ABSTRACT
Purpose@#Adverse transfusion reactions (ATRs) are unfavorable reactions to the transfused unit, and the severity may be different among individuals, depending upon the type of reactions and the patient’s susceptibility. It is necessary to operate and manage a systematic monitoring system to minimize these ATRs and increase the safety. This study was conducted to evaluate clinical features of transfusion-related adverse events and morbidities. @*Methods@#We retrospectively analyzed transfusion data from electronic medical records during the recent 3 years (April 2017 to April 2020) at Seoul National University Bundang Hospital. The electronic search strategy was applied to search for the type of blood products prescribed and identify symptoms that occurred during transfusion as recorded in the nursing chart which is based on the International Classification for Nursing Practice. @*Results@#A total of 18,772 people were transfused during the study period. A total of 524 people were reported as suspected ATRs, of whom 466 were finally confirmed. Red blood cell was the most frequent culprit blood product (59.9%), followed by apheresis platelet (25.1%), fresh frozen plasma (10.1%), and platelet (4.9%). Clinical symptoms included fever (54.9%), urticaria and itching (34.7%), chillness and shivering (21.9%), and chest discomfort (6.0%), dyspnea (5.3%), cold sweating (3.8%), hypotension (2.1%), and palpitations (1.9%). The severity of ATRs were mild (91.8%), moderate (7.1%), and severe (1.1%). @*Conclusion@#ATRs are mostly mild, but life-threatening reactions may occur. Physicians should be aware of various features of ATRs to appropriately recognize and treat such patients.
ABSTRACT
Purpose@#Many studies have shown that obesity is one of the major causes of lung function decline. However, a longitudinal study of the correlation between changes in obesity degree and lung function is still lacking. This study aimed to analyze alterations in lung function according to changes in body and abdominal fat amount over time in healthy individuals. @*Methods@#A retrospective cohort study of individuals who received annual health screening was performed. Individuals who underwent health screening at least 3 times with follow-up periods more than 5 years were included. Using a linear mixed model, we analyzed associations between the change in total body fat amount/abdominal fat ratio and lung function decline over time by dividing each quartile according to the fat change rate. @*Results@#A total of 15,484 individuals over 40 years old was enrolled prospectively. A longitudinal increase in total body fat amount over time was associated with a predicted value of forced expiratory volume in 1 second (FEV1p ; %) and predicted value of forced vital capacity (FVCp; %) declines, regardless of sex. A similar phenomenon was observed between an increase in abdominal fat ratio and FEV 1p /FVCp decline, which was predominant in males. In addition, the change in abdominal fat ratio showed a significant correlation with differences in the initial values of FEV 1p and FVCp after 40 years old. @*Conclusion@#Increases in total body fat amount and abdominal fat ratio may cause lung function decline over time.
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Purpose@#Rituximab is prone to infusion-related reactions, which commonly requires desensitization to maintain its administration. Conventional desensitization protocols are using multistep infusion by diluting solutions. However, the process of diluting drugs and stepwise delivery needs additional time and effort. The objective of this study was to investigate the safety and efficacy of a nondiluting, one-bag protocol of rituximab desensitization. @*Methods@#A retrospective study was performed by reviewing the medical records of patients who underwent rituximab desensitization between 2009 and 2018. The completion rate, occurrence and severity of breakthrough reactions (BTR), and time required to complete the therapy were compared between one-bag protocol and multibag protocol. Results were analyzed by generalized estimation equation method, and odds ratios (ORs) of completion rate and BTR incidence were estimated. @*Results@#Total 190 cases of desensitization therapy were performed in 49 patients; the incidence of BTR was 16.84% and the overall completion rate was 96.32%. No significant difference in completion rate was found (OR, 3.58; 95% confidence interval [CI], 0.79– 16.38) and there was no significant difference in BTR incidence (OR, 0.81; 95% CI, 0.23–2.82) in one-bag protocol. BTR in the one-bag protocol tended to occur even through entire steps, whereas most of the BTR in the multibag protocol occurred at later steps of the process. The average time spent in the desensitization was 60 minutes shorter in the one-bag than the multibag protocol (258.15 minutes vs. 329.81 minutes, P< 0.001). @*Conclusion@#One-bag desensitization protocol showed no significant difference in safety and efficiency compared to the conventional multibag protocol, with shortening the time required for completion.
ABSTRACT
As an essential part of patient safety, pharmacovigilance is of worldwide interest and should expand its scope and focus on new emerging issues. South Korea has been making continuous efforts in the field of pharmacovigilance for the last 3 decades since voluntary adverse drug reaction (ADR) reporting system was first launched in 1988. Korea joined the World Health Organization Program for International Drug Monitoring in 1992, and the activities of Pharmacovigilance Research Network, Korean Society for Pharmacoepidemiology and Risk Management, and Regional Pharmacovigilance Center (RPVC) have contributed to the remarkable progress in the pharmacovigilance area and global status. RPVCs have played pivotal roles in establishment of pharmacovigilance system in Korea by monitoring voluntary ADR reports. RPVCs started with 3 hospitals in 2006 and have now expanded to 27 hospitals nationwide. The Korea Institute of Drug Safety & Risk Management was established in 2012 and in charge of operating the decentralized national pharmacovigilance system. The voluntary report of ADR, which is the basis of current pharmacovigilance system, has various limitations and an active surveillance system can be the overarching alternative. This change in pharmacovigilance paradigm is a global trend and Korea has excellent infrastructure such as broad distribution of electronic medical recording systems and a nationwide single healthcare insurance. As a result, the pharmacovigilance in Korea is now expected to progress to a new active surveillance system from traditional spontaneous reporting system.