ABSTRACT
Aim: There is need of an objective "standard procedure" that is reliable and clinically applicable for estimating oral neutrophil content in relation to oral diseases. Methods: Forty-one patients with suspected oral candidosis (OC) and nine healthy controls with no oral mucosal disease were flushing with 10 ml mouth rinse (MR) (sterile phosphate-buffered saline) for 1 min. Aliquots were stored on different conditions to explore stability, storage, and fixation conditions for analysis by flow cytometry. Results: The optimal storage and fixation condition for MR was by fixation 1 : 1 in 10% formalin and stored at 5°C. This procedure yielded stable results up to 7 days after collection. The ability of the optimized method to relate oral neutrophils to inflammation was demonstrated by the significantly higher number of neutrophils in patients with primary OC (p = 0.0334) compared to healthy controls. Conclusion: This method is rapid, reliable, and clinically applicable for establishing the content of oral neutrophils. We demonstrate increased density of oral neutrophils in the MR of patients with OC. The potential of the method is to be "the standard procedure" for investigation of the oral inflammation in patients with oral diseases as it is noninvasive and provides high stability, clinical relevance, and minimal handling.
ABSTRACT
Post-marketing pharmacosurveillance is important to reduce harm to patients from marketed drugs. Oral adverse drug reactions (OADRs) are seldom reported and only few OADRs are listed scarcely in summary of product characteristics (SmPC) of drugs. OBJECTIVE: Structured search for OADRs in the Danish Medicines Agencies database from January 2009 to July 2019. RESULTS: Forty-eight percent of OADRs were categorized as "serious" where oro-facial swelling was reported 1041 times, medication-related osteonecrosis of the jaw (MRONJ) 607 times and para- or hypoaesthesia 329 times. Four-hundred-eighty OADRs in 343 cases were related to biologic or biosimilar drugs where 73% affected the jawbone as MRONJ. Physician reported 44%, dentists 19% and citizens 10% of OADRs. CONCLUSIONS: Health care professionals had a sporadic reporting pattern that seemed to be influenced by the debate in the community and in professional circles but also by the information in the SmPC of the drugs. The results indicate some reporting stimulation of OADRs in relation to Gardasil 4, Septanest, Eltroxin and MRONJ. Eventually the knowledge of OADRs increases but there is a risk of skewed information if reporting is not systematic, reliable and consistent. All healthcare professionals must be educated in spotting and reporting all suspected adverse drug reactions.
