中药生产过程质量控制关键技术研究进展

中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。     

Direct insertion of an ultra‐slim upper endoscope for cholangioscopy in patients undergoing choledochoduodenostomy

Direct peroral cholangioscopy (POC) using an ultra‐slim upper endoscope is one modality of POC for intraductal endoscopic evaluation and treatment of the bile duct. Choledochoduodenostomy (CDS) is one modality of biliary bypass surgery that provides a new route to the bile duct. We carried out direct POC using an ultra‐slim upper endoscope without the use of accessories in 10 patients (four sump syndromes, three bile duct strictures and three intrahepatic duct stones) previously undergoing surgical CDS. Direct POC was successful in all patients. The use of an intraductal balloon catheter was required in one patient for advancement of the endoscope into the bile duct. Distal bile ducts with sump syndromes were cleared using baskets and water irrigation under direct POC. Cholangiocarcinoma was diagnosed in one patient with hilar bile duct stricture after cholangioscopic evaluation and a targeting forceps biopsy under direct POC. Intrahepatic duct stones were successfully extracted after intraductal fragmentation under direct POC. Oozing bleeding occurred during intraductal lithotripsy but stopped spontaneously. Direct POC using an ultra‐slim upper endoscope without the assistance of accessories can easily be carried out in patients undergoing CDS.     

Troubled-Cell Indicator Based on Mean Value Property for Hybrid WENO Schemes

In this paper, we introduce a new type of troubled-cell indicator to improve hybrid weighted essentially non-oscillatory (WENO) schemes for solving the hyperbolic conservation laws. The hybrid WENO schemes selectively adopt the high-order linear upwind scheme or the WENO scheme to avoid the local characteristic decompositions and calculations of the nonlinear weights in smooth regions. Therefore, they can reduce computational cost while maintaining non-oscillatory properties in non-smooth regions. Reliable troubled-cell indicators are essential for efficient hybrid WENO methods. Most of troubled-cell indicators require proper parameters to detect discontinuities precisely, but it is very difficult to determine the parameters automatically. We develop a new troubled-cell indicator derived from the mean value theorem that does not require any variable parameters. Additionally, we investigate the characteristics of indicator variable; one of the conserved properties or the entropy is considered as indicator variable. Detailed numerical tests for 1D and 2D Euler equations are conducted to demonstrate the performance of the proposed indicator. The results with the proposed troubled-cell indicator are in good agreement with pure WENO schemes. Also the new indicator has advantages in the computational cost compared with the other indicators.     

Uncalcified Synovial Chondromatosis in the Pisotriquetral Joint

Synovial chondromatosis is a rare lesion in the wrist, but some cases in the distal radioulnar joint have been reported and previous case reports emphasize joint calcifications, shown on preoperative plain radiographs. We report an extremely uncommon case of synovial chondromatosis in the pisotriquetral joint, in which radiographs and magnetic resonance imaging did not demonstrate apparent calcified bodies. In our case, for the accurate diagnosis and treatment, surgical exploration of the joint and synovectomy with removal of loose bodies was performed.     

保妇康凝胶联合诺氟沙星治疗宫颈糜烂50例疗效观察

目的：探讨保妇康凝胶联合诺氟沙星治疗宫颈糜烂的临床效果。方法将100例宫颈糜烂患者根据随机数字表法分为观察组和对照组各50例。观察组给予保妇康凝胶和诺氟沙星联合治疗，对照组单独给予治糜灵栓治疗，比较两组患者临床症状的变化，并对临床疗效进行评价。结果观察组治愈率为86.00%，明显高于对照组的74.00%，临床症状评分改善较对照组明显，且其临床症状消失的时间短于对照组，差异均有统计学意义(P<0.05)。结论保妇康凝胶与诺氟沙星合用比治糜灵栓治疗宫颈糜烂效果更佳，且治愈时间上明显较优，值得临床上推广应用。     

CTA诊断右下肺叶基底段异常体动脉供血1例

患者男,22岁,无明显诱因咳嗽、痰中带血1周,起初干咳,后咳痰并痰中带血,偶咯出少量暗红色血液;无发热、盗汗、乏力,无胸闷、胸痛及呼吸困难,平素体健,无家族病史。查体:双肺呼吸音稍粗,右肺下叶闻及细湿啰音。胸部增强CT:右肺下叶基底段见片状磨玻璃影,内见直径约8mm粗大供血动脉自腹腔干发出;支气管树分支及肺发育正常,未见隔离肺(图1A^1C)。肺动脉CTA示右下肺基底段动脉部分缺如(图1D),考虑为右下肺异常体动脉供血并周围肺组织肺泡出血可能。     

尘肺病患者心理、社会支持状况调查及相关性研究

目的为了解尘肺病患者心理状况及社会支持对患者心理健康的影响,为对尘肺病患者建立干预措施提供技术支撑。方法采用SCL-90症状清单、社会支持量表对在全省尘肺病住院病人较多的3家医院进行尘肺病患者问卷调查。结果 208名尘肺病患者男性205人,女性3人。文化程度均为高中及以下;Ⅰ期尘肺148人,Ⅱ期尘肺41人,Ⅲ期尘肺19人;尘肺患者SCL-90症状清单总分为162.00±64.77,低于全国常模,差异有统计学意义(P0.05);不同分期、不同年齡段、不同病程尘肺病患者各组之间社会支持得分差异无统计学意义。结论尘肺病患者心理健康水平低于全国水平,社会支持各维度得分与SCL-90各因子得分呈负相关,建立尘肺病患者心理干预体系十分必要。     

利福霉素类药物治疗结核病的临床应用研究进展

结核病是由结核分枝杆菌复合群引起的传染性疾病，是全球主要的流行病种之一。利福平是当前最主要的一线抗结核药物，因其长期应用和不规范治疗，利福平耐药逐渐增加，利福喷丁、利福布汀等利福霉素类衍生物在抗结核治疗方面起到了重要作用。基于利福霉素类药物的药理及药动学特性，对该类药物在结核病治疗中进行最优用药选择分析，并对该类药物与其他抗结核药物联用进行综述，旨在为利福霉素类抗结核药物的临床用药提供文献依据。