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Purpose@#Even though pazopanib, a multitargeted tyrosine kinase inhibitor, has been approved for refractory soft tissue sarcoma (STS), little is known about the molecular determinants of the response to pazopanib. We performed integrative molecular characterization to identify potential predictors of pazopanib efficacy. @*Materials and Methods@#We obtained fresh pre-treatment tumor tissue from 35 patients with advanced STS receiving pazopanib-based treatment. Among those, 18 (51.4%) received pazopanib monotherapy, and the remaining 17 (48.6%) received pazopanib in combination with durvalumab, programmed death-ligand 1 blockade. Whole-exome and transcriptome sequencing were performed for each tumor and patient germline DNA. @*Results@#Of the 35 patients receiving pazopanib-based treatment, nine achieved a partial response (PR), resulting in an objective response rate (ORR) of 27.3%, and the median progression-free survival (PFS) was 6.0 months. Patients with CDK4 amplification (copy ratio tumor to normal > 2) exhibited shorter PFS (3.7 vs. 7.9 months, p=2.09×10–4) and a poorer response (ORR; 0% vs. 33.3%) compared to those without a gene amplification (copy ratio ≤ 2). Moreover, non-responders demonstrated transcriptional activation of CDK4 via DNA amplification, resulting in cell cycle activation. In the durvalumab combination cohort, seven of the 17 patients (41.2%) achieved a PR, and gene expression analysis revealed that durvalumab responders exhibited high immune/stromal cell infiltration, mainly comprising natural killer cells, compared to non-responders as well as increased expression of CD19, a B-cell marker. @*Conclusion@#Despite the limitation of heterogeneity in the study population and treatment, we identified possible molecular predictors of pazopanib efficacy that can be employed in future clinical trials aimed at evaluating therapeutic strategies.
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Purpose@#For precision medicine, exploration and monitoring of molecular biomarkers are essential. However, in advanced gastric cancer (GC) with visceral lesions, an invasive procedure cannot be performed repeatedly for the follow-up of molecular biomarkers. @*Materials and Methods@#To verify the clinical implication of serial liquid biopsies targeting circulating tumor DNA (ctDNA) on treatment response, we conducted targeted deep sequencing for serially collected ctDNA of 15 HER2-positive metastatic GC patients treated with anti-PD-1 inhibitor in combination with standard systemic treatment. @*Results@#In the baseline ctDNAs, 14 patients (93%) harbored more than one genetic alteration. A number of mutations in wellknown cancer-related genes, such as KRAS and PIK3CA, were identified. Copy number alterations were identified in eight GCs (53.3%), and amplification of the ERBB2 gene (6/15, 40.0%) was the most recurrent. When we calculated the mean variant allele frequency (VAF) of mutations in each ctDNA as the molecular tumor burden index (mTBI), the mTBI trend was largely consistent with the VAF profiles in both responder and non-responder groups. Notably, in the longitudinal analysis of ctDNA, mTBI provided 2–42 weeks (mean 13.4 weeks) lead time in the detection of disease progression compared to conventional follow-up with CT imaging. @*Conclusion@#Our data indicate that the serial genetic alteration profiling of ctDNA is feasible to predict treatment response in HER2-positive GC patients in a minimally invasive manner. Practically, ctDNA profiles are useful not only for the molecular diagnosis of GC but also for the selection of GC patients with poor prognosis for systemic treatment (ClinicalTrials.gov identifier:NCT02901301).
