参附注射液联合重组人脑利钠肽治疗急性失代偿性心力衰竭的临床疗效及安全性研究

Clinical efficacy and safety of Shenfu injection combined with recombinant human brain natriuretic peptide in patients with acute decompensated heart failure

目的对参附注射液联合重组人脑利钠肽(rh BNP)治疗急性失代偿性心力衰竭(ADHF)的临床疗效进行研究,并对其安全性进行评价。方法将新汶矿业集团有限责任公司华丰煤矿医院收治的117例ADHF患者采用随机数字表法分为对照组(n=58)和联合组(n=59)(全部患者均知情同意,并经医院伦理委员会批准)。对照组患者在常规治疗的基础上采用rh BNP进行治疗,联合组患者在对照组治疗的基础上加用参附注射液进行治疗,从而比较2组患者治疗前后心脏彩超的心功能,左室舒张期末内径(LVDD)、左室射血分数(LVEF)、左室缩短分数(LVFS)指标水平,血清中心房利钠肽前体中间片段(MR-proANP)、N末端心房利钠肽前体(NT-proANP)、可溶性基质溶素-2(s ST2)、半乳糖凝集素-3(galectin-3)指标水平,呼吸困难、肺部啰音及周身水肿等评分结果,同时比较2组患者治疗前及治疗后24、48、72 h的心率(HR)、呼吸频率(RR)、收缩压(SBP)、血氧饱和度(Sa O2)、尿量、中心静脉压(CVP)、肺动脉压(PAP)、肺毛细血管楔压(PCWP)及心输出量指标水平的差异,并比较2组患者的临床疗效及不良反应发生情况。结果联合组治疗后心功能指标LVDD、LVEF、LVFS均显著低于对照组(P<0.05);联合组治疗后血清中MR-proANP、NT-proANP、s ST2、galectin-3的水平优于对照组(P<0.05);联合组治疗后的呼吸困难、肺部啰音及周身水肿评分结果均显著低于对照组(P<0.05);联合组治疗后24、48、72 h的HR、RR及CVP的结果均显著低于对照组(P<0.05),尿量和心输出量的结果显著高于对照组(P<0.05);联合组临床疗效的总有效率显著高于于对照组(96.61%vs 86.21%,χ~2=4.050,P=0.044);2组患者在治疗期间均无严重不良反应发生,且2组不良反应发生率差异无统计学意义(P>0.05)。结论参附注射液联合rhBNP能够明显改善心功能指标、生物学标志物水平、临床症状、生命特征及血液动力学,提高临床疗效,且安全性较高。

To study the clinical efficacy of Shenfu injection combined with recombinant human brain natriuretic peptide(rhBNP)in patients with acute decompensated heart failure(ADHF),and also to evaluate its clinical safety.One hundred and seventeen cases of ADHF admitted into the Hospital Attached to Huanfeng Coal Mining Company Ltd were randomly divided into the control group(n=58)and the combined group(n=59).With the knowledge and consent of the patients,and also with the approval of the hospital ethics committee,the patients of the control group received rhBNP treatment in addition to routine therapy,and the patients of the combined group were treated with Shenfu injection in addition to the treatment given to the control group.Then,with the detection by color Doppler echocardiography,the levels of cardiac function,left ventricular diastolic diameter(LVDD),left ventricular ejection fraction(LVEF),and the levels of MR-proANP,NT-proANP,sST2 and galectin-3 in serum,as well as the scores of dyspnea,pulmonary rale and edema were compared between the patients of the 2 groups both before and after treatment.At the same time,differences in the levels of heart rate(HR),respiratory rate(RR),systolic blood pressure(SBP),oxygen saturation(SaO 2),urine volume,central venous pressure(CVP),pulmonary artery pressure(PAP),pulmonary capillary wedge pressure(PCWP)and cardiac output(CO)were also compared between the patients of the 2 groups both before treatment and 24,48 and 72 hours after treatment.Consequently,clinical efficacy and adverse reactions were compared between the patients of the 2 groups.After treatment,such indicators as cardiac functions(LVDD,LVEF,LVFS)of the combined group were all significantly lower than those of the control group(P<0.05)The serum levels of MR-proANP,NT-proANP,sST2 and galectin-3 of the combined group were superior to those of the control group(P<0.05).The scores of dyspnea,pulmonary rale and systemic edema of the combined group after treatment were significantly lower than those of the control group(P<0.05).The HR,RR,CVP of the combined group detected at hours 24,48 and 72 after treatment were all significantly lower than those of the control group(P<0.05),and the urine volume and cardiac output of the combined group were considerably higher than those of the control group(P<0.05).Total efficacy of the combined group was significantly higher than that of the control group(96.61%vs 86.21%,χ2=4.050,P=0.044).During the treatment,there were no serious adverse reactions in the patients of the 2 groups,and no significant differences in the incidence of adverse reactions could be noted in the patients of the 2 groups(P>0.05).Shenfu injection combined with rhBNP could significantly improve cardiac function index,the levels of biological markers,clinical symptoms,life signs as well hemodynamics,and clinical efficacy was obviously improved with better safety.