• Title/Summary/Keyword: Adverse reactions

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The Influence of Adverse Drug Reactions on First-line Anti-tuberculosis Chemotherapy in the Elderly Patients (고령에서 일차 항결핵 화학요법에 의한 약물 이상반응이 치료에 미치는 영향)

  • Jeong, Jeong Ihm;Jung, Bock Hyun;Kim, Mi Hye;Lim, Jae Min;Ha, Dong Cheon;Cho, Sung-Won;Rhui, Dae Sik
    • Tuberculosis and Respiratory Diseases
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    • v.67 no.4
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    • pp.325-330
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    • 2009
  • Background: Pulmonary tuberculosis (TB) is still common disease among the elderly patients in Korea where the overall incidence of TB is decreasing. Adverse drug reactions (ADR) associated with anti-TB drugs occurs frequently. Especially the aged tends to have more frequent ADRs than younger ones. These ADRs can cause significant morbidity, compromise therapeutic effects of drugs and even induce drug resistance. Therefore we evaluated the effect of ADRs on the first-line anti-TB drugs in elderly patients with active pulmonary TB. Methods: We retrospectively reviewed the charts and radiological findings of the patients with 65 and older who were bacteriologically confirmed as active TB and treated with standard anti-TB drugs for at least 6 months. Major ADR was defined with temporary or continuous stop of any first-line drugs intake. Results: An ADR was noted in 54% of all patients. The incidence of major ADR was 32% in all elderly patients. Dermatologic ADR (9%) was the most common among the major ADRs. GI trouble (8%), arthralgia (6%), visual change (6%), hepatotoxicity (4%), and fever (1%) were also noted. The drugs responsible for major ADR were ethambutol (62%), pyrazinamide (35%), rifampin (18%) and isoniazid (9%). Major ADRs were associated with higher ESR level at the initiation of anti-TB drugs. Conclusion: First-line anti-TB drugs in elderly patients frequently caused the major ADRs. Therefore the elderly patients receiving anti-TB drugs should be closely monitored and better tolerable therapy should be considered as part of a TB research agenda.

Effect of Cetylpyridinium Chloride on Gingival Inflammation and Plaque Accumulation (염화 세틸피리디늄 분말의 치태제거와 치은염 완화 효과에 관한 임상시험)

  • Jun, Hyung-Sik;Ko, Young-Kyung;Ku, Young;Rhyu, In-Chul;Choi, Sang-Mook;Chung, Chong-Pyoung
    • Journal of Periodontal and Implant Science
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    • v.29 no.1
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    • pp.141-151
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    • 1999
  • To evaluate the effect of cetylpyridinium chloride in a powder form when used concomitantly with a commercial flouride containing tooth paste on inhibition of plaque formation, on gingivitis, and on irritation of oral mucosa, a double--blind, randomized parallel study was set up. Cetylpyridinium chloride was incorporated into a ligh brown colored powder with menthol added for scent. There were no diffemces between the active agent and the placebo which did not contain cetylpyridinium chloride in appearance, color, smell, taste, or dispenser. 98 healthy volunteers were assigned to one of two groups: brushing 3 times a day with flouride toothpaste and cetylpyridinium chloride powder, or brushing 3 times a day with flouride toothpaste and placebo. Before the test period, the subjects received through tooth cleaning and polishing. At basteline, GI, PI, BOP, and GCF of the Ramfjord teeth were measured in the experimental and placebo groups including 58 and 42 subjects repectively, After 4 weeks, GI, PI, BOP, GCF, compliance, irritation of the oral mucosa(redness, pus drainage, edema) and adverse reactions were measured. The PI, GI, and BOP of the experimental group recorded at baseline are 0.19${\pm}$0.19, 0.42${\pm}$0.31, and 0.08${\pm}$0.15. These scores showed significant decrease after 4 weeks of test period(0.11${\pm}$0.15, 0.22${\pm}$0.24, 0.02${\pm}$0.09 repectively at the end of the study) and inhibition of plaque accumulation and resolution of gingival inflammation could be observed. GCF shoed slight increase but this was not statistically different. Comparison of changes in measured scores of control and experimental groupshow GI, PI of the test indices have decreased. Test group showed significantly greater decrease in gingivitis and plaque accumulation after 4 weeks. GCF and BOP also showed greater decrease thant the control group but this difference was not statistically significant. At no time of the study period did any of the subjects show signs of irritation of the oral mucosa or adverse reactions. Following conclusions could be obtained from this study. The combined use of cetl powder and flouride toothpaste showed greater inhibition of plaque accumulation and greater decrease of gingivitis than use of flouride toothpaste with placebo agent.

