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Jan.  2024
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Predictive effects of serum levels of GDF11 and Copeptin in the therapeutic effects and death risk of congestive heart failure patients treatment with Nesiritide

  • Department of Cardiology, The Third Hospital of Xingtai, Xingtai Hebei 054000, China

  • Corresponding author: ZHOU Song, 53833029@qq.com ; 
  • Received Date: 2022-05-30
    Accepted Date: 2023-05-30
  • ObjectiveTo investigaste the predictive effects of serum levels of growth differentiation factor 11 (GDF11) and Copeptin in the therapeutic effects and death risk of congestive heart failure(CHF) patients treated with Nesiritide.MethodsA total of 156 CHF patients were selected, and treated with Nesiritide.The NYHA cardiac function grade, ECG QRS width, left ventricular end-diastolic diameter(LVEDD), left ventricular ejection fraction(LVEF) and serum levels of GDF11 and Copeptin were compared before and after treatment.The patients were followed up to October 2021, and divided into the survival group and death group according to their prognosis.The univariate and multivariate logistic regression analysis were used to analyze the baseline data of two groups, and the receiver operating characteristic curve(ROC) was used to analyze the value of serum GDF11 and Copeptin in predicting the risk of death.ResultsIn NYHA cardiac function classification before treatment, 48 cases were grade Ⅱ, 36 cases were grade Ⅲ and 72 cases were grade Ⅳ.In NYHA cardiac function grading after treatment, 29 cases were grade Ⅰ, 67 cases were grade Ⅱ, 43 cases were grade Ⅲ and 17 cases were grade Ⅳ, the cardiac function were significantly improved(P < 0.01).After treatment, the QRS width and LVEDD values were significantly lower than those before treatment(P < 0.01), the LVEF values were significantly higher than those before treatment(P < 0.01), and the GDF11 and Copeptin values were significantly lower than those before treatment (P < 0.01).The results of Pearson correlation analysis showed that the serum levels of GDF11 and Copeptin were positively correlated with LVEDD(r=0.291 and 0.268) and QRS width(r=0.247 and 0.222) (P < 0.01), and negative correlation with LVEF(r=-0.310 and -0.261) (P < 0.01).The patients were followed up to October 2021, and the median follow-up time was (29.23±3.00) months.The indexes of hs-CRP, TNF-α, GDF11 and Copeptin in the death group were higher than those in survival group(P < 0.01).The results of logistic regression analysis showed that the serum levels of GDF11 (OR=1.702, 95%CI: 1.348-2.150) and serum Copeptin(OR=2.166, 95%CI: 1.458-3.219) were the influencing factors of the death of CHF patients(P < 0.01).According to the ROC curve, the critical value of serum GDF11 diagnosis was 765.44 ng/mL, the corresponding sensitivity, specificity and AUC were 70.37%, 70.16%, and 0.785(95%CI: 0.730-0.839), respectively.The critical value of serum Copeptin diagnosis was 26.29 pmol/L, the corresponding sensitivity, specificity and AUC were 59.26%, 59.68% and 0.635(95%CI: 0.571-0.700), respectively.The sensitivity, specificity and AUC of the combined diagnosis were 88.89%, 78.23% and 0.878(95%CI: 0.831-0.908), resdpectively, which were significantly higher than those of GDF11 and Copeptin alone(P < 0.05).ConclusionsThe treatment of CHF with Nesiritide is effective, which can effectively improve the cardiac function, and reduce the serum levels of GDF11 and Copeptin.The serum GDF11 and Copeptin are the independent influencing factors of CHF death, and which can improve the diagnostic efficiency of predicting death in CHF patients through combined diagnosis.
