Evaluation of Clinical Efficacy of Shengmaisan Granules in Inhibiting Myocardial Fibrosis in Patients with Chronic Heart Failure with Qi-Yin Deficiency Syndrome Based on CMR

YANG Yuedong; WANG Maolin; ZHAO Juan; SHI Mingyu; MAO Chenhan; ZHANG Sujie; ZHI Hao; SHEN Jianping

doi:10.13422/j.cnki.syfjx.20230799

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Evaluation of Clinical Efficacy of Shengmaisan Granules in Inhibiting Myocardial Fibrosis in Patients with Chronic Heart Failure with Qi-Yin Deficiency Syndrome Based on CMR

更新时间：2023-11-07

- Evaluation of Clinical Efficacy of Shengmaisan Granules in Inhibiting Myocardial Fibrosis in Patients with Chronic Heart Failure with Qi-Yin Deficiency Syndrome Based on CMR
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 29, Issue 23, Pages: 89-97(2023)
- 作者机构：
  
  1.南京中医药大学附属中西医结合医院，南京 210028
  2.江苏省中医药研究院，南京 210028
  3.中国中医科学院中药研究所，北京 100700
  4.南京中医药大学第三临床医学院，南京 210028
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20230799
  CLC： R242;R2-031;R287;R259;R541.6
- Published：05 December 2023，
  
  Published Online：23 October 2023，
  
  Received：19 July 2023，
- 稿件说明：
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杨月东,汪茂林,赵娟等.基于CMR评价生脉散颗粒抑制慢性心力衰竭气阴两虚证患者心肌纤维化的临床疗效[J].中国实验方剂学杂志,2023,29(23):89-97.

YANG Yuedong,WANG Maolin,ZHAO Juan,et al.Evaluation of Clinical Efficacy of Shengmaisan Granules in Inhibiting Myocardial Fibrosis in Patients with Chronic Heart Failure with Qi-Yin Deficiency Syndrome Based on CMR[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(23):89-97.
杨月东,汪茂林,赵娟等.基于CMR评价生脉散颗粒抑制慢性心力衰竭气阴两虚证患者心肌纤维化的临床疗效[J].中国实验方剂学杂志,2023,29(23):89-97. DOI： 10.13422/j.cnki.syfjx.20230799.

YANG Yuedong,WANG Maolin,ZHAO Juan,et al.Evaluation of Clinical Efficacy of Shengmaisan Granules in Inhibiting Myocardial Fibrosis in Patients with Chronic Heart Failure with Qi-Yin Deficiency Syndrome Based on CMR[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(23):89-97. DOI： 10.13422/j.cnki.syfjx.20230799.

摘要

目的

通过心脏核磁共振（CMR）成像及血清学指标评价生脉散颗粒对慢性心力衰竭气阴两虚证患者心肌纤维化的影响。

方法

选择2021年10月至2023年1月于南京中医药大学附属中西医结合医院就诊的慢性心力衰竭气阴两虚证患者66例，采用最小化随机方法分为对照组和观察组各33例，两组均给予心力衰竭西医标准化治疗，对照组加予安慰剂颗粒治疗，观察组加予生脉散颗粒治疗，疗程6个月。比较两组患者基线资料、中医临床疗效、中医证候积分、炎症及纤维化指标［超敏C反应蛋白（hs-CRP）、可溶性生长刺激表达基因2蛋白（sST2）、Ⅲ型前胶原氨基末端肽（PⅢNP）、白细胞介素-6（IL-6）、白细胞介素-11（IL-11）、转化生长因子-

（TGF-

）］、超声心动图［左心房内径（LAD）、左室收缩末期内径（LVEDs）左室舒张末期内径（LVEDd）］、CMR指标［左心室射血分数（LVEF）、心肌细胞外容积分数（ECV）和纵向弛豫时间（T1值）］。

结果

最终，对照组纳入31例患者，治疗组纳入30例患者。两组患者基线资料、治疗前观察指标差异无统计学意义。与本组治疗前比较，治疗后观察组患者中医证候积分（气短/喘息、乏力、心悸、自汗或盗汗、口渴/咽干、手足心热、双下肢水肿、中医证候总积分）、ECV、T1值、炎症/纤维化指标（hs-CRP、sST2、PⅢNP、IL-6、IL-11、TGF-

