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.     

Inhibition of carbohydrate hydrolyzing enzymes associated with type 2 diabetes and antioxidative properties of some edible seeds in vitro

This study sought to evaluate the antioxidant properties and effects of some edible wild seeds [Afzelia africana Sm. (AFZ), Cyperus esculentus L. (CYP), Eleusine coracana Gaertn. (ELE), Irvingia gabonensis (Aubry-Lecomte ex O’Rorke) Baill. (IRV), Monodora myristica Dunal. (MON) and Parinari curatellifolia Planch. ex Benth. (PAR)] on α-amylase and α-glucosidase activities. The phenolic content and antioxidant activities of aqueous extracts of the seeds as typified by 1,1-diphenyl-2 picrylhydrazyl (DPPH) and hydroxyl (OH) radicals scavenging abilities and inhibition of Fe²⁺-induced malondialdehyde (MDA) production in rat’s pancreas in vitro were also assessed. ELE had significantly (p < 0.05) higher total phenol content than the other seeds; however, AFZ had the highest flavonoid content. The extracts scavenged DPPH· and OH· in a dose-dependent manner with aqueous extracts of PAR having the highest DPPH· scavenging ability, while extracts from IRV had the highest OH· scavenging ability and inhibition of Fe²⁺-induced MDA production in rat’s pancreas. Furthermore, all the extracts inhibited α-amylase and α-glucosidase activities in a dose-dependent manner. The α-amylase inhibitory effect of MON (IC₅₀ = 0.48 mg/mL) was comparable to that of acarbose (IC₅₀ = 0.40 mg/mL), while the α-glucosidase inhibitory effect of AFZ (IC₅₀ = 0.45 mg/mL) was comparable to that of acarbose (IC₅₀ = 0.39 mg/mL). The results suggest the potential use of the seeds in the dietary management of blood glucose levels associated with type 2 diabetes.

     

某医学期刊送审论文的统计学问题分析

<正>医学科研论文大多涉及数据收集和统计分析,正确合适的数据统计分析方法,才可能保证科研结果的正确性。虽然论文撰写的国际规范对数据统计学分析有明确的要求,科研人员也学习过医学统计学,但如何正确选择统计分析方法,准确描述统计分析结果,仍然是很多科研人员比较困惑的问题。有些作者在论文中误用、错用统计学方法,直接影响研究结果的可信度,导致论文质量不高或者结论错误[1-3]。本文对某杂志2014年至2015年度送审论文中的统计学问题进行分析,旨在帮助作者避免类似的错误,提升科研论文质量。资料与方法     

The influence of processed total non-forward and non-motile sperm count on the outcome of artificial insemination with the husband’s semen

BackgroundArtificial insemination with the husband’s semen (AIH) is an economical and noninvasive method of infertility treatment. However, AIH’s pregnancy rate is much lower than in vitro fertilization (IVF) as its multiple and complex uncertainty factors. Semen quality has been one of the main factors which affect the pregnancy outcome of AIH.MethodsThe relevant parameters of 1,142 AIH cycles were retrospectively studied, including the general parameters and the semen quality parameters among clinical pregnancy, biochemical pregnancy, non-pregnancy group, age, infertility duration, infertility type, body mass index (BMI), cycle count, morphology in previously semen examination, and semen quality parameters on the day of AIH.ResultsThe statistically significant difference was only found on processed total non-forward and non-motile sperm count (N-TFMSC). The mean processed N-TFMSC in the biochemical pregnancy group was 6.37±4.27 million, significantly higher than the other two groups (vs. 4.40±3.15 million or vs. 4.48±3.60 million, P<0.05). The study was then divided into two groups according to processed N-TFMSC, Group 1 ≤5.0 million, and Group 2 >5.0 million. A statistical increase in biochemical pregnancy rate was observed when the processed N-TFMSC was >5.0 million (2.72% vs. 0.90%).ConclusionsProcessed N-TFMSC may be one of the independent factors on AIH’s outcome; it should be given equal attention the same as processed total forward motile sperm count (TFMSC).     

A comparison of head injuries in male and female lacrosse participants seen in US emergency departments from 2005 to 2016

Introduction

In the United States there has been a large increase in participation in lacrosse for both males and females. The purpose of this study was to analyze the number of head injuries, injury rates (calculated using the reported number of participants) and types of head injuries that are seen in emergency departments in the United States.

乳腺癌21基因检测的研究进展

乳腺癌是一类具有异质性的肿瘤，不同患者的治疗方法和疗效都不相同。尽管目前仍在努力为激素受体（hormone receptor，HR）阳性（+）、人表皮生长因子受体2（human epidermal growth factor receptor 2,HER-2）阴性（-）、淋巴结（axillary lymph node，ALN）阴性（-）的早期乳腺癌患者寻找合适的治疗方法，但其术后是否需要化疗仍然是肿瘤科医生面临的一个难题。以往治疗主要依赖于经典的组织病理学和免疫组织化学技术，随着精准医疗时代的到来，我们需要更定量的诊断方法和合理的个体化治疗。虽然化疗可降低疾病复发风险并提高生存率，但它带来的不良反应事件会降低患者的生活质量，尤其低复发风险（recurrence risk,RS)有可能超过化疗益处。21基因检测不仅可以预测这类早期乳腺癌化疗疗效及评估预后，还可提供精准的个体化治疗方案指导用药，为患者增添信心。本文就乳腺癌21基因检测的研究进展进行综述。