• Title/Summary/Keyword: New drugs

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COMPARISON OF TRAMADOL/ACETAMINOPHEN AND CODEINE/ACETAMINOPHEN/IBUPROFEN IN ONSET OF ANALGESIA AND ANALGESIC EFFICACY FOR POSTOPERATIVE ACUTE PAIN (수술후 급성 동통에 대한 Tramadol/Acetaminophen과 Codeine/Acetaminophen/Ibuprofen의 효과 발현시점과 진통효과의 비교)

  • Jung, Young-Soo;Kim, Dong-Kee;Kim, Moon-Key;Kim, Hyung-Jun;Cha, In-Ho;Han, Moo-Young;Lee, Eui-Wung
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.30 no.2
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    • pp.143-149
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    • 2004
  • Background: Some clinical trials have reported that a new analgesic combination of tramadol and acetaminophen provides good efficacy in various pain models. For the more clinical uses of this agent, comparisons about the onset of analgesia and analgesic efficacy in the acute state of pain with the other drugs known as strong analgesics were needed. Purpose: The goal of this study was to compare the times to onset of analgesia and the other analgesic efficacy of 75 mg tramadol/650 mg acetaminophen and 20 mg codeine/500 mg acetaminophen/400 mg ibuprofen in the treatment of acute pain after oral surgery. Patients and Methods: Using a randomized, single-dose, parallel-group, single-center, and active-controlled test design, this clinical study compared the times to onset of analgesia using a two-stopwatch technique and the other analgesic efficacy of the single-dose tramadol/acetaminophen and codeine/acetaminophen/ibuprofen. These were assessed in 128 healthy subjects with pain from oral surgical procedures involving extraction of one or more impacted third molars requiring bone removal. From the time of pain development, the times to onset of perceptible and meaningful pain relief, pain intensity, pain relief, an overall assessment, and adverse events of the study medications were recorded for 6 hours. Results: The demographic distribution and baseline pain data in the two groups were statistically similar. The median times to onset of perceptible pain relief were 21.0 and 24.4 minutes in the tramadol/acetaminophen and codeine/acetaminophen/ibuprofen groups respectively and those to onset of meaningful pain relief were 56.4 and 57.3 minutes, which were statistically similar. The other efficacy variables such as mean total pain relief (TOTPAR) and the sum of pain intensity differences (SPID) were also similar in the early period after pain development and drug dosing. The safety of tramadol/acetaminophen was well tolerated and very comparable to that of codeine/acetaminophen/ibuprofen. Conclusions: In this acute dental pain model, the onset of analgesia and analgesic efficacy of tramadol/acetaminophen was comparable to that of codeine/acetaminophen/ibuprofen. These results showed that tramadol/acetaminophen was recommendable for fast and effective treatment in the management of postoperative acute pain.

A study on the Legislations and Amendments of the Medical and Pharmaceutical Laws and Regulations - Focusing on the Duties of Korean (Oriental) Medicine Doctors and Korean (Oriental) Pharmacists as well as the Public Health System - (한의사·한약사 임무 및 공공제도 중심의 의약법규 제·개정 고찰)

  • Eom, Seok-Ki;Shin, Min-Seop;Kwon, Soon-Jo
    • The Journal of Korean Medical History
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    • v.26 no.2
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    • pp.175-185
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    • 2013
  • Purpose : The current Medical Law and the Pharmaceutical Affairs Act, which are incapable of utilizing the research results and the advanced academic, clinical, and pharmaceutical system of the present-day Korean (Oriental) medicine, have limitations and create a paradox by provoking social conflict among the professionals in the field. The aim of this study was to find out the legal and systematic problems that contributed to a complicated conflict amongst Korean (Oriental) medicine doctors, doctors, pharmacists, and Korean (Oriental) pharmacists regarding the classification of their functions. Methods : We reviewed the history and characteristics of the legislation regarding the duties of Korean (Oriental) medicine doctors and Korean (Oriental) pharmacists as well as the relevant and important public health policies since the enactment of the National Medical Services Law in 1951. We focused on the laws and regulations that are made in the process of the separating functions of physicians and pharmacists and the dispute between the Korean (Oriental) medicine doctors and the Korean (Oriental) pharmacists in the 1990s and 2000s. Results : The legislations and amendments of the medical and pharmaceutical laws and regulations that reflect the modern academic, clinical, and pharmaceutical system of the Korean (Oriental) medicine and the research results could be summarized as follows: 1) A partial amendment of the Medical Law in 1987, which added the provision of "Oriental health guidance" as one of the duties of Korean (Oriental) medicine doctors, assured a place for Korean (Oriental) medicine doctors in the field of public health. 2) A partial revision of Pharmaceutical Affairs Act in 1994 established a new system for Korean (Oriental) pharmacists, bringing about the creation of dualistic pharmaceutical system that complements the dualistic medical system. 3) The Promotion of the Research and Development of Wonder Drugs by Using Natural Substances Act was legislated in 2000 in order to stimulate research and development of Korean (Oriental) medicine and its industrialization. 4) Oriental Medicine Promotion Act in 2003 was enacted to lay foundation to specify and promote technology and industry that are related to Korean (Oriental) medicine. Discussions and conclusions : Although the dualistic medical and pharmaceutical system is set up by the Medical Law and Pharmaceutical Affairs Act, it is shown that the relevant regulations have been developed from a perspective of the western medicine.

