• Korean Journal of Clinical Pharmacy
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• v.33 no.2
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• pp.128-134
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• 2023

Background: This systematic review and meta-analysis aimed to evaluate the efficacy and cardiovascular safety of romosozumab compared with placebo. Methods: Randomized controlled trials (RCTs) were searched from Medline, EMBASE, Cochrane Central, and Web of Science until July 2022. Primary outcomes included the change in bone mineral density (BMD) from baseline at month 6. The secondary outcomes were the change of bone turnover markers (N-terminal propeptide of type 1 procollagen (P1NP); C-terminal telopeptide of type 1 collagen (CTX)) from baseline at month 3, and the incidence of cardiovascular adverse events for the total follow-up period. Results: A total of 7 RCTs on 8,370patients were included. Romosozumab showed better effects in improving BMD in both lumbar spine and femoral neck at month 6 (standardized mean difference, SMD 2.20 [95% CI: 1.89-2.52], SMD 0.63 [95% CI: 0.41-0.86]). In contrast to placebo, romosozumab significantly increased PINP levels and reduced CTX levels at month 3 (SMD 0.93 [95% CI: 0.65-1.22], SMD -1.03 [95% CI: -1.23~ -0.82]. However, there was no significant difference in the composite incidence of cardiovascular adverse events and major adverse cardiovascular events (OR 1.16 [95% CI: 0.82-1.65], OR 1.08 [95% CI: 0.75-1.56]). Conclusion: This analysis showed that romosozumab significantly improved BMD compared to placebo and was beneficial for change in bone turnover markers. There is no significant difference in the incidence of cardiovascular adverse events compared to placebo.

• Journal of Korean Medicine for Obesity Research
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• v.23 no.2
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• pp.78-85
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• 2023

Objectives: Weight gain is one of the symptoms of hypothyroidism and it could deteriorate thyroid function. Our objectives are to evaluate weight changes and analyze adverse events in overweight and obese women with hypothyroidism who were prescribed Gamitaeeumjowee-tang. Methods: A retrospective chart review was conducted using medical records of patients with hypothyroidism, who had body mass indexes (BMI) above 23 and were prescribed Gamitaeeumjowee-tang for 12 weeks between August 2017 and November 2022. Reported adverse events (AEs) were assessed by severity, causality and system-organ classes. Results: Thirty patients were included (mean±standard deviation, age 46.10±9.94 years, weight 70.52±11.18 kg, BMI 28.30±3.80 kg/m²). The mean total weight loss of hypothyroidism patients was 5.45±2.77 kg, while the mean weight loss rate and mean BMI change were 7.66±3.41% and 2.18±1.07 kg/m², respectively. Among evaluated causality of adverse events, 'Unlikely' was predominant (80.8%) and severity assessment showed most of the symptoms were mild (91.7%). Conclusions: Gamitaeeumjowee-tang could be an option for hypothyroidism patients, who are overweight or obese, to lose weight and no serious adverse events occurred. Further well-designed clinical studies are recommended.

• The Journal of Korean Medicine
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• v.45 no.1
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• pp.65-79
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• 2024

Objectives: The purpose of this study is to evaluate weight change and analyze adverse events in post-menopausal obese women with Gamitaeeumjowee-tang for weight loss. Methods: A retrospective chart review was conducted for medical records of 115 post-menopausal obese women (body mass index, BMI≥25 kg/m²) who were administered with Gamitaeeumjowee-tang for 12 weeks for the purpose of weight loss. Weight, skeletal muscle ratio and BMI changes were compared before and after the program. Adverse events were evaluated by causality, severity and system-organ classes. Results: A total of 115 patients were included in this study. The average total weight loss in post-menopausal women was 5.72±2.04kg(p<0.001) and the average weight loss rate was 8.06±2.70%(p<0.001). After the 12-week program, the body fat rate was significantly decreased(3.76±2.20%)(p<0.001) and the skeletal muscle ratio was significantly increased(2.07±1.24%)(p<0.001). There were no significant differences in weight loss, skeletal muscle ratio change and body fat rate change depending on the number of hospital visits. Insomnia was frequently reported throughout the period, and no serious adverse events were reported. Conclusions: This study showed the potential that weight management treatment with Gamitaeeumjowee-tang could be a good way to lose weight of post-menopausal obese women without serious adverse events. Continuous well designed clinical studies are needed.

