• Title/Summary/Keyword: Clinical safety

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A Retrospective Analysis of Characteristics of Probiotics Associated with Invasive Bacterial Infections in Children (소아청소년에서 발생한 유산균 제제에 포함된 균주에 의한 침습성 감염증의 후향적 분석)

  • Koh, June Young;Seo, Euri;Lee, Jina
    • Pediatric Infection and Vaccine
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    • v.24 no.3
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    • pp.168-177
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    • 2017
  • Purpose: The purpose of this study was to analyze the clinical features and risk factors of invasive infections caused by Lactobacillus spp. and Saccharomyces spp., components of commercially available probiotics. Methods: We analyzed demographic and clinical data from children ${\leq}18$ years of age with an invasive infection caused by Lactobacillus spp. or Saccharomyces spp. at the Asan Medical Center Children's Hospital from January 1998 to June 2016. Probiotic consumption data were also analyzed. Results: During the study period, a total of 24 episodes of invasive infections were caused by Lactobacillus spp. (n=16) and Saccharomyces cerevisiae (n=8). Along with the increase of probiotic use (755,594 [days/1,000 patient-admission days] in 2001 to 2005, 1,444,066 in 2006 to 2010, and 6,904,736 in 2011 to 2016), the incidence of probiotic-associated invasive infection increased ($R^2=0.70$). The median age of the patients was 1.8 years (range, 2 months to 17 years), and most of them had underlying medical conditions. The 30-day mortality rate was 20.8% (5/24), and 11 (45.8%) of these patients resulted from a severe invasive infection. We determined the risk factors for invasive infection to be: previous intensive care unit stay (odds ratio [OR], 3.0; 95% confidence interval [CI], 1.5 to 6.1] and the presence of a central venous catheter (OR, 2.2; 95% CI, 1.2 to 4.3). Conclusions: Although the probiotic-associated invasive infections rarely occurred in children, the incidence has increased along with probiotic pressure. Judicious use of probiotics is mandatory, especially in young children with underlying medical conditions and continuous surveillance will be needed to minimize the safety concerns.

Efficacy and Safety of Red Ginseng on Women's Health Related Quality of Life and Sexual Function (여성의 건강관련 삶의 질과 성기능에 대한 홍삼의 효과 및 안전성 연구)

  • Kim, Dong-II;Choi, Min-Sun;Alm, Hong-Yeop
    • Journal of Ginseng Research
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    • v.33 no.2
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    • pp.115-126
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    • 2009
  • To evaluate the efficacy and safety of red ginseng on women's health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFl) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFl scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFl total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants' sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFl, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

Clinical assessment of whitening efficacy and safety of in-office tooth whitening system containing 15% hydrogen peroxide with or without light activation (15% 과산화수소 함유 전문가용 치아 미백제의 광활성화 여부에 따른 미백효과 및 안전성에 관한 임상평가)

  • Noh, Young-Suk;Rho, Young-Jee;Yoo, Yeon-Jee;Lee, Hyang-Ok;Lim, Sang-Min;Kweon, Hyun-Jeong;Kim, Ye-Un;Park, Seong-Yeon;Yoon, Hee-Young;Lee, Jung-Hyun;Lee, Chan-Hee;Oh, So-Ram;Kum, Kee-Yeon
    • Restorative Dentistry and Endodontics
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    • v.36 no.4
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    • pp.306-312
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    • 2011
  • Objectives: This clinical study evaluated the effect of light activation on the whitening efficacy and safety of in-office bleaching system containing 15% hydrogen peroxide gel. Materials and Methods: Thirty-three volunteers were randomly treated with (n = 17, experimental group) or without light activation (n = 16, control group), using Zoom2 white gel (15% $H_2O_2$, Discus Dental) for a total treatment time of 45 min. Visual and instrumental color measurements were obtained using Vitapan Classical shade guide and Shadepilot (DeguDent) at screening test, after bleaching, and 1 month and 3 month after bleaching. Data were analyzed using t-test, repeated measure ANOVA, and chi-squared test. Results: Zoom2 white gel produced significant shade changes in both experimental and control group when pre-treatment shade was compared with that after bleaching. However, shade difference between two groups was not statistically significant (p > 0.05). Tooth shade relapse was not detected at 3 months after bleaching. The incidence of transient tooth sensitivity was 39.4%, with being no differences between two groups. Conclusions: The application of light activation with Zoom2 white gel system neither achieved additional whitening effects nor showed more detrimental influences.

