• Title/Summary/Keyword: Clinical trial,

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Value of KRAS, BRAF, and PIK3CA Mutations and Survival Benefit from Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

  • Sasaki, Yusuke;Hamaguchi, Tetsuya;Yamada, Yasuhide;Takahashi, Naoki;Shoji, Hirokazu;Honma, Yoshitaka;Iwasa, Satoru;Okita, Natsuko;Takashima, Atsuo;Kato, Ken;Nagai, Yushi;Taniguchi, Hirokazu;Boku, Narikazu;Ushijima, Toshikazu;Shimada, Yasuhiro
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.2
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    • pp.539-543
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    • 2016
  • Background: It is well known that peritoneal carcinomatosis (PC) from colorectal cancer (CRC) is associated with a poor prognosis. However, data on the prognostic significance of modern chemotherapy containing bevacizumab, cetuximab or panitumumab are not available. Materials and Methods: This retrospective review concerned 526 patients with metastatic CRC who were classified into two groups according to the presence or absence of PC, and were treated with systemic chemotherapy, with or without bevacizumab or anti-EGFR antibodies. The genetic background, in particular KRAS, BRAF, and PIK3CA gene mutations, and overall survival (OS) were compared between the two groups. Results: The median OS values were 23.3 and 29.1 months for PC and non-PC patients, respectively (hazard ratio [HR]=1.20; p=0.17). Among all patients, tumor location, number of metastatic sites and BRAF mutation status were significant prognostic factors, whereas the presence of PC was not. In the PC group, chemotherapy with bevacizumab resulted in a significantly longer OS than forchemotherapy without bevacizumab (HR=0.38, p<0.01), but this was not the case in the non-PC group (HR=0.80, p=0.10). Furthermore, the incidence of the BRAF V600E mutation was significantly higher in PC than in non-PC patients (27.7% versus 7.3%, p<0.01). BRAF mutations displayed a strong correlation with shorter OS in non-PC (HR=2.26), but not PC patients (HR=1.04). Conclusions: Systemic chemotherapy, especially when combined with bevacizumab, improved survival in patients with PC from CRC as well as non-PC patients. While BRAF mutation demonstrated a high frequency in PC patients, but it was not associated with prognosis.

Effect of Cognitive Behavioral Therapy (CBT) for Perinatal Depression: A Systematic Review and Meta-Analysis (산전우울 임부를 위한 인지행동치료 프로그램의 효과: 체계적 문헌고찰 및 메타분석)

  • Shin, Hyeon-Hee;Shin, Yeong-Hee;Kim, Ga-Eun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.11
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    • pp.271-284
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    • 2016
  • This study was carried out to evaluate the efficacy of CBT for perinatal depression through systematic literature review and meta-analysis. The following databases were used to search the literature: CINAHL, PubMed, EMBASE, Koreamed, Library of Korean Congress, KISS, and Korean Academic Publication Database. Keywords included 'perinatal depression,' 'pregnant women,' and 'cognitive behavioral therapy,' and the evaluated articles were published up to May 2016. Using the R program, the effect size of perinatal depression and anxiety were calculated by random-effects model. The heterogeneity of the effect size was analyzed by data moderator analysis using the meta-ANOVA. Furthermore, the funnel plot, Egger's regression test, fail-safe N, trim-and-fill test, and publication bias analysis were conducted and used to verify the results. Out of the 180 selected articles, 16 clinical trial studies were meta-analyzed. Each articles were evaluated for the risk of bias by the checklist of SIGN; the overall risk of bias was low. The effect size of CBT for perinatal depression was Hedges' g=-0.55 (95% CI: -0.76~-0.33), which was a moderate level, while for anxiety reduction, Hedges' g=-0.20 (95% CI: -0.48~-0.08) and it was not statistically significant. Heterogeneity or risk of publication bias were low. This meta-analytic study found that CBT is moderately effective in reducing perinatal depression in pregnant women.

Advances in Radiation Oncology in New Millennium in Korea (21세기 방사선종양학의 전망:최근의 진보와 한국에서의 발전)

