Using Bayesian network as a basis to analyze the substitution mechanism of surrogate endpoints for traditional Chinese medicine clinical efficacy evaluation of chronic heart failure_Chinese Journal of Evidence-Based Medicine

Authors：

REN Lili ¹ ,  DAI Guohua ² , GAO Wulin ² , GUAN Hui ¹

1. Shandong University of Traditional Chinese Medicine, Jinan 250014, P.R.China;
2. Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250014, P.R.China;

Corresponding author：

DAI Guohua, Email: daigh2004@163.com

Keywords：

Surrogate end point; Substitution mechanism; Bayesian network model; Logistic regression model; Chronic heart failure; Clinical efficacy evaluation

DOI：

10.7507/1672-2531.202104057

Video：

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Objective To analyze the substitution mechanism of surrogate endpoints for traditional Chinese medicine (TCM) clinical efficacy evaluation of chronic heart failure (CHF). Methods To obtain data from the occurrence of surrogate endpoints and cardiogenic death of patients with CHF in 7 hospitals. The causal relationship between surrogate endpoints and cardiogenic mortality was inferred by the Bayesian network model, and the interaction among surrogate endpoints was analyzed by non-conditional logistic regression model. Results A total of 2 961 patients with CHF were included. The results of Bayesian network causal inference showed that cardiogenic mortality had a causal relationship with the surrogate endpoints including NYHA classification (P=0.46), amino-terminal pro-B-type natriuretic peptide (NT-proBNP) (P=0.24), left ventricular ejaculation fraction (LVEF) (P=0.19), and hemoglobin (HB) (P=0.11); non-conditional logistic regression analysis showed that NYHA classification had interaction with NT-proBNP, LVEF, and HB prior to and after adjusting confounders. Conclusions The substitution capability of surrogate endpoints for TCM clinical efficacy evaluation of CHF for cardiogenic mortality are NYHA classification, NT-proBNP, LVEF, and HB in turn, and there is a multiplicative interaction between the main surrogate endpoint NYHA classification and the secondary surrogate endpoints including NT-proBNP, LVEF, and HB, suggesting that when the two surrogate endpoints with interaction exist at the same time, it can enhance the substitution capability of surrogate endpoints for cardiogenic mortality.

Citation： REN Lili, DAI Guohua, GAO Wulin, GUAN Hui. Using Bayesian network as a basis to analyze the substitution mechanism of surrogate endpoints for traditional Chinese medicine clinical efficacy evaluation of chronic heart failure. Chinese Journal of Evidence-Based Medicine, 2021, 21(12): 1381-1386. doi: 10.7507/1672-2531.202104057 Copy