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Prevalence of dog erythrocyte antigen 1, determined via immunochromatography, in domestic dogs in Korea (면역 크로마토그래피법을 이용한 국내 반려견의 Dog erythrocyte antigen 1 분포도 조사 연구)

  • Kim, Eunju;Choe, Changyong;Yoo, Jae Gyu;Oh, Sang-Ik;Jung, Younghun;Cho, Ara;Kim, Suhee;Do, Yoon Jung
    • Korean Journal of Veterinary Research
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    • v.58 no.2
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    • pp.81-85
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    • 2018
  • Blood group determination in dogs is an important factor in transfusion medicine to minimize immediate or delayed adverse reactions after red blood cells transfusion in small animal clinics. Dog erythrocyte antigen (DEA) 1 is the most important blood type due to its high degree of antigenicity causing acute transfusion adverse reactions. The aim of this study was to investigate the prevalence of DEA 1 in various dog breeds in Korea. As a result of testing 592 blood samples from more than 35 dog breeds, DEA 1 blood typing for each breed showed that 57.8% of Malteses, 63.3% of Poodles, 76.2% of Mastiff-like dogs, 72.5% of Pomeranians, 47.7% of Shih Tzus, 70.3% of mixed breeds, 60.0% of Yorkshire Terriers, and 71.4% of Beagles were DEA 1-positive. Miniature Schnauzers and Jindo breeds had a significantly high prevalence (100%) of DEA 1-positive dogs compared to that in other small breed dogs. This is the first report of immunochromatography-detected DEA 1 prevalence in various domestic dog breeds. Although additional studies need clarifying the potential blood transfusion risks in domestic breed dogs with DEA 1, the results of this study may be useful when selecting a blood donor.

A Retrospective Study for Relapse Rate According to the Discontinuance of Para-aminosalicylic acid(PAS) after Bacteriological Conversion during the Course of Chemotherapy for Multidrug- Resistant Tuberculosis(MDR-TB) (Para-aminosalicylic acid(PAS)가 포함된 처방으로 치료한 다제내성 결핵환자에서 치료경과 중 균음전 후 PAS 중단시 재발율에 관한 조사)

  • Park, Seung-Kyu;Kim, Byoung-Ju;Shin, Dong-Ohk;Jun, Byung-Yool
    • Tuberculosis and Respiratory Diseases
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    • v.60 no.2
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    • pp.180-186
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    • 2006
  • Background : Para-aminosalicylic acid(PAS) is a 2nd-line drug that can cause severe adverse reactions leading to poor patient compliance. This study evaluated the relapse rate according to the discontinuance of PAS at a certain point after bacteriological conversion during the course of chemotherapy for multidrug-resistant tuberculosis(MDR-TB). Methods : 42 out of 452 MDR-TB patients were enrolled in this study. All subjects were receiving chemotherapy including PAS at National Masan TB Hospital between Jan. 1, 2000 and Dec. 31, 2001. The relapse rate was evaluated after the discontinuance of PAS from their initial regimen as a result of the severe adverse reactions at a certain point after the bacteriological conversion during the course of chemotherapy for MDR-TB. Results : The male to female ratio was 2.5:1, and the mean age was 47.2 years old. The average number of past histories, used drugs and resistant drugs was 1.2, 3.9 and 4.3. The mean number of sensitive drugs included in the inirial regimen was 3.9. The mean time for bacteriological conversion and discontinuance of the PAS was 2.3 months after initiating treatment and 6 months after bacteriological conversion, respectively. There was no relapse after discontinuing PAS during a mean follow up period of 31.6 months. Conclusion : PAS may be discontinued in the cases of serious gastrointestinal problems approximately 6 months after bacteriological conversion without concern about relapse.

