• Title/Summary/Keyword: Safe dose

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Adjusted maximum tolerated dose estimation by stopping rule in phaseⅠclinical trial (제 1상 임상시험에서 멈춤 규칙을 이용한 수정된 최대허용용량 추정법)

  • Park, Ju Hee;Kim, Dongjae
    • Journal of the Korean Data and Information Science Society
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    • v.23 no.6
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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.

Methylene Blue (메틸렌 블루)

  • You, Ji-Young
    • Journal of The Korean Society of Clinical Toxicology
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    • v.8 no.1
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    • pp.1-6
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    • 2010
  • Methylene blue is a very effective reducer of drug-induced methemoglobinemia. It has dose-dependent oxidation or reduction properties. In most cases, a dose of 1 to 2 mg/kg IV given over 5 minutes and immediately followed by a 15- to 30-mL fluid flush to minimize the local pain is both effective and relatively safe. The onset of action is quite rapid, and the effects are usually seen within 30 minutes. The dose may be repeated after 30 to 60 minutes and then every 2 to 4 hours as needed. The total dose should not exceed 7 mg/kg as a single dose or 15 mg/kg within 24 hours. Repeated treatment may be needed for treating compounds that have prolonged elimination or those compounds that undergo enterohepatic recirculation (e.g., dapsone). Methylene blue can cause dose-related toxicity. At high doses, methylene blue can also induce an acute hemolytic anemia and rebound methemoglobinemia. The reasons for treatment failure with methylene blue include ineffective GI decontamination, the existence of other forms of hemoglobin (e.g., sulfhemoglobin), a low or high dose of methylene blue and the toxicokinetics of some agents, such as aniline, benzocaine or dapsone.

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Propofol Patient-Controlled Sedation Using $Perfusor^{\circledR}$ fm (B. Braun, Germany) Infusion Pump in Dental Patients-Preliminary Study (치과 환자에서의 $Perfusor^{\circledR}$ fm 자가통증조절기를 이용한 Propofol 자가진정조절법)

  • Park, Chang-Joo;Yum, Kwang-Won;Kim, Hyun-Jeong
    • Journal of The Korean Dental Society of Anesthesiology
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    • v.2 no.2 s.3
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    • pp.97-100
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    • 2002
  • Background: Patient-controlled sedation (PCS) has been blown for a safe and effective sedative method on the same pharmacological concepts of patient-controlled analgesia. Many different kinds of infusion devices have been used but they often have too long nominal infusion rate and lockout time. $Perfuser^{\circledR}$ fm (B. Braun, Germany) is a new PCA device with 999.9 ml/hr nominal infusion rate and minimum 1 min lockout time. In this study, the feasibility of propofol PCS using $Perfuser^{\circledR}$ fm was examined in order to provide a safe satisfactory sedation for dental patients. Methods: Eleven healthy patients presenting for oral surgery were studied. Propofol PCS was performed using $Perfuser^{\circledR}$ fm, which was set to deliver a bolus dose of 5 mg with 999.9 ml/hr nominal infusion rate and 1 min lockout time. Propofol loading dose was randomly assigned to a bolus dose ${\times}$ 0, 2, and 3 (initial bolus). Patients were told to press the bolus button as often as they needed to relieve discomfort. Results: Total infused dose of propofol was mean 1.8 mg/kg/hr and D (Delivery)/A (Attempt) ratio was mean 72.8%. All patients was awake and there were no clinically significant intraoperative side effects during the sedation. Almost all patients were very satisfied with this type of PCS. Conclusion: Propofol PCS using $Perfuser^{\circledR}$ fm infusion pump provided good conscious sedation for dental procedures.