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    [2] CHEN J, ARONOWITZ P. Congestive heart failure[J]. Med Clin North Am, 2022, 106(3): 447. doi: 10.1016/j.mcna.2021.12.002
    [3] GUO L, GUO X, CHANG Y, et al. Prevalence and risk factors of heart failure with preserved ejection fraction: a population-based study in Northeast China[J]. Int J Environ Res Public Health, 2016, 13(8): 770. doi: 10.3390/ijerph13080770
    [4] SIONIS A, SIONIS GREEN A, MANITO LORITE N, et al. Comments on the 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure[J]. Rev Esp Cardiol (Engl Ed), 2016, 69(12): 1119. doi: 10.1016/j.recesp.2016.09.056
    [5] ZHAO X, ZHANG DQ, SONG R, et al. Nesiritide in patients with acute myocardial infarction and heart failure: a meta-analysis[J]. J Int Med Res, 2020, 48(1): 300060519897194.
    [6] ZHANG C, LIN Y, LIU Q, et al. Growth differentiation factor 11 promotes differentiation of MSCs into endothelial-like cells for angiogenesis[J]. J Cell Mol Med, 2020, 24(15): 8703. doi: 10.1111/jcmm.15502
    [7] CHRIST-CRAIN M, FENSKE WK. Copeptin in the differential diagnosis of hypotonic polyuria[J]. J Endocrinol Invest, 2020, 43(1): 21. doi: 10.1007/s40618-019-01087-6
    [8] BALLING L, GOETZE JP, JUNG MH, et al. Copeptin levels and invasive hemodynamics in patients with advanced heart failure[J]. Biomark Med, 2018, 12(8): 861. doi: 10.2217/bmm-2017-0439
    [9] 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[J]. 中华心血管病杂志, 2018, 46(10): 30.
    [10] GIUSTINO G, LINDENFELD J, ABRAHAM WT, et al. NYHA functional classification and outcomes after transcatheter mitral valve repair in heart failure: The COAPT Trial[J]. JACC Cardiovasc Interv, 2020, 13(20): 2317. doi: 10.1016/j.jcin.2020.06.058
    [11] SINNENBERG L, GIVETZ MM. Acute heart failure[J]. Trends Cardiovasc Med, 2020, 30(2): 104. doi: 10.1016/j.tcm.2019.03.007
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    [13] 王丹. 冠心病PCI术患者HMGB1、BNP水平变化及与发生心力衰竭的关系[J]. 河北医药, 2019, 41(2): 199.
    [14] 彭龙希, 李正翔. 脑钠肽相关药物在心力衰竭治疗中的研究进展[J]. 药学与临床研究, 2019, 27(1): 61.
    [15] 缪世锋, 钱炜春. 新活素对老年急性心肌梗死伴心力衰竭后心脏纤维化的影响及预后分析[J]. 实用老年医学, 2021, 35(8): 852. doi: 10.3969/j.issn.1003-9198.2021.08.016
    [16] YUAN X, BHAT OM, LOHNER H, et al. Inhibitory effects of growth differentiation factor 11 on autophagy deficiency-induced dedifferentiation of arterial smooth muscle cells[J]. Am J Physiol Heart Circ Physiol, 2019, 316(2): H345. doi: 10.1152/ajpheart.00342.2018
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    [18] SKVORTSOV AA, NARUSOV OY, MUKSINOVA MD, et al. Clinical significance of serial biomarkers activity determination after acute heart failure decompensation: sST2 NT-proBNP role during long-term follow-up[J]. Kardiologiia, 2018, 58(12S): 27. doi: 10.18087/cardio.2634
    [19] LATYPOVA GM, BYCHENKOVA MA, KATAYEV VA, et al. Composition and cardioprotective effects of Primula veris L. solid herbal extract in experimental chronic heart failure[J]. Phytomedicin, 2019, 54: 17. doi: 10.1016/j.phymed.2018.09.015
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Predictive effects of serum levels of GDF11 and Copeptin in the therapeutic effects and death risk of congestive heart failure patients treatment with Nesiritide

