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A Randomized, Double-Blind Study to Assess the Efficacy and Safety of Oral LB20304 (Gemifloxacin) at Doses of 160mg or 320mg (Equivalent to 200mg or 400mg of the Mesylate Salt) Once Daily for 7 Days for the Treatment of Acute Exacerbations of Chronic Bronchitis (AECB) in Korean Adult Population (한국인에서 만성기관지염의 급성악화를 치료하기 위한 LB20304(Gemifloxacin) 160mg 또는 320mg 1일 1회 7일간 투여의 유효성과 안전성에 대한 연구)

  • Kim, Young Whan;Shim, Young-Soo;Kim, Won Dong;Shim, Tae Sun;Kang, Hong Mo;Choi, ByoungWhui;Kim, Jae-Yeol;Kwon, O Jung;Kim, Hojoong;Kim, Ju Ock;Jung, Ki-Suck;Hyeon, In Gyou;Mo, Eun Kyung;Lee, Seung-Joon;Nam, Gui Hyun;Lee, Kye Young;Park, Jae Seuk
    • Tuberculosis and Respiratory Diseases
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    • v.55 no.1
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    • pp.69-87
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    • 2003
  • Background : LB20304(gemifloxacin) is a new fluoroquinolone antibacterial agent with excellent activity against both Gram-negative and Gram-positive organisms. In vitro studies using clinical isolates have shown gemifloxacin to be highly active against penicillin-resistant strains of S. pneumoniae and in contrast to other reference quinolones, gemifloxacin retained good activity against clinical isolates of S. pneumoniae that were resistant to other members of the quinolone class. Therefore, gemifloxacin is thought to be effective in treating acute bacterial exacerbation of chronic bronchitis(AECB). The objective of this study was to evaluate the efficacy and safety of oral gemifloxacin at doses of 160mg or 320mg once daily for 7 days for the treatment of AECB in Korean adult population. Methods : This was a randomized, multicenter, double-blind, parallel group Phase II study to assess the clinical and antibacterial efficacy and safety of oral gemifloxacin for the treatment of AECB. Treatment Group A (67 patients) took oral gemifloxacin 160mg once daily for seven days and treatment Group B (70 patients) took oral gemifloxacin 320mg once daily for seven days. Results : The demographic profiles of the two treatment groups were similar. The clinical response at follow-up was 84.2% in the gemifloxacin 160-mg group, and 88.7% in the gemifloxacin-320 mg group, showing no statistically significant difference between two treatment groups(p=0.49). The clinical response at the end of therapy was 96.5% in the 160-mg group, and 96.4% in the 320-mg group. The bacteriological response at the end of therapy and follow-up were 81.8% and 78.9%, respectively, in the 160-mg group, and 86.4% and 84.2%, respectively, in the 320-mg group, showing no statistically significant difference between two treatment groups(p=0.68 and 0.68, respectively). S. pneumoniae(12 isolates) and H. influenzae(10 isolates) were the most prevalent pathogens. The MICs were lower for gemifloxacin than other quinolones against these key pathogens, and for S. pneumoniae, the MICs for gemifloxacin were considerably lower(${\leq}0.03$ ug/mL) than those for other quinolones, beta-lactams and macrolides. In the period on-therapy plus 30 days post-therapy, a total of 18 patients(26.9%) in the gemifloxacin 160mg group and 22 patients(31.4%) in the 320mg group reported at least one adverse event(AE). The most frequently reported AE was abdominal pain(3/67 patients, 4.5%) in the gemifloxacin 160mg group and increased level of hepatic enzyme(5/70 patients, 7.1%) in the 320mg group. The overall AE profiles for the two treatment groups were similar. Two out of 67 patients(3.0%) in the gemifloxacin 160mg group and 1/70 patients(1.4%) in the 320mg group reported at least one serious AE, however, none of which was considered by the investigator to be of suspected or probable relationship to study medication. Conclusion : The results of this study showed that gemifloxacin at doses of 160mg or 320mg once daily for 7 days in the treatment of acute exacerbations of chronic bronchitis(AECB) in adult Koreans was a very effective and safe treatment both clinically and bacteriologically.