Investigation on the Perception of Mandatory Clinical Practice in the Department of Radiology Following the Amendment of the Medical Technologists Act (의료기사 등에 관한 법률 개정으로 방사선(학)과 현장실습 의무화에 따른 인식 조사)

  • Jeong-Mu Lee;Yong-Ki Lee;Sung-Min Ahn
    • Journal of the Korean Society of Radiology
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    • v.18 no.3
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    • pp.293-300
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    • 2024
  • On October 31, 2023, the revision of the Medical Technologist Act made it mandatory to complete field training courses in order to obtain a license as a radiologic technologist. Therefore, we would like to survey the actual situation of field training in medical institutions to inform the revised Medical Technologist Act and propose improvement measures to increase the effectiveness of field training. A survey was conducted from March to April, 2023, among radiologic technologists working in medical institutions. The questionnaire was sent through a form on a domestic portal site, Company N, and 120 respondents completed it. Eighty-two respondents, or 68.3 percent, had experience in educating on-the-job training students. 58% of the respondents were aware of the fact that the amendment to the Act on Medical Technologist etc. made field training mandatory to obtain a radiologic technologist license. In accordance with Article 9 of the Medical Technologist Act, which prohibits unlicensed persons from practicing, 50% of the respondents were aware that those who are in training to complete an education course equivalent to the license they are seeking to obtain at a university or other institution are allowed to practice as medical Technologists. When asked what is currently taught during fieldwork, 6% of respondents said that they are required to perform radiation-generating activities in addition to observing, guiding patients, and positioning and moving patients. When asked about the future direction of education as fieldwork becomes mandatory for licensure, 77% of respondents said that they will teach more than they currently do. When asked about the appropriate total length of fieldwork, 35% said 12 weeks and 480 hours, 33% said 8 weeks and 320 hours, and 27% said 16 weeks and 640 hours. It can be seen that the current on-the-job training is inadequate according to various regulations, and students' satisfaction is low. However, with the revision of the Act on Medical Technologists, field training has become mandatory to obtain a license as a radiologist, and it is necessary to improve the educational conditions of field training. Therefore, it is necessary to comply with the Nuclear Safety Act and the Rules on the Safety Management of Diagnostic Radiation Generating Devices, introduce standardized training objectives and evaluation systems, designate training hospitals and radiologists in charge of training, and introduce extended training periods and simulation exercises to internalize field training.

Clinical Efficacy of Erdosteine in Patients with Acute or Chronic Bronchitis -A Randomized, Double Blind, Comparative Study vs. Ambroxol- (급.만성 기관지염 환자에서 엘도스$^{(R)}$(Erdosteine)의 임상효과 -염산 암브록솔과의 무작위 이중맹검 비교시험-)

