• Title/Summary/Keyword: Non-clinical outcomes

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Assessment for Nutrient Intakes in Korean Women according to Obesity and Metabolic Syndrome (비만과 대사증후군 동반 여부에 따른 한국 성인 여성의 영양소 섭취 상태 평가)

  • Chung, Hye-Kyung;Kang, Ju-Hee;Shin, Min-Jeong
    • Korean Journal of Community Nutrition
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    • v.15 no.5
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    • pp.694-703
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    • 2010
  • Recent studies have reported that a subset of obese individuals who were metabolically healthy but obese had more favorable clinical outcomes than obese subjects with metabolic disturbances. The purpose of this study was to evaluate the distribution and agreement of obesity subtypes according to body mass index (BMI) and metabolic syndrome (MS). Furthermore, we examined the differences of nutrient intake among the groups. Data was analyzed for 1,095 female subjects older than 40 years using Korean National Health and Nutrition Survey in 2008. The degree of obesity was classified by two methods, using BMI (obese ${\geq}\;25\;kg/m^2$, not obese < $25\;kg/m^2$) and MS (meet ${\geq}\;3$ criteria among 5 index: waist circumference, triglyceride, glucose, HDL-cholesterol and blood pressure). Subjects were divided into 4 groups according to $2{\times}2$ cross table: non-obese without MS, non-obese with MS, obese without MS and obese with MS. Nutrient intakes were compared among 4 groups. The results showed that the proportions of non-obese without MS, non-obese with MS, obese without MS and obese with MS were 47.6%, 13.6%, 16.6%, and 22.2% of total subjects, respectively. The agreement (kappa value) of two methods was 0.354 (fair) in total subjects, 0.365 (fair) in 40-60 year old subjects and 0.304 (fair) in ${\geq}\;61$ year old subjects. In ${\geq}\;61$ years old subjects, intakes of percentage energy from carbohydrate, percentage of energy from fat, calcium, phosphorous, sodium, vitamin A, carotene, thiamine, riboflavin and niacin were significantly different among the groups. In contrast, the subjects of 40-60 years old, no differences in nutrient intakes were observed. In conclusion, there were differences in nutrient intakes among the groups subdivided by obesity and MS, especially in elderly female subjects. Individualized dietary guideline for subtype of obesity will be needed to treat metabolic disturbance of obesity.

Treatment of non-odontogenic orofacial pain using botulinum toxin-A: a retrospective case series study

  • Kim, Sang-Yun;Kim, Young-Kyun;Yun, Pil-Young;Bae, Ji-Hyun
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.40
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    • pp.21.1-21.5
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    • 2018
  • Background: The purpose of this study was to evaluate the clinical outcomes of treatment of non-odontogenic atypical orofacial pain using botulinum toxin-A. Methods: This study involved seven patients (seven females, mean age 65.1 years) who had non-odontogenic orofacial pain (neuropathic pain and atypical orofacial pain) and visited the Seoul National University Bundang Hospital between 2015 and 2017. All medication therapies were preceded by botulinum toxin-A injections, followed by injections in the insignificant effects of medication therapies. Five of the seven patients received intraoral injections in the gingival vestibule or mucosa, while the remaining two received extraoral injections in the masseter and temporal muscle areas. Results: In five of the seven patients, pain after botulinum toxin-A injection was significantly reduced. Most of the patients who underwent surgery for dental implantation or facial nerve reconstruction recovered after injections. However, the pain did not disappear in two patients who reported experiencing persistent pain without any cause. Conclusions: The use of botulinum toxin-A for the treatment of non-odontogenic neuropathic orofacial pain is clinically useful. It is more effective to administer botulinum toxin-A in combination with other medications and physical therapy to improve pain.

Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for Lung Cancer] (폐암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Gajin;Cho, Minji;Park, Eunjoo;Seong, Sin;Kim, Sungsu;Kim, Kwan-Il;Jung, Hee-Jae;Lee, Beom-Joon;Leem, Jungtae
    • The Journal of Korean Medicine
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    • v.40 no.1
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    • pp.153-173
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    • 2019
  • Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

Triple Negative Status is a Poor Prognostic Indicator in Chinese Women with Breast Cancer: a Ten Year Review

  • Ma, K.K.;Chau, Wai Wang;Wong, Connie H.N.;Wong, Kerry;Fung, Nicholas;Lee, J.T. Andrea;Choi, L.Y. Catherine;Suen, Dacita T.K.;Kwong, Ava
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.5
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    • pp.2109-2114
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    • 2012
  • Background: Ethnic variation in tumor characteristics and clinical presentation of breast cancer is increasingly being emphasized. We studied the tumor characteristics and factors which may influence the presentation and prognosis of triple negative breast cancers (TNC) in a cohort of Chinese women. Methods: A prospective cohort of 1800 Chinese women with breast cancer was recruited in a tertiary referral unit in Hong Kong between 1995 and 2006 and was followed up with a median duration of 7.2 years. Of the total, 216 (12.0%) had TNC and 1584 (88.0%) had non-TNC. Their clinicopathological variables, epidemiological variables and clinical outcomes were evaluated. Results: Patients with TNC had similar age of presentation as those with non-TNC, while presenting at earlier stages (82.4% were stage 1-2, compared to 78.4% in non-TNC, p=0.035). They were likely to be associated with grade 3 cancer (Hazard Ratio(HR)=5.8, p<0.001). TNC showed higher chance of visceral relapse (HR=2.69, p<0.001), liver metastasis (HR=1.7, p=0.003) and brain metastasis (HR=1.8, p=0.003). Compared with non-TNC group, TNC had similar 10-year disease-free survival (82% vs 84%, p=0.148), overall survival (78% vs 79%, p=0.238) and breast cancer-specific mortality (18% vs 16%, p=0.095). However, TNC showed poorer 10-year stage 3 and 4 specific survival (stage 3: 53% vs. 67%, p=0.010; stage 4: 0% vs. 40%, p=0.035). Conclusions: Chinese women with triple negative breast cancer do not have less aggressive biological behavior compared to the West and presentation at a later stage results in worse prognosis compared with those with non triple negative breast cancer.

The Local Effect after Surgery in Non-small Cell Lung Cancer (비소세포성 폐암에서 수술 후의 국소 제어효과)

  • Sa, Young-Jo;Jeon, Hyun-Woo;Lee, Sun-Hee;Wang, Young-Pil;Park, Jae-Kil
    • Journal of Chest Surgery
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    • v.40 no.5 s.274
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    • pp.356-361
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    • 2007
  • Background: Recent progress in the surgical therapy for lung cancer is one of the best examples of the successful evolution of clinical medicine. We reviewed our experience to evaluate the surgical outcomes in patients with non-small cell lung cancer. Material and Method: We reviewed clinical records of 432 consecutive patients with proven non-small cell lung cancer who underwent complete removal of the primary tumor together with hilar and mediastinal lymph nodes from 1995 to 2005. The clinical characteristics, surgical methods, and recurrence patterns were analyzed. Result: Lobectomy was the most common procedure (66.7%) performed and sleeve lobectomy was the least (5.6%). In 179 patients (42.6%) the recurrence was noted and the regional recurrence (67 cases, 16.0%) was less than systemic recurrence (112 cases, 26.7%). The main sites of regional recurrence were hilum (25 cases, 37.3%) and ipsilateral mediastinum (54/432 cases, 25.4%). The hospital mortality rate was 2.8% (12/432 cases) and resection-morbidity rate was 12.5% (54/432 cases). Conclusion: The low recurrence rate, especially regional recurrence rate indicated that our surgical procedures with preoperative measures were considered useful and effective.

Pretreatment Neutrophil-to-Lymphocyte Ratio and Smoking History as Prognostic Factors in Advanced Non-Small Cell Lung Cancer Patients Treated with Osimertinib

