• Title/Summary/Keyword: Efficacy confirmation

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A Study on Improvement of Labeling on the Caution for Intake for Health Functional Food (건강기능식품의 섭취 시 주의사항 표시제도 개선에 대한 연구)

  • Park, Sun-Jung;Yang, Sung-Bum
    • The Korean Journal of Food And Nutrition
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    • v.32 no.3
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    • pp.202-207
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    • 2019
  • The objective of this study was to analyze labeling improvements and evaluate willingness to pay for health functional foods with a focus on the caution for intake. For this study, we conducted a survey on health functional food intake behavior, confirmation and improvements of cautions for intake. We assessed the willingness to pay for improvement of the caution for intake. Consumers anticipate improved immune function, and fatigue improvement after consumption of health functional foods. They mainly checked the function components related to efficacy and effectiveness, ingredients and their contents, ingestion amount and method, expiry date and best mode of storage, product name, and cautions associated with ingestion of health functional foods. They has been difficulties in obtaining sufficient caution information for intake from the current labeling method. Therefore, it is necessary to improve the labeling of caution for intake. The analysis indicated that about 5.14% of the respondents were willing to pay more if new labeling was introduces. However, there is still controversy over their safety, which is damaging to the consumers. Therefore, by providing consumers with accurate and detailed information on cautions for intake, it can contribute to securing safety and improving the quality of health functional foods.

Study on Development of Assessment Guideline and Endpoints for Clinical Trial with Antitumor Natural Products (천연물 항암제제 임상시험 평가지표 개발연구)

  • Namgung, Mi-Ae;Chang, Yoo-Sung;Jeong, Seung-Gi;Kim, Jin-Seung;Yoon, Sung-Woo;Jang, Ki-Young;Yoo, Hwa-Seung;Jung, Myeon-Woo;Lee, Sung-Ho;Kim, Sung-Hoon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.20 no.6
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    • pp.1678-1727
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    • 2006
  • This study was perfromed to develop the assessment guideline and endpoints for clinical trial with anticancer herbal medicine. The botanical products used to humans for long time may be applied to phase 3 clinical trial after submitting the evidences for safety and efficacy of them or completion of basic requirement of phase 1 and phase 2 for safety confirmation and dose determination. Syndrome improvement was chiefly evaluated by Zubrod and karnofsky(%) methods. We suggest the general clinical trial assessment with botanical products, by following assessment points, that is, tumor size for 50 points, survival fate for 10 points, major syndromes for 40 points. It is recommendable that the each symptom of Qi deficiency syndrome, blood deficiency syndrome and Qi stagnation syndrome was allocated by assessment points, Similarly, the each symptom was given the assessment points according to the severity of symptom, for example, slight for 3 points, moderate for 2 points and severe for 1 point in hepatocelluar carcinoma and lung cancer. Then, the efficacy of botanical products was evaluated by the difference between pre-treatment and post-treatment. Asking the neoplastic patients of questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. In addition, in case of lung cancer, 13 questions will be asked by the EORTC QLQ-C13 forms. As the assessment of endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hemopoietic damage and injury of liver and kidney, while the changes of syndromes of side effect can be evaluated by differentiation methods of Qi and blood and five viscera. However, it is still necessary to determine the ratio between scientific analytical method and Oriental differentiation method as well as confirm the Oriental assessment endpoints by clinical trial. In addition, we suggest the continuous development of assessment endpoints on other carcinomas except of hepatocelluar carcinoma and lung cancer in future.

Improvement of Motor Behavior of Parkinson′s Disease Animal Model by Nurr1-Transfected Human Embryonic Stem Cells.