    Corresponding author: ZHOU Song, 53833029@qq.com; 
  • Department of Cardiology, The Third Hospital of Xingtai, Xingtai Hebei 054000, China
  • Received Date: 2022-05-30
  • Accepted Date: 2023-05-30
  • Available Online: 2024-01-15

Abstract: ObjectiveTo investigaste the predictive effects of serum levels of growth differentiation factor 11 (GDF11) and Copeptin in the therapeutic effects and death risk of congestive heart failure(CHF) patients treated with Nesiritide.MethodsA total of 156 CHF patients were selected, and treated with Nesiritide.The NYHA cardiac function grade, ECG QRS width, left ventricular end-diastolic diameter(LVEDD), left ventricular ejection fraction(LVEF) and serum levels of GDF11 and Copeptin were compared before and after treatment.The patients were followed up to October 2021, and divided into the survival group and death group according to their prognosis.The univariate and multivariate logistic regression analysis were used to analyze the baseline data of two groups, and the receiver operating characteristic curve(ROC) was used to analyze the value of serum GDF11 and Copeptin in predicting the risk of death.ResultsIn NYHA cardiac function classification before treatment, 48 cases were grade Ⅱ, 36 cases were grade Ⅲ and 72 cases were grade Ⅳ.In NYHA cardiac function grading after treatment, 29 cases were grade Ⅰ, 67 cases were grade Ⅱ, 43 cases were grade Ⅲ and 17 cases were grade Ⅳ, the cardiac function were significantly improved(P < 0.01).After treatment, the QRS width and LVEDD values were significantly lower than those before treatment(P < 0.01), the LVEF values were significantly higher than those before treatment(P < 0.01), and the GDF11 and Copeptin values were significantly lower than those before treatment (P < 0.01).The results of Pearson correlation analysis showed that the serum levels of GDF11 and Copeptin were positively correlated with LVEDD(r=0.291 and 0.268) and QRS width(r=0.247 and 0.222) (P < 0.01), and negative correlation with LVEF(r=-0.310 and -0.261) (P < 0.01).The patients were followed up to October 2021, and the median follow-up time was (29.23±3.00) months.The indexes of hs-CRP, TNF-α, GDF11 and Copeptin in the death group were higher than those in survival group(P < 0.01).The results of logistic regression analysis showed that the serum levels of GDF11 (OR=1.702, 95%CI: 1.348-2.150) and serum Copeptin(OR=2.166, 95%CI: 1.458-3.219) were the influencing factors of the death of CHF patients(P < 0.01).According to the ROC curve, the critical value of serum GDF11 diagnosis was 765.44 ng/mL, the corresponding sensitivity, specificity and AUC were 70.37%, 70.16%, and 0.785(95%CI: 0.730-0.839), respectively.The critical value of serum Copeptin diagnosis was 26.29 pmol/L, the corresponding sensitivity, specificity and AUC were 59.26%, 59.68% and 0.635(95%CI: 0.571-0.700), respectively.The sensitivity, specificity and AUC of the combined diagnosis were 88.89%, 78.23% and 0.878(95%CI: 0.831-0.908), resdpectively, which were significantly higher than those of GDF11 and Copeptin alone(P < 0.05).ConclusionsThe treatment of CHF with Nesiritide is effective, which can effectively improve the cardiac function, and reduce the serum levels of GDF11 and Copeptin.The serum GDF11 and Copeptin are the independent influencing factors of CHF death, and which can improve the diagnostic efficiency of predicting death in CHF patients through combined diagnosis.

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  • 充血性心力衰竭(congestive heart failure, CHF)是指心脏泵血功能障碍以致心脏排血量不足以满足正常组织代谢的临床综合征，主要临床表现为呼吸困难、活动限制及器官循环淤血等[1-2]。流行病学显示[3]，成人心力衰竭(心衰)患病率为1.0%，且70岁以上人群患病率高达10%，且5年死亡率近50%，是临床重点关注的心血管疾病。临床指南指出[4]，解除呼吸困难、纠正血流动力学紊乱及维系重要脏器官功能等治疗CHF的主要原则。新活素即重组人脑利钠肽(BNP)，属于内源性脑钠肽，在排钠、利尿、扩张血管及降低心脏负荷等方面具有一定生理作用，该药物可明显改善病症，控制疾病进展，但CHF预后极差，重症病人1年死亡率高达50%，因而研究CHF死亡风险预测因子，对降低复发和死亡复发率等具有重要临床作用[5]。生长分化因子11(growth differentiation factor 11, GDF11)是转化生长因子β家族的重要成员，与机体组织再生和功能恢复密切相关，并在CHF病人中表达升高[6]。羧基端糖基化肽(Copeptin)是精氨酸加压素C端的多肽，可激活血管平滑肌，诱发心肌肥厚，造成心肌缺血，同时可作用于肾脏V2R受体，导致水钠潴留，加重心脏负荷[7]，且BALLING等[8]证实，Copeptin可兴奋交感神经系统，激活神经内分泌，促进心肌重构，恶化心功能。二者均与CHF的发生、发展相关，但其具体应用于CHF死亡预测研究相对较少，因而本研究探讨血清GDF11、Copeptin水平对CHF病人新活素治疗疗效及死亡风险的预测作用，旨在为临床治疗和预后预测等提供依据。

