可吸收性心包膜填补材料预防心包粘连效果及安全性的随机对照试验  

Effectiveness and Safety of Bioabsorbable Anti-adhesive Pericardial Substitute to Eliminate Pericardial Adhesion:A Randomized Controlled Trial

作　　者：王德[1] 李守军[1] 郭少先[1] 花中东[1] 张浩[1] 

机构地区：[1]中国医学科学院北京协和医学院国家心血管病中心阜外医院心血管疾病国家重点实验室,北京100037

出　　处：《中国胸心血管外科临床杂志》2016年第10期944-948,共5页Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

摘　　要：目的探索可吸收性心包膜填补材料(GM042)预防心包粘连的效果及其安全性。方法将80例实施心脏手术且预计3年内需再次手术的患者随机分为两组:试验组,40例,年龄(1.79±1.72)岁;对照组,40例,年龄(1.63±1.52)岁。两组最终纳入患者共73例:试验组36例,男23例、女13例;对照组37例,男20例、女17例。试验组在手术时使用GM042填补心包膜缺损部位,对照组不使用。评价GM042的可操作性、安全性及减轻心包粘连的作用。结果试验组术前与术后半年的临床检查指标差异无统计学意义,未见GM042明显相关不良反应。GM042在术中可操作性良好;再次手术时试验组粘连评分低于对照组(P<0.05),且心表心包膜肥厚、心表面钙化及心表结构可见度均优于对照组(P<0.05)。结论 GM042在心外科手术中具有防粘连效果,符合临床安全性要求,适用于需再次手术的患者。Objective To explore effectiveness and safety of bioabsorbable anti-adhesive pericardial substitute （GM042） to eliminate pericardial adhesion. Method Eighty patients who were expected to undergo multistage cardiac surgery in three years were randomly divided into a trial group （40 patients） and a control group （40 patients）. The mean age of the patients in the trial group was 1.79_＋1.72 years and 1.63＋1.52 years in the control group. Finally, 73 patients were included with 36 patients （13 females and 23 males） in the trial group and 37 patients （20 males and 17 females） in the control group. The trial group used GM042 to fill the pericardium defect at the first surgery while the control group didn＇t. The manipuility, safety, and the anti-adhesive role of GM042 were evaluated. Result There was no significant difference in clinical indexes between at first surgery and six months after surgery in the trial group. There was no significant adverse event correlated to GM042. GM042 presented fine maneuverability during surgery. The adhesive score of the trial group was significantly lower than that of the control group （P〈0.05）. Adhesion score, pericardiac thickening, calcification, and visibility of heart surface structures were better in the trial group than those in the control group （P〈0.05）. Conclusion GM042 presented anti-adhesion effect and safety in cardiac surgery. Therefore, it＇s applicable to patients requiring re-operation.

关 键 词：防粘连 心外科分期手术 可吸收性 心包膜填补材料 

分 类 号：R654.2[医药卫生—外科学]