• 제목/요약/키워드: Ethics committee

검색결과 82건 처리시간 0.027초

A Study on the Oral Toxicity of Mecasin in Rats

  • Jeong, Hohyun;Lee, Jongchul;Cha, Eunhye;Park, Manyong;Son, Ilhong;Song, Bongkeun;Kim, Sungchul
    • 대한약침학회지
    • /
    • 제17권4호
    • /
    • pp.61-65
    • /
    • 2014
  • Objectives: In this study, we investigated the oral toxicity of Gami-Jakyak Gamcho buja Decoction (Mecasin) to develop safe treatments. Methods: All experiments were conducted at the Medvill, an institution authorized to perform non-clinical studies, under the Good Laboratory Practice (GLP) regulations. In order to investigate the oral toxicity of Mecasin, we administered Mecasin orally to rats. Sprague-Dawley rats were divided into four groups of five male and five female animals per group: group 1 being the control group and groups 2, 3, and 4 being the experimental groups. Doses of Mecasin, 500 mg/kg, 1,000 mg/kg and 2,000 mg/kg, were administered to the experimental groups, and a dose of normal saline solution, 10 mL/kg, was administered to the control group. We examined the survival rate, weight, clinical signs, and gross findings. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths or abnormalities occurred in any of the four groups. Although slight decreases in the weights of some female rats were noted on the third day, no significant changes in weights or gross findings between the control group and the experimental groups were observed. To check for abnormalities in organs, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs. Conclusion: The results showed that administration of 500 - 2,000 mg/kg of Mecasin did not cause any changes in weight or in the results of necropsy examinations. It also did not result in any mortalities. The above findings suggest that treatment with Mecasin is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

Study on a Single-Dose Toxicity Test of D-Amino Acid Oxidase (DAAO) Extracts Injected into the Tail Vein of Rats

  • Kang, Jungue;Lee, Eun-Yong;Song, Bong-Keun;Lee, Seung-Deok;Yook, Tae-Han;Ahn, Seong-Hun;Son, Il-Hong;Kim, Sungchul
    • 대한약침학회지
    • /
    • 제16권2호
    • /
    • pp.28-32
    • /
    • 2013
  • Objective: This study was performed to analyze the single-dose toxicity of D-amino acid oxidase (DAAO) extracts. Methods: All experiments were conducted at the Korea Testing & Research Institute (KTR), an institution authorized to perform non-clinical studies, under the regulations of Good Laboratory Practice (GLP). Sprague-Dawley rats were chosen for the pilot study. Doses of DAAO extracts, 0.1 to 0.3 cc, were administered to the experimental group, and the same doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: In all 4 groups, no deaths occurred, and the $LD_{50}$ of DAAO extracts administered by IV was over 0.3 ml/kg. No significant changes in the weight between the control group and the experimental group were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ, the results showed no significant differences in any organs or tissues. Conclusion: The above findings suggest that treatment with D-amino acid oxidase extracts is relatively safe. Further studies on this subject should be conducted to yield more concrete evidence.

Intravenous Toxicity Study of Water-soluble Ginseng Pharmacopuncture in SD Rats

  • Yu, Jun-Sang;Sun, Seung-Ho;Lee, Kwang-Ho;Kwon, Ki-Rok
    • 대한약침학회지
    • /
    • 제18권4호
    • /
    • pp.38-44
    • /
    • 2015
  • Objectives: Radix Ginseng has been used for thousands of years to treat a wide variety of diseases. Radix ginseng has also been used as a traditional medicine for boosting Qi energy and tonifying the spleen and lungs. Traditionally, its effect could be obtained orally. Nowadays, a new method, the injection of herbal medicine, is being used. This study was performed to investigate the single-dose intravenous toxicity of water-soluble ginseng pharmacopuncture (WSGP) in Sprague-Dawley (SD) rats. Methods: All experiments were carried out at Biotoxtech, an institute authorized to perform non-clinical studies under the regulation of Good Laboratory Practice (GLP). At the age of six weeks, 40 SD rats, 20 male rats and 20 female rats, were allocated into one of 4 groups according to the dosages they would receive. The WSGP was prepared in the Korean Pharmacopuncture Institute under the regulation of Korea-Good Manufacturing Practice (K-GMP). Dosages of WSGP were 0.1, 0.5 and 1.0 mL/animal for the experimental groups, and normal saline was administered to the control group. The rat's general conditions and body weights, the results of their hematological and biochemistry tests, and their necropsy and histopathological findings were investigated to identify the toxicological effect of WSGP injected intravenously. The effect was examined for 14 days after the WSGP injection. This study was performed under the approval of the Institutional Animal Ethics Committee of Biotoxtech. Results: No deaths were found in this single-dose toxicity test on the intravenous injection of WSGP, and no significant changes in the rat's general conditions and body weights, the results on their hematological and biochemistry test, and their necropsy findings were observed during the test. The local area of the injection site showed minial change. The lethal dose was assumed to be over 1.0 mL/animal in both sexes. Conclusion: These results indicate that WSGP is safe at dosages up to 1 mL/animal.