1.   资料与方法

    1.1.   一般资料

  • 前瞻性选取2018年4月至2021年3月由我院收治的156例CHF病人，其中男96例，女60例；年龄61~79岁；NYHA心功能分级：Ⅱ级48例，Ⅲ级36例，Ⅳ级72例。纳入标准：(1)年龄≥60岁；(2)休息或小幅度活动时存在呼吸困难症状；(3)符合《中国心力衰竭诊断和治疗指南2018》[9]中关于心衰急性发作的诊断标准；(4)首次入院治疗，病例资料齐全者，生存时间超过3个月；(5)病人入院时纽约心脏病协会(NYHA)心功能分级Ⅱ~Ⅳ级；(6)病人或家属知情并签署知情同意书。排除标准：(1)肝、肾功能损伤者；(2)合并急性心肌梗死、出血等急性疾病者；(3)心源性休克者；(4)不耐受新活素或对新活素过敏者；(5)低钠、低氯血症者、血容量不足、静脉血管扩张剂使用禁忌者；(6)不配合治疗或基线资料采集者。本研究经医院伦理委员会审核通过。

    • 1.2.   治疗方法

  • 入组病人均给予常规治疗，如应用强心利尿剂、纠正电解质紊乱、控制感染等，并强调卧床休息，并注射新活素(成都诺迪康生物制药有限公司，国药准字S20050033，0.5 mg)，首次给予负荷剂量1.5 mg/kg，并按照指定剂量0.0075 mg·kg-1·min-1，持续泵住新活素，连续给药24 h，治疗疗程为7 d。

    • 1.3.   观察指标

    1.3.1.   NYHA心功能分级

  • 于治疗后评估病人心功能分级[10]，比较治疗前后的变化。

    • 1.3.2.   心电图和心功能指标

  • 分别于治疗前和治疗后应用GE Ultrasound Vivid 7超声心动仪检测病人的心电图QRS宽度、左心室舒张末期内径(LVEDD)和左室射血分数(LVEF)。

    • 1.3.3.   血清GDF11和Copeptin水平

  • 分别于治疗前和治疗后采集病人清晨空腹静脉血3 mL，静置30 min，应用Thermo微量Heraeus Fresco 21型号离心机，转速3 000 r/min，半径8 cm，温度4 ℃，时间15 min，双抗体夹心法检测血清Copeptin和GDF11水平；试剂盒均购自上海江莱生物科技有限公司。

    • 1.3.4.   随访

  • 随访至2021年10月，失访5例，中位随访时间为(29.23±3.00)个月，根据病人预后情况，将病人分成生存组124例和死亡组27例，并采集2组病人基线资料，如年龄、性别、民族、体质量指数、吸烟史和饮酒史等人口学指标；高血压、糖尿病及房颤等基础疾病；收缩压、舒张压、空腹血糖、血钠、血钾等实验室指标。

    • 1.4.   统计学方法

  • 采用t检验、χ2检验、秩和检验、Pearson相关分析、logistic回归分析和ROC曲线分析。

2.   结果

    2.1.   治疗前后NYHA心功能分级比较

  • 治疗前NYHA心功能分级中Ⅱ级48例, Ⅲ级36例和Ⅳ级72例；治疗后NYHA心功能分级中Ⅰ级29例, Ⅱ级67例, Ⅲ级43例和Ⅳ级17例，较治疗前心功能有所改善(uc=7.48，P＜0.01)。

