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Evaluation of Usefulness and Procedures for Safety of Radiopharmaceuticals in Cisternography (Cisternography 검사 시 사용되는 방사성의약품의 안정성 확보를 위한 검사도입 및 유용성 평가)

  • Kim, Da-Eun;Yoo, Yeon-Wook;Choi, Ho-Yong;Kim, Yun-Cheol;Kim, Yeong-Seok;Won, Woo-Jae;Kim, Seok-Ki
    • The Korean Journal of Nuclear Medicine Technology
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    • v.14 no.2
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    • pp.45-49
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    • 2010
  • Purpose: Several radiopharmaceuticals were used for cisternography. But recently, due to more short acquisition time, high resolution than other radiopharmaceuticals like In-111 DTPA, we were using Tc-99m DTPA in cisternography. Using of Tc-99m DTPA for intrathecal, was not officially recognised by the FDA. And there are matters of aseptic meningitis, muscular tetany, seizures by inappropriate radiopharmaceuticals handling. So, it is necessary to prevent adverse reactions while handling the radiopharmaceuticals using in cisternography. Therefore, this study aims to evaluation of usefulness and procedures for safety of radiopharmaceuticals in cisternography. Materials and Methods: Subjects were 12radioactive tracer vials using in cisternography in 2008 Dec. 16 - 2009 Dec. 30. (1) Radioactive tracer Vial test - We were measured NaPertechnetate radiation dose and volume, normal saline volume for dilution, source volume and dose activity for patient injection. And then, calculated mass of pure DTPA. (2) Bacterial endotoxin test - We performed pyrogen test using by negative/positive control vials which was added normal saline 0.2 mL and added normal saline 0.1 mL, Tc-99m DTPA 0.1 mL in test control vial. And then, reacted by digital hot plate in $37.5^{\circ}C$ for 1 hour and compared of gel-clot in each control vials. (3) Compliance safety procedure - We were checked safety issues and wrote out a safety procedure exam sheet. Results: (1) Radioactive tracer Vial test - Mass of DTPA per dose for patient injection (mg) was 0.88 (mg) on average, and Mass of DTPA per volume for patient injection (mg) was 0.74 (mg) on average. (2) Bacterial endotoxin test - All control test vials showed negative reactions. (3) Compliance safety procedure - We were checked safety issues and wrote out a safety exam sheet in all the exams. So, there were no adverse reactions. Conclusion: We could examine easier to safety tests using by Techscan - DTPA (Mallinckrodt): CaNa3. Each test results were passed the safety tests and there are no adverse reactions. The use of Tc-99m DTPA for cisternography, always has been become an issue. Since it has occur adverse reaction while examine the cisternography using by Tc-99m DTPA, it needs to set up the 'Standard Operating procedures'.

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A Clinical Study of Tsutsugamushi Fever in Children during 1997~2000 in the Western Kyungnam Province (최근 4년간 서부 경남지역의 소아에서 발생한 쯔쯔가무시열의 임상적 고찰)

  • Ju, Hye Young;Lee, Jun Su;Kim, Jeong Hee;Yoo, Hwang Jae;Kim, Chun Soo
    • Pediatric Infection and Vaccine
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    • v.8 no.2
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    • pp.213-221
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    • 2001
  • Propose : Tsutsugamushi fever is a acute febrile disease, which is caused by O. tsutsugamushi. Recently, this disease is increasingly reported in children. This study was undertaken to investigate clinical features of tsutsugamushi fever in children. Methods : This study involved 17 children with tsutsugamushi fever who were admitted to Masan Samsung hospital between September 1997 and December 2000. We investigated the age, sex ratio, clinical manifestations, laboratory findings, response of therapy and prognosis. Results : The age of patients was $6.9{\pm}3.6$ years, ranging from 6 months to 12 years and male predilection(58.8%) was noted and all cases of patients occured in October or November. The most common symptoms were fever in all cases and headache in 8(47.1%). The most common signs were skin rash in all cases, eschar in 14(82.4%) and lymphadenopathy 8(47.1%). Locations of the eschars were back and inguinal area in each 3 cases, neck and chest in each 2, popliteal area in 2, scalp and thigh in each 1. Laboratory findings included anemia in 1 case, leukopenia and thrombocytopenia in each 5, hematuria and proteinuria in each 1, ESR elevation in 2 and positive CRP in 12, AST elevation in 9 and ALT elevation in 7. Serologic diagnosis was made by passive hemagglutination assay(PHA) in 8 cases(47%) on admission, 4 cases in initial negative group were performed follow-up test at 2nd or 3rd weeks of illness and then all cases of 4 were converted to positive reaction. Clinical improvement was noticed in all cases after treatment to chloramhenicol or doxycycline. Mean duration for defervescence after treatment was $1.4{\pm}0.8$ days. Complications were interstitial pneumonia in 1 case and aseptic meningitis in 3, but all cases of patients were recovered without sequelae or recurrence. Conclusions : Tsutsugamushi fever in children was similiar to adult in the clinical features except male predilection. Early diagnosis and empirical treatment based on clinical manifestations such as fever, skin rash, eschar, lymphadenopathy is important and serologic diagnosis need to perform follow-up test at 2nd or 3rd weeks of illness.

