摘要
目的:基于真实世界数据开展超声刀耗材的临床应用评价。方法:回顾性选取病案系统中手术术式包含“左肝”的手术记录,排除联合其他肝段切除的手术、成形术或重建术、开放手术后,纳入比较。第一次评价时回顾性选取2019年9月~2021年7月病案系统中手术术式包含“左肝”的手术患者67例,最终纳入56例,其中,使用国产超声刀手术者20例,使用进口超声刀手术者36例。2023年通过病案系统检索1~6月份包含“左肝”的手术,纳入观察组患者60例,与2021年的对照组36例进行比较。评价指标:手术时长及术中出血量。结果:所有手术均顺利完成,围手术期无死亡病例,通过分析进口超声刀组与国产超声刀组的统计资料,2021年、2023年组患者术前在年龄、性别、切口类别、是否糖尿病、是否高血压、是否联合手术等指标方面没有明显差别(P>0.05)。2021年数据显示进口和国产产品手术时长有统计学差异;术中出血量无明显差异(P>0.05)。2021年多重线性回归表明,超声刀分组、糖尿病、切口类别和联合手术对手术时长的影响有统计学意义(P<0.05)。结论:腹腔镜下左肝手术应用超声刀耗材手术时间2021年和2023年统计分析结果不同,表明持续开展临床应用评价有助于及时分析不同时间段的耗材使用效果。
Objective:In this study,the clinical application evaluation of ultrasound consumables was carried out based on real-world data.Methods:The surgical records of the surgical method including“left liver”in the case system were retrospectively selected,and the surgery,plasty or reconstruction surgery,and open surgery combined with other liver segment resection were excluded for comparison.During the first evaluation,a retrospective selection was conducted on 67 patients who underwent surgery for"left liver"in the medical record system from September 2019 to July 2021.A total of 56 patients were included,including 20 who underwent surgery with domestically produced ultrasound knives and 36 who underwent surgery with imported ultrasound knives.In 2023,a medical record system was used to search for surgeries involving"left liver"from January to June.60 patients were included in the observation group and compared with 36 patients in the control group in 2021.Evaluation index:length of operation and amount of intraoperative bleeding.Results:All surgeries were successfully completed,there were no deaths in the perioperative period,and through the analysis of the statistical data of imported ultherapy group and domestic ultherapy group,there was no significant difference in age,gender,incision type,diabetes diabetic,hypertension,combined surgery and other indicators in the 2021 and 2023 groups(P>0.05).The 2021 data shows a statistically significant difference in the length of surgery between imported and domestic products;There was no significant difference in intraoperative blood loss(P>0.05).Multiple linear regression in 2021 showed that ultrasound grouping,diabetes,incision category,and combined surgery had statistically significant effects on procedure duration(P<0.05).Conclusion:The results of the statistical analysis of the operation time of ultrasound consumables in laparoscopic left liver surgery carried out in this study are different in 2021 and 2023,indicating that continuous clinical application evaluation i
作者
郑沁春
张晓霞
陈实
林强
林天生
陈秋旸
邱梅钗
陈东
叶阿琴
ZHENG Qin-chun;ZHANG Xiao-xia;CHEN Shi;LIN Qiang;LIN Tian-sheng;CHEN Qiu-yang;QIU Mei-chai;CHEN Dong;YE A-qin(Fujian Provincial Hospital,Fujian Fuzhou 350001)
出处
《中国医疗器械信息》
2024年第5期39-41,68,共4页
China Medical Device Information
基金
福建省科技厅创新战略研究(项目名称:公立医院医用耗材使用评价体系研究,项目编号:2022R0128)。
关键词
超声刀耗材
真实世界研究
临床使用评价
ultrasonic scalpel consumables
real-world study
evaluation of clinical use