  • Huh, Seung-Jae;Park, Chan-Il
    • Radiation Oncology Journal
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    • v.18 no.3
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    • pp.167-176
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    • 2000
  • The objective of recent radiation therapy is to improve the quality of treatment and the after treatment quality of life. In Korea, sharing the same objective, significant advancement was made due to the gradual increase of patient number and rapid increase of treatment facilities. The advancement includes generalization of three-dimensional conformal radiotherapy (3D-CRT), application of linac-based stereotactic radiosurgery (SRS), and furthermore, the introduction of intensity modulated radiation therapy (IMRT). Authors in this paper prospectively review the followings: the advancement of radiation oncology in Korea, the recent status of four-dimensional radiation therapy, IMRT, the concept of the treatment with biological conformity, the trend of combined chemoradiotherapy, the importance of internet and radiation oncology information management system as influenced by the revolution of information technology, and finally the global trend of telemedicine in radiation oncology. Additionally, we suggest the methods to improve radiotherapy treatment, which include improvement of quality assurance (QA) measures by developing Koreanized QA protocol and system, regional study about clinical protocol development for phase three clinical trial, suggestion of unified treatment protocol and guideline by academic or research societies, domestic generation of treatment equipment's or system, establishment of nationwide data base of radiation-oncology-related information, and finally patterns-of-care study about major cancers.

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Comparison of the Effects of Virtual Reality and Task-Oriented Programs of Balance for the Elderly (가상현실 프로그램과 현실화된 과제 지향 프로그램이 노인의 균형에 미치는 효과 비교)

  • Kim, Jin-Joo;Shin, Sun-Jung;An, Seul-Gi;Lee, Eun-Byeol;Jo, Han-Ul;Paik, Young-Rim;Cha, Jung-Jin;Lee, Hyang-Sook;Noh, Jong-Su
    • The Journal of Korean society of community based occupational therapy
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    • v.3 no.2
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    • pp.33-46
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    • 2013
  • Objective : The purpose of this research is to discuss on comparative assessments between virtual reality and task-oriented programs of balance for elderly. Method : 12 healthy elderly for each program are received twice a week for 6 week period. Changes in balance ability were assessed using Berg Balance Scale (BBS), Timed Up and Go(TUG), One-Legged Stance Test(OLST) and 5 - Repetition Sit-To-Stand test(5R-STS test). Result : All groups were not statistically meaningful differences between pre- and post-program. However, comparative outcomes among three groups were statistically significant in opening the eyes of One-Legged Stance Test(OLST) from the left and right side, and Berg Balance Scale(BBS). In post hoc, shows a statistically significant in both programs with opening the eyes of One-Legged Stance Test(OLST) from left side. Conclusion : Task-oriented programs is more useful and effective clinical methodology for balance excise programs for elderly. In addition, this clinical trial may be easily implemented by elder care facilities.

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Panax ginseng exerts antidepressant-like effects by suppressing neuroinflammatory response and upregulating nuclear factor erythroid 2 related factor 2 signaling in the amygdala

  • Choi, Jong Hee;Lee, Min Jung;Jang, Minhee;Kim, Hak-Jae;Lee, Sanghyun;Lee, Sang Won;Kim, Young Ock;Cho, Ik-Hyun
    • Journal of Ginseng Research
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    • v.42 no.1
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    • pp.107-115
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    • 2018
  • Background: Depression is one of the most commonly diagnosed neuropsychiatric diseases, but the underlying mechanism and medicine are not well-known. Although Panax ginseng has been reported to exert protective effects in various neurological studies, little information is available regarding its antidepressant effects. Methods: Here, we examined the antidepressant effect and underlying mechanism of P. ginseng extract (PGE) in a chronic restraint stress (CRS)-induced depression model in mice. Results: Oral administration of PGE for 14 d decreased immobility (depression-like behaviors) time in forced swim and tail suspended tests after CRS induction, which corresponded with attenuation of the levels of serum adrenocorticotropic hormone and corticosterone, as well as attenuated c-Fos expression in the amygdala. PGE enhanced messenger RNA expression level of brain-derived neurotrophic factor but ameliorated microglial activation and neuroinflammation (the level of messenger RNA and protein expression of cyclooxygenase-2 and inducible nitric oxide synthase) in the amygdala of mice after CRS induction. Interestingly, 14-d treatment with celecoxib, a selective cyclooxygenase-2 inhibitor, and $N_{\omega}$-nitro-L-arginine methyl ester hydrochloride, a selective inducible nitric oxide synthase inhibitor, attenuated depression-like behaviors after CRS induction. Additionally, PGE inhibited the upregulation of the nuclear factor erythroid 2 related factor 2 and heme oxygenase-1 pathways. Conclusion: Taken together, our findings suggest that PGE exerts antidepressant-like effect of CRS-induced depression by antineuroinflammatory and antioxidant (nuclear factor erythroid 2 related factor 2/heme oxygenase-1 activation) activities by inhibiting the hypothalamo-pituitary-adrenal axis mechanism. Further studies are needed to evaluate the potential of components of P. ginseng as an alternative treatment of depression, including clinical trial evaluation.

