国产与进口内镜吻合器在腹腔镜辅助直肠癌根治术中的应用比较

摘要

Objective To compare the clinical effects of domestic and imported endoscopic stapling instrument in the application of laparoscopic assisted rectal cancer resection.Method 96 patients with rectal cancer,as research objects,were divided into three groups-group A,group B,and group C,with 32 patients in each group.The quality of life of all these patients who underwent laparoscopic assisted rectal cancer resection by the same operation team were evaluated before and six months after the operaticn,according to the Chinese version of EORTC QLQ-V3.0.Group A underwent the separation and suture of rectum by using endoscopic linear cutter,single-use loading unit,and circular staplers with staples produced by Reach Medical Instruments Co.Ltd.(Beijing),while group B used relevant products made by Johnson & Johnson Medical Ltd.and group C used the products from Covidien Ltd.(U.S.).We observed and compared clinical data,quality of life,and other indexes during and after the operations.Results Ninety patients completed the Dixon laparoscopes successfully,30 in each group,They were followed up for six months after the operation.Difference in clinical characteristics,quality of life,conditions during operation,the restoration of intestinal function after operation,the security of instrument,and the average time in hospital stay had no statistical significance (P＞0.05).In the aspect of cost of instruments,group A was (6 946.30-±-380.64) yuan per patient,while group B was (8 453.81±995.18) yuan per patient and group C was (12 039.61±645.46) yuan per patient.The difference in the price was statistically significant(P＜0.01).Conclusion Compared with the endoscopic instrument produced by Johnson & Johnson Medical Ltd.and Covidien Ltd.(U.S.),the instrument produced by Reach Medical Instruments Co.Ltd.is worth clinical promotion and it offers the application that is cost effective,safe,and practical.%目的 比较国产与进口内镜吻合器在腹腔镜辅助直肠癌根治术(Dixon)中应用的临床效果. 方法 96例直肠癌患者随机分为A,B,C3组,每组32例.96例患者均由相同的手术团队行腹腔镜辅助Dixon术,并在术前及术后6月采用生命质量测定量表核心量表V3.0中文版评价其生活质量.手术实施过程中,A组采用瑞奇外科器械(北京)有限公司生产的通用内镜直线切割吻合器、一次性钉匣及端端吻合器进行直肠的离断及吻合;B组和C组分别采用强生医疗器材有限公司、柯惠医疗器材制造有限公司(美外)生产的相应产品.观察比较3组患者的一般资料、生活质量、术中及术后的各项指标. 结果 顺利完成腹腔镜辅助Dixon术并如期随访至6月的患者共90例,每组30例.3组患者的一般资料、生活质量、术中情况、术后肠道功能恢复、吻合器安全性及平均住院天数比较,差别均无统计学意义(P＞0.05).3组的吻合器费用分别为A组(6 946.30±380.64)元,B组(8 453.81±995.18)元,C组(12 039.61±645.46)元,组间比较,差别均有统计学意义(P＜0.01). 结论 国产吻合器在腹腔镜辅助Dixon术中的使用具有较好的安全性及可行性,给患者带来了与进口吻合器相似的良好体验感,且价格低廉,值得临床上推广应用.