• Journal of Pharmaceutical Investigation
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• v.36 no.3
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• pp.209-215
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• 2006

Zaltoprofen, (2-(10,11-dihydro-10-oxodibenzo[b,f]thiepin-2-yl)propionic acid) is an NSAID with powerful anti-inflammatory effects as well as an analgesic action on inflammatory pain. The purpose of the present study was to evaluate the bioequivalence of two zaltoprofen tablets, $Soleton^{\circledR}$ (CJ Corp.) and SCD Zaltoprofen (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of zaltoprofen from the two zatoprofen formulations in vitro was tested using KP Vlll Apparatus ll method with various dissolution media. Twenty six healthy male subjects, $23.2{\pm}2.26$ years in age and$64.7{\pm}8.08$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 80 mg as zaltoprofen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of zaltoprofen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Soleton^{\circledR}$ were 6.33, 5.91 and 17.7% for $AUC_t$, $C_{max}$ and untransformed $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g.,log $1.01{\sim}1og\;1.11$ and log $0.928{\sim}1og\;1.18$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating SCD Zaltoprofen tablet was bioequivalent to $Soleton^{\circledR}$ tablet.

• The Journal of Korean Obstetrics and Gynecology
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• v.33 no.2
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• pp.29-43
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• 2020

Objectives: The purpose of this study is to review and evaluate the effectiveness of oriental medicine per oral for recurrent vulvovaginal candidiasis (RVVC). Methods: We searched articles from Korean journal databases including Journal of Korean Obstetrics and Gynecology, Korean studies Information Service Studies, and Chinese National Knowledge Infrastructure, Cochrane Library, PubMed. Searched keywords were "재발성 칸디다성 외음질염", "recurrent vulvovaginal candidiasis", "㚆发性外阴阴道假丝酵母菌病", "中藥". Results: 10 randomized controlled trials with 700 patients were identified and reviewed. 8 studies compared combination of oriental medicine and anti-fungal agent with anti-fungal agent, and 6 of them reported that treatment group (TG) showed statistically higher total effective rate or cure rate and lower recurrence rate. One study compared oriental medicine and anti-fungal agent and TG showed statistically higher total effective rate and lower recurrence rate after 1 month. One study compared combination of oriental medicine and lacto bacillus capsule with lacto bacillus capsule, and TG showed statistically higher total effective rate and lower positive fungul test rate after 6 months. No severe adverse response was reported. Conclusions: Our review found that oriental medicine per oral is effective for alleviating symptoms, lowering recurrence rate and positive fungal test in RVVC patients. We recommend standardized randomized controlled trial guideline should be made to obtain stronger evidence and well designed trials with larger sample sizes are needed.

• The Journal of Korean Academic Society of Nursing Education
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• v.23 no.1
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• pp.15-26
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• 2017

Purpose: This study evaluated the efficacy of a communication ability enhancement program for nursing students in Korea through a systematic review of literature and meta-analysis. Methods: The researchers searched data-bases, including the Data Base Periodical Information Academic, Research Information Sharing Service, National Digital Science Library and National Assembly Library. The key words used included 'communication' and 'nursing student'. The researchers evaluated articles published up to July 2016. Out of 381 selected articles, 20 clinical trial studies were meta-analyzed. Each article was evaluated in accordance with the Checklist of Scottish Intercollegiate Guideline Network. The effect size of communication ability, self-efficacy and interpersonal relations were synthesized by a random effects model from analysis software (R 3.2.3). The heterogeneity of effect size was analyzed by exploratory and confirmatory moderator analysis. Results: The overall effect size of the program was of a moderate level (SMD=0.78, 95% CI: 0.49~1.07) along with each outcome of self-efficacy (SMD=0.80, 95% CI: 0.23~1.37), and interpersonal relations (SMD=0.47, 95% CI: 0.14~0.80). For heterogeneity, moderator analysis was performed, by grade, and a statistically significant moderator was found. Conclusion: It is evident that a communication ability enhancement program for nursing students is moderately effective in improving communication ability, self-efficacy and interpersonal relations.

• Journal of Gastric Cancer
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• v.23 no.1
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• pp.224-249
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• 2023