    • 2.2.   治疗前后心电图和心功能指标比较

  • 治疗后QRS宽度和LVEDD数值均明显低于治疗前(P＜0.01)，LVEF数值明显高于治疗前(P＜0.01)(见表 1)。

    分组 QRS宽度/mm LVEDD/mm LVEF/%
    治疗前 134.43±10.23 6.91±0.38 39.78±3.01
    治疗后 122.01±6.09 6.74±0.32 45.43±2.87
    t 13.03 4.27 16.97
    P ＜0.01 ＜0.01 ＜0.01

    • 2.3.   治疗前后血清GDF11和Copeptin水平比较

  • 治疗后GDF11和Copeptin数值均明显低于治疗前(P＜0.01)(见表 2)。

    分组 GDF11/(ng/mL) Copeptin/(pmol/L)
    治疗前 763.23±15.78 23.12±5.18
    治疗后 718.02±14.09 16.74±4.27
    t 26.69 11.87
    P ＜0.01 ＜0.01

    • 2.4.   Pearson相关性分析

  • Pearson相关分析显示，血清GDF11和Copeptin均与LVEDD(r=0.291和0.268)、QRS宽度(r=0.247和0.222)呈正相关关系(P＜0.01)，而与LVEF呈负相关关系(r=-0.310和-0.261, P＜0.01)。

    • 2.5.   生存组与死亡组治疗前相关临床资料比较

  • 死亡组病人的超敏C反应蛋白(hs-CRP)、肿瘤坏死因子(TNF)-α、GDF11和Copepti均明显高于生存组病人(P＜0.01)(见表 3)。

    指标 死亡组
    (n=27)    		 生存组
    (n=124)    		 t P
    人口学指标
    年龄/岁 69.89±2.01 70.10±2.43 0.42 >0.05
    性别
      男
      女    		 16
    11    		 79
    45    		 0.19* >0.05
    体质量指数/(kg/m2) 24.56±1.98 24.76±1.67 0.54 >0.05
    民族
      汉族
      少数民族    		 26
    1    		 112
    12    		 1.01* >0.05
    饮酒史 3 10 0.26* >0.05
    吸烟史 4 12 0.62* >0.05
    基础疾病
      高血压 6 19 0.76 >0.05
      糖尿病 7 21 1.19 >0.05
      房颤 4 34 1.87 >0.05
    实验室指标
      收缩压/(mmHg) 147.61±18.43 138.90±22.17 1.90 >0.05
      舒张压/(mmHg) 90.27±13.91 91.68±13.47 0.49 >0.05
      空腹血糖/(mmol/L) 5.11±0.68 5.10±0.72 0.07 >0.05
      血钠/(mmol/L) 141.29±8.91 139.86±9.57 0.71 >0.05
      血钾/(mmol/L) 4.53±0.89 4.64±0.91 0.57 >0.05
      hs-CRP/ (mg/L) 5.79±1.25 4.26±1.14 6.21 ＜0.01
      TNF-α/(ng/L) 54.27±6.32 41.77±6.12 8.30 ＜0.01
      LVEF/% 39.70±4.23 40.01±4.04 0.36 >0.05
      LVEDD /mm 6.90±0.43 6.87±0.38 0.36 >0.05
      QRS宽度/mm 133.23±10.18 134.02±9.89 0.37 >0.05
      GDF11/(ng/mL) 805.43±10.28 744.32±9.32 30.31 ＜0.01
      Copeptin/(pmol/L) 28.01±3.12 24.86±2.87 5.09 ＜0.01
    *示χ2值

    • 2.6.   logistic回归分析

  • 以单因素中差异有统计学意义的4项指标为自变量，以预后是否死亡为因变量，行logistic回归分析，结果表明血清GDF11(OR=1.702, 95%CI: 1.348~2.150)和血清Copeptin(OR=2.166, 95%CI: 1.458~3.219)是CHF病人死亡的影响因素(P＜0.01)(见表 4)。

    自变量 B SE Waldχ2 P OR 95%CI
    血清GDF11 0.532 0.119 19.97 ＜0.01 1.702 1.348~2.150
    血清Copeptin 0.773 0.202 14.64 ＜0.01 2.166 1.458~3.219
    常数项 -0.650 0.182 12.75 ＜0.01 — —

