• 제목/요약/키워드: Adverse events

검색결과 997건 처리시간 0.022초

Infection prevention measures and outcomes for surgical patients during a COVID-19 outbreak in a tertiary hospital in Daegu, South Korea: a retrospective observational study

  • Kwak, Kyung-Hwa;Kim, Jay Kyoung;Kwon, Ki Tae;Yeo, Jinseok
    • Journal of Yeungnam Medical Science
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    • 제39권3호
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    • pp.223-229
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    • 2022
  • Background: The first large coronavirus disease 2019 (COVID-19) outbreak outside China occurred in Daegu. In response, we developed infection prevention measures for surgical patients during the outbreak at our hospital and retrospectively reviewed the outcomes of COVID-19-related surgical patients. Methods: We reviewed the medical records of 118 COVID-19-related surgical patients and monitored their clinical outcomes until March 31, 2021. We also interviewed healthcare workers who participated in their perioperative care at Kyungpook National University Chilgok Hospital. The perioperative management guidelines for COVID-19-related patients were prepared through multidisciplinary discussions, including the infection control department, surgical departments, and anesthesiology department before and during the COVID-19 outbreak. Results: One standard operating room was temporarily converted to a negative-pressure room by increasing the exhaust air volume, creating a relative pressure of -11.3 Pa. The healthcare workers were equipped with personal protective equipment according to the patient's classification of the risk of COVID-19 transmission. The 118 COVID-19-related patients underwent emergent surgery in the negative-pressure room, including three COVID-19-confirmed patients and five COVID-19-exposed patients. Conclusion: All surgeries of the COVID-19-related patients were performed without specific adverse events or perioperative COVID-19 transmission. Our experience setting up a negative-pressure operating room and conservative perioperative protocol to prevent COVID-19 transmission will help plan and execute infection control measures in the future.

비만의 펩타이드 치료제 (Peptides in Obesity Treatment)

  • 김경곤
    • 비만대사연구학술지
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    • 제1권1호
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    • pp.4-13
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    • 2022
  • Currently, pharmacotherapy is becoming essential for obesity, owing to its expanding and increasing epidemiology. In this review, novel peptide-based drugs of four classes are covered: GLP-1 receptor agonist, GIP/GLP-1 receptor dual agonist, glucagon/GLP-1 receptor dual agonist, and a combination of amylin receptor agonist/GLP-1 receptor agonist. Semaglutide is a next-generation GLP-1 receptor agonist with a longer duration and stronger weight and glucose reduction effects than liraglutide and dulaglutide. In the STEP1 trial, semaglutide 2.4 mg reduced body weight by approximately 15% in people with obesity with similar or milder adverse events than liraglutide 3.0 mg. Tirzepatide, a GIP/GLP-1 receptor dual agonist, also has a long duration and strong weight- and glucose-lowering effect. According to SURPASS-2, 3, and 4, in patients with BMI≥25 kg/m2 and type 2 diabetes mellitus (T2DM), tirzepatide 15 mg reduced the initial body weight by >13%. Cotadutide, a glucagon/GLP-1 receptor dual agonist, showed weaker weight-lowering effects than semaglutide and tirzepatide, while it was comparable to that of liraglutide in a phase 2 clinical trial for non-alcoholic fatty liver disease in patients with BMI≥25 kg/m2 and T2DM. Additionally, its effect on the liver was noticeable. The long-acting amylin receptor agonist cargrilintide combined with semaglutide can be another effective option for obesity treatment. Even in a small phase 1 trial with a short study period of 20 weeks, cargrilintide 2.4 mg/semaglutide 2.4 mg reduced by 17% of initial body weight in people with BMI 27-39.9 kg/m2. In coming several years, semaglutide, tirzepatide, and cargrilintide/semaglutide will become available for obesity treatment in Korea.

임상시험 대상자 모집 광고에 대한 정부의 규제 효과 (The Effect of Regulation on Recruitment Advertising for Clinical Trial Subjects in Korea)

