• 한국콘텐츠학회논문지
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• 제12권12호
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• pp.714-720
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• 2012

임상 연구에서 가장 중요한 것은 임상 자료를 정확하게 수집하는 것이다. 이를 위해, 최근 많은 제약회사들과 임상 연구기관에서는 전자 증례기록지(electronic Case Report Form, eCRF)를 도입하려고 노력하고 있다. eCRF는 임상연구에서 임상 자료를 수집하고 관리하기 위해 디자인된 컴퓨터 시스템이다. 하지만, 임상연구에서 eCRF의 중요성을 인식하고 있지만, eCRF 도입 초기에 많은 노력과 비용이 소요되기 때문에 널리 사용되고 있지는 못한다. 본 연구에서는 한의학연구원에서 임상연구를 위해 개발된 eCRF의 사용현황을 실증적 자료를 바탕으로 조사했다. 특히, eCRF에 자료를 입력하는데 걸리는 시간, 사용 시간, 쿼리 수 등을 시간적 흐름에 따른 변화에 중점을 두었다.

• 한국임상수의학회지
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• 제35권1호
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• pp.1-6
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• 2018

This study reviewed the regulatory safety management system for prevention of side effects of veterinary medical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure the safety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing, test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the good manufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establish regulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinary medicine of FDA in the United States has been operated side effects reporting system of veterinary medical devices from user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices for animals, it should be required to improve regulation related to the licensing procedures, GMP system, and the side effects reporting system in our country.

• 대한한방내과학회지
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• 제38권6호
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• pp.980-999
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• 2017

Objectives: This study aimed to evaluate the efficacy of Daegunjoong-tang for improvement of gastrointestinal motility after surgery due to gastrointestinal cancer by analyzing the existing clinical research. Methods: Clinical studies about Daegunjoong-tang for improvement of gastrointestinal motility after surgery due to gastrointestinal cancer were identified in a literature search using the search term "Daikenchuto AND cancer AND ileus." The studies were analyzed in terms of design, inclusion and exclusion of participants, intervention, control, outcomes, and results. Results: Nine articles were identified in the literature search. Four trials included colon cancer participants with colectomy, and three studies included gastric cancer with total gastrectomy. The intervention in each case was Daegunjoong-tang, and most interventions were made by a pharmaceutical company with a Good Manufacturing Practice facility. The most frequently used control was a placebo. The methods were diverse, including measuring gastrointestinal function, motility, quality of life, symptom scores with a numeric rating scale, and blood tests. Safety was investigated by recording adverse events. Conclusions: Some issues were discovered by reviewing the existing clinical research about Daegunjoong-tang for improvement of gastrointestinal motility after surgery for gastrointestinal cancer. These results will be utilized as evidence for using Daegunjoong-tang in clinical practice and designing a clinical trial for Korean patients.

• 셀메드
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• 제13권6호
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• pp.4.1-4.10
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• 2023

Background and objective: Cervicitis are an inflammatory condition of the cervix. This may be acute, chronic, active & specific or non-specific, which may cause various sign & symptoms. Abnormal vaginal discharge, lower abdominal pain, lower backache, post coital bleeding. If not treated timely it causes various complications viz PID, infertility, endometritis, ectopic pregnancy etc. Hence it has been decided to conduct a clinical trial for its management. Method: This study was an open observational study. The entire patients were allocated by considering the criteria of inclusion & exclusion. Marhame dakhilyun with roghane sausan is given 10 mg as ḥamūl at bed time, after menses for 21 days. All the patients were assessed by primary outcome of abnormal vaginal discharge, lower abdominal pain, lower backache, post coital bleeding & secondary outcomes of vaginal symptoms scale score (VSS) which score the vaginal discharge with QOL in cervicitis patients and vaginal analogue scale (VAS) for pain. Result: In this present study, marked improvement is observed in cervicitis. The mean ± SD of vaginal discharge before & after treatment is 2.57±0.050, 0.33±0.48 respectively which is highly significant with p value of<0.0001^**. VSS score before & after treatment is 21.27±6.12, 7.47±2.48 respectively with p<0.0001^** which is highly significant. VAS score used for LAB & LPA before & after treatment is 6.63±1.09, 1.90±1.29 respectively with p<0.0001^** which is highly significant. Interpretation & Conclusion: The study revealed that the formulation has been found effective in healing congestion, hypertrophied of the cervix and discharge and relieving the others associated symptoms of cervicitis. It is useful and provided immediate and effective treatment for cervicitis. Hence, the trial drug can be recommended for its management.

