• Title/Summary/Keyword: Food and Drug Administration (FDA)

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Reviews of Radiation Protection and Shielding for Computed Tomography in Foreign Countries (외국의 컴퓨터 단층촬영 장치의 방어시설 문헌 조사)

  • Jahng, Geon-Ho;Yang, Dal-Mo;Sung, Dong-Wook;Lee, Kwang-Yong;Kim, Hyeog-Ju
    • Progress in Medical Physics
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    • v.19 no.4
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    • pp.276-284
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    • 2008
  • A computed tomography (CT) is a powerful system for the effectively fast and accurate diagnosis. The CT system, therefore, has used substantially and developed for improving the performance over the past decade, resulting in growing concerns over the radiation dose from the CT. Advanced CT techniques, such as a multidetector row CT scanner and dual energy or dual source CT, have led to new clinical applications that could result in further increases of radiation does for both patients and workers. The objective of this study was to review the international guidelines of the shielding requirements for a CT facility required for a new installation or when modifying an existing one. We used Google Search Engine to search the following keywords: computed tomography, CT regulation or shield or protection, dual energy or dual source CT, multidetector CT, CT radiation protection, and regulatory or legislation or regulation CT. In addition, we searched some special websites, that were provided for sources of radiation protection, shielding, and regulation, RSNA, AAPM, FDA, NIH, RCR, ICRP, IRPA, ICRP, IAEA, WHO (See in Table 1 for full explanations of the abbreviations). We finally summarized results of the investigated materials for each country. The shielding requirement of the CT room design was very well documented in the countries of Canada, United States of America, and United Kingdom. The wall thickness of the CT room could be obtained by the iso-exposure contour or the point source method. Most of documents provided by international organizations were explained in importance of radiation reduction in patients and workers. However, there were no directly-related documents of shielding and patient exposure dose for the dual energy CT system. Based international guidelines, the guideline of the CT room shielding and radiation reduction in patients and workers should be specified for all kinds of CT systems, included in the dual energy CT. We proposed some possible strategies in this paper.

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Dabigatran Toxicity Secondary to Acute Kidney Injury (급성신손상으로 인해 발생한 dabigatran 독성)

  • Moon, Hyoung Ho;Lee, Seung Eun;Oh, Dong Jun;Jo, Hee Bum;Kwon, Ki Hwan;Kim, Yoon Jin;Kim, Kyung Soo;Shin, Sung Joon
    • Journal of The Korean Society of Clinical Toxicology
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    • v.12 no.2
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    • pp.92-96
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    • 2014
  • Dabigatran is the first oral direct thrombin inhibitor approved by the US Food and Drug Administration (FDA) for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Because dabigatran is excreted mainly by the kidneys, serum levels of dabigatran can be elevated to a supratherapeutic range in patients with renal failure, predisposing to emergent bleeding. We describe the case of a 66-year-old man taking dabigatran 150 mg twice daily for atrial fibrillation and cerebral infarction who presented with hematochezia and disseminated intravascular coagulation. Laboratory evaluation showed a hemoglobin level of 6.3 g/dL, platelets of $138,000/mm^3$, activated partial thromboplastin time (aPTT) of 10 s, and an international normalized ratio (INR) of 8.17. Colonoscopy showed a bleeding anal fissure. Hemostasis was provided by hemoclips and packed red blood cells and fresh frozen plasma were transfused. Since then, there was no further hematochezia, however, bleeding including oral mucosal bleeding, hematuria, and intravenous site bleeding persisted. At presentation, his serum creatinine was 4.96 mg/dL (baseline creatinine, 0.9 mg/dL). Dabigatran toxicity secondary to acute kidney injury was presumed. Because acute kidney injury of unknown cause was progressing after admission, he was treated with hemodialysis. Fresh frozen plasma transfusion was provided with hemodialysis. At 15 days from admission, there was no further bleeding, and laboratory values, including hemoglobin, partial thromboplastin time, and prothrombin time were normalized. He was discharged without bleeding. After 2 months, he undergoes dialysis three times per week and no recurrence of bleeding has been observed.