  • Park, Ji Young;Jang, Seung Hun;Lee, Chang Youl;Kim, Taehee;Chung, Soo Jie;Lee, Ye Jin;Kim, Hwan Il;Kim, Joo-Hee;Park, Sunghoon;Hwang, Yong Il;Jung, Ki-Suck
    • Tuberculosis and Respiratory Diseases
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    • v.85 no.2
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    • pp.155-164
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    • 2022
  • Background: The remarkable efficacy of osimertinib in non-small cell lung cancer (NSCLC) with acquired T790M mutation has been widely documented in clinical trials and real-world practice. However, some patients show primary resistance to this drug. Even patients who initially show a favorable response have inconsistent clinical outcomes later. Therefore, the aim of this study was to identify additional clinical predictive factors for osimertinib efficacy. Methods: A prospective cohort of patients with acquired T790M positive stage IV lung adenocarcinoma treated with osimertinib salvage therapy in Hallym University Medical Center were analyzed. Results: Sixty-one eligible patients were analyzed, including 38 (62%) women and 39 (64%) who never smoked. Their mean age was 63.3 years. The median follow-up after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) was 36.0 months (interquartile range, 24.7-50.2 months). The majority (n=45, 74%) of patients were deceased. Based on univariate analysis, low baseline neutrophil-to-lymphocyte ratios (NLR), age ≥50 years, never-smoking history, stage IVA at osimertinib initiation, and prolonged response to previous TKIs (≥10 months) were associated with a significantly longer progression-free survival (PFS). Multivariate analysis showed that never-smoking status (hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.30-0.98; p=0.041) and a baseline NLR less than or equal to 3.5 (HR, 0.23; 95% CI, 0.12-0.45; p<0.001) were independently associated with a prolonged PFS with osimertinib. Conclusion: Smoking history and high NLR were independent negative predictors of osimertinib PFS in patients with advanced NSCLC developing EGFR T790M resistance after the initial EGFR-TKI treatment.

Acupuncture for Prehypertension and Stage 1 Hypertension in Postmenopausal Women: A Randomized Controlled Pilot Trial (폐경 후 고혈압 전단계 및 1기 고혈압에 대한 침 치료 효과: 무작위 대조 예비연구)

  • Kim, Jung-Eun;Choi, Sun-Mi;Choi, Jin-Bong;Kim, Hyeong-Jun;Kwon, Ojin;Kim, Jae-Hong;Park, Ji-Eun
    • Korean Journal of Acupuncture
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    • v.34 no.3
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    • pp.116-125
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    • 2017
  • Objectives : The aim of this study was to assess the effectiveness of acupuncture in treating prehypertension and stage 1 hypertension in postmenopausal women. Methods : The study was a multi-center, four-arm, non-blinded, randomized clinical trial. Sixty participants were randomly assigned to experimental or control groups. The experimental groups received 10 acupuncture sessions over 4 weeks(Group A, n=20) or 20 sessions over 8 weeks(Group B, n=20) along with usual care. The acupoints were GB20, LI11, ST36, and SP6, bilaterally. The acupuncture groups were followed-up for an additional 12 weeks after acupuncture treatment. The control groups received usual care for 16 weeks(Group C, n=10) or 20 weeks(Group D, n=10). The outcomes were blood pressure, blood pressure control rates, lipid profile, and high-sensitivity C-reactive protein(hs-CRP). Results : After 4 weeks, DBP in the acupuncture groups(A+B) showed no significant decrease compared to the control group(C+D). However, after 8 weeks of acupuncture treatment, group B showed a significant decrease in DBP after acupuncture treatment and follow-up period compared to control group. Although there was no difference between the acupuncture and control groups in SBP after acupuncture treatment, group B showed a significant decrease in SBP compared to control group after follow-up period. Lipid profiles and hs-CRP did not differ significantly between acupuncture and control groups. Conclusions : Acupuncture treatment for 8 weeks showed the effect on prehypertension and mild hypertension. To verify the effect of acupuncture on blood pressure, rigorous trials including more participants are required.

Treatment of Distal Tibial Metaphyseal Fracture Using MIPPO Technique (MIPPO 수기를 이용한 원위 경골 골간단 골절의 치료)

  • Lee, Ho-Seung;Kim, Jung-Jae;Oh, Se-Kwan;Ahn, Hyung-Sun
    • Journal of Korean Foot and Ankle Society
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    • v.8 no.2
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    • pp.166-170
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    • 2004
  • Purpose: To evaluate the results of MIPPO (minimal invasive percutaneous plate osteosynthesis) technique for distal tibial metaphyseal fractures. Materials and Methods: It is a retrospective study of 13 patients who were treated by MIPPO technique for distal tibial metaphyseal fractures from Jan. 2001 to Jan. 2003. The average age was 46.7 years and mean follow-up period was 13.3 months. According to AO classification, there were 8 cases of A1, 3 cases of A2, 1 case of B1 and 1 case of C2. One case of A1 was a Gustilo-Anderson type I open fracture and fibular fractures were combined in 12 cases. We applied anatomical reduction and internal fixation for the fibular fractures and internal fixation on the medial side of the tibia by MIPPO technique for distal tibial metaphyseal fractures. Clinical results were evaluated using radiographic results, Neer score, the starting time of postoperative exercise and clinical complications. Results: According to the Neer score, all cases showed satisfactory results. Active ankle ROM was started at average 2.4 weeks ($2{\sim}4$ weeks) and full weight bearing ambulation at average 5.2 weeks ($4{\sim}8$ weeks) postoperatively. Union of fractures was obtained by average 14.4 weeks ($8{\sim}18$ weeks) postoperatively. Two cases showed $5^{\circ}$ limitation of motion without functional deficits and other cases showed satisfactory ROM results. One case had $6^{\circ}$ valgus deformity without functional deficits. There were not any other complications like soft tissue problems and delayed-or non-union. Conclusion: MIPPO technique for the treatment of distal tibial metaphyseal fractures is a feasible technique with a good clinical outcomes.

