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
We previously reported that lymphatic mapping using isosulfan blue can be used to identify sentinel nodes (SNs). This study
was undertaken to evaluate the feasibility of using the SN technique in treating early gastric cancer and to explore its usefulness
for minimal invasive surgery. Twenty-three patients with early gastric cancer who underwent SN biopsy were retrospectively
evaluated. Based on SN evaluation, individualized surgery was performed in five patients with T1N0M0 gastric cancer. When
pathological examination of frozen sections revealed metastasis in SNs, we performed a standard D2 gastrectomy. Laparoscopic
local resection was applied when the SN biopsy was negative. Our results showed that the success rate with SN biopsy in early
gastric cancer was 100%, as were the accuracy, sensitivity, and specificity. All five patients with early gastric cancer had
SNs negative for metastases both by frozen section and by postoperative pathology. Thus, all these patients underwent laparoscopic
local resection without extended lymphadenectomy. We conclude that SN biopsy is a useful tool to individualize the operative
procedure, and laparoscopic local resection can be safely performed using SN guidance in selected patients with early gastric
cancer. 相似文献