Efficacy and Safety of Sublingual Immunotherapy in Elderly Rhinitis Patients Sensitized to House Dust Mites

  • Kim, Ji Hye;Lee, Ji Ho;Ye, Young-Min;Lee, Jae-Hyun;Park, Jung Won;Hur, Gyu-Young;Kim, Joo-Hee;Lee, Hyn-Young;Shin, Yoo Seob;Yang, Eun-Mi;Park, Hae-Sim
    • Allergy, Asthma & Immunology Research
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    • v.10 no.6
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    • pp.675-685
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    • 2018
  • Purpose: This study aims to determine the efficacy and safety of house dust mite (HDM)-sublingual immunotherapy (SLIT) in elderly patients with AR. Methods: A total of 45 patients aged ${\geq}60years$ with HDM-induced AR who had ${\geq}3$ A/H ratio on skin prick test and/or ${\geq}0.35IU/L$ to both Dermatophagoides farinae and Dermatophagoides pteronyssinus by ImmunoCAP were enrolled in 4 university hospitals. To evaluate additional effects of HDM-SLIT, they were randomized to the SLIT-treated group (n = 30) or control group (n = 15). Rhinoconjunctivitis total symptom score (RTSS), rhinoscopy score, Korean rhinoconjunctivitis quality of life questionnaire, rhinitis control assessment test, asthma control test scores, and adverse reactions, were assessed at the first visit (V1) and after 1 year of treatment (V5); for immunological evaluation, serum levels of HDM-specific immunoglobulin A/IgE/IgG1/IgG4 antibodies and basophil response to HDMs were compared between V1 and V5 in both groups. Results: There were no significant differences in demographics, RTSS, skin reactivity to HDMs, or serum total/specific IgE levels to HDMs (P > 0.05, respectively) between the 2 groups. Nasal symptom score and RTSS decreased significantly at year 1 in the 2 groups (P < 0.05). There were no significant differences in percent decrease in nasal symptom score and RTSS at year 1 between the 2 groups (P > 0.05); however, rhinoscopic nasal symptom score decreased significantly in the SLIT-treated group (P < 0.05). Immunological studies showed that serum specific IgA levels (not specific IgE/IgG) and CD203c expression on basophils decreased significantly at V5 in the SLIT-treated group (P = 0.011 and P = 0.001, respectively), not in the control group. The control group required more medications compared to the treatment group, but there were no differences in adverse reactions. Conclusions: It is suggested that HDM-SLIT for 1 year could induce symptom improvement and may induce immunomodulation in elderly rhinitis patients.

Cleansing of Fine Dust on the Skin, Application to the Human Body and Safety Effect of Botanical-sourced Soap (식물성 재료원 비누의 피부 위 미세먼지 세정, 인체 적용 및 안전성 효과에 관한 연구)

