• Tuberculosis and Respiratory Diseases
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• v.73 no.2
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• pp.93-99
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• 2012

Background: Local adverse events associated with inhaled corticosteroid use, including dysphonia, pharyngitis and oral candidiasis, can affect adherence for treatment. 'Mouth rinsing method' has been used for reducing local adverse events, but it cannot ensure complete prevention. The goal of this pilot study was to identify whether the 'immediate diet method' can reduce local adverse events in a limited number of patients. Methods: The study was conducted in a total of 98 patients, who had been prescribed a medium-dose fluticasone propionate for the first time, from January to October in 2010. One training nurse had performed the education on how to use the inhaler, including the mouth rinsing method. And with follow-ups at one month intervals, any patient who experienced such adverse events were educated on the immediate diet method, having a meal within 5 minutes after using an inhaler and they were checked on any incurrence of adverse events with one month intervals for 2 months. Results: The mean age of patients was 65.9 years old. The local adverse events had incurred from 18.4% of the study subjects. When performed the follow-up observation in 18 patients with local adverse events after education on the immediate diet method, 14 patients (77.8%) had shown symptomatic improvements. Three of 4 patients did not show any improvement, in spite of implementing the immediate diet method. The other 1 patient did not practice the immediate diet method properly. Conclusion: The immediate diet method may be useful in reducing the local adverse events, caused by the use of inhaled corticosteroid.

• Clinical and Experimental Pediatrics
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• v.62 no.7
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• pp.269-273
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• 2019

Purpose: There is limited data on the use of perampanel in children under 12 years of age. We evaluated the efficacy and tolerability of adjunctive perampanel treatment in children under 12 years of age with refractory epilepsy. Methods: This retrospective observational study was performed in Kyungpook National University Hospital from July 2016 to March 2018. A responder was defined as a patient with ${\geq}50%$ reduction in monthly seizure frequency compared with the baseline. Adverse events and discontinuation data were obtained to evaluate tolerability. Results: Twenty-two patients (8 males, 14 females) aged 3.1-11.4 years (mean, $8.0{\pm}2.5years$) were included in this study. After an average of 9.2 months (range, 0.5-19 months) of follow-up, 15 patients (68%) showed a reduction in seizure frequency, including 5 patients (23%) with seizure freedom. The age at epilepsy onset was significantly lower (P=0.048), and the duration of epilepsy was significantly longer (P=0.019) in responders than in nonresponders. Nine patients (41%) experienced adverse events, including somnolence (23%), respiratory depression (9%), violence (4.5%), and seizure aggravation (4.5%). The most serious adverse event was respiratory depression, which required mechanical ventilation in 2 patients (9%). Eight patients (36%) discontinued perampanel due to lack of efficacy or adverse events. Three out of 4 patients (75%) who discontinued perampanel due to adverse events had an underlying medical condition. Conclusion: Perampanel offers a treatment option for refractory epilepsy in children. Adjunctive treatment with perampanel requires special consideration in those with underlying medical conditions to prevent serious adverse events.

• Journal of Dental Anesthesia and Pain Medicine
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• v.20 no.3
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• pp.107-118
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• 2020

Chloral hydrate is the oldest and most common sedative drug used in moderate sedation for pediatric dental patients. Hence, the purpose of this article is to review the safety and possible adverse events of this drug when used for pediatric dental treatment. A bibliographic search in PubMed, MEDLINE, Cochrane Library and KMbase, KISS, DBpia, KoreaMed, and RISS databases was performed. Using the keywords "dental sedation," "chloral hydrate," and "children or adolescent," 512 scientific articles were found. Subsequently, 183 studies were individually assessed for their suitability for inclusion in this literature review. Altogether, 24 studies were selected. They included 12 cases of death before, during, or after chloral hydrate sedation for dental treatment, majorly due to dosing error and use of multiple sedatives. Additionally, intraoperative adverse events were mostly respiratory problems such as hypoxia and apnea, but most events were temporary. After treatment, prolonged sedation, including excessive sleep and less activity were the most common postoperative adverse events, and even death cases were reported. Despite the wide acceptance of chloral hydrate as a sedative-hypnotic agent, the risk of adverse events and adequate dose should be of great concern when using it for pediatric dental sedation.