Effect of Hanwoo Diets Containing Linseed on Plasma Cholesterol Levels of Humans to Beef Consumption and Change in n-6/n-3 Fatty Acid of Loin Fat (아마씨앗 첨가 한우사료가 등심 지방의 n-6/n-3 변화 및 이를 섭취한 사람의 혈중 콜레스테롤 함량에 미치는 영향)

  • Park, Sang-Oh;Park, Byung-Sung;Yuh, In-Suh;Hwangbo, Jong;Bang, Han-Tae
    • Journal of the Korean Applied Science and Technology
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    • v.31 no.2
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    • pp.265-276
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    • 2014
  • The purpose of this study was to evaluate the effect on lowering blood LDL-C in an adult human, by taking n-6/n-3 balanced Hanwoo beef and reducing n-6/n-3 in loin of Hanwoo beef. The randomized complete block design was used to conduct an experiment with a total of 20 castrated Hanwoo cattles, which were divided into two groups. Each group had 10 cattles, and the control group consisted of absence of linseed, while n-3 treatment group (n-3 group) had linseed. The results showed that n-6/n-3 in loin and blood was decreased to under 4:1 in n-3 group, while oleic acid as an monounsaturated fatty acid was increased by 52.79% compared to the control group. In above 70% of the clinical subjects who ate the balanced Hanwoo beef, the blood triglyceride, total cholesterol, and LDL-C were decreased by 25.35, 5.22, and 17.59%. However, in the subjects who ate the imported beef, and not the common Hanwoo beef, the same parameters were increased by 9.05, 8.21, and 21.70%, respectively. When the balanced Hanwoo beef were eaten, HDL-C were increased by 6.07% but the imported beef and common Hanwoo beef had those values decreased by 14.46 and 11.46%, respectively. The blood glucose was decreased by 6.42 and 11.82% in the subjects who ate balanced Hanwoo beef and common Hanwoo beef, respectively but the subjects who ate the imported beef had an increase by 15.19%.

A case of acquired acrodermatitis enteropathica with a normal serum zinc level but a low level in the hair (혈중 아연 농도는 정상이나 모발 검사에서는 감소된 아연 농도를 보인 일과성 장병성 선단 피부염 1례)

  • Oh, Kyung Il;Kim, Jung Hee;Lee, Ji Eun;Lim, Dae Hyun;Son, Byong Kwan
    • Clinical and Experimental Pediatrics
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    • v.50 no.2
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    • pp.209-212
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    • 2007
  • Acrodermatitis enteropathica (AE) is a rare autosomal recessive disorder of early infancy, and is characterized by periorificial dermatitis, alopecia, and intractable diarrhea. Serum zinc levels are usually low in untreated patients and the oral administration of zinc sulfate can clear skin lesions and other symptoms. Although premature and cow's milk-fed infants are at particular risk of developing AE, there have been a few reports about AE in term and breast-fed infants. We report a case of transient AE in a 4-month-old breast-fed infant. This patient suffered from diarrhea and dermatitis for more than a month. Her skin lesions were erythematous, scaly, crusted, psoriasiform, eczematous, with an eruption at the chin, and a periorificial disposition with involvement of the flexural areas of lower extremities. Her serum zinc level was almost normal at $129{\mu}g/dL$ (reference range: $60-121{\mu}g/dL$), but the zinc level in her hair was low: 8 mg percent (reference range: 10-21 mg percent). Skin biopsy findings were consistent with AE. Seven days after zinc supplementation, the skin lesions and diarrhea improved. The authors recommend that a clinical trial of zinc supplementation be considered in cases where there are suspicious of AE, even when the serum zinc level is normal.

Intestinal Lymphangiectasia in a Yorkshire terrier Dog: Clinical Outcome, Clinicopathological and Histopathological Findings (요크셔테리어견에서 발생한 Intestinal Lymphangiectasia: 임상적 결과와 임상병리학적, 조직병리학적 소견)

  • Hwang Du-Na;Park Chul;Kang Byeong-Teck;Jeong Soon-Wuk;Sur Jung-Hyang;Park Hee-Myung
    • Journal of Veterinary Clinics
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    • v.23 no.2
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    • pp.175-179
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    • 2006
  • A 7-year-old, 3.16 kg intact male Yorkshire terrier had the history of abdominal distension, diarrhea, and weight loss. On the basis of history takings, physical examination, laboratory tests, radiography, ultrasonography, exploratory laparotomy, and histopathological examination, the dog was diagnosed definitely as intestinal lymphangiectasia. In this case, signs and results are consistent with those of other reports, but some clinicopathological findings such as hypocalcemia and hypocholesterolemia are not. This means that the findings were not completely in accord with the typical ones of intestinal lymphangiectasia in this dog. Prednisolone was prescribed to treat. However, it was not effective sufficiently. Thus, azathioprine was added to the regimen used in the first trial, and it was quite efficient in inducing remission in intestinal lymphangiectasia. The clinical signs were improved to the combined therapy. This case report demonstrates that the combined therapy for intestinal lymphangiectasia can be used as an alternative to only glucocorticoid therapy.

