• Title/Summary/Keyword: Randomized Response

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Sepsis: Early Recognition and Optimized Treatment

  • Kim, Hwan Il;Park, Sunghoon
    • Tuberculosis and Respiratory Diseases
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    • v.82 no.1
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    • pp.6-14
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    • 2019
  • Sepsis is a life-threatening condition caused by infection and represents a substantial global health burden. Recent epidemiological studies showed that sepsis mortality rates have decreased, but that the incidence has continued to increase. Although a mortality benefit from early-goal directed therapy (EGDT) in patients with severe sepsis or septic shock was reported in 2001, three subsequent multicenter randomized studies showed no benefits of EGDT versus usual care. Nonetheless, the early administration of antibiotics and intravenous fluids is considered crucial for the treatment of sepsis. In 2016, new sepsis definitions (Sepsis-3) were issued, in which organ failure was emphasized and use of the terms "systemic inflammatory response syndrome" and "severe sepsis" was discouraged. However, early detection of sepsis with timely, appropriate interventions increases the likelihood of survival for patients with sepsis. Also, performance improvement programs have been associated with a significant increase in compliance with the sepsis bundles and a reduction in mortality. To improve sepsis management and reduce its burden, in 2017, the World Health Assembly and World Health Organization adopted a resolution that urged governments and healthcare workers to implement appropriate measures to address sepsis. Sepsis should be considered a medical emergency, and increasing the level of awareness of sepsis is essential.

Nutritional Support for Neurocritically Ill Patients (신경계 중환자의 영양 집중 치료)

  • Jeong, Hae-Bong;Park, Soo-Hyun;Ryu, Ho Geol
    • Journal of Neurocritical Care
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    • v.11 no.2
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    • pp.71-80
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    • 2018
  • Nutritional assessment and support are often overlooked in the critically ill due to other urgent priorities. Unlike oxygenation, organ dysfunction, infection, or consciousness, there is no consensus of indicators. Making it difficult to evaluate the effectiveness of an intervention. Nevertheless, appropriate nutritional support in the critically ill has been associated with less morbidity and lower mortality. But, nutritional support has been considered an adjunct, for body weight maintenance and to help patients during the inflammatory phase of illness. Thus, it has been assigned a lower priority, compared to mechanical ventilation or hemodynamic stability. Recent findings have shown that nutritional support may prevent cellular injury due to oxidative stress and help strengthen the immune response. Large-scale randomized trials and clinical guidelines have shown a shift from nutritional support to nutritional therapy, with an emphasis on the importance of protein, minerals, vitamins, and trace elements. Nutrition is also important in neurocritically ill patients. Since there are few studies or recommendations with regard to the neurocritical population, the general recommendations for nutritional support should be applied.

Effects of leucine-enriched essential amino acid supplementation on muscular fatigue and inflammatory cytokines in wheelchair basketball players

  • An, Young Hwan;Kim, Jisu;Kim, Hee-Jae;Lim, Kiwon
    • Korean Journal of Exercise Nutrition
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    • v.24 no.2
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    • pp.38-46
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    • 2020
  • [Purpose] This study aimed to investigate the effects of leucine-enriched essential amino acid (LEAA) supplementation on muscle fatigue and the level of inflammatory cytokines in wheelchair basketball players after a basketball game and interval training. [Methods] Of the ten recruited wheelchair basketball players (aged 34.5±8.9 years; lean body mass of 34.3±10.0 kg) who had spinal cord injury (SCI) and had undergone amputation, nine participated in the final test. These nine athletes received LEAA supplements (3 times 4.0 g/day) or placebo treatment in a double-blind, randomized, crossover study. We measured variables related to muscular fatigue and inflammatory response before the intense exercise and 4 days after recovery. [Results] The significant effect of LEAA supplementation was inhibition of circulating IL-6 levels in the LEAA-treated group compared with the placebo group (P < .05). However, no changes were observed in the TNF-α and creatinine kinase levels. Moreover, analysis of variance analysis showed no significant difference in the relative values of muscle soreness. However, the effect size analysis with Cohen's d reported a significant improvement in the relative values of whole body and back muscle soreness. [Conclusion] Our results revealed that LEAA supplementation before and after intense exercise could help reduce muscle soreness and IL-6 levels in wheelchair basketball players.