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A Study of Clinical Efficacy of GnRH Antagonist (Cetrorelix) Single and Multiple Dose Protocol for Controlled Ovarian Hyperstimulation (과배란유도에서 GnRH Antagonist (Cetrorelix) Single 및 Multiple Dose Protocol의 임상적 효용성에 관한 연구)

  • Ko, Sang-Hyeon;Kim, Dong-Ho;Bae, Do-Hwan;Lee, Sang-Hoon
    • Clinical and Experimental Reproductive Medicine
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    • v.29 no.4
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    • pp.259-267
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    • 2002
  • Objective: This study was performed to compare the clinical outcomes of GnRH antagonist (Cetrorelix) single dose and multiple dose protocols for controlled ovarian hyperstimulation with GnRH agonist long protocol. Materials and Method: From September 2001 to March 2002, 48 patients (55 cycles) were performed controlled ovarian hyperstimulation for ART using by either GnRH antagonist and GnRH agonist. Single dose of 3 mg GnRH antagonist was administered in 15 patients (17 cycles, single dose group) at MCD #8 and multiple dose of 0.25 mg of GnRH antagonist was administered in 15 patients (18 cycles, multiple dose group) from MCD #7 to hCG injection day. GnRH agonist was administered in 18 patients (20 cycles, control group) by conventional GnRH agonist long protocol. We compared the implantation rate, number of embryos, and clinical pregnancy rate among three groups. Student-t test and Chi-square were used to determine statistical significance. Statistical significance was defined as p<0.05. Results: There were no significant differences in ampules of used gonadotropins, number of mature oocytes, obtained embryos between single and multiple dose group, but compared with control group, ampules of used gonadotropins, number of mature oocytes, obtained embryos were decreased significantly in both groups. Clinical pregnancy rate and implantation rate were not different in three groups. There were no premature LH surge and ovarian hyperstimulation syndrome in three groups. Multiple pregnancy were occurred 1 case in multiple dose group and 2 case in control group. Conclusions: GnRH antagonist is a safe, effective, and alternative method in the controlled ovarian hyperstimulation compared with GnRH agonist. Clinical outcomes and efficacy of both single and multiple dose protocol are similar between two groups.

Single Oral Dose Toxicity Test of Bojungikgi-tang (Buzhongyiqi-tang) and Fermented Bojungikgi-tang (Buzhongyiqi-tang) Extracts in Mice (보중익기탕 및 발효보중익기탕의 단회투여 독성에 대한 연구)

  • Lee, Ji-Hye;Hwang, Yoon-Hwan;Kwak, Dong-Hoon;Kim, Tae-Soo;Ma, Jin-Yeul
    • The Journal of Internal Korean Medicine
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    • v.32 no.4
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    • pp.599-609
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    • 2011
  • Objectives : The aim of this study was to evaluate the single oral dose toxicity and safety of Bojungikgi-tang (Buzhongyiqi-tang) and fermented Bojungikgi-tang (Buzhongyiqi-tang) extracts in male and female ICR mice. Methods : In the single oral dose toxicity study, non-fermented and fermented Bojungikgi-tang (Buzhongyiqi-tang) were administered to male and female ICR mice as an oral dose of 1250, 2500 and 5000 mg/kg. Changes of body weights, general behaviors, adverse effects and mortality were determined throughout the experimental period. Hematological parameters, serum chemistry, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There was no mortality or sign of toxicity in the single oral dose toxicity study. There were also no significant differences in body weights, organ weights, and hematological parameters, serum chemistry values between treatment and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of fermented Bojungikgi-tang (Buzhongyiqi -tang) in both female and male mice can be considered as well over 5,000 mg/kg, so these medicines can be safe in clinics.

A Study on the Performance Evaluation of Portable Radiation Shielding Apparatus (이동형 방사선 차폐장치의 성능평가에 관한 연구)

