Objective To introduce the evidence-based evaluation on off-label uses at home and abroad, so as to investigate a systematic method of evidence-based evaluation on off-label uses. Methods In combination with the domestic and international research literature, a systematic method of evidence-based evaluation on off-label uses was discussed from the following three aspects: sources of evidence, levels of evidence, and recommendation strength. Results Sources of evidence included Clinical Pharmacology, DRUGDEX? System, NCCN Drugs amp; Biologics Compendium and handsearched literature. Levels of evidence and recommendation strength could refer to the 2009 grade system of Oxford Centre for Evidence-Based Medicine, and the strength of recommendations and scientific support of DRUGDEX? System. Conclusion A systematic method of evidence-based evaluation on off-label uses is initially established.
Objective
Through assessing the quality of systematic reviews/meta-analyses conducted by hospital pharmacists in China, to learn relevant situations and to promote the development and application of evidence-based pharmacy in hospital.
Methods
The following databases such as CBM, CNKI, Wanfang Database, VIP, CMCI, The Cochrane Library, EMbase and PubMed were searched from the establishment date to April 15th, 2011, to collect all published systematic reviews/meta-analyses conducted by hospital pharmacists in China. Two reviewers independently extracted the published information according to the inclusive and exclusive criteria, and assessed the methodology and reporting quality of the included literatures with OQAQ and PRISMA. Disagreements were discussed or resolved by the third reviewer. Data analysis was conducted by using SPSS17.0 software.
Results
Two hundred and sixteen Chinese literatures (including 40 on traditional Chinese medicine), and 15 English literatures were identified. The number of literatures has increased rapidly since 2008. Beijing and Sichuan were the top 2 districts in the number of literatures. All of the included literatures were published in 62 magazines sponsored by 87 hospitals, such as China Pharmacy, and Chinese Journey of Evidence-Based Medicine. The total downloads of Chinese literatures were 14346, and the total citations of all literatures were 154. The methodology and reporting quality of the randomized controlled trials (RCTs) involved in 220 systematic reviews/meta-analyses literatures were assessed, which showed the highest and lowest scores of methodological quality were 6 and 3, respectively, and the average score was 4.27±0.55. The highest and lowest scores of reporting quality were 22.5 and 9, respectively, and the average score was 16.49±2.98.
Conclusion
Although the evidence-based pharmacy in hospital begins late in China, it develops rapidly, and offers lots of evidence to policy decision, guidelines and rational drug use. However, there is still room for improvement of the methodology and reporting quality in future reviews.
Objective To analyze the characteristics and risk factors of hemorrhagic adverse events (AEs) associated with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Methods AEs reports with SSRIs/SNRIs as the primary suspected (PS) drugs from the first quarter of 2009 to the third quarter of 2024 in the FAERS database were extracted. Hemorrhagic AEs reports were screened using the MedDRA standard terminology (SMQ). Descriptive statistics were used to analyze patient characteristics, and signal detection was performed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), and the polynomial gamma Poisson distribution reduction method (MGPS). Multiplicative and additive models were used to assess the interaction risk with antiplatelet/anticoagulant drugs. Results A total of 5 073 reports of hemorrhagic AEs associated with SSRIs (6.5%) and 2 740 reports related to SNRIs (4.1%) were included. The proportion of patients aged ≥65 years (P<0.001), the time-to-onset >90 days (P<0.001), reports from healthcare professionals (P<0.001), and serious adverse events (P<0.001) were higher. The gastrointestinal tract and central nervous system were the main bleeding sites for SSRIs, among which sertraline had the most signals for gastrointestinal adverse events, while the central nervous system had the fewest. All positive signals for SNRIs were associated with venlafaxine. Among AEs of various SSRIs/SNRIs combined with other drugs, the proportion of hemorrhagic AEs was higher in the combination with antiplatelet or anticoagulant drugs (P<0.001). Conclusion Hemorrhagic adverse events associated with SSRIs/SNRIs are mostly severe. In clinical practice, it is essential to implement proper pharmaceutical care, focusing on the bleeding risks associated with SSRIs/SNRIs use in elderly patients, those on long-term medication regimens, and patients concurrently using anticoagulants. Individualized medication regimens should be implemented based on the patient's underlying diseases and drug characteristics.