The Effect of Artificial Sweetener Use on Obesity (인공감미료 섭취가 비만에 미치는 영향)

  • Ju Sam Hwang
    • Archives of Obesity and Metabolism
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    • v.2 no.2
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    • pp.45-53
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    • 2023
  • Despite the emergence of obesity as a significant public health concern, artificial sweeteners have made their way into various food products due to the perception, that they serve as substitutes for sugar. Artificial sweeteners are used to supposedly achieve weight management and health improvement. However, their efficacy and safety remain debatable. Commonly used artificial sweeteners include aspartame, acesulfame potassium, saccharin, and sucralose. This article discusses the effects of artificial sweetener consumption on weight loss, appetite regulation, blood glucose control, and gut microbiota. Research findings, concerning the consumption of artificial sweeteners and their association with body weight, have shown inconsistencies between randomized controlled trials and cohort studies. Studies, comparing artificial sweeteners to sugar, have reported no significant differences in satiety. Although artificial sweeteners have no calories, they can affect blood sugar levels through the cephalic phase insulin response. A recent study suggested that artificial sweeteners influenced the occurrence of diabetes. Due to limitations in the study design, excluding diabetes-influencing factors was not feasible. The evidence showed that artificial sweeteners harbored potential health risks, necessitating further investigation. According to recent studies, the consumption of artificial sweeteners was associated with gut microbiota changes and individual blood sugar responses. It is important to note that artificial sweeteners cannot be considered safe alternatives to sugar, and further research is required.

Effects of Dietary Zinc on Performance and Immune Response of Growing Pigs Inoculated with Porcine Reproductive and Respiratory Syndrome Virus and Mycoplasma hyopneumoniae

  • Roberts, E.S.;Heugten, E. van;Spears, J.W.;Routh, P.A.;Lloyd, K.L.;Almond, G.W.
    • Asian-Australasian Journal of Animal Sciences
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    • v.17 no.10
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    • pp.1438-1445
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    • 2004
  • The objective of this study was to determine the effects of dietary Zn level on performance, serum Zn concentrations, alkaline phosphatase activity (ALP), and immune response of pigs inoculated with Porcine Reproductive and Respiratory Syndrome virus (PRRSv) and Mycoplasma hyopneumoniae. A $2{\times}4$ factorial arrangement of treatments was used in a randomized design. Factors included; 1) PRRSv and M. hyopneumoniae inoculation (n=36 pigs) or sham inoculation (n=36 pigs) with media when pigs entered the grower facility (d 0) at 9 weeks of age and 2) 10, 50, 150 ppm supplemental Zn sulfate (${ZnSO}_4$) from weaning until the completion of the study, or 2,000 ppm supplemental ${ZnSO}_4$for two weeks in the nursery and then supplementation with 150 ppm ${ZnSO}_4$for the remainder of the trial. The basal diet contained 34 ppm Zn. Pigs were weighed on d 0, 10, 17, 24 and 31 and blood samples were collected on d 0, 7, 14, 21 and 28. Pigs inoculated with PRRSv were serologically positive at d 28 and control pigs remained negative to PRRSv. In contrast, the M hyopneumoniae inoculation was inconsistent with 33.3% and 52.8% of pigs serologically positive at d 28 in the control and infected groups, respectively. A febrile response was observed for approximately one week after inoculation with PRRSv. Feed intake (p<0.01) and gain (p<0.1) were less in PRRSv infected pigs than control pigs for the 31 d study. However, performance did not differ among pigs in the four levels of ${ZnSO}_4$. Assessments of immune responses failed to provide unequivocal influence of either PRRSv inoculation or ${ZnSO}_4$level. These data suggest that PRRSv and M. hyopneumoniae act to produce some performance deficits and the influence of Zn supplementation of nursery age pigs does not have clear effect in grower pigs affected with disease.

