吸盘型封闭式负压引流护创系统临床有效性和安全性评价：一项前瞻性、随机、开放、平行对照、非劣效性临床试验  

Evaluation of the effectiveness and safety of closed negative pressure drainage nursing system(PU suction cup type):a perspective, randomized, open, parallel controlled and non-inferiority trial

作　　者：袁亚翠 刘琳娜 刘喜文 李跃军 赵聪颖 韩琳 Yuan Yacui;Liu Linna;Liu Xiwen;Li Yuejun;Zhao Congying;Han Lin(Department of Plastic Surgery and Burn,Tangdu Hospital of Air Force Medical University, Xi'an 710038, Shaanxi Province, China;Department of Pharmacy, Tangdu Hospital of Air Force Medical University, Xi'an 710038, Shaanxi Province, China;School of Nursing, Air Force Medical University, Xi'an 710032, Shaanxi Province, China)

机构地区：[1]空军军医大学唐都医院整形烧伤科,陕西省西安市710038 [2]空军军医大学唐都医药学部,陕西省西安市710038 [3]空军军医大学护理学院,陕西省西安市710032

出　　处：《中国组织工程研究》2019年第35期5676-5681,共6页Chinese Journal of Tissue Engineering Research

摘　　要：背景:吸盘型封闭式负压引流护创系统是近几年在负压封闭引流技术基础上研发的、具有持续密闭负压引流功能的创面治疗装置。正确使用、保证有效引流的前提下,与传统换药清创相比,便于医护人员实时监控创面愈合情况,可显著减少大剂量抗菌药物的应用及换药次数,进而降低治疗费用,缩短住院日,减轻患者痛苦。目的:评价试验产品吸盘型封闭式负压引流护创系统的临床有效性及安全性,为其临床推广及产品应用注册提供理论及数据支持。方法:将132例需负压封闭引流治疗的患者随机分为2组,试验组66例使用封闭式负压引流护创系统(PU)(型号:PU吸盘型),对照组66例使用封闭式负压引流套件(规格型号:Ⅱ-PU型)。评估治疗14d的结局变化,主要结局指标:治疗14d内治疗有效率;次要结局指标(首次使用,拆除或更换时):目测类比评分、操作满意度、产品物理性能;安全性评价指标:不良事件/反应发生率、并发症发生率及实验室检查指标。结果与结论:①有效性指标:治疗后14d内两组有效率均为100%;与治疗前相比,治疗后(10±3)d两组目测类比评分均显著下降(P<0.05),且治疗后两组间比较无显著性意义;②安全性指标:两组治疗前后实验室检测指标(血常规,肝功能,凝血4项)差异无显著性意义;两组产品操作满意度、产品物理性能均能100%满足临床使用;试验组和对照组产品均未出现并发症;整个试验期间,试验组66例患者中有9例(13.6%)发生不良事件,66例对照组受试者中有10例(15.2%)发生不良事件;③结果证实,封闭式负压引流护创材料套装(PU)用于创面引流的疗效与安全性与对照产品相当。试验于2016-09-13获得空军军医大学唐都医院医学伦理委员会批准,批准号:第201609-10号。BACKGROUND: The closed negative pressure drainage nursing system(PU suction cup type) is a wound treatment device with continuous closed negative pressure drainage function developed on the basis of vacuum sealing drainage in recent years. Under the premise of correct use and effective drainage, it is convenient for medical personnel to monitor wound healing in real time compared with traditional dressing debridement, which can obviously reduce the application of large doses of antibacterial drugs and the number of dressing changes, thereby reducing treatment costs, shortening hospitalization time, and alleviating patient suffering. OBJECTIVE: To evaluate the clinical efficacy and safety of the closed-type negative pressure drainage nursing system(PU suction cup type), and to provide theoretical and data support for its clinical promotion and product application registration. METHODS: Totally 132 patients needing vacuum sealing drainage were randomly divided into trial group(closed suction drainage system record(PU suction type) and control group(the use of closed suction drainage kit(II-PU type))(n=66/group). The therapeutic effect within 14 days was evaluated. The primary measurement outcome was the efficacy with 14 days. The secondary measurement outcomes were Visual Analog Scale score, operating satisfaction, physical properties, and safety evaluation indexes: incidence of adverse events/reactions, incidence of complications, and laboratory examination indexes. RESULTS AND CONCLUSION:(1) Effectiveness index: the effective rate of both groups was 100% within 14 days of treatment. Compared with before treatment, the Visual Analog Scale scores in the two groups were significantly decreased after treatment of(10±3) days(P < 0.05), and there was no significant difference between two groups.(2) Safety indicators: There were no significant differences in laboratory test indicators(blood routine, liver function, coagulation) before and after treatment. The two groups of product operation satisfaction, product physic

关 键 词：封闭式负压引流护创材料 皮肤组织 创伤创面 创面愈合 有效性 安全性 评价指标 

分 类 号：R473[医药卫生—护理学] R459.2[医药卫生—临床医学]