• Title/Summary/Keyword: Clinical safety

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Delphi Survey for COVID-19 Vaccination in Korean Children Between 5 and 11 Years Old (국내 5-11세 소아의 코로나19 백신 접종에 대한 델파이 연구)

  • Choe, Young June;Lee, Young Hwa;Choi, Jae Hong
    • Pediatric Infection and Vaccine
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    • v.29 no.1
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    • pp.37-45
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    • 2022
  • Purpose: During the coronavirus disease 2019 (COVID-19) pandemic, we conducted a Delphi survey that included the experts from the field of COVID-19 immunization in children aged 5-11 years. The aim was to organize collective expert opinions on COVID-19 vaccination in young children in the Republic of Korea, and so thus assist the vaccination policy. Methods: The panels included pediatric infectious disease specialists, preventive medicine experts, infectious disease physicians, and COVID-19 vaccine experts consulting the Ministry of Health and Welfare. The Delphi survey was conducted online using a questionnaire from February 14 to February 27, 2022. Results: The Delphi panels agreed that children were vulnerable to COVID-19, and the severity of illness was modest. Furthermore the panels reported that children with chronic illness were more susceptible to a worsening clinical course. There were generally positive opinions on the effectiveness of COVID-19 vaccination in children aged 5-11 years, and experts gathered a slightly positive opinion that the adverse events of pediatric COVID-19 were not numerous. The benefits of COVID-19 vaccination were evaluated at a level similar to the potential risks in children. Currently, the only approved mRNA platform vaccine in children seemed to be sustainable; however, the recombinant protein platform COVID-19 vaccines were evaluated as better options. Conclusions: Due to the surge of the Omicron variant and an increase in pediatric cases, the COVID-19 vaccination in young children may have to be considered. Panels had neutral opinions regarding the COVID-19 vaccination in children aged 5-11 years. Thus monitoring of the epidemiology and the data about the safety of COVID-19 vaccination should be continued.

Optimal Duration of Dual Antiplatelet Therapy after Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms : A Prospective Randomized Multicenter Trial

  • Ban, Seung Pil;Kwon, O-Ki;Kim, Young Deok;Kim, Bum-Tae;Oh, Jae Sang;Kim, Kang Min;Kim, Chang Hyeun;Kim, Chang-Hyun;Choi, Jai Ho;Kim, Young Woo;Lim, Yong Cheol;Byoun, Hyoung Soo;Park, Sukh Que;Chung, Joonho;Park, Keun Young;Park, Jung Cheol;Kwon, Hyon-Jo;Korean NeuroEndovascular Society,
    • Journal of Korean Neurosurgical Society
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    • v.65 no.6
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    • pp.765-771
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    • 2022
  • Objective : Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and short-term dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs). Methods : This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 top-performing, high-volume Korean institutions specializing in coil embolization. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.

Differences in Health Status-related Characteristics Before and After Falls in Adult Hospitalized Patients (성인 입원 환자의 낙상전후 건강상태 관련 특성의 차이)

  • Kim, Myo-Youn;Lee, Mi-Joon;So, Hye-Eun;Youn, Byoung-Sun
    • Journal of Industrial Convergence
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    • v.20 no.10
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    • pp.51-59
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    • 2022
  • This study aims to investigate the changes in health status of inpatients before and after a fall accident, and it is a retrospective study using data from 328 inpatients who fell from January 1, 2016 to December 31, 2020, reported to the patient safety reporting system. The average age of the study subjects was 68.57(±14.13), and those in their 70s accounted for the most at 30.49%. Falls occurred on average 13.86(±25.03) days after hospitalization, and the time when the most falls occurred was between 22:30 and 06:59 with 42.99%. Before and after a fall during hospitalization, bowel problems (x2=314.0, p<.001), urination problems (x2=284.0, p<.001), intravenous fluid therapy (x2=85.16, p<.001), and walking (x2=69.77. p<.001), bedridden state (x2=51.60, p< .001), mental state and performance (x2=17.52, p<.001) patient's attitude (x2=220.17, p<.001), there was a statistically significant difference. It is necessary to develop an appropriate method and education program for fall prevention in hospital by considering the individual characteristics of inpatient.

