• Title/Summary/Keyword: Clinical safety

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Effect of diabetes-specific oral nutritional supplements with allulose on weight and glycemic profiles in overweight or obese type 2 diabetic patients

  • Jihye Tak;Minkyung Bok;Hyunkyung Rho;Ju Hyun Park;Yunsook Lim;Suk Chon;Hyunjung Lim
    • Nutrition Research and Practice
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    • v.17 no.2
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    • pp.241-256
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    • 2023
  • BACKGROUND/OBJECTIVES: Diabetes-specific oral nutritional supplements (ONS) have anti-hyperglycemic effects, while D-allulose exerts anti-diabetic and anti-obesity effects. In this study, we investigated the efficacy and safety of diabetes-specific ONS, including allulose, on glycemic and weight changes in overweight or obese patients with type 2 diabetes mellitus (T2DM). SUBJECTS/METHODS: A single-arm, historical-control pilot clinical trial was conducted on 26 overweight or obese patients with T2DM (age range: 30-70 yrs). The participants were administered 2 packs of diabetes-specific ONS, including allulose (200 kcal/200 mL), every morning for 8 weeks. The glycemic profiles, obesity-related parameters, and lipid profiles were assessed to evaluate the efficacy of ONS. RESULTS: After 8 weeks, fasting blood glucose (FBG) level significantly decreased from 139.00 ± 29.66 mg/dL to 126.08 ± 32.00 mg/dL (P = 0.007) and glycosylated hemoglobin (HbA1c) improved (7.23 ± 0.82% vs. 7.03 ± 0.69%, P = 0.041). Moreover, the fasting insulin (δ: -1.81 ± 3.61 μU/mL, P = 0.017) and homeostasis model assessment for insulin resistance (HOMA-IR) (δ: -0.87 ± 1.57, P = 0.009) levels decreased at 8 weeks, and body weight significantly decreased from 67.20 ± 8.29 kg to 66.43 ± 8.12 kg (P = 0.008). Body mass index (BMI) also decreased in accordance with this (from 25.59 ± 1.82 kg/m2 to 25.30 ± 1.86 kg/m2, P = 0.009), as did waist circumference (δ: -1.31 ± 2.04 cm, P = 0.003). CONCLUSIONS: The consumption of diabetes-specific ONS with allulose in overweight or obese patients with T2DM improved glycemic profiles, such as FBG, HbA1c, and HOMA-IR, and reduced body weight and BMI.

Comparative Study on Anti-thrombotic Effects of Gamihyunbooleekyungtang with Decoction Method (탕전기의 추출방법(抽出方法)에 따른 가미현부이경탕(加味玄附理經湯)의 항혈전(抗血栓) 효능(效能) 비교(比較) 연구(硏究))

  • Jeong, Ji-Hye;Lee, Soon-Yee;Jang, Yun-Jeong;Choe, Chang-Min;Cho, Han-Baek;Kim, Song-Baeg
    • The Journal of Korean Obstetrics and Gynecology
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    • v.22 no.3
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    • pp.99-116
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    • 2009
  • Purpose: In this study, we investigated anti-thrombotic effects of Gamihyunbooleekyungtang currently used clinical treatment of dysmenorrhea and compared effects by decoction methods. Methods: Gamihyunbooleekyungtang was extracted by pressure extractor (GHYT) and nonpressure extractor(GHYT-1). Inhibitory effect of platelet cohesion, suppression effect of GPIIb/IIIa activity, inhibitory effect of $TXB_2$ and $PEG_2$ biosynthesis, and oxidative damage suppression effect were tested in vitro. Also suppression of pulmonary embolism was studied in vivo. Results: In this study, both GHYT and GHYT-1 extract showed a safety in cytotoxicity of hFCs. Both showed dose-dependent inhibitory effect on platelet coagulation. GHYT-1 extract is usually higher than GHYT, especially for $E_{max}$. GHYT and GHYT-1 extract showed dose-dependent inhibitory effect on GPIIb/IIIa activities. GHYT extract suppressed significantly $TXB_2$ biosynthesis at 1000, $500{\mu}g/m{\ell}$ and also suppressed significantly $PEG_2$ biosynthesis at $1000{\mu}g/m{\ell}$ as compared with the control group. GHYT-1 suppressed significantly $TXB_2$ biosynthesis at $1000{\mu}g/m{\ell}$ as compared with the control group. Also it suppressed pulmonary embolism triggered by collagen and epinephrine by respectively 50%, 75% as compared with the control group. Both GHYT and GHYT-1 extract showed dose-dependent decrease of oxidative damages caused by DPPH, whereas dose-dependent increase of superoxide dismutase like activity was observed. Conclusion: These results suggest that Gamihyunbooleekyungtang can be used for treating dysmenorrhea caused by thrombosis. Nonpressure decoction method is a little more effective, but more detailed studies would be needed.