Study of Single-dose Toxicity of Aconitum Kusnezoffii Reichb. Pharmacopuncture in Rats

  • Kim, Jae-Kyoun;Kim, Sung-Ha;Lee, Sang-Mi;Jeong, Ho-Hyun;Park, Man-Yong;Kim, Dong-Woung;Song, Bong-Keun;Lee, Jong-Deok;Kim, Sung-Chul
    • 대한약침학회지
    • /
    • 제15권3호
    • /
    • pp.48-52
    • /
    • 2012
  • Objective: This study was performed to analyze the single-dose toxicity of Aconitum kusnezoffii Reichb. pharmacopuncture (AKRP). Methods: All experiments were conducted at the Korea Testing & Research Institute (KTRI), an institute authorized to perform non-clinical studies, under the regulations of Good Laboratory Practice (GLP). Twenty (20) Sprague-Dawley rats were chosen for the pilot study. The animals were divided into four groups of five animals per group: group 1 (G1) being the control group with each animal receiving an injection of 0.3 ml of saline and groups 2, 3, and 4 (G2, G3, and G4) being the experimental groups with each animal receiving an injection of 0.1, 0.2 or 0.3 ml of AKRP, respectively. This study was conducted with the approval of the Institutional Animal Ethics Committee. Results: No deaths occurred in any of the 4 groups, and the $LD_{50}$ of AKRP administered via IV was higher than 1.77 ml/kg. Some changes in the weights of the male rates were observed between the control group and the experimental groups, but no significant differences were noted in the weights of the female rats. To check for abnormalities in organs and tissues, we stained representative sections of each specified organ with Hematoxylin & Eosin for light microscopic examination. The results showed no significant differences in any of the organs or tissues. Conclusions: The above findings suggest that Aconitum kusnezoffii Reichb. pharmacopuncture is a relatively safe treatment. Further studies on the subject should be conducted to yield more concrete evidence.

Acupuncture for Subacute and Chronic Post-thoracotomy Pain in Patients with Traumatic Multiple Rib Fractures: A Study Protocol for a Randomised-controlled, Two-arm, Parallel Design, Pilot Trial

  • Kim, Kun Hyung;Cho, Hyun Min;Lee, Chan Kyu;Seok, JunePill;Kim, Seon Hee;Kim, Jung-Eun;Shin, Yu Kyung;Kim, Min Kyung
    • Journal of Acupuncture Research
    • /
    • 제35권2호
    • /
    • pp.95-100
    • /
    • 2018
  • Background: The aim of this study is to assess the feasibility of acupuncture treatment for the management of subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures. Methods: A total of 30 participants who have undergone thoracotomy after traumatic multiple rib fractures will be recruited. Participants will be invited and equally randomised into acupuncture plus usual care and usual care alone groups. A computer-generated random number sequence will be used and concealed using opaque, sealed, sequentially numbered envelopes. Twelve sessions of manual and electrical acupuncture performed by Korean medicine doctors will be provided over a span of 3 months to participants allocated to the acupuncture group. Participants in the usual care group will continue pain medication, exercise and physical therapy as required. Study feasibility will be measured based on the proportion of patients who complete the measurement of pain at 12 or 24 weeks after baseline. The clinical outcomes will include; the average pain intensity over the recent week at rest, movement and cough, quality of life, patient's global assessment of recovery, respiratory function measured by the pulmonary function test and use of pain medication at 4, 8, 12 and 24 weeks after enrolment. Adverse events will be recorded for all participants. Written informed consent will be obtained from all participants. The local ethics committee has approved the study. This pilot trial will inform further studies investigating the potential role of acupuncture for subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures.