  • 김현진;손현순
    • 한국임상약학회지
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    • 제32권3호
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    • pp.166-177
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    • 2022
  • Background: Recently clinical trials have expanded extensively in Korea; thus, ensuring the rights of subjects participating in clinical trials is imperative. Accordingly, national regulations on subject recruitment advertisement were enforced from October 25, 2018. In this study, the effect of this regulation was evaluated by analyzing the difference in the provision of information before and after enforcement of the regulation. Methods: Recruitment advertisements for clinical trial subjects 3 years before and after enforcement of the regulation were collated by the significance sampling approach. Print-based (newspapers, buses, and subways) and web-based (clinical trial center websites and online platforms) materials for recruitment in clinical trials of phase 1 to 4 for investigational drugs, medical devices, and oriental medicine were considered. Chi-square tests were conducted for inter-group comparisons. SPSS version 26 was employed for statistical analyses. Results: A total of 137 advertisements were collected comprising 60 pre- and 77 post-regulation enforcement. The overall rate of delivery of critical information in advertisements increased significantly from 47.5% before regulation to 93.2% after regulation enforcement. Particularly, details on expected adverse events augmented significantly (p<0.001). Benefits from participation in clinical trial reduced significantly from 88.3% to 70.1% (p<0.05). As the information provision amplified, the inclusion of professional terms increased. Conclusions: Enforcement of regulations has led to a surge in the amount of information and challenging terms contained in advertisements for recruiting subjects. Therefore, additional efforts are required by subjects to completely understand the information provided in the advertisements.

Potential Efficacy of Multiple-shot Long-pulsed 1,064-nm Nd:YAG in Nonablative Skin Rejuvenation: A Pilot Study

  • Kim, Young-Koo;Lee, Hae-Jin;Kim, Jihee
    • Medical Lasers
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    • 제9권2호
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    • pp.159-165
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    • 2020
  • Background and Objectives The ultimate goal in current skin rejuvenation practice is to achieve a good result with minimal pain and downtime. Nonablative skin rejuvenation (NSR) is one technique. The efficacy of the long-pulsed 1064 nm Nd:YAG laser (LPNDY) has not been assessed in NSR. Materials and Methods Three target areas were selected (bilateral cheeks and glabellar region) in six volunteer subjects. A LPNDY with an integral skin temperature monitor delivered three stacked shots to each target area (1064 nm, 12 mm spot, 13 J/cm2, 1 Hz) without any skin cooling or anesthesia. The skin temperature was recorded before, during, and after each set of shots using the system monitor and in real-time using a high-sensitivity (±0.001℃) near-infrared video camera. The skin reaction was observed with the naked eye, and pain and discomfort were assessed by the subjects during and after treatment. Results The subjects reported a mild feeling of heat with no discomfort during or after the test treatments. Mild erythema was observed around the treatment areas, without noticeable edema. A series of three ascending skin temperature stepwise peaks, with a decrease in skin temperature towards the baseline after the third shot, was observed consistently. The mean temperatures for shots 1, 2, and 3 for the cheeks were 39.5℃, 42.0℃, and 44.4℃, respectively, and for the glabella, 40.8℃, 43.9℃, and 46.2℃, respectively. Similar ranges were indicated on the system integral temperature monitor. Conclusion A set of three stacked pulses with the LPNDY at a low fluence achieved ideal dermal temperatures to achieve some dermal remodeling but without any downtime or adverse events. The temperature data from the integral thermal sensor matched the video camera measurements with practical accuracy for skin rejuvenation requirements. These data suggest that LPNDY would satisfy the necessary criteria to achieve effective NSR, but further studies will be needed to assess the actual results in clinical practice.

Low-level Laser Therapy with Novel Array of Light Source and Individualized Program for Treatment of Androgenetic Alopecia: A 16-week, Randomized, Double-blind, Sham Device-controlled Study

  • Kim, Jee-Woo;Kwon, Yeo-Seon;Chang, Yoon-Young;Hong, Sung-Ho;Shin, Jung-Won;Na, Jung-Im;Huh, Chang-Hun
    • Medical Lasers
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    • 제9권2호
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    • pp.150-158
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    • 2020
  • Background and Objectives Low-level laser therapy (LLLT) is used widely to promote hair growth in androgenetic alopecia (AGA). This study examined the clinical efficacy and safety of a home-use LLLT device with a newly designed array of light sources and software optimized for individual types of AGA. Materials and Methods The study was a randomized, double-blind, sham device-controlled trial. Forty-eight subjects (39 men and nine women) were assigned randomly in a 2:1 ratio to use either the test device (LG Pra'L HGN1, LG electronics, Korea) or sham device. The subjects used the LLLT device three times a week for 16 weeks. Phototrichogram was used to measure the hair density and hair thickness at 0, 8, and 16-weeks. Adverse events were closely monitored. Results After 16 weeks of using the device, the test group showed a significant increase in hair density and hair thickness compared to the control. In the test group, the hair density increased 6.96 counts/cm2 at eight weeks and 13.67 counts/cm2 at 16 weeks from the baseline. The hair thickness increased 7.21 ㎛ at eight weeks and 11.80 ㎛ at 16 weeks compared to the baseline. Conclusion The home-use LLLT device with a novel array of light sources and an individualized program according to the types of hair loss appears to be an effective and safe treatment modality for both male and female AGA patients.