The National Survey of Open Lung Biopsy and Thoracoscopic Lung Biopsy in Korea (개흉 및 흉강경항폐생검의 전국실태조사)

  • 대한결핵 및 호흡기학회 학술위원회
    • Tuberculosis and Respiratory Diseases
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    • v.45 no.1
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    • pp.5-19
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    • 1998
  • Introduction: Direct histologic and bacteriologic examination of a representative specimen of lung tissue is the only certain method of providing an accurate diagnosis in various pulmonary diseases including diffuse pulmonary diseases. The purpose of national survey was to define the indication, incidence, effectiveness, safety and complication of open and thoracoscopic lung biopsy in korea. Methods: A multicenter registry of 37 university or general hospitals equipped more than 400 patient's bed were retrospectively collected and analyzed for 3 years from the January 1994 to December 1996 using the same registry protocol. Results: 1) There were 511 cases from the 37 hospitals during 3 years. The mean age was 50.2 years(${\pm}15.1$ years) and men was more prevalent than women(54.9% vs 45.9%). 2) The open lung biopsy was performed in 313 cases(62%) and thoracoscopic lung biopsy was performed in 192 cases(38%). The incidence of lung biopsy was more higher in diffuse lung disease(305 cases, 59.7%) than in localized lung disease(206 cases, 40.3%) 3) The duration after abnormalities was found in chest X-ray until lung biopsy was 82.4 days(open lung biopsy: 72.8 days, thoracoscopic lung biopsy: 99.4 days). The bronchoscopy was performed in 272 cases(53.2%), bronchoalveolar lavage was performed in 123 cases(24.1%) and percutaneous lung biopsy was performed in 72 cases(14.1%) before open or thoracoscopic lung biopsy. 4) There were 230 cases(45.0%) of interstitial lung disease, 133 cases(26.0%) of thoracic malignancies, 118 cases(23.1%) of infectious lung disease including tuberculosis and 30 cases (5.9 %) of other lung diseases including congenital anomalies. No significant differences were noted in diagnostic rate and disease characteristics between open lung biopsy and thoracoscopic lung biopsy. 5) The final diagnosis through an open or thoracoscopic lung biopsy was as same as the presumptive diagnosis before the biopsy in 302 cases(59.2%). The identical diagnostic rate was 66.5% in interstitial lung diseases, 58.7% in thoracic malignancies, 32.7% in lung infections, 55.1 % in pulmonary tuberculosis, 62.5% in other lung diseases including congenital anomalies. 6) One days after lung biopsy, $PaCO_2$ was increased from the prebiopsy level of $38.9{\pm}5.8mmHg$ to the $40.2{\pm}7.1mmHg$(P<0.05) and $PaO_2/FiO_2$ was decreased from the prebiopsy level of $380.3{\pm}109.3mmHg$ to the $339.2{\pm}138.2mmHg$(P=0.01). 7) There was a 10.1 % of complication after lung biopsy. The complication rate in open lung biopsy was much higher than in thoracoscopic lung biopsy(12.4% vs 5.8%, P<0.05). The incidence of complication was pneumothorax(23 cases, 4.6%), hemothorax(7 cases, 1.4%), death(6 cases, 1.2%) and others(15 cases, 2.9%). 8) The 5 cases of death due to lung biopsy were associated with open lung biopsy and one fatal case did not describe the method of lung biopsy. The underlying disease was 3 cases of thoracic malignancies(2 cases of bronchoalveolar cell cancer and one malignant mesothelioma), 2 cases of metastatic lung cancer, and one interstitial lung disease. The duration between open lung biopsy and death was $15.5{\pm}9.9$ days. 9) Despite the lung biopsy, 19 cases (3.7%) could not diagnosed. These findings were caused by biopsy was taken other than target lesion(5 cases), too small size to interpretate(3 cases), pathologic inability(11 cases). 10) The contribution of open or thoracoscopic lung biopsy to the final diagnosis was defininitely helpful(334 cases, 66.5%), moderately helpful(140 cases, 27.9%), not helpful or impossible to judge(28 cases, 5.6%). Overall, open or thoracoscopic lung biopsy were helpful to diagnose the lung lesion in 94.4 % of total cases. Conclusions: The open or thoracoscopic lung biopsy were relatively safe and reliable diagnostic method of lung lesion which could not diagnosed by other diagnostic approaches such as bronchoscopy. We recommend the thoracoscopic lung biopsy when the patients were in critical condition because the thoracoscopic biopsy was more safe and have equal diagnostic results compared with the open lung biopsy.

