• Journal of Korean Traditional Oncology
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• 제20권1호
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• pp.11-21
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• 2015

Objectives : The cancer incidence and cancer burden is increasing. In addition, the use of botanical agents in cancer care is increasing. This article aims to review a research strategy for botanical agents. Methods : The clinical studies of anticancer botanical agents and the papers about clinical research methodology of botanical agents were reviewed. Results : In phase I study, safety confirmation, optimal dose determination and drug interaction study are important. Most botanical agents have low toxicity and some have non-monotone dose response. Therefore, dose-response curve must be evaluated separately from the dose-toxicity curve to determine optimal dose. Although anticancer botanical agents can't shrink tumor size rapidly, they do extend survival. So, in phase II study, response should be evaluated by the survival. Conclusions : Clinical research of botanical agents in cancer is different from traditional methods and strategies. Considering the characteristics of botanical agents and experimental mechanism is necessary in conducting botanical based clinical trials.

• The Korean Journal of Applied Statistics
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• 제33권2호
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• pp.137-145
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• 2020

Phase I clinical trials (Dose Finding Studies) are the first step in administering new drugs developed through animal experiments or in vitro experiments to humans. An important area of interest in designing Phase I clinical trials is determining the dose that provides the greatest efficacy and acceptable safe dose to the patient. In this paper, we propose a method to determine the maximum tolerated dose considering efficacy and safety using Biased coin design and stopping rule. The proposed method is compared with existing methods through simulation.

• Journal of the Korean Data and Information Science Society
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• 제23권6호
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• pp.1085-1091
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• 2012

Phase I clinical trials are designed to identify an appropriate dose; the maximum tolerated dose, which assures safety of a new drug by evaluating the toxicity at each dose-level. The adjusted maximum tolerated dose estimation is presented by stopping rule in phase I clinical trial on this research. The suggested maximum tolerated dose estimation is compared to the standard method3 and NM method using a Monte Carlo simulation study.

• Imaging Science in Dentistry
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• 제53권1호
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• pp.69-75
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• 2023

Purpose: Maxillofacial trauma predominantly affects young adults between 20 and 40 years of age. Although radioprotection is a legal requirement, the significant potential of dose reduction in computed tomography (CT) is still underused in the clinical routine. The objective of this study was to evaluate whether maxillofacial fractures can be reliably detected and classified using ultra-low-dose CT. Materials and Methods: CT images of 123 clinical cases with maxillofacial fractures were classified by two readers using the AOCOIAC software and compared with the corresponding results from post-treatment images. In group 1, consisting of 97 patients with isolated facial trauma, pre-treatment CT images at different dose levels (volumetric computed tomography dose index: ultra-low dose, 2.6 mGy; low dose, <10 mGy; and regular dose, <20 mGy) were compared with post-treatment cone-beam computed tomography (CBCT). In group 2, consisting of 31 patients with complex midface fractures, pre-treatment shock room CT images were compared with post-treatment CT at different dose levels or CBCT. All images were presented in random order and classified by 2 readers blinded to the clinical results. All cases with an unequal classification were re-evaluated. Results: In both groups, ultra-low-dose CT had no clinically relevant effect on fracture classification. Fourteen cases in group 2 showed minor differences in the classification code, which were no longer obvious after comparing the images directly to each other. Conclusion: Ultra-low-dose CT images allowed the correct diagnosis and classification of maxillofacial fractures. These results might lead to a substantial reconsideration of current reference dose levels.

• Biomedical Science Letters
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• 제25권1호
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• pp.83-91
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• 2019

This study was undertaken to investigate the therapeutic effect of Angelica acutiloba on allergic dermatitis, which Angelica acutiloba is traditionally known to have antiinflammatory effects. Sprague-Dawley (SD) rats were divided into five groups: normal control group, experimental allergic dermatitis group (vehicle group), low dose of Angelica acutiloba extract (low-dose group), high dose of Angelica acutiloba extract (high-dose group), and antihistamine treated group with experimental dermatitis (antihistamine group). Total leukocyte, neutrophil, lymphocyte, monocyte and eosinophil counts were significantly higher in the vehicle group than in the control group, but these variables were significantly lower in the low- and high-dose groups than in the vehicle group. The platelet/lymphocyte ratio in the red blood cell index was significantly lower in the low- and high-dose groups than in the vehicle group. Low and high doses of the Angelica acutiloba extract did not have toxic effects on liver and kidney. Serum NO, iNOS and levels were highest in the vehicle group but significantly lower in the low- and high-dose groups, especially in the high-dose group. The results of this study suggested that the Angelica acutiloba extract had the effect of alleviating or treating the experimental allergic dermatitis, and it was concluded that the high dose was more effective.