문자 기반 유해사이트 판별 기법 (A Harmful Site Judgement Technique based on Text)

  • 정규철;이진관;이태헌;박기홍
    • 컴퓨터교육학회논문지
    • /
    • 제7권5호
    • /
    • pp.83-91
    • /
    • 2004
  • 본 논문에서 청소년들의 정신 건강을 해치는 유해 정보 사이트를 차단하기 위해 기존 방식이 아닌 내용 기반을 중심으로 하여 중요도가 가장 높은 한 개의 복합 키워드와 정보통신윤리 위원회에서 제시한 유해단어의 가중치를 이용하여 가중치 평균을 더해 유해도를 판단하여 유해 사이트와 일반 사이트를 구별하는 시스템을 구현하였다. 예비 실험을 통해 구해진 유해도의 값 3.5를 유해정보 사이트를 판단하는 기준으로 정한 다음 유해 정보 차단 시스템의 성능 실험을 위해 유해 정보 사이트와 일반 사이트를 각각 무작위로 100개씩 추출해 접속해 본 결과 유해 사이트를 유해 정보 사이트로 판명한 비율이 78%를 보였고 일반 사이트를 일반 사이트로 판명한 비율이 96%가 되어 본 시스템의 유효성을 확인 할 수가 있었다.

  • PDF

수행능력 기반 사용자 평가를 활용한 노인용 고혈압치료제 안전사용설명서 개발 (Developing a Drug Information Leaflet of Antihypertensives for Senior Citizens; Employing Performance-based User-testing)

  • 김진;이인향
    • 한국임상약학회지
    • /
    • 제26권3호
    • /
    • pp.254-263
    • /
    • 2016
  • Objective: Written information could be helpful for senior population to adhere to complex medication therapies, but must be well prepared and empirically assessed to achieve such end. We purposed to develop a drug information leaflet for senior citizens by applying 'performance-based user-testing.' Methods: We employed a user-testing, a mixed method to figure difficulties out with patients' leaflets from the user perspective. The cycle made of test and revision can be repeated as necessary. We recruited senior citizens with age of 65 or above who were taking antihypertensive medications at the point of participating and excluded the elderly who suffered illiteracy. We firstly rectified a drug information leaflet of antihypertensive medications for the general public distributed by the Korean authority based on focus group interviews (9 participants). The revised leaflets were tested four times with 8~12 participants in each round (40 seniors in total). We targeted to develop a leaflet which more than 80% of participants understood 10 key information. Main outcomes measures were to be able to find information and be able to understand information. This study was approved by the Yeungnam University Research Ethics Committee. Results: Focus group interviews identified difficulties with small font of words, professional language, long information, and a poor structure. The leaflet was revised and in the first round questionnaire found problems with 4/10 information points; interviews disclosed all but one (normal blood pressure range) were ill-understood. The second round questionnaire and interview found fewer problems but the comprehensiveness of participants was still poor in several points. For the third and fourth rounds we revised the leaflets in the individual-targeted manner. Finally, the fourth round showed all key information found and understood by at least 80% of participants except one question about drug name. Conclusion: The drug leaflets need to be developed in a personalized mode for the seniors. There was a limit for Korean seniors to understand nonproprietary name of their drugs because they used to producers' trade names which the Korean health system predominantly works with.

Quality of Life of Multiethnic Adolescents Living with a Parent with Cancer

  • Ainuddin, Husna A.;Loh, Siew Yim;Low, Wah Yun;Sapihis, Musaropah;Roslani, April Camilla
    • Asian Pacific Journal of Cancer Prevention
    • /
    • 제13권12호
    • /
    • pp.6289-6294
    • /
    • 2012
  • Background: Research evidence suggests a debilitating impact of the diagnosis of cancer on the quality of life of the afflicted individuals, their spouses and their families. However, relatively few studies have been carried out on the impact on the QOL of adolescents living with parents diagnosed with cancer. This paper presents a sub-analysis on the impact of parental cancer (colorectal, breast and lung) on adolescents. Materials and Methods: This is a cross-sectional study on adolescents aged 13-18 years old. Upon ethical clearance obtained from UMMC Medical Ethics Committee, patients with colorectal, breast or lung cancer and their adolescent children were recruited from the Clinical Oncology Unit of University of Malaya Medical Centre. Respondents who gave consent completed a demographic questionnaire and the Pediatric Quality of Life Inventory, via the post, email, home visit or meetings at the clinics. Results: 95 adolescents from 50 families responded, giving a response rate of 88 percent. The adolescent's mean age was 16 years (ranging between 13-18 years). Adolescents with parental cancer had the lowest mean score in emotional functioning (p<0.05). Male adolescents had significantly higher quality of life overall and in physical functioning compared to female adolescents. Adolescents with a father with cancer had better school functioning compared to adolescents whose mothers had cancer. Families with household income of RM 5000 and above have significantly better quality of life compared to families with lower household income. Conclusions: Adolescent sons and daughters of parents with a cancer diagnosis show lowered QOL, particularly with reference to emotional functioning and school performance. Addressing the needs of this young group has been slow and warrants special attention. Revisiting the risk and resilience factors of adolescents might also inform tailored programs to address the needs of this neglected adolescent population.