• Journal of Korean Medicine for Obesity Research
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• v.24 no.1
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• pp.54-67
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• 2024

Objectives: The purpose of this study was to evaluate changes in body weight and blood pressure and also analyze adverse events after weight loss program using Gamitaeeumjowee-tang in patients with class II or III obesity, considering for metabolic and bariatric surgery. Methods: A retrospective chart review was conducted on class III obesity or class II obesity patients with comorbidities, who participated in 24-week weight loss program using Gamitaeeumjowee-tang (n=54). The analysis included changes in body weight, body mass index, fat mass, skeletal muscle mass, waist-hip ratio and blood pressure before and after the program. And also calculated the proportion of patients who lost more than 5%, 10%, and 15% of their initial weight. Adverse events were assessed by causality, severity and system-organ classes. Results: After the weight loss program, body weight decreased 12.21±6.43 kg (12.77%), and BMI decreased 4.61±2.25 kg/m² (12.75%) on average (P<0.05). The 90.7% of the subjects lost more than 5% of their weight, 68.5% lost more than 10%, and 35.1% lost more than 15% of their weight. Blood pressure significantly decreased 11.04±14.53 mmHg in systolic and 7.28±11.89 mmHg in diastolic on average (P<0.05). The 97% of adverse events were mild, and 75% were evaluated as 'unlikely' in the causality evaluation. Conclusions: The results of this study, the weight loss program using Gamitaeeumjowee-tang showed significant weight loss and blood pressure reduction in patients with class III obesity or class II obesity with comorbidities, without serious adverse events. Well-designed clinical studies are recommended for the future.

• Clinical Endoscopy
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• v.55 no.1
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• pp.77-85
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• 2022

Background/Aims: Endoscopic submucosal dissection (ESD) of gastric tumors in the mid-to-upper stomach is a technically challenging procedure. This study compared the therapeutic outcomes and adverse events of ESD of tumors in the mid-to-upper stomach performed under general anesthesia (GA) or monitored anesthesia care (MAC). Methods: Between 2012 and 2018, 674 patients underwent ESD for gastric tumors in the midbody, high body, fundus, or cardia (100 patients received GA; 574 received MAC). The outcomes of the propensity score (PS)-matched (1:1) patients receiving either GA or MAC were analyzed. Results: The PS matching identified 94 patients who received GA and 94 patients who received MAC. Both groups showed high rates of en bloc resection (GA, 95.7%; MAC, 97.9%; p=0.68) and complete resection (GA, 81.9%; MAC, 84.0%; p=0.14). There were no significant differences between the rates of adverse events (GA, 16.0%; MAC, 8.5%; p=0.18) in the anesthetic groups. Logistic regression analysis indicated that the method of anesthesia did not affect the rates of complete resection or adverse events. Conclusions: ESD of tumors in the mid-to-upper stomach at our high-volume center had good outcomes, regardless of the method of anesthesia. Our results demonstrate no differences between the efficacies and safety of ESD performed under MAC and GA.

• Korean Medical Education Review
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• v.22 no.1
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• pp.32-45
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• 2020

This narrative review introduces global trends in pharmacovigilance (PV) education for healthcare professionals and the status of PV education in Korea. Proactive participation of healthcare professionals, including physicians, pharmacists, and nurses in reporting suspected adverse events is the main driving force for effective operation of the spontaneous adverse event reporting system database, which in turn facilitates early safety signal detection of otherwise unknown suspected adverse events. The World Health Organization recognizes PV education curriculum as a key aspect in promoting awareness of PV and adverse event reporting among healthcare professionals, and multiple studies have demonstrated that PV educational interventions for healthcare professionals have increased overall adverse event reporting. Considering the global trends in PV education, the curriculum in Korean universities still has room for improvement in promoting PV obligation among future healthcare professionals. Further research is needed to develop PV education curriculum. We suggest a three-step project for innovating PV education in Korea to meet the global PV educational standards: a survey to gauge current PV competencies among healthcare professionals, reform of current PV academic curriculum, and evaluation and fine-tuning of the reformed curriculum.