Analysis of the Results of the 2022 Gyeonggi-do Korean Medicine Infertility Support Project (2022년도 경기도 한의약 난임지원사업 결과 분석 연구)

  • Hye-Sung Lee;Hyo-Jung Jung;Su-Ji Choi;Dong-Il Kim
    • The Journal of Korean Obstetrics and Gynecology
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    • v.36 no.4
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    • pp.78-95
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    • 2023
  • Objectives: This study aims to analyze the results of the 2022 Gyeonggi-do Oriental Medicine Fertility Treatment Support Project, review the outcomes and satisfaction of Oriental Medicine fertility support initiatives, and propose progressive fertility treatment support strategies by comparing them with the results of the past three years. Methods: Total of 242 women and 205 spouses participated in the Korean Medicine fertility treatment support project, which encompassed herbal medicine, acupuncture, and counseling treatments over a 3-month period, followed by a 3-month post-treatment follow-up. Data pertaining to patients' general, demographic, and fertility-related characteristics were collected before treatment initiation. During treatment, information regarding the treatments administered by Korean medical doctors was recorded, along with post-treatment outcomes and satisfaction levels. Safety assessments included pre- and post-treatment blood tests and monitoring for adverse events. Results: Among the 242 female subjects, 209 successfully completed the treatment program. Of these, 35 (16.7%) achieved pregnancy, with 30 (15%) attaining pregnancy through herbal monotherapy. Out of the 35 pregnancies, 17 were maintained, while 10 resulted in miscarriage. Notably, 83.8% of patients expressed satisfaction with the treatment outcomes. An analysis spanning three years revealed a continuous increase in the average age of patients, surpassing 38 years in 2022, a critical point in fertility decline age. Additionally, there was a notable rise in the prevalence of patients with a history of gynecological issues, advanced spouse age, and semen abnormalities, which is assumed to have contributed to the decrease in the pregnancy success rate. Conclusions: This study compares the clinical results of the 2022 Gyeonggi-do Korean Medicine Fertility Treatment Support Project with those of the past three years. Based on these findings, recommendations are made to enhance the project, including stricter age criteria for patient selection, enhanced specialized treatment tools for medical doctors, and combining Korean Medicine treatment and medical assisted reproductive technologies, all aimed at increasing pregnancy success rates. These results provide a foundation for the development of fertility support projects and related policies.

TheAssessment of risk of bias in randomized controlled trials published in the Korean Journal of Physical Therapy: A 2018~2022 review (한국 물리치료 학술지에 무작위대조연구의 비뚤림 위험 평가: 2018~2022년 검토)

  • Jae Hyun Lim;Chi Bok Park;Byeong Geun Kim
    • Journal of Korean Physical Therapy Science
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    • v.30 no.4
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    • pp.82-91
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    • 2023
  • Background: Randomized controlled trials (RCTs) provide evidence on the effectiveness and safety of interventions and inform systematic reviews and guideline preparation for clinical application. However, methodological flaws can occur in many RCTs, and Cochrane's risk of bias version 2 (RoB2) can be used to evaluate RCTs' risk of bias (RoB). However, physical therapy RCTs in Korea did not confirm RoB. Therefore, the purpose of this study was to evaluate RoB using RoB2 in RCTs published in the Korean Physical Therapy Journal. Design: Review. Methods: The RCTs subject to evaluation were RCTs published in 11 physical therapy journals in Korea from 2018 to 2022. RoB2 evaluated a total of five domains: bias arising from the randomization process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in measurement of the outcome, and bias in selection of the reported result. Results: A total of 616 RCTs were evaluated. As for bias arising from the randomization process, high risk was the highest at 555 (90.1%), followed by low risk at 41 (6.7%) and some concerns at 20 (3.2%). For bias due to deviations from intended interventions, the proportion of some concerns was the highest at 390 (63.3%), followed by high risk at 218 (35.4%) and low risk at 8 (1.3%). As for the bias due to missing outcome data, the rate of low risk was the highest at 399 (64.8%), followed by high risk at 159 (25.8%) and some concerns at 58 (9.4%). As for bias in measurement of the outcome, high risk was the highest at 294 (47.7%), followed by low risk at 224 (36.4%) and some concerns at 98 (15.9%). In the bias due to missing outcome data, the ratio of high risk was the highest at 610 (99%), followed by low risk at 4 (0.7%) and some concerns at 2 (0.3%). Conclusion: Most of the RoB evaluation results of RCTs published in the Korean Physical Therapy Journal were rated as high risk. Methodological quality of RCTs needs to be improved.