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Review of the Korean Indigenous Species Investigation Project (2006-2020) by the National Institute of Biological Resources under the Ministry of Environment, Republic of Korea (한반도 자생생물 조사·발굴 연구사업 고찰(2006~2020))

  • Bae, Yeon Jae;Cho, Kijong;Min, Gi-Sik;Kim, Byung-Jik;Hyun, Jin-Oh;Lee, Jin Hwan;Lee, Hyang Burm;Yoon, Jung-Hoon;Hwang, Jeong Mi;Yum, Jin Hwa
    • Korean Journal of Environmental Biology
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    • v.39 no.1
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    • pp.119-135
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    • 2021
  • Korea has stepped up efforts to investigate and catalog its flora and fauna to conserve the biodiversity of the Korean Peninsula and secure biological resources since the ratification of the Convention on Biological Diversity (CBD) in 1992 and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits (ABS) in 2010. Thus, after its establishment in 2007, the National Institute of Biological Resources (NIBR) of the Ministry of Environment of Korea initiated a project called the Korean Indigenous Species Investigation Project to investigate indigenous species on the Korean Peninsula. For 15 years since its beginning in 2006, this project has been carried out in five phases, Phase 1 from 2006-2008, Phase 2 from 2009-2011, Phase 3 from 2012-2014, Phase 4 from 2015-2017, and Phase 5 from 2018-2020. Before this project, in 2006, the number of indigenous species surveyed was 29,916. The figure was cumulatively aggregated at the end of each phase as 33,253 species for Phase 1 (2008), 38,011 species for Phase 2 (2011), 42,756 species for Phase 3 (2014), 49,027 species for Phase 4 (2017), and 54,428 species for Phase 5(2020). The number of indigenous species surveyed grew rapidly, showing an approximately 1.8-fold increase as the project progressed. These statistics showed an annual average of 2,320 newly recorded species during the project period. Among the recorded species, a total of 5,242 new species were reported in scientific publications, a great scientific achievement. During this project period, newly recorded species on the Korean Peninsula were identified using the recent taxonomic classifications as follows: 4,440 insect species (including 988 new species), 4,333 invertebrate species except for insects (including 1,492 new species), 98 vertebrate species (fish) (including nine new species), 309 plant species (including 176 vascular plant species, 133 bryophyte species, and 39 new species), 1,916 algae species (including 178 new species), 1,716 fungi and lichen species(including 309 new species), and 4,812 prokaryotic species (including 2,226 new species). The number of collected biological specimens in each phase was aggregated as follows: 247,226 for Phase 1 (2008), 207,827 for Phase 2 (2011), 287,133 for Phase 3 (2014), 244,920 for Phase 4(2017), and 144,333 for Phase 5(2020). A total of 1,131,439 specimens were obtained with an annual average of 75,429. More specifically, 281,054 insect specimens, 194,667 invertebrate specimens (except for insects), 40,100 fish specimens, 378,251 plant specimens, 140,490 algae specimens, 61,695 fungi specimens, and 35,182 prokaryotic specimens were collected. The cumulative number of researchers, which were nearly all professional taxonomists and graduate students majoring in taxonomy across the country, involved in this project was around 5,000, with an annual average of 395. The number of researchers/assistant researchers or mainly graduate students participating in Phase 1 was 597/268; 522/191 in Phase 2; 939/292 in Phase 3; 575/852 in Phase 4; and 601/1,097 in Phase 5. During this project period, 3,488 papers were published in major scientific journals. Of these, 2,320 papers were published in domestic journals and 1,168 papers were published in Science Citation Index(SCI) journals. During the project period, a total of 83.3 billion won (annual average of 5.5 billion won) or approximately US $75 million (annual average of US $5 million) was invested in investigating indigenous species and collecting specimens. This project was a large-scale research study led by the Korean government. It is considered to be a successful example of Korea's compressed development as it attracted almost all of the taxonomists in Korea and made remarkable achievements with a massive budget in a short time. The results from this project led to the National List of Species of Korea, where all species were organized by taxonomic classification. Information regarding the National List of Species of Korea is available to experts, students, and the general public (https://species.nibr.go.kr/index.do). The information, including descriptions, DNA sequences, habitats, distributions, ecological aspects, images, and multimedia, has been digitized, making contributions to scientific advancement in research fields such as phylogenetics and evolution. The species information also serves as a basis for projects aimed at species distribution and biological monitoring such as climate-sensitive biological indicator species. Moreover, the species information helps bio-industries search for useful biological resources. The most meaningful achievement of this project can be in providing support for nurturing young taxonomists like graduate students. This project has continued for the past 15 years and is still ongoing. Efforts to address issues, including species misidentification and invalid synonyms, still have to be made to enhance taxonomic research. Research needs to be conducted to investigate another 50,000 species out of the estimated 100,000 indigenous species on the Korean Peninsula.