）均明显降低（

0.05，

0.01），对照组患者中医证候积分（除外手足心热）、T1值、炎症/纤维化指标均明显降低（

0.05，

0.01）。与对照组治疗后比较，观察组治疗后中医证候积分（除外手足心热、双下肢水肿）、ECV、T1值、炎症/纤维化指标均明显降低（

0.05，

0.01）。治疗后，观察组患者总有效率为93.33%（28/30），对照组总有效率为80.65%（25/31），观察组患者心力衰竭改善程度优于对照组，差异具有统计学意义（

=2.976，

0.01）。治疗期间两组不良反应比较，差异无统计学意义（

=0.002，

=0.963）。

结论

生脉散可改善慢性心力衰竭气阴两虚证患者中医临床证候，降低炎症反应，抑制心肌纤维化，其作用机制可能与调控TGF-

/IL-11信号轴相关。

Abstract

Objective

To evaluate the effect of Shengmaisan granules on myocardial fibrosis in chronic heart failure patients with Qi-Yin deficiency syndrome by cardiac magnetic resonance （CMR） imaging and serological indicators.

Method

Sixty-six chronic heart failure patients with Qi-Yin deficiency syndrome who visited the Affiliated Hospital of Integrated Traditional Chinese and Western Medicine， Nanjing University of Chinese Medicine from October 2021 to January 2023 were selected. The patients were assigned into a control group （33 cases） and an observation group （33 cases） by the minimization random method. Both groups received standardized Western medicine treatment for heart failure. In addition， the control group was treated with placebo granules， and the observation group with Shengmaisan granules for a course of 6 months. The baseline data， clinical efficacy， TCM symptom scores， serological indicators ［high-sensitivity C-reactive protein （hs-CRP）， soluble growth stimulation expressed gene 2 protein （sST2）， pro-collagen Ⅲ N-terminal peptide （PⅢNP）， interleukin （IL）-6， IL-11， transforming growth factor-

（TGF-

）］， echocardiography ［Left atrial diameter （LAD）， left ventricular end systolic diameter （LVEDs）， left ventricular end diastolic diameter （LVEDd）］ and CMR indicators ［left ventricular ejection fraction （LVEF）， myocardial extracellular volume fraction （ECV）， and longitudinal relaxation time （T1）］ were compared between the two groups.

Result

Finally， 31 patients in the control group and 30 patients in the observation group were included. There was no significant difference in baseline data or indicators between the two groups before treatment. Compared with those before treatment， the scores of TCM symptoms （shortness of breath， fatigue， palpitations， spontaneous or night sweats， thirst/dry throat， feverish feeling in palms and soles， and edema in lower limbs）， total score of TCM symptoms， ECV， T1， inflammation/fibrosis indicators （hs-CRP， sST2， PⅢNP， IL-6， IL-11， and TGF-

） in observation group decreased （

0.05，

0.01）， and the scores of TCM symptoms （except feverish feeling in palms and soles）， T1， and inflammation/fibrosis indicators in the control group decreased （

0.05，

0.01）. After treatment， the observation group had lower scores of TCM symptoms （except feverish feeling in palms and soles and edema in lower limbs）， ECV， T1， and inflammation/fibrosis indicators than the control group （

0.05，

0.01）. After treatment， the total response rate in the observation group was 93.33% （28/30）， which was higher than that （80.65%， 25/31） in the control group （

=2.976，

0.01）. There was no significant difference in adverse reactions between the two groups during treatment.

Conclusion

For patients with chronic heart failure with Qi-Yin deficiency syndrome， Shengmaisan Granules can alleviate the TCM symptoms， reduce inflammation， and inhibit myocardial fibrosis by regulating the TGF-

/IL-11 signaling axis.

关键词

慢性心力衰竭气阴两虚证心肌纤维化生脉散心脏核磁共振白细胞介素-11（IL-11）Ⅲ型前胶原氨基末端肽（PⅢNP）

Keywords

chronic heart failureQi-Yin deficiency syndromemyocardial fibrosisShengmaisancardiac magnetic resonanceinterleukin-11（IL-11）pro-collagen Ⅲ N-terminal peptide （PⅢNP）

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Related Institution

Cardiovascular Department，Jiangsu Province Academy of Traditional Chinese Medicine

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine （TCM）

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The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Anhui Provincial Hospital of Integrated Medicine （Anhui Hospital of Shuguang Hospital Affiliated to Shanghai University of TCM，，）

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