항암화학요법 유발 말초신경병증에 대한 한방치험 1례 (Case Report of Chemotherapy-Induced Peripheral Neuropathy Treated with Korean Medicine)

  • 신혜령;서욱철;안성후;원진희;송봉근
    • 대한한방내과학회지
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    • 제42권2호
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    • pp.104-113
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    • 2021
  • Introduction: The aim of this study is to report on the effectiveness of Korean medicine to improve symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Some patients are treated with medication, but medications may have no effect in some patients. Korean medicine treatments have been used in such patients, but few reports exist. Case Presentation: A 58-year-old female patient with CIPN reported symptoms of bilateral limb pain and tingling sensations as well as cold sensations in bilateral lower legs and hands, fatigue, and bilateral limb weakness. To reduce the patient's symptoms, we provided Korean medical treatment, including herbal medicine (Uchashinki-hwan), acupuncture, and moxibation. To evaluate the results of this treatment, we used a numeric rating scale (NRS), the manual muscle test (MMT), the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), and the European Organization for Research and Treatment of Cancer quality-of-life questionnaire about CIPN (EORTC-QLQ-CIPN20). After 49 days of treatment, the NRS scores decreased for bilateral limb pain and tingling, for bilateral lower leg and hand cold sensation, and for fatigue. The MMT results for the upper and lower extremities were improved. CTCAE Grade and EORTC QLQ-CIPN20 score were also decreased. Conclusion: According to these results, Korean medicine treatment may be considered an effective treatment for CIPN. Prospective studies are needed in the future to confirm and expand these findings.

Association Between the Frailty Index and Clinical Outcomes after Coronary Artery Bypass Grafting

  • Kim, Chan Hyeong;Kang, Yoonjin;Kim, Ji Seong;Sohn, Suk Ho;Hwang, Ho Young
    • Journal of Chest Surgery
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    • 제55권3호
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    • pp.189-196
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    • 2022
  • Background: This study investigated the predictive value of the frailty index calculated using laboratory data and vital signs (FI-L) in patients who underwent coronary artery bypass grafting (CABG). Methods: This study included 508 patients (age 67.3±9.7 years, male 78.0%) who underwent CABG between 2018 and 2021. The FI-L, which estimates patients' frailty based on laboratory data and vital signs, was calculated as the ratio of variables outside the normal range for 32 preoperative parameters. The primary endpoints were operative and medium-term all-cause mortality. The secondary endpoints were early postoperative complications and major adverse cardiac and cerebrovascular events (MACCEs). Results: The mean FI-L was 20.9%±10.9%. The early mortality rate was 1.6% (n=8). Postoperative complications were atrial fibrillation (n=148, 29.1%), respiratory complications (n=38, 7.5%), and acute kidney injury (n=15, 3.0%). The 1- and 3-year survival rates were 96.0% and 88.7%, and the 1- and 3-year cumulative incidence rates of MACCEs were 4.87% and 8.98%. In multivariable analyses, the FI-L showed statistically significant associations with medium-term all-cause mortality (hazard ratio [HR], 1.042; 95% confidence interval [CI], 1.010-1.076), MACCEs (subdistribution HR, 1.054; 95% CI, 1.030-1.078), atrial fibrillation (odds ratio [OR], 1.02; 95% CI, 1.002-1.039), acute kidney injury (OR, 1.06; 95% CI, 1.014-1.108), and re-operation for bleeding (OR, 1.09; 95% CI, 1.032-1.152). The minimal p-value approach showed that 32% was the best cutoff for the FI-L as a predictor of all-cause mortality post-CABG. Conclusion: The FI-L was a significant prognostic factor related to all-cause mortality and postoperative complications in patients who underwent CABG.

Platelet-rich plasma versus corticosteroid injections for rotator cuff tendinopathy: a comparative study with up to 18-month follow-up