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Purpose@#Gastric cancer (GC) is among the most prevalent and fatal cancers worldwide.National cancer screening programs in countries with high incidences of this disease provide medical aid beneficiaries with free-of-charge screening involving upper endoscopy to detect early-stage GC. However, the coronavirus disease 2019 (COVID-19) pandemic has caused major disruptions to routine healthcare access. Thus, this study aimed to assess the impact of COVID-19 on the diagnosis, overall incidence, and stage distribution of GC. @*Materials and Methods@#We identified patients in our hospital cancer registry who were diagnosed with GC between January 2018 and December 2021 and compared the cancer stage at diagnosis before and during the COVID-19 pandemic. Subgroup analyses were conducted according to age and sex. The years 2018 and 2019 were defined as the “before COVID” period, and the years 2020 and 2021 as the “during COVID” period. @*Results@#Overall, 10,875 patients were evaluated; 6,535 and 4,340 patients were diagnosed before and during the COVID-19 period, respectively. The number of diagnoses was lower during the COVID-19 pandemic (189 patients/month vs. 264 patients/month) than before it.Notably, the proportion of patients with stages 3 or 4 GC in 2021 was higher among men and patients aged ≥40 years. @*Conclusions@#During the COVID-19 pandemic, the overall number of GC diagnoses decreased significantly in a single institute. Moreover, GCs were in more advanced stages at the time of diagnosis. Further studies are required to elucidate the relationship between the COVID-19 pandemic and the delay in the detection of GC worldwide.
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Next-generation sequencing (NGS) is becoming essential in the fields of precision oncology. With implementation of NGS in daily clinic, the needs for continued education, facilitated interpretation of NGS results and optimal treatment delivery based on NGS results have been addressed. Molecular tumor board (MTB) is multidisciplinary approach to keep pace with the growing knowledge of complex molecular alterations in patients with advanced solid cancer. Although guidelines for NGS use and MTB have been developed in western countries, there is limitation for reflection of Korea’s public health environment and daily clinical practice. These recommendations provide a critical guidance from NGS panel testing to final treatment decision based on MTB discussion.
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Over the last two decades, numerous studies have investigated the presence of human cytomegalovirus (CMV) within glioblastoma or gliomas; however, the results are severely conflicting. While a few researchers have suggested the potential benefits of cytotoxic T lymphocyte or dendritic cell-based vaccines for recurrent or newly diagnosed glioblastoma patients, several studies did not at all agree with the existence of CMV in glioblastoma cells. In this review, we summarized the conflicting results and issues about the detection of CMV in glioblastoma or glioma patients. We also provided the clinical data of published and unpublished clinical trials using CMV-specific immunotherapy for glioblastomas.
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Purpose@#The purpose of this study was to investigate the exercise effect of two types of training with a recumbent cycle ergometer on ankle muscle strength (dorsiflexor strength, DFS; dorsiflexor strength/weight, DFS/kg; plantar flexor strength, PFS; and plantar flexor strength/weight, PFS/kg) in healthy male subjects. @*Methods@#Twenty-three healthy males (27.91 ± 8.66 yr) were randomly allocated into two groups (high-intensity interval training (HIIT), and aerobic exercise training (AET) after the first measurement. The subjects were trained for 24 sessions (40 min/rep, three times/week) and ankle strength was measured for a second time. Two-way mixed model analysis of variance (ANOVA) was used to identify significant differences between changes in ankle muscle strength between before and after training (within factors) in the HIIT and AET groups (between factors). The statistical significance level was set at α = 0.05. @*Results@#In both HIIT and AET groups, all variables of ankle muscle strength were significantly increased after training compared to before training (p = 0.001). However, there were no differences in all variables of ankle strength between the HIIT and AET group (p > 0.05). @*Conclusion@#Both types (HIIT and AET) of recumbent cycle exercise training could be effective training methods to increase ankle muscle strength in healthy individuals, and the HIIT type with high intensity and low frequency pedaling could be recommended more to strengthen ankle muscles.