Development and evaluation of a triplex real-time quantitative reverse transcription-polymerase chain reaction for rapid and differential detection of three feline respiratory viral pathogens

  • Ji-Su Baek;Jong-Min Kim;Hye-Ryung Kim;Ji-Hoon Park;Yeun-Kyung Shin;Hae-Eun Kang;Jung-Hoon Kwon;Won-Jae Lee;Min Jang;Sang-Kwon Lee;Ho-Seong Cho;Yeonsu Oh;Oh-Deog Kwon;Choi-Kyu Park
    • Korean Journal of Veterinary Service
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    • v.46 no.4
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    • pp.269-281
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    • 2023
  • In this study, a new triplex real-time quantitative reverse transcription polymerase chain reaction (tqRT-PCR) assay was developed for the rapid and differential detection of three feline viral pathogens including feline calicivirus (FCV), feline herpesvirus 1 (FHV-1), and influenza A virus (IAV) in a single reaction. The assay specifically amplified three targeted viral genes with a detection limit of below 10 copies/reaction. The assay showed high repeatability and reproducibility, with intra- and inter-assay coefficients of variation of less than 1%. Based on the diagnostic results of the assay using 120 clinical samples obtained from cats with feline respiratory disease complex (FRDC)-suspected signs, the prevalence of FCV, FHV-1, or IAV was 43.3%, 22.5%, or 0%, respectively, indicating that the diagnostic sensitivity was comparable or superior to those of previously reported monoplex qRT-PCR/qPCR assays. The dual infection rate for FCV and FHV-1 was 8.3%. These results indicate that FCV and FHV-1 are widespread and that co-infection with FCV and FHV-1 frequently occur in the Korean cat population. The developed tqRT-PCR assay will serve as a promising tool for etiological and epidemiological studies of these three bacterial pathogens, and the prevalence data for three feline viruses obtained in this study will contribute to expanding knowledge about the epidemiology of FRDC in the current Korean cat population.

Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode

  • Jae Won Choi;Jeong Min Lee;Dong Ho Lee;Jung-Hwan Yoon;Yoon Jun Kim;Jeong-Hoon Lee;Su Jong Yu;Eun Ju Cho
    • Korean Journal of Radiology
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    • v.22 no.2
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    • pp.179-188
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    • 2021
  • Objective: This study aimed to prospectively compare the efficacy, safety, and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) to those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC). Materials and Methods: This single-center, two-arm, parallel-group, randomized controlled study was approved by the Institutional Review Board. Written informed consent was obtained from all patients upon enrollment. A total of 80 patients with 94 HCC nodules were randomized into either the DSM-RFA group or SSM-RFA group in a 1:1 ratio, using a blocked randomization method (block size 2). The primary endpoint was the minimum diameter of the ablation zone per unit time. The secondary endpoints included other technical parameters, complication rate, technique efficacy, and 2-year clinical outcomes. Results: Significantly higher ablation energy per unit time was delivered to the DSM-RFA group than to the SSM-RFA group (1.7 ± 0.2 kcal/min vs. 1.2 ± 0.3 kcal/min; p < 0.001). However, no significant differences were observed between the two groups for the analyzed variables, including primary endpoint, regarding size of the ablation zone and ablation time. Major complication rates were 4.9% in the DSM-RFA group and 2.6% in the SSM-RFA group (p = 1.000). The 2-year local tumor progression (LTP) rates of the HCC nodules treated using DSM-RFA and SSM-RFA were 8.5% and 4.7%, respectively (p = 0.316). The 2-year LTP-free survival rates of patients in the DSM-RFA and SSM-RFA groups were 90.0% and 94.4%, respectively (p = 0.331), and the 2-year recurrence-free survival rates were 54.9% and 75.7%, respectively (p = 0.265). Conclusion: Although DSM-RFA using a separable clustered electrode delivers higher ablation energy than SSM-RFA, its effectiveness failed to show superiority over SSM-RFA in the treatment of HCC.