• Korean Journal of Clinical Pharmacy
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• v.34 no.1
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• pp.71-78
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• 2024

Background: Oral cancer drugs, particularly tyrosine kinase inhibitors (TKIs), are increasingly popular due to their convenience. However, they pose challenges like drug interactions, especially with medications like azole antifungals. While the FDA provides some guidance, more detailed information is needed to manage these interactions effectively. A meta-analysis was conducted to understand the impact of interactions between TKIs and azole antifungals on adverse events during clinical studies. Methods: A meta-analysis followed PRISMA guidelines. Data from PubMed, EMBASE, and references were searched until November 30, 2021. Inclusion criteria encompassed studies on TKI-antifungal interactions in English. Study selection and quality assessment were conducted by two independent investigators. Results: Out of 158 articles, 11 were selected for analysis. Combination therapy showed a slight increase in adverse events but was not statistically significant (OR 1.02, 95% CI 0.49-2.13, p=0.95). AUC and Cmax fold changes did not significantly impact adverse event development. Both itraconazole and ketoconazole showed no significant difference in adverse event development compared to TKI alone. Conclusions: Study finds TKI-DDI not significantly linked to AE increase; azole antifungal types not related to AE. Future DDI research crucial for drug development.

• Korean Journal of Acupuncture
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• v.25 no.2
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• pp.95-105
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• 2008

Objectives : This study is to establish the appropriate assessment of causalities from adverse events (AEs) which are related to acupuncture treatment. Methods : We assessed thirty AEs which were caused in the early phase trial on concomitant use of acupuncture and herbal medicines. We scored each AE on the questionnaire in Naranjo and SNU algorithm scale which are for drug causality assessment in pharmacoepidemiology. Results : In Naranjo scale, there were consistencies among the evaluators qualitatively with "Probable", "Possible" degree. In reliability test, parameters, such as, gamma and kendall's tau-b revealed the degrees of 73%, and 32%, respectively. There were disaccordant tendency in SNU algorithm scale. Conclusion : A new algorithm which reflects acupuncture properties should be developed and elucidated.

• Korean Journal of Clinical Pharmacy
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• v.15 no.2
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• pp.94-99
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• 2005

The aim of this study was to evaluate the safety and efficacy of treatment of mesoglycan. This study was conducted between September 2003 and May 2004. A total of 292 patients with vascular disorders including cerebral infarction were enrolled. The patients were administered with 50-100mg of mesoglycan by an oral route everyday for eight weeks. Subjective physicians' assessments of efficacy had ratings of 'improvement', 'invariability', 'exacerbation' and 'not being able to assess'. An improvement was observed in 241 patients out of 274; 18 patients were rules out. The efficacy rate was influenced statistically significantly by the duration of therapy (p=0.0392) and daily mean drug dose (p<0.0001). The adverse events were reported in 8 patients (9 cases) out of 292 patients: skin/appendages disorders (0.7%), liver/biliary system disorders (0.7%), cardiovascular system disorders (0.7%), neurologic disorders (0.3%). respiratory disorders (0.3%) and gastrointestinal system disorders (0.3%). There showed no serious adverse events. These results indicate that mesoglycan was well tolerated and effective for the prevention of vascular disorders.

• Industrial Engineering and Management Systems
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• v.8 no.1
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• pp.37-46
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• 2009

Patient safety has become a growing concern in health care. The U.S. Institute of Medicine (IOM) report "To Err Is Human: Building a Safer Health System" in 1999 included estimations that medical error is the eighth leading cause of death in the United States and results in up to 100,000 deaths annually. However, many adverse events and errors occur in surgical practice. Within all kinds of surgical adverse events, wrong-side/wrong-site, wrong-procedure, and wrong-patient adverse events are the most devastating, unacceptable, and often result in litigation. Much literature claims that systems must be put in place to render it essentially impossible or at least extremely difficult for human error to cause harm to patients. Hence, this research aims to develop a prototype system based on active RFID that detects and prevents errors in the OR. To fully comprehend the operating room (OR) process, multiple rounds of on site discussions were conducted. IDEF0 models were subsequently constructed for identifying the opportunity of improvement and performing before-after analysis. Based on the analysis, the architecture of the proposed RFID-based OR system was developed. An on-site survey conducted subsequently for better understanding the hardware requirement will then be illustrated. Finally, an RFID-enhanced system based on both the proposed architecture and test results was developed for gaining better control and improving the safety level of the surgical operations.