• 대한기관윤리심의기구협의회지
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• 제5권1호
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• pp.21-32
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• 2023

Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

• Journal of Periodontal and Implant Science
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• 제44권4호
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• pp.194-200
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• 2014

Purpose: The purpose of this study was to assess and compare the clinical and radiographic outcomes of guided tissue regeneration therapy for human periodontal intrabony defects using two different collagen membranes: a porous nonchemical cross-linking collagen membrane (NC) and a bilayer collagen membrane (BC). Methods: Thirty subjects were randomly assigned and divided into the following 3 groups: a test group (NC+BM), in which a NC was used with xenograft bone mineral (BM), a positive control group (BC+BM), in which a BC was used with xenograft BM, and a negative control group (BM), in which only xenograft BM was used. The following clinical measurements were taken at baseline and 3 months after surgery: plaque index, gingival index, probing pocket depth, gingival recession, and clinical attachment level. Radiographic analysis was performed at baseline, 1 week and 3 months after surgery. Results: Membrane exposure was not observed in any cases. Significant probing depth reduction, attachment-level gain and bone fill were observed for both test and control groups compared to baseline at 3 months after surgery (P<0.05). However, there were no statistically significant differences in clinical improvement and radiographic bone fill between treatment protocols (P>0.05). Conclusions: Within the limitations of this study, the results suggest that both NC and BC were comparable in terms of clinical and radiographic outcomes for the treatment of periodontal intrabony defects in human subjects.

• 사상체질의학회지
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• 제26권1호
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• pp.45-54
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• 2014

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Soeumin Disease of Sasang Constitutional Medicine(SCM): Greater Yin Symptomatology. This CPG was developed by the national-wide experts committee consisting of SCM professors. Methods First, it was performed that search and collection of literature related SCM such as "Dongeuisusebowon", Textbook of SCM, Clinical Guidebook of SCM and Fundamental research to standardize diagnosis of Sasang Constitutional Medicine. And journal search related clinical trial or Human complementary medicine of SCM was performed domestic and overseas. Finally, 1 article was selected and included in CPG for Greater Yin Symptomatology of Stomach Cold-based Interior Cold disease in Soeumin disease. Results & Conclusions CPG of Greater Yin symptomatology in Soeumin Disease include classification, definition and standard symptoms of each pattern. Greater Yin symptomatology is classified into mild and moderate pattern by severity. Greater Yin Symptomatology Mild pattern is classified into Greater Yin Symptomatology accompanied abdominal pain and bowel irritability and Greater Yin pattern accompanied Epigastric stuffiness and fullness. And Greater Yin Symptomatology moderate pattern is classified into Greater Yin pattern accompanied Jaundice, Greater Yin pattern accompanied Edema and Greater Yin pattern by Yin toxin.

• 사상체질의학회지
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• 제26권1호
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• pp.27-36
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• 2014

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Soeumin Disease of Sasang Constitutional Medicine(SCM): Congestive Hyperpsychotic symptomatology. This CPG was developed by the national-wide experts committee consisting of SCM professors. Methods First, it was performed that search and collection of literature related SCM such as "Dongeuisusebowon", Textbook of SCM, Clinical Guidebook of SCM and Fundamental research to standardize diagnosis of Sasang Constitutional Medicine. And journal search related clinical trial or Human complementary medicine of SCM was performed domestic and overseas. Finally, no article was selected and included in CPG for Congestive Hyperpsychotic symptomatology of Kidney Heat-based Exterior Heat disease in Soeumin disease. Results & Conclusions CPG of Congestive Hyperpsychotic symptomatology in Soeumin Disease include classification, definition and standard symptoms of each pattern. Congestive Hyperpsychotic symptomatology is classified into mild and severe pattern by severity. Congestive Hyperpsychotic symptomatology mild pattern is classified into initial pattern. Congestive Hyperpsychotic symptomatology severe pattern is classified into intermediate and advanced pattern and Greater Yang disease Reverting Yin pattern.

• 대한의용생체공학회:의공학회지
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• 제37권5호
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• pp.195-207
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• 2016

This study examined the effectiveness of micro-current stimulation (MCS) to improve the facial skin qualities by performing clinical test. The MCS is generally known that provide healing response in the damaged tissue and pain relief through activating the adenosine triphosphate (ATP) and protein synthesis. In here, we can hypothesize that the improvement of facial skin qualities may occur due to MCS, since the induction of micro-current from outside may enhance the cellular activity according to ATP activation. From the clinical test, our results showed that a variety of evaluating categories, which is able to assess the skin qualities, significantly enhanced due to stimulation of micro-current after 7 and 14 days. Therefore, we can estimate that MCS in human facial skin may be effective to improve the skin qualities.