• 과학기술학연구
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• 제18권3호
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• pp.1-45
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• 2018

한국은 최근 세계 임상시험 중심지의 하나로 떠올랐다. 임상시험을 가장 많이 한 국가 순위에서 미국과 독일 등 전통적 제약 강국에 이어 6위를 차지했고, 도시별 순위에선 서울이 1위 자리에 올랐다. 이 논문은 한국에서 임상시험이 급격하게 증가한 배경으로 수요공급의 시장 메카니즘 외에 다른 요인, 즉 정부의 임상시험 산업화 정책이 중요했음을 보일 것이다. 1990년대 말 금융위기 이후 정부는 바이오테크놀로지(BT)를 차세대 국가 성장 동력으로 정하고 이를 위한 정책개발에 심혈을 기울였다. 바로 이러한 맥락에서 다국적 제약사의 임상시험을 국내에 유치하고 이 분야를 키울 계획을 세우게 된 것이다. 정부가 제도정비, 인프라 구축, 관련 인력 양성 및 국민의식 개선 등의 작업을 수행하는 가운데, 해외 CRO(Contract Research Organization: 임상시험수탁기관)가 들어와 사업을 시작했고, 국내 업체들도 생겨났다. 한국에서 임상시험은 정부에 의해 '초대?된 것이다. 이 논문은 한국의 임상시험 산업화 과정 속에 묻혀있는 생명윤리의 문제를 끄집어내 다루고자 한다. 이를 위해 최근 인류학과 과학기술학에서 논의되고 있는 ??생명자본?? (biocapital)과 ??윤리 가변성??(ethical variability)의 개념을 활용하여, 임상시험을 둘러싼 주요 행위자인 정부 담당자, CRO 직원, 병원 의료진, 환자 등이 실제로 어떤 동기와 목적을 가지고 여기에 참여했는지를 사회 구조적 관점에서 분석할 것이다. 임상시험 참여자의 동의서를 받고, IRB의 심의를 통과하고, 국제기준을 충분히 만족시킨다고 해도, 실제 상황에선 생명윤리의 원칙이 무시될 여지는 충분히 있고, 국가의 산업육성 프레임 안에서 생명윤리는 관련 서류를 갖추면 되는 절차상의 문제로 환원될 수 있음을 보일 것이다.

• 셀메드
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• 제4권2호
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• pp.10.1-10.8
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• 2014

Affecting more than half of menstruating women, dysmenorrhea is a cramp which causes abdominal or lower back pain just before or during a menstruation. In western medicine, non-steroidal anti-inflammatory drugs (NSAIDs) are normally used to treat primary dysmenorrheal symptoms. Despite their rapidity in relieving pain, NSAIDs have many serious side effects on the liver, kidney, and gastrointestinal tract. Thai traditional medicines comprise many preparations for treating dysmenorrhea, especially Prasaplai preparation which has been listed in the Thai traditional common household drug list since 2006. The use of Prasaplai was originated about 100 years ago and is still being used in the present time to treat dysmenorrhea. This review focuses on the history of the preparation, active ingredients, and biological activities especially on cyclooxygenase inhibitor, artifacts occurred in the preparation, quantitative analysis, and clinical trial of Prasaplai formulation.

• 대한약학회:학술대회논문집
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• 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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• pp.237-237
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• 2002

Creatine phosphokinase (CPK) was a marker in diagnosis of rhabdomyolysis. The CPK abnormality could be induced by intake of HMG CoA reductase inhibitors (statins). The objective of this study was to estimate the incidence rate of CPK abnormality by each statin. (omitted)

• Genomics & Informatics
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• 제21권3호
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• pp.31.1-31.8
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• 2023

