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.
Anaphylaxis ; Anti-Bacterial Agents ; Antineoplastic Agents ; Demography ; Drug Labeling ; Female ; Humans ; Korea ; Mortality ; Pharmacovigilance ; United States Food and Drug Administration

Perioperative hypersensitivity reaction have been reported to have a variable degree of the incidence from differ countries and to be 1/353–18,600 approximately and its mortality has been reported to be 4%–4.76% in the United States and Japan, respectively. A 65-year-old male patient with hypertension, rheumatoid arthritis, and history of amoxicillin allergy was scheduled for laparoscopic radical prostatectomy due to prostate cancer. Lidocaine, propofol, and rocuronium were administered sequentially to induce general anesthesia. Twenty minutes after the rocuronium administration, severe hypotension and tachycardia developed. But key signs of hypersensitivity such as urticaria and bronchospasm were not appeared. The operation was canceled and we evaluated the cause of severe hypotension and could confirm hypersensitivity for rocuronium with intradermal test after 4 weeks.
Aged ; Amoxicillin ; Anaphylaxis ; Anesthesia, General ; Arthritis, Rheumatoid ; Bronchial Spasm ; Humans ; Hypersensitivity ; Hypertension ; Hypotension ; Incidence ; Intradermal Tests ; Japan ; Lidocaine ; Male ; Mortality ; Propofol ; Prostatectomy ; Prostatic Neoplasms ; Tachycardia ; United States ; Urticaria

Objective To study the protein expression of cluster of differentiation 63 （CD63） in lung tissues of guinea pigs that died of anaphylactic shock and discuss the diagnostic value of CD63 for death from anaphylactic shock. Methods Twenty guinea pigs were randomly divided into control group, anaphylactic shock immediate death group, cold storage group （4 ℃ for 48 h） and frozen group （-20 ℃ for 7 d）. The animal model of guinea pigs that died of anaphylactic shock was established with human mixed serum injection. The expression changes of CD63 protein and CD63 mRNA in lung tissues were detected by hematoxylin-eosin （HE） staining, immunohistochemical staining, Western blotting, enzyme-linked immunosorbent assay （ELISA） and real-time RT-PCR. Results HE staining results showed congestion, and edema of lung tissues, and eosinophil infiltration in the anaphylactic shock groups. Western blotting analysis results showed that the expression of CD63 protein in the lung tissues of guinea pigs that died of anaphylactic shock was significantly higher than that in the control group （P<0.05）. Comparison between the anaphylactic shock groups was made, and the differences had no statistical significance. The results of immunohistochemical staining and real-time RT-PCR were consistent with that of Western blotting. ELISA results showed that CD63 protein expression in the immediate death group was higher than that in the control group （P<0.05）. Conclusion The expression of CD63 protein and CD63 mRNA in the lung tissues of guinea pigs that died of anaphylactic shock is significantly enhanced. Animal carcasses which were put in cold storage for 48 h and frozen for 7 d do not affect the examination of the above indicators. CD63 protein is expected to become an auxiliary diagnostic indicator of death from anaphylactic shock.
Anaphylaxis/mortality* ; Animals ; Disease Models, Animal ; Enzyme-Linked Immunosorbent Assay ; Guinea Pigs ; Humans ; Lung/metabolism* ; Real-Time Polymerase Chain Reaction ; Reverse Transcriptase Polymerase Chain Reaction ; Serum ; Tetraspanin 30/metabolism*

Misoprostol is widely used in daily practice for induction of labor and cervical dilatation prior to intrauterine procedures, including dilatation and curettage or hysteroscopy. Anaphylactic shock to intravaginal misoprostol can occur not only in pregnant women, as reported in 2 previous cases, but also in a non-pregnant, perimenopausal woman, as in the case described herein. A 49-year-old woman received vaginal misoprostol for cervical ripening prior to hysteroscopic myomectomy and experienced anaphylactic shock. Two 400 μg doses of misoprostol 6 hours apart caused uncontrolled shaking and high fever followed by shock. In conclusion, the possibility of anaphylactic shock should be considered in patients with sudden hypotension following misoprostol administration. Prompt identification and management are crucial to prevent morbidity and mortality following an anaphylactic shock to misoprostol.
Anaphylaxis* ; Cervical Ripening ; Dilatation and Curettage ; Female ; Fever ; Humans ; Hypotension ; Hysteroscopy ; Labor Stage, First ; Middle Aged ; Misoprostol* ; Mortality ; Pregnancy ; Pregnant Women ; Shock