Gefitinib in Selected Patients with Pre-Treated Non-Small-Cell Lung Cancer: Results from a Phase IV, Multicenter, Non-Randomized Study (SELINE)

  • Lee, Kwan-Ho;Lee, Kye-Young;Jeon, Young-June;Jung, Maan-Hong;Son, Choonhee;Lee, Min-Ki;Ryu, Jeong-Seon;Yang, Sei-Hoon;Lee, Jae-Cheol;Kim, Young-Chul;Kim, Sun-Young
    • Tuberculosis and Respiratory Diseases
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    • v.73 no.6
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    • pp.303-311
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    • 2012
  • Background: This study was designed to analyze the efficacy of gefitinib as a second-line therapy, according to the clinical characteristics in Korean patients with non-small-cell lung cancer (NSCLC). Methods: In this Phase IV observational study, we recruited patients, previously failed first-line chemotherapy, who had locally advanced or metastatic NSCLC, and who were found to be either epidermal growth factor receptor (EGFR) mutation-positive or satisfied 2 or more of the 3 characteristics: adenocarcinoma, female, and non-smoker. These patients were administered with gefitinib 250 mg/day, orally. The primary endpoints were to evaluate the objective response rate (ORR) and to determine the relationship of ORRs, depending on each patient's characteristics of modified intent-to-treat population. Results: A total of 138 patients participated in this study. One subject achieved complete response, and 42 subjects achieved partial response (ORR, 31.2%). The subgroup analysis demonstrated that the ORR was significantly higher in patients with EGFR mutation-positive, compared to that of EGFR mutation-negative (45.8% vs. 14.0%, p=0.0004). In a secondary efficacy variable, the median progression-free survival (PFS) was 5.7 months (95% confidence interval, 3.9~8.4 months) and the 6-month PFS and overall survival were 49.6% and 87.9%, respectively. The most common reported adverse events were rash (34.4%), diarrhea (26.6%), pruritus (17.5%), and cough (15.6%). Conclusion: Gefitinib was observed in anti-tumor activity with favorable tolerability profile as a second-line therapy in these selected patients. When looking at EGFR mutation status, EGFR mutation-positive showed strong association with gefitinib by greater response and prolonged PFS, compared with that of EGFR mutation-negative.

Combined Modality Therapy of Non-Hodgkin's Lymphoma of Waldeyer's Ring (Waldeyer's Ring 비호치킨 림프종의 병합요법)

  • Park In-Kyu;Yun Sang-Mo;Park Jun-Sik;Kim Jae-Cheol
    • Korean Journal of Head & Neck Oncology
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    • v.15 no.1
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    • pp.22-28
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    • 1999
  • Purpose: We performed this study retrospectively to evaluate local control, survival, prognostic factors, and failure patterns in patients with non-Hodgkin's lymphoma of Waldeyer's ring. Materials and Methods: From April 1984 to November 1996,41 patients with non-Hodgkin's lymphoma of Waldeyer's ring were treated with combined chemotherapy and radiation therapy. Age was ranged from 19 to 73 years old with a median age of 55 years, and there were 26 male and 15 female patients. Primary site was tonsil in 26 and base of the tongue in 7 and nasopharynx in 8, and stage distribution showed stage I in 12 and stage II in 29 patients. Pathologic classification was done according to Working Formulation. There were 1 with follicular mixed small cleaved and large cell, 8 with diffuse small cleaved cell, 7 with diffuse mixed small and large cell, and 25 cases with diffuse large cell. All patients were treated with combination of chemotherapy and radiation therapy. Chemotherapy regimen consisted of either CHOP-Bleo(cyclophosphamide, adriamycin, vincristine, prednisolone, bleomycin) or COP-BLAM III(cyclophosphamide, vincristine, prednisolone, bleomycin, adriamycin, procarbazine). Radiation dose ranged from 3600cGy to 6620cGy with a median dose of 5040cGy. Follow-up time was ranged from 15 months to 159 months(median 55 months). Results: The complete response was achieved in 98%(40/41) and partial response in 2%(1/41). The complete response rate were the followings: 66.7% for stage I and 51.7% for stage II after chemotherapy, 100% for stage I and 96.6% for stage II after overall treatment respectively. The overall survival rate and disease-tree survival rates at 5 years were 82.6% and 79.5%, respectively. Prognostic factors for overall survival were age(p=0.007), stage(p=0.03), nodal status(p=0.006) and radiation dose(p=0.003). The factors associated with disease-tree survival were stage(p=0.04), nodal status(p=0.004) and radiation dose(p=0.009). The failure patterns were analized in evaluable 35 patients with complete response. Locoregional failure was noted in 2 patients and distant metastasis in 5 patients. Conclusion: Our results suggest that combined modality therapy is the appropriate treatment for stage I-II intermediate grade non-hodgkin's lymphoma of the Waldeyer's ring. However, our material is small and the analysis is retrospective. Randomized prospective studies for combined therapy, radiation therapy alone and chemotherapy alone are needed.

