CAJ | 학술논문

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.
목적 험증의용방점련개성각취당막(백비미)재심장외과수술응용중적안전성.방법 채용전첨성연구방법,선택2010년8-12월재수도의과대학부속북경안정의원심외과림상진단위선천성심장병、심장판막질병、결혈성심장병이접수심장수술적환자공42례,의조수궤수자표법분위시험조(22례)화대조조(20례)량조:시험조재술필지혈후장2장의용방점련개성각취당막평포방재심장급대혈관표면,연후안조상규방법관흉.대조조불사용의용방점련개성각취당막.관찰해산품림상사용후적환자전신급국부유무반응、인류액정황급실험실적화험결과.기중술후인류액진행세균배양.수술전、수술후제1천화술후1주분별추혈화험,관찰혈상규、혈생화、면역지표적변화.결과 소유환자술후개무전신반응,국부상구무홍종、삼액등,Ⅰ기유합.량조간적심포、종격인류액차이무통계학의의,시험조인류통창,미발생인류관도새현상.량조혈상규、면역지표급생화지표비교,지유술전천동안산전안매[(24±17)비(40±22) U/L]、면역구단백A[IgA,(1.9±0.7)비(2.9±1.4)g/L]화술후수방IgA[(2.3±0.9)비(3.3±1.5) g/L]차이균유통계학의의(균P＜0.05),단시량조평균치도재삼고치범위지내,무림상의의,기여소유지표차이균무통계학의의.시험조소유수시자적인류액세균배양균위음성.결론 의용방점련개성각취당막재심장외과수술중사용미발생전신급국부적불량반응,불영향간신공능급면역공능,가안전응용우심장외과수술.
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 ischemic heart disease were selected and divided into testing (n =22) and control (n =20) groups.After complete intraoperative hemostasis,two sheets of antiadhesion 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.