• Toxicological Research
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• 제11권1호
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• pp.137-145
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• 1995

HRccine was administered subcutaneously to rats for 4 weeks at dose levels of 300, 60 and 12 times the expected clinical dose to evaluate the subacute toxicity. There were no treatment-related effects in clinical signs, body weight changes, food consumption, water consumption, urinalysis and blood biochemistry in any dose groups. In hematological examinations, increase of leucocyte counts and decrease of hemoglobin concentration were observed in the high dose-treated group. However, no treatment-attributable pathological changes were observed in microscopic examinations. The no-effect dose in subacute toxicity study of rats was considered to be 300 times the expected clinical dose.

• Korean Journal of Clinical Pharmacy
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• 제14권1호
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• pp.1-10
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• 2004

Studies of oxaliplatin, 5-fluorouracil and leucovorin in pretreated metastatic colorectal cancer showed that oxaliplatin dose intensity is important prognostic factor for objective response rates and progression-free-survival (PFS). To evaluate response rates, PFS and toxicity according to oxaliplatin dose intensity, we retrospectively analyzed data from patients with metastatic colorectal cancer received oxaliplatin,5-fluorouracil, leucovorin regimens. Sixty-three patients were reviewed in this study, 42 patients received low dose intensity oxaliplatin (LDI: $\leq85\;mg/m^2/2wks$) and 21 patients high dose intensity oxaliplatin (HDI: $>85\;mg/m^2/2wks$). Objective responses occurred in 10 $(47.7\%)$ HDI patients and 9 $(21.4\%)$ LDI patients (p = 0.014). Median PFS was 24.7 weeks in HDI group, with $45.1\%$ of HDI patients progression free at 6 months, and 20.5 weeks in LDI group, with $33.5\%$ of LDI patients progression free at 6 months (p = 0.344). Increased oxaliplatin dose intensity was not associated with neutropenia, thrombocytopenia, neuropathy, nausea and vomiting. This study showed that oxaliplatin dose intensification significantly improves objective response rate in pretreated metastatic colorectal cancer without increasing severe toxicity.

• Journal of the Korean Society of Radiology
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• 제11권3호
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• pp.109-115
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• 2017

The purpose of this study was to evaluate the clinical efficacy of 128 MDCT (multi-detector computed tomography) for reducing the CareDose 4D dose and comparing the image quality with the fixed tube current technique. For this purpose, we conducted the phantom and clinical studies to evaluate the exposure dose and image of the subject before and after applying the CareDose 4D system in abdominal examination using 128 MDCT. In the phantom study, ROI (Region of interest) was located at the center, 3, 6, 9, 12 o'clock, into two groups: group A without CareDose 4D and Group B applied were measured. In the clinical study, ROI was located at the liver 8 segments, divided into two groups too. The measured items were CT number, noise, and dose length product (DLP) dose. The result of CTDIvol (CT Dose Index volume) measurements in phantom and clinical studies were lower than those before CareDose 4D application, and dose and effective dose were also measured lower (p<.05). There was no difference in CT number before and after application (p>.05). In conclusion, using CareDose 4D, we can obtain optimal image information without deteriorating image quality while reducing patient dose.

• Journal of radiological science and technology
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• 제40권3호
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• pp.355-361
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• 2017

Pediatrics are more sensibility to radiation than adults and because they are organs that are not completely grown, they have a life expectancy that can be adversely affected by exposure. Therefore, the management of exposure dose is more important than the case of adult. The purpose of this study was to determine the suitability of the 10 year old phantom for the 5 year old pediatric's recommendation and the incident surface dose, and to measure the organ absorbed dose. This study is compared the organ absorbed dose and the entrance surface dose in the clinical conditions at 5 and 10 years old pediatric. Clinical 5 year old condition was slightly higher than recommendation condition and 10 year old condition was very high. In addition, recommendation condition ESD was found to be 43% higher than the ESD of the 5 year old group and the ESD of the 10 year old group was 126% higher than that of the 5 year old group. The recommended ESD at 5 years old and the ESD according to clinical imaging conditions were 31.6%. There was no significant difference between the 5 year old recommended exposure conditions and the organ absorbed dose due to clinical exposure conditions, but there was a large difference between the Chest and Pelvic. However, it was found that there was a remarkable difference when comparing the organ absorbed dose by 10 year clinical exposure conditions. Therefore, more detailed standard exposure dose for the recommended dose of pediatric should be studied.

• The Korean Journal of Applied Statistics
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• 제27권7호
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• pp.1115-1123
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• 2014

The main purpose of phase I clinical trials is to estimate the Maximum Tolerated Dose (MTD), which minimizes side effect and assures safety of a new drug by evaluating the toxicity at each dose-level. The conventional MTD estimation methods is Standard method (Storer, 1989; Korn et al., 1994), Accelerated Titration Designs (Simon et al., 1997) and DM method (Dixon and Mood, 1948) etc. In this paper, MTD estimation method with de-escalation is suggested phase I clinical trials. The proposed MTD estimation method is compared to Accelerated Titration Designs, SM3 without de-escalation method and SM3 with de-escalation method using a Monte Carlo simulation.