Review of Allowable Condition of the Discretionary not Covered Service (임의비급여 허용요건에 관한 검토)

  • Park, Tae-Shin
    • The Korean Society of Law and Medicine
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    • v.13 no.2
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    • pp.11-38
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    • 2012
  • The Supreme Court stand in the position in specific lawsuit that it doesn't allow the discretionary not covered service, but recently in revocation suit of fine disposal that is imposed on medical fee of leukemia patient, it altered the existing adjudgement and admitted the discretionary not covered service exceptionally. It put forward the allowable condition roughly in that case. According as this alteration, it has become more important to embody the allowance conditions of exceptions. The Supreme Court presented three things, which are procedural condition, medical condition and subscriber's agreement. Concerning procedural condition, several present conciliation procedures are as follows: medical care benefit arret request, relative value conciliation etc, prior request on anti-cancer drug among chemicals which exceed acceptance criteria, request of non benefit object on common drugs. To be granted the existence of those system, there should be no obstacle to use that. Even if it were so, we should take circumstances into consideration; individual situation is unescapable concerning substance and urgency of the discretionary not covered service, process of the procedure, time required etc. Regarding medical condition, safety and effectiveness will be verified through evaluation procedures of new medical skill. About the necessity, the Supreme Court made clear through a sentence that it allow the discretionary not covered service, in case that needs to treat a patient out of the standard of medical benefit. Strict interpretation is right and it answer the purpose of the sentence that the supreme court permit the discretionary not covered service, exceptionally. We need to differentiate medical necessity and medical validity. Subscriber's agreement should holds true if it entails full explanation, and if it is preliminary, explicit and individual. On this account, it should be difficult to admit that someone agree effectively when he call for the affirmation that he is recipient of medical care. Reasonable expense needs to be a part of review whether the agreement is valid. Meanwhile If we adjust system of medical expense and eventually reorganize a fee for consultation payment system (Fee-for-service controlled by item to DRG (Diagnosis Related Groups)), controversial area of the discretionary not covered service will be decreased and that will guarantee the discretion of the doctor.

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Increasing Transnational Threats and Terrorism and Establishment of Integrated Border Security Systems: Focused on U.S., Canada and Australia (초국가적 위협 및 테러리즘 증가와 통합국경안보체계 구축: 미국, 캐나다, 호주를 중심으로)

  • Yoon, Taeyoung
    • Convergence Security Journal
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    • v.17 no.4
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    • pp.69-78
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    • 2017
  • Since the September 11, 2001, transnational crimes and terrorism have increased, the importance of border security has been emphasized and integrated CIQ capability has been required. The U.S., Canada, and Australia are consolidating CIQ to strengthen border security, focusing on strengthening travelers and goods immigration control and airports, ports and land border security. In 2003, the U.S. established the Customs and Border Protection(CBP) under the Department of Homeland Security. Canada also established the Canada Border Services Agency(CBSA) under the Public Safety Canada in 2003. The Australian Customs and Border Protection Service was integrated with the Department of Immigration and Border Protection(DIBP) and the Australian Border Force was established in 2015. However, Korea operates a distributed border management system for each CIQ task which is unable to respond to complex border threats such as illegal immigration, entry of terrorists, smuggling of drugs, and gun trade in the airports, ports and land borders. In order to solve this problem, it is possible to consider integrating sequentially the customs and quarantine services which have high similarities, and to integrate the entire CIQ tasks with the Korea Customs Service delegated to the immigration control duties in the mid to long term. There is also a plan to benchmark the CIQ single accountability agencies in the U.S., Canada, and Australia in accordance with the Korean situation and to establish a new integrated border security organization.

