基于以"味"统方、苦辛平逆法的葶鹿益心饮治疗射血分数保留型心力衰竭合并糖尿病的临床疗效
Clinical Effect of Tinglu Yixin Prescription on Heart Failure with Preserved Ejection Fraction with Diabetes:From Taste-based Compatibility and Descending Adverse Qi with Bitter and Pungent Medicinals
张蒙 1王新东2
作者信息
- 1. 上海中医药大学附属曙光医院,上海 201203
- 2. 南京中医药大学附属中西医结合医院,南京 210028
- 折叠
摘要
目的:观察以"味"统方、苦辛平逆法指导下的葶鹿益心饮治疗射血分数保留型心力衰竭(HFpEF)合并糖尿病(证属气阴两虚、水瘀内停)患者的临床疗效及安全性.方法:选取南京中医药大学附属中西医结合医院2022年5月至2023年3月符合纳入标准的HFpEF合并2型糖尿病气阴两虚,水瘀内停证患者108例,随机分为对照组、观察组(每组各54例).两组均遵循指南推荐予以慢性心力衰竭及糖尿病西医常规基础治疗,观察组在此基础上予葶鹿益心饮加载治疗,治疗疗程为12周.观察患者治疗前后纽约心脏协会(NYHA)心功能分级、左室舒张末径(LVEDD)、左房内径(LAD)、左心室舒张早期二尖瓣血流最大速度(E)/舒张早期二尖瓣环峰值速度(e')比值(E/e')、N末端B型脑钠肽前体(NT-proBNP)、糖化血红蛋白(HbA1c)、运动耐量评价指标6 min步行试验距离、明尼苏达心力衰竭生活质量调查表、中医证候积分及其他安全性指标.结果:最终完成试验观察病例104例,其中对照组52例,观察组52例;对照组治疗后心功能分级改善显效及有效患者35例,总有效率为67.3％;观察组治疗后心功能分级改善显效及有效患者47例,总有效率为90.4％,观察组患者总有效率明显优于对照组(x2=2.754,P＜0.05).观察组改善LVEDD、LAD、E/e'水平明显优于对照组(P＜0.05);观察组降低NT-proBNP及HbA1c水平明显优于对照组(P＜0.05);观察组提高6 min步行试验距离明显优于对照组(P＜0.05);观察组对于生活质量(明尼苏达生活质量评分)的改善程度均明显优于对照组(P＜0.05);观察组中医证候改善程度明显优于对照组(P＜0.05).两组患者治疗前后各项安全性指标均未出现明显异常,未发现不良事件.结论:葶鹿益心饮能显著改善HFpEF合并糖尿病证属气阴两虚,水瘀内停患者的心功能、运动耐量及生活质量,降低HbA1c水平,改善中医证候积分.
Abstract
Objective:To observe the clinical efficacy and safety of Tinglu Yixin prescription in the treatment of patients with heart failure with preserved ejection fraction(HFpEF)combined with diabetes(syndromes of Qi and Yin deficiency and water retention and blood stasis)from taste-based compatibility and descending adverse Qi with bitter and pungent medicinals.Method:A total of 108 HFpEF patients with diabetes(syndromes of Qi and Yin deficiency and water retention and blood stasis)treated in the Nanjing Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Nanjing University of Chinese Medicine from May 2022 to March 2023 were enrolled in this study and randomized into an observation group(54 patients)and a control group(54 patients).Both groups received conventional Western medicine treatment according to the guide recommendations for chronic heart failure and diabetes,and the observation group additionally received Tinglu Yixin prescription.The treatment course for both groups was 12 weeks.The New York Heart Association(NYHA)grading of cardiac function,left ventricular end diastolic diameter(LVEDD),left atrium diameter(LAD),the ratio of early diastolic maximum mitral flow velocity(E)to early diastolic mitral annular motion velocity(e')(E/e'),N-terminal pro-B-type natriuretic peptide(NT-proBNP),hemoglobin A1c(HbA1c),6-minute walking test(6MWT),Minnesota Living with Heart Failure Questionnaire,traditional Chinese medicine(TCM)syndrome scores,and safety indicators were determined before and after treatment.Result:Finally,104 patients were included for analysis,including 52 patients in the observation group and 52 patients in the control group.After treatment,35 and 47 patients in the control and observation groups showed improved cardiac function,which indicated the total response rates of 67.3％and 90.4％,respectively.The total response rate regarding the cardiac function in the observation group was higher than that in the control group(x2=2.754,P＜0.05).The observation group outperformed the control group in reducing LVEDD and LAD(P＜0.05),decreasing the E/e'ratio(P＜0.05),lowering the NT-proBNP and HbA1c levels(P＜0.05),and recovering the 6MWT and Minnesota quality of life score TCM syndrome scores(P＜0.05).None of the safety indicators in the two groups showed abnormal values before and after treatment,and no serious adverse reaction was observed.Conclusion:Tinglu Yixin prescription can improve the heart function,exercise tolerance,and quality of life,lower the HbA1c level,and alleviate the TCM syndrome in the patients with HFpEF combined with diabetes(syndrome of qi and yin deficiency and water stagnation and blood stasis).
关键词
射血分数保留型心力衰竭/2型糖尿病/气阴两虚、水瘀内停/葶鹿益心饮/临床疗效Key words
heart failure with preserved ejection fraction/type 2 diabetes mellitus/Qi and Yin deficiency,water stagnation and blood stasis/Tinglu Yixin decoction/clinical effect引用本文复制引用
基金项目
全国名老中医药专家董其美传承工作室建设项目(国中医药人教函[2022]75号)
国家自然科学基金项目(81973766)
江苏省自然科学基金项目(BK20211387)
出版年
2024
国家科技期刊平台
NSTL
万方数据