The quality of spontaneous adverse drug reaction reports from the pharmacovigilance centre in western China

Background: High-quality adverse drug reaction (ADR) reports are essential for conducting drug safety monitoring in pharmacovigilance. The study aim was to assess the current quality of ADR reports in western China, and to identify problems with ADR report quality.

Research design and methods: A sample of 1139 reports received by the Shaanxi ADR Monitoring Center from January 2015 to December 2017 was selected. ADR report quality was evaluated using an ADR report quality evaluation system.

Results: None of the reports were rated as excellent and 1.40% (n = 16) as good. Report quality was better for new and serious reports than for general reports. Medical institutions generated higher quality reports than pharmaceutical manufacturers. Nurses generated higher quality reports than doctors, pharmacists, and other professionals. Reporters of different occupations showed significant differences in the quality of the indicators Reporting time limit, Intervention ADR time, ADR termination time, ADR intervention measures, Original disease, and Cause of medication (P = 0.000).

Conclusions: The ADR data quality was poor in western China, and of lower quality than reported data from previous research in other regions. Improvements in the quality and availability of ADR reports are urgently needed.     

A novel DDC gene deletion mutation in two Chinese mainland siblings with aromatic l-amino acid decarboxylase deficiency

Background

Aromatic l-amino acid decarboxylase (AADC) deficiency (OMIM #608643) is a rare and severe disorder of biogenic amine synthesis caused by mutations in the DDC gene. The phenomenology of the movement disorder includes intermittent oculogyric crises and limb dystonia, generalized athetosis, and impaired voluntary movement.

金莲花提取物代谢产物研究

目的:研究金莲花化学成分的体内代谢产物及代谢规律。方法:静脉注射方式给予大鼠金莲花提取物并在各时间段采血,利用高效液相色谱-电喷雾电离-串联质谱技术(LC-ESI-MS)对血清中的代谢产物进行研究。结果:根据LC-ESI-MS结果发现了23种原型成分及45种代谢产物。原型成分中有3种酚酸类物质、19种黄酮类物质、1种生物碱类物质。通过准分子离子峰及二级碎片得到了代谢产物可能的化学结构,分析了这些代谢产物的裂解途径,推测19种来源于酚酸类物质、20种来源于黄酮类物质、6种来源于生物碱类物质。结论:本研究探讨了金莲花提取物中化学成分的代谢规律,为其血液移行成分及药理作用的进一步研究奠定基础。     

手术室新护士三年阶梯式培训模式探讨

目的探讨手术室新护士三年培训模式和方法。方法采用三年阶梯式培养模式,建立完整的系统培训架构,包括培训对象的界定、培训原则及目的、培训目标师资队伍的培养、阶段培养计划、使用培训手册、培训考核体系的建立、培训评价体系的建立等。结果新护士培训系统、科学。结论新护士三年阶梯式培养值得深入研究和推广应用。     

环状软骨前裂开对兔环状软骨生长发育的影响

目的:观察环状软骨前裂开对环状软骨生长发育的影响。方法:将幼兔环状软骨前正中裂开,8月后测量环状软骨内径,计算其管腔面积。结果:(1)与对照组比较,实验组兔环状软骨管腔面积无显著性差异(P>0.05)。(2)裂开处均由软组织连接,未形成过多瘢痕。结论:环状软骨前裂开对环状软骨及动物的生长发育无明显影响。     

血管内皮生长因子及炎性因子在油酸性犬急性呼吸窘迫综合征中的变化

目的探讨油酸性急性呼吸窘迫综合征（ARDS）beagle犬血浆及肺泡灌洗液血管内皮生长因子（VEGF）、可溶性细胞间黏附分子-1（ICAM-1）、白细胞介素-8（IL-8）、肿瘤坏死因子-α（TNF—α）水平的改变。方法12只英国纯种beagle犬，静脉注射油酸0．15mL／kg，在注射油酸前、后1h，出现ARDS的典型表现时，抽血测VEGF、sICAM-1、IL-8、TNF—α，并对此时相作肺泡灌洗液VEGF、sICAM—1、IL-8、TNF-α的测定。结果beagle犬静脉注射油酸后1h血浆TNF—α升高（P〈0．05），血浆反肺泡灌洗液IL8、sICAM-1和VEGF在1h较油酸前没有明显变化（P〉0．05），beagle犬油酸型ARDS模型建立后血浆及肺泡灌洗液VECF、sICAM-1、IL-8、TNF—α均显著高于建模前（P〈0．05）。结论VEGF、sICAM-1、IL-8、TNF～α在beagle犬油酸型ARDS发生发展过程中可能均起重要作用，其水平的高低可能与ARDS严重程度及预后有关。