Experimental Studies on the Antitumor Effects of Jinryungtang Gagambang Extract (진령탕가감방의 항종양효과(抗腫瘍效果)에 관(關)한 실험적(實驗的) 연구(硏究))

  • Jeong, Jun-Tak;Moon, Goo;Moon, Suk-Jae
    • THE JOURNAL OF KOREAN ORIENTAL ONCOLOGY
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    • v.4 no.1
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    • pp.37-53
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    • 1998
  • The sprig of Jinryungtang Gagambang has been used for curing as a traditional medicine without any experimental evidence to support the rational basis for their clinical use. This experiment was carried out to evaluate the possible therapeutic or antitumoral effects of Jinryungtang Gagambang extract against cancer, and to study some mechanisms responsible for its effect. The cytotoxic and antitumor effects were evaluated on human cell liens (A549, hep3B, Caki-1, Sarcoma 180) after exposure to Jinryungtang Gagambang extract using in ILS, colony forming efficency and SRB assay which were regarded as a valuable method for cytotoxic and antitumor effects of unknown compound on tumor cell lines. The results obtained in this studies were as follows. 1. As a result of exposure to Jinryungtang Gagambang extract, the proliferation of A549, hep3B, Caki-1, good correlations were shown from the results of SRB assay and those of clogenetic assay. 2. The oral administration of Jinryungtang Gagambang extract showed significant effects of increase of MST(mean survival time) and ILS(increased life span) depending on the increasing concentration. 3. Against squamous cell carcinoma induced by MCA, Jinryungtang Gagambang decreased not only the frequency of tumor production but also the number and weight of tumors per tumor bearing mice(TBM). Jinryungtang Gagambang also significantly suppressed the development of 3LL cell-implanted tumors by frequency and their size, and some developed tumors were regressed by the continuous treatment of Jinryungtang Gagambang extract into TBM. 4. Jinryungtang Gagambang extract also increased NK cell activities. According to the above results, it could be suggested that Jinryungtang Gagambang extract has prominent antiutmor effect.

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A Study of the Time-Space and Appreciation for the Performance Culture of Gwanseo Region in Late Joseon Period: Focusing on Analysis of Terminology (조선후기 관서지방의 공연 시공간과 향유에 관한 연구)