Comparison of Kinematics and Myoelectrical Activity during Deadlift, with and without Variable Banded Resistance, in Healthy, Trained Athletes

  • Everett B. Lohman;Mansoor Alameri;Fulden Cakir;Chih Chieh Chia;Maxine Shih;Owee Mulay;Kezia Marceline;Simran Jaisinghani;Gurinder Bains;Michael DeLeon;Noha Daher
    • Physical Therapy Rehabilitation Science
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    • v.13 no.1
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    • pp.53-70
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    • 2024
  • Background: The conventional deadlift is a popular exercise for enhancing trunk, core, and lower extremity strength. However, its use in sports medicine is constrained by concerns of lumbar injuries, despite evidence supporting its safety and rehabilitative benefits. To optimize muscle activation using resistive bands in variable resistance therapy, we explored their feasibility in the deadlift. Design: Comparative experimental design Methods: Surface electromyography recorded muscle activity in the trunk and lower extremities during lifting, with normalization to the isometric Floor Lift using Maximal Voluntary Contraction. Kinematics were measured using inclinometer sensors to track hip and trunk sagittal plane angles. To prevent fatigue, each subject only used one of the three pairs of bands employed in the study. Results: Our study involved 45 healthy subjects (mean age: 30.4 ± 6.3 years) with similar baseline characteristics, except for years of lifting and strength-to-years-of-lifting ratio. Various resistance band groups exhibited significantly higher muscle activity than conventional deadlifts during different phases. The minimal resistance band group had notably higher muscle activity in the trunk, core, and lower extremity muscles, particularly in the end phase. The moderate resistance band group showed increased muscle activity in the mid-and end-phases. The maximum resistance band group demonstrated greater muscle activity in specific muscles during the early phase and overall higher activity in all trunk and lower extremity muscles in the mid and end phases of the deadlift (p<0.05). Conclusion: Our findings provide valuable insights into muscle activation with various resistance bands during deadlift exercise in clinical and gym settings. There appears to be a dose-response relationship between increased resistance bandwidth, external load, myoelectric activation, and range.

Identification of an effective and safe bolus dose and lockout time for patient-controlled sedation (PCS) using dexmedetomidine in dental treatments: a randomized clinical trial

  • Seung-Hyun Rhee;Young-Seok Kweon;Dong-Ok Won;Seong-Whan Lee;Kwang-Suk Seo
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.24 no.1
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    • pp.19-35
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    • 2024
  • Background: This study investigated a safe and effective bolus dose and lockout time for patient-controlled sedation (PCS) with dexmedetomidine for dental treatments. The depth of sedation, vital signs, and patient satisfaction were investigated to demonstrate safety. Methods: Thirty patients requiring dental scaling were enrolled and randomly divided into three groups based on bolus doses and lockout times: group 1 (low dose group, bolus dose 0.05 ㎍/kg, 1-minute lockout time), group 2 (middle dose group, 0.1 ㎍/kg, 1-minute), and group 3 (high dose group, 0.2 ㎍/kg, 3-minute) (n = 10 each). ECG, pulse, oxygen saturation, blood pressure, end-tidal CO2, respiratory rate, and bispectral index scores (BIS) were measured and recorded. The study was conducted in two stages: the first involved sedation without dental treatment and the second included sedation with dental scaling. Patients were instructed to press the drug demand button every 10 s, and the process of falling asleep and waking up was repeated 1-5 times. In the second stage, during dental scaling, patients were instructed to press the drug demand button. Loss of responsiveness (LOR) was defined as failure to respond to auditory stimuli six times, determining sleep onset. Patient and dentist satisfaction were assessed before and after experimentation. Results: Thirty patients (22 males) participated in the study. Scaling was performed in 29 patients after excluding one who experienced dizziness during the first stage. The average number of drug administrations until first LOR was significantly lower in group 3 (2.8 times) than groups 1 and 2 (8.0 and 6.5 times, respectively). The time taken to reach the LOR showed no difference between groups. During the second stage, the average time required to reach the LOR during scaling was 583.4 seconds. The effect site concentrations (Ce) was significantly lower in group 1 than groups 2 and 3. In the participant survey on PCS, 8/10 in group 3 reported partial memory loss, whereas 17/20 in groups 1 and 2 recalled the procedure fully or partially. Conclusion: PCS with dexmedetomidine can provide a rapid onset of sedation, safe vital sign management, and minimal side effects, thus facilitating smooth dental sedation.