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Purpose@#To verify the anti-microbiotic activity and to develop eco-friendly surface disinfectants using the Opuntia ficus-indica extract. @*Methods@#The stem and fruits of the Opuntia cultivated in Jeju Island were extracted with hot water, 70% EtOH and 100% MeOH, respectively. To examine the antimicrobial activity of the extracts, gram positive bacteria (Bacillus subtilis, Staphylococcus aureus), gram negative bacteria (Escherichia coli, Salmonella typhimurium), yeast (Candida albicans), mold (Aspergillus flavus) and antibiotic resistant bacteria (E. coli, S. aureus) were measured to form a clear zone. @*Results@#The antibacterial activity of the fruit extract was higher than that of the stem extract, and the antibacterial activity of the 100% MeOH (FM) extract and the 70% EtOH (FE) extract of the palm cactus fruit was suitable for the surface disinfectant overall, and clear-zone formed even at relatively low concentrations (250 mg/mL). The FM and FE have antibacterial activity against various bacteria, therefore they can be used as disinfectants. @*Conclusion@#The antimicrobial activity of Opuntia ficus-indica extract from Jeju Island by stem and fruit was determined at relatively low concentrations (250 mg/mL). The Opuntia ficus-indica extract will be useful for surface disinfectants dissolving the patients’ bath, oral gargling, and powdered powder in water or ethanol in appropriate concentrations.
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Background@#Delirium is a neuropsychiatric disorder characterized by sudden impairments in consciousness, attention, and perception. The evidence of successful pharmacological interventions for delirium is limited, and medication recommendations for managing delirium are not standardized. This study aimed to provide evidence of antipsychotics for symptomatic treatment of delirium in cancer patients receiving palliative care. @*Methods@#We retrospectively reviewed adult cancer patients in palliative care who received antipsychotic delirium treatment at Severance Hospital between January 2016 and June 2019. The efficacy was evaluated primarily by resolution rates. The resolution of delirium was defined as neurological changes from drowsiness, confusion, stupor, sedation, or agitation to alertness or significant symptomatic improvements described in the medical records. The safety was studied primarily by adverse drug reaction incidence ratios. @*Results@#Of the 63 enrolled patients, 60 patients were included in the statistical analysis and were divided into three groups based on which antipsychotic medication they were prescribed [quetiapine (n=27), haloperidol (n=25) and co-administration of quetiapine and haloperidol (n=8)]. The resolution ratio showed quetiapine to be more effective than haloperidol (p=0.001). No significant differences were seen in adverse drug reaction rates among the three groups (p=0.332). @*Conclusions@#Quetiapine was considered the most effective medication for delirium, with no significant differences in adverse drug reaction rates. Therefore, quetiapine may be considered a first-line medication for treating delirium in cancer patients receiving palliative care. However, further studies comparing more diverse antipsychotics among larger populations are still needed.
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An increasing number of studies are using healthcare claims databases to assess healthcare intervention utilization patterns or outcomes in real-world clinical settings. However, methodological issues affecting study design or data analysis can make conducting and reporting these types of studies difficult. This review presents an overview of the types of information contained in claims data, describes some advantages and limitations of using claims data for research purposes, and outlines steps for utilizing the Korea Health Insurance Review and Assessment and National Health Insurance Service databases. The study also reviews epidemiological approaches utilizing healthcare claims databases (including cross-sectional, case-control, case-crossover, and cohort designs) with respect to protocol development, analysis, and reporting of results, and introduces relevant guidelines and checklists, including the Guidelines for Good Pharmacoepidemiology Practices, the Strengthening the Reporting of Observational Studies in Epidemiology checklist, and the Risk of Bias in Nonrandomized Studies of Interventions tool.
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Objective@#: We attempted to compare the incidence of pyogenic spondylitis (PS) and tuberculous spondylitis (TS) between 2007 and 2016. Furthermore, we investigated the patients who underwent surgery in 2016 compared to that in 2007. @*Methods@#: We used a nationwide database managed by the Korean National Health Insurance Service (NHIS) in 2007 and 2016. Total 9655 patients with a newly diagnosis of PS or TS were enrolled in PS or TS group. Among them, 1721 patients underwent either fusion or decompression surgery. We analyzed demographic distribution of patients according to gender and age and year of diagnosis. @*Results@#: Comparing between 2007 and 2016, the incidence of PS has increased in 2016 than in 2007 (4874 vs. 2431, p<0.0001). Conversely, declination of incidence of TS was discovered in 2016 compared to 2007 (594 vs. 1756, p<0.0001). Females showed predominance over males regarding both PS and TS (5228 vs. 4427, p<0.0001). Among them, the number of PS patients who underwent surgery increased significantly in 2016 relative to that in 2007 (979 vs. 592, p<0.0001). @*Conclusion@#: This nationwide study suggests that PS may increase and TS may decrease in Korea. In addition, demand for surgery regarding PS may increase.