Verification of the Correlation between Progression-free Survival and Overall Survival Considering Magnitudes of Survival Post-progression in the Treatment of Four Types of Cancer

  • Liu, Li-Ya;Yu, Hao;Bai, Jian-Ling;Zeng, Ping;Miao, Dan-Dan;Chen, Feng
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.3
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    • pp.1001-1006
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    • 2015
  • Background: With development and application of new and effective anti-cancer drugs, the median survival post-progression (SPP) is often prolonged, and the role of the median SPP on surrogacy performance should be considered. To evaluate the impact of the median SPP on the correlation between progression-free survival (PFS) and overall survival (OS), we performed simulations for treatment of four types of cancer, advanced gastric cancer (AGC), metastatic colorectal cancer (MCC), glioblastoma (GBM), and advanced non-small-cell lung cancer (ANSCLC). Materials and Methods: The effects of the median SPP on the statistical properties of OS and the correlation between PFS and OS were assessed. Further, comparisons were made between the surrogacy performance based on real data from meta-analyses and simulation results with similar scenarios. Results: The probability of a significant gain in OS and HR for OS was decreased by an increase of the SPP/OS ratio or by a decrease of observed treatment benefit for PFS. Similarly, for each of the four types of cancer, the correlation between PFS and OS was reduced as the median SPP increased from 2 to 12 months. Except for ANSCLC, for which the median SPP was equal to the true value, the simulated correlation between PFS and OS was consistent with the values derived from meta-analyses for the other three kinds of cancer. Further, for these three types of cancer, when the median SPP was controlled at a designated level (i.e., < 4 months for AGC, < 12 months for MCC, and <6 months for GBM), the correlation between PFS and OS was strong; and the power of OS reached 34.9% at the minimum. Conclusions: PFS is an acceptable surrogate endpoint for OS under the condition of controlling SPPs for AGC, MCC, and GBM at their limit levels; a similar conclusion cannot be made for ANSCLC.

Retinoid Receptors in Gastric Cancer: Expression and Influence on Prognosis

  • Hu, Kong-Wang;Chen, Fei-Hu;Ge, Jin-Fang;Cao, Li-Yu;Li, Hao
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.5
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    • pp.1809-1817
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    • 2012
  • Background: Gastric cancer is frequently lethal despite aggressive multimodal therapies, and new treatment approaches are therefore needed. Retinoids are potential candidate drugs: they prevent cell differentiation, proliferation and malignant transformation in gastric cancer cell lines. They interact with nuclear retinoid receptors (the retinoic acid receptors [RARs] and retinoid X receptors [RXRs]), which function as transcription factors, each with three subclasses, ${\alpha}$, ${\beta}$ and ${\gamma}$. At present, little is known about retinoid expression and influence on prognosis in gastric cancers. Patients and Methods: We retrospectively analyzed the expression of the subtypes RARa, $RAR{\beta}$, $RAR{\gamma}$, RXRa, $RXR{\beta}$, $RXR{\gamma}$ by immunohistochemistry in 147 gastric cancers and 51 normal gastric epithelium tissues for whom clinical follow-up data were available and correlated the results with clinical characteristics. In addition, we quantified the expression of retinoid receptor mRNA using real-time PCR (RT-PCR) in another 6 gastric adenocarcinoma and 3 normal gastric tissues. From 2008 to 2010, 80 patients with gastric cancers were enrolled onto therapy with all-trans-retinoic acid (ATRA). Results: RARa, $RAR{\beta}$, $RAR{\gamma}$ and $RXR{\gamma}$ positively correlated with each other (p < 0.001) and demonstrated significantly lower levels in the carcinoma tissue sections (p < 0.01), with lower $RAR{\beta}$, $RAR{\gamma}$ and RXRa expression significantly related to advanced stages (p < =0.01). Tumors with poor histopathologic grade had lower levels of RARa and $RAR{\beta}$ in different histological types of gastric carcinoma (p < 0.01). Patients whose tumors exhibited low levels of RARa expression had significantly lower overall survival compared with patients who had higher expression levels of this receptor (p < 0.001, HR=0.42, 95.0% CI 0.24-0.73), and patients undergoing ATRA treatment had significantly longer median survival times (p = 0.007, HR=0.41, 95.0% CI 0.21-0.80). Conclusions: Retinoic acid receptors are frequently expressed in epithelial gastric cancer with a decreased tendency of expression and RARa may be an indicator of a positive prognosis. This study provides a molecular basis for the therapeutic use of retinoids against gastric cancer.