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Klotho plays a critical role in clear cell renal cell carcinoma progression and clinical outcome

  • Kim, Ji-Hee;Hwang, Kyu-Hee;Lkhagvadorj, Sayamaa;Jung, Jae Hung;Chung, Hyun Chul;Park, Kyu-Sang;Kong, In Deok;Eom, Minseob;Cha, Seung-Kuy
    • The Korean Journal of Physiology and Pharmacology
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    • v.20 no.3
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    • pp.297-304
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    • 2016
  • Klotho functions as a tumor suppressor predominantly expressed in renal tubular cells, the origin of clear cell renal cell carcinoma (ccRCC). Altered expression and/or activity of growth factor receptor have been implicated in ccRCC development. Although Klotho suppresses a tumor progression through growth factor receptor signaling including insulin-like growth factor-1 receptor (IGF-1R), the role of Klotho acting on IGF-1R in ccRCC and its clinical relevance remains obscure. Here, we show that Klotho is favorable prognostic factor for ccRCC and exerts tumor suppressive role for ccRCC through inhibiting IGF-1R signaling. Our data shows the following key findings. First, in tumor tissues, the level of Klotho and IGF-1R expression are low or high, respectively, compared to that of adjacent non-neoplastic parenchyma. Second, the Klotho expression is clearly low in higher grade of ccRCC and is closely associated with clinical outcomes in tumor progression. Third, Klotho suppresses IGF-1-stimulated cell proliferation and migration by inhibiting PI3K/Akt pathway. These results provide compelling evidence supporting that Klotho acting on IGF-1R signaling functions as tumor suppressor in ccRCC and suggest that Klotho is a potential carcinostatis substance for ccRCC.

Mortality and Real Cause of Death from the Nonlesional Intracerebral Hemorrhage

  • Kim, Ki-Dae;Chang, Chul-Hoon;Choi, Byung-Yon;Jung, Young-Jin
    • Journal of Korean Neurosurgical Society
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    • v.55 no.1
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    • pp.1-4
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    • 2014
  • Objective : The case fatality rate of nonlesional intracerebral hemorrhage (n-ICH) was high and not changed. Knowing the causes is important to their prevention; however, the reasons have not been studied. The aims of this study were to determine the cause of death, to improve the clinical outcomes. Methods : We retrospectively analyzed consecutive cases of nonlesional intracerebral hemorrhage in a prospective stroke registry from January 2010 to December 2010. Results : Among 174 patients ($61.83{\pm}13.36$, 28-90 years), 29 patients (16.7%) died during hospitalization. Most common cause of death was initial neurological damage (41.4%, 12/29). Seventeen patients who survived the initial damage may then develop various potentially fatal complications. Except for death due to the initial neurological sequelae, death associated with immobilization (such as pneumonia or thromboembolic complication) was the most common in eight cases (8/17, 47.1%). However, death due to early rebleeding was not common and occurred in only 2 cases (2/17, 11.8%). Age, initial Glasgow Coma Scale, and diabetes mellitus were statistically significant factors influencing mortality (p<0.05). Conclusion : Mortality of n-ICH is still high. Initial neurological damage is the most important factor; however, non-neurological medical complications are a large part of case fatality. Most cases of death of patients who survived from the first bleeding were due to complications of immobilization. These findings have implications for clinical practice and planning of clinical trials. In addition, future conduct of a randomized study will be necessary in order to evaluate the benefits of early mobilization for prevention of immobilization related complications.