• 제목/요약/키워드: Clinical safety

검색결과 2,546건 처리시간 0.028초

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

  • 박가희;박정연
    • 한국엔터테인먼트산업학회논문지
    • /
    • 제14권7호
    • /
    • pp.589-597
    • /
    • 2020
  • 본 연구는 천연물질인 증류 죽초액이 함유된 천연화장품의 여드름 피부 개선에 대한 효과성을 검증하여 여드름 화장품 소재 개발을 목적으로 하였다. 연구의 대상 10대 남·여 20명을 선정하여 난수표방식에 따라 10명은 천연화장품(폼 클렌징, 토너, 팩)을 사용한 대조군으로 10명은 증류 죽초액이 함유된 천연화장품(폼 클렌징, 토너, 팩) 사용한 실험군으로 배정하였다. 화장품 사용 기간은 12주로 하였고, Mark-·Vu 피부 측정기를 사용하여 사전, 6주 후, 12주 후 피부의 피지, 모공 크기, 붉은기를 측정하였다. 수집된 자료는 SPSS v. 21.0 통계 패키지 프로그램을 활용하여 분석하였으며, 결과는 다음과 같다. 첫째, 천연화장품의 피부 안정성 확인을 위한 인체첩포시험 결과 피부에 안전한 제품으로 확인되었다. 둘째, 대조군과 실험군의 피지, 모공 크기, 붉은기에 대한 동질성 검증 결과 동질성이 확보되었다. 셋째, 증류 죽초액이 함유된 천연화장품의 여드름 피부 개선 효과 검증에서 실험군이 대조군에 비해 이마와 오른 볼 부위의 피지, 모공 크기, 붉은기 변화의 감소율이 더 크게 나타났다. 이에 증류 죽초액이 함유된 천연화장품은 피부에 안전하며, 여드름 피부에서 피부의 피지 감소와 모공 크기 및 붉은기 감소에 효과적인 것으로 확인됨에 따라 화장품 산업에서 증류 죽초액 활용을 기대하는 바이다.

산수유(山茱萸)와 보골지(補骨脂) 복합추출물의 Sprague-Dawley 랫드를 이용한 13 주 반복경구투여 독성시험 및 4 주 회복시험 (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)

  • 심서아;강성철;진보람;김민정;여수정;박인화;정의민;차윤엽;안지혜;안효진
    • 대한본초학회지
    • /
    • 제36권6호
    • /
    • pp.27-37
    • /
    • 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.

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

  • 황보경;정우진;남궁진;김수덕;박미소;구승혁;김성현;문현우;백혜경;정재중
    • 대한한방부인과학회지
    • /
    • 제35권4호
    • /
    • pp.19-36
    • /
    • 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.

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

  • 남재우;김영준
    • 생명과학회지
    • /
    • 제33권8호
    • /
    • pp.663-679
    • /
    • 2023
  • 본 리뷰 논문은 2010년부터 2022년까지의 인공지능을 활용한 신약개발 관련 연구동향을 분석하여 정리하였다. 이러한 분석을 통해 2,421개 연구의 초록을 코퍼스로 구성하고, 전처리를 거쳐 빈도가 높고 연결 중심성이 높은 단어를 추출하였다. 분석 결과 2010-201년과 2020-2022년 단어빈도 추이는 비슷한 것으로 구분되어 나타났다. 연구 방법으로는 2010년부터 2020년까지 머신 러닝을 활용한 연구가 많이 진행되었고, 2021년부터는 딥러닝을 활용한 연구가 증가하고 있다. 이러한 연구를 통해 이루어지고 있는 인공지능 활용연구 동향에 대해 분야별로 살펴보고 관련 연구의 장점, 문제점, 도전과제 등을 살펴보았다. 파악되어진 연구 동향은 2021년 이후로 약물의 재배치를 인공지능 활용 연구, 항암제 개발을 위한 컴퓨터 활용 연구, 임상시험에 인공지능 적용 연구 등과 같이 인공지능 적용 분야가 확대되고 있다는 점이다. 이러한 과정을 통해 향후 이루어질 것으로 예상되는 인공지능 활용 신약개발 연구의 전망에 대해 간략히 제시하였다. 위의 인공지능 기술 발전과 함께 바이오와 의료데이터의 신뢰성과 안전성이 확보되어진다면 인공지능 활용 신약개발의 방향이 개인 맞춤형 의료와 정밀의료 분야로 진행되어질 것으로 판단하기에 이에 대한 지속적인 노력이 필요하리라 본다.

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
    • /
    • 제17권2호
    • /
    • pp.241-256
    • /
    • 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.

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) (Comparative Study on Anti-thrombotic Effects of Gamihyunbooleekyungtang with Decoction Method)

  • 정지혜;이순이;장윤정;최창민;조한백;김송백
    • 대한한방부인과학회지
    • /
    • 제22권3호
    • /
    • pp.99-116
    • /
    • 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.

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

  • 이혜성;정효정;최수지;김동일
    • 대한한방부인과학회지
    • /
    • 제36권4호
    • /
    • pp.78-95
    • /
    • 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.

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

  • 임재현;박치복;김병근
    • 대한물리치료과학회지
    • /
    • 제30권4호
    • /
    • pp.82-91
    • /
    • 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
    • 한국동물위생학회지
    • /
    • 제46권4호
    • /
    • pp.269-281
    • /
    • 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
    • /
    • 제22권2호
    • /
    • pp.179-188
    • /
    • 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.