Knockdown of Archvillin by siRNA Inhibits Myofibril Assembly in Cultured Skeletal Myoblast

  • Lee, Yeong-Mi;Kim, Hyun-Suk;Choi, Jun-Hyuk;Choi, Jae-Kyoung;Joo, Young-Mi;Ahn, Seung-Ju;Min, Byung-In;Kim, Chong-Rak
    • Biomedical Science Letters
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    • v.13 no.4
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    • pp.251-261
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    • 2007
  • A myofiber of skeletal muscle is composed of myofibrils, sarcolemma (plasma membrane), and constameres, which anchor the myofibrils to the sarcolemma. Achvillin is a recently identified F-actin binding muscle protein, co-isolates with dystrophin and caveolin-3 in low-density sarcolemma of striated muscle, and colocalizes with dystrophin at costameres, the specialized adhesion sites in muscle. Archvillin also binds to nebulin and localizes at myofibrillar Z-discs, the lateral boundaries of the sarcomere in muscle. However other roles of archvillin on the dynamics of myofibrillogenesis remain to be defined. The goal of this study is, by using siRNA-mediated gene silencing technique, to investigate the effect of archvillin on the dynamics of myofibrillogenesis in cell culture of a mouse skeletal myogenic cell line (C2C12), where presumptive myoblasts withdraw from the cell cycle, fuse, undergo de novo myofibrillogenesis, and differentiate into mature myotubes. The roles of archvillin in the assembly and maintenance of myofibril and during the progression of myofibrillogenesis induced in skeletal myoblast following gene silencing in the cell culture were investigated. Fluorescence microscopy demonstrated that the distribution of archvillin was changed along the course of myofibril assembly with nebulin, vinculin and F-actin and then located at Z-lines with nebulin. Fluorescence microscopy demonstrated that knockdown of mouse archvillin expression led to an impaired assembly of new myofibrillar clusters and delayed fusion and myofibrillogenesis although the mouse archvillin siRNA did not affect those expressions of archvillin binding proteins, such as nebulin and F-actin. This result is corresponded with that of RT-PCR and western blots. When the perturbed archvillin was rescued by co-transfection with GFP or Red tagged human archvillin construct, the inhibited cell fusion and myotube formation was recovered. By using siRNA technique, archvillin was found to be involved in early stage of myofibrillogenesis. Therefore, the current data suggest the idea that archvillin plays critical roles on cell fusion and dynamic myofibril assembly.

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Mad1p, a Component of the Spindle Assembly Checkpoint in Fission Yeast, Suppresses a Novel Septation-defective Mutant, sun1, in a Cell Division Cycle

  • Kim In G.;Rhee Dong K.;Jeong Jae W.;Kim Seong C.;Won Mi S.;Song Ki W.;Kim Hyong B.
    • Proceedings of the Microbiological Society of Korea Conference
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    • 2002.10a
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    • pp.162-172
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    • 2002
  • Schizosaccharomyces pombe is suited for the study of cytokinesis as it divides by forming a septum in the middle of the cell at the end of mitosis. To enhance our understanding of the cytokinesis, we have carried out a genetic screen for temperature-sensitive S. pombe mutants that show defects in septum formation and cell division. Here we present the isolation and characterization of a new temperature-sensitive mutant, sun1(septum uncontrolled), which undergoes uncontrolled septation during cell division cycle at restrictive temperature $(37^{\circ}C)$. In sun1 mutant, actin ring and septum are positioned at random locations and angles, and nuclear division cycle continues. These observations suggest that the sun] gene product is required for the proper placement of the actin ring as well as precise septation. The sun] mutant is monogenic recessive mutation unlinked to previously known various cdc genes of S. pombe. In a screen for $sunl^+$ gene to complement the sun] mutant, we have cloned a gene, $susl^+$(suppressor of sun1 mutant), that encodes a protein of 689 amino acids. The predicted amino acid sequence of $susl^+$ gene is similar to the human hMadlp and Saccharomyces cerevisiae Mad1p, a component of the spindle checkpoint in eukaryotic cells. The null mutant of $susl^+$ gene grows normally at various temperatures and has the increased sensitivity to anti-microtubule drug, while $susl^+$ mutant shows no sensitivity to microtubule destabilizing drugs. The putative S. pombe Sus1p directly interacts with S. pombe Mad2p in yeast two-hybrid assays. These data suggest that the newly isolated susr gene encodes S. pombe Mad1p and suppresses sun] mutant defective in controlled septation in a cell division cycle.

