加味参芪益心方对射血分数保留型心力衰竭伴胰岛素抵抗患者心血管危险因素的影响

Effect of Jiawei Shenqi Yixin Prescription on Cardiovascular Risk Factors in Patients with Heart Failure with Preserved Ejection Fraction and Insulin Resistance

目的:观察加味参芪益心方对射血分数保留型心力衰竭伴胰岛素抵抗患者心血管危险因素的影响。方法:自2021年1月至2022年1月源于黑龙江中医药大学附属第一医院病房共82例射血分数保留型心力衰竭患者。随机分两组各41例,两组基础治疗一致,观察组加入加味参芪益心方,疗程8周,观察临床疗效、中医疗效、心功能指标[血浆N末端B型利钠肽原(NT-proBNP)及6 min步行试验(6MWT)];超声指标[左房容积指数(LAVI)、左室质量指数(LVMI)、舒张早期二尖瓣血流峰值/舒张晚期二尖瓣血流峰值(E/A)];胰岛素抵抗相关指标[空腹胰岛素(FINS)、空腹血糖(FPG)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、胰岛素抵抗指数(HOMA-IR)、甘油三酯葡萄糖乘积指数(TYG)、TG高密度脂蛋白胆固醇比值(TG/HDL)];炎症因子[肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)、脂联素(ADP)、C反应蛋白(CRP)];血管内皮功能[一氧化氮(NO)、内皮型一氧化氮合酶(eNOS)、诱导型一氧化氮(iNOS)、内皮素-1(ET-1)]及治疗的安全性。此外,采用Pearson相关分析法,分析胰岛素抵抗、炎性因子、血管内皮因子与心力衰竭改善之间的相关性。结果:临床疗效方面,观察组显效26例,有效12例,无效3例,总有效率92.68%;对照组显效14例,有效12例,无效15例,总有效率63.41%。观察组和对照组总有效率比较,观察组优于对照组(χ^(2)=11.6,P<0.05)。在中医疗效方面,观察组显效26例,有效11例,无效4例,总有效率90.24%;对照组显效9例,有效13例,无效19例,总有效率53.66%。观察组和对照组总有效率比较,观察组优于对照组(χ^(2)=8.19,P<0.05)。与本组治疗前比较,两组治疗后的NT-proBNP、LAVI、LVMI、FPG、FINS、HOMA-IR、TYG、TG/HDL、TNF-α、IL-6、CRP、ET-1及iNOS等指标均降低(P<0.05),且6MWT、E/A、ADP水平、NO、eNOS水平提高(P<0.05);治疗后与对照组比较,观察组NT-proBNP、LAVI、LVMI、FPG、FINS、HOMA-IR、TYG、TG/HDL、TNF-α、CRP、ET-1水平均降低(P<0.05),6MWT、E/A、ADP、NO水平均升高(P<0.05)。治疗前后6MWT增长量与NO呈正相关,且与ET-1的降低呈正相关;治疗前后LVMI的降低与NO升高呈正相关,且与FINS降低呈正相关;治疗前后左室射血分数的升高与TNF-α的降低呈正相关,且与TYG的降低呈正相关(P<0.05);两组患者均未见明显不良反应。结论:加味参芪益心方能明显改善射血分数保留型心力衰竭症状,并且能够减轻炎症,改善血管内皮功能,无不良反应,具有安全性。

Objective:To observe the effect of Jiawei Shenqi Yixin prescription on cardiovascular risk factors in the patients with heart failure with preserved ejection fraction and insulin resistance.Method:From January 2021 to January 2022,a total of 82 patients with heart failure with preserved ejection fraction were enrolled in the ward of the First Affiliated Hospital of Heilongjiang University of Chinese Medicine.The patients were randomly assigned into two groups(41 cases)and received the same basic treatment.The observation group was additionally treated with Jiawei Shenqi Yixin prescription for 8 weeks.The clinical efficacy,traditional Chinese medicine(TCM)efficacy,cardiac function indexes[NT-probrain natriuretic peptide(NT-proBNP)and 6-min walking test(6MWT)],echocardiographic parameters[left atrial volume index(LAVI),left ventricular mass index(LVMI),peak early diastolic to peak late diastolic mitral flow velocity(E/A)ratio],insulin resistance-related indexes[fasting insulin(FINS),fasting plasma glucose(FPG),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C),homeostatic model assessment of insulin resistance(HOMA-IR),triglyceride-glucose index(TYG),and triglyceride to high-density lipoprotein cholesterol(TG/HDL-C)ratio],inflammatory cytokines[tumor necrosis factor-α(TNF-α),interleukin-6(IL-6),adiponectin(ADP),and C-reactive protein(CRP)],vascular endothelial function indicators[nitric oxide(NO),endothelial nitric oxide synthase(eNOS),inducible nitric oxide synthase(iNOS),and endothelin-1(ET-1)],and the safety of treatment were determined.In addition,Pearson correlation analysis was performed to analyze the correlations of insulin resistance,inflammatory cytokines,and vascular endothelial factors with the mitigation of heart failure.Result:In terms of clinical efficacy,the therapy of the observation group was significantly effective in 26 patients,effective in 12 patients,ineffective in 3 patients,with the total effective rate of 92.68%,the therapy of the control group was significantly effective in 14 patients,effective in 12 patients,and ineffective in 15 patients,with the total effective rate of 63.41%.The clinical total effective rate of the observation group was higher than that of the control group(χ^(2)=11.6,P<0.05).In terms of TCM efficacy,the therapy of the observation group was significantly effective in 26 patients,effective in 11 patients,and ineffective in 4 patients,with the total effective rate of 90.24%;the therapy of the control group was significantly effective in 9 patients,effective in 13 patients,and ineffective in 19 patients,with the total effective rate of 53.66%.The TCM total effective rate of the observation group was higher than that of the control group(χ^(2)=8.19,P<0.05).Compared with those before treatment,the levels of NT-proBNP,LAVI,LVMI,FPG,FINS,HOMA-IR,TYG,TG/HDL-C,TNF-α,IL-6,CRP,ET-1,and iNOS in two groups declined after treatment(P<0.05),while the levels of 6MWT,E/A,ADP,NO,and eNOS elevated(P<0.05).After treatment,the observation group had lower levels of NT-proBNP,LAVI,LVMI,FPG,FINS,HOMA-IR,TYG,TG/HDL-C,TNF-α,CRP,and ET-1(P<0.05)and higher levels of 6MWT,E/A,ADP,and NO than the control group(P<0.05).In addition,the increase in 6MWT after treatment was positively correlated with the increase in NO and the decrease in ET-1.The decrease in LVMI after treatment was positively correlated with the increase in NO and the decrease in FINS.The increase in left ventricular ejection fraction after treatment was positively correlated with the decreases in TNF-αand TYG(P<0.05).Adverse reactions were observed in neither group.Conclusion:Jiawei Shenqi Yixin prescription can significantly mitigate the symptoms,reduce inflammation,and improve vascular endothelial function in the patients with heart failure with preserved ejection fraction and insulin resistance,being safe without causing adverse reactions.