  • Kim, Seok-Chan;Lee, Sang-Hoak;Song, So-Hyang;Kim, Young-Kyoon;Moon, Hwa-Sik;Song, Jeong-Sup;Park, Sung-Hak
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.6
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    • pp.1296-1307
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    • 1997
  • Background : Erdosteine is a thiol derivative developed for the treatement of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis. Erdosteine has mucomodulating and antioxidant properties and especially exhibits excellent gastrointestinal tolerability. Methods : The study was conducted as a prospective evaluation, with 2 comparative groups orally treated with erdosteine 300mg (bid.) or ambroxol 30mg (b.i.d.) for 7 days and the design of trial was double-blind. The treatments have been assigned randomly to patients (n=80) with acute or chronic bronchitis. The primary end-point used to determine efficacy in this study was subjective symptoms including expectorating frequence, expectoration volume, expectorating difficulty, expectoration viscosity, cough intensity and dyspnea. The secondary end-points of efficacy was the result of arterial blood gas analysis and pulmonary function test. Safety was evaluated with adverse drug reactions and laboratory tests monitoring. 61 patients was included in the efficacy analysis, due to the fact that 19 patients drop-out for different reasons. The obtained values have been analyzed with paired Hest., ANOVA test., multivariate $t^2$-test, repeated measures analysis of covariance, two sample t-test, loglinear-logit model analysis, Fisher's exact test. Results : 1) There was no significant difference on demographic data and vital signs between erdosteine and ambroxol treated groups. 2) The comparison between erdosteine and ambroxol treated groups showed no significant difference in improvement of each symptom in spite of the more favorable efficacy obtained with erdosteine. No difference on the contrary was observed for arterial blood gas analysis and pulmonary function test. 3) As safety is concerned, no clinical significant changes in laboratory test and symptom were induced in erdosteine and ambroxol treated group and two patients in ambroxol treated group drop-out for adverse reactions in symptom. 4) In the evaluation of final clinical efficacy, erdosteine improved more effectively patient's overall symptoms {very good effect (11/31), good effect (12/31), moderate effect (6/31), no effect (2/31), aggravation (0/31)} than ambroxol {very good effect (6/30), good effect (14/30), moderate effect (5/30), no effect (4/30), aggravation (2/30)}. And the probability of symptomatic improvement by erdosteine compared to ambroxol was 2.5 times. (p<0.05). Conclusion : This study showed that erdosteine was clinically effective and safe drug for treatment of acute and chronic bronchitis.

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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.

Clinical Study of Thalidomide Combined with Dexamethasone for the Treatment of Elderly Patients with Newly Diagnosed Multiple Myeloma

  • Chen, Hai-Fei;Li, Zheng-Yang;Tang, Jie-Qing;Shen, Hong-Shi;Cui, Qing-Ya;Ren, Yong-Ya;Qin, Long-Mei;Jin, Ling-Juan;Zhu, Jing-Jing;Wang, Jing;Ding, Jie;Wang, Ke-Yuan;Yu, Zi-Qiang;Wang, Zhao-Yue;Wu, Tian-Qin
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.9
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    • pp.4777-4781
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    • 2012
  • Objective: To investigate the relationship between the efficacy and safety of different doses of thalidomide (Thal) plus dexamethasone (Dex) as the initial therapy in elderly patients with newly diagnosed multiple myeloma (MM). Methods: Clinical data of 28 elderly patients with newly diagnosed MM who underwent the TD regimen as the initial therapy were analyzed retrospectively. The patients were divided into two groups according to the maximal sustained dose of Thal: lower dose (group A) and higher dose (group B). The overall response rate (ORR), progression free survival (PFS), overall survival (OS), and adverse events (AES) were compared between the two groups. Results: A total of 28 patients were followed up with a median of 18 months. The ORR was 60.1%. The median response time and PFS were 2.0 and 17.0 months, respectively. The mean sustained dose of Thal in group B was significantly higher than group A (292.9 mg v 180.4 mg, P=0.01). There was no significantly difference in ORR (57.1% v 64.3%, P=1.00) and PFS (9.63months v 17.66 months, P=0.73) between groups A and B. During the follow up, only five patients died (<40%) and, therefore, median OS values were not available. It is estimated, however, that the mean survival time in the two groups was 35.6 and 33.4 months (P>0.05), respectively. All of the patients tolerated the treatment well. The incidence of AES in patients with a grading above 3 in group B was significantly higher than in group A (P=0.033). Conclusions: The TD regimen results in a high response rate and manageable AES as the initial therapy in elderly patients with MM. TD should be considered as the front line regimen for the treatment of elderly patients with MM in areas with financial constraints. The clinical response can be achieved at a low dose Thal with minimal toxicity.