1.	中华医学会心血管病学分会心力衰竭学组, 中国医师协会心力衰竭专业委员会, 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2018. 中华心血管病杂志, 2018, 46(10): 760-789.
2.	高风, 马晓昌. 活血化瘀法治疗慢性心力衰竭的研究进展. 中华中医药杂志, 2019, 34(4): 1602-1604.
3.	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, 3(2): 81-82.
4.	Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart, 2007, 93(9): 1137-1146.
5.	苏锦锋, 陈军. 大于75岁的左室射血分数正常心衰患者的临床特征和预后. 心血管康复医学杂志, 2014, 23(1): 18-22.
6.	王拴虎, 毛静远, 侯雅竹, 等. 西药常规加用芪参益气滴丸治疗慢性心力衰竭随机对照试验的系统评价. 中国中西医结合杂志, 2013, 33(11): 1468-1475.
7.	郭新峰, 朱泉, 赖世隆. 替代指标和中间指标及其在中医药疗效评价研究中应用价值的思考. 中国中西医结合杂志, 2005, 25(7): 585-590.
8.	谭博, 杜永成, 张爱珍, 等. 发掘慢性阻塞性肺疾病临床终点预测性替代指标纵向研究成果及意义. 中国实用内科杂志, 2016, 36(8): 698-700.
9.	李雄文, 胡展瑞, 罗洪民, 等. 芪苈强心胶囊治疗慢性心力衰竭疗效的Meta分析. 中国循证心血管医学杂志, 2014, 6(5): 529-533.
10.	Fu S, Zhang J, Menniti-Ippolito F, et al. Huangqi injection (a traditional Chinese patent medicine) for chronic heart failure: a systematic review. PLoS One, 2011, 6(5): e19604.
11.	吴荣, 聂晓燕, 王阶, 等. 基于贝叶斯网络的名老中医治疗冠心病辩证规律. 中国中医药信息杂志, 2010, 17(5): 98-99.
12.	徐小国, 蒋萌. 替代指标在临床试验中的应用与局限性. 中国临床药理学与治疗学, 2006, 11(10): 1194-1197.
13.	唐杨章, 高华康, 程训民, 等. 心功能不全多参数的相关性. 临床医学, 2010, 30(4): 19.
14.	Masson S, Latini R, Anand IS, et al. Direct comparison of B-type natriuretic peptide (BNP) and amino-terminal proBNP in a large population of patients with chronic and symptomatic heart failure: the Valsartan Heart Failure (Val-HeFT) data. Clin Chem, 2006, 52(8): 1528-1538.
15.	Anand IS, Florea VG, Fisher L. Surrogate end points in heart failure. J Am Coll Cardiol, 2002, 39(9): 1414-1421.
16.	Bytyçi I, Bajraktari G. Mortality in heart failure patients. Anatol J Cardiol, 2015, 15(1): 63-68.
17.	McDonagh TA, Cunningham AD, Morrison CE, et al. Left ventricular dysfunction, natriuretic peptides, and mortality in an urban population. Heart, 2001, 86(1): 21-26.
18.	杨瑞红. 心源性猝死的预测及相关危险因素分析. 中国心血管病研究, 2005, 3(1): 62-63.
19.	成军霞. 贫血、铁缺乏与心衰. 北京: 北京协和医学院, 2017.
20.	管慧, 戴国华, 高武霖, 等. 基于Cox和Logistic回归模型优选慢性心力衰竭中医临床疗效评价的替代指标. 时珍国医国药, 2020, 31(12): 3036-3038.
21.	Garg P, Wood S, Swift AJ, et al. Clinical predictors of all-cause mortality in patients presenting to specialist heart failure clinic with raised NT-proBNP and no heart failure. ESC Heart Fail, 2020, 7(4): 1791-1800.
22.	成静. 血清心肌损伤标志物水平变化与慢性心力衰竭患者NYHA分级的相关性分析. 基层医学论坛, 2019, 23(34): 4965-4967.
23.	吴彬, 戴国华, 高武霖, 等. 慢性心力衰竭中医临床疗效评价替代指标的文献调查分析. 西部中医药, 2020, 33(8): 74-78.
24.	郭玮, 吴炯, 张春燕, 等. 氨基末端B型利钠肽在心功能分级中的应用. 中国临床医学, 2009, 16(2): 321-324.
25.	魏艺, 胡元会, 杨传华, 等. 老年高血压伴慢性心力衰竭患者心功能分级与血红蛋白相关性分析. 中西医结合心脑血管病杂志, 2015, 13(1): 6-8.

