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.     

关节镜联合关节牵张成形术治疗踝关节创伤性关节炎

目的对比分析单纯关节镜手术与关节镜手术联合Ilizarov外固定架关节牵张术治疗踝关节创伤性关节炎的临床疗效。 方法纳入2016年10月至2018年4月聊城市中医医院收治的早中期踝关节创伤性关节炎患者30例，排除非创伤性关节炎和终末期踝关节炎。其中接受单纯踝关节镜手术者纳入对照组(n＝15)，接受关节镜手术联合Ilizarov外固定架关节牵张成形术者纳入研究组(n＝15)，术后随访6个月，对比分析两组患者的治疗效果：疼痛视觉模拟评分(VAS)、踝关节功能评分(Kofoed评分)以及生活质量的变化。计数资料比较采用卡方或Fisher精确检验，计量资料比较采用独立样本t检验。 结果研究组治疗有效率大于对照组(χ²＝7.214，P<0.05)，术后疼痛视觉模拟评分明显低于对照组(t ＝10.342，P<0.05)，Kofoed评分高于对照组(t ＝10.452，P<0.05)；研究组生活质量显著高于对照组(P<0.05)。 结论关节镜手术联合关节牵张成形术对早中期踝关节创伤性关节炎较单纯关节镜手术短期效果更好，可成为临床治疗中的一种选择，但远期效果尚需进一步研究。     

从形气神谈溃疡性结肠炎的中西医认识

溃疡性结肠炎(Ulcerative colitis,UC)是一种病情反复、迁延难愈的炎症肠病,已被世界卫生组织列为现代难治病之一[1]。本病病因及发病机制尚不明确,西药治疗效果欠佳。近年来中医药的介入,临床取得显著疗效。西医学认为疾病是机体在一定致病因素的作用下自稳调节紊乱,经过机体内损伤和抗损伤反应的相互斗争,表现出的一系列功能。