• Clinics in Shoulder and Elbow
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• v.18 no.4
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• pp.237-241
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• 2015

Background: We investigated the effectiveness of pain management and the adverse events of intravenous (IV) patient-controlled analgesia (PCA) after orthopedic surgery. Methods: From September 2014 and August 2015, we performed a retrospective analysis of 77 patients who underwent orthopedic surgery of the shoulder or the elbow in our hospital. The composition of the intravenous PCA administered to the patients was as follows: 250 mg of dexketoprofen trametamol, 70 mg of oxycodone, and 0.6 mg of ramosetron, which were made up to 79 ml of normal saline. We evaluated and statistically analyzed the difference in the visual analogue scale (VAS) scores for pain at immediate postoperation, at 24 hours of PCA, at 72 hours of PCA, and after discontinuation of PCA and in the incidence of adverse events. Results: We found that VAS score decreased for 3 postoperative days and that with discontinuation of IV PCA a meaningful change in VAS score was no longer seen. Of the 77 patients, 22 presented with adverse events (28.6%). We terminated IV PCA temporarily in the 21 patients who presented with adverse events; we terminated analgesia permanently in one patient (1.2%). Consequently, 76 of 77 patients carried out IV PCA till the designated period. Conclusions: Intravenous PCA after orthopedic surgery of the shoulder or the elbow may be accompanied with adverse events. Careful assessment of the patient and treatment of the adverse outcomes are key to a successful maintenance of PCA and to a successful management of postoperative pain.

• Journal of Chest Surgery
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• v.56 no.6
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• pp.394-402
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• 2023

Background: The optimal choice of valve substitute for aortic valve replacement (AVR) in pediatric patients remains a matter of debate. This study investigated the outcomes following AVR using mechanical prostheses in children. Methods: Forty-four patients younger than 15 years who underwent mechanical AVR from March 1990 through March 2023 were included. The outcomes of interest were death or transplantation, hemorrhagic or thromboembolic events, and reoperation after mechanical AVR. Adverse events included any death, transplant, aortic valve reoperation, and major thromboembolic or hemorrhagic event. Results: The median age and weight at AVR were 139 months and 32 kg, respectively. The median follow-up duration was 56 months. The most commonly used valve size was 21 mm (14 [31.8%]). There were 2 in-hospital deaths, 1 in-hospital transplant, and 1 late death. The overall survival rates at 1 and 10 years post-AVR were 92.9% and 90.0%, respectively. Aortic valve reoperation was required in 4 patients at a median of 70 months post-AVR. No major hemorrhagic or thromboembolic events occurred. The 5- and 10-year adverse event-free survival rates were 81.8% and 72.2%, respectively. In univariable analysis, younger age, longer cardiopulmonary bypass time, and smaller valve size were associated with adverse events. The cut-off values for age and prosthetic valve size to minimize the risk of adverse events were 71 months and 20 mm, respectively. Conclusion: Mechanical AVR could be performed safely in children. Younger age, longer cardiopulmonary bypass time and smaller valve size were associated with adverse events. Thromboembolic or hemorrhagic complications might rarely occur.

• Annals of Clinical Neurophysiology
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• v.8 no.1
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• pp.48-52
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• 2006

Background: Intravenous immunoglobulin (IVIg) has been administered for various immune-mediated neurological diseases such as autoimmune neuropathy, inflammatory myopathies, and other autoimmune neuromuscular disorders. The purpose of this study is to investigate side effects and complications of IVIg therapy in neuromuscular disorders. Methods: We enrolled 29 patients (age 8~63 years) with IVIg therapy for various neurological diseases including Guillain-Barre syndrome, myasthenia gravis, dermatomyositis, polymyositis, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy. IVIg therapy was used at a dose of 0.4 g/kg body weight/day for 5 consecutive days. Results: 10 patients (34%) had adverse events. There are adverse events in 16 courses (11%) among total 145 courses. The majority of patients presented with mild side effects, mostly asymptomatic laboratory changes. Rash or mild headache occurred in 3 patients. One patient showed a serious side effect of deep vein thrombosis. Conclusions: IVIg therapy is safe for a variety of immune-mediated neurological diseases in our study.

