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

Safety analysis of application of medical anti-adhesion modified chitosan in cardiac surgery

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。

Objective To verify the application safety of medical anti-adhesion modified chitosan （Baifeimi） in cardiac surgery. Methods From August to December 2010, 42 patients undergoing surgery for congenital heart disease, valvular heart disease or isehemic heart disease were selected and divided into testing （ n = 22） and control （ n = 20 ） groups. After complete intraoperative hemostasis, two sheets of anti- adhesion modified chitosan （Baifeimi） were placed on the surface of heart and vessels in the testing group and then chest was closed. And the control group underwent routine chest closing without an application of Baifeimi. The systemic and local reactions and drainage fluid were observed. The postoperative drainage fluid was subject to bacteria culture. Blood routines and laboratory tests at preoperation and Day 1 and Week 1 postoperation were performed to evaluate the changes of chemical, biological and immunological parameters. Results There was no occurrence of systemic reaction, local inflammation or exudation. Wounds were healed at Phase I. The drainage fluid of pericardium and mediastina had no significant intergroup difference. Drainage was unobstructed in the testing group. A comparison of two groups revealed that the differences of aspartate aminotransferase （ （ 24 ± 17 ） vs （ 40 ± 22 ） U/L）, preoperative and postoperative immunoglobulin A （ （ 1.9 ± 0. 7 ） vs （ 2. 9 ± 1.4 ） g/L, （ 2. 3 ± 0. 9 ） vs （ 3.3 ± 1.5 ） g/L ） were statistically significant （ all P 〈 0. 05 ）. But the average values of both group stayed within a normal range without clinical significance while other indices had no significant difference. The bacteria cultures of all patients in the control group were negative. Conclusions Anti-adhesion modified chitosan is both convenient and safe for clinical application. The duration of cardiac surgery is not extended. No systemic or local adverse event is reported. There is no interference of hepatic, renal or immune functions.