BACKGROUND: Robot-assisted radical prostatectomy (RARP) is a feasible treatment option for high-risk prostate cancer (PCa). While patients may achieve undetectable prostate-specific antigen (PSA) levels after RARP, the risk of disease progression is relatively high. We investigated metastasis-free survival, cancer-specific survival (CSS), and overall survival (OS) outcomes and prognosticators in such patients. METHODS: In a single-center cohort of 342 patients with high-risk PCa (clinical stage ≥ T3, biopsy Gleason score ≥ 8, and/or PSA levels ≥ 20 ng/mL) treated with RARP and pelvic lymph node dissection between August 2005 and June 2011, we identified 251 (73.4%) patients (median age, 66.5 years; interquartile range [IQR], 63.0–71.0 years) who achieved undetectable PSA levels (< 0.01 ng/mL) postoperatively. Survival outcomes were evaluated for the entire study sample and in groups stratified according to the time to biochemical recurrence dichotomized at 60 months. RESULTS: During the median follow-up of 75.9 months (IQR, 59.4–85.8 months), metastasis occurred in 38 (15.1%) patients, most often to the bones, followed by the lymph nodes, lungs, and liver. The 5-year metastasis-free, cancer-specific, and OS rates were 87.1%, 94.8%, and 94.3%, respectively. Multivariate Cox-regression analysis revealed time to recurrence as an independent predictor of metastasis (P < 0.001). Time to metastasis was an independent predictor of OS (P = 0.003). Metastasis-free and CSS rates were significantly lower among patients with recurrence within 60 months of RARP (log-rank P < 0.001). CONCLUSION: RARP confers acceptable oncological outcomes for high-risk PCa. Close monitoring beyond 5 years is warranted for early detection of disease progression and for timely adjuvant therapy.
Biopsy ; Cohort Studies ; Disease Progression ; Early Diagnosis ; Follow-Up Studies ; Humans ; Liver ; Lung ; Lymph Node Excision ; Lymph Nodes ; Mortality* ; Neoplasm Grading ; Neoplasm Metastasis* ; Passive Cutaneous Anaphylaxis ; Prostate* ; Prostate-Specific Antigen* ; Prostatectomy* ; Prostatic Neoplasms* ; Recurrence*

Active surveillance (AS) is currently accepted as a good management option for men with low-risk prostate cancer (PCa). Moreover, given the grade migration following the 2005 International Society of Urologic Pathology consensus conference, AS may be appropriate for men presenting with favorable intermediate-risk PCa. Three contemporary experiences of AS for men with intermediate-risk features suggest that although these men are at higher risk for radical treatment, most of them are not significantly compromising chances for long-term cure. From the long-term randomized ProtectT trial, 10-year outcomes after active monitoring, surgery, or radiotherapy for localized PCa revealed that PCa specific mortality was low irrespective of the treatment assigned, with no significant difference among treatments. Multiparametric magnetic resonance imaging, molecular biomarkers, and new Gleason grading system could enhance diagnostic accuracy and decrease the demerits of current AS protocols. Particularly, uniform recording of the percentage pattern 4 in Gleason 7 cancers will enable better understanding of prognostic risks and consideration of careful expansion of AS to populations with minimal Gleason pattern 4 disease.
Biomarkers ; Clothing ; Consensus ; Humans ; Magnetic Resonance Imaging ; Male ; Mortality ; Neoplasm Grading ; Passive Cutaneous Anaphylaxis ; Pathology ; Prostate* ; Prostatic Neoplasms* ; Radiotherapy

BACKGROUND: The aim of this study was to investigate the relationships between left ventricular ejection fraction (LVEF) and mortality and neurologic outcomes with post-cardiac arrest syndrome (PCAS) after out-of-hospital cardiac arrest (OHCA). METHODS: Patients with PCAS after OHCA admitted to the intensive care unit between January 2014 and December 2015 were analyzed retrospectively. RESULTS: total of 104 patients were enrolled in this study. The mean age was 54.4 ± 15.3 years, and 75 of the patients were male (72.1%). Arrest with a cardiac origin was found in 55 (52.9%). LVEF < 45%, 45-55%, and > 55% was measured in 39 (37.5%), 18 (17.3%), and 47 (45.2%) of patients, respectively. In multivariate analysis, severe LV dysfunction (LVEF < 45%) was significantly related to 7-day mortality (odds ratio 3.02, 95% Confidence Interval 1.01-9.0, p-value 0.047). CONCLUSIONS: In this study, moderate to severe LVEF within 48 hours after return of spontaneous circulation was significantly related to 7-day short-term mortality in patients with PCAS after OHCA. Clinicians should actively treat myocardial dysfunction, and further studies are needed.
Echocardiography ; Humans ; Intensive Care Units ; Male ; Mortality* ; Multivariate Analysis ; Out-of-Hospital Cardiac Arrest* ; Passive Cutaneous Anaphylaxis ; Retrospective Studies ; Stroke Volume*