• International journal of thyroidology
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• v.11 no.2
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• pp.61-70
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• 2018

Tyrosine kinase inhibitors (TKIs) are widely used for the treatment of advanced radioiodine-refractory thyroid cancer. Although the previous studies including large-scale randomized controlled trials have demonstrated the effects of TKIs in advanced thyroid cancers, it has been found that most patients experienced adverse events (AEs). Unlike other cancers, even patients with advanced thyroid cancers are often asymptomatic. Rather, TKI use can make patients suffer adverse events. Therefore, the use of TKI should be decided after the full consideration of AEs as well as its efficacies. While using TKI, AEs should be monitored, evaluated, and managed appropriately, if AEs develop. In this review, the occurrence, evaluation, and management of AEs of sorafenib, lenvatinib, and vandetanib will be described, which TKIs are most commonly used for the treatment of advanced thyroid cancer. Some suggestions for the management of AEs in the real life are also provided.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.2
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• pp.697-702
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• 2016

Background: The Asia-Pacific Breast Initiatives (APBI) I and II registries were established to collect safety data for patients with early stage breast cancer receiving adjuvant docetaxel-based regimens in the Asia-Pacific region. Materials and Methods: Data from the two registries were combined to perform a safety analysis. Participants in the registry were women with early stage operable breast cancer with an intermediate or high risk of recurrence. These women received adjuvant chemotherapy that included docetaxel between 2006 and 2011. Adverse events (AEs) were recorded and analyzed. Results: Data were collected from 3,224 patients from 13 countries. The mean dose intensity of docetaxel was 24.1, 22.7, $25.1mg/m^2/week$ among patients receiving docetaxel-based monotherapy, combination therapy and sequential therapy, respectively. Granulocyte colony-stimulating factor (G-CSF) was given with docetaxel to 41.8% of women and 20.6% of women receiving prophylactic antibiotics. Adverse events were reported in 86% of patients (anthracycline-containing regimens vs. non-anthracycline regimens; 87% vs. 80%). The most common adverse events were alopecia, nausea, neutropenia, vomiting, and myalgia. Adverse events NCI CTCAE ${\geq}$Grade 3 were reported in 45.4% of patients. Serious adverse events were reported in 13% of patients, of which 2.5% led to study discontinuation. Forty-six deaths (1.4%) were reported, with no significant difference between regimens. Conclusions: The safety parameters of adjuvant docetaxel therapy used to treat sequential Asian women were comparable to those reported in clinical trials evaluating the role of adjuvant docetaxel. No unusual adverse events linked to Asia-Pacific region patients were observed.

• The Journal of Korean Medicine
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• v.42 no.1
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• pp.46-58
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• 2021

Objectives: The purpose of this study is to report weight changes and analyze adverse events in diabetic patients with Gamitaeeumjowee-Tang for weight loss. Methods: A retrospective chart review of weight change and adverse events was performed during the 10-week weight loss program using Gamitaeeumjowee-tang with low-calorie diets for diabetics(n=61). Weight and BMI changes were compared before and after the program and calculated the percentage of people who lost more than 5% of their weight, also identified whether subjects felt satiated or not. Adverse events were evaluated in terms of causality, severity and system-organ classes. Results: After 10-week weight loss program, significant weight loss (5.9±2.32kg, 7.73% reduction from baseline) and BMI reduction (2.9±0.86) were reported (n=61). Those who lost more than 5 percent of their body weight accounted for 88.5%, and also 88.5% of the participants felt full to help control their appetite. In assessing the causality of adverse events, 'Unlikely' was the most common (66%) and in severity evaluations, almost all symptoms were mild. Insomnia was the most frequently reported during the first 8 weeks, and constipation was reported the most afterwards. Conclusions: A combination of Gamitaeeumjowee-tang and low-calorie diets for 10 weeks appears to help weight reduction without serious adverse events in diabetic patients. Future well-designed prospective clinical studies testing the effectiveness and safety of this weight loss program are warranted.

• Journal of Acupuncture Research
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• v.31 no.4
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• pp.71-79
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• 2014

Objectives : The aim of this study is to evaluate the safety of acupuncture therapy when applied to patients who are undergoing anticoagulants / antiplatelet medication therapy combined with herbal medicine using a retrospective, case-control study. Methods : 428 charts of patients were reviewed in this study. Odds ratio between case of bleeding-related adverse event and control was calculated as main analysis. Exposures were anticoagulants / antiplatelet medication, Hwalhyeolgeoeo herbal medicine and combination of both drugs. Additionally, odds ratios were calculated according to the severity of bleeding-related adverse events. Results : The results were as following: 1. Analysis of all bleeding-related adverse events showed there was no increased risk of combined therapy compared with other exposures and control group. 2. Analysis of only clinically significant adverse events showed there was no increased risk of combined therapy compared with other exposure and control group. 3. Hwalhyeolgeoeo herbal medicine group showed a tendency of increased risk of bleeding-related adverse events in all analysis but was not statistically significant. Conclusions : The results suggest that Hwalhyeolgeoeo herbal medicine-anticoagulant / antiplatelet medication combined therapy may not increase risk of bleeding-related adverse events in acupuncture therapy. By executing various modules of analysis, it was possible to acquire useful data for possible future studies. Further research is needed to confirm such results.