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Effects of β-glucan with vitamin E supplementation on the physiological response, litter performance, blood profiles, immune response, and milk composition of lactating sows

  • Tae Wook, Goh;Jinsu, Hong;Hong Jun, Kim;Sun Woo, Kang;Yoo Yong, Kim
    • Animal Bioscience
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    • v.36 no.2
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    • pp.264-274
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    • 2023
  • Objective: This study was conducted to evaluate the effects of β-glucan with vitamin E supplementation on the physiological response, litter performance, blood profiles, immune response, and milk composition of lactating sows. Methods: A total of 50 multiparous F1 sows (Yorkshire×Landrace) with an average body weight (BW) of 233.6±4.30 kg and an average parity of 4.00±0.307 and their litters were used in this experiment. All sows were allotted to one of five treatments, taking into consideration BW, backfat thickness, and parity in a completely randomized design with 10 replicates. The experimental diets included a corn-soybean meal-based basal diet with or without 0.1% or 0.2% β-glucan and 110 IU vitamin E/kg diet. Results: All treatments added with β-glucan or vitamin E were statistically higher in the average daily feed intake (ADFI) of lactating sows compared to those of the control (Diet, p<0.01). Additionally, the ADFI of lactating sows was significantly higher in the groups supplemented with 0.1% β-glucan compared to 0.2% β-glucan (BG, p<0.01). There was an increasing trend in piglet weight at weaning (BG, p = 0.07), litter weight at the 21st day of lactation (BG, p = 0.07) and litter weight gain (BG, p = 0.08) in groups supplemented with 0.1% β-glucan. The addition of 110 IU vitamin E/kg diet increased vitamin E concentration significantly in lactating sows (VE, p<0.01) and exhibited a trend for higher concentrations of vitamin E (VE, p = 0.09) in piglets. Adding 0.1% β-glucan compared to 0.2% β-glucan induced a decrease in the concentration of tumor necrosis factor-α in lactating sows (BG, p = 0.06) and in piglets (BG, p = 0.09) on the 21st day of lactation. There were no significant differences in the milk composition of sows. Conclusion: Adding 0.1% β-glucan and 110 IU vitamin E/kg to a lactating sow's diet was beneficial to the growth performance of piglets by leading to an increase in the feed intake of sows and efficiently supplying vitamin E to both the sows and piglets.

An Open-label, Randomized, Comparative Assessment of the Efficacy and Safety between Tofisopam and Lorazepam in Anxiety Disorder (Tofisopam과 lorazepam의 항불안효과와 안전성에 대한 비교 연구)