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The Safety and Immunogenicity of a Trivalent, Live, Attenuated MMR Vaccine, PriorixTM (MMR(Measles-Mumps-Rubella) 약독화 생백신인 프리오릭스주를 접종한 후 안전성과 유효성의 평가에 관한 연구)

  • Ahn, Seung-In;Chung, Min-Kook;Yoo, Jung-Suk;Chung, Hye-Jeon;Hur, Jae-Kyun;Shin, Young-Kyu;Chang, Jin-Keun;Cha, Sung-Ho
    • Clinical and Experimental Pediatrics
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    • v.48 no.9
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    • pp.960-968
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    • 2005
  • Purpose : This multi-center, open-label, clinical study was designed to evaluate the safety and immunogenicity of a trivalent, live, attenuated measles-mumps-rubella(MMR) vaccine, $Priorix^{TM}$ in Korean children. Methods : From July 2002 to February 2003, a total of 252 children, aged 12-15 months or 4-6 years, received $Priorix^{TM}$ at four centers : Han-il General Hospital, Kyunghee University Hospital, St. Paul's Hospital at the Catholic Medical College in Seoul, and Korea University Hospital in Ansan, Korea. Only subjects who fully met protocol requirements were included in the final analysis. The occurrence of local and systemic adverse events after vaccination was evaluated from diary cards and physical examination for 42 days after vaccination. Serum antibody levels were measured prior to and 42 days post-vaccination using IgG ELISA assays at GlaxoSmithKline Biologicals (GSK) in Belgium. Results : Of the 252 enrolled subjects, a total of 199 were included in the safety analysis, including 103 from the 12-15 month age group and 96 from the 4-6 year age group. The occurrence of local reactions related to the study drug was 10.1 percent, and the occurrence of systemic reactions was 6.5 percent. There were no episodes of aseptic meningitis or febrile convulsions, nor any other serious adverse reaction. In immunogenicity analysis, the seroconversion rate of previously seronegative subjects was 99 percent for measles, 93 percent for mumps and 100 percent for rubella. Both age groups showed similar seroconversion rates. The geometric mean titers achieved, 42 days pos-tvaccination, were : For measles, in the age group 12-15 months, 3,838.6 mIU/mL [3,304.47, 4,458.91]; in the age group 4-6 years, 1,886.2 mIU/mL [825.83, 4,308.26]. For mumps, in the age group 12-15 months, 956.3 U/mL [821.81, 1,112.71]; in the age group 4-6 years, 2,473.8 U/mL [1,518.94, 4,028.92]. For rubella, in the age group 12-15 months, 94.5 IU/mL [79.56, 112.28]; in the age group 4-6 years, 168.9 IU/mL [108.96, 261.90]. Conclusion : When Korean children in the age groups of 12-15 months or 4-6 years were vaccinated with GlaxoSmithKline Biologicals' live attenuated MMR vaccine ($Priorix^{TM}$), adverse events were limited to those generally expected with any live vaccine. $Priorix^{TM}$ demonstrated excellent immunogenicity in this population.

The Frequency of Chromosomal Aberrations of Peripheral Lymphocytes according to Radiation Dose and Dose Rate (선량 및 선량률 변화에 따른 말초혈액 임파구의 염색체 이상의 빈도)

