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Desensitization therapy can help overcome severe hypersensitivity reactions and allow continuing administration of the culprit agents. However, this is time- and labor-intensive due to a prolonged infusion time and the serial adjustment of infusion rate between steps. Therefore, simplified protocols using fewer steps have been tested, although currently there is no established standard strategy. Cetuximab plays an important role in the treatment of metastatic colorectal cancer. Although cetuximab is well tolerated, severe infusion reactions occur in 1.1% of patients, and most occur within 1 hour of receiving the first dose. Here, we report a recent attempt to shorten the steps of gradual cetuximab desensitization. A 57-year-old male patient diagnosed with obstructive sigmoid colon cancer received cetuximab chemotherapy and experienced immediate anaphylaxis at the first cycle. A one-bag, 17-step desensitization protocol was applied to cetuximab administration. After the first successful desensitization cycle, the process of desensitization was shortened 1–2 step(s) per cycle, down to 2 steps, without a breakthrough reaction. The patient ultimately received regular infusions. Shortening of the rapid desensitization protocol can be considered if the previous cycle is well-tolerated, even in a patient who suffered previous anaphylaxis to cetuximab.
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Background/Aims@#Tuberculosis has incidence and mortality rates that are among the highest for all communicable diseases. Adverse drug reactions (ADRs) to anti-tubercular drugs are common, and have a major impact on treatment maintenance and prognosis. It is important to understand the characteristics of ADRs and establish a suitable management plan. @*Methods@#We retrospectively reviewed patients with ADRs during treatment with first-line antitubercular drugs such as isoniazid, rifampicin, ethambutol, and pyrazinamide from 2009 to 2018. Age, sex, and total treatment period, and the onset, severity, seriousness, and system organ class of ADRs, were analyzed to understand the characteristics of first-line anti-tubercular drug-related ADRs. @*Results@#A total of 1,606 of 5,482 patients (29.3%) experienced ADRs after administration of first-line anti-tubercular drugs. The incidence of ADRs related to isoniazid, rifampicin, ethambutol, and pyrazinamide was 22.2%, 21.3%, 24.5%, and 29.6%, respectively. A total of 2,098 ADR reports were made (mean of 1.3 ± 0.6 per patient). The rates of mild, moderate, and severe ADRs were 32.4%, 61.1%, and 6.5%, respectively. There were 127 reports (6.1%) of serious ADRs. Skin and appendage disorders were most frequently reported (27.5%), followed by gastrointestinal disorders (17.5%), and liver and biliary system disorders (13.1%). The total treatment period was longer in patients who experienced ADRs (224.0 ± 3.1 days vs. 247.0 ± 4.7 days, p = 0.009). @*Conclusions@#The incidence of ADRs to first-line anti-tuberculosis drugs was 29.3%, and 6.5% were severe ADRS. ADRs prolonged the overall treatment duration, indicating the importance of their detection and management.
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Background/Aims@#Despite proper use of pharmaceuticals, adverse drug reactions (ADRs) can lead to problems related to patient safety. We analyzed the characteristics of ADRs, particularly serious adverse events (SAEs), in a single tertiary medical institution. @*Methods@#Spontaneous ADR report data collected from 2010 to 2019 in Seoul National University Hospital were assessed. Causality was evaluated according to the World Health Organization-Uppsala Monitoring Centre criteria. Age, sex, onset, severity, seriousness, and system organ class (SOC) of ADRs and SAEs were analyzed. @*Results@#During the study period, a total of 49,955 individual case safety reports were assessed as possible, probable, or certain. Although the number of gastrointestinal ADR reports was high (25.9%), severe cases were uncommon (2.6%). By contrast, the number of hematologic disorders was low (6.6%) but 39.2% of them were severe. Among ADRs, 10.2% were assessed as SAEs, the proportion of which was high at extreme ages and in males. Body as a whole-general disorders were the most frequently reported SOC for SAEs, followed by skin and appendage disorders. Antineoplastic agents and antibiotics were the most common causative agents of SAEs and ADRs. Anaphylactic reaction was the most frequent SAE (6.5%). @*Conclusions@#The proportion of SAE differs according to SOC and drug. Attention should be paid to SAEs in children and older adults because the rate of SAEs is significantly higher at extreme ages.
