医用防粘连改性壳聚糖膜在心脏外科手术应用中的安全性分析

目的 验证医用防粘连改性壳聚糖膜(百菲米)在心脏外科手术应用中的安全性.方法 采用前瞻性研究方法,选择2010年8-12月在首都医科大学附属北京安贞医院心外科临床诊断为先天性心脏病、心脏瓣膜疾病、缺血性心脏病而接受心脏手术的患者共42例,依照随机数字表法分为试验组(22例)和对照组(20例)两组:试验组在术毕止血后将2张医用防粘连改性壳聚糖膜平铺放在心脏及大血管表面,然后按照常规方法关胸.对照组不使用医用防粘连改性壳聚糖膜.观察该产品临床使用后的患者全身及局部有无反应、引流液情况及实验室的化验结果.其中术后引流液进行细菌培养.手术前、手术后第1天和术后1周分别抽血化验,观察血常规、血生化、免疫指标的变化.结果 所有患者术后皆无全身反应,局部伤口无红肿、渗液等,Ⅰ期愈合.两组间的心包、纵隔引流液差异无统计学意义,试验组引流通畅,未发生引流管堵塞现象.两组血常规、免疫指标及生化指标比较,只有术前天冬氨酸转氨酶[(24±17)比(40±22) U/L]、免疫球蛋白A[IgA,(1.9±0.7)比(2.9±1.4)g/L]和术后随访IgA[(2.3±0.9)比(3.3±1.5) g/L]差异均有统计学意义(均P＜0.05),但是两组平均值都在参考值范围之内,无临床意义,其余所有指标差异均无统计学意义.试验组所有受试者的引流液细菌培养均为阴性.结论 医用防粘连改性壳聚糖膜在心脏外科手术中使用未发生全身及局部的不良反应,不影响肝肾功能及免疫功能,可安全应用于心脏外科手术.     

代谢综合征对不停跳冠状动脉旁路移植围术期的影响

目的 探讨代谢综合征(metabolic syndrome,MS)对不停跳冠状动脉旁路移植(OPCABG)围术期的影响.方法 2009年8月至2010年3月,连续1060例OPCABG病人分为MS组与非MS组,比较两组的病死率、房颤发生率、多器官衰竭评分(MODS)、心脏外科术后评分(PSCS)、PaO2/FiO2以及心率×中心静脉压/平均动脉压(pressure-adjusted heart rate,PAHR).结果 MS对OPCABG的病死率、房颤发生率、脑卒中、IABP和ECMO、透析的使用率无影响.但手术当天,MS组的MODS评分为2.57±1.62,PSCS评分为4.27±2.15,显著高于非MS组的2.15±1.65,3.92±2.29,P＜0.05;PaO2/FiO2在MS组为249.23±110.99,显著低于非MS组的283.33±114.35,P＜0.01;MS组的PAHR为9.98±3.54,显著高于非MS组的9.23±3.88,P＜0.05.手术后第1天,MS组的MODS评分为3.05±1.64.显著高于非Ms组的2.82±1.72,P＜0.05;PaO2/FiO2在MS组为277.11±122.99,显著低于非MS组,318.47±143.84,P＜0.05.结论 MS对OPCABG的病死率、房颤发生率、脑卒中、IABP和ECMO、透析的使用率无影响,但在术后当天和术后第1天,MS可以对OPCABG病人的呼吸和循环系统产生短暂的负面影响.

Abstract：

Objective Metabolic syndrome ( MS), a disorder involving multiple metabolic abnormalities such obesity,hypertension, diabetes or abnormal glucose tolerance and dyslipidemia, has been observed in many patients receiving coronary artery bypass procedures. In this study we try to examine the perioperative effects of metabolic syndrome on the off-pump coronary artery bypass (OPCABG). Methods A prospective study was conducted in 1060 consecutive OPCABG patients who were admited to Beijing Anzhen Hospital from July 2009 to March 2010. The patients were grouped as MS group and non-MS group according to the diagnostic criteria for Chinese metabolic syndrome. The outcomes such as mortality, atrial fibrillation,stroke, staying in ICU for more than three days, use of IABP, ECMO, dialysis, multiple organ dysfunction score ( MOOS) ,postoperative score for cardiac surgery (PSCS), PaO2/FiO2 , heart rate x central venous pressure/mean artery pressure(pressure-adjusted heart rate, PAHR) ,renal and liver function, platelets, and the dosage of vasoactive agents were analyzed and compared between the two groups by x2 test or t test. Results Three hundred and eighty-nine cases were diagnosed with MS among 1060 cases with OPCABG. In the MS group, 17 cases stayed in ICU for more than 3 days, 2 cases died, 76 had atrial fibrillation, 3 had stroke, 18 cases were treated with intra-aortic balloon counterpulsation (IABP). In the non-MS group, 47 cases stayed in ICU for more than 3 days, 12 cases died, 148 had atrial fibrillation, 3 had stroke, 48 cases were treated withIABP, 3 cases received ECMO and 4 cases received dialysis. No significant difference between MS group and non-MS group was identified in the aspects of mortality, atrial fibrillation, stroke, duration of more than three days in ICU, the use of IABP,ECMO, dialysis after OPACBG based on the x2 test(P＞0.05). However, on the operative days, the MODS and PSCS in MS group were significantly higher than that in non-MS group (P ＜ 0.05). MODS 2. 57 ± 1. 62 in MS group vs. 2. 15 ± 1.65 in non-MS group, PSCS 4.27 ±2.15 in MS group vs. 3.92 ±2.29 in non-MS group. PaO2/FiO2 in MS group was significantly lower than that in non-MS group (249.23 ± 110.99 vs. 283. 33 ± 114. 35), P ＜ 0. 01. PAHR in MS group was significantly higher than that in non-MS group (9.98 ±3.54 vs. 9.23 ±3. 88), P ＜0.05. On the first postoperative days, the MODS in MS group was also significantly higher than that in non-MS group (3.05 ±1.64 vs. 2.82 ± 1.72), P＜0.05. PaO2/FiO2 in MS group was significantly lower than that in non-MS group (277.11 ±122.99 vs.318.47 ±143.84), P＜0.05. Conclusion MS was not a predictor for death, atrial fibrillation, stroke, duration of more than three days in 1CU, the use of IABP, ECMO, dialysis after OPACBG. However, MS had a temporary adverse effect on the respiratory and circulatory systems on the operative day and the first postoperative day after OPCABG.