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基于真实世界数据分析国产与进口吻合器的临床使用价值OACSTPCD

Analysis of the clinical value of domestic and imported staplers based on real-world data

中文摘要英文摘要

目的:基于真实世界数据探讨分析进口和国产品牌吻合器的临床使用价值.方法:选取2022年度陆军军医大学大坪医院使用吻合器进行吻合手术的466例患者临床相关资料,根据患者术中使用吻合器的品牌不同将其分为进口吻合器组(294例)和国产吻合器组(172例),对比两组患者中术中、术后、并发症和仓钉使用的差异.结果:国产吻合器组患者中手术时间中位数为170.00 min(120.75~205.00 min),显著少于进口吻合器组,其差异有统计学意义(W=29157,P<0.05);术后3 d咳嗽伴咳痰患者发生率为16.86%(29/172),少于进口吻合器组,切口疼痛患者发生率为44.19%(76/172),多于进口吻合器组,其差异有统计学意义(x2=12.49、15.13,P<0.05).国产吻合器组患者中吻合出血、水肿、狭窄和口瘘并发症的发生率与进口吻合器组比较差异无统计学意义(x2=0.77、0.02、0.52、2.18,P>0.05);国产吻合器组患者中使用仓钉的中位数为2.5个(0~3个),少于进口吻合器组,其差异有统计学意义(W=35160,P<0.05).结论:国产吻合器与进口品牌吻合器临床应用表现相当,国产吻合器具有潜在的进口替代优势.

Objective:To discuss and analyze the clinical value of imported and domestic brand staplers based on real-world data.Methods:The clinical data of 466 patients who used staplers for anastomosis surgery in Daping Hospital,Army Medical University in 2022 were selected and divided into imported group(294 cases)and domestic stapler group(172 cases)according to different brands of staplers used in the surgery.The differences in intraoperative,postoperative,complications and the use of staples were compared between the two groups.Results:The median operation time of the domestic group was 170 min(120.75-205 min),which was significantly lower than that of the imported group,the difference was statistically significant(W=29157,P<0.05).The incidence rate of patients with cough with sputum on the 3rd day after surgery in the domestic group was 16.86%(29/172),which was less than that in the imported group,and incidence of incision pain was 44.19%(76/172),which was more than that in the imported group,the difference was statistically significant(x2=12.49,15.13,P<0.05).There was no statistically significant difference in the incidence of anastomotic hemorrhage,edema,stenosis and oral fistula complications between the domestic group and the imported group(x2=0.77,0.02,0.52,2.18,P>0.05).The median number of staples used by patients in the domestic group was 2.5(0-3),which was less than that in the imported group,the difference was statistically significant(W=35160,P<0.05).Conclusion:The clinical application performance of domestic staplers is comparable to that of imported brand staplers,and domestic staplers have potential import substitution advantages.

王红丹;张本兴;魏安海;杨利;张和华

陆军军医大学大坪医院医学工程科 重庆 400042

预防医学

真实世界数据吻合器临床应用国产替代

Real-world dataStaplerClinical applicationDomestic substitution

《中国医学装备》 2024 (004)

151-155 / 5

国家卫生健康委医院管理研究所基金资助课题(2022MEB202) The project funded by the Hospital Management Institute of the National Health Commission(2022MEB202)

10.3969/j.issn.1672-8270.2024.04.030

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