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Purpose@#Non-vitamin K antagonist oral anticoagulants (NOACs) are widely used in patients with atrial fibrillation (AF) because of their effectiveness in preventing stroke and their better safety, compared with warfarin. However, there are concerns for an increased risk of bleeding associated with concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) or selective serotonin reuptake inhibitors (SSRIs) with NOACs. In this study, we aimed to evaluate the risk of bleeding events in individuals taking concomitant NSAIDs or SSRIs with NOACs after being diagnosed with AF. Materials and Methods: A nested case-control analysis to assess the safety of NSAIDs and SSRIs among NOAC users with AF was performed using data from Korean National Health Insurance Service from January 2012 to December 2017.Among patients who were newly prescribed NOACs, 1233 cases hospitalized for bleeding events were selected, and 24660 controls were determined. @*Results@#The risk of bleeding events was higher in patients receiving concomitant NSAIDs [adjusted odds ratio (aOR) 1.41; 95% confidence interval (CI) 1.24–1.61] or SSRIs (aOR 1.92; 95% CI 1.52–2.42) with NOACs, compared to no use of either drug, respectively.The risk of upper gastrointestinal bleeding was higher in patients receiving concomitant NSAIDs or SSRIs without proton pump inhibitors (PPIs) (NSAIDs: aOR 2.47; 95% CI 1.26–4.83, SSRI: aOR 10.8; 95% CI 2.41–2.48) compared to no use. @*Conclusion@#When NSAIDs or SSRIs are required for NOAC users with AF, physicians need to monitor bleeding events and consider the use of PPIs, especially for combined use of both drugs or when initiating NOACs treatment.
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Objectives@#. The aim of this study was to evaluate the effectiveness of subtotal parathyroidectomy for patients with renal hyperparathyroidism. @*Methods@#. We studied 25 patients with renal hyperparathyroidism who underwent subtotal parathyroidectomy from October 2002 to October 2017. We analyzed serum intact parathyroid hormone (iPTH), calcium, and inorganic phosphorus levels before and at multiple time points following surgery, and evaluated the surgical outcomes and complications. @*Results@#. Of the 25 patients, 13 (52%) were male and 12 (48%) were female, and the mean age was 53.4±9.3 years. The mean duration of dialysis before parathyroidectomy was 156.8±79.5 months. Mean preoperative serum iPTH and calcium levels were 1,199.0±571.3 pg/mL and 10.5±1.0 mg/dL, respectively. At 6 months postoperatively, the mean iPTH and calcium levels decreased to 49.2±47.6 pg/mL (P<0.01) and 8.0±1.0 mg/dL (P<0.01), respectively. Recurrent hyperparathyroidism occurred in two patients: one subsequently underwent kidney transplantation and the other continued hemodialysis and maintained normal calcium levels. One patient developed postoperative permanent hypoparathyroidism. @*Conclusion@#. Subtotal parathyroidectomy is a safe and effective surgical treatment for renal hyperparathyroidism.