    • 2.7.   血清GDF11和Copeptin单独诊断及回归分析预测价值

  • 以血清GDF11和Copeptin作为检验变量，预后是否死亡为状态标量，以敏感度为Y轴，以“1-特异性”为X轴绘制ROC曲线。根据ROC曲线可得，血清GDF11诊断的临界值为765.44 ng/mL，其对应的敏感度为70.37%，特异性为70.16%，AUC为0.785(95%CI: 0.730~0.839)；血清Copeptin诊断的临界值为26.29 pmol/L，其对应的敏感度为59.26%，特异性为59.68%，AUC为0.635(95%CI: 0.571~0.700)。二者联合诊断敏感度为88.89%，特异性为78.23%，AUC为0.878(95%CI: 0.831~0.908)，敏感度和AUC明显高于GDF11和Copeptin单独预测(P＜0.05)(见图 1)。

3.   讨论

  • 冠心病、高血压、扩张型心肌病是住院心衰病人常见的病因，临床宜综合个性化临床指征制定治疗方案，且随着医学水平的不断进步，心衰控制率明显提高，但再入院和死亡率仍较高[11]。目前CHF未见统一、有效的方法，仅为纠正呼吸困难、稳定血流动力学等对症治疗方式，且该疾病需长期稳定治疗，若能及时监测病情，并提前预测疾病预后，对提高临床治疗有效率、改善生活质量等具有重要意义[12]。研究发现[13-14]，严重心衰病人体内BNP分泌不足，补充外源性的BNP对急性心衰具有较好的疗效，BNP作为多肽，在扩张血管、利尿、利钠、拮抗交感神经系统和肾素-血管紧张素-醛固酮系统活性等多种生理作用，心衰发作时，BNP水平显著升高，但病人仍可见明显的心室充盈压升高和水钠潴留，提示存在BNP抵抗或相对不足，外源性BNP的补充可有效改善病症。新活素是临床推荐的药物，本研究结果显示，156例CHF病人治疗后，NYHA心功能分级和心功能指标均有一定程度的改善，且血清GDF11和Copeptin亦明显降低，可作为疾病预测的有效指标，即新活素可补充内源性BNP，或改善BNP抵抗症状，可能与恢复内源性BNP对肾素-血管紧张素-醛固酮系统过度激活拮抗作用有关[15]。

    GDF11是新近发现的转化生长因子β家族成员，作为分泌性蛋白，可参与多种生理环节，如骨骼、肝脏等器官、组织的形成或分化，且研究发现，其可促进骨骼肌代谢、提高大脑认知及逆转心肌组织肥厚等病理过程[16]。LU等[17]药理实验证实，对小鼠模型给予重组GDF11可明显缩小心肌细胞体积，降低心肌厚度，进而恢复心肌细胞功能。Copeptin作为精氨酸加压素的前体物质，可参与调节渗透压、稳定血流动力学和循环系统等生理环节，化学结构上具有一定的稳定性，且在体内几乎不发生降解，便于检测，具有舒张血管和保护神经细胞的功能[18]。病理研究表明[19]，CHF发生时，左心室充盈存在不足，激发心脏压力感受器，刺激大脑垂体分泌Copeptin，心肌损伤越严重，刺激程度越强，即Copeptin水平越高；而CHF后期，左心室出现功能性障碍，大量血液淤积于静脉系统中，造成左心室过度充盈，负反馈刺激压力感受器，进一步增加Copeptin分泌量，加重水钠潴留，恶化病情。本研究结果证实，血清GDF11和Copeptin与LVEF、心电图QRS宽度、LVEDD等心功能指标均相关，且logistic回归分析和ROC曲线分析均证实上述两种指标在CHF疾病死亡预测的诊断价值，值得临床进一步研究。本研究不足之处在于样本量和血液学指标的单一性，仍需进一步扩充样本量，并纳入血液学指标的动态变化性，以验证模型的稳定性和可靠性。

    综上所述，应用新活素治疗CHF效果确切，可有效改善心功能，且降低血清GDF11和Copeptin，可应用于预测心功能的改善程度。血清GDF11和Copeptin是CHF死亡的独立影响因素，且可通过单独或回归联合诊断提高预测CHF病人死亡的诊断效能。

Reference (19)

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