with chronic heart failure. J Ethnopharmacol, 2016,186:136-142.
38 Liangtao Luo J W A H. Chinese herbal medicine for chronic heart failure:a multicenter, randomized, double-blind, placebo-controlled trial. Journal of traditional chinese medical sciences, 2014, 1(2):98-108.
39 参附注射液治疗冠心病慢性心力衰竭急性加重期(阳气亏虚证)有效性及安全性的随机对照、盲法、多中心临床评价研究试验总结报告.天津中医药大学第一附属医院, 2016.
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2 Ambrosy A P, Fonarow G C, Butler J, et al. The global health and economic burden of hospitalizations for heart failure:lessons learned from hospitalized heart failure registries. J Am Coll Cardiol, 2014, 63(12):1123-1133.
3 张鹏,陈婵,王娟,等.基于两种研究结果的冠心病心力衰竭症状、证和证素分布特点的比较研究.中华中医药杂志, 2016(12):4969-4973.
4 黄峻.中国心力衰竭流行病学特点和防治策略.中华心脏与心律电子杂志, 2015(2):2-3.
5 曹雅旻,胡大一,王宏宇,等.我国基层医院慢性心力衰竭药物治疗现状调查.中华内科杂志, 2006(11):907-909.
6 程康安,吴宁.国部分地区1980、1990、2000年慢性心力衰竭住院病例回顾性调查.中华心血管病杂志, 2002(8):5-9.
7 郑筱萸.中药新药临床研究指导原则.北京:中国医药科技出版社,2002:77-85.
8 张占锋.中西医结合治疗冠心病重度心力衰竭临床观察.光明中医,2018, 33(4):561-563.
9 张松雨,李纲,李燕,等.稳心颗粒联合倍他乐克对冠状动脉粥样硬化性心脏病心力衰竭合并室性早搏患者血浆N-末端B型利钠肽原水平的影响.中医学报, 2018(5):865-869.
10 王永智,浦奎.自拟益气祛瘀方辅助西药治疗冠心病心衰疗效及对心功能、炎症相关细胞因子水平的影响.中国中医急症, 2018, 27(6):1053-1056.
11 屈历涛,张万里,王贺毅.三仙强心汤治疗冠心病合并慢性心力衰竭60 例临床观察.光明中医, 2017(8):1116-1118.
12 吕俊芳,朱明军.加味三仁汤治疗冠心病慢性心力衰竭三焦湿热证临床研究.陕西中医, 2018(5):596-598.
13 邹清,邓桂兰,彭桂元,等.参芪强心汤治疗冠心病心力衰竭50例临床观察.湖南中医杂志, 2012, 28(6):6-9.
14 周志天,李翊卫,祝红明.参附注射液对冠心病心力衰竭患者血浆C反应蛋白浓度的影响.天津中医药, 2005(3).
15 周华,杨婧.鹿红方治疗充血性心力衰竭合并心绞痛的临床研究.中西医结合心脑血管病杂志, 2007, 5(4):286-288.
16 赵德语.三参益心汤对老年冠心病心力衰竭患者左室功能的影响.新中医, 2011, 43(9):11-13.
17 张为,鲁卫星.养心氏片治疗冠心病慢性心力衰竭气虚血瘀证临床研究.辽宁中医药大学学报, 2010, 12(3):115-118.
18 杨震,李蜜蜂,于连云.益气温阳活血利水中药治疗冠心病心力衰竭的疗效观察.光明中医, 2016, 31(13):1910-1911.
19 许杰.益肾舒心丸改善冠心病左室舒张功能障碍的临床研究.中西医结合心脑血管病杂志, 2005(3).
20 王冬,王岩.芪参益气滴丸治疗冠心病心力衰竭的临床观察.吉林医学, 2010, 31(16):2418-2419.
21 任兰芳,李冰,何开莉.芪参益气滴丸治疗心肌梗死后慢性心衰100例临床观察.疾病监测与控制杂志, 2017, 11(6):503-504.
22 祁俊仙,袁如玉,李广平,等.冠心病慢性心力衰竭患者血清脂联素水平及芪参益气滴丸对其影响.陕西医学杂志, 2010(12).
23 牛新萍,王霞,杨林.益气养阴方对心肌梗死后心力衰竭患者心功能影响的研究.中国实用医药, 2015(22).
24 马友合.强心汤治疗胸痹心水68例临床观察.河北中医, 2001(9).
25 卢军利,芦桂云,吴艳杰,等.保元汤对冠心病心力衰竭患者血管内皮依赖性舒张功能的影响.河北中医, 2012, 34(9):1304-1306.
26 刘元,王亚红,赵悦茹,等.益气活血对冠心病左室功能不全的影响.北京中医药大学学报, 1996(6).
27 刘海涛.中西医结合治疗冠心病慢性心力衰竭76例.四川中医,2003(2).
28 刘东敏,赵明君.加味苓桂术甘汤治疗冠心病心衰34例.陕西中医,2011, 32(9):1190-1192.
29 林娜,高积慧.平喘固本汤治疗慢性心力衰竭心肺气虚证50例临床观察.湖南中医杂志, 2017, 33(3):44-46.
30 李鹤,刘亚洋,汪再舫.益气升陷法治疗冠心病左室舒张功能不全的临床研究.四川中医, 2013, 31(2):66-67.
31 赖仁奎,盛小刚,潘光明.暖心胶囊治疗冠心病心力衰竭临床疗效及对左室功能的影响.新中医, 2015, 47(5):32-33.
32 黄浩.益气通络利水方治疗冠心病心衰气虚血瘀证临床观察.吉林中医药, 2006, 26(1):10-11.
33 顾旭,尚树忠,郭锐.黄芪注射液辅助治疗充血性心力衰竭68例.医药导报, 2003(8).
34 宫丽鸿,张艳.中医药干预慢性心衰的治疗方案研究.世界中西医结合杂志, 2012, 07(2):166-168.
35 程运友,朱秋灵,杨进玉,等.冠心康胶囊联合西药治疗冠心病慢性心力衰竭60例.中医研究, 2012, 25(7):23-25.
36 Yuan C L, D S. Efficacy of Yi Qi Fu Mai injection on heart failure complicated with angina pectoris in patients with coronary heart disease.Chinese journal of new drugs, 2012, 21(15):1774-1777.
37 Xian S, Yang Z, Lee J, et al. A randomized, double-blind, multicenter,placebo-controlled clinical study on the efficacy and safety of Shenmai injection in patients with chronic heart failure. J Ethnopharmacol, 2016,186:136-142.
38 Liangtao Luo J W A H. Chinese herbal medicine for chronic heart failure:a multicenter, randomized, double-blind, placebo-controlled trial. Journal of traditional chinese medical sciences, 2014, 1(2):98-108.
39 参附注射液治疗冠心病慢性心力衰竭急性加重期(阳气亏虚证)有效性及安全性的随机对照、盲法、多中心临床评价研究试验总结报告.天津中医药大学第一附属医院, 2016.
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