  • Kim, Su Nam;Lee, Hyung H.
    • Journal of Naturopathy
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    • v.11 no.1
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    • pp.31-38
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    • 2022
  • Background: New beauty soaps are always subject to evaluation. Purposes: This study performed a human application test and safety evaluation on the cleaning effect of the fine dust mimic of the test product, Daziwar soap bar, on 52 women. Methods: The quantitative change measured the cleaning effect of fine dust before and after washing immediately after spraying the fine mimetic dust on the forearm of 22 women. In addition, the safety was evaluated at 30 minutes, 24 hours, and 48 hours after 24 hours after applying the patch to the woman's back. Results: After one time washing with the soap immediately after spraying dust on the inside of the arm, the amount of the remaining mimetic was statistically significantly decreased in both the test group and the control group (p < .001). However, the washing rate was 99.96% in the experimental group and 75.58% in the control group. The questionnaire was evaluated as 'Good' or higher in terms of efficacy. In the evaluating of adverse reactions after washing fine dust by a dermatologist, there were no reports or observations of specific skin adverse reactions or abnormal findings in the subjects. The safety evaluation was judged as non-irritating in the skin reaction evaluation at 30 minutes, 24 hours, and 48 hours after instillation on the back for 24 hours. Conclusions: The test product, Daziwar soap, was found to be very helpful in cleaning fine dust on the human body and was found to be safe for the human body.

Safety assessments of recombinant DTaP vaccines developed in South Korea

  • Gi-Sub Choi;Kyu-Ri Kang;Seung-Bum Kim;Joon-Hwan Ji;Gyu-Won Cho;Hyun-Mi Kang;Jin-Han Kang
    • Clinical and Experimental Vaccine Research
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    • v.13 no.2
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    • pp.155-165
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    • 2024
  • Purpose: Pertussis bacteria have many pathogenic and virulent antigens and severe adverse reactions have occurred when using inactivated whole-cell pertussis vaccines. Therefore, inactivated acellular pertussis (aP) vaccines and genetically detoxified recombinant pertussis (rP) vaccines are being developed. The aim of this study was to assess the safety profile of a novel rP vaccine under development in comparison to commercial diphtheria-tetanus-acellular pertussis (DTaP) vaccines. Materials and Methods: The two positive control DTaP vaccines (two- and tri-components aP vaccines) and two experimental recombinant DTaP (rDTaP) vaccine (two- and tri-components aP vaccines adsorbed to either aluminum hydroxide or purified oat beta-glucan) were used. Temperature histamine sensitization test (HIST), indirect Chinese hamster ovary (CHO) cell cluster assay, mouse-weight-gain (MWG) test, leukocytosis promoting (LP) test, and intramuscular inflammatory cytokine assay of the injection site performed for safety assessments. Results: HIST results showed absence of residual pertussis toxin (PTx) in both control and experimental DTaP vaccine groups, whereas in groups immunized with tri-components vaccines, the experimental tri-components rDTaP absorbed to alum showed an ultra-small amount of 0.0066 IU/mL. CHO cell clustering was observed from 4 IU/mL in all groups. LP tests showed that neutrophils and lymphocytes were in the normal range in all groups immunized with the two components vaccine. However, in the tri-components control DTaP vaccine group, as well as two- and tri-components rDTaP with beta-glucan group, a higher monocyte count was observed 3 days after vaccination, although less than 2 times the normal range. In the MWG test, both groups showed changes less than 20% in body temperature and body weight before the after the final immunizations. Inflammatory cytokines within the muscle at the injection site on day 3 after intramuscular injection revealed no significant response in all groups. Conclusion: There were no findings associated with residual PTx, and no significant differences in both local and systemic adverse reactions in the novel rDTaP vaccine compared to existing available DTaP vaccines. The results suggest that the novel rDTaP vaccine is safe.

Purification of Diphtheia Toxin and the Production of Detoxificated Toxoid Vaccine (디프테리아 toxin 정제와 무독화 toxoid 백신 생산)

  • Cho, Min;Ryu, Yeon-Woo
    • KSBB Journal
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    • v.14 no.2
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    • pp.248-254
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    • 1999
  • Adverse reactions after injection of diphtheria vaccine are induced by impurities present in crude toxoids that cannot be removed completely by purification of toxoids after formalization. To increase toxoid purity, toxin purification was tried before formalization. Crude toxin was purified with ultrafiltration and ion-exchange chromatography. Purified toxin purity was improved 2.9 times higher than crude toxin, and purity was 2,560 Lf/mg PN. Purified toxin was detoxified with formalin and lysine, and potency test were performed. Toxoid, prepared from toxin treated with formalin and lysine, did not show reversion to toxin and purity was higher than the toxoid purified after formalization. Therefore, we concluded that the use of toxoid vaccine prepared from toxin purified is a useful method of minimize adverse reaction after injection of diphtheria vaccine.

