早期应用参附注射液预防脓毒性心肌病的探索性随机对照研究

An exploratory randomized controlled study on early application of Shenfu injection to prevent septic cardiomyopathy

目的观察早期应用参附注射液预防脓毒症患者脓毒性心肌病(SIC)的临床疗效。方法2022年6月至2023年1月急诊ICU收治的未发生SIC的脓毒症或脓毒性休克患者,按1∶1随机被分为治疗组和对照组。治疗组予参附注射液50 mL静脉泵入,每12 h 1次,疗程5 d;对照组生理盐水50 mL静脉泵入,每12 h 1次,疗程5 d。主要观察终点为前5 d SIC发生率。次要观察终点为血管活性药物应用时间、前一周液体平衡、ICU住院时间、总通气时间及28 d病死率。结果112例患者进入随机分组,治疗组7例被二次排除,纳入49例进行分析,对照组二次排除6例纳入50例进行分析。治疗组5 d内SIC总发生率为42.9%,低于对照组的64.0%(P=0.035)。其中左室收缩功能障碍治疗组低于对照组(24.5%vs.52.0%,P=0.005),左室舒张功能障碍发生率两组差异无统计学意义,对照组右室功能障碍发生率28.0%,高于治疗组10.2%(P=0.025)。治疗组缩血管药物应用时长75(48,97)h,低于对照组的97(66,128)h(P=0.039);强心药物应用时长治疗组为32(18,49)h,短于对照组的44(25,61)h(P=0.046)。对照组第一周液体平衡为(1260±850)mL,显著高于治疗组的(450±520)mL(P=0.008)。ICU住院时间、总通气时间及28 d病死率两组间均差异无统计学意义(均P>0.05)。结论早期应用参附注射液可以显著降低SIC的发生率,伴有更少的血管活性药物应用和液体正平衡,具有良好的临床应用前景。

Objective To observe the clinical effect of Shenfu injection in preventing septic cardiomyopathy(SIC)in septic patients.Methods From June 2022 to January 2023,patients with sepsis or septic shock who did not develop SIC were randomly divided into treatment group and control group according to the ratio of 1:1.In the treatment group,Shenfu injection(50 mL)was pumped intravenously once every 12 hours for 5 days.In the control group,50 mL of normal saline was pumped intravenously once every 12 hours,and the course of treatment was 5 days.The primary end point was the incidence of SIC in the first 5 days.The secondary end points were the application time of vasoactive drugs,fluid balance in the previous week,hospitalization time in ICU,total ventilation time and 28-day mortality.Results 112 patients were randomly divided into two groups.Seven patients in the treatment group were excluded twice,and finally 49 patients were included in the analysis,while six patients in the control group were excluded twice and 50 patients included in the analysis.The total incidence of SIC in the treatment group within 5 days was significantly lower than that in the control group(42.9%vs.64.0%,P=0.035).Among them,the left ventricular systolic dysfunction in the treatment group was significantly lower than that in the control group(24.5%vs 52.0%,P=0.005),and there was no significant difference in the incidence of left ventricular diastolic dysfunction between the two groups.The incidence of right ventricular dysfunction in the control group was 28.0%,which was significantly higher than 10.2%in the treatment group(P=0.025).The duration of using vasoconstrictors in the treatment group was 75(48,97)hours,which was significantly lower than 97(66,28)hours in the control group(P=0.039).The duration of inotropic drugs use in the treatment group was 32(18,49)h,which was also significantly shorter than 44(25,61)h in the control group(P=0.046).The fluid balance of the control group in the first week was(1260±850)mL,which was significantly higher than(450±520)mL in the treatment group(P=0.008).There was no statistical difference in ICU stay,total ventilation time and 28-day mortality between the two groups(all P>0.05).Conclusion Early application of Shenfu injection can significantly reduce the incidence of SIC,accompanied by less use of vasoactive drugs and positive fluid balance,which has a good clinical application prospect.