关于医疗器械软件变更监管要求探讨

由于医疗器械软件的特殊性，在产品注册后变更相对频繁，但现在对于医疗器械软件变更的监管要求尚未能充分考虑这种情况，应进一步科学合理设置相应监管要求。本文针对业内人士所关注焦点，分析了医疗器械软件变更类型划分原则，并基于相关变更类型划分，探讨了医疗器械软件变更的监管要求，最后提出了相关工作建议。     

Trends of robotic-assisted surgery for thyroid,colorectal, stomach and hepatopancreaticobiliary cancer: 10 year Korea trend investigation

BackgroundThe current position of robotic surgery in the field of minimally invasive surgery remains ambiguous. We evaluated long-term trends of robotic general surgery and the future direction of its development.MethodsData on robotic cancer surgeries between 2005 and 2014 were retrospectively collected by volunteer institutions in the Republic of Korea. Spearman's correlation and logistic regression analyses were used to compare robotic and laparoscopic surgery trends in general surgery.ResultsThe odds that robotic surgery was performed instead of laparoscopic surgery significantly decreased in the fields of colorectal, stomach, and hepato-biliary-pancreatic surgery (odds ratio [OR]: 0.95, 95% confidence interval [CI]: 0.93–0.97; OR: 0.90, 95% CI: 0.88–0.92; and OR: 0.71, 95% CI: 0.65–0.78, respectively), except for thyroid surgery (OR: 1.28, 95% CI: 1.25–1.30). Of the total numbers of each procedure, proportions of robotic intersphincteric resections, abdominoperineal resections, and pylorus-preserving surgery performed significantly increased (r = 0.98, P < .001; r = 0.78, P = .01; and r = 0.86, P = .007, respectively).ConclusionsThe use of robotic surgery failed to preponderate that of laparoscopic surgery, except for thyroid surgery. Robotic surgery is increasingly preferred for limited fields or complex surgeries, but the use of robotics in simple surgeries has decreased.     

中老年房间隔缺损的心脏CT与经食管超声评估对比研究

目的:探讨心脏CT血管成像(CTA)在评估房间隔缺损(ASD)方面的精确性及对介入治疗的指导价值。方法:回顾性分析已行ASD封堵术或手术修补的中老年患者63例资料,男性18例,女性45例,年龄50~77岁,平均(56.9±5.8)岁,患者均于术前行经胸超声(TTE)和经食管超声(TEE)检查,并常规行CTA检查以除外冠心病。在GE工作站上行ASD三维(3D)重建,以CT横断面辅助测量技术(CTAS)测量缺损大小及边缘长度,与TTE及TEE对比,并总结其他重要影像学表现。结果:在缺损大小方面,CTA与TTE及TEE分别相差约4.48(3.28~5.76)mm和1.98(0.94~3.03)mm;CTA与TTE及TEE之间有良好的相关性,且与后者相关性最强;在房间隔长度及缺损边缘方面,除下腔侧边缘外,CTA及TEE测量值均差异无统计学意义;CTA所测下腔侧边缘长度较TEE测量值约>2.2(1.35~3.08)mm;15例患者因CTA提供重要解剖信息而改变治疗方案,其中13例患者行外科手术治疗,2例于介入封堵ASD同时行冠状动脉成形及支架置入术。结论:对于拟行ASD封堵术的中老年患者,术前心脏CT检查可准确测量缺损大小及边缘长度,且在评估下腔侧边缘方面可能优于TEE。     

Left ventricular pseudoaneurysm complicating a ruptured isolated congenital diverticulum

We report a case of 41-year-old woman who presented with chest tightness and shortness of breath. Transthoracic echocardiogram (TTE) showed left ventricular (LV) pseudoaneurysm of the inferior wall with preserved LV systolic function. Coronary angiogram was normal. Surgical repair of the pseudoaneurysm with a pericardial patch was performed, and pathological results confirmed rupture of an isolated congenital LV diverticulum, as the most likely etiology.     

以馆藏资源助力地域文化符号搭建文旅融合底蕴平台

地域文化符号是地方历史文化发展的载体,也是地域文明的象征。图书馆作为地域信息及文献资源的收藏地,在地域文化发展中起着至关重要的作用,在当前经济社会发展的背景下,也是文旅融合发展的重要组成部分。本文以图书馆助力地域文化符号搭建文旅融合底蕴平台为出发点,通过分析找准地域文化符号的意义和方法,探究图书馆在充分利用馆藏资源的基础上,找准文旅融合的契合点,厚积地域文化底蕴的方式和路径,通过进一步融合现代发展元素,打造文化旅游特色品牌项目,使文旅产业成为带动地域经济发展的"动力产业"。     

杂交技术对难复性腹股沟疝治疗效果的前瞻性随机对照研究

目的对比杂交技术与单纯腹腔镜技术在难复性腹股沟疝修补术中的应用价值。 方法将2015年1月至2017年12月廊坊市第四人民医院收治的单侧难复性腹股沟疝患者共60例纳入本研究，采用随机法分为2组。其中试验组患者30例，采用杂交技术；对照组患者30例，采用腹腔镜技术。对比2组患者手术时间、气腹持续时间、术中出血量、住院时间、住院费用、术后并发症等指标。 结果对照组1例患者因腹腔镜下难以分离还纳，后转为开放手术，淘汰出组，其余患者均顺利完成手术。试验组单侧难复性腹股沟疝患者住院时间、住院费用、术后发热情况、异物感发生情况分别为（5.00±0.85）d、（10 901.8±830.22）元、5例（16.7%）、2例（6.7%），与对照组（5.00±0.82）d、（11 116.45±813.73）元、6例（20.7%）、2例（6.9%）比较，差异无统计学意义（P均>0.05）。试验组单侧难复性腹股沟疝患者手术时间、气腹持续时间、术中出血量、血清肿发生情况分别为（57.00±5.81）min、（36.30±4.90）min、（21.00±3.80）ml、1例（3.3%），与对照组（72.90±3.66）min、（65±4.43）min、（56.7±8.69）ml、7例（24.1%）比较，差异均有统计学意义（t=－6.544、－6.698、－6.678、χ²=5.450，P均<0.05）。 结论相对于腹腔镜技术，杂交技术治疗难复性腹股沟疝可减少手术时间、气腹持续时间和术中出血量，降低术后血清肿的发生，不会增加术后疝复发等并发症的风险和住院费用，具有较高的临床应用价值。     

Vascular ring and sling in a fetus who developed esophageal and airway compression after birth

Vascular ring and sling are congenital anomalies of the vascular structure in the thorax with a prevalence of 2.4/10,000 live births. Double aortic arch (DAA), right aortic arch with left ductus arteriosus and aberrant left subclavian artery (RAA-ALSA), and pulmonary artery sling (PAS) are the three common types of vascular ring and sling. These anomalies can be isolated or accompanied by intracardiac malformation. The presence of both vascular ring and PAS is extremely rare. Here, we report a fetus who was prenatally diagnosed with PAS and RAA-ALS, and developed symptoms due to esophageal and airway compression after birth.