Gastric cancer is heterogeneous in morphology, biology, genomics, and treatment response. Alterations in human epidermal growth factor receptor 2 (HER2) overexpression, microsatellite instability (MSI) status, programmed death-ligand 1 (PD-L1) levels, and fibroblast growth factor receptor 2 (FGFR2) can be used as biomarkers. Since the combination of fluoropyrimidine/platinum plus trastuzumab that was investigated in the ToGA trial was approved as a standard of care in HER2-positive patients in 2010, no other agents showed efficacy in the first- (HELOISE, LOGiC, JACOB trials) and second- (TyTAN, GATSBY, T-ACT trials) line treatments. Despite the success in treating breast cancer, various anti-HER2 agents, including a monoclonal antibody (pertuzumab), an antibody-drug conjugate (ADC; trastuzumab emtansine [T-DM1]), and a small molecule (lapatinib) failed to translate into clinical benefits until the KEYNOTE-811 (first-line) and DESTINY-Gastri01 (≥second-line) trials were conducted. The incorporation of HER2-directed treatment with immune checkpoint inhibitors in the form of a monoclonal antibody or ADC is now approved as a standard treatment. Despite the promising results of new agents (engineered monoclonal antibodies, bi-specific antibodies, fusion proteins, and small molecules) in the early phase of development, the management of HER2-positive gastric cancer requires further optimization to achieve precision medicine with a chemotherapeutic backbone. Treatment resistance is a complex process that can be overcome using a combination of chemotherapy, targeted agents, and immune checkpoint inhibitors, including novel agents. HER2 status must be reassessed in patients undergoing anti-HER2 treatment with disease progression after the first-line treatment. As a general guideline, patients who need systemic treatment should receive chemotherapy plus targeted agents, anti-angiogenic agents, immune checkpoint inhibitors, or their combinations.

• The Journal of KAIRB
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• v.2 no.2
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• pp.37-48
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• 2020

Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.17 no.11
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• pp.271-284
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• 2016

This study was carried out to evaluate the efficacy of CBT for perinatal depression through systematic literature review and meta-analysis. The following databases were used to search the literature: CINAHL, PubMed, EMBASE, Koreamed, Library of Korean Congress, KISS, and Korean Academic Publication Database. Keywords included 'perinatal depression,' 'pregnant women,' and 'cognitive behavioral therapy,' and the evaluated articles were published up to May 2016. Using the R program, the effect size of perinatal depression and anxiety were calculated by random-effects model. The heterogeneity of the effect size was analyzed by data moderator analysis using the meta-ANOVA. Furthermore, the funnel plot, Egger's regression test, fail-safe N, trim-and-fill test, and publication bias analysis were conducted and used to verify the results. Out of the 180 selected articles, 16 clinical trial studies were meta-analyzed. Each articles were evaluated for the risk of bias by the checklist of SIGN; the overall risk of bias was low. The effect size of CBT for perinatal depression was Hedges' g=-0.55 (95% CI: -0.76~-0.33), which was a moderate level, while for anxiety reduction, Hedges' g=-0.20 (95% CI: -0.48~-0.08) and it was not statistically significant. Heterogeneity or risk of publication bias were low. This meta-analytic study found that CBT is moderately effective in reducing perinatal depression in pregnant women.

• Radiation Oncology Journal
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• v.18 no.3
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• pp.167-176
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• 2000

The objective of recent radiation therapy is to improve the quality of treatment and the after treatment quality of life. In Korea, sharing the same objective, significant advancement was made due to the gradual increase of patient number and rapid increase of treatment facilities. The advancement includes generalization of three-dimensional conformal radiotherapy (3D-CRT), application of linac-based stereotactic radiosurgery (SRS), and furthermore, the introduction of intensity modulated radiation therapy (IMRT). Authors in this paper prospectively review the followings: the advancement of radiation oncology in Korea, the recent status of four-dimensional radiation therapy, IMRT, the concept of the treatment with biological conformity, the trend of combined chemoradiotherapy, the importance of internet and radiation oncology information management system as influenced by the revolution of information technology, and finally the global trend of telemedicine in radiation oncology. Additionally, we suggest the methods to improve radiotherapy treatment, which include improvement of quality assurance (QA) measures by developing Koreanized QA protocol and system, regional study about clinical protocol development for phase three clinical trial, suggestion of unified treatment protocol and guideline by academic or research societies, domestic generation of treatment equipment's or system, establishment of nationwide data base of radiation-oncology-related information, and finally patterns-of-care study about major cancers.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.14 no.1
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• pp.12-25
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• 2003

