左西孟旦治疗瓣膜置换术后急性心功能衰竭疗效的临床研究

Levosimendan for the treatment of acute heart failure after valvular replacement

目的观察左西孟旦对心脏瓣膜置换术后急性心功能衰竭患者的疗效及安全性。方法选取福建省立医院2013年3月1日至2016年3月1日心脏瓣膜病患者166例,按照数字随机法分为对照组88例(术后接受常规心力衰竭治疗),左西孟旦组78例(在常规治疗基础上给予左西孟旦治疗)。在术前1 d、术后1 d、术后7 d抽取静脉血,检测血清肌酸激酶(CK)、肌酸激酶同工酶(CK-MB)、乳酸脱氢酶(LDH)、心肌肌钙蛋白T(c Tn T)、氨基末端脑利钠肽前体(NT-pro BNP)。术前1 d、术后7 d行超声心动图检查,记录左心室射血分数(LVEF)、短轴收缩率、左心室舒张末期内径(LVEDd)。记录术后呼吸机辅助时间、术后ICU治疗时间、术后住院时间及术后并发症情况。结果左西孟旦组术后呼吸机辅助时间[(22.40±8.65)h比(23.23±7.15)h,P=0.681]比对照组略缩短,但差异无统计学意义;在术后ICU治疗时间[(3.11±2.12)d比(5.10±2.45)d,P=0.000]、术后住院时间[(10.20±2.36)d比(15.10±3.26)d,P=0.000]均较对照组明显缩短,差异均有统计学意义。两组患者术后7 d内无死亡病例,未出现围术期心肌梗死、恶性心律失常、中枢神经系统相关并发症。对照组1例术后出现心脏压塞,行二次开胸止血术。左西孟旦组胃肠道并发症[10例(12.8%)比18例(20.4%),P=0.192]、肝功能不全[15例(19.2%)比18例(20.5%),P=0.843]发生率与对照组比较,差异均无统计学意义;但肾功能不全[1例(1.3%)比8例(9.1%),P=0.041]、不良事件总发生率(术后心肌梗死、顽固性低血压、恶性心律失常、二次开胸、中枢神经系统相关并发症、胃肠道反应、肾功能不全、肝功能不全和死亡)[26例(33.3%)比38例(43.2%),P=0.033]显著低于对照组,差异均有统计学意义。两组患者术前1 d的CK、CK-MB、LDH、c Tn T、NT-pro BNP比较,差异均无统计学意义(均P>0.05)。术后1 d,两组患者血清学指标均有明显改善;左西孟旦组改善更加明显,且这种效应一直持续到术后7 d,差异有统计学意义(P<0.05)。两组患者基线状态下LVEF、短轴收缩率、LVEDd比较,差异均无统计学意义(均P>0.05)。术后7 d,左西孟旦组LVEF[(0.59±0.09)%比(0.51±0.12)%,P=0.000]、短轴收缩率[(0.33±0.07)%比(0.24±0.06)%,P=0.000]、LVEDd[(5.01±0.57)cm比(5.98±1.01)cm,P=0.000]均较对照组明显改善,差异均有统计学意义。结论左西孟旦治疗瓣膜置换后急性心功能衰竭患者的血清学及超声心动图指标改善明显,有助于术后患者心功能的恢复,不良反应较少。

Objective To evaluate the efficacy of Levosimendan in patients with acute heart failure（ HF） after valvular replacement. Methods From March 1,2013 to March 1,2016,166 patients with acute heart failure after valvular replacement were randomly divided into two groups. There were 88 patients（ the control group） who received conventional anti-HF treatment and the other 78 patients（ Levosimendan group） were given same conventional anti-HF treatment plus Levosimendan. All patients had blood test for cardiac enzymes and NT-pro BNP on 1 d before operation and 1 d,7 d after operation. All patients underwent echocardiography before operation and on day 7 after operation for assessment of LVEF,FS and LVEDd.Results No mortality was recorded in both groups. Patients in the levosimendan group had shorter ICU stay[（ 3. 11 ± 2. 12） d vs.（ 5. 10 ± 2. 45） d,P = 0. 000]and post-operative hospital stay [（ 10. 20 ± 2. 36） d vs.（ 15. 10 ± 3. 26） d,P = 0. 000]than the antrol group. Patients in the levosimendan group needed shorter time to be weaned off from ventilator [（ 22. 40 ± 8. 65） h vs.（ 23. 23 ± 7. 15） h,P = 0. 681] as compared to the control but without stastical significance. No differences was found in cardiac enzymes and NT-pro BNP levels between the 2 groups 1 day before surgery（ all P 0. 05） but patients receiving levosimendan had lower levels of CK,CK-MB,c Tn T,LDH and NT-pro BNP after surgery on both day 1 and day 7（ all P 0. 05）. There was no difference in echocardiography findings between the 2 groups at baseline before surgery. Improvement in LVEF [（ 0. 59 ± 0. 09） % vs.（ 0. 51 ± 0. 12） % ],FS [（ 0. 33 ± 0. 07） % vs.（ 0. 24 ± 0. 06） %] and LVEDd[（ 5. 01 ± 0. 57） cm vs.（ 5. 98 ± 1. 01） cm] was found the levosimendan group as compared to the control with significant difference（ all P = 0. 000）. Conclusions Levosimendan help to restore cardiac function in patients with acute heart failure after valvular replacement.