  • Lee, Min Soo;Kim, Yong-Ku;Kwak, Dong-Il
    • Korean Journal of Biological Psychiatry
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    • v.4 no.2
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    • pp.265-271
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    • 1997
  • Objective : A 4-week, single-blind, parallel group study was conducted to evaluate the efficacy and safety of tofisopam and lorazepam in 32 outpatients with anxiety disorder. Methods : Patients were randomized to receive either tofisopam(N=17) or lorazepam(N=15). The starting dose of tofisopam was 50mg t.i.d. daily, which could be increased to a maximum of 100mg t.i.d. according to the patient's clinical response and side effect. The starting dose of lorazepam was 0.75mg b.i.d. daily, which could be increased to a maximum of 1.5mg b.i.d. depending on the patient's clinical response and side effect. Efficacy evaluations at baseline, week 1, 2, and 4 used the 14-item Hamilton Rating Scale for Anxiety(HAM-A) and Clinical Global Impression(CGI). Tolerability was assessed by response to a nonleading question concerning adverse events. Laboratory parameters including vital sign, EKG, hematological, and biochemical values were measured during trial. Results : No significant differences between HAM-A total scores, two HAM-A factors(psychic, somatic) and CGI severity scores were recorded at any point during tofisopam and lorazepam treatments. However, in each group there was a significant decrease in HAM-A total scores, two HAM-A factor s(psychic, somatic), CGI severity scores over time. The pecentages of patients with tofisopam who at least minimally improved increased from 64.7% at week 1 to 94.1% at week 4. The pecentages of patients with lorazepam who at least minimally improved increased from 40.0% at week 1 to 66.7% at week 4. The pecentages of patients with tofisopam who had not any adverse event increased from 58.8% at week 1 to 87.9% at week 4. The pecentages of patients with lorazepam who had not any adverse event were not changed from 46.7% at week 1 to 46.7% at week 4. Laboratory parameters including vital sign, EKG, hematological, and biochemical values showed no significant changes during the trial in both groups. Conclusion : These data suggest that tofisopam may be effective in reducing anxiety and is a anti-anxiety drug of identical potency with lorazepam. Tolerability of tofisopam was superior to lorazepam. These findings should be confirmed by using double-blind crossover study with a large member of patients.

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Long-term Results of Radiotherapy for Subfoveal Choroidal Neovascularization (CNV) in Age-related Macular Degeneration (ARMD) (연령관련 황반하 맥락막 신생혈관증에서 방사선의 장기적 치료 결과)

  • Kim, Bo-Kyong;Kim, Il-Han
    • Radiation Oncology Journal
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    • v.25 no.2
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    • pp.63-69
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    • 2007
  • [ $\underline{Purpose}$ ]: We performed this prospective randomized study to evaluate the efficacy and the complications of radiotherapy for Subfoveal CNV in ARMD and to compare the treatment results at two dosages (14.4 Gy and 19.8 Gy). $\underline{Materials\;and\;Methods}$: 60 eyes of 55 patients were enrolled, and randomized into 14.4 Gy (31 eyes) or 19.8 Gy (29 eyes) groups. CT was used to plan the radiotherapy. All patients received radiotherapy with a 1.8 Gy daily dose using 4 MV photon. We categorized treatment results as improved, stable, or deteriorated based on visual acuity changes of more than 2 lines on the ETDRS chart. $\underline{Results}$: Median follow-up period was 33.5 months. At 12 months, visual acuity improved in 9 (16.7%), stable in 41 (75.9%), and aggravated in 4 (7.4%) of 54 evaluated eyes. At 24 months, 49 eyes (81.7%) were evaluated. Visual acuity improved in 6 (12.2%), was stable in 33 (67.4%), and deteriorated in 10 (20.4%). At 36 months, 37 eyes were evaluated. Six (16.2%) eyes were improved, 21 (56.8%) stable, and 10 (27.0%) deteriorated. No significant difference in response was observed between the 14.4 Gy and 19.8 Gy groups (Mantel-Haenszel $x^2=0.4756$). The proportion of eyes with a vision of $20/100{\leq}increased$ from 28.3% initially to 32.7% after 24 months of radiotherapy. There were no severe acute or chronic complications. $\underline{Conclusion}$: External beam radiotherapy with doses of 14.4 or 19.8 Gy may be an effective treatment for subfoveal CNV in ARMD. No dose-response relationships with respect to treatment response or toxicity were observed between the 14.4 Gy and 19.8 Gy groups.