• 대한한의학회지
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• 제31권5호
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• pp.12-32
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• 2010

Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1993년도 제2회 신약개발 연구발표회 초록집
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• pp.74-74
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• 1993

The in vitro cytotoxicity of SKI 2053R was evaluated against human tumor cell lines along with those of cisplatin and carboplatin using MTT assay. The cell lines tested were two human lung cancer cell lines and five human stomach cancer celt lines. The level of cytotoxic effects of SKI 2053R against two human lung cancer cell lines was located between cisplatin and carboplatin. However, the cytotoxic activity of SKI 2053R against five human stomach cancer cell lines was similar to that of cisplatin. SKI 2053R is considered to be selectively cytotoxic toward human stomach cancer cell lines. We carried out pharmacokinetic and ex vivo phrmacodynamic studies of SKI 2053R in beagle dogs to predict the clinical antitumor effect of SKI2053R, comparing with those of cisplatin and carboplatin. In ex vivo pharmacodynamics which used MTT assay as bioassay on the 2 lung and 5 stomach cancer cell, mean antitumor indexes (ATIs) of SKI 2053R were highest among three compounds in both lung and stomach cancer cell lines, especially in stomach cancer cell. Much higher ATI profile and maximal inhibition rates of SKI 2053R appeared in the stomach cancer cells will give desirable advantages to clinical trial s against gastric carcinoma. The anti tumor activity and target organ toxicity of SKI 2053R were compared with those of cisplatin on stomach cancer cell line, KATO III xenografted into nude BALB/c(nu/nu) mice. All groups of cisplatin and SKI 2053R showed active tumor regression. The inhibition rates(IR) of SKI 2053R were higher than that of cisplatin on the basis of mean IR. Though the loss of body weight was observed in all groups from the first week, the SKI 2053R group recovered it soon from the third week after the initiation of treatment, maintaining the most active anti tumor activity among three groups.

• Journal of Nutrition and Health
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• 제52권2호
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• pp.242-242
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• 2019

• Clinical and Experimental Reproductive Medicine
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• 제47권1호
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• pp.68-76
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• 2020

Objective: Since sperm abnormalities are known to be a major reason for recurrent pregnancy loss (RPL), any defects in DNA structure and chromatin condensation can place embryos at risk in the early stage of development and implantation. As antioxidants such as vitamin C may play a protective role against the destruction of protamine genes in sperm chromatin, this study was conducted to evaluate the effects of vitamin C on chromatin and the expression of protamine genes in the male partners of couples with RPL. Methods: Twenty male partners of couples with RPL were selected as the intervention group and received vitamin C supplementation (250 mg daily for 3 months). Healthy fertile men (n = 20) were included as controls. Sperm chromatin, DNA integrity, and the expression levels of protamine genes were evaluated before and after treatment. Results: Significant differences were found in sperm morphology, protamine deficiency, and apoptosis between the two groups and before and after vitamin C administration. A significant change was found in mRNA levels of PRM1, PRM2, and the PRM1/PRM2 ratio after treatment. Conclusion: Daily oral administration of vitamin C may improve human sperm parameters and DNA integrity by increasing protamine gene expression levels in the male partners of couples with RPL. The beneficial effects of vitamin C supplementation as an antioxidant for the male partners of couples with RPL could lead to improved pregnancy outcomes in these cases.

• 약학회지
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• 제42권5호
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• pp.473-479
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• 1998

Lovastatin (LOVA), a fungal metabolite isolated from cultures of Aspergillus terreus, is a competitive HMG-CoA reductase inhibitor used for the treatment of primary hyper cholesterolemia, and has also been shown to suppress growth in a variety of non-glioma tumor cell lines. A sensitive reversed-phase high-perfonnance liquid chromatographic method with ultraviolet (UV) absorbance detection has been developed to quantitate LOVA in human plasma and urine samples using liquid-liquid extraction procedure. Baseline separation of LOVA and internal standard, simvastatin was achieved on a Novapak $C_{18}$ analytical column with a mobile phase containing 0.025M $NaH_2PO_4$: CAN (35:65, v/v%), adjusted pH to 4.5. The flow rate was set at 1.5ml/min, and the column effluent was monitored by a UV detection at 238nm. The limit of quantification was determined to be 0.5${\mu}$g/ml while extraction efficiency of LOVA ranged from 73.4-82.9% at LOVA concentrations of 0.5 to 10${\mu}$g/ml. Good linearity with correlation coefficients greater than 0.999 was obtained in the range of LOVA concentrations from 0.5 to 10${\mu}$g/ml. The accuracy and the precision were proven excellent with relative standard deviation (RSD, %) and relative error (RE, %) of less than 4.2 and 4.0, respectively. Intraday precision, evaluated at five LOVA concentrations (0.5, 1, 2, 5, 10${\mu}$g/ml) and expressed as RSD ranged from 0-1.82% while the interday precision at the same concentrations ranged from 0.7-10.5%. The analytical method described was then successfully employed for the determination of LOVA concentrations in plasma samples obtained during a phase II clinical trial using high doses of LOVA (30-40mg/kg/day). This method could be further utilized for the ongoing pharmacolkinetic studies and therapeutic drug monitoring of the high-dose LOVA therapy in adenocarcinoma patients.