Interim Report about The Effect of Sihogayonggolmoryeo-tang on the Anxiety of Hwa-byung (화병의 불안 증상에 대한 시호가용골모려탕의 효능 임상연구 중간보고)

  • Choi, Woo-Chang;Park, Dae-Myung;Kang, Wee-Chang;Lee, Sang-Ryong;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.4
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    • pp.133-152
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    • 2012
  • Objectives : The purpose of this study is to investigate the effect of Sihogayonggolmoryeo-tang on the anxiety of Hwa-byung. Methods : In this randomized, double blinded, placebo-controlled study, we planned to give Sihogayonggolmoryeo-tang or controlled medication for anxiety of Hwa-byung. Hamilton Anxiety Scale (HAM-A) was measured as the 1st evaluative instrument, and Korean State-Trait Anxiety Inventory (STAI-K), Likert scale for major symptom of Hwa-byung, Hwa-Byung Scale Score, Korean Beck's Depression Inventory (BDI-K), Korean State-Trait Anger Expression Inventory (STAXI-K), Insomnia severity Index (ISI), Instrument of Oriental Medical Evaluation for Hwa-Byung, WHO Quality of Life Avvreviated (WHOQOL-BREF), genral self-Efficacy Scale (GSES), Rosenberg Self-Esteem Inventory (SRE) and Heart Rate Variability (HRV) were also measured as the 2nd evaluative instrument before treatment. Results : Clinical characteristics-vital signs and demographic characteristics showed no significant difference between both groups. The characteristics of disease-chief complaint, pattern Identification, period, etiological factor, and etc, also showed similarity of distribution in both groups. The results of Chest PA, EKG and clinicopathologic examination showed no significant difference between both groups. There were no significant difference between both groups in all valuation scales; HAM-A was measured as the first evaluative instrument, and STAI-K, Likert scale for major symptom of Hwa-byung, Hwa-Byung Scale Score, BDI-K, STAXI-K, ISI, Instrument of Oriental Medical Evaluation for Hwa-Byung, WHOQOL-BREF, GSES, SRE and HRV. Conclusions : We considered that establishment of the experimental group and controlled group was objective and worth conducting this research. In addition, this methodology is expected to be applied to the subsequent research. Further, we hope to make up for this study through various study and discussion.

Clinical Study on Food Safety evaluation of Panax ginseng (고려인삼의 식품 안전성에 관한 임상 연구)

  • Kim, Dong Hwi;Xu, Yong Hua;Kim, Young Chang;Bang, Kyong Hwan;Kim, Jang Uk;Cha, Seon Woo;He, Zhong Mei;Yang, He;Jang, In Bok;Zhang, Lian Xue
    • Korean Journal of Medicinal Crop Science
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    • v.23 no.3
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    • pp.185-189
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    • 2015
  • In this study, the clinical safety and toxicology of oral ingestion of supplement capsules containing ginseng radix was investigated in healthy young volunteers. This study was a pilot randomized, double blinded, placebo controlled trial. The healthy volunteers were divided into 6 groups of 20 each (10 males and 10 females). They took the ginseng powder for 35 days (3g/day) for safety evaluation. There were measured general healthy levels such as hematological, biochemical and electrocardiographic parameters. After the first week, besides Korean white ginseng the other treatments led to an significant increase of white blood cells. Korean red ginseng increased UREA (blood urea nitrogen) in healthy volunteers, but it didn't exceed the range of normal values, and in the subsequent process of treatment there is no effect of elevating UREA. After the three weeks, Korean white ginseng showed relatively low the content of blood glucose and low-density lipoprotein cholesterol. After the five weeks, compared with the other treatments, Korean red ginseng increased white blood cells, platelet distribution width and average volume of platelet. Korean white ginseng decreased low-density lipoprotein cholesterol. American ginseng decreased blood creatinine in healthy volunteers. In conclusion, through test the blood routine, urine routine, liver function, renal function, blood glucose, blood lipid and electrocardiogram, the healthy volunteers continuous taking ginseng for 35 days (3 g/day) is safe and reliable, and have no obvious adverse reactions and side effects.