注射用盐酸柔红霉素的质量评价

目的 按照国家计划抽验要求，评价国内不同企业生产的注射用盐酸柔红霉素的质量。方法 按国家标准检验与探索性研究相结合，对抽验样品进行检验，对检验结果进行统计分析。结果 共抽取样品17批次，按国家标准检验合格率100.0%。探索性研究对主要杂质的来源与结构进行了研究；建立溶液的澄清度检查方法；对包材相容性及稳定性进行了考察。结论 目前国内注射用盐酸柔红霉素总体质量较好；现行标准有待进一步提高，建议现行标准修订有关物质检查方法，增加特定杂质的控制，增加溶液的澄清度检查；建议企业优化生产工艺，以提高产品质量。     

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。     

Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry

Central illustration: cumulative major adverse cardiac events (MACE) and bioresorbable vascular scaffold (BVS) thrombosis rates after 1, 2, 3, 4 and 5 years.

     

健康干预在肥胖中学生中所起的效果评价

目的：探讨健康干预应用于肥胖中学生的效果。方法：抽取张掖市第一中学肥胖中学生180例，随机分为观察组与对照组，观察组实施健康干预，对照组仅予以常规健康教育，比较两组肥胖改善情况。结果：观察组干预效果显著优于对照组（P＜0．05）；干预后观察组的 BMI、腰围、胸围及皮脂厚度均较对照组显著降低（P＜0．05）。结论：在肥胖中学生中实施健康干预有利于促进学生身体形态生长水平的改善，控制和降低学生 BMI和肥胖增长速度。     

Platelets in Early Antibody-Mediated Rejection of Renal Transplants

Antibody-mediated rejection is a major complication in renal transplantation. The pathologic manifestations of acute antibody-mediated rejection that has progressed to functional impairment of a renal transplant have been defined in clinical biopsy specimens. However, the initial stages of the process are difficult to resolve with the unavoidable variables of clinical studies. We devised a model of renal transplantation to elucidate the initial stages of humoral rejection. Kidneys were orthotopically allografted to immunodeficient mice. After perioperative inflammation subsided, donor-specific alloantibodies were passively transferred to the recipient. Within 1 hour after a single transfer of antibodies, C4d was deposited diffusely on capillaries, and von Willebrand factor released from endothelial cells coated intravascular platelet aggregates. Platelet-transported inflammatory mediators platelet factor 4 and serotonin accumulated in the graft at 100- to 1000-fold higher concentrations compared with other platelet-transported chemokines. Activated platelets that expressed P-selectin attached to vascular endothelium and macrophages. These intragraft inflammatory changes were accompanied by evidence of acute endothelial injury. Repeated transfers of alloantibodies over 1 week sustained high levels of platelet factor 4 and serotonin. Platelet depletion decreased platelet mediators and altered the accumulation of macrophages. These data indicate that platelets augment early inflammation in response to donor-specific antibodies and that platelet-derived mediators may be markers of evolving alloantibody responses.     

Differentiating autoimmune pancreatitis from pancreatic ductal adenocarcinoma with CT radiomics features

PurposeThe purpose of this study was to determine whether computed tomography (CT)-based machine learning of radiomics features could help distinguish autoimmune pancreatitis (AIP) from pancreatic ductal adenocarcinoma (PDAC).Materials and MethodsEighty-nine patients with AIP (65 men, 24 women; mean age, 59.7 ± 13.9 [SD] years; range: 21–83 years) and 93 patients with PDAC (68 men, 25 women; mean age, 60.1 ± 12.3 [SD] years; range: 36–86 years) were retrospectively included. All patients had dedicated dual-phase pancreatic protocol CT between 2004 and 2018. Thin-slice images (0.75/0.5 mm thickness/increment) were compared with thick-slices images (3 or 5 mm thickness/increment). Pancreatic regions involved by PDAC or AIP (areas of enlargement, altered enhancement, effacement of pancreatic duct) as well as uninvolved parenchyma were segmented as three-dimensional volumes. Four hundred and thirty-one radiomics features were extracted and a random forest was used to distinguish AIP from PDAC. CT data of 60 AIP and 60 PDAC patients were used for training and those of 29 AIP and 33 PDAC independent patients were used for testing.ResultsThe pancreas was diffusely involved in 37 (37/89; 41.6%) patients with AIP and not diffusely in 52 (52/89; 58.4%) patients. Using machine learning, 95.2% (59/62; 95% confidence interval [CI]: 89.8–100%), 83.9% (52:67; 95% CI: 74.7–93.0%) and 77.4% (48/62; 95% CI: 67.0–87.8%) of the 62 test patients were correctly classified as either having PDAC or AIP with thin-slice venous phase, thin-slice arterial phase, and thick-slice venous phase CT, respectively. Three of the 29 patients with AIP (3/29; 10.3%) were incorrectly classified as having PDAC but all 33 patients with PDAC (33/33; 100%) were correctly classified with thin-slice venous phase with 89.7% sensitivity (26/29; 95% CI: 78.6–100%) and 100% specificity (33/33; 95% CI: 93–100%) for the diagnosis of AIP, 95.2% accuracy (59/62; 95% CI: 89.8–100%) and area under the curve of 0.975 (95% CI: 0.936–1.0).ConclusionsRadiomic features help differentiate AIP from PDAC with an overall accuracy of 95.2%.     

护理干预对放疗科头颈部肿瘤放疗患者生活质量的影响

目的本文主要研究和探讨护理干预对放疗科头颈部肿瘤放疗患者生活质量的影响。方法将我院2017年2月份至2018年10月份收治的100例头颈部肿瘤放疗患者作为本次研究的对象,在随机原则的指导下把100例患者分为对照组和实验组,每组患者的数量为50例。对照组患者给予常规护理,实验组患者实施护理干预,对两组患者的生活质量、睡眠质量、护理满意度和护理依从性等进行对比分析。结果在生活质量、睡眠质量、护理满意度和护理依从性等方面,组间进行对比分析,实验组都明显优于对照组,P<0.05差异具有统计学意义。结论对头颈部肿瘤放疗患者实施护理干预可以让患者的生活质量、睡眠质量、护理依从性以及护理满意度等都得到显著的改善,从而让患者以一种积极、乐观的心态接受放疗,这对于放疗效果的提高具有重要的作用。总之,这一护理模式应该在临床中进行推广和使用。