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Background@#Basiliximab is used as an alternative to tacrolimus in patients with decreased renal function. However, studies on basiliximab as a maintenance immunosuppressant, particularly in patients with lung transplantation, are limited. Therefore, here, we investigated the efficacy and safety of basiliximab in patients with lung transplantation. @*Methods@#Adult patients with acute kidney injury (AKI) who received lung transplantation at a single general hospital between July 1, 2014 and June 30, 2018, were selected and classified in tacrolimus and basiliximab groups. Both groups received a triple-drug regimen (tacrolimus, mycophenolate mofetil, and steroids). However, tacrolimus was discontinued in the basiliximab group when AKI occurred, and two or more repeat basiliximab doses were administered within 3 months after transplantation. The electronic medical records were analyzed retrospectively. @*Results@#Of the 85 patients who met the selection criteria, 61 and 24 were assigned to the tacrolimus and basiliximab groups, respectively. Significant improvement in renal function was observed in the basiliximab group (p <0.001).However, there were no differences in acute and chronic rejection rates in both the groups. No difference was observed in the incidence rate of complications between the groups, except for chronic kidney disease, which showed higher incidence in the basiliximab group (25.0% vs. 4.9%; p =0.013). @*Conclusions@#We suggest the use of basiliximab as an immunosuppressant alternative to tacrolimus in patients with acute renal failure after lung transplantation. Basiliximab demonstrated effectiveness as an immunosuppressant and improved renal function. Therefore, basiliximab can be used in patients with decreased renal function.
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Background@#Recently, a study comprising adult patients with sepsis admitted in the intensive care unit (ICU) was conducted. The patients were treated with high doses of intravenous ascorbic acid, thiamine, and hydrocortisone; the clinical outcomes demonstrated significant therapeutic benefits. The mortality rate in children with sepsis is approximately 25%. However, the effects of additional treatment with ascorbic acid and thiamine (“vitamin protocol”) in children are rarely investigated. @*Methods@#A retrospective analysis was performed using medical records of patients diagnosed with sepsis and admitted to the pediatric ICU (PICU) between September 2016 and June 2019. The control group received treatment only as per sepsis protocol, whereas the treated group received both sepsis protocol and the vitamin protocol. The primary endpoint was change in Vasoactive-Inotropic Score (VIS) for 5 days. The secondary endpoints included the length of stay in the PICU, duration of using mechanical ventilators and vasopressors, and mortality rate. @*Results@#The number of patients in the treated and control groups was 33 and 24, respectively. The treated group showed greater decrease in their VIS for 5 days than the control group (44.4 vs 18.6); however, the difference was not statistically significant. The length of stay in the PICU was significantly longer for the treated group than for the control group [10.0 days (Interquartile range (IQR), 6-18) vs 4.5 days (IQR, 4-10.3); p=0.004]. @*Conclusions@#No significant treatment benefits were observed following vitamin protocol administration to the pediatric patients with sepsis. Further studies are necessary for improving the efficacy and safety of the vitamin protocol.
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Objective@#To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. @*Methods@#We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability.Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. @*Results@#Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. @*Conclusion@#BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.
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Purpose@#The aim of this study was to determine the effects of lower rib cage lateral expansion limitation on the maximal inspiratory and expiratory pressures and on abdominal muscle activity during maximal respiratory breathing in healthy subjects. @*Methods@#Fifteen healthy male subjects voluntarily participated in this cross-sectional study. During maximal breathing, maximal inspiratory and expiratory pressures were measured, and abdominal muscle activity was determined with using surface electromyography. Also, the measurement was repeated with using a non-elastic belt to the lower rib cage for limiting of lateral expansion. A Wilcoxon signed-rank test was performed for obtaining the statistical difference with a significance level of 0.05. @*Results@#The findings of this study are as follows: 1) There were no significant differences in maximal inspiratory and expiratory pressure with and without lower rib cage lateral expansion (p>0.05), 2) There was no significant difference in abdominal muscle activity during the maximal inspiratory phase (p>0.05). However, right external oblique muscle activity decreased significantly during maximum exhalation with lower rib expansion limitation (p<0.05). @*Conclusion@#The results of the current study indicate that a non-elastic belt was effective in decreasing right external oblique muscle activity during forced expiratory breathing in healthy subjects.
