摘要
目的比较国产easyUSTM超声刀系统与某进口品牌Harmonic TM超声刀系统在普外科和泌尿外科手术中应用效果。方法筛选18~75岁需要使用超声刀系统行开放或内窥镜下外科手术的患者,应用基于网络的中央随机化系统将受试者随机分成观察组和对照组,两组受试者分别按照一定比例完成开放性或内窥镜下外科手术,对围术期的各项临床指标进行统计学分析和临床评价。结果131例受试者完成试验,观察组66例,对照组65例,组间基线均衡可比。手术部位、手术方式、手术时间、术中出血量、闭合血管直径,组间差异无统计学意义(P>0.05)。除对照组1例外,其余所有患者均未出现重度焦痂、重度临近组织损伤、焦糊味和烟雾。共发生7例并发症,观察组4例,对照组3例,差异无统计学意义(P>0.05)。观察组切割凝血功能总体优良率为96.97%,对照组为98.46%,两组优良率差值为-1.49(95%CI:-8.52~5.98),以-10%为非劣效界值,观察组非劣于对照组。结论两款超声刀系统均表现出优越的性能,国产超声刀系统实现安全性和切割凝血功能等临床性能非劣效于进口品牌。
Objective To compare the difference of using easy USTM ultrasonic scalpel versus harmonic TM ultrasonic scalpel in terms of safety,performance,overall excellent rate of cutting and coagulation(OERCC),and so on.Methods 18-75 years of age patients required the use of ultrasonic scalpel system under open or laparoscopic surgery were screened and randomly divided into trial group and control group using the central randomization system based on nctwork.The clinical parameters of perioperative period were analysed and evaluated.Results 131 patients completed all the procedures(Trial group:66,Control Group:65)。There were no significant differences between two groups in terms of demographic information,disease factors,surgery,performance,and so on.Trail group had 4 complications versus control group's 3 complications(P=1.0000)。The difference value of OERCC in trial group(96.97%)and in control group(98.46%)was-1.49%(95%CI:-8.52-5.98).One-sided hypohesis test(dividing value:-10%)showed non-inferiority for easyUS ulrasonie scalpel and harmonie ulrasonic scalpel.Conclusions EasyUSTM ultrasonic scalpel is non-inferiority to harmonicTM ultrasonic scalpel and it is a safe and useful altermative device.
出处
《浙江临床医学》
2021年第5期705-707,共3页
Zhejiang Clinical Medical Journal