Herbal Medicine for Liver Cancer: A Protocol for Systematic Review and Meta-Analysis (간암에 대한 한약치료: 체계적 문헌고찰 및 메타분석의 프로토콜)

  • Kwon, Seungwon;Song, Ga Yeon;Yang, Seung-Bo
    • The Journal of Internal Korean Medicine
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    • v.43 no.4
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    • pp.559-566
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    • 2022
  • Introduction: The aim of this systematic review is to provide evidence confirming the efficacy and safety of herbal medicines used in the treatment of liver cancer. Methods: The review will include randomized clinical trials that compared herbal medicines used as treatments for liver cancer with other therapies, such as placebos and Western medicine. Only randomized controlled trials will be included in this review, and all types of herbal medicine will be evaluated. Eleven electronic databases will be searched from the inception date: the Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, AMED, CINAHL, one Chinese database (CNKI), and five Korean databases (OASIS, DBpia, RISS, KISS, and NDSL). The selection of studies, data extraction, and management will be performed independently by four researchers. Methodological quality, including the risk of bias, will be assessed using the Cochrane risk-of-bias assessment tool. Results: The review of current evidence for the effectiveness of herbal medicine for liver cancer will be summarized and quantitatively analyzed. Conclusions: Our systematic review will provide evidence of the efficacy of herbal medicines as treatments for liver cancer. This evidence will provide useful information for practitioners and patients in the fields of oncology and complementary medicine.

Early Outcomes of Robotic Versus Video-Assisted Thoracoscopic Anatomical Resection for Lung Cancer

  • Park, Ji Hyeon;Park, Samina;Kang, Chang Hyun;Na, Bub Se;Bae, So Young;Na, Kwon Joong;Lee, Hyun Joo;Park, In Kyu;Kim, Young Tae
    • Journal of Chest Surgery
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    • v.55 no.1
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    • pp.49-54
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    • 2022
  • Background: We compared the safety and effectiveness of robotic anatomical resection and video-assisted thoracoscopic surgery (VATS). Methods: A retrospective analysis was conducted of the records of 4,283 patients, in whom an attempt was made to perform minimally invasive anatomical resection for lung cancer at Seoul National University Hospital from January 2011 to July 2020. Of these patients, 138 underwent robotic surgery and 4,145 underwent VATS. Perioperative outcomes were compared after propensity score matching including age, sex, height, weight, pulmonary function, smoking status, performance status, comorbidities, type of resection, combined bronchoplasty/angioplasty, tumor size, clinical T/N category, histology, and neoadjuvant treatment. Results: In total, 137 well-balanced pairs were obtained. There were no cases of 30-day mortality in the entire cohort. Conversion to thoracotomy was required more frequently in the VATS group (VATS 6.6% vs. robotic 0.7%, p=0.008). The complete resection rate (VATS 97.8% vs. robotic 98.5%, p=1.000) and postoperative complication rate (VATS 17.5% vs. robotic 19.0%, p=0.874) were not significantly different between the 2 groups. The robotic group showed a slightly shorter hospital stay (VATS 5.8±3.9 days vs. robotic 5.0±3.6 days, p=0.052). N2 nodal upstaging (cN0/pN2) was more common in the robotic group than the VATS group, but without statistical significance (VATS 4% vs. robotic 12%, p=0.077). Conclusion: Robotic anatomical resection in lung cancer showed comparable early outcomes when compared to VATS. In particular, robotic resection presented a lower conversion-to-thoracotomy rate. Furthermore, a robotic approach might improve lymph node harvesting in the N2 station.

Animal Skin Irritation and Skin Sensitization Tests of High Intensity Focused Ultrasound System Cartridges (집속형초음파자극시스템 카트리지의 동물실험을 통한 피부자극시험 및 피부 감작성시험)

  • Jun-tae, Kim;Ju-hee, Kim;Kyu-tai, Joo;Kyung-ah, Kim;Ahnryul, Choi;Jae-hyun, Jo;Jin-houng, Jeong
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.15 no.6
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    • pp.477-484
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    • 2022
  • In this study, the cartridge part of the focused ultrasound stimulation system was used as a sample to conduct a skin irritation test and a skin sensitization test through animal experiments among the tests related to GLP (Good Laboratory Practice), a medical device safety evaluation standard. The test was conducted after IACUC approval using 6 female New Zeland White Rabbits. The polar and non-polar stimulation indices were all '0.0'. In addition, in the case of skin sensitization evaluation, 30 guinea pigs approved by IACUC were divided into control and experimental groups, and all induction and induction steps were applied using the eluate itself without separate dilution of the test sample and blank test solution. As a result of the experiment, the skin reaction grade of the control animal was 0 grade, and there was no animal showing more than 1 grade in the skin reaction of the test animal. As a result of both tests, no abnormal skin symptoms were observed, and when applied to the human body to treat patients, the test materials used in the tests will investigate the stability of whether any diseases that cause skin abnormal symptoms will occur.

