药品审评检查机构质量管理体系建设实践探索

目的:贯彻国务院强化质量管理、落实全国药监部门完善自身质量管理体系工作部署,梳理山东省药品审评检查机构质量管理体系建设情况,总结经验、查找不足,加强审评检查质量管理。方法:调研药品审评检查机构导入质量管理体系的现实意义,剖析山东省药品审评检查机构质量管理体系建设的实践经验,思考存在的问题。结果:行之有效的质量管理体系对药品审评检查机构规范化建设和药品审评检查发展起到了积极的推动作用。结论:药品审评检查机构推进质量管理体系建设,对规范自身建设、提高工作质量、降低业务风险、服务医药产业发展具有重要作用,也是必然要求,药品审评检查机构质量管理体系需要持续改进,逐渐与国际接轨。     

达芬奇机器人与传统腹腔镜在治疗小儿先天性胆总管囊肿的对比研究

目的对比达芬奇机器人与传统腹腔镜在治疗小儿先天性胆总管囊肿的优劣势。方法回顾性收集2018年3月至2019年9月郑州大学第一附属医院诊断为胆总管囊肿的103例患儿的临床资料,其中行达芬奇机器人手术的21例患儿作为机器人组,行传统腹腔镜治疗的82例患儿为腹腔镜组,所有手术均由同一团队完成。其中,机器人组患儿的年龄为(3.85±0.79)岁,范围为1~11岁;Todani分型为胆总管囊性扩张型(Ⅰ型)17例,其他分型4例;囊肿最大径为(36.76±10.13)mm,范围为16~79 mm。腹腔镜组患儿的年龄为(3.71±0.67)岁,范围为3个月至12岁;Todani分型为Ⅰ型70例,其他分型12例;囊肿最大径为(35.98±8.25)mm,范围为10~82 mm。分析两组在一般资料及术前情况、术中及术后等方面的差异。结果①机器人组与腹腔镜组患儿在年龄、性别、体重、临床表现、Todani分型、囊肿最大径、术前C反应蛋白(C-reactive protein,CRP)值、术后并发症发生率、术后疼痛评分方面差异无统计学意义(P>0.05);②机器人组的术中失血量、术后第一天及第三天腹腔引流液量、术后CRP值、术后禁食时间、术后出院时间均小于腹腔镜组,差异具有统计学意义(P<0.05)。结论达芬奇机器人在治疗小儿先天性胆总管囊肿方面较传统腹腔镜具有术中出血量少、组织损伤小、恢复快、愈合好等优点,具有可行性、安全性、有效性等优点。不足之处为手术总时间较长、费用较高。随着技术的进步及手术医生经验的积累,机器人治疗小儿先天性胆总管囊肿将会发挥更大的优势。     

Current status and future perspective of robot‐assisted radical cystectomy for invasive bladder cancer

The current status of robot‐assisted radical cystectomy was reviewed 16 years after the initial robot‐assisted radical cystectomy for the treatment of invasive bladder cancer. Articles associated with robot‐assisted radical cystectomy and written in English were selected from the PubMed database from January 2003 to February 2019. The present review article focused on the distribution of robot‐assisted radical cystectomy, patient selection, preoperative management, surgical technique, lymph node dissection, urinary diversion, recurrence pattern, oncological outcomes, cost, learning curve, complications and educational programs. A total of 400 articles were divided according to the country of the first author's affiliation. The USA was the most dominant at 198 (50%), whereas the number of articles from the countries belonging to the Urological Association of Asia was 15 (3.8%) for China, 17 (4.3%) for South Korea, 10 (2.5%) for Japan, eight (2%) for Taiwan, eight (2%) for Turkey and one (0.2%) for Iran. The percentage of robot‐assisted radical cystectomy carried out is increasing, and intracorporeal urinary diversion and ileal neobladder are also frequently carried out. With a refined technique being performed in high‐volume centers, robot‐assisted radical cystectomy has contributed to the reduction in transfusion rate, length of stay and severe complications; however, it has not yet shown any cancer‐specific survival benefits. Robot‐assisted radical cystectomy is not fully spread throughout the Urological Association of Asia. Further investigation with respect to worldwide results is needed to prove the real benefit of robot‐assisted radical cystectomy regarding low morbidity, reduced total medical cost, and survival benefit. In the era of precision medicine, appropriate drug and surgery will be given based on each genetic profile.     

新旧化妆品检验规范的对比及对化妆品审评的影响

目的： 全面解读2019年9月10日国家药品监督管理局发布的《化妆品注册和备案检验工作规范》，为开展化妆品审评提供参考。方法： 从多个方面对比已实施的《化妆品注册和备案检验工作规范》和同步废止的《化妆品行政许可检验规范》，分析二者的不同之处对化妆品审评可能带来的影响，并对今后的工作方向提出预见和建议。结果： 《化妆品注册和备案检验工作规范》取消了现行的由药品监管部门对化妆品注册和备案检验检测机构进行资格认定和指定，允许社会优质资源承担化妆品注册和备案检验工作，并对检验工作流程进行了优化，对检验项目要求进行了调整和规范。结论： 《化妆品注册和备案检验工作规范》的发布和实施，对化妆品注册和备案检验以及化妆品审评工作都提出了新的要求，相关部门应尽快适应。