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Effect of Sodium Hydroxide Treatment on Scaffold by Solid Freeform Fabrication (조형가공기술을 이용한 인공지지체의 수산화나트륨 개질 효과)

  • Park, SuA;Lee, JungBok;Kim, YangEun;Kim, JiEun;Kwon, IlKeun;Lee, JunHee;Kim, WanDoo;Kim, HyungKeun;Kim, MiEun;Lee, JunSik
    • Polymer(Korea)
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    • v.38 no.6
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    • pp.815-819
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    • 2014
  • Scaffolds of tissue engineering should be biocompatible and biodegradable for cell attachment, proliferation and differentiation. In the various scaffold fabrication, 3D printing technique can make the three dimensional scaffold with interconnected pores for cell ingrowth. Polycaprolactone (PCL) is biodegradable polyester with a low melting temperature and has been approved by the Food and Drug Administration (FDA). In this study, PCL scaffold was fabricated by 3D bioprinting system and surface modification of PCL scaffold was controlled by NaOH treatment. Morphological change and wetability of NaOH-treated scaffold were observed by SEM and contact angle measurement system. The remnant of PCL treated with NaOH was measured by ATR-FTIR. In vitro study of scaffolds was evaluated with WST-1 and ALP activity assay. NaOH treatment of PCL scaffolds increased surface roughness, hydrophilicity, cell proliferation and osteogenic differentiation. These results indicate that NaOH-treated PCL scaffold made by 3D bioprinting has tissue engineered potential for the development of biocompatible material.

Effect of Photodynamic Therapy in Lung Cancer (폐암에서 광역동치료술의 효과)

  • Yoon, Sung Ho;Han, Kyung Taek;Kim, Gyung Nam;Lee, Seung Il
    • Tuberculosis and Respiratory Diseases
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    • v.57 no.4
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    • pp.358-363
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    • 2004
  • Background : Photodynamic therapy (PDT) involves the use of photosensitizing agents for treatment of malignant disease. PDT is approved by the U.S. Food and Drug Administration for the endobronchial microinvasive nonsmall cell lung cancer and for palliation in patients with obstructing tumors. We report our experience and results of PDT in lung cancer. Method : Ten patients with lung cancer who were diagnosed in Chosun university hospital by histologic confirm through bronchoscopy were included between August 2002 and May 2003. The photosensitizer (Photogem$^{(R)}$, Lomonosov institute of Fine Chemical, Russia/dose 2.0 mg/kg body weight) was injected 48 hours prior to the PDT session. For PDT with the photosensitizer (Photogem$^{(R)}$), Diode LASER system (Biolitec Inc., Germany, wavelength; 633nm) were used. PDTs were done at 48-72 hours after photogem injection. Follow up bronchoscopy and chest X-ray or thorax computerized tomography were done for evaluate PDT response. Results : 9 of 10 patients with endobronchial obstruction showed partial remission with bronchus opening after PDT. Direct reaction of the tumor to PDT was similar in despite of its localization. It was as follows; edema, hyperemia, in-situ bleeding, fibrin film occurrence. Any other complications such as sunburns of skin, inflammation within the PDT zone were not occurred by the end of the fourth week. Conclusion : In the advanced endobronchial disease, PDT has been shown to be useful in treating endobronchial tumors that are causing clinically significant dyspnea or are likely to progress and lead to further clinical complications, such as postobstructive pneumonia.

Effect of Cardiotonic Pills$^{(R)}$ on Chest Pain and Discomfort: A Multi-center Double-blind Randomized Controlled Trial. (심적환$^{(R)}$이 흉통 흉민에 대하여 미치는 영향에 대한 다기관 무작위배정 이중맹검 임상연구)