  • Song, Hye-jin
    • (The) Research of the performance art and culture
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    • no.22
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    • pp.287-325
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    • 2011
  • This paper studies the time-space and appreciation of the performance culture of Gwanseo region, which is considered to have formed a characteristic culture in late Joseon period. For this purpose, 4 gasa written in hangeul (Korean alphabet), as well as 4 yeonhaeng gasa, 108 articles of Gwanseoakbu were examined. Plus, among the 9 types of yeonhaengrok (Documents of Performance culture) written in Chinese character, those parts which describe the performance traits have been analyzed. Then, 'main list of terminology' has been deduced based on the categorization according to the following points : 1) subjects of performance and appreciation 2) time and period of performance 3) space of performance 4) contents of performance 5) background and motive for performance and 6) method of performance. Through this process, various 'nouns' and 'predicate verbs' in relation to performance culture emerged, which were systemized according to types of performance elements and categories. Major terminology includes predicate verbs and symbolic verbs such as nokuihongsang,' 'baekdaehongjang,' 'jeolsaekgeumga,' 'cheonga,' 'hwaryu,' 'gamuja,' and 'tongsoja,' as well as the terms already known such as gisaeng, iwon, yangbang, akgong, and jeonak, which refer to musicians and dancers. Subjects of performance were divided into performers and listeners, categorized into concert, music, and dance, according to performance form. In the case for music, it was divided into instrumental or vocal, solo or accompanied (byeongju, self-accompaniment). In the case for vocal music, noteworthy was the inclusion of profesional artist's singing (called gwangdae or uchang). The record of 23 names of popular artists from Gwanseo region, with mention of special talents for each person, reflects the degree of activeness and artistic level of the province. Depending on the appreciating patrons, the audience were indicated as the terms including 'yugaek (party guest),' jwasang,' 'on jwaseok,' and 'sonnim (guests).' It seems that appraisal for a certain performance was very much affected by the tastes, views, and disposition of the appreciating patrons. Therefore it is interesting to observe different comparative reviews of concerts of different regions given by literary figures, offering various criticism on identical performance. In terms of performance space, it has been divided into natural or architectural space, doing justice to special performance sites such as a famous pavilion or an on-the-boat performance. Specific terms related to the scale and brightness of stage, as well as stage props and cast, based on descriptions of performance space were found. The performance space, including famous pavilions; Yeongwangjeong, Bubyeokru, Baeksangru, Wolparu, and Uigeomjeong, which are all well-known tourist sites of Gwanseo province, have been often visited by viceroys. governors, and envoys during a tour or trip. This, and the fact that full-scale performances were regularly held here, and that more than 15 different kinds of boats which were used for boat concert are mentioned, all confirm the general popularity of boat concerts at the time. Performance time, categorized by season or time of day (am/pm/night) and analyzed in terms of time of occurrence and duration, there were no special limitation as to when to have a performance. Most morning concerts were held as part of official duties for the envoys, after their meeting session, whereas evening concerts were more lengthy in duration, with a greater number of people in the audience. In the case of boat concert, samples include day-time concert and performances that began during the day and which lasted till later in the evening. Major terminology related to performance time and season includes descriptions of time of day (morning, evening, night) and mention of sunset, twilight, moonlight, stars, candles, and lamps. Such terms which reflect the flow of time contributed in making a concert more lively. Terminology for the contents of performance was mostly words like 'instrumental,' 'pungak,' or 'pungnyu.' Besides, contextual expressions gave hints as to whether there were dance, singing, ensemble, solo, and duets. Words for dance and singing used in Gwanseo province were almost identical to those used for gasa and jeongjae in the capital, Hanyang. However, many sentences reveal that performances of 'hangjangmu' of hongmunyeon, sword dance, and baettaragi were on a top-quality level. Moreover, chants in hanmun Chinese character and folk songs, which are characteristic for this region, show unique features of local musical performance. It is judged that understanding the purpose and background of a performance is important in grasping the foundation and continuity of local culture. Concerts were usually either related to official protocol for 'greeting,' 'sending-off,' 'reports,' and 'patrols' or for private enjoyment. The rituals for Gwanseo province characteristically features river crossing ceremony on the Daedong river, which has been closely documented by many. What is more, the Gwanseo region featured continued coming and goings of Pyeongan envoys and local officers, as well as ambassadors to and fro China, which required an organized and full-scale performance of music and dance. The method of performance varied from a large-scale, official ones, for which female entertainers and a great banquet in addition to musicians were required, to private gatherings that are more intimate. A performance may take the form of 'taking turns' or 'a competition,' reflecting the dynamic nature of the musical culture at the time. This study, which is deduction of terminology in relation to the time-space and appreciation culture of musical performances of Gwanseo region in late Joseon period, should be expanded in the future into research on 'the performance culture unique to Gwanseo region,' in relation to the financial and administrative aspects of the province, as well as everyday lifestyle. Furthermore, it could proceed to a more intensive research by a comparative study with related literary documents and pictorial data, which could serve as the foundation for understanding the use of space and stage, as well as the performance format characteristic to Korean traditional performing arts.