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Purpose@#The aim of this study was to determine the effects of lower rib cage lateral expansion limitation on the maximal inspiratory and expiratory pressures and on abdominal muscle activity during maximal respiratory breathing in healthy subjects. @*Methods@#Fifteen healthy male subjects voluntarily participated in this cross-sectional study. During maximal breathing, maximal inspiratory and expiratory pressures were measured, and abdominal muscle activity was determined with using surface electromyography. Also, the measurement was repeated with using a non-elastic belt to the lower rib cage for limiting of lateral expansion. A Wilcoxon signed-rank test was performed for obtaining the statistical difference with a significance level of 0.05. @*Results@#The findings of this study are as follows: 1) There were no significant differences in maximal inspiratory and expiratory pressure with and without lower rib cage lateral expansion (p>0.05), 2) There was no significant difference in abdominal muscle activity during the maximal inspiratory phase (p>0.05). However, right external oblique muscle activity decreased significantly during maximum exhalation with lower rib expansion limitation (p<0.05). @*Conclusion@#The results of the current study indicate that a non-elastic belt was effective in decreasing right external oblique muscle activity during forced expiratory breathing in healthy subjects.
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Background@#Basiliximab is used as an alternative to tacrolimus in patients with decreased renal function. However, studies on basiliximab as a maintenance immunosuppressant, particularly in patients with lung transplantation, are limited. Therefore, here, we investigated the efficacy and safety of basiliximab in patients with lung transplantation. @*Methods@#Adult patients with acute kidney injury (AKI) who received lung transplantation at a single general hospital between July 1, 2014 and June 30, 2018, were selected and classified in tacrolimus and basiliximab groups. Both groups received a triple-drug regimen (tacrolimus, mycophenolate mofetil, and steroids). However, tacrolimus was discontinued in the basiliximab group when AKI occurred, and two or more repeat basiliximab doses were administered within 3 months after transplantation. The electronic medical records were analyzed retrospectively. @*Results@#Of the 85 patients who met the selection criteria, 61 and 24 were assigned to the tacrolimus and basiliximab groups, respectively. Significant improvement in renal function was observed in the basiliximab group (p <0.001).However, there were no differences in acute and chronic rejection rates in both the groups. No difference was observed in the incidence rate of complications between the groups, except for chronic kidney disease, which showed higher incidence in the basiliximab group (25.0% vs. 4.9%; p =0.013). @*Conclusions@#We suggest the use of basiliximab as an immunosuppressant alternative to tacrolimus in patients with acute renal failure after lung transplantation. Basiliximab demonstrated effectiveness as an immunosuppressant and improved renal function. Therefore, basiliximab can be used in patients with decreased renal function.
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Background@#Recently, a study comprising adult patients with sepsis admitted in the intensive care unit (ICU) was conducted. The patients were treated with high doses of intravenous ascorbic acid, thiamine, and hydrocortisone; the clinical outcomes demonstrated significant therapeutic benefits. The mortality rate in children with sepsis is approximately 25%. However, the effects of additional treatment with ascorbic acid and thiamine (“vitamin protocol”) in children are rarely investigated. @*Methods@#A retrospective analysis was performed using medical records of patients diagnosed with sepsis and admitted to the pediatric ICU (PICU) between September 2016 and June 2019. The control group received treatment only as per sepsis protocol, whereas the treated group received both sepsis protocol and the vitamin protocol. The primary endpoint was change in Vasoactive-Inotropic Score (VIS) for 5 days. The secondary endpoints included the length of stay in the PICU, duration of using mechanical ventilators and vasopressors, and mortality rate. @*Results@#The number of patients in the treated and control groups was 33 and 24, respectively. The treated group showed greater decrease in their VIS for 5 days than the control group (44.4 vs 18.6); however, the difference was not statistically significant. The length of stay in the PICU was significantly longer for the treated group than for the control group [10.0 days (Interquartile range (IQR), 6-18) vs 4.5 days (IQR, 4-10.3); p=0.004]. @*Conclusions@#No significant treatment benefits were observed following vitamin protocol administration to the pediatric patients with sepsis. Further studies are necessary for improving the efficacy and safety of the vitamin protocol.
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Objective@#To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. @*Methods@#We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability.Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. @*Results@#Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. @*Conclusion@#BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.