  • Jang Insoo;Ko Changnam;Lee In;Park Jung-mi;Kim Sehyun;Kim Sangwoo
    • The Journal of Korean Medicine
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    • v.26 no.2 s.62
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    • pp.95-104
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    • 2005
  • Objectives: This was a double blinded, randomized, placebo-controlled clinical study for evaluation of safety and effective dose finding of Cardiotonic Pills$^{(R)}$ in patients with chest pain and discomfort. Cardiotonic Pills$^{(R)}$ are composed of Salviae Miltiorrhizae Radix (丹蔘), Notoginseng Radix (三七根) and Borneolum (龍腦). Major effects of Salviae Miltiorrhizae Radix and Notoginseng Radix are vasodilatation, sedation and analgesic action. Borneolum has an antibacterial effect, and can stimulate the central nervous system. All of these substances are oriental herbs that have been used for a long time in east Asia. Cardiotonic Pills fi received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) in the USA and 40 million people in the world take this pill. We performed a phase IV clinical study to confirm its efficacy and safety in patients who have probable cardiogenic or psychogenic chest pain or chest stifling. Methods: This study was planned for a multi-center clinical trial including four university hospitals of oriental medicine in Korea. This was the first time to evaluate the 'planning treatment according to diagnosis (辨證施治)' of chest pain or chest discomfort according to oriental medical guidelines. The patients who were included in this trial were adult volunteers from 20 to 70 years old who had chest pain or chest discomfort more than twice during a recent month, and we received written consent to participate in this study from all of them. After administration of Cardiotonic Pills$^{(R)}$ for 8 weeks, number of occurrences, duration, appearance and degree of chest pain or chest discomfort was observed and degree of symptoms (severity of illness, global improvement) were measured using a patient's global assessment composite scale. Results: In the patient's global assessment scale, the severity of illness of the Cardiotonic Pills$^{(R)}$ group (n=25) was 14/25=0.56 but of the placebo group (n=25) was 7/25=0.28 (p-value=0.0449). This result indicates Cardiotonic Pills$^{(R)}$have a positive effect on the symptoms of chest pain and discomfort. However, the global improvement of the Cardiotonic Pills$^{(R)}$group was 23/25=0.92, and of the placebo group was 22/25=0.88 (p-value=0.6374). The total symptom score of the Cardiotonic Pills$^{(R)}$ group was $1.68\pm20.06$, and of the placebo group was $16.76\pm72.l4$(p-value=0.2285). The number of symptom events of the Cardiotonic Pills$^{(R)}$ group was $72\pm29.78$, and of the placebo group (n=25) was $10.80\pm38.42$ (p­value=0.3660). We could not find any effects on the other factors examined besides the severity of illness, beyond the difference of standard deviations. Conclusions: Cardiotonic Pills$^{(R)}$ significantly reduced chest pain and chest discomfort in patients. Therefore, we expect that Cardiotonic Pills$^{(R)}$ will be helpful for patients with chest pain and chest discomfort not only caused by heart disease but also by other diseases.

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Isolation and Characteristics of Yersinia spp. from Mineral Spring Waters (먹는 샘물에서 분리한 Yersinia spp.의 분리 및 특성)

  • 이택수;박부길;오덕환
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.30 no.5
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    • pp.796-801
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    • 2001
  • A total of 277 mineral spring water samples in Kangwon province from 1999 to 2000 were analyzed for the presence of Yersinia spp. by the conventional Food and Drug Administration protocol, and presumptive strains were identified by morphological, cultural and biochemical tests according to Bergey’s manual. Also, the biotypes, serotypes, and susceptibility to 12 antibiotics were tested. Among the total 277 mineral spring water samples, 40 samples (14.4%) were found to be contaminated with Yersinia species. Among the 40 strains of Yersinia spp. isolates, 33 strains (82.5%) for Yersinia enterocolitica, 4 strains (10%) for Yersinia frederiksenii, 2 strains (5%) for Yersinia intermedia, and 1 strain (2.5%) for Yersinia sakazaki were identified, respectively. Of 40 Yersinia spp. isolates, Yersinia enterocolitica (82.5%) was the most predominant species in the mineral spring water samples compared to other Yersinia species. Compared to direct culture method after KOH treatment and KOH treatment method after cold enrichment for better isolation ratio of according to comparision of Yersinia species, the detection ration (18.5%) of KOH treatment method after cold enrichment was about 3 times better than that (6.1%) of direct culture method after KOH treatment. According to serotypes of Y. enterocolitica isolates, O : 5 (12.9%) was the most predominant and followed by O : 3 (9.7%), O : 8 (6.5%), and O : 9 (3.2%), and others. For biotypes of Y. enterocolitica isolates, 1A (71.0%) was the most predominantly abundant and followed by 3A (12.9%), 3B (9.7%), 1B (3.2%) and 5 (3.2%). Also, an antibiotic susceptibility test showed that Yersinia spp. isolates were very susceptible to the antibiotics tested, but they were very strongly resistant to ampicillin, cephalothin and carbenicillin.

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