  • Annaniemi, Juho Aleksi;Pere, Juri;Giordano, Salvatore
    • Clinics in Shoulder and Elbow
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    • 제25권1호
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    • pp.28-35
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    • 2022
  • Background: Given the complications involved in corticosteroid (CS) injections, subacromial platelet-rich plasma (PRP) injections may provide a valid alternative to CS in the treatment of rotator cuff (RC) tendinopathy. Methods: We retrospectively reviewed a total of 98 patients affected by RC tendinopathy who were treated with either subacromial injection of PRP or CS. The PRP group received three injections of autologous PRP at 2 weeks interval, and the CS group received one injection of CS. The Western Ontario Rotator Cuff Index (WORC) was the primary outcome measure, while the secondary outcome measures were the visual analog scale (VAS), range of motion (ROM), and need for cuff repair surgery, which were analyzed at intervals of 6, 12, and 18 months. Results: A total of 75 patients were included in the analysis (PRP, n=35; CS, n=40). The mean follow-up for PRP was 21.1±8.7 months and for CS was 33.6±16.3 months (p<0.001). Both groups showed improvement in WORC, VAS, and ROM. No significant differences were detected between the two groups in any of the primary (WORC) or secondary outcomes over 6, 12, and 18 months (all p>0.05). No adverse events were detected. Conclusions: Both treatments improved patient symptoms, but neither resulted in a significantly better outcome in this series of patients. PRP can be a safe and feasible alternative to CS, even at long-term follow-up, to reduce local and systemic effects involved with CS injections.

The Impact of Fractional Flow Reserve on Clinical Outcomes after Coronary Artery Bypass Grafting: A Meta-analysis

  • Yoonjin, Kang;Heeju, Hong;Suk Ho, Sohn;Myoung-jin, Jang;Ho Young, Hwang
    • Journal of Chest Surgery
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    • 제55권6호
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    • pp.442-451
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    • 2022
  • Background: This meta-analysis was conducted to evaluate the effect of fractional flow reserve (FFR) on clinical outcomes after coronary artery bypass grafting (CABG). Methods: Five online databases were searched for studies that (1) enrolled patients who underwent isolated CABG or CABG with aortic valve replacement and (2) demonstrated the effect of an FFR-guided strategy on major adverse cardiac events (MACE) after surgery based on a randomized controlled trial or adjusted analysis. MACE included cardiac death, acute myocardial infarction (MI), and repeated revascularization. The primary outcomes were all MACE outcomes and a composite of all-cause death and MI, and the secondary outcomes were the individual MACE outcomes. Publication bias was assessed using a funnel plot and the Egger test. Results: Six articles (3 randomized and 3 non-randomized studies: n=1,027) were selected. MACE data were extracted from 4 studies. The pooled analyses showed that the risk of MACE was not significantly different between patients who underwent FFR-guided CABG and those who underwent angiography-guided CABG (hazard ratio [HR], 0.80; 95% CI, 0.57-1.12). However, the risk of the composite of death or MI was significantly lower in patients undergoing FFR-guided CABG (HR, 0.62; 95% CI, 0.41-0.94). The individual MACE outcomes were not significantly different between FFR-guided and angiography-guided CABG. Conclusion: FFR-guided CABG might be beneficial in terms of the composite outcome of death or MI compared with angiography-guided CABG although data are limited.

Outcomes of Urgent Interhospital Transportation for Extracorporeal Membrane Oxygenation Patients

  • Jun Tae, Yang;Hyoung Soo, Kim;Kun Il, Kim;Ho Hyun, Ko;Jung Hyun, Lim;Hong Kyu, Lee;Yong Joon, Ra
    • Journal of Chest Surgery
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    • 제55권6호
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    • pp.452-461
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    • 2022
  • Background: Extracorporeal membrane oxygenation (ECMO) can be used in patients with refractory cardiogenic shock or respiratory failure. In South Korea, the need for transporting ECMO patients is increasing. Nonetheless, information on urgent transportation and its outcomes is scant. Methods: In this retrospective review of 5 years of experience in ECMO transportation at a single center, the clinical outcomes of transported patients were compared with those of in-hospital patients. The effects of transportation and the relationship between insertion-departure time and survival were also analyzed. Results: There were 323 cases of in-hospital ECMO (in-hospital group) and 29 cases transferred to Hallym University Sacred Heart Hospital without adverse events (mobile group). The median transportation time was 95 minutes (interquartile range [IQR], 36.5-119.5 minutes), whereas the median transportation distance was 115 km (IQR, 15-115 km). Transportation itself was not an independent risk factor for 28-day mortality (odds ratio [OR], 0.818; IQR, 0.381-1.755; p=0.605), long-term mortality (OR, 1.099; IQR, 0.680-1.777; p=0.700), and failure of ECMO weaning (OR, 1.003; IQR, 0.467-2.152; p=0.995) or survival to discharge (OR, 0.732; IQR, 0.337-1.586; p=0.429). After adjustment for covariates, no significant difference in the ECMO insertion-departure time was found between the survival and mortality groups (p=0.435). Conclusion: The outcomes of urgent transportation, with active involvement of the ECMO center before ECMO insertion and adherence to the transport protocol, were comparable to those of in-hospital ECMO patients.