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
OBJECTIVE: To reduce the incidence of sensory deficits and Frey's syndrome by modifying the traditional superficial parotidectomy. STUDY DESIGN: After raising the skin flap, the parotid gland fascia (PGF) was elevated to form a posterior pedicle fascial flap and then was replaced after the gland removal. The great auricular nerve (GAN) that runs within the PGF was not separated, so both the GAN and the PGF were preserved. Before this modification, the GAN and PGF were examined anatomically. The complication rates in the modified and control groups were compared. RESULTS: 1) The GAN, which runs within the thick and pycnotic PGF, trifurcates into postauricular, preauricular and lobule branches. The modification could be carried out practically based on the anatomy study. 2) Long-term sensory deficit was encountered in 13.3% of the control group, but 0% in the modified one. Frey's syndrome was suffered by 66.7% and 16.7% cases in the control and modified group respectively. The incidence of other complications was not significantly different. CONCLUSION: Our modification is practical. It decreases the complications significantly. EBM rating: B-3b. 相似文献
Objective To investigate the dynamic changes of intercellular adhesion molecule-1 (ICAM-1) expression in endothelial cells (EC) during hindlimb allograft acute rejection in rats and the inhibitory effect of cyclospofine A (CsA) on the acute rejection. Methods The rat model of hindlimb allograft was developed. The rats were randomly divided into following groups: control group (Wistar→Wistar), rejection group ( Sprague-Dawley→Wistar) and CsA-treated group (Sprague-Dawley→Wistar). At postoperative day 1, day 4 and day 7samples of the femoral artery from the allograft limb were harvested to observe the pathologic changes. ICAM-1 expression in EC was quantified using immunohistochemical assay. Results Slight swelling and weak ICAM-1expression of EC were observed in the control group. In the rejection groups, obvious EC swelling and massive lymphocyte infiltration were seen. ICAM-1 expression in EC was significantly stronger and elevated. In CsA-group only mild infiltration of lymphocytes was seen and ICAM-I expression in EC was also much weaker.Conclusion During rat hindlimb allograft acute rejection the expression of ICAM-1 in EC was closely related to the occurrence and development of acute rejection. CsA could reduce the expression of ICAM-1 in EC and hence inhibit acute rejection of composite allograft. 相似文献