• Title/Summary/Keyword: safety outcomes

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Systematic Review of Single Large and/or Multinodular Hepatocellular Carcinoma: Surgical Resection Improves Survival

  • Yang, Xiang-Di;Pan, Ling-Hui;Wang, Lin;Ke, Yang;Cao, Ji;Yang, Chun;Zhong, Jian-Hong;Luo, Wang;Guo, Jiao;Li, Le-Qun
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.13
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    • pp.5541-5547
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    • 2015
  • Background: The role of surgical resection for patients with single large (${\geq}5cm$) and/or multinodular (${\geq}2$) hepatocellular carcinoma (HCC) is still controversial. This systematic review was performed to evaluate the safety and efficacy of resection for patients with single large and/or multinodular HCC. Materials and Methods: Databases (the PubMed, Web of Science, Embase, and Cochrane databases) were systematically searched to identify relevant studies exploring the safety and efficacy of resection for single large and/or multinodular HCC, published between January 2000 and December 2014. Perioperative morbidity and mortality, overall survival, and disease-free survival of the resection group were calculated. In addition, these outcome variables were also calculated for the control group in the included studies. Results: One randomized controlled trial and 42 nonrandomized studies involving 9,580 patients were eligible for analysis. Eight (1,594 patients) of the 43 studies also reported the outcomes of transarterial chemoembolization (TACE). Although 51.4% of patients featured cirrhosis, 90.7% of them demonstrated Child-Pugh A liver function in the resection group. The median rates of morbidity (24.5%) and mortality (2.5%) after resection were significantly higher than that of TACE (11.0%, P<0.001; 1.9%, P<0.001). However, patients who underwent resection had significantly higher median one-, three-, and five-year overall survival (76.1%, 51.7%, and 37.4%) than those who underwent TACE (68.3%, 31.5%, and 17.5%, all P<0.001). The median 1-, 3-, and 5-year DFS rates after resection were 58.3%, 34.6%, and 24.0%, respectively. Conclusions: Although tumor recurrence after resection for patients with single large and/ or multinodular HCC continues to be a major problem, resection should be considered as a strategy to achieve long-term survival.

Efficacy and Safety of Sorafenib for Advanced Non-Small Cell Lung Cancer: a Meta-analysis of Randomized Controlled Trials

  • Wang, Wei-Lan;Tang, Zhi-Hui;Xie, Ting-Ting;Xiao, Bing-Kun;Zhang, Xin-Yu;Guo, Dai-Hong;Wang, Dong-Xiao;Pei, Fei;Si, Hai-Yan;Zhu, Man
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.14
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    • pp.5691-5696
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    • 2014
  • Background: Many clinical trials have been conducted to evaluate sorafenib for the treatment of advanced NSCLC, but the results for efficacy have been inconsistent. The aim of this study was to evaluate the efficacy and safety of sorafenib in patients with advanced NSCLC in more detail by meta-analysis. Methods: This meta-analysis of randomized controlled trials (RCTs) was performed after searching PubMed, EMBASE, ASCO Abstracts, ESMO Abstracts, and the proceedings of major conferences for relevant clinical trials. Two reviewers independently assessed the quality of the trials. Outcomes analysis were disease control rate (DCR), progression- free survival (PFS), overall survival (OS) with 95% confidence intervals (CI) and major toxicity. Subgroup analysis was conducted according to sorafenib monotherapy, in combination with chemotherapy or EGFR-TKI to investigate the preferred therapy strategy. Results: Results reported from 6 RCTs involving 2, 748 patients were included in the analysis. Compared to sorafenib-free group, SBT was not associated with higher DCR (RR 1.31 (0.96- 1.79), p=0.09), PFS (HR 0.82 (0.66-1.02), p=0.07) and OS (HR 1.01 (0.92-1.12), p=0.77). In terms of subgroup results, sorafenib monotherapy was associated with significant superior DCR and longer PFS, but failed to show advantage with regard to OS. Grade 3 or greater sorafenib-related adverse events included fatigue, hypertension, diarrhea, oral mucositis, rash and HFSR. Conclusions: SBT was revealed to yield no improvement in DCR, PFS and OS. However, sorafenib as monotherapy showed some activity in NSCLC. Further evaluation may be considered in subsets of patients who may benefit from this treatment. Sorafenib combined inhibition therapy should be limited unless the choice of platinum-doublet regimen, administration sequence or identification of predictive biomarkers are considered to receive better anti-tumor activity and prevention of resistance mechanisms.