A Clinical Research of Acne Skin through Natural Cosmetics with Distilled Bamboo Vinegar Contents for Skin Health Care (스킨헬스케어를 위한 증류 죽초액 함유 천연화장품의 여드름 피부 임상 적용 연구)

  • Park, Ga-Hui;Park, Jeong-Yeon
    • Journal of Korea Entertainment Industry Association
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    • v.14 no.7
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    • pp.589-597
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    • 2020
  • The purpose of this study was to verify the acne care improvement effects of natural cosmetics with distilled bamboo vinegar contents and develop the materials for acne cosmetics. For the research subjects, 20 teenage boys and girls were selected and based on random number table, 10 subjects were assigned in the control group that used natural cosmetics (foam cleanser, toner, facial pack) and 10 subjects were assigned in the experimental group that used natural cosmetics with distilled bamboo vinegar contents (foam cleanser, toner, facial pack). The natural cosmetics was used for 12 weeks, and Mark-·Vu facial analysis system was used to measure the sebum, pore size, and redness before using the natural cosmetics, 6 weeks after using the natural cosmetics, and 12 weeks after using the natural cosmetics. For the collected data, SPSS v. 21.0 statistics package program was used for the analysis, and the results are as follows. First, it is a safe natural cosmetics based on the results of the patch test to confirm the skin safety of the natural cosmetics. Second, homogeneity was secured based on the results of the test of homogeneity for the sebum, pore size, and redness of the control group and experimental group. Third, in the verification of acne skin improvement effects of natural cosmetics with distilled bamboo vinegar content, the experimental group had higher reduction rate of changes in the sebum, pore size, and redness on the forehead and right cheek compared to the control group. Therefore, it was identified that the natural cosmetics with distilled bamboo liquid content is safe for the skin and effective for reducing the sebum, pore size, and redness for acne skin. For this reason, it is anticipated for distilled bamboo vinegar to be used in the cosmetics industry.

A 13-Week Repeated Oral Dose Toxicity Test and a 4-Week Recovery Test of Standardized Cornus officinalis and Psoralea corylifolia L . in Sprague-Dawley Rats (산수유(山茱萸)와 보골지(補骨脂) 복합추출물의 Sprague-Dawley 랫드를 이용한 13 주 반복경구투여 독성시험 및 4 주 회복시험)

  • Sim, Seo-Ah;Kang, Sung-Chul;Jin, Bo-Ram;Kim, Min-jeong;Yeo, Sujung;Park, In-hwa;Jerng, Ui Min;Cha, Yun-yeop;Ahn, Ji-Hye;An, Hyo-Jin
    • The Korea Journal of Herbology
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    • v.36 no.6
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    • pp.27-37
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    • 2021
  • Objectives : In the current study, we performed the 13-week repeated oral dose toxicity test and a 4-week recovery test of standardized Cornus officinalis Sieb. et Zucc. and Psoralea corylifolia L. 30 % ethanol extract (SCP) in Sprague-Dawley (SD) rats owing to aims for verifying no observed adverse effect level (NOAEL). Methods : The animal study was performed according to OECD guidelines for the testing of chemicals section 4 health effects test No.408 repeated dose 90-day oral toxicity study in rodents (03 October 2008). In the repeated dose toxicity study, SCP was orally administered to female and male rats at dose levels of 1,000, 2,000, and 4,000 mg/kg/day for 13-week. The control group and high dose (4,000 mg/kg/day) group were then monitored for 4 extra weeks to determine recovery time after the study period. 1) Results : Compared with the control group, there were no treatment-related adverse effects in clinical signs, body weight, hematology, serum biochemistry (Aspartate aminotransferase, Alanine aminotransferase, Alkaline phosphatase, 𝛾-Glutamyl transpeptidase, Blood urea nitrogen, Creatinine, Glucose, Total cholesterol, Total protein, Creatine phosphokinase, Albumin, Total bilirubin, Triglyceride, Inorganic phosphorus, Albumin/Globulin ratio, Calcium ion, Sodium ion, Potassium ion, Chloride ion), necropsy findings and organ weight (Ovary, Adrenal gland, Pituitary, Thymus, Prostate, Testis, Epididymis, Spleen, Kidney, Heart, Lung, Brain, Liver) at any dose tested. Conclusions : Taken together, these results suggest that the NOAEL of SCP in both genders was considered as over 4,000 mg/kg. Results from this study provide scientific evidence for the safety of SCP.

