• Title/Summary/Keyword: Clinical safety

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Systematic Analysis of Icotinib Treatment for Patients with Non-Small Cell Lung Cancer

  • Shi, Bing;Zhang, Xiu-Bing;Xu, Jian;Huang, Xin-En
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.13
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    • pp.5521-5524
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    • 2015
  • Purpose: This analysis was conducted to evaluate the efficacy and safety of icotinib based regimens in treating patients with non-small cell lung cancer (NSCLC). Methods: Clinical studies evaluating the efficacy and safety of icotinib-based regimens with regard to response and safety for patients with NSCLC were identified using a predefined search strategy. Pooled response rates of treatment were calculated. Results: With icotinib-based regimens, 7 clinical studies which including 5,985 Chinese patients with NSCLC were considered eligible for inclusion. The pooled analysis suggested that, in all patients, the positive reponse rate was 30.1% (1,803/5,985) with icotinib-based regimens. Mild skin itching, rashes and diarrhea were the main side effects. No grade III or IV renal or liver toxicity was observed. No treatment-related death occurred in patients treated with icotinib-based regimens. Conclusions: This evidence based analysis suggests that icotinib based regimens are associated with mild response rate and acceptable toxicity for treating Chinese patients with NSCLC.

The Review on the Study of Bee Venom in the domestic papers (최근 10년간 국내의 봉독 관련 연구에 대한 고찰)

  • Lee, Hong-seok;Lee, Jae-dong;Koh, Hyung-kyun
    • Journal of Acupuncture Research
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    • v.20 no.3
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    • pp.154-165
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    • 2003
  • Objective : to research the trend of the study related to Bee venom and o establish the hereafter direction for the study on Bee Venom therapy. Methods : We reviewed the domestic papers published last ten years(1992-2001). Results: 1.We have searched 53 papers in 7 journals and the pattern of study was as follow: the experimental studies were 33, the clinical studies were 10 and the reviewed studies were 10. 2. The experimental studies were 2 papers of analysis of Bee Venom, 3 papers of safety assessment, 1 paper on production of antibody against Bee Venom and 26 paper of safety assessment. 3. Bee Venom used in studies was made in Korea, China and U.S.A.. There were differences of component and effect according to the place of production. 4. There were the experimental studies of LD50 in mouse, acute toxicity, local irritation test, antigenicity and pyrogen test of Bee Venom. Conclusions : We need more studies of unification of term about Bee Venom, difference according to the place of production, clinical safety and effects.

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Toxic Encephalopathy

  • Kim, Yangho;Kim, Jae Woo
    • Safety and Health at Work
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    • v.3 no.4
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    • pp.243-256
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    • 2012
  • This article schematically reviews the clinical features, diagnostic approaches to, and toxicological implications of toxic encephalopathy. The review will focus on the most significant occupational causes of toxic encephalopathy. Chronic toxic encephalopathy, cerebellar syndrome, parkinsonism, and vascular encephalopathy are commonly encountered clinical syndromes of toxic encephalopathy. Few neurotoxins cause patients to present with pathognomonic neurological syndromes. The symptoms and signs of toxic encephalopathy may be mimicked by many psychiatric, metabolic, inflammatory, neoplastic, and degenerative diseases of the nervous system. Thus, the importance of good history-taking that considers exposure and a comprehensive neurological examination cannot be overemphasized in the diagnosis of toxic encephalopathy. Neuropsychological testing and neuroimaging typically play ancillary roles. The recognition of toxic encephalopathy is important because the correct diagnosis of occupational disease can prevent others (e.g., workers at the same worksite) from further harm by reducing their exposure to the toxin, and also often provides some indication of prognosis. Physicians must therefore be aware of the typical signs and symptoms of toxic encephalopathy, and close collaborations between neurologists and occupational physicians are needed to determine whether neurological disorders are related to occupational neurotoxin exposure.

A clinical analysis of patients that used herbal medicine in pregnancy and retrospective survey of patient's treatment satisfaction (임신 중 치료목적으로 한약을 복용한 환자에 대한 실태분석 및 치료에 대한 만족도 조사)

  • Choi, Min-Sun;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.18 no.3
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    • pp.127-138
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    • 2005
  • Purpose : This study was designed to establish safety and efficacy of using herbal medicine in pregnancy and to investigate patient's treatment satisfaction. Methods : We investigated general pregnancy outcomes of twenty-five gynecological outpatients who visited Dongguk univ. Kangnam Oriental Hospital, from July 1, 2002 through December 31, 2004 and have taken herbal medicine in pregnancy. Additionally we investigated newborn's growth status and patient's treatment satisfaction. Results : The rate of normal delivery of patients used herbal medicine for diseases that possibility of abortion is not high was 100% and there was no malformation in normally delivered 21 cases. Most of Newborn's growth status was normal and the average score of patient's satisfaction was 3.5(absolutely satisfied=5). Conclusion : The results of this study show safety and efficacy of using herbal medicine in pregnancy. And In the future, It is thought that more exactly constructed clinical survey need to be carried out.