  • Lee, Chang-Hyun;Cho, Hwang-Yoon;Kil, Kwang-Soo;Lee, Gun-Soup;Yoon, Ji-Yeon;Lee, Young-Jae;Kim, Eun-Young;Park, Se-Pill;Lim, Jin-Ho
    • Proceedings of the Korean Society of Developmental Biology Conference
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    • 2003.10a
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    • pp.103-103
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    • 2003
  • The purpose of this study is to evaluate an efficacy of in vitro differentiated human embryonic stem (hES, MB03) cells expressing Nurr1 in relief of symptomatic motor behavior of Parkinson's disease (PD) animal models MB03 was genetically modified to express Nurr1 protein and was induced to differentiate according to 2-/4+ protocol using retinoic acid and ascorbic acid. The differentiation-induced cells were selected for 10 to 20 days thereafter in N2 medium. Upon selection, cells expressing GFAP, TH, or NF200 were 38.8%, 11%, and 20.5%, respectively. in order to examine therapeutic effects of the differentiated cells in PD animal model, rats were unilaterally lesioned by administration of 6-kydroxydopamine HCI (6-OHDA) into medial forebrain region (MFB, AP -4.4 mm, ML 1.2 mm, DV 78 mm with incision bar set at -2.4 mm), as a reference to bregma and the surface of the skull. Confirmation of successful lesion by apomorphine-induced rotational behavior, differentiated cells were transplanted into the striatum (AP 1.0, ML 3.5, DV -5.0; AP 0.6, ML 2.5, DV -4.5). Improvements of asymmetric motor behavior by the transplantation were examined every two weeks after the surgery. In two weeks, numbers of rotation by the experimental rats were $-14.8 \pm 33.9%$ (P<0.05) of the number before transplantation, however, the ratio increased slightly to $13.6 \pm 56.3%$ in six weeks. In contrast, the ratio of sham-grafted animals ranged from 112.3+8.5% to 139.2+28.9% during the examination. Immunohistochemical studies further confirmed the presence, survival, migration, and expression of TH of the transplanted human cells.

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Usefulness of Sputum Induction with Hypertonic Saline in a Real Clinical Practice for Bacteriological Yields of Active Pulmonary Tuberculosis

  • Seong, Gil Myeong;Lee, Jaechun;Lee, Jong Hoo;Kim, Jeong Hong;Kim, Miok
    • Tuberculosis and Respiratory Diseases
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    • v.76 no.4
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    • pp.163-168
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    • 2014
  • Background: Mycobacterial identification in active pulmonary tuberculosis (APTB) is confirmative, even though successful rates using self-expectorated sputum are limited. Sputum specimens collected by hypertonic saline nebulization showed higher bacteriologic diagnostic sensitivities over those of self-expectoration, mostly studied in smear-negative or sputum-scarce patients. The efficacy of induced sputum was rarely assessed in real clinical settings. Methods: A prospective randomized case-control study was performed in one hospital. The subjects highly suspicious of APTB were asked to provide 3 pairs of sputum specimens in 3 consecutive days. The first pairs of the specimens were obtained either by self-expectoration (ES) from the next day of the visit or sputum induction with 7% saline nebulization in clinic (SI), and the other specimens were collected in the same way. The samples were tested in microscopy, culture, and polymerase chain reaction (PCR). The outcomes of the bacteriological diagnosis were compared. Results: Seventy six patients were assigned to either ES (38 subjects, median age of 51, 65.8% male) or SI (38 subjects, median age of 55, 52.6% male). APTB was clinically confirmed in 51 patients (70.8%), 27 in ES and 24 in SI. Among the APTB, more adequate specimens were collected from SI (41/65, 63.1%) than ES (34/80, 42.5%) (p=0.01). Bacteriological confirmation was achieved in 14 (58.3%) patients in SI, and 13 (48.1%) in ES (p=0.46). In the same-day bacteriological diagnosis with microscopy and PCR, there were positive results for 9 patients (37.5%) in SI and 7 patients (25.9%) in ES (p=0.37). Conclusion: Sputum induction improves sputum specimen adequacy. It may be useful for the same-day bacteriological diagnosis with microscopic examination and PCR.

Biological Effectiveness of Methionine Hydroxy-analogue Calcium Salt in Relation to DL-Methionine in Broiler Chickens

  • Elwert, C.;de Fernandes, E. Abreu;Lemme, A.
    • Asian-Australasian Journal of Animal Sciences
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    • v.21 no.10
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    • pp.1506-1515
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    • 2008
  • Two feeding trials were conducted to assess the relative bioavailability (RBV) of methionine hydroxy analogue calcium salt (MHA-Ca) in comparison to DL-methionine (DL-Met). Male Ross 308 (1-38 days) and Cobb 500 chickens (1-42 days) were used in studies 1 and 2, respectively. Experimental diets based on wheat and soybean meal or sorghum and soybean meal were fed during three phases. In both experiments graded levels of DL-Met and MHA-Ca were supplemented to Met+Cys deficient basal diets. Additionally, in experiment 1, increasing levels of a DL-Met preparation diluted with corn starch to 65% purity (DL-Met65) were supplemented. Birds were kept in floor pens and feed and water were available ad libitum. Body weights and feed consumption were recorded at the beginning and end of the experimental periods and weight gain and feed efficacy were computed subsequently. At the end of the experiments, a number of birds were slaughtered for carcass evaluation (dressing percentage, breast meat yield). Dose response data were analysed by both ANOVA and nonlinear common plateau asymptotic regression. In both experiments birds responded significantly to increasing levels of either methionine source. However, RBV of MHA-Ca compared to DL-Met was markedly (in many cases significantly) below 84%, the value which would have been expected from MHA-Ca's chemical characteristics. Excluding some extremely low RBV figures of trial 2, RBV of MHA-Ca averaged to about 63% in relation to DL-Met. In addition, supplementation of DL-Met65 allowed confirmation of nonlinear common plateau asymptotic regression to be suitable to determine RBV.

