• 제목/요약/키워드: Clinical safety

검색결과 2,518건 처리시간 0.03초

Subacute Oral Toxicity Evaluation of Expanded-Polystyrene-Fed Tenebrio molitor Larvae (Yellow Mealworm) Powder in Sprague-Dawley Rats

  • Choi, Eun-Young;Lee, Jae-Han;Han, So-Hee;Jung, Gi-Hwan;Han, Eun-Ji;Jeon, Su-Ji;Jung, Soo-Hyun;Park, Jong-Uk;Park, Ji-Hoon;Bae, Yoon-Ju;Park, Eun-Soo;Jung, Ji-Youn
    • 한국축산식품학회지
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    • 제42권4호
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    • pp.609-624
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    • 2022
  • Tenebrio molitor larvae, as known as edible insects, has advantages of being rich in protein, and has been recognized as a suitable alternate protein source for broiler and pig feed. Moreover, given their ability to biodegrade polystyrene, a major pollutant, Tenebrio molitor larvae has been proposed as an innovative solution to environmental problems. In the present study, we investigated the toxicity of Tenebrio molitor larvae powder (TMlp) ingested with expanded-polystyrene (W/ eps) through in vitro and in vivo experiments. The objective of this study was to determine whether TMlp W/ eps can be applied as livestock alternative protein source. For in vitro experiments, cytotoxicity test was performed to investigate the effects of TMlp-extract on the viability of estrogen-dependent MCF-7 cells. The possibility of estrogen response was investigated in two groups: Expanded-polystyrene-fed (W/ eps) TMlp group and without expanded-polystyrene-fed (W/o eps) TMlp group. For in vivo experiments, The male Sprague-Dawley rats were divided based on the dosage of TMlp administered and oral administration was performed to every day for 5 weeks. A toxicological assessments were performed, which included clinical signs, food consumption, body and organ weights, hematology, serum chemistry, and hematoxylin and eosin staining of liver and kidney. There were no specific adverse effect of TMlp W/ eps-related findings under the experimental conditions of this study, but further studies on both sexes and animal species differences should be investigated. In conclusion, TMlp W/ eps was considered non-toxic and observed to be applicable as an alternative protein source for livestock feed.

도수치료의 정의에 대한 고찰 및 발전 방향에 관한 연구 (A study on the definition and development direction of manual therapy)

  • 박종항;박현식;신영일;이호종
    • 대한물리치료과학회지
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    • 제29권1호
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    • pp.1-14
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    • 2022
  • Background: The legal and academic definitions of manual therapy in domestic and foreign countries are reviewed, and problems and improvement plan of manual therapy are established through comparative analysis of the current status and system of manual therapy in Korea and abroad. Design: Review. Methods: In this study, the development direction of manual therapy in Korea was derived by analyzing the definition, application status, and service system of domestic and foreign manual therapy. Results: Firstly, it lays the foundation for a more comprehensive national health promotion by solving problems arising from the current unclear definition of manual therapy. Secondly, the subject of manual therapy is a physiotherapist but the subject of claiming non-benefit costs is a doctor, moreover illegal manual therapy by an unqualified or non-professional who is not a physiotherapist is being carried out in the medical field. Thirdly, in order to provide quality physiotherapy services (manual therapy) under a cooperative relationship between medical staff and physiotherapists, it is appropriate that physiotherapist have a clear "prescription" or "request" by a doctor. Fourth, there is no provision for the preparation of medical records in the current Medical Technicians Act, and this causes safety accidents of patients during manual treatment. Conclusion: As described above, the current manual therapy in Korea is being performed indiscriminately without a clear interpretation, resulting in various problems. I think it is necessary to lay the foundation for institutional and legal re-establishment of manual therapy through additional research on manual therapy in the future.