A new strategy for transcatheter closure of patent ductus arteriosus with recent-generation devices (경피적 동맥관 폐쇄술에서 최근의 기구들의 전략적 이용과 결과)

  • Kim, Sang Yee;Lee, Soo Hyun;Kim, Nam Kyun;Choi, Jae Young;Sul, Jun Hee
    • Clinical and Experimental Pediatrics
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    • v.52 no.4
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    • pp.488-493
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    • 2009
  • Purpose : The aim of this study was to assess the efficacy and safety of recent-generation patent ductus arteriosus (PDA) closure devices applied by a new selection strategy according to the characteristics of each PDA. Methods : From February 2003 to January 2006, 138 patients underwent transcatheter closure of PDA (study group). According to the size and morphology of each ductus, a COOK Detachable Coil or 'flex' PFM Nit-Occlud was used for a small ductus (group 1, n=43); 'medium' PFM Nit-Occlud (group 2, n=49) for a moderate ductus; and an Amplatzer Duct Occluder (group 3, n=46) for a large ductus. The 83 patients who underwent transcatheter closure of PDA from February 2000 to January 2003 were defined as the comparison group. The Qp/Qs ratio, pulmonary/aorta pressure ratio, and MD of the ductus were compared. Immediate and follow-up results including residual shunts and complications were also evaluated and compared among groups. Results : In all 138 patients, complete occlusions were confirmed without major complications, while procedure failure (n=2, 2.2%), device embolization (n=1, 1.1%), and persistent residual shunt (n=4, 4.5%) were documented in the comparison group. Total complication rates were lower in the study group than in the comparison group (study group, 1.4%; comparison group, 9.0%; P<0.05). Conclusion : A novel strategy adopting the merits of various recent-generation devices for transcatheter closure of PDA provides excellent clinical results with minimal risk.

Analysis of Global Gene Expression Profile of Human Adipose Tissue Derived Mesenchymal Stem Cell Cultured with Cancer Cells (암세포주와 공동 배양된 인간 지방 조직 유래 중간엽 줄기 세포의 유전자 발현 분석)

  • Kim, Jong-Myung;Yu, Ji-Min;Bae, Yong-Chan;Jung, Jin-Sup
    • Journal of Life Science
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    • v.21 no.5
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    • pp.631-646
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    • 2011
  • Mesenchymal stem cells (MSC) are multipotent and can be isolated from diverse human tissues including bone marrow, fat, placenta, dental pulp, synovium, tonsil, and the thymus. They function as regulators of tissue homeostasis. Because of their various advantages such as plasticity, easy isolation and manipulation, chemotaxis to cancer, and immune regulatory function, MSCs have been considered to be a potent cell source for regenerative medicine, cancer treatment and other cell based therapy such as GVHD. However, relating to its supportive feature for surrounding cell and tissue, it has been frequently reported that MSCs accelerate tumor growth by modulating cancer microenvironment through promoting angiogenesis, secreting growth factors, and suppressing anti-tumorigenic immune reaction. Thus, clinical application of MSCs has been limited. To understand the underlying mechanism which modulates MSCs to function as tumor supportive cells, we co-cultured human adipose tissue derived mesenchymal stem cells (ASC) with cancer cell lines H460 and U87MG. Then, expression data of ASCs co-cultured with cancer cells and cultured alone were obtained via microarray. Comparative expression analysis was carried out using DAVID (Database for Annotation, Visualization and Integrated Discovery) and PANTHER (Protein ANalysis THrough Evolutionary Relationships) in divers aspects including biological process, molecular function, cellular component, protein class, disease, tissue expression, and signal pathway. We found that cancer cells alter the expression profile of MSCs to cancer associated fibroblast like cells by modulating its energy metabolism, stemness, cell structure components, and paracrine effect in a variety of levels. These findings will improve the clinical efficacy and safety of MSCs based cell therapy.