Objectives：As increasing number of new antidepressants have been being introduced in clinical practice, pharmacological understanding has been broadened. These changes mandate new information and theories to be incorporated into the treatment process of children with depressive disorders. In light of newly coming knowledge, this review intended to recapitulate the characteristics of new antidepressants and to consider the pivotal issues to develope guidelines for the treatment of depression in childhood and adolescence. Methods：Searching the Pub-Med online database for the articles with the key words of 'new', 'antidepressants' and 'children' ninety-seven headings of review articles were obtained. The author selected the articles of pertinent subjects in terms of either treatment guideline or psychopharmacology of new antidepressants. When required, articles about the clinical effectiveness of individual antidepressants were separatedly searched. In addition, the safety information of new antidepressants was acquired by browsing the official sites of the United States Food and Drugs Administration and Department of Health and Human Services. Results：1) For the clinical course, treatment phase, and treatment outcome, the reviews or treatment guidelines adopted the information from adult treatment guidelines. 2) Systematic and critical reviews unambiguously concluded that selective serotonin reuptake inhibitors(SSRIs) excelled tricyclic antidepressants( TCAs) for both efficacy and side effect profiles, and were recommend for the first-line choice for the treatment of children with depressive disorders. 3) New antidepressants generally lacked treatment experiences and randomized controlled clinical trials. 4) SSRIs and other new antidepressants, when used together, might result in pharmacokinetic and/or pharmacodynamic drug-to-drug interaction. 5) The difference of the clinical effectiveness of antidepressants between children and adults should be addressed from developmental aspects, which required further evidence. Conclusion：Treatment guidelines for the pharmacological treatment of childhood and adolescence depression could be constructed on the basis of clinical trial findings and practical experiences. Treatment guidelines are to best serve as the frame of reference for a clinician to make reasonable decisions for a particular therapeutic situation. In order to fulfill this role, guidelines should be updated as soon as new research data become available.

• Journal of Nutrition and Health
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• v.51 no.5
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• pp.386-399
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• 2018

Purpose: This study examined whether the supply of healthy Korean diets for 12 weeks is effective in improving the risk factors related to serum GGT and cardiovascular diseases in patients with hypertension and diabetes. Methods: This study selected 41 patients, who were treated with hypertension and diabetes. The Korean diet was composed of cooked-rice, soup, kimchi, and various banchan with one serving called bapsang, which emphasize proportionally high consumption of vegetables and fermented foods, moderate to high consumption of legumes and fish, and low consumption of animal foods. The control group was instead instructed to "eat and exercise as usual" while following the Korean Diabetes Association's dietary guidelines with an intake that can assist in glycemic control, maintain adequate weight, and meet the nutritional requirements. The Korean diet group (21 patients) were served three healthy Korean meals a day for 12 weeks, and the control group (20 patients, who trained in the diet guideline of diabetes) maintained their usual diabetic diet. The serum GGT, blood pressure, heart rate, glycemic control data, cardiovascular risk indicators, and changes in diet measured at the four visits (week 0, 4, 8, and 12) during the course of 12 weeks were compared and evaluated. Results: The serum GGT (p < 0.001), HbA1c (p = 0.004), heart rate (p = 0.007), weight (p = 0.002), Body Mass Index (p = 0.002), body fat mass (p < 0.001), body fat (%) (p < 0.001), and free fatty acid (p = 0.007) in the Korean diet group decreased significantly after the dietary intervention compared to the control group. The amount of intake of rice, whole grains, green vegetables, Kimchi, and soybean fermented food were increased significantly compared to the control group (p < 0.001). The Korean diet group showed significant decreases (p < 0.001) in the intake of animal protein, lipid, and cholesterol derived from animal foods compared to the control group but significant increases (p < 0.001) in the intake of total calories, folic acid, dietary fiber, sodium, potassium, and vitamins A, E, and C. Conclusion: In patients with hypertension and diabetes, it was confirmed that regular eating of a healthy Korean diet helps improve the risk factors for GGT and cardiovascular diseases.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.46 no.4
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• pp.240-249
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• 2020

Objectives: Although the side effects of radiation therapy vary from mucositis to osteomyelitis depending on the dose of radiation therapy, to date, an experimental animal model has not yet been proposed. The aim of this study was to develop an animal model for assessing complications of irradiated bone, especially to quantify the dose of radiation needed to develop a rat model. Materials and Methods: Sixteen Sprague-Dawley rats aged seven weeks with a mean weight of 267.59 g were used. Atraumatic extraction of a right mandibular first molar was performed. At one week after the extraction, the rats were randomized into four groups and received a single dose of external radiation administered to the right lower jaw at a level of 14, 16, 18, or 20 Gy, respectively. Clinical alopecia with body weight changes were compared and bony volumetric analysis with micro-computed tomography (CT), histologic analysis with H&E were performed. Results: The progression of the skin alopecia was different depending on the irradiation dose. Micro-CT parameters including bone volume, bone volume/tissue volume, bone mineral density, and trabecular spaces, showed no significant differences. The progression of osteoradionecrosis (ORN) along with that of inflammation, fibrosis, and bone resorption, was found with increased osteoclast or fibrosis in the radiated group. As the radiation dose increases, osteoclast numbers begin to decrease and osteoclast tends to increase. Osteoclasts respond more sensitively to the radiation dose, and osteoblasts are degraded at doses above 18 Gy. Conclusion: A standardized animal model clinically comparable to ORN of the jaw is a valuable tool that can be used to examine the pathophysiology of the disease and trial any potential treatment modalities. We present a methodology for the use of an experimental rat model that incorporates a guideline regarding radiation dose.