A Survey on the General Public's Perception of Korean Medicine Treatment for Traffic Accident Patients during Pregnancy (임신 중 교통사고 환자의 한방치료에 대한 일반인 인식조사)

  • Hwang, Bo-Kyung;Jung, Woo-Jin;Namgoong, Jin;Kim, Soo-Duk;Park, Mi-So;Ku, Seung-Hyeok;Kim, Sung-Hyun;Moon, Hyun-Woo;Baek, Hye-Kyung;Jung, Jae-Joong
    • The Journal of Korean Obstetrics and Gynecology
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    • v.35 no.4
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    • pp.19-36
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    • 2022
  • Objectives: This study was conducted to find out the general public's perception of Korean Medicine (KM) treatment for traffic accident (TA) patients during pregnancy. Methods: A self-developed questionnaire was distributed to outpatients and inpatients between the ages of 19 and 70 at KM hospitals located in Bucheon. The subjects were asked whether they thought KM treatment could be applied to TA patients during pregnancy. The perceptions of acupuncture, pharmacupuncture, herbal medicine, and Chuna treatment during pregnancy were also investigated. Results: 87.50% answered that KM treatment could be applied to TA patients during pregnancy. Most respondents thought that musculoskeletal symptoms of TA could be treated with KM (85.71%). 93.75%, 87.50%, 56.25%, and 52.08% of the respondents said they were willing to recommend acupuncture, pharmacupuncture, herbal medicine, and Chuna treatment to patients after TA during pregnancy. The respondents answered that acupuncture (95.83%), pharmacupuncture (91.67%), herbal medicine (62.50%), and Chuna (66.67%) is effective for pain controlling during pregnancy, and acupuncture (8.33%), pharmacupuncture (12.50%), herbal medicine (45.83%), and Chuna (39.58%) could be affect the risk of premature birth, miscarriage or birth defects. Conclusions: Acupuncture and pharmacupunture treatment are perceived positively, whereas herbal medicine and Chuna treatment are perceived negatively by the general public for the TA patients during pregnancy. In order to establish the correct awareness of KM treatment for TA patients during pregnancy, more clinical studies and case reports on the efficacy and safety of KM treatment during pregnancy are required.

Analysis of Research Trends in New Drug Development with Artificial Intelligence Using Text Mining (텍스트 마이닝을 이용한 인공지능 활용 신약 개발 연구 동향 분석)

  • Jae Woo Nam;Young Jun Kim
    • Journal of Life Science
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    • v.33 no.8
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    • pp.663-679
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    • 2023
  • This review analyzes research trends related to new drug development using artificial intelligence from 2010 to 2022. This analysis organized the abstracts of 2,421 studies into a corpus, and words with high frequency and high connection centrality were extracted through preprocessing. The analysis revealed a similar word frequency trend between 2010 and 2019 to that between 2020 and 2022. In terms of the research method, many studies using machine learning were conducted from 2010 to 2020, and since 2021, research using deep learning has been increasing. Through these studies, we investigated the trends in research on artificial intelligence utilization by field and the strengths, problems, and challenges of related research. We found that since 2021, the application of artificial intelligence has been expanding, such as research using artificial intelligence for drug rearrangement, using computers to develop anticancer drugs, and applying artificial intelligence to clinical trials. This article briefly presents the prospects of new drug development research using artificial intelligence. If the reliability and safety of bio and medical data are ensured, and the development of the above artificial intelligence technology continues, it is judged that the direction of new drug development using artificial intelligence will proceed to personalized medicine and precision medicine, so we encourage efforts in that field.