1. 中华医学会心血管病学分会心力衰竭学组, 中国医师协会心力衰竭专业委员会, 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2018. 中华心血管病杂志, 2018, 46(10): 760-789.
2. 高风, 马晓昌. 活血化瘀法治疗慢性心力衰竭的研究进展. 中华中医药杂志, 2019, 34(4): 1602-1604.
3. 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, 3(2): 81-82.
4. Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart, 2007, 93(9): 1137-1146.
5. 苏锦锋, 陈军. 大于75岁的左室射血分数正常心衰患者的临床特征和预后. 心血管康复医学杂志, 2014, 23(1): 18-22.
6. 王拴虎, 毛静远, 侯雅竹, 等. 西药常规加用芪参益气滴丸治疗慢性心力衰竭随机对照试验的系统评价. 中国中西医结合杂志, 2013, 33(11): 1468-1475.
7. 郭新峰, 朱泉, 赖世隆. 替代指标和中间指标及其在中医药疗效评价研究中应用价值的思考. 中国中西医结合杂志, 2005, 25(7): 585-590.
8. 谭博, 杜永成, 张爱珍, 等. 发掘慢性阻塞性肺疾病临床终点预测性替代指标纵向研究成果及意义. 中国实用内科杂志, 2016, 36(8): 698-700.
9. 李雄文, 胡展瑞, 罗洪民, 等. 芪苈强心胶囊治疗慢性心力衰竭疗效的Meta分析. 中国循证心血管医学杂志, 2014, 6(5): 529-533.
10. Fu S, Zhang J, Menniti-Ippolito F, et al. Huangqi injection (a traditional Chinese patent medicine) for chronic heart failure: a systematic review. PLoS One, 2011, 6(5): e19604.
11. 吴荣, 聂晓燕, 王阶, 等. 基于贝叶斯网络的名老中医治疗冠心病辩证规律. 中国中医药信息杂志, 2010, 17(5): 98-99.
12. 徐小国, 蒋萌. 替代指标在临床试验中的应用与局限性. 中国临床药理学与治疗学, 2006, 11(10): 1194-1197.
13. 唐杨章, 高华康, 程训民, 等. 心功能不全多参数的相关性. 临床医学, 2010, 30(4): 19.
14. Masson S, Latini R, Anand IS, et al. Direct comparison of B-type natriuretic peptide (BNP) and amino-terminal proBNP in a large population of patients with chronic and symptomatic heart failure: the Valsartan Heart Failure (Val-HeFT) data. Clin Chem, 2006, 52(8): 1528-1538.
15. Anand IS, Florea VG, Fisher L. Surrogate end points in heart failure. J Am Coll Cardiol, 2002, 39(9): 1414-1421.
16. Bytyçi I, Bajraktari G. Mortality in heart failure patients. Anatol J Cardiol, 2015, 15(1): 63-68.
17. McDonagh TA, Cunningham AD, Morrison CE, et al. Left ventricular dysfunction, natriuretic peptides, and mortality in an urban population. Heart, 2001, 86(1): 21-26.
18. 杨瑞红. 心源性猝死的预测及相关危险因素分析. 中国心血管病研究, 2005, 3(1): 62-63.
19. 成军霞. 贫血、铁缺乏与心衰. 北京: 北京协和医学院, 2017.
20. 管慧, 戴国华, 高武霖, 等. 基于Cox和Logistic回归模型优选慢性心力衰竭中医临床疗效评价的替代指标. 时珍国医国药, 2020, 31(12): 3036-3038.
21. Garg P, Wood S, Swift AJ, et al. Clinical predictors of all-cause mortality in patients presenting to specialist heart failure clinic with raised NT-proBNP and no heart failure. ESC Heart Fail, 2020, 7(4): 1791-1800.
22. 成静. 血清心肌损伤标志物水平变化与慢性心力衰竭患者NYHA分级的相关性分析. 基层医学论坛, 2019, 23(34): 4965-4967.
23. 吴彬, 戴国华, 高武霖, 等. 慢性心力衰竭中医临床疗效评价替代指标的文献调查分析. 西部中医药, 2020, 33(8): 74-78.
24. 郭玮, 吴炯, 张春燕, 等. 氨基末端B型利钠肽在心功能分级中的应用. 中国临床医学, 2009, 16(2): 321-324.
25. 魏艺, 胡元会, 杨传华, 等. 老年高血压伴慢性心力衰竭患者心功能分级与血红蛋白相关性分析. 中西医结合心脑血管病杂志, 2015, 13(1): 6-8.

Chinese Journal of Evidence-Based Medicine

Using Bayesian network as a basis to analyze the substitution mechanism of surrogate endpoints for traditional Chinese medicine clinical efficacy evaluation of chronic heart failure

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