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Mitochondrial transplantation: an overview of a promising therapeutic approach

  • Ji Soo Kim;Seonha Lee;Won-Kon Kim;Baek-Soo Han
    • BMB Reports
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    • v.56 no.9
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    • pp.488-495
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    • 2023
  • Mitochondrial transplantation is a promising therapeutic approach for the treatment of mitochondrial diseases caused by mutations in mitochondrial DNA, as well as several metabolic and neurological disorders. Animal studies have shown that mitochondrial transplantation can improve cellular energy metabolism, restore mitochondrial function, and prevent cell death. However, challenges need to be addressed, such as the delivery of functional mitochondria to the correct cells in the body, and the long-term stability and function of the transplanted mitochondria. Researchers are exploring new methods for mitochondrial transplantation, including the use of nanoparticles or CRISPR gene editing. Mechanisms underlying the integration and function of transplanted mitochondria are complex and not fully understood, but research has revealed some key factors that play a role. While the safety and efficacy of mitochondrial transplantation have been investigated in animal models and human trials, more research is needed to optimize delivery methods and evaluate long-term safety and efficacy. Clinical trials using mitochondrial transplantation have shown mixed results, highlighting the need for further research in this area. In conclusion, although mitochondrial transplantation holds significant potential for the treatment of various diseases, more work is needed to overcome challenges and evaluate its safety and efficacy in human trials.

Evaluation of Inpatient Use for IV Quinolones in an University Hospital Formulary (대학병원의 Formulary로 선정되어 사용 중인 원내 퀴놀론 주사제의 약물사용에 대한 평가)

  • Kim, Hoon-Hee;Lee, Ok-Sang;Jung, Sun-Hoi;Lim, Sung-Cil
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.1
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    • pp.55-64
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    • 2012
  • The quinolones are broad-spectrum antibiotics and enhanced antimicrobial activity has extended the use of the quinolones beyond the traditional indications for quinolone antibiotics in the treatment of urinary tract infections. The quinolones are effective in a wider variety of infectious diseases, including skin and respiratory infections. Because of their excellent safety and tolerability, they have become popular alternatives to penicillin and cephalosporin derivatives in the treatment of various infections. A retrospective study was performed to evaluate efficacy and safety of IV quinolones for inpatient use. Total 117 patients who administerd quinolones for longer than 3 continuous days at community hospital from October 1st, 2008 to December 31st, 2008 were reviewed. The criterias for drug evaluation were included the validation of indication, outcome, dosage and side effects. In the results, ciprofloxacin 13 (total 93), levofloxacin 3 (total 59) and moxifloxacin 2 (total 19) cases were not met the criterias based on the culture results. Major indications were pneumonia (ciprofloxacin 16.3%, levofloxacin 67.8%, moxifloxacin 84.2%), urinary tract infection (ciprofloxacin 44.1%), skin infection (ciprofloxacin 7.5%, levofloxacin 20.3%, moxifloxacin 10.5%), intra-abdominal infection (ciprofloxacin 10.8%, moxifloxacin 5.3%), etc.. In the results of quinolone monotherapy, the frequencies were each ciprofloxacin 74.2%, levofloxacin 50.8% and moxifloxacin 47.4%. In the results of dosage validation, the validities were each ciprofloxacin 54.8%, levofloxacin 94.9% and moxifloxacin 100.0%. In the results of duration validation, the validities were each ciprofloxacin 59.1%, levofloxacin 78.0% and moxifloxacin 89.5%. Adverse drug reactions were reported for total 49 cases and those were gastrointestinal tract effects including nausea, vomiting, diarrhea and central nervous system effects including headache, dizziness. In summary, the quinolones appropriately used for hospitalized patients based on this study. A focused approach emphasizing "correct use of quinolones" may reduce development of antimicrobial resistance and maximize class efficacy. Consequently, correct use of antibiotics will contribute to decrease medical expenses for person and community.