The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia

  • Kim, Sang Bum;Lee, Jang Hoon;Lee, Juyoung;Shin, Seung Han;Eun, Ho Sun;Lee, Soon Min;Sohn, Jin A;Kim, Han Suk;Choi, Byung Min;Park, Min Soo;Park, Kook In;Namgung, Ran;Park, Moon Sung
    • Clinical and Experimental Pediatrics
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    • v.58 no.9
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    • pp.347-353
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    • 2015
  • Purpose: The purpose of this study was to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonarydysplasia (BPD). Methods: The Interventional study was designed as a multicenter, prospective, and randomized trial, with open labeled and parallel-experimental groups, 66 infants were enrolled and allocated to either the case group (n=30) or the control group (n=36) based on gestational age (GA). Infants in the case group were given Montelukast sodium (Singulair) based on their body weight (BW). Zero week was defined as the start time of the study. Results: The incidence of moderate to severe BPD was not different between the groups (case group: 13 of 30 [43.3%] vs. control group: 19 of 36 [52.8%], P=0.912). Additionally, secondary outcomes such as ventilation index, mean airway pressure and resort to systemic steroids were not significantly different. There were no serious adverse drug reactions in either group, and furthermore the rate of occurrence of mild drug related-events were not significantly different (case group: 10 of 42 [23.8%] vs. control group: 6 of 48 (15.8%), P=0.414). Conclusion: Montelukast was not effective in reducing moderate or severe BPD. There were no significant adverse drug events associated with Montelukast treatment.

Management of Enteral Nutrition in the Pediatric Intensive Care Unit: Prokinetic Effects of Amoxicillin/Clavulanate in Real Life Conditions

  • Chiusolo, Fabrizio;Capriati, Teresa;Erba, Ilaria;Bianchi, Roberto;Atti, Marta Luisa Ciofi degli;Picardo, Sergio;Diamanti, Antonella
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.23 no.6
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    • pp.521-530
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    • 2020
  • Purpose: Malnutrition is a common feature in critically ill children. Enteral nutrition (EN) is the main strategy to nutritionally support critical ill children, but its use can be hindered by the development of intolerance. The study aimed to assess the effectiveness and safety of amoxicillin/clavulanate (A/C) to treat EN intolerance. Methods: We retrospectively evaluated patients admitted to the pediatric intensive care unit from October 2018 to October 2019. We conducted a case-control study: in the first 6 months (October 2018-April 2019) we implemented the nutritional protocol of our Institution with no drug, whereas in the second half (May 2019-October 2019) we employed A/C for 1 week at a dose of 10 mg/kg twice daily. Results: Twelve cases were compared with 12 controls. At the final evaluation, enteral intake was significantly higher than that at baseline in the cases (from 2.1±3.7 to 66.1±27.4% of requirement, p=0.0001 by Wilcoxon matched-pairs signed rank test) but not in the controls (from 0.2±0.8 to 6.0±14.1% of the requirement, p=NS). Final gastric residual volume at the end of the observation was significantly lower in the cases than in the controls (p=0.0398). The drug was well tolerated as shown by the similar safety outcomes in both cases and controls. Conclusion: Malnutrition exposes critically ill children to several complications that affect the severity of disease course, length of stay, and mortality; all may be prevented by early EN. The development of intolerance to EN could be addressed with the use of A/C. Future prospective clinical trials are needed to confirm these conclusions.

Antiviral Efficacy of Citra-kill®, Disinfectant Solution Against Avian Influenza Virus

  • Cha, Chun-Nam;Lee, Yeo-Eun;Kang, In-Jin;Yoo, Chang-Yeul;Park, Eun-Kee;An, Sun-Jeong;Kim, Suk;Lee, Hu-Jang
    • Journal of Food Hygiene and Safety
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    • v.27 no.1
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    • pp.18-23
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    • 2012
  • Highly pathogenic avian influenza virus (HPAIV) is already panzootic in poultry and caused a considerable economic loss in poultry industry. In addition, HPAIV continues to cross species barriers to infect humans and other mammals, often with fatal outcomes. In this study, the virucidal efficacy of Citra-$Kill^{(R)}$ composed to quaternary ammonium chloride and citric acid was investigated against avian influenza H9N2 virus (AIV). A virucidal efficacy was determined with the viability of AIV contacted with the disinfectant in the allantoic membrane of chicken embryos. Citra-$Kill^{(R)}$ and AIV was reacted on the distilled water (DW), hard water (HW) or organic matter suspension (OM) condition. On DW condition, AIV was inactivated with 2,000 fold dilutions of Citra-$Kill^{(R)}$. When the antiviral effect on HW condition was evaluated, the antiviral activity of the disinfectant showed on 1,500 fold dilutions against AIV. With the investigation of the antiviral effect of the disinfectant on OM condition, AIV was inactivated on 500 fold dilutions of Citra-$Kill^{(R)}$. As Citra-$Kill^{(R)}$ possesses virucidal efficacy against AIV, the disinfectant solution can be used to limit the spread of animal viral diseases.