• Quality Improvement in Health Care
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• v.21 no.1
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• pp.66-76
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• 2015

Objectives: The purpose of this study is to develop a case review form for detecting adverse events through a medical records review in hospitalized patients in South Korea. Methods: To develop the case review form, several literatures were reviewed, first. Through the clinical expert meeting, screening criteria were selected and case review form was developed. Result: The Korean version of case review form consisted of the review form-1 for adverse event screening and form-2 for adverse event identification. The applied methodology for the case review form is determined according to the previous studies. For example, the method used in the first stage review is nurse review. Furthermore, the National Coordinating Council for Medication Errors Reporting and Prevention index is used to categorize disability, and a scale of 1 to 6 was used in the causation scores and preventability scores, respectively. Through the clinical expert meeting, a total of 41 screening criteria were selected. Conclusion: The Korean specific case review form was developed for detecting adverse events in hospitalized patients. The results from this study can be used in a large-scale study regarding the nationwide incidence of adverse events.

• Pediatric Infection and Vaccine
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• v.7 no.2
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• pp.183-192
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• 2000

Purpose : Adverse events(AE) associated with vaccination have not been systematically monitored in Korea. But since 1994, several deaths after inactivated mouse brain derived Japanese encephalitis vaccine injection arouse the safety problem of immunization in the public, and a evaluation of vaccination program including the effectiveness and safety problem had been started. We have been using MMR vaccine containing Japanese mumps vaccine strains, which are known to be associated with the high rate of adverse events including aseptic meningitis, for the last decade. Methods : We conducted a prospective study of vaccine adverse events associated with MMR vaccine through a tracking system using telephone calls. We followed up 7,594 cases of MMR vaccinees. Results : Reported adverse events included fever, couvulsion, parotitis, and aseptic meningitis. Nine cases of parotitis and seven cases of aseptic meningitis were recognized during follow up period. The incidence of both parotitis and aeptic meningitis was $85.1/10^5$, for Urabe mumps strain. For Hoshino strain, the incidence of parotitis and aseptic meningitis was $158.0/10^5$ and $94.8/10^5$, respectively. Conclusions : The incidence of adverse events was to be a higher than that of natural infection in Korea and was comparable to the results of studies done in other countries.

• Journal of Veterinary Clinics
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• v.36 no.1
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• pp.30-37
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• 2019

The purpose of this present study was to objectively evaluate gastrointestinal and bone marrow AEs after administration of various chemotherapeutic agents in canines with malignant tumors, using the Veterinary Cooperative Oncology Group-Common Terminology Criteria for Adverse Events (VCOG-CTCAE), which includes descriptive terminology used for adverse events (AEs) reported in dogs and cats. The medical records of 42 dogs with malignant tumor that underwent chemotherapy were reviewed retrospectively. There were no significant differences in the prevalence of gastrointestinal AEs among the 5 chemotherapeutic agents (vincristine, cyclophosphamide, doxorubicin, lomistine, and carboplatin). The prevalence of bone marrow AEs was significantly higher after administration of lomustine than after administration of vincristine or doxorubicin. Grade 1 AEs of the gastrointestinal tract and bone marrow were most often observed after administration of various chemotherapeutic agents. Delayed and cumulative myelosuppression of lomustine in some dogs receiving regular blood examination were identified. The findings of this study will help predict possible gastrointestinal and bone marrow AEs due to the use of chemotherapeutic agents to treat canines with malignant tumors.

• Journal of Korean Medicine for Obesity Research
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• v.21 no.2
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• pp.95-104
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• 2021

Objectives: The purpose of this study is to analyze the adverse events and safety of Mahuang used as anti-obesity treatment in Korean medicine. Methods: PubMed, EMBASE, Cochrane, KoreaMed, Oriental Medicine Advanced Searching Integrated System (OASIS) and SCIENCE-ON were used as searching for randomized controlled trials investigating the safety of Mahuang for treating obesity from January, 2000 to July, 2021. Results: Total 6 studies were included for analyzing. In most studies, heart rate was higher in experimental group than in placebo group with statistically significant difference. Both systolic and diastolic blood pressure had no significant differences between both groups, but systolic blood pressure got lower in experimental group. Most adverse events reported in experimental group were dry mouth, constipation, diarrhea, palpitation and insomnia, but serious adverse events were not reported. Conclusions: This study provides the evidence about the safety of Mahuang for treating obesity. However, increase of heart rate and minor adverse events could be occurred. Further study is needed to confirm the safety of Mahuang.