Clinical Study of Nimotuzumab Combined with Chemotherapy in the Treatment of Late Stage Gastric Cancer

  • Xu, Chong-De
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.23
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    • pp.10273-10276
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    • 2015
  • Objective: To explore the clinical effects of nimotuzumab combined with chemotherapy in the treatment of late gastric cancer. Methods: A total of 34 reoccurrence or metastatic patients with late stage gastric cancer who were confirmed by histopathology and/or cytology were selected and randomly divided into observational and control groups, of 17 cases each. Patients in the control group were treated with the standard DCF plan, while patients in observational group additionally received nimotuzumab. The short-term and long-term efficacy and adverse reactions in the 2 groups were followed. Results: The objective response rate (ORR) and disease control rate (DCR) were 64.7% (11/17) and 82.4% (14/17) in observational group and 25.0%(4/16) and 37.5%(6/16) in the control group(ORR and DCR between 2 groups, ${\chi}^2=5.2412$, P=0.0221 and ${\chi}^2=6.9453$, P=0.0084). The median progression-free survival (PFS) time and median overall survival (OS) time were 6.50 months and 12.50 months in observational group and 4.50 months and 8.25 months in the control group (P=0.0212; P=0.0255). The main toxic and side effects in the 2 groups were reduced leukocytes and hemoglobin, gastrointestinal reactions and hair loss and these were relieved after symptomatic treatment and nutrition support therapy. There were no differences in the occurrence of toxic and side effects between the 2 groups. Conclusions: Nimotuzumab combined with DCF plan is effective in treating late stage gastric cancer. A larger scale study is now warranted for confirmation of the findings.

Emodin Successfully Inhibited Invasion of Brucella abortus Via Modulting Adherence, Microtubule Dynamics and ERK Signaling Pathway in RAW 264.7 Cells

  • Huy, Tran Xuan Ngoc;Reyes, Alisha Wehdnesday Bernardo;Hop, Huynh Tan;Arayan, Lauren Togonon;Son, Vu Hai;Min, Wongi;Lee, Hu Jang;Kim, Suk
    • Journal of Microbiology and Biotechnology
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    • v.28 no.10
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    • pp.1723-1729
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    • 2018
  • The aim of this work is to investigate the protective efficacy of emodin, an active, naturally-occurring anthraquinone derivative of several traditional Chinese herbs, against Brucella abortus infection in macrophages. Brucella were incubated with different concentrations of emodin and showed that bacterial survival rates were markedly reduced in a dose-dependent manner at increasing incubation time points. Through bacterial infection assay, the highest non-cytotoxic concentration of emodin demonstrated attenuated invasion of Brucella into macrophages, however it did not inhibit the growth of these pathogens within the host cells. On the other hand, emodin effectively decreased the number of bacteria that adhered to host cells, which indicated its potential as an anti-adhesin agent. Furthermore, using immunoblotting and FACS assay for detecting MAPK signaling proteins and F-actin polymerization, respectively, the results showed that the emodin-incubated cells displayed modest reduction in the phosphorylation levels of ERK1/2 and inhibition of F-actin polymerization as compared to control cells. These findings indicate the potential use of emodin as a naturally-occurring alternative method for the prevention of animal brucellosis although this requires confirmation of safe clinical doses.