Responsibilities and Difficulties of Caregivers of Cancer Patients in Home Care

  • Ugur, Ozlem;Elcigil, Ayfer;Arslan, Deniz;Sonmez, Ayfer
    • Asian Pacific Journal of Cancer Prevention
    • /
    • 제15권2호
    • /
    • pp.725-729
    • /
    • 2014
  • Background: Having been known as a virulent disease in 1970s, cancer is now onsidered a chronic disease and 64% of cancer patients live for five years after diagnosis. Home care has gradually gained more importance and it is a great burden on the shoulders of caregivers. Caregivers have to undertake the responsibility of the cancer patient's home management, and organize care and arrange health care services according to the ever-changing condition of patients. Caregivers should be prepared for home care so they can provide accurate and complete care to patients. This descriptive study aims to investigate challenges that caregivers encounter in the home care of patients and the reasons for these challenges. Materials and Methods: The research group consisted of caregivers of outpatients in a daily treatment center in a university hospital. The research sampling consisted of 137 voluntary caregivers of patients who attended the Daily Treatment Center for control, chemotherapy or other supportive cares services between January-June, 2011. Data were collected with face-to-face interviews in the Daily Treatment Center. Ethics Committee approval was taken university hospital; caregivers and their patients were informed about the research and their approval was taken as well. Results: It was found that 54.01% of caregivers help patient's nutrition, 50.36% help medicine use, 26.28% help oral hygiene, 26.28% help to meet urinary needs and 51.82% help to change clothes, 69.34% of caregivers help to change bed sheets, 38.69% help the patient to communicate with their environment and 71.53% help to bring the patient to hospital or outside. Conclusions: This study, it was found that caregivers experience challenges due to following factors: patient nutrition, medicine use, oral and body hygiene, colostomy maintenance and stomach tube feeding, concern of dropping the patient, feeling incompetency in body temperature and fever control, fatigue, and lack of personal time.

Lifestyle Behaviors and Early Diagnosis Practices of Cancer Patients

  • Yilmaz, Medine;Sanli, Deniz;Ucgun, Mujde;Kaya, Nur Sahin;Tokem, Yasemin
    • Asian Pacific Journal of Cancer Prevention
    • /
    • 제14권5호
    • /
    • pp.3269-3274
    • /
    • 2013
  • Background: The aim was to determine the lifestyle behaviors and the practices for early diagnosis of cancer of cancer patients. Materials and Methods: A descriptive cross-sectional design was used for this study. The sample consisted of 222 patients with a diagnosis of cancer (non-random sample method). Ethical permission was obtained of the Non-interventional Research Ethics Committee of our Institution. Values of p<0.05 were accepted as statistically significant. Results: It was observed that 54.4% of the patients had never performed breast self-examination, 60.8% had never had a mammography, and 71.2% had never had a Pap smear. Sixty-six point two percent of patients had never had screening for colon cancer within the past ten years. GIS cancers were higher in smokers and ex-smokers (p=0.005), in drinkers and in ex-drinkers (p=0.000). The breast cancer rate was higher in obese people (p=0.019). Conclusions: The results of this study provide information on the healthy lifestyle behavior of cancer patients before their diagnosis, and their use of early diagnosis practices. The important aspect of this study is to extend cancer patients' period of life after the diagnosis and treatment process, to make them conscious of risky lifestyle and nutritional behavior so that they can maintain a high quality of life, and to start initiatives in this direction that would ensure changes in behavior.