Experimental Pathogenesis of Pullorum Disease with the Local Isolate of Salmonella enterica serovar. enterica subspecies Pullorum in Pullets in Bangladesh

  • Haider, M.G.;Chowdhury, E.H.;Khan, M.A.H.N.A.;Hossain, M.T.;Rahman, M.S.;Song, H.J.;Hossain, M.M.
    • Korean Journal of Poultry Science
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    • v.35 no.4
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    • pp.341-350
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    • 2009
  • The research work was carried out to study the pathogenesis covering the clinical signs, gross and histopathological lesions in different organs, and reisolation and identification of the organisms after experimental infection with the local isolate of Salmonella enterica serovar. enterica subspecies (S.) Pullorum at different time interval of the experiment during the period February 2006 to December 2006. One hundred pullets (seronegative to S. Pullorum of 12 weeks age were purchased and divided into 5 (A, B, C, D and E) groups and each group consisted of 20 birds. Four groups (A, B, C and D) were infected orally with a dose of $10^6\;CFU$, $10^7\;CFU$, $2{\times}10^7\;CFU$, $10^8\;CFU$ of S. Pullorum, respectively, and one group (E) was treated as uninfected control. The used methods were necropsy and histopathology, culture of bacteria, staining and biochemical test of Salmonella. Five birds from each group were randomly selected and sacrificed $1^{st}$ week, $2^{nd}$, $3^{rd}$ and $4^{th}$ weeks of post infection (PI). From all the groups, the bacteriological samples (crop, liver, lung, heart, spleen, bile duodenum, ceca and blood) were collected with pre enriched in buffered peptone water in sterile poly bags. Liver, lungs, heart, spleen, intestine, etc. were collected in 10% buffered-formalin for histopathological examination. No clinical signs, gross and histopathological lesions were found in control group and no S. Pullorum was reisolated. Clinical sign of experimentally infected with S. Pullorum in pullets were loss of appetite (100%), slight depression (75%), ruffled feathers (85%), diarrhea (60%) and loss of weight (100%) in chickens. The feed intake and body weight at different weeks after PI differed significantly (p<0.01) among the groups. Grossly, the highest recorded lesion was button-like ulcer in the ceca (80%) and the lowest was white nodules in lungs (1.25%). S. Pullorum were reisolated from crop (91.25%), liver (91.25%), lung (83.75%), heart (71.25%), spleen (87.75%), bile (33.25%), duodenum (92.50%), ceca (97.50%) and from different group of infection (61.25%). The highest microscopic findings were intestinal and cecal mucosa and submucosa exhibited infiltration of mononuclear cells and congestion (96.25%), and the lowest finding was nodule formation in the lungs (3.75%). The pattern of the disease production by local isolate of S. Pullorum in Bangladesh is almost similar with other isolates in different countries.

Prospects for development of cosmetic industry using natural products in Chungbuk (충북지역의 천연 자원을 활용한 화장품 산업의 발전 전망)