Disparities between African American and Caucasian men in prostate cancer (PCa) diagnosis and treatment in the United States have been well established, with significant racial disparities documented at all stages of PCa management, from differences in the type of treatment offered to progression-free survival or death. These disparities appear to be complex in nature, involving biological determinants as well as socioeconomic and cultural aspects. We present a review of the literature on racial disparities in the diagnosis of PCa, treatment, survival, and genetic susceptibility. Significant differences were found among African Americans and whites in the incidence and mortality rates; namely, African Americans are diagnosed with PCa at younger ages than whites and usually with more advanced stages of the disease, and also undergo prostate-specific antigen testing less frequently. However, the determinants of the high rate of incidence and aggressiveness of PCa in African Americans remain unresolved. This pattern can be attributed to socioeconomic status, detection occurring at advanced stages of the disease, biological aggressiveness, family history, and differences in genetic susceptibility. Another risk factor for PCa is obesity. We found many discrepancies regarding treatment, including a tendency for more African American patients to be in watchful waiting than whites. Many factors are responsible for the higher incidence and mortality rates in African Americans. Better screening, improved access to health insurance and clinics, and more homogeneous forms of treatment will contribute to the reduction of disparities between African Americans and white men in PCa incidence and mortality.
African Americans ; Diagnosis* ; Disease-Free Survival ; Genetic Predisposition to Disease ; Healthcare Disparities ; Humans ; Incidence ; Insurance, Health ; Male ; Mass Screening ; Mortality ; Obesity ; Passive Cutaneous Anaphylaxis ; Prostate* ; Prostate-Specific Antigen ; Prostatic Neoplasms* ; Risk Factors ; Social Class ; United States ; Watchful Waiting

Disparities between African American and Caucasian men in prostate cancer (PCa) diagnosis and treatment in the United States have been well established, with significant racial disparities documented at all stages of PCa management, from differences in the type of treatment offered to progression-free survival or death. These disparities appear to be complex in nature, involving biological determinants as well as socioeconomic and cultural aspects. We present a review of the literature on racial disparities in the diagnosis of PCa, treatment, survival, and genetic susceptibility. Significant differences were found among African Americans and whites in the incidence and mortality rates; namely, African Americans are diagnosed with PCa at younger ages than whites and usually with more advanced stages of the disease, and also undergo prostate-specific antigen testing less frequently. However, the determinants of the high rate of incidence and aggressiveness of PCa in African Americans remain unresolved. This pattern can be attributed to socioeconomic status, detection occurring at advanced stages of the disease, biological aggressiveness, family history, and differences in genetic susceptibility. Another risk factor for PCa is obesity. We found many discrepancies regarding treatment, including a tendency for more African American patients to be in watchful waiting than whites. Many factors are responsible for the higher incidence and mortality rates in African Americans. Better screening, improved access to health insurance and clinics, and more homogeneous forms of treatment will contribute to the reduction of disparities between African Americans and white men in PCa incidence and mortality.
African Americans ; Diagnosis* ; Disease-Free Survival ; Genetic Predisposition to Disease ; Healthcare Disparities ; Humans ; Incidence ; Insurance, Health ; Male ; Mass Screening ; Mortality ; Obesity ; Passive Cutaneous Anaphylaxis ; Prostate* ; Prostate-Specific Antigen ; Prostatic Neoplasms* ; Risk Factors ; Social Class ; United States ; Watchful Waiting

BACKGROUND: Drug allergy (DA) is one of the most important contributors to iatrogenic morbidity and mortality. Currently DA remains a major challenge for healthcare practitioners (HCPs). OBJECTIVE: To assess the knowledge, attitudes and practices of DA among HCPs in Central China. METHODS: A 25-item self-administered DA questionnaire were developed and applied in our study. The questionnaire covered 3 domains: knowledge, attitudes, and practice patterns. From July 2015 to October 2015, HCPs in 7 cities of Central China anonymously participated in the cross-sectional study. RESULTS: A total of 350 HCPs participated the study, 91 questionnaires uncompleted and 259 were analyzed. Among the respondents, 166 (64.1%) were doctors, 55 (21.2%) were nurses and 38 (14.7%) were medical students. The mean knowledge precision was 59.8%. HCPs agreed that drug induced immediate allergic reactions were IgE mediated (83.4%) and happened within 6 hours after drug administration (89.6%), and epinephrine was the first choice for drug induced anaphylaxis (79.5%). They also agreed that penicillin skin test was valuable to predict allergic reaction (88.4%). However, high proportion of HCPs (66.0%) believed glucocorticoids had an impact on drug skin test rather than antihistamines (4.2%), 47.1% never performed positive and negative control during skin test. More than 90% of the respondents would take patients' allergic history before drug administration, 98.8% agreed that they should receive advanced training of DA knowledge and practice. CONCLUSION: The HCPs demonstrated a low level of knowledge regarding DA. Advanced education is urgently needed for better understanding and filling the gaps exist in knowledge and clinical practice of DA.
Anaphylaxis ; Anonyms and Pseudonyms ; China ; Cross-Sectional Studies ; Delivery of Health Care ; Drug Hypersensitivity ; Education ; Epinephrine ; Glucocorticoids ; Histamine Antagonists ; Humans ; Hypersensitivity ; Immunoglobulin E ; Mortality ; Penicillins ; Skin Tests ; Students, Medical ; Surveys and Questionnaires