Efficacy and Safety of Miniscalpel Acupuncture on Knee Osteoarthritis - A randomized controlled pilot trial -

  • Jun, Seungah;Lee, Jung Hee;Gong, Han Mi;Choi, Seong Hun;Bo, Min Hwang;Kang, Mi Suk;Lee, Geon-Mok;Lee, Hyun-Jong;Kim, Jae Soo
    • Journal of Pharmacopuncture
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    • v.21 no.3
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    • pp.151-158
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    • 2018
  • Objectives: We investigated the efficacy and safety of miniscalpel acupuncture (MA) for knee osteoarthritis (KOA) in an assessor-blinded randomized controlled pilot trial; this would provide information for a large-scale randomized controlled trial. Methods: Participants (n = 24) were recruited and randomly allocated to the MA group (experimental) or acupuncture group (control). The MA group received treatment once a week for 3 weeks (total of 3 treatments), while the acupuncture group received treatment two times per week for 3 weeks (total of 6 treatments). The primary outcome was pain as assessed by a visual analogue scale (VAS). The secondary outcomes (intensity of current pain, stiffness, and physical function) were assessed using the short-form McGill Pain Questionnaire (SF-MPQ) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Assessments were performed at baseline, 1, 2, and 3 during treatment and at week 5 (2 weeks after the end of treatment). Results: Of the 24 participants, 23 completed the study. Both groups showed significant improvements in VAS, SF-MPQ, and WOMAC. However, there were no significant differences between the MA and acupuncture groups. No serious adverse event occurred and blood test results were within normal limits. Conclusion: Our results suggest that although both MA and acupuncture provide similar effects with regard to pain control in patients with KOA, MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments. A large-scale clinical study is warranted to further clarify these findings.

The Flow Behavior Characteristics of Methane with Phase Change at Low Heat Flux (저열유속에서 상변화를 수반하는 메탄의 유동거동특성)

  • Choi, Bu-Hong
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.20 no.1
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    • pp.96-103
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    • 2014
  • A liquefied natural gas(LNG) in cryogenic liquid is converted back into gaseous form for distribution to residential and industrial consumers. In this re-gasification process, LNG supplies a plenty of cold thermal energy about $83.7{\times}10^4kJ/kg$. The LNG cold thermal energy is utilized for the re-liquefaction process of cryogenic fluids such as Nitrogen, Hydrogen and Helium, and ice manufacturing process and air-conditioning system in some advanced countries. Therefore, it is also necessary to establish the recovery systems of the LNG cold thermal energy around Incheon, Pyungtaek and Tongyung LNG import terminals in our country. Methane is used as working fluid in this paper, which is the major component of LNG over 85 % by volume, in order to investigate the flow behavior characteristics of LNG with phase change at low heat flux. This paper presents the effects of pipe diameters, pipe inclinations and saturation pressures on the flow boundaries of methane flowing in a cryogenic heat exchanger tube, together with those of nitrogen, propane, R11 and R134a. The outcomes obtained from this theoretical researches are also compared with previous experimental data. It was also found that the effect of pipe inclination on the methane flow boundaries was significant.

Analysis of the contents of the Act on the Development, Management, etc. of Marinas using Semantic Network Analysis (언어네트워크 분석 기법을 활용한 마리나항만법 내용 분석)

  • Park, Gyung-Yeol;Hong, Jang-Won
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.24 no.2
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    • pp.163-170
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    • 2018
  • The purpose of this study is to describe quantitatively the characteristics and the structure of the Act on the development, management, etc. of Marinas (the Marinas Act) by analysing its provisions using semantic network analysis. The method of semantic network analysis has its advantages in overcoming limitations of the traditional content analysis method, as it is easy for the user to understand the structure and the shape of a network by figuring out the structural network among words. The object of the analysis is the full text of Marinas Act recently revised from Chapters 1 to 4, while partial analysis is carried out respectively for each chapter from Chapters 2 to 4. The structural characteristic of the Marinas Act shows that the act focuses on the development of marinas, as its main goal is interpreted to set up hardwares and to construct facilities rather than to promote the marina industry itself. Even though some clauses for human capital development and business development are included, they are of less importance compared to the development of marina facilities. This study provides some basic information on the structural characteristics of the current act, which can be referred to in subsequent studies. In the future, it also needs to be complemented through comparative analysis with government policy outcomes and performance of diverse analytical approaches.