  • Koo, Bon-Yeoul;Han, Sang-Hyun
    • Journal of radiological science and technology
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    • v.41 no.4
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    • pp.289-295
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    • 2018
  • When using a mobile X-ray unit, primary radiation creates medical images and secondary radiation scatters in many directions, which reduces image quality and causes exposure to patients, care givers and medical personnel. The purpose of this study was to develop a radiation shielding system for effectively shielding secondary radiation and evaluate its effectiveness. Using a mobile X-ray unit, spatial dose according to presence of human equivalent phantom and spatial dose using the developed shielding device were measured, and the phantom at 80 cm equidistance from center of X-ray was compared with spatial dose according to use of a shield. Measurements were taken at intervals of 10 cm every $30^{\circ}$ from the head direction($-90^{\circ}$) to the body direction($+90^{\circ}$). In the spatial dose measurement with and without the phantom, when the human equivalent Phantom was used, the spatial dose was increased by 40% in all directions from 40 cm to 100 cm from the central X-ray, and about 88% of the space dose was reduced when using the developed shields with the phantom. The equidistance dose at 80 cm from the central X-ray was increased by 39% from $5.1{\pm}0.26{\mu}Gy$ to $7.1{\pm}0.15{\mu}Gy$ when the human equivalent phantom was used, and when phantom was used and shielding was used, the spatial dose was reduced by about 90% from $7.1{\pm}0.15{\mu}Gy$ to $0.7{\pm}0.07{\mu}Gy$. The spatial dose of natural radiation was measured to be about $0.2{\pm}0.04{\mu}Gy$ when using the developed shielding with Phantom at a distance of 1 m or more. It is expected that by using the developed shielding system, it will be possible to effectively reduce secondary radiation dose received in all directions and to ensure safe imaging.

Solution to Decrease Spatial Dose Rate in Laboratory of Nuclear Medicine through System Improvement (시스템 개선을 통한 핵의학 검사실의 공간 선량률 감소방안)

  • Moon, Jae-Seung;Shin, Min-Yong;Ahn, Seong-Cheol;Yoo, Mun-Gon;Kim, Su-Geun
    • Quality Improvement in Health Care
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    • v.20 no.1
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    • pp.60-73
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    • 2014
  • Objectives: This study aims at decreasing spatial dose rate through work improvement whilst spatial dose rate is the cause of increasing personal exposure dose which occurs in the process of handling radioisotope. Methods: From February 2013 until July 2013, divided into "before" and "after" the improvement, spatial dose rate in laboratory of nuclear medicine was measured in gamma image room, PET/CT-1 image room, and PET/CT-2 image room as its locations. The measurement time was 08:00, 12:00 and 17:00, and SPSS 21.0 USA was opted for its statistical analysis. Result: The spatial dose rate at distribution worktable, injection table, the entrance to the distribution room, and radioisotope storage box, which had showed high spatial dose rate, decreased by more than 43.7% a monthly average. The distribution worktable, that had showed the highest spatial dose rate in PET/CT-1 image room, dropped the rate to 42.3% as of July. The injection table and distribution worktable in the PET/CT-2 image room also showed the decline of spatial dose rate to 89% and 64.4%, respectively. Conclusion: By improving distribution process and introducing proper radiation shielding material, we were able to drop the spatial dose rate substantially at distribution worktable, injection table, and nuclide storage box. However, taking into account of steadily increasing amount of radioisotope used, strengthening radiation related regulations, and safe utilization of radioisotope, the process of system improvement needs to be maintained through continuous monitoring.

Single Oral Dose Toxicity Study of Modified Samjung-Hwan in Sprague-Dawley Rats (삼정환의 랫드를 이용한 단회 경구투여 독성시험)

  • Kim, Min-Jee;Lee, Myeong-Jong;Kim, Hojun
    • Journal of Korean Medicine for Obesity Research
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    • v.17 no.2
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    • pp.96-100
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    • 2017
  • Objectives: Samjung-hwan (SJH) is a Korean herbal formula that has been used for antilipidemic, antioxidant, and antidepressant effects. As a part of safety evaluation, single oral dose toxicity study of modified SJH in Sprague-Dawley (SD) rats was carried out. Methods: Modified SJH extract was administered orally in male and female SD rats at dose of 5,000 mg/kg. After single oral administration of modified SJH, we monitored the changes of mortalities, clinical signs, and body weight daily for 14 days. Gross necropsy findings were also evaluated at the end of the experiment. Results: Modified SJH extract did not induce any toxic signs in the changes of mortalities, clinical signs, and body weight. There were also observed no gross necropsy findings in rats. Conclusions: As results, the approximate lethal dose of modified SJH extract in SD rats was considered to be over 5,000 mg/kg. This suggests that modified SJH is safe herbal formula for the treatment with.