Clinical Comparison of Proximal Gastrectomy With Double-Tract Reconstruction Versus Total Gastrectomy With Roux-en-Y Anastomosis for Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction

  • Ma, Xiaoming;Zhao, Mingzuo;Wang, Jian;Pan, Haixing;Wu, Jianqiang;Xing, Chungen
    • Journal of Gastric Cancer
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    • 제22권3호
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    • pp.220-234
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    • 2022
  • Purpose: The incidence of adenocarcinoma of the esophagogastric junction (AEG) has increased in recent years, and the optimal surgical strategy for AEG remains highly controversial. We aimed to evaluate the safety and efficacy of proximal gastrectomy with double-tract reconstruction (PG-DT) for the treatment of patients with AEG. Materials and Methods: We retrospectively analyzed patients with Siewert type II/III AEG between January 2013 and July 2018. Clinicopathological characteristics, survival, surgical outcomes, quality of life (QOL), and nutritional status were compared between the PG-DT and total gastrectomy with Roux-en-Y anastomosis (TG-RY) groups. Results: After propensity score matching, 33 patients in each group were analyzed. There were no statistical differences between the 2 groups in terms of disease-free survival and overall survival. The surgical option was not an independent prognostic factor based on the multivariate analysis. In addition, no differences were found in terms of surgical complications. There were no significant differences in QOL assessed by the Visick grade, Gastrointestinal Symptom Rating Scale, or endoscopic findings. Furthermore, the long-term nutritional advantage of the PG-DT group was significantly greater than that of the TG-RY group. Conclusions: PG-DT is a safe and effective procedure for patients with local Siewert type II/III AEG, regardless of the TNM stage.

Laser-assisted Delivery of a Combined Antioxidant Formulation Enhances the Clinical Efficacy of Fractional Microneedle Radiofrequency Treatment: A Pilot Study

  • Kim, Jihee;Kim, Soo Min;Jung, Bok Ki;Oh, Sang Ho;Kim, Young-Koo;Lee, Ju Hee
    • Medical Lasers
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    • 제10권3호
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    • pp.161-169
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    • 2021
  • Background and Objectives Fractional microneedle radiofrequency systems are popular options to increase elasticity in aging skin. Laser-assisted drug delivery is a promising method for the epidermal injection of topically applied drugs and cosmetic ingredients. This study assesses the safety and efficacy of topical delivery of L-ascorbic acid, vitamin E, and ferulic acid after fractional microneedle radiofrequency treatment for reducing photodamage. Materials and Methods In this prospective, single-center, split-face, controlled pilot study, six women (mean age, 48.0 years; range, 35-57 years; Fitzpatrick skin types III and IV) exhibiting mild to moderate photodamage, underwent a single session of fractional microneedle radiofrequency treatment. The patients were instructed to apply the antioxidant formulation to only one side of the face. Patients were evaluated 3 days, 7 days, and 4 weeks thereafter, using three-dimensional imaging and ultrasound. Ex vivo, the full-thickness human skin was used for molecular and histological evaluation. Statistical analysis was achieved by applying t-tests, Mann-Whitney U tests, and one-way analyses of variance. Results Compared to the untreated side, the antioxidant-treated side exhibited a significant increase in dermal thickness (10.32% vs. 17.54%, p < 0.05), but not in skin elasticity (4.76% vs. 4.69%, p > 0.05). The difference in erythema between the sides was statistically not significant (p > 0.05). In the ex vivo model, expression of FGF2 in the skin was significantly increased after application of the antioxidant formulation, as compared to results obtained subsequent to fractional microneedle radiofrequency treatment only (p < 0.01). Conclusion This study demonstrates that for the treatment of photodamaged skin, laser-assisted delivery of the antioxidant formulation is a safe and effective adjuvant modality following fractional microneedle radiofrequency.

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.