  • Hwang, Hyung seo
    • Proceedings of the Plant Resources Society of Korea Conference
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    • 2018.10a
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    • pp.26-27
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    • 2018
  • With entry into force of the Nagoya Protocol to promote the fair sharing of the benefits of accessing and utilizing genetic resources, much support has been given to research on the development of biomaterials and products using domestic natural resources. Conservation and resource-saving of native species became very important through Nagoya Protocol enactment. The trend of cosmetic industry has been shifing from use synthetic chemicals to natural biomaterials, due to the safety regulations on new materials, ban on animal experiments, and expansion of cosmeceuticals range. In addition, functional cosmetic range has been expanded from whitening, wrinkle improvement, and ultraviolet shielding, to hair loss, hair loss alleviation, acne relaxation, and moisturizing of atopic skin, thus causing the activation of research about field of efficacy evaluation on natural biomaterials and commercialization. Chungbuk province is fostering the bio industry as a key industry for regional economic growth. For this purpose, Osong Biotechnology Complex/Ochang Science Industrial Complex in middle area, Jecheon biovalley in northern region, and Chungju Enterprise city have been established, thus playing a pivotal role in Bio innovative cluster in Korea. In particular, it was established the osong cosmetics clinical research support center to develop the cosmetics industry in chungbuk, thereby supporting clinical trials, efficacy evaluations, overseas certification, and overseas market entry in order to advance into the global market. In addition, oriental plants such as astragalus propinquus, schisandra chinensis, eucommia, alpiniae oxyphyllae fructus and biancaea sappan are being actively studied as global cosmetic ingredients through the promotion of various national research and development projects using natural materials in chungbuk province. The chungbuk natural product industry is expected to grow further throughout cosmetics industry development in the future, as companies and research institutes are actively promoting the secure index of effective material in natural products and effective material commercialization.

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The Clinical Considerations of Serous Otitis Media and Ventilation Tube (삼출성중이염과 중이내 통기관 유치술의 임상적 고찰)

  • 김영명;박인용;장태영;심형보
    • Proceedings of the KOR-BRONCHOESO Conference
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    • 1982.05a
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    • pp.14.2-15
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    • 1982
  • Serous otitis media (SOM) is one of the most common otologic diseases which was first discribed by Politzer in 1869. Currentely, among many methods introduced to treat SOM, ventilation tube insertion is considered to be the most popular and standard method being used. However due to complication of it, there remains many disputable various problems. In order to review the clinical aspect of SOM and search for the effects and safety of ventilation tube, we studied 97 SOM patients, who had performed V-tube from Jan. 1981 to Feb. 1982 at ENT dept. of Severance Hospital. Analizing the clinical symptoms, age distribution, associated disease, otoscopic findings of ear drum, degree of hearing loss, hearing gain after insertion of V-tube and complications, following results were obtained. 1) As a subjective symptom, among 29 cases all patients had hearing loss, 19 cases (65.6%) had tinnitus, 12 cases (44.4%) had autophony and 10 cases (34.5%) of the patients had sensation of ear fullness. 2) In age distribution, 6 to 10 year old group was most numerous up to 42 cases (43.3%) and 20 years and over was 23 cases (23.5%) 3) In adult group SOM tend to be involved unilaterally whereas young child group had tendency involving bilaterally. 4) 49 cases (50.05%) were associated with tonsillitis and adenoid vegetation, 15 cases (15.5%) were associated with sinusitis, 4 cases (4.1%) had nasal allergy. 5) In preoperative otoscopic findings, 62 ears (47.7%) had retraction, 37 ears (23.6%) had bulging, 34 ears (21.7%) had color change, and 29 ears (19.7%) had no significant findings. 6) In characteristics of middle ear fluid, child group was tend to have mucinous content (84.2%) while adult group had serous content (62.5%). 7) Average preoperative air-bone gap of pure tone was 25.3 dB. 8) 24 ears (72.7%) had over 10 dB of postoperative hearing gain and average hearing gain was 17.2 dB. 9) There were 44 ears (28.1%) of complications. Among them 37 ears (23.6%) had infection, 3 ears had atelectasis, 2 ears had granulation tissue, 2 ears had permanent perforations. 10) Among 37 ears suffered from post-op. infection, 19 ears (51.4%) had initial infection just after insertion of ventilation tube, 18 ears (48.6%) were infected during the course of post-ventilation tube. Of 37 infected ears, 26 ears (70.3%) responded to conservative care, while 11 ears (29.7%) was cured after removal of ventilation tube.

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