Objective To assess the clinical therapeutic effects and safety of Jiangtang Shuxin decoction (JTSXD) on diabetic patients complicated with chronic heart failure (CHF),and to search for its possible function mechanisms.Methods A prospective randomized controlled study was conducted,80 diabetic patients complicated with CHF [New York Heart Association (NYHA) functional class Ⅱ-Ⅲ] admitted into the Department of Traditional Chinese Medicine (TCM) or of Cardiology in Affiliated Hospital of Guangxi Youjiang National Medical College from October 2015 to September 2016 were enrolled,they were assigned to an observation group and a control group by randomized method with a computer,and finally 77 patients (39 cases in observation group and 38 cases in control group) completed this trial.The patients in control group received standardized routine western medical treatment,while the observation group was additionally administered JTSXD (including ingredients:astragalus 15 g,ginseng 10 g,radix ophiopogonis 15 g,radix rehmanniae 15 g,comus 10 g,rhizome coptidis 8 g,peach kernel 10 g,salvia mitiorrhiza 10 g,magnoliaceae 10 g,yam 15 g) on the basis of conventional therapy.The therapeutic course for all the patients in both groups was 2 months.Before and after treatment,the 6-minute walking distance (6MWD) was assessed;the TCM syndrome accumulated scores of the two groups were calculated;the left ventricular end-diastolic volume (LVEDV),the left ventricle ejection fraction (LVEF),the stroke volume (SV),the cardiac output (CO),and the maximum blood flow velocity of early diastolic/atrium late diastolic (E/A) were detected by echocardiography.The serum levels of glycosylated hemoglobin (HbA1c),angiotensin Ⅱ (Ang Ⅱ) and plasma B type brain natriuretic peptide (BNP) were tested with enzyme linked immunosorbent assay (ELISA);the level changes of total cholesterol (TC),triglyeride (TG),high density lipoprotein cholesteral (HDL-C) and low density lipoprotein cholesteral (LDL-C) were observed.Results Compared with the control group,after treatment in the observed group,the TCM syndrome score of palpitation,fatigue and thetotal accumulated score were all obviously decreased (palpitation score:0.9 ± 0.4 vs.1.2 ± 0.8,fatigue score:1.1 ± 0.7 vs.1.7 ± 0.8,total accumulated score:4.8 ± 1.2 vs.8.1 ± 1.8,all P ＜ 0.05);the LVEDV,the serum levels of HbA1c,Ang Ⅱ and BNP were also obviously decreased in the observed group [LVEDV (mL):136.28 ± 17.52 vs.158.82 ± 19.03,HbA1c (％):6.11±0.36 vs.6.89 ±0.32,Ang Ⅱ (ng/L):66.48 ± 17.64 vs.84.55 ± 20.39,BNP (μg/L):138.45 ± 87.55 vs.219.14±88.83,all P ＜ 0.05];The 6MWD,LVEF,SV,CO and E/A were all increased plainly in the observed group [6MWD (m):470.47 ± 79.66 vs.428.46 ± 88.56,LVEF:0.51 ±0.05 vs.0.46 ± 0.04,SV (mL):55.36 ± 2.88 vs.50.32±2.76,CO (L/min):5.74±0.91 vs.4.92±0.74,E/A:1.18±0.27 vs.0.83±0.28,all P ＜ 0.05].The degrees of decreased levels in TC,TG,LDL-C and the degrees of increased levels of HDL-C in observed group were superior to those of the control group,but there were no statistical significant differences (all P ＞ 0.05).Conclusion JTSXD shows good therapeutic effect and safety for treatment of diabetic patients accompanied by CHF (NYHA functional class Ⅱ-Ⅲ),and its mechanisms may be related to its regulation of glucose (reduction of HbA1c level),correction of lipid metabolism disorders,improvement of myocardial energy supply,inhibition of the activation of renin-angiotensin-aldosterone system (RAAS) and the secretion of BNP.%目的 评价降糖舒心方治疗糖尿病合并慢性心力衰竭(CHF)的有效性及安全性,并探讨可能的作用机制.方法 采用前瞻性随机对照研究方法,选择2015年10月至2016年9月广西右江民族医学院附属医院中医科和心内科收治的80例糖尿病合并纽约心脏病学会(NYHA)心功能分级Ⅱ～Ⅲ级CHF患者,按计算机产生的随机数字分为观察组和对照组,最终77例患者完成试验,观察组39例,对照组38例.对照组给予西医标准化治疗;观察组在标准化治疗基础上加用降糖舒心方(黄芪15 g、人参10 g、麦冬15 g、生地黄15g、山茱萸10 g、黄连8g、桃仁10 g、丹参10 g、五味子10 g、山药15 g),疗程均为2个月.观察两组治疗前后6 min步行距离(6MWD)的变化;计算中医症状积分.采用心脏彩色超声检测左室舒张期末容积(LVEDV)、左室射血分数(LVEF)、每搏量(SV)、心排血量(CO)、二尖瓣快速充盈期与心房收缩期血流速度比值(E/A).采用酶联免疫吸附试验(ELISA)检测血清糖化血红蛋白(HbA1c)、血管紧张素Ⅱ(AngⅡ)、血浆B型脑钠肽(BNP)水平;观察总胆固醇(TC)、甘油三脂(TG)、高密度脂蛋白胆固醇(HDL-C)和低密度脂蛋白胆固醇(LDH-C)等血脂水平的变化.结果 与对照组比较,观察组治疗后心悸、乏力积分和症状总积分均明显降低[心悸积分(分):0.9±0.4比1.2±0.8,乏力积分(分):1.1±0.7比1.7±0.8,症状总积分(分):4.8±1.2比8.1±1.8,均P＜0.05];LVEDV、HbA1c、AngⅡ及BNP水平也明显降低[LVEDV (mL):136.28±17.52比158.82±19.03,HbA1c(％):6.11±0.36比6.89±0.32,AngⅡ(ng/L):66.48±17.64比84.55±20.39,BNP(μg/L):138.45±87.55比219.14±88.83,均P＜0.05];6MWD明显延长(m:470.47±79.66比428.46±88.56,P＜0.05);LVEF、SV、CO、E/A比值均明显升高[LVEF:0.51±0.05比0.46±0.04,SV (mL):55.36±2.88比50.32±2.76,CO(L/min):5.74±0.91比4.92±0.74,E/A比值:1.18±0.27比0.83±0.28,均P＜0.05].观察组TC、TG、LDH-C的下降程度及HDL-C升高程度均优于对照组,但两组比较差异均无统计学意义(均P＞0.05).结论 降糖舒心方对糖尿病NYHA分级Ⅱ～Ⅲ级的CHF患者具有很好的疗效,且安全性良好,其作用机制可能与控制血糖(调节HbA1c)、纠正脂质代谢紊乱、改善心肌能量供给、抑制肾素-血管紧张素-醛固酮系统(RASS)的激活及BNP的分泌有关.
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