Comparing the Efficacy and Safety on Intravenous Administration of Aminoglycosides Twice versus Thrice Daily (아미노글리코사이드계 항생제의 투약간격에 따른 안전성 및 효과)

  • Lee, Ju Eun;Kim, Ho Soon;Shin, Wan Gyoon;Cho, Nam Chun
    • Korean Journal of Clinical Pharmacy
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    • v.8 no.2
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    • pp.83-88
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    • 1998
  • Improved knowledge of the time course of antimicrobial activity should provide useful information for designing optimal dosage regimen. In contrast to $\beta$-lactam, aminoglycosides tend to induce a prolonged postantibiotic effect against aerobic or facultative gram negative rods and clinical outcome was significantly correlated with achieving peak serum concentrations. The objective of this study was to compare the efficacy, safety of e same total daily dose of amikacin and gentamicin given either twice or thrice daily in the treatment of patients. Consecutive patients over 20 years old with a suspected or confirmed infection for which an aminoglycosides was indicated were eligible. Exclusion criteria were known allergy to aminoglycosides, renal impairment, granulocytopenia and pregnancy. Patients were treated with intravenous amikacin 15 mg/kg/day or gentamicin 4.5 mg/kg/day either in two devided or in three devided. Seventy-four patients with infection were enrolled in this study of amikacin twice daily (A2, n=29), gentamicin twice daily (G2, n=8) vs amikacin thrice daily (A3, n=30), gentamicin thrice daily (G3, n=7). Baseline characteristics were comparable in G2 and G3. The clinical cure rate (including partial improve) were $89.0\%\;and\;86.0\%$ in A2 group and A3 group respectively. The bacteriologic cure rate were $99.0\%\;and\;85.7\%$ in A2 group and in A3 group respectively. The clinical and bacteriologic effects were difficult to compare G2 with G3, because of the small numbers of patients. The serum creatinin rose in $3.44\%$ (1 in 29) of patients in the A2 group compared to $13.3\%$ (4 in 30) in e A3 group. Although audiometry was not performed, there was no clinical evidence of ototoxicity in any of the patients. In our opinion, twice-daily regimen of aminoglycosides is more effective and less nephrotoxic than thrice-daily regimen.

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Analysis of Risk Factors for Patient Safety Management (환자안전 관리를 위한 위험요인 분석)

  • Ahn, Sung-Hee
    • Journal of Korean Academy of Nursing Administration
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    • v.12 no.3
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    • pp.373-384
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    • 2006
  • Purpose: This is a pilot study to identify patient safety risk factors and strategies for patient safety management perceived by nurses. Methods: Data were collected and analyzed with an open questionnaire from April to May 2005, targeted on 100 nurses working in two hospitals. The issues were 'what are risk factors for patients, nurses, and other medical practitioners? How do they prevent with the aftermath of risk factors, causes of incidents?' For data analysis, types and frequency of risk factors were worked out, using the Australian Incident Monitoring System Taxonomy. Results: The types of patient safety risk factor perceived by nurses were as follows ; therapeutic devices or equipment, infrastructure and services (29.5%), nosocomial infections (16.3%), clinical processes or procedures (15.4%), behavior, human performance, violence, aggression, security and safety (12.2%), therapeutic agents (9.7%), injuries and pressure ulcers (8.7%), logistics, organization, documentation, and infrastructure technology (5.6%). Strategies for patient safety included training of prevention of infection, education about safety management for patients and medical professionals, establishment of reporting system, culture of care, pre-elimination of risk factors, cooperative system among employees, and sharing information. Conclusion: These results will be used to provide evidences for patient safety management and educational program.

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Current use of safety restraint systems and front seats in Korean children based on the 2008-2015 Korea National Health and Nutrition Examination Survey

  • Kong, Seom Gim
    • Clinical and Experimental Pediatrics
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    • v.61 no.12
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    • pp.381-386
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    • 2018
  • Purpose: The use of proper safety restraint systems by children is vital for the reduction of traffic accident-related injury and death. This study evaluated the rates of use of safety restraint systems and front seats by Korean children. Methods: Based on data from the National Health and Nutrition Examination Survey from 2008 to 2015, I investigated the frequencies of safety restraint systems and front seat use by children under six and 12 years of age, respectively. Results: The percentage of respondents who said they always use safety restraint systems increased from 17.7% in 2008 to 45.0% in 2015. The rate of children who did not use the front seats at all was 47.3 % in 2008 compared to 33.4% in 2015. Multivariate logistic regression analysis showed a decrease in safety-restraint-system use as age increased (odds ratio, 0.63; 95% confidence interval [CI], 0.51-0.77). The use rate of front-passenger seat belts by the mother is significantly correlated with the safety-restraint-system use rate by children (odds ratio, 2.14; 95% CI, 1.12-4.06). Conclusion: Although the rate of safety-restraint-system use for children is increasing annually, it remains low. Additionally, the use rate of front passenger seats for children is high. To reduce the rates of injury and death of children from traffic accidents, it is necessary to educate on the appropriate use of safety restraint systems according to age and body size and to develop stronger regulations.