Multiple myeloma (MM) is a hematological malignancy. It is widely believed that genetic factors play a significant role in the development of MM, as investigated in numerous studies. However, the application of genomic information for clinical purposes, including diagnostic and prognostic biomarkers, remains largely confined to research. In this study, we utilized genetic information from the Genomic-Driven Clinical Implementation for Multiple Myeloma database, which is dedicated to clinical trial studies on MM. This genetic information was sourced from the genome-wide association studies catalog database. We prioritized genes with the potential to cause MM based on established annotations, as well as biological risk genes for MM, as potential drug target candidates. The DrugBank database was employed to identify drug candidates targeting these genes. Our research led to the discovery of 14 MM biological risk genes and the identification of 10 drugs that target three of these genes. Notably, only one of these 10 drugs, panobinostat, has been approved for use in MM. The two most promising genes, calcium signal-modulating cyclophilin ligand (CAMLG) and histone deacetylase 2 (HDAC2), were targeted by four drugs (cyclosporine, belinostat, vorinostat, and romidepsin), all of which have clinical evidence supporting their use in the treatment of MM. Interestingly, five of the 10 drugs have been approved for other indications than MM, but they may also be effective in treating MM. Therefore, this study aimed to clarify the genomic variants involved in the pathogenesis of MM and highlight the potential benefits of these genomic variants in drug discovery.

• Molecules and Cells
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• 제40권7호
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• pp.466-475
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• 2017

Dietary supplements have exhibited myriads of positive health effects on human health conditions and with the advent of new technological advances, including in the fields of proteomics, genomics, and metabolomics, biological and pharmacological activities of dietary supplements are being evaluated for their ameliorative effects in human ailments. Recent interests in understanding and discovering the molecular targets of phytochemical-gene-protein-metabolite dynamics resulted in discovery of a few protein signature candidates that could potentially be used to assess the effects of dietary supplements on human health. Persimmon (Diospyros kaki) is a folk medicine, commonly used as dietary supplement in China, Japan, and South Korea, owing to its different beneficial health effects including anti-diabetic implications. However, neither mechanism of action nor molecular biomarkers have been discovered that could either validate or be used to evaluate effects of persimmon on human health. In present study, Mass Spectrometry (MS)-based proteomic studies were accomplished to discover proteomic molecular signatures that could be used to understand therapeutic potentials of persimmon leaf extract (PLE) in diabetes amelioration. Saliva, serum, and urine samples were analyzed and we propose that salivary proteins can be used for evaluating treatment effectiveness and in improving patient compliance. The present discovery proteomics study demonstrates that salivary proteomic profile changes were found as a result of PLE treatment in prediabetic subjects that could specifically be used as potential protein signature candidates.

• Journal of Pharmaceutical Investigation
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• 제39권3호
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• pp.207-216
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• 2009

Fluconazole is used as an orally administrated antifungal drug for the treatment of tinea corporis, candidiasis including skin mycotic pneumonia infections. The dosage of fluconazole varies with indication ranging from 50 mg/day to 400 mg/day. The fluconazole capsule 50 mg (3 capsules daily) is already available in Korean market. To improve the patient compliance, a fluconazole tablet 150 mg (once a day administration) was developed recently. The purpose of this study was to evaluate the bioequivalence of three doses of fluconazole capsule 50 mg (Diflucan 50 mg, Pfizer Korea Inc., as a reference drug) and a single dose of fluconazole tablet 150 mg (Plunazol 150 mg, Daewoong Pharm. Co., Korea) according to the guidelines of the Korea Food and Drug Administration (KFDA). The bioequivalence for three capsules of Diflucan 50 mg and a single tablet of Plunazol 150 mg was investigated in twenty-four healthy male volunteers under a randomized 2${\times}$2 crossover trial design. The average age of twenty-four volunteers was 24.78${\pm}$3.27 year-old, average height was 175.56${\pm}$5.45 cm and average weight was 67.24${\pm}$6.86 kg. After three capsules of Diflucan 50 mg or a single tablet of Plunazol 150 mg were orally administered, blood was taken at predetermined time intervals and the plasma concentrations of fluconazole in plasma were determined using LC-MS-MS. The 90% confidence intervals for the main parameters of statistical results after logarithmic transformation were AUCt 0.9272-1.0084 and Cmax 0.8423-0.9544 respectively, which are in the range of log 0.8 to log 1.25 and the statistical results of additional parameters (AUClast, t1/2 and MRT) were also in the 90% confidence interval that is in the range of log 0.8 to log 1.25. Therefore, the results of this study confirm the bioequivalence of three capsules of Diflucan 50 mg to one tablet of Plunazol 150 mg.