Incidence of Intravascular Penetration during Transforaminal Lumbosacral Epidural Steroid Injection (요부 경추간공 스테로이드 주입 시 혈관천자의 발생률)

  • Kim, Dong Won;Shim, Jae Chol
    • The Korean Journal of Pain
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    • v.20 no.1
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    • pp.26-30
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    • 2007
  • Background: Epidural steroid injections (ESI) are a common treatment for spinal disorders. Previous research has shown that aspiration of the syringe is not a sensitive test for placement of an intravascular needle. Serious complications have been reported from injection of steroids and local anesthetics into the vascular space. In addition to safety concerns, the efficacy may decline with partial injection outside the desired epidural location. We hypothesized that incidence of vascular problems is increased in patients who undergo spine surgery compared with the patients who don't undergo spine surgery. We investigated the incidence of vascular problems during lumbosacral transforaminal ESI and we compared the difference of vascular problems between the patients who undergo spinal surgery and those patients who don't undergo spinal surgery. Methods: Two hundreds and three patients were consecutively recruited and they received 299 fluoroscopically guided lumbosacral transforaminal ESIs. Injection of contrast was performed under live dynamic fluoroscopy with using digital substraction analysis. The observed uptake pattern was classified into one of three categories: flashback, aspirated, and positive contrast with negative flashback and aspiration. Results: The vascular incidence rate was 20.4%. Transforaminal ESIs performed at S1 had avascular incidence rate of 27.8% compared with 17.7% for all the other lumbar injection sites. The sensitivity of spontaneous observation of blood in the needle hub or blood aspirate for predicting an intravascular injection in lumbar transforaminal ESIs was 70.4%. Conclusions: There is a high incidence of intravascular problems when performing transforaminal ESIs, and this is significantly increased in patients with previous spine surgery. Using a flash or blood aspiration to predict an intravascular injection is not sensitive therefore; a negative flash or aspiration is not reliable. Fluoroscopically guided procedures without contrast confirmation are prone to instill medications intravascularly. This finding confirms the need for not only fluoroscopic guidance, but also for contrast injection instillation when performing lumbosacral transforaminal ESIs, and especially for patients with previous spine surgery.

Clinical efficacy of chloroquine versus artemether-lumefantrine for Plasmodium vivax treatment in Thailand

  • Krudsood, Srivicha;Tangpukdee, Noppadon;Muangnoicharoen, Sant;Thangchartwet, Vipa;Luplertlop, Nutthanej;Srivilarit, Siripan;Wilairatana, Polrat;Kano, Shigeyuki;Ringwald, Pascal;Looareesuwan, Sornchai
    • Parasites, Hosts and Diseases
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    • v.45 no.2 s.142
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    • pp.111-114
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    • 2007
  • Chloroquine remains the drug of choice for the treatment of vivax malaria in Thailand. Mixed infections of falciparum and vivax malaria are also common in South-East Asia. Laboratory confirmation of malaria species is not generally available. This study aimed to find alternative regimens for treating both malaria species by using falciparum antimalarial drugs. From June 2004 to May 2005, 98 patients with Plasmodium vivax were randomly treated with either artemether-lumefantrine (n = 47) or chloroquine (n = 51). Both treatments were followed by 15 mg of primaquine over 14 days. Adverse events and clinical and parasitological outcomes were recorded and revealed similar in both groups. The cure rate was 97.4% for the artemether-lumefantrine treated group and 100% for the chloroquine treated group. We concluded that the combination of artemether-lumefantrine and primaquine was well tolerated, as effective as chloroquine and primaquine, and can be an alternative regimen for treatment of vivax malaria especially in the event that a mixed infection of falciparum and vivax malaria could not be ruled out.

Components of Astragali Radix at Various Ages and Their Effects of Physiological Activity (황기의 연근 별 성분과 생리 활성에 미치는 영향)

  • Lee, Jang-Cheon;Sung, Dae Dong;Ha, Uram;Lee, Boo-Kyun
    • Herbal Formula Science
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    • v.26 no.4
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    • pp.319-327
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    • 2018
  • Objectives : Astragali Radix is known as a perennial plant, and it is estimated that there may be differences in the contents and their components depending on the ages. The components of astragali radix may activate differently. Methods : The astragali radix components cultivated in Jecheon( one year ), Korea, Shanxi province( 7 years ), China, Inner Mongolia( 5 years) and Inner Mongolia ( 8 years ) were extracted with pure ethyl alcohol and identified the component molecules. The extracted components of astragali radix were measured the activity of Telomerase for confirmation of their Telomere lengths. Results : The cell activity has been shown the greatest contribution in astragali radix of Inner Mongolia(8 years). Although there is the difference in cell activity between the two products of the 5 and 7 years, the difference between the values was small and the 7 years product was slightly higher than 5 years product. Conclusions : Total Astragaloside contents were highest in the product of Inner Mongolia(8 years), followed by the 7 year product of Shanxi province. Especially, astragaloside and cycloastragenol (TA-65) among the astragali radix components have shown to be increased Telomerase activity in the DNA metabolism of the cells, and the efficacy depends on the ages of growth.