Department of Cardio-Thoracic Surgery, Nanjing Drum Tower Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Graduate School of Peking Union Medical College, Number 321 Zhongshan Road, Nanjing, 210008, Jiangsu, China.
Department of Cardio-Thoracic Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Crit Care. 2023 Feb 7;27(1):49. doi: 10.1186/s13054-023-04341-9.
Recent high-quality trials have shown that the anti-inflammatory effects of colchicine reduce the risk of cardiovascular events in patients suffering post-myocardial infarction and chronic coronary disease. The effect of colchicine in patients undergoing non-coronary artery bypass grafting (non-CABG) with cardiopulmonary bypass remains unclear. We aim to evaluate the effect of colchicine on myocardial protection in patients who underwent non-CABG cardiac surgery.
Patients were randomly assigned to colchicine or placebo groups starting 72 h before scheduled cardiac surgery and for 5 days thereafter (0.5 mg daily).The primary outcome was the level of cardiac troponin T (cTnT) at postoperative 48 h. The secondary outcomes included troponin I (cTnI) and creatine kinase-MB (CK-MB), inflammatory biomarkers (procalcitonin and interleukin-6, etc.), and adverse events (30-day mortality, stroke, ECMO and IABP use, etc.).
A total of 132 patients underwent non-CAGB cardiac surgery, 11were excluded because of diarrhea (n = 6) and long aortic cross-clamp time > 2 h (n = 5), 59 were assigned to the colchicine group and 62 to the placebo group. Compared with the placebo group, cTnT (median: 0.3 μg/L, IQR 0.2-0.4 μg/L vs. median: 0.4 μg/L, IQR 0.3-0.6 μg/L, P < 0.01), cardiac troponin I (median: 0.9 ng/ml, IQR 0.4-1.7 ng/ml vs. median: 1.3 ng/ml, IQR 0.6-2.3 ng/ml, P = 0.02), CK-MB (median: 1.9 ng/ml, IQR 0.7-3.2 ng/ml vs. median: 4.4 ng/ml, IQR 1.5-8.2 ng/ml, P < 0.01), and interleukin-6 (median: 73.5 pg/ml, IQR 49.6-125.8 pg/ml vs. median: 101 pg/ml, IQR 57.5-164.7 pg/ml, P = 0.048) were significantly reduced in colchicine group at postoperative 48 h. For safety evaluation, the colchicine (n = 65) significantly decreased post-pericardiotomy syndrome (3.08% vs. 17.7%, P < 0.01) and increased the rate of diarrhea (9.23% vs. 0, P = 0.01) compared with the placebo group (n = 62). No significant difference was observed in other adverse events between the two groups.
A short perioperative course of low-dose colchicine was effective to attenuate the postoperative biomarkers of myocardial injury and inflammation, and to decrease the postoperative syndrome compared with the placebo. Trial registration ChiCTR2000040129. Registered 22nd Nov. 2020. This trial was registered before the first participant was enrolled. http://www.chictr.org.cn/showproj.aspx?proj=64370 .
最近的高质量试验表明，秋水仙碱的抗炎作用可降低心肌梗死后和慢性冠心病患者发生心血管事件的风险。秋水仙碱在接受非心脏搭桥手术（非 CABG）并使用体外循环的患者中的作用尚不清楚。我们旨在评估秋水仙碱对非 CABG 心脏手术患者心肌保护的作用。
患者在计划心脏手术前 72 小时开始随机分配至秋水仙碱或安慰剂组，并在术后 5 天内每天服用 0.5 毫克。主要结局是术后 48 小时的心脏肌钙蛋白 T（cTnT）水平。次要结局包括肌钙蛋白 I（cTnI）和肌酸激酶-MB（CK-MB）、炎症生物标志物（降钙素原和白细胞介素-6 等）和不良事件（30 天死亡率、中风、ECMO 和 IABP 使用等）。
共有 132 名患者接受了非 CAGB 心脏手术，其中 11 名因腹泻（n=6）和主动脉夹闭时间过长>2 小时（n=5）而被排除，59 名患者被分配至秋水仙碱组，62 名患者被分配至安慰剂组。与安慰剂组相比，cTnT（中位数：0.3μg/L，IQR 0.2-0.4μg/L 与中位数：0.4μg/L，IQR 0.3-0.6μg/L，P<0.01）、心肌肌钙蛋白 I（中位数：0.9ng/ml，IQR 0.4-1.7ng/ml 与中位数：1.3ng/ml，IQR 0.6-2.3ng/ml，P=0.02）、CK-MB（中位数：1.9ng/ml，IQR 0.7-3.2ng/ml 与中位数：4.4ng/ml，IQR 1.5-8.2ng/ml，P<0.01）和白细胞介素-6（中位数：73.5pg/ml，IQR 49.6-125.8pg/ml 与中位数：101pg/ml，IQR 57.5-164.7pg/ml，P=0.048）在秋水仙碱组术后 48 小时明显降低。为了进行安全性评估，与安慰剂组（n=62）相比，秋水仙碱（n=65）组心包切开后综合征（3.08%比 17.7%，P<0.01）的发生率降低，腹泻发生率（9.23%比 0，P=0.01）增加。两组其他不良事件发生率无显著差异。
与安慰剂相比，短疗程低剂量秋水仙碱可有效减轻术后心肌损伤和炎症的生物标志物，并降低术后综合征的发生率。
ChiCTR2000040129。于 2020 年 11 月 22 日注册。本试验在首例参与者入组前已注册。http://www.chictr.org.cn/showproj.aspx?proj=64370。