Subsequent Embryo Transfers (SET) on Day 2 and Day 5: It's Safety and Effectiveness (난자채취 2일과 5일에 연속으로 실시한 배아이식의 안전성과 효과)

  • Park, Kee-Sang;Song, Hai-Bum;Lee, Taek-Hoo;Jeon, Sang-Sik
    • Clinical and Experimental Reproductive Medicine
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    • v.27 no.2
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    • pp.165-172
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    • 2000
  • Objective: In vitro fertilization (IVF) and a prolonging the time of culture may be helpful in establishing a viable pregnancy through a selection effect. Some embryos do not develop beyond the 4-cell stage and some may not develop to the blastocyst stage. We have evaluated the safety of SET and the outcomes of pregnancy. Methods: Sperms were treated with Ham's F-10 supplemented with 10% human follicular fluid (hFF). oocytes or fertilized oocytes were cultured in Dulbecco's Modified Eagle Medium (DMEM) with 10% or 20% hFF respectively. Up to five oocytes were inseminated with approximately 200,000 sperm cells/2 ml in each well. Fertilization was examined in the following morning and fertilized oocytes were co-cultured until embryo transfer. Vero cells for co-culture were prepared in Tissue Culture Medium - 199 (TCM-199) with 10% fetal bovine serum. At the two to four cell and blastocyst on day 2 and day 5, embryo and blstocyst grading were evaluated. Pregnancy rate was determined after transfer of human embryos at the two to four cell stage on day 2 (Group I) or subsequent transfer of embryos on day 2 and at the blastocyst stage on day 5 (Group II). For statistical analysis, Student's t-test and Chi-square (${\chi}^2$_test) were used. Results were considered statistically significant when p value was less than 0.05. Results: No differences was found in the fertilization between Group I (81.0%, 98/121) and Group II (81.8%, 180/220). In case of cleavage rate, no difference was found in Group I (95.9%, 94/98) and Group II (97.8%, 174/178). However, the rate of-clinical pregnancy was significantly higher (p=0.014) in Group II (66.7%, 12/18) than in Group I (26.3%, 5/19). Conclusion: The results of this study showed that SET is safe and effective, and significantly increases the pregnancy rate.

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An Open-Label Study of the Improvements in Clinical Symptoms and Neurocognitive Functions in Korean Children and Adolescents with Attention-Deficit Hyperactivity Disorder after Treatment with Metadate CD (국내 주의력결핍 과잉행동장애 아동 및 청소년에서 메타데이트CD의 임상증상 및 신경인지기능 개선 효과에 대한 개방 연구)

  • Yoo, Han-Ik K.;Kim, Bong-Seog;Joung, Yoo-Sook;Bahn, Geon-Ho;Song, Dong-Ho;Ahn, Dong-Hyun;Lee, Young-Sik
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.22 no.4
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    • pp.253-261
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    • 2011
  • Objectives : This study aimed to investigate the efficacy and safety of Metadate CD (MCD) when given to Korean children and adolescents with attention-deficit hyperactivity disorder (ADHD). We also explored the effects of the drug on diverse neuro-cognitive functions. Methods : Ninety-one subjects with ADHD (mean age 8.6${\pm}$2.2 years) were recruited at 6 outpatient clinics in Seoul, Korea. We used the ADHD Rating Scale (ARS), Clinical Global Impression (CGI), and comprehensive attention test (CAT) to measure the drug's effects. Results : After 0.92${\pm}$0.32mg/kg/day of MCD were administered for 57.4${\pm}$7.6 days, there was a 48.5% reduction in the mean total ARS scores (p<.001). Fifty-seven subjects (64.8%) showed either much improved or very much improved outcomes on the CGI-Improvement scale. The CGI-Severity scale also decreased from an average of 4.7 to an average of 2.9 (p<.001). Errors and response time standard deviations of the CAT, sustained attention test-to-response tasks, the flanker test, and divided attention test scores decreased after treatment (p<.05). The forward memory span of the spatial working memory test scores increased (p<.05). Thirty-five patients (39.8%) experienced side effects, of which the most common were headache (14.8%), nausea (12.5%), and anorexia (9.1%). Conclusion : This open-label study suggests that MCD is effective and safe in improving the symptoms and neurocognitive functions of Korean children and adolescents with ADHD.