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A Retrospective Questionnaire Survey on the Clinical Effects of HongYi Pharmacopuncture Monotherapy on Female Lower Urinary Tract Symptoms (홍의약침 단일요법이 여성 하부요로증상에 미치는 임상적 효과에 대한 후향적 설문조사 연구)

  • Hwang, Yun-kyeong;Kim, Yong-soo;Choi, Seung-bae;Kim, Won-ill
    • The Journal of Internal Korean Medicine
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    • v.38 no.6
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    • pp.930-943
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    • 2017
  • Objectives: The purpose of this study was to investigate the clinical effects of HongYi pharmacopuncture monotherapy on female voiding dysfunction. Methods: Korean medical practitioners who used HongYi pharmacopuncture to treat female patients complaining of dysuria were surveyed. They performed a retrospective chart review of 31 female patients who visited their Korean medical clinic for dysuria. General characteristics, marital status, urologic medical history, International Prostate Symptom Score (IPSS), International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), and related adverse events were examined. Results: Of 31 cases received, 29 were selected for analysis. Two cases were excluded because treatment was not continued through four weeks. In all cases, IPSS and ICIQ-FLUTS scores were significantly decreased after treatment. Adverse reactions occurred during treatment in four cases. Conclusions: These results suggest that treatment by HongYi pharmacopuncture is effective in improving lower urinary tract symptoms in women. Further studies will be needed for evaluation of clinical responses, to evaluate the safety and efficacy of HongYi pharmacopuncture treatment for female patients complaining of dysuria.

A Review of Research Trends in Gold Implantation Therapy Focused on Gold Thread, Gold Needle and Gold Bead (금사, 금침, 금주를 중심으로 한 금(金)의 인체 내 매장요법에 대한 연구동향 고찰연구)

  • Jo, Dae Hyun;Baatarkhuyag, Ariunchimeg;Jo, Ye Eun;Lee, Sang Hoon;Lee, Jae Dong
    • Journal of Acupuncture Research
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    • v.33 no.1
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    • pp.79-93
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    • 2016
  • Objectives : The purpose of this study is to explore research trends in gold implantation therapy performed on the animal and human body, through a review of clinical studies focused on gold thread, gold needle and gold bead. Methods : Medical databases, including Pubmed, CENTRAL, MEDLINE, EMBASE, RISS4u, KISTI, OASIS and KTKP, were searched for relevant articles published from their launch to December 31, 2015 using the key word 'gold' with '$thread^*$', '$needle^*$', '$acupuncture^*$', '$wire^*$', '$bead^*$', '$embed^*$', '$implant^*$', or '$insert^*$'. The results were classified into in vivo studies, clinical trials and clinical reports. Analysis of the results was conducted in several research areas, from the identity of studies such as nationality and published year, to the gold preparations-features and implanted locations and to the outcomes that reflect the clinically favorable or adverse effect of gold implantation therapy. Results : A total of 30 studies including 11 in vivo studies, 4 clinical trials and 15 case reports, were found in the search. We observed certain research trends according to the research time, nationality and target indication of the studies. The studies primarily revealed a chronic local inflammatory response which could be a useful mechanism for pain-relief in musculoskeletal diseases and facial rejuvenation. Researches concerning long-term reactions or adverse effects were rare. Conclusion : The results show that the efforts to discover the level of clinical efficacy of gold implantation therapy were steady and worldwide. However, further researches on the longterm effect, and more importantly, the safety of gold implantation therapy are required.