  • Jeong Tae Sik;Baek Heum Man;Shin Byung Chul;Moon Chang Woo;Kim Mi Hyang;Lee Yong Hwan;Yum Ha Yong
    • Radiation Oncology Journal
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    • v.18 no.2
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    • pp.138-149
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    • 2000
  • Purpose : It was studied that the relationship between radiation dose, dose rate and the frequency of chromosomal aberrations in peripheral lymphocytes. Methods and Materials : Peripheral lymphocytes were irradiated in vitro with 6 MeV X-ray at dose ranges from 50 cGy to 800 cGy. The variations of the frequency of chromosomal aberrations were observed according to different radiation dose rate from 20 cGy/min to 400 cGy/min at constant total dose of 400 cGy which it was considered as factor to correct biological radiation dose measurement. Results : The yields of lymphocytes with chromosomal aberrations (dicentric chromosome, ring chromosome, acentric fragment pairs) are 0% at 50 cGy, 9% at 100 cGy, 20% at 200 cGy, 27% at 300 cGy, 55% at 400 cGy, 88% at 600 cGy, and 100% at 800 cGy. The value of Ydr is 0.000 at 50 cGy, 0.093 at 100 cGy, 0.200 at 200 cGy, 0.354 at 300 cGy, 0.612 at 400 cGy, 2.040 at 600 cGy, and 2.846 at 800 cGy. The relationship between radiation (D) and the frequency of dicentrlc chromosomes and ring Chromosomes (Ydr) can be expressed as Ydr=0.188${\times}$10$^{-2}$ D/Gy+0.422${\times}$10$^{-4}$/Gy$^{2}$${\times}$D$^{2}$ The Value of Qdr is 0.000 at 50 cGy, 1.000 at 100 cGy, 1.000 at 200 cGy, 1.333 at 300 cGy, 1.118 at 400 cGy, 2.318 at 600 cGy, and 2.846 at 800 cGy. When 400 cGy is irradiated with different dose rate each of 20, 40, 60, 80, 100, 160, 240, 320, and 400 cGy/min, Ydr is each of 0.982, 0.837, 0.860, 0.732, 0.763, 0.966, 0.909, 1.006, and 0.806, and Qdr is each of 1.839, 1.555, 1.654, 1.333, 1.381, 1.750, 1.6000, 1.710, and 1.318. Conclusion : There are not the significant variations of Ydr and Qdr values according to different dose rate. And so radiation damage is influenced by total exposed radiation doses and is influenced least of all by different dose rate when it is acute single exposure.

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Effect of Dietary Streptococcus faecium on the Performances and the Changes of Intestinal Microflora of Broiler Chicks (Streptococcus faecium의 급여가 육계의 성장과 장내 세균총 변화에 미치는 영향)

  • Kim, K.S.;Chee, K.M.;Lee, S.J.;Cho, S.K.;Kim, S.S.;Lee, W.
    • Korean Journal of Poultry Science
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    • v.18 no.2
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    • pp.97-119
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    • 1991
  • Effect of Streptococcus faecium(SF) and an antibiotic, Colistin(Col), supplemented to diets singly or in combination, on the performances and changes of intestinal population of microflora of broiler chicks studied. A total of 252, day-old chicks(Arbor Acre) of mixed sex(M:F=1:1) were alloted into six groups. A diet with no Col and SF was referred as a control diet. The basal diets were added with two levels of SF, 0.04 and 0.08%, singly or in combination with Col 10ppm Another diet was prepared by adding only Col 10 ppm. Numbers of the microorganism in diets added with SF 0.04% and 0.08% were 7$\times$10$^{4}$ and 1.4$\times$10$^{5}$ /g diet respectively The diets consisting of corn and soybean meal as major ingredients were fed for a period of seven weeks . During the feeding trial, fresh excreta were sampled at the end of every week in a sterilized condition to count microbial changes from each dietary group. Microbial changes of large intestine were also measured from nine birds sacrificed at the end of the 4th and 7th weeks each time per dietary group. Excreta from all the groups were also collected quantitatively at the end of 3rd and 6th weeks to measure digestibility of the diets, At the end of 7th week, nine birds from each group were also sacrificed to measure weight changes of gastrointestinal tracts . Average body weight gains of broilers fed the diets added with SF 0.08% (2.37kg) or SF 0. 08%+col 10ppm(2.34kg) were significantly larger than that of the control(2.18kg). The weight gains of the other groups were not statistically different from that of the control Feed/gain ratios of the supplemental groups were better than that of control (P<0.05) except that of birds fed the diet added only with SF 0.04%. Digestibilities of nutrients such as dry matter, crude protein, crude fat and total carbohydrates were not altered by the consumption of the diets added with SF and/or Col throughout the whole feeding period. As expected, the numbers of Streptococci in the excreta from birds fed diets added with SF increased significantly with a statistical difference between groups with SF 0.04% and SF 0.08% most of the time. However. addition of Colistin to the diets supplemented with SF did not give any effects on the number of the microorganism. Numbers of coliforms in the excreta were apparently reduced by feeding the diets added with SF and/or Col(P<0.05). There were, however, no additive effects observed between the two feed additives in this regard when supplementing Col to the SF diets. Distributions of intestinal microflora exhibited exactly the same pattern as those of the excreta. Length of small intestine of the birds fed diets added with SF 0.08% with or without Col 10 ppm became significantly longer with a range of about 10% than those of the birds fed diets without SF. However, the empty weight of the small inestine of the former group was lighter than that of control These changes resulted in a significant reduction in weight/unit length of the intestine of the birds fed diets supplemented with Col and SF singly or in combination. In overall conclusion, diet added with SF 0.08% appeared most effective in improving broiler performances. Colistin added at a level of 10ppm was not beneficial at all in itself or in combination with SF in terms of broiler performances or changes of intestinal microflora population. The efficacy of SF and Col could be attributed to the changes of wall thickness of the small intestine.

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