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.	中華醫學會心血管病學分會心力衰竭學組, 中國醫師協會心力衰竭專業委員會, 中華心血管病雜志編輯委員會. 中國心力衰竭診斷和治療指南2018. 中華心血管病雜志, 2018, 46(10): 760-789.
2.	高風, 馬曉昌. 活血化瘀法治療慢性心力衰竭的研究進展. 中華中醫藥雜志, 2019, 34(4): 1602-1604.
3.	黃峻. 中國心力衰竭流行病學特點和防治策略. 中華心臟與心律電子雜志, 2015, 3(2): 81-82.
4.	Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart, 2007, 93(9): 1137-1146.
5.	蘇錦鋒, 陳軍. 大于75歲的左室射血分數正常心衰患者的臨床特征和預后. 心血管康復醫學雜志, 2014, 23(1): 18-22.
6.	王拴虎, 毛靜遠, 侯雅竹, 等. 西藥常規加用芪參益氣滴丸治療慢性心力衰竭隨機對照試驗的系統評價. 中國中西醫結合雜志, 2013, 33(11): 1468-1475.
7.	郭新峰, 朱泉, 賴世隆. 替代指標和中間指標及其在中醫藥療效評價研究中應用價值的思考. 中國中西醫結合雜志, 2005, 25(7): 585-590.
8.	譚博, 杜永成, 張愛珍, 等. 發掘慢性阻塞性肺疾病臨床終點預測性替代指標縱向研究成果及意義. 中國實用內科雜志, 2016, 36(8): 698-700.
9.	李雄文, 胡展瑞, 羅洪民, 等. 芪藶強心膠囊治療慢性心力衰竭療效的Meta分析. 中國循證心血管醫學雜志, 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.	吳榮, 聶曉燕, 王階, 等. 基于貝葉斯網絡的名老中醫治療冠心病辯證規律. 中國中醫藥信息雜志, 2010, 17(5): 98-99.
12.	徐小國, 蔣萌. 替代指標在臨床試驗中的應用與局限性. 中國臨床藥理學與治療學, 2006, 11(10): 1194-1197.
13.	唐楊章, 高華康, 程訓民, 等. 心功能不全多參數的相關性. 臨床醫學, 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.	Byty?i 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.	楊瑞紅. 心源性猝死的預測及相關危險因素分析. 中國心血管病研究, 2005, 3(1): 62-63.
19.	成軍霞. 貧血、鐵缺乏與心衰. 北京: 北京協和醫學院, 2017.
20.	管慧, 戴國華, 高武霖, 等. 基于Cox和Logistic回歸模型優選慢性心力衰竭中醫臨床療效評價的替代指標. 時珍國醫國藥, 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.	成靜. 血清心肌損傷標志物水平變化與慢性心力衰竭患者NYHA分級的相關性分析. 基層醫學論壇, 2019, 23(34): 4965-4967.
23.	吳彬, 戴國華, 高武霖, 等. 慢性心力衰竭中醫臨床療效評價替代指標的文獻調查分析. 西部中醫藥, 2020, 33(8): 74-78.
24.	郭瑋, 吳炯, 張春燕, 等. 氨基末端B型利鈉肽在心功能分級中的應用. 中國臨床醫學, 2009, 16(2): 321-324.
25.	魏藝, 胡元會, 楊傳華, 等. 老年高血壓伴慢性心力衰竭患者心功能分級與血紅蛋白相關性分析. 中西醫結合心腦血管病雜志, 2015, 13(1): 6-8.

1. 中華醫學會心血管病學分會心力衰竭學組, 中國醫師協會心力衰竭專業委員會, 中華心血管病雜志編輯委員會. 中國心力衰竭診斷和治療指南2018. 中華心血管病雜志, 2018, 46(10): 760-789.
2. 高風, 馬曉昌. 活血化瘀法治療慢性心力衰竭的研究進展. 中華中醫藥雜志, 2019, 34(4): 1602-1604.
3. 黃峻. 中國心力衰竭流行病學特點和防治策略. 中華心臟與心律電子雜志, 2015, 3(2): 81-82.
4. Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart, 2007, 93(9): 1137-1146.
5. 蘇錦鋒, 陳軍. 大于75歲的左室射血分數正常心衰患者的臨床特征和預后. 心血管康復醫學雜志, 2014, 23(1): 18-22.
6. 王拴虎, 毛靜遠, 侯雅竹, 等. 西藥常規加用芪參益氣滴丸治療慢性心力衰竭隨機對照試驗的系統評價. 中國中西醫結合雜志, 2013, 33(11): 1468-1475.
7. 郭新峰, 朱泉, 賴世隆. 替代指標和中間指標及其在中醫藥療效評價研究中應用價值的思考. 中國中西醫結合雜志, 2005, 25(7): 585-590.
8. 譚博, 杜永成, 張愛珍, 等. 發掘慢性阻塞性肺疾病臨床終點預測性替代指標縱向研究成果及意義. 中國實用內科雜志, 2016, 36(8): 698-700.
9. 李雄文, 胡展瑞, 羅洪民, 等. 芪藶強心膠囊治療慢性心力衰竭療效的Meta分析. 中國循證心血管醫學雜志, 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. 吳榮, 聶曉燕, 王階, 等. 基于貝葉斯網絡的名老中醫治療冠心病辯證規律. 中國中醫藥信息雜志, 2010, 17(5): 98-99.
12. 徐小國, 蔣萌. 替代指標在臨床試驗中的應用與局限性. 中國臨床藥理學與治療學, 2006, 11(10): 1194-1197.
13. 唐楊章, 高華康, 程訓民, 等. 心功能不全多參數的相關性. 臨床醫學, 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. Byty?i 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. 楊瑞紅. 心源性猝死的預測及相關危險因素分析. 中國心血管病研究, 2005, 3(1): 62-63.
19. 成軍霞. 貧血、鐵缺乏與心衰. 北京: 北京協和醫學院, 2017.
20. 管慧, 戴國華, 高武霖, 等. 基于Cox和Logistic回歸模型優選慢性心力衰竭中醫臨床療效評價的替代指標. 時珍國醫國藥, 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. 成靜. 血清心肌損傷標志物水平變化與慢性心力衰竭患者NYHA分級的相關性分析. 基層醫學論壇, 2019, 23(34): 4965-4967.
23. 吳彬, 戴國華, 高武霖, 等. 慢性心力衰竭中醫臨床療效評價替代指標的文獻調查分析. 西部中醫藥, 2020, 33(8): 74-78.
24. 郭瑋, 吳炯, 張春燕, 等. 氨基末端B型利鈉肽在心功能分級中的應用. 中國臨床醫學, 2009, 16(2): 321-324.
25. 魏藝, 胡元會, 楊傳華, 等. 老年高血壓伴慢性心力衰竭患者心功能分級與血紅蛋白相關性分析. 中西醫結合心腦血管病雜志, 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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