Usability Evaluation of Lateral Sliding Table in CT Examination (CT 검사에서 Lateral Sliding Table의 유용성 평가)

  • Choi, Jeong Hun;Kong, Chang gi;Song, Jong Nam;Han, Jae Bok
    • Journal of the Korean Society of Radiology
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    • v.14 no.5
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    • pp.677-684
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    • 2020
  • Miscentering in the left and right X axis direction during CT examination affects dose and quality. When the CT Gantry Isocenter and the center of the examination objective are matched using the Lateral Sliding Table, the image quality is improved and the exposure dose is reduced. CTDI Head Phantom (Kimda, Korea) and dosimeter (Ray Safe, Sweden) were used to measure dose comparison CTDI (mGy) due to center deviation, and Water Phantom (HITACHI, Japan) was used to measure noise to see the difference in uniformity due to center deviation. Measurements of doses for dose comparison CTDI (mGy) with a deviation showed that doses were consistently reduced and exact dose was not projected until they were moved to 80 mm by 20 mm from the Isocenter. SD values were measured to see the difference in uniformity due to center deviation and the noise continued to increase until it was moved by 20 mm to 80 mm. The range of collimation has increased by the extent of deviating from the center and the range of exposure has increased. Using the Lateral Sliding Table, you can easily adjust the Isocenter, increase the quality of the image by adjusting the Isocenter in areaa such as the cardiac examination of the location away from the Isocenter, Extreme bone and Shoulder, and greatly reduce the collimation to the Isocenter, so it can be used to reduce unnecessary exposure dose.

Gamma Knife Radiosurgery for Craniopharyngioma (두개인두종에 대한 감마나이프 방사선수술)

  • Chang, Jong Hee;Chang, Jin Woo;Park, Yong Gou;Chung, Sang Sup
    • Journal of Korean Neurosurgical Society
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    • v.30 no.5
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    • pp.561-566
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    • 2001
  • Objective : The purpose of this study are to evaluate the effectiveness of Gamma Knife radiosurgery(GKS) as a treatment of craniopharyngioma and to investigate the proper dose planning technique in GKS for craniopharyngioma. Method : Between May 1992 and March 1999, seven Gamma Knife radiosurgical procedures were done for residual tumor mass of 6 patients with craniopharyngioma after microsurgical resection. Conventional radiation therapy was not performed. In this study, their clinical, radiological and radiosurgical data were analyzed and the radiation dosage to the optic pathway, hypothalamus, pituitary stalk, and cavernous sinus were calculated and correlation with clinical outcome was evaluated. The mean follow-up period was 33.5 months(12.3-55.2 months). Result : The mean tumor volume was 4.4cc(0.4-18.0cc) and the maximum radiation dose ranged from 14 to 32 Gy(mean 20.9Gy). The radiation was given with isodose curve, 50-90% and the marginal dose varied within 8-22.4Gy(mean 12.7Gy). The mean number of isocenter was 4.3(1-12). The tumor was well controlled in all cases. In 5 of 7 cases, the size of tumor decreased to 10-50% of pre-GKS volume and remaining two showed no volume change. The mean dose to optic pathway was 5.7Gy(5.1-11.2Gy) and there were no complications. Conclusion : GKS seems to be effective for control of craniopharyngioma as an adjuvant treatment after microsurgical resection and even suboptimal dose for tumor margin is considered to be enough for tumor control. It is safe with careful dose planning to protect surrounding important structures, especially optic pathway. We believe conventional radiation therapy should be avoided because it has limitation for dose planning of additional treatments such as radiosurgery or intracystic instillation of radioisotope in case of recurrence.

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