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Comparative Study on the Regulations about In-Use Stability, and Analysis the In-Use Stability Application on Approved Syrups - Focused on the Guidelines in US, Europe and Korea - (국내외 의약품 개봉 후 안정성 규정 비교와 국내 시럽제의 안정성 적용 현황 분석 - 미국, 유럽, 한국의 가이드라인을 중심으로 -)

  • Park, Onnuri;Jang, Kyoung won;Ha, Dong mun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.3
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    • pp.137-146
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    • 2020
  • Syrup agents are often used after opening, and therefore, there is a high possibility of decreased quality. The Ministry of Food and Drug Safety (MFDS) published guideline on stability testing for pharmaceuticals after opening in December, 2016. We compared guidelines related to the period of use after opening between the United States of America (USA), Europe (EU), and Korea, and we analyzed whether the period of use or storage conditions is stated based on the data of drug approval for 4 dry syrups and 3 large packing syrups before and after the introduction of the guideline. First, in USA and EU, the period of use and storage conditions after opening should be listed on the label on the packaging container (as well as the expiration date), while in Korea, those are included in the area of precautions for use. Second, all of the analyzed drugs were not changed by the guidelines for establishing the new post-opening period of use, and they were only presented for the existing expiration date prior to the establishment of the guideline. Medicines that are used for multiple uses after opening may need improved instructions to ensure that the period of use and storage conditions are listed on the packaging according to stability evaluation after opening.

Establishment of ethanol-pretreating animal model to study Helicobacter pylori infection (Helicobacter pylori의 in vivo 연구를 위한 ethanol-pretreating animal model의 개발)

  • Lee, Jin-Uk;Kim, Seung-Hee;Park, Tan-Woo;Kim, Okjin
    • Korean Journal of Veterinary Research
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    • v.46 no.4
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    • pp.327-335
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    • 2006
  • A stable and reliable Helicobacter pylori (H. pylori) infection animal model would be necessary for evaluating vaccine efficacy and helpful for understanding the pathological mechanism of the organism. The aim of the present study is to investigate the effect of ethanol treatment prior to H. pylori inoculation on associated gastric mucosal injury and to establish ethanol-pretreating animal model to study H. pylori infection. Male Mongolian gerbils were used for the study. H. pylori was orally inoculated after 12 h fasting. 3 h prior to H. pylori inoculation, a group of gerbils was orally treated with absolute ethanol, 60% and 40% ethanol respectively. Another group of animals was treated either with H. pylori culture media alone or with different concentrations of ethanol plus culture media. Gerbils were killed 4 or 8 weeks after H. pylori inoculation. The colonization of H. pylori was confirmed by both histological examination and rapid urease test. Mucosal damage was evaluated grossly and histologically according to the criteria. The colonization of H. pylori and pathological changes in gastric mucosa of the animals were also observed. Although no significant change to the gastric mucose was observed in the animals treated either with H. pylori culture media alone or with different concentrations of ethanol plus culture media, persistent H. pylori infection was seen in the mucosa and mucosal leucocyte infiltration and severe epithelial damage was observed in the Helicobacter and ethanol + Helicobacter groups after 4 weeks. The gross and histological scores were higher in the ethanol + Helicobacter than in the Helicobacter alone group. As the results, ethanol-pretreatment with 60% concentration induced severe pathogenic changes by H. pylori infection in 5 weeks-old Mongolian gerbils. These results suggested that ethanol-pretreatment before H. pylori inoculation could increase the severity of gastric mucosal inflammation and enhance the colonization of H. pylori. The established ethanol-pretreating animal model would contribute to screen new drugs against H. pylori and be used as an useful tool for various animal experiments with H. pylori strains.