당뇨 환자의 체중감량을 위한 가미태음조위탕의 임상적 활용: 후향적 차트 리뷰 (Gamitaeeumjowee-Tang for weight loss in diabetic patients: A retrospective chart review)

  • 이아름;이다연;김민지;이향숙;최가혜;김서영;임영우;박영배
    • 대한한의학회지
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    • 제42권1호
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    • pp.46-58
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    • 2021
  • Objectives: The purpose of this study is to report weight changes and analyze adverse events in diabetic patients with Gamitaeeumjowee-Tang for weight loss. Methods: A retrospective chart review of weight change and adverse events was performed during the 10-week weight loss program using Gamitaeeumjowee-tang with low-calorie diets for diabetics(n=61). Weight and BMI changes were compared before and after the program and calculated the percentage of people who lost more than 5% of their weight, also identified whether subjects felt satiated or not. Adverse events were evaluated in terms of causality, severity and system-organ classes. Results: After 10-week weight loss program, significant weight loss (5.9±2.32kg, 7.73% reduction from baseline) and BMI reduction (2.9±0.86) were reported (n=61). Those who lost more than 5 percent of their body weight accounted for 88.5%, and also 88.5% of the participants felt full to help control their appetite. In assessing the causality of adverse events, 'Unlikely' was the most common (66%) and in severity evaluations, almost all symptoms were mild. Insomnia was the most frequently reported during the first 8 weeks, and constipation was reported the most afterwards. Conclusions: A combination of Gamitaeeumjowee-tang and low-calorie diets for 10 weeks appears to help weight reduction without serious adverse events in diabetic patients. Future well-designed prospective clinical studies testing the effectiveness and safety of this weight loss program are warranted.

A comparison of different O-antigen serogroups of Escherichia coli in semen samples of fertile and infertile men

  • Nabi, Ali;Khalili, Mohammad Bagher;Eslami, Gilda;Vakili, Mahmood;Anbari, Fatemeh;Torki, Alireza
    • Clinical and Experimental Reproductive Medicine
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    • 제49권1호
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    • pp.33-39
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    • 2022
  • Objective: Male genital tract infections have been associated with infertility, and Escherichia coli has drawn increasing attention as an important bacterium in this context. This investigation aimed to characterize and compare the distributions of O-antigen serogroups of E. coli in the semen samples of fertile and infertile men. Methods: In this case-control study, semen samples were collected from 618 fertile and 1,535 infertile men. The E. coli-positive samples were evaluated in terms of concentration, morphology, viability, and motility parameters according to the World Health Organization 2010 guidelines. Finally, different serogroups of E. coli were identified by multiplex polymerase chain reaction targeting the O-antigen variations of the bacterium. Results: The prevalence of E. coli among fertile men was significantly higher than among infertile men (p<0.001). The sperm morphology, viability, and motility in the E. coli-positive fertile group were significantly higher than in the E. coli-positive infertile group (p<0.001). E. coli O6 was the most prevalent serogroup found in both groups. However, there was no significant difference in the frequency of different serogroups of E. coil between the two groups (p=0.55). Conclusion: Despite the higher prevalence of E. coli among fertile men, E. coli had more detrimental effects on semen parameters in infertile men. There was no significant difference in E. coli serogroups between the fertile and infertile groups.

녹용 발효 케라틴 펩타이드에 의한 인체 모발 연구 (Study on Effect of Human Hair by Deer Antler Fermented Keratin Peptide)

  • 남개원
    • 대한화장품학회지
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    • 제48권4호
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    • pp.385-392
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    • 2022
  • 본 연구에서는 녹용에 함유한 단백질인 케라틴을 Fervidobacterium islandicum AW-1로 고온 혐기 발효를 통하여 케라틴 펩타이드를 생산하고, 인체 모발 관련한 인자를 확인하여, 화장품 원료로서 케라틴 펩타이드의 가능성을 확인하였다. 모유두 세포주에서 녹용 발효 케라틴 펩타이드를 농도에 따라 세포 독성 및 증식을 확인한 결과, 세포 독성은 나타나지 않았고, 세포 증식 효과를 보였다. 인체 모유두 세포에 대하여 녹용 발효 케라틴 펩타이드에 따른 성장인자의 증가를 확인하여 모발에 영향을 준다고 판단하였다. 이러한 녹용 발효 케라틴 펩타이드를 함유한 화장품을 제조하여 피부 안전성 및 탈모 증상 완화 인체 효력 시험을 수행한 결과, 사용 12 주 후에 제품 사용 전 대비 전체 모발 수의 증가 및 대조군과 비교시 전체 모발 개수의 차이가 통계적으로 유의하게 나타났다. 이를 통해 녹용 발효 케라틴 펩타이드는 기능성 화장품 원료뿐만 아니라 건강 기능 식품 소재로의 가능성을 확인하였다.

