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. 相似文献
目的系统评价自然周期和促排卵周期联合宫腔内人工授精(intrauterine insemination,IUI)对不孕患者治疗的有效性,旨在更合理有效的指导临床治疗。方法计算机检索2000年1月至2013年6月中国生物医学文献数据库(CBMDisc)、万方数据库、中国学术期刊网专题全文数据库(CNKI)、维普数据库、Pubmed、外文生物医学期刊文献数据(FMJS)中自然周期和促排卵周期联合IUI治疗不孕患者的随机对照试验(RCT)或临床对照试验。由2位评价员根据纳入与排除标准独立进行文献筛选、资料提取和质量评价后,采用Rev Man 5.0软件进行Meta分析。结果最终纳入9个研究,共8814个周期。Meta分析结果显示:对行IUI的不孕症患者,促排卵周期组与自然周期组相比,妊娠率[OR=1.47,95%CI(1.26,1.72),P0.00001]、流产率[OR=2.49,95%CI(1.49,4.16),P=0.0005]、多胎率[OR=6.94,95%CI(1.94,24.83),P=0.003]均大于自然周期组,且差异有统计学意义;OHSS发生率[OR=4.17,95%CI(0.74,23.49),P=0.11]和宫外孕发生率[OR=2.22,95%CI(0.92,5.37),P=0.08]无明显差异。结论对自然周期和促排卵周期联合IUI治疗不孕患者的有效性而言,促排卵周期组能更好的改善其妊娠率,但其流产率和多胎率的发生较高,因此促排卵方案用于IUI时,其疗效及安全性需要进行更多的临床研究。由于纳入文献存在质量和数量不足以及方法学差异,本研究结论仅作为临床分析的参考,尚需后效评价和不断更新。 相似文献