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目的观察参附注射液治疗急性失代偿性心力衰竭(ADHF)的临床疗效,探讨可能的作用机制。方法入选ADHF患者100例,采用随机数字表法分为参附组和对照组,每组50例,2组均给予常规治疗心力衰竭药物,参附组给予参附注射液80ml+5%葡萄糖100ml静脉滴注,疗程10~14d。检测治疗前后血浆N末端B型脑钠肽前体(NT-proBNP)、肌钙蛋白T(cTnT)、白细胞介素(IL)-6、IL-8、IL-10、TNF-α及LVEF、左心室舒张末容积(LVEDV)、左心室短轴缩短率(LVFS)等相关指标,评估2组患者治疗后心功能(NYHA)分级的改善情况,6min步行距离(6-MWD),同时观察药物的不良反应。结果参附组治疗后总有效率明显高于对照组(96.0%vs80.0%,χ2=7.212,P=0.027),6-MWD较对照组明显延长[(473.06±24.09)mvs(430.09±23.31)m,P=0.043)];2组治疗后NT-proBNP、cTnT、IL-6、IL-8、TNF-α和LVEDV较治疗前下降,IL-10、LVFS、LVEF较治疗前升高,参附组变化幅度明显高于对照组,差异有统计学意义(P<0.05);参附组3例出现皮疹、1例出现头痛等不良反应。结论参附注射液改善ADHF患者心功能的机制可能为降低促炎性因子,升高抗炎性因子表达,纠正心力衰竭时两者的失衡状态。
Objective To observe the clinical efficacy of Shenfu Injection in the treatment of acute decompensated heart failure (ADHF) and to explore the possible mechanism. Methods A total of 100 patients with ADHF were enrolled in this study. They were randomized into the reference group and control group, 50 cases in each group. The patients in both groups were given conventional therapy of heart failure. The reference group was given Shenfu injection 80ml + 5% glucose 100ml Intravenous drip, treatment 10 ~ 14d. The levels of plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), troponin T (cTnT), interleukin (IL) -6, IL-8, IL-10, TNF-α and LVEF were measured before and after treatment. Left ventricular end-diastolic volume (LVEDV), left ventricular shortening (LVFS) and other related indicators to assess the improvement of cardiac function (NYHA) grade, 6min walking distance (6-MWD) Adverse reactions. Results The total effective rate in the Shenfu group was significantly higher than that in the control group (96.0% vs80.0%, χ2 = 7.212, P = 0.027), and the 6-MWD was significantly longer than that in the control group [473.06 ± 24.09 vs 430.09 ± 23.31 (P <0.05). The levels of NT-proBNP, cTnT, IL-6, IL-8, TNF-αand LVEDV in the two groups were decreased before treatment and the levels of IL-10, The changes in the reference group were significantly higher than those in the control group (P <0.05). There were 3 cases of skin rash in the treatment group and 1 case of headache and other side effects. Conclusion Shenfu injection may improve cardiac function in patients with ADHF by decreasing proinflammatory cytokines, increasing the expression of anti-inflammatory cytokines and correcting the imbalance of heart failure.