Analysis of Clinical Research Trends for Thread Embedding Acupuncture of Cervical Radiculopathy

  • Eun Sil, Heo;Hyun-Jong, Lee;Jung Hee, Lee;Sang Ha, Woo;Yun Kyu, Lee;Seong Hun, Choi;Jae Soo, Kim
    • Journal of Acupuncture Research
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    • 제39권4호
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    • pp.283-296
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    • 2022
  • In this study, the evidence of thread embedding acupuncture (TEA) in treating cervical radiculopathy in randomized controlled trials was investigated. We searched 16 databases up to August 22, 2022. Of the 2,644 studies retrieved, 22 randomized controlled trials (2,483 participants) were selected. Quality assessments were performed using Cochrane's risk-of-bias tool and RevMan 5.4 software. Outcome measures in the included studies typically showed TEA had a significant therapeutic effect compared with simple acupuncture and other remedies, and TEA was better than sham TEA. Catgut and polydioxanone had no difference in effectiveness, however, catgut was considered to be less safe. TEA was shown to be more therapeutic when inserted deeper into the skin. Ultrasound guided TEA was more effective and safer than conventional TEA, and using a flat blade needle was better than conventional needles for TEA. No serious adverse events were reported from using TEA, and only a few mild side effects were observed. However, the limited number and heterogeneity of the included studies, together with the unclear methodological quality, indicate that higher-quality studies need to be conducted to determine the effectiveness and safety of TEA for cervical radiculopathy.

HBX-6의 Sprague-Dawley rat를 이용한 단회경구투여 독성시험 (Single Oral Dose Toxicity Test of HBX-6 in Sprague-Dawley Rat)

  • 진보람;서동욱;김명석;이광호;윤일주;김창은;안효진
    • 대한본초학회지
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    • 제33권1호
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    • pp.71-76
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    • 2018
  • Objectives : This study was performed to investigate the single oral toxicity of HBX-6 in Sprague-Dawley (SD) rats. Methods : Twenty SD rats were randomly assigned to four groups of 5 rats each and were administrated singly to female and male SD rats, as an oral dose of 2000 mg/kg. HBX-6 is a newly combined Korean herbal medicine formula 30 % Ethanol extract derived from The Dongui Bogam. Now we are developing the prescription for the aim of improving benign prostatic hyperplasia (BPH) without undesirable side effects. HBX-6 is composed of nine medicinal herbs: Aconiti Lateralis Radix Preparata, Corni Fructus, Cistanchis Herba, Psoraleae Semen, Dendrobii Herba, Morindae Radix, Cuscutae Semen, Trigonellae Semen, Foeniculi Fructus. Animals were monitored for the mortality and changes in the body weight, clinical signs, gross observation and necropsy findings for the 14 days according to "Standard for Toxicity Study of Pharmaceuticals" of Korea Food and Drug Administration (KFDA) guideline and "Acute Oral Toxicity - Fixed Dose Procedure" of OECD Test Guideline. Results : We could not find any mortality. Compared with the control group, significant weight change was not observed in the experimental group. After administration, the more common symptoms were not observed. There were no gross abnormalities in all cases. Conclusions : Taken together, these results suggest that the approximate lethal dose of HBX-6 in both female and male SD rats were considered as over 2000 mg/kg.