• Journal of Preventive Medicine and Public Health
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• v.48 no.5
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• pp.239-248
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• 2015

Objectives: The purpose of this study was to assess the inter-rater reliability and intra-rater reliability of medical record review for the detection of hospital adverse events. Methods: We conducted two stages retrospective medical records review of a random sample of 96 patients from one acute-care general hospital. The first stage was an explicit patient record review by two nurses to detect the presence of 41 screening criteria (SC). The second stage was an implicit structured review by two physicians to identify the occurrence of adverse events from the positive cases on the SC. The inter-rater reliability of two nurses and that of two physicians were assessed. The intra-rater reliability was also evaluated by using test-retest method at approximately two weeks later. Results: In 84.2% of the patient medical records, the nurses agreed as to the necessity for the second stage review (kappa, 0.68; 95% confidence interval [CI], 0.54 to 0.83). In 93.0% of the patient medical records screened by nurses, the physicians agreed about the absence or presence of adverse events (kappa, 0.71; 95% CI, 0.44 to 0.97). When assessing intra-rater reliability, the kappa indices of two nurses were 0.54 (95% CI, 0.31 to 0.77) and 0.67 (95% CI, 0.47 to 0.87), whereas those of two physicians were 0.87 (95% CI, 0.62 to 1.00) and 0.37 (95% CI, -0.16 to 0.89). Conclusions: In this study, the medical record review for detecting adverse events showed intermediate to good level of inter-rater and intra-rater reliability. Well organized training program for reviewers and clearly defining SC are required to get more reliable results in the hospital adverse event study.

• Journal of Acupuncture Research
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• v.25 no.1
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• pp.199-209
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• 2008

Objectives : To explore the adverse events and safety following facial cosmetic acupuncture treatment (Miso-Acupuncture). Subjects and methods : This study was a retrospective survey of practitioner's reports. The practitioners worked as facial cosmetic acupuncturists, gave informed consent, and completed a case report form between July and November of 2007. On this form, practitioners were asked to report the degree of adverse events relating to the Miso-Acupuncture, the total safety of the treatment, and reasons patients gave for quitting treatment. The practitioners in this study were all Oriental Medicine Doctors(OMD) who had trained at the Miso-Acupuncture Academy for 40 hours we received 23 final report cases. Results : In this study, adverse events following Miso-Acupuncture treatment were mild bruising(15 ; 65.2%), bleeding(12 ; 52.2%), pain(8 ; 34.8%), fatigue(7 ; 30.4%), headache(5 ; 21.7%), and others(10 ; 43.5%). The average degree of adverse events was between mild and moderate, which needs no extra treatment. The total safety of treatment for 16 weeks was between safe and nearly safe, and there was no need to quit treatment in spite of mild adverse events. Eight patients(34.8%) quit treatment, almost all for personal reasons unrelated to the Miso-Acupuncture. Conclusions : These results suggest that the Miso-Acupuncture has no serious adverse events and is a relatively safe treatment.

• Journal of The Korean Dental Society of Anesthesiology
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• v.11 no.1
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• pp.22-26
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• 2011

Background: There is controversy regarding the relative perioperative benefits of desflurane when used for induction of anesthesia. Inhalation induction with desflurane alone causes adverse airway events, such as coughing, bronchospasm, laryngospasm, and copious secretion of varying severity. The aim of this study was to determine whether desflurane minimize cardiovascular activation during induction. Methods: Sixty ASA I and II patients were randomized to receive 1 MAC or 1.5 MAC of desflurane during manual vernilation or not. Patients received propofol (2 mg/kg) to induce loss of consciousness (LOC). Rocuronium (0.8 mg/kg) was given at LOC and the trachea was intubated after 90 seconds of manual breathing support with or without inhaled anesthetics. Vital signs and adverse airway events were recorded until 10 minutes post-intubation. Results: A significant increase in blood pressure and heart rate were seen in no desflurane group. The stable vital signs were seen in desflurane groups. The adverse airway events were increased in 1.5 MAC group but 1 MAC group. Conclusions: Desflurane was able to be stable blood pressure and heart rate at 1 MAC but adverse airway events were increased at 1.5 MAC of desflurane.