新型外科可吸收材料用于手术创面止血有效性和安全性多中心临床试验研究  

A multi-center clinical study on effectiveness and safety of new surgical absorbable material for surgical wound hemostasis

作　　者：仝聪[1] 周哲琦 肖扬 阎立昆[1] 王小强[1] TONG Cong;ZHOU Zheqi;XIAO Yang;YAN Likun;WANG Xiaoqiang(The First Department of General Surgery,Shaanxi Provincial People’s Hospital,Xi’an 710068,China)

机构地区：[1]陕西省人民医院普外一科,陕西西安710068

出　　处：《陕西医学杂志》2021年第11期1379-1382,共4页Shaanxi Medical Journal

基　　金：陕西省创新能力支撑计划项目(2020TD-048)。

摘　　要：目的:研究新型外科可吸收材料与可吸收止血纱在外科手术止血中的有效性和安全性。方法:随机选取多中心临床病例按多中心随机对照原则分为两组,对照组104例、观察组103例,比较两组患者治疗前后的生命体征、血常规、尿常规、肝功能、凝血酶原指标、心电图情况以及不良事件发生情况,以评价新型外科可吸收材料用于手术创面止血的有效性和安全性。结果:两组患者的5 min内止血率、器械黏贴情况比较均无统计学差异(均P>0.05);两组患者生命体征、血常规、尿常规、肝功能、凝血酶原指标、心电图及并发症发生情况比较均无统计学差异(均P>0.05);观察组患者的严重不良事件发生率显著低于对照组(P<0.05)。结论:新型外科可吸收材料用于手术创面止血的有效性与可吸收止血纱无差异,但其安全性要优于可吸收止血纱。Objective:To compared the effectiveness and safety of new surgical absorbable material and absorbable hemostatic gauze in surgical hemostasis.Methods:According to the multi-center,randomized controlled principle,the patients were randomly divided into control group(n=104)and observation group(n=103).Vital signs,blood routine,urine routine,liver function,prothrombin,electrocardiogram and adverse events were compared between the two groups to evaluate the effectiveness and safety of the new surgical absorbable material for surgical wound hemostasis.Results:There were no significant differences in hemostasis rate within 5 minutes,instrument fixation,vital signs,blood routine,urine routine,liver function,prothrombin,electrocardiogram and complications between the two groups(all P>0.05).The incidence of serious adverse events in the observation group was significantly higher than that in the control group(P<0.05).Conclusion:New surgical absorbable material has similar effect to absorbable hemostatic gauze in surgical wound hemostasis,but the former is safer than the latter.

关 键 词：外科手术 新型外科可吸收材料 可吸收止血纱 止血 安全性 有效性 

分 类 号：R608[医药卫生—外科学]