乌司他丁注射剂用于冠状动脉搭桥术后患者的临床研究

Clinical trial of ulinastatin injection in the treatment of patients after coronary artery bypass graft

目的观察乌司他丁注射剂对冠状动脉搭桥术后患者的临床疗效及安全性。方法将163例拟进行冠状动脉搭桥术患者随机分为对照组82例和试验组81例。对照组术后给予等剂量0.9%NaCl,q8 h,静脉泵入;试验组术后给予乌司他丁每次3.0×10^(5) U,q8 h,30 min缓慢静脉泵入。比较2组患者的心肌肌钙蛋白Ⅰ(cTnⅠ)、脑钠肽(BNP),以及药物不良反应的发生情况。结果治疗期间共脱落3例。治疗后,试验组和对照组的BNP分别为(354.55±23.47)和(465.87±43.78)mol·mL^(-1),cTnⅠ分别为(1.04±0.44)和(1.13±0.32)ng·mL^(-1),差异均有统计学意义(均P<0.05)。2组患者均未发生药物不良反应。结论乌司他丁注射剂能有效地改善冠状动脉搭桥术后患者异常的cTnⅠ和BNP,且安全性较高。

Objective To observe the clinical efficacy and safety of ulinastatin injection in the treatment of patients after coronary artery bypass graft.Methods A total of 163 patients with coronary artery bypass graft were randomly divided into control group(n=82 cases)and treatment group(n=81 cases).After surgery,the control group was given 0.9%NaCl,q8 h,intravenous infusion,and the treatment group received ulinastatin 3.0×10^(5) U per time,q8 h,slow intravenous infusion within 30 min.The serum levels of B-type natriuretic peptide(BNP)and cardiac troponinⅠ(cTnⅠ),and adverse drug reactions were compared between two groups.Results A total of three cases shed during the trial.After treatment,the levels of BNP in the treatment and control groups were(354.55±23.47)and(465.87±43.78)mol·mL^(-1),the levels of cTnⅠwere(1.04±0.44)and(1.13±0.32)ng·mL^(-1),the differences were statistically significant(all P<0.05).There were no adverse drug reactions occurred in two groups.Conclusion Ulinastatin can effectively improve the levels of cTnⅠand BNP in patients after coronary artery bypass grafting,and the safety is high.