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Background/Aims@#Despite proper use of pharmaceuticals, adverse drug reactions (ADRs) can lead to problems related to patient safety. We analyzed the characteristics of ADRs, particularly serious adverse events (SAEs), in a single tertiary medical institution. @*Methods@#Spontaneous ADR report data collected from 2010 to 2019 in Seoul National University Hospital were assessed. Causality was evaluated according to the World Health Organization-Uppsala Monitoring Centre criteria. Age, sex, onset, severity, seriousness, and system organ class (SOC) of ADRs and SAEs were analyzed. @*Results@#During the study period, a total of 49,955 individual case safety reports were assessed as possible, probable, or certain. Although the number of gastrointestinal ADR reports was high (25.9%), severe cases were uncommon (2.6%). By contrast, the number of hematologic disorders was low (6.6%) but 39.2% of them were severe. Among ADRs, 10.2% were assessed as SAEs, the proportion of which was high at extreme ages and in males. Body as a whole-general disorders were the most frequently reported SOC for SAEs, followed by skin and appendage disorders. Antineoplastic agents and antibiotics were the most common causative agents of SAEs and ADRs. Anaphylactic reaction was the most frequent SAE (6.5%). @*Conclusions@#The proportion of SAE differs according to SOC and drug. Attention should be paid to SAEs in children and older adults because the rate of SAEs is significantly higher at extreme ages.
ABSTRACT
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
PURPOSE: To identify causative agents of the drug-induced anaphylaxis (DIA) by using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System (KIDS-KAERS) database (Ministry of Food and Drug Safety) in Korea and to check their labeling information regarding anaphylaxis.METHODS: Among Individual Case Safety Reports from January, 2008 to December 2017, cases of DIA were analyzed for demographics, causative agents and fatal cases resulting in death. The domestic drug labeling, Micromedex and U.S. Food and Drug Administration (FDA) drug package insert, were reviewed to check if the labeling information on suspected causative agents contains anaphylaxis.RESULTS: A total of 4,700 cases of DIA were analyzed. The mean age was 49.85±18.32 years, and 2,642 patients (56.2%) were females. Among 8,664 drugs reported as causative agents, antibiotics (27.4%) accounted for the largest portion. There were 18 fatal cases: antibiotics (7 cases), antineoplastic agents (4 cases) were the major causative drugs for the mortality cases. Of 513 drugs reported as suspected causative agents, 103 (20.1%) did not list anaphylaxis as an adverse effect on domestic drug labeling and 16 (3.1%) did not reflect anaphylaxis in any of 3 adverse drug information.CONCLUSION: Analysis of 10-year data showed that antibiotics were the main cause of DIA and the mortality rate was 0.7%. In 3.1% of suspected drugs, there was no description of anaphylaxis in any of the drug labeling.
Subject(s)
Female , Humans , Anaphylaxis , Anti-Bacterial Agents , Antineoplastic Agents , Demography , Drug Labeling , Korea , Mortality , Pharmacovigilance , United States Food and Drug AdministrationABSTRACT
In order to give basic data to teenager's healthcare, we investigated the food habits according to BMI (Body Mass Index), life style, dietary related self-efficacy and food intake through conducting a research surveying 732 middle school students of the Kwang-ju and Chonnam areas. The results of this study were compared groups in under weight (UW), normal weight (NW), and overweight (OW) groups according to BMI levels. In the male students, height was significantly differently in the UW group as 158.2 +/- 0.7 cm compared to other NW and OW groups respectively as 163.7 +/- 0.6 cm and 162.6 +/- 0.7 cm but in the female students there was no significantly difference within groups. Weight was significantly different between the groups in the male students, whereas there were minor differences in the female students. The average of BMI was 20.7 +/- 0.1 on the male students and 20.6 +/- 0.1 on the female students which were all within the average, and their obesity was increased as the school grade was higher. Under less than 30,000 won of pocket money was dominating, and most of the students were in a nuclear family. In all male and female students, the inactive hours like watching TV and using computers had no differences between groups. The difference between groups was minor on breakfast time and most of the students thought their problems on unbalanced diet. There was significant difference in the OW group in female students as they thought their problems on unbalanced diets. The frequency of snack was significantly low in the OW group of male students but there were no differences in snack and eating-out food. All students chose fruits as snack food and Korean-style food as eating out food. The OW group in male students were significantly low in the dietary related self-efficacy when they were with their families and feeling depressed but there were no differences in female students between groups. When all students were getting higher BMI, they evaluated themselves badly in their self-dietary habits. Also the more male students had non-physical activity time, the less they had the dietary related self-efficacy and the more female students had physical activity time, the higher they had the dietary related self-efficacy. In conclusion, the OW group had good habits in physical activities for weekends, meal times, frequency of snack consumption but it showed undesirable when they were low in dietary related self-efficacy. Therefore we will provide the systematic nutrition education to them through this study.
Subject(s)
Female , Humans , Male , Body Mass Index , Breakfast , Delivery of Health Care , Diet , Eating , Feeding Behavior , Fruit , Life Style , Meals , Motor Activity , Nuclear Family , Obesity , Overweight , SnacksABSTRACT
No abstract available.