• Journal of Chest Surgery
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• v.49 no.3
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• pp.171-176
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• 2016

Background: A previous percutaneous coronary intervention (PCI) may affect the outcomes of patients who undergo coronary artery bypass grafting (CABG). The objective of this study was to compare the early in-hospital postoperative outcomes between patients who underwent CABG with or without previous PCI. Methods: The present study included 160 patients who underwent isolated elective on-pump CABG at the department of cardiothoracic surgery, Minia University Hospital from January 2010 to December 2014. Patients who previously underwent PCI (n=38) were compared to patients who did not (n=122). Preoperative, operative, and early in-hospital postoperative data were analyzed. The end points of the study were in-hospital mortality and postoperative major adverse events. Results: Non-significant differences were found between the study groups regarding preoperative demographic data, risk factors, left ventricular ejection fraction, New York Heart Association class, EuroSCORE, the presence of left main disease, reoperation for bleeding, postoperative acute myocardial infarction, a neurological deficit, need for renal dialysis, hospital stay, and in-hospital mortality. The average time from PCI to CABG was $13.9{\pm}5.4$ years. The previous PCI group exhibited a significantly larger proportion of patients who experienced in-hospital major adverse events (15.8% vs. 2.5%, p=0.002). On multivariate analysis, only previous PCI was found to be a significant predictor of major adverse events (odds ratio, 0.16; 95% confidence interval, 0.03 to 0.71; p=0.01). Conclusion: Previous PCI was found to have a significant effect on the incidence of early major adverse events after CABG. Further large-scale and long-term studies are recommended.

• Journal of Korean Medicine for Obesity Research
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• v.22 no.2
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• pp.136-146
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• 2022

Objectives: The objective of this study is to evaluate weight change and analyze adverse events in overweight and obese women with polycystic ovary syndrome (PCOS) who were prescribed with Gamitaeeumjowee-tang. Methods: A retrospective chart review was conducted for medical records of patients with PCOS, who were administered with Gamitaeeumjowee-tang for a period of 12 weeks between January 2019 and December 2021. Outcomes were total weight loss/weight loss rate, the percentage of patients who lost more than 5% and 10% of their baseline weight. Adverse events (AEs) reported by patients were evaluated by severity, causality and system-organ classes. Results: A total of sixty-seven patients were included (mean±standard deviation, Age 28.78±5.25 years, weight 76.78±12.84 kg, body mass index 29.2±4.26 kg/m²). The average total weight loss in PCOS patients was 6.57±3.07 kg and the average weight loss rate was 8.55±3.65%. The percentage of patients with more than 5% and 10% weight loss compared to their baseline weight was 86.56% and 25.37% respectively. The analysis of adverse events are as follows: Causality assessment with World Health Organization-Uppsala Monitoring Centre of AEs showed 'Unlikely' was the most common (71.7%) and severity evaluations with Common Terminology Criteria for Adverse Events showed almost all symptoms were mild (98.9%). Conclusions: Gamitaeeumjowee-tang helps to lose weight of PCOS patients, which is overweight or obese, and no serious adverse events have occurred. Additional well-designed clinical studies are recommended.

• The Journal of Korean Medicine
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• v.43 no.3
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• pp.65-78
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• 2022

Objectives: The purpose of this study is to analyze the weight loss and the adverse events of overweight and obese adults on weight loss program with face-to-face treatment (FTF) and non-face-to-face treatment (NFTF) in 6 Korean Medicine obesity clinics. Methods: From March 2nd to March 10th, 2021, we collected data with a retrospective way from overweight and obese adults (body mass index, BMI≥23 kg/m²) who registered for a 12-week Gamitaeeumjowi-tang prescription program. After matching initial information of the FTF group and the NFTF group using propensity matching score, weight loss and BMI change were analyzed, and adverse events were evaluated in terms of causality, severity and system-organ classes. Results: Weight and BMI change from baseline to 12 weeks was -7.98±3.09kg (10.41±3.57%), -3.03±1.14kg/m² and -7.30±3.11kg (9.59±3.45%), -2.76±1.15kg/m² for FTF group and NFTF group, respectively. Body weight and BMI significantly decreased before and after treatment in both groups, and there was no significant difference in weight loss and BMI change between the two groups. No serious adverse events were reported. Conclusions: This study showed the potential that NFTF weight management treatment could be a good alternative way to FTF weight management treatment without serious adverse events.