• Title/Summary/Keyword: Clinical dose

Search Result 2,903, Processing Time 0.026 seconds

A Study for Safe Dose and Clinical Use of Glycyrrhizae Radix in Shanghanlun (『상한론(傷寒論)』 처방에서 감초(甘草) 용량의 안전성 및 임상 사용에 대한 문헌 고찰)

  • Kim, Hyeong-Seop;Lee, Soong-In
    • 대한상한금궤의학회지
    • /
    • v.8 no.1
    • /
    • pp.1-23
    • /
    • 2016
  • Objectives : The purpose of this paper is to find out the safe dose and clinical use for administration of Glycyrrhizae Radix in Shanghanlun(傷寒論). Methods : Web-databases(OASIS, NDSL, Pubmed, Google) were searched with keywords including 'Licorice', 'Pseudoaldosteronism', 'Glycyrrhizin', 'Testosterone' on 14/10/2016. The searched about 40 papers and books were reveiwed. Results : Glycyrrhizin(GL) and 3-monoglucuronyl glycyrrhetinic acid(3MGA) in Glycyrrhizae Radix are found to be the main compounds vulnerable for inducing pseudoaldosteronism. The dose range of Glycyrrhizae Radix in Shanghanlun prescriptions is from 0.25 g to 12 g as a daily administration, and this dose satisfies the guidelines of WHO, European Union, ABC etc. And risk factors contributing for personal sensitivities are old age(>60), female sex, liver dysfunction, hypokalemia, prolonged gastrointestinal transit time, anorexia nervosa, decreased 11-${\ss}$-hydroxysteroid dehydrogenase-2 activity and hypertension. Conclusions : As a result, dose of Glycyrrhizae Radix in Shanghanlun(傷寒論) is safe. However, the personal sensitivity and unexpected drug interactions are independent from doses of GL, so doctors should monitor those risk factors and symptoms of pseudoaldosteronism when administering Glycyrrhizae Radix.

A Single Oral Dose Toxicity Study of Plant Sterol Ester in Sprague-Dawley Rats

  • Kim, Jong-Choon;Kim, Kab-Sig;Chung, Dae-Won;Chung, Moon-Koo
    • Biomolecules & Therapeutics
    • /
    • v.8 no.2
    • /
    • pp.167-170
    • /
    • 2000
  • The present study was conducted to investigate the acute toxicity of plant sterol ester by a single oral dose in Sprague-Dawley rats. Ten males and 10 females aged 5 weeks were randomly assigned to two groups of 5 rats each and were administered by gavage at dose level of 0 or 20 ml/kg body weight. Parameters measured during the 14-day observation period were mortality, clinical signs, body weight changes, and gross findings. No mortality was observed in the present study. Treatment-related clinical signs, such as pasty stool and diarrhea, were observed on the day of treatment and these signs resulted in soiled fur on day 1 after the treatment. However, no clinical signs were observed on days 2-14 after the treatment. There was no significant difference in body weight changes between the control and treatment groups. At necropsy on day 14 after the treatment, no treatment-related gross findings were observed in the treatment group. Based on these results, it was concluded that a single oral dose of plant sterol ester induced pasty stool and diarrhea in Sprague-Dawley rats at dose level of 20 ml/kg and that the lethal doses were considered to be over 20 ml/kg for both sexes.

  • PDF

A Pilot Study on Single-dose Toxicity Testing of Hominis placenta Pharmacopuncture in Sprague-Dawley Rats

  • Lee, Yoo-Hwan;Yoon, Hyun-Min;Jang, Kyung-Jeon;Kim, Cheol-Hong
    • Journal of Pharmacopuncture
    • /
    • v.18 no.2
    • /
    • pp.51-59
    • /
    • 2015
  • Objectives: This study was performed to analyze the toxicity and to find the lethal dose of the test substance Hominis placenta pharmacopuncture when used as a single-dose in 6 week old, male and female Sprague-Dawley (SD) rats. Methods: All experiments were conducted at Biotoxtech (Chungwon, Korea), an institution authorized to perform non clinical studies, under the regulations of Good Laboratory Practice (GLP). SD rats were chosen for the pilot study. Doses of Hominis placenta pharmacopuncture extracts, 0.125, 0.25 and 0.5 mL, were administered to the experimental group, and 0.5 mL doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths or abnormalities occurred in any of the groups. Also, no significant changes in body weights were observed among the groups, and no significant differences in hematology/biochemistry, necropsy, and histopathology results were noted. Hematologically, some changes in the male rats in two experimental groups were observed, but those changes had no clinical or toxicological meaning because they were not dose dependent. Histopathological tests on the injected parts showed cell infiltration in the male rats in one of the experimental groups; however, that result was due to spontaneous generation and had no toxicological meaning. Therefore, this study showed that Hominis placenta pharmacopuncture had no effect on the injected parts in terms of clinical signs, body weight, hematology, clinical chemistry, and necropsy. Conclusion: As a result of single-dose tests of the test substance Hominis placenta pharmacopuncture in 4 groups of rats, the lethal dose for both males and females exceeded 0.5 mL/animal. Therefore, the above findings suggest that treatment with Hominis placenta pharmacopuncture is relatively safe. Further studies on this subject are needed.

Single Oral Dose Toxicity Study of Pinelliae Rhizoma Aqueous Extract in ICR Mice

  • Lim, Young-Kwon;Park, Ji-Ha;Seo, Bu-Il;Roh, Seong-Soo;Ku, Sae-Kwang
    • Toxicological Research
    • /
    • v.25 no.3
    • /
    • pp.147-157
    • /
    • 2009
  • This study was conducted to obtain acute information of the oral dose toxicity of lyophilized water extract of Pinelliae Rhizoma, a dried tuber of Pinellia ternata (PR) in male and female mice. In order to calculated 50% lethal dose (LD$_{50}$) and approximate lethal dose (ALD), test material was once orally administered to male and female ICR mice at dose levels of 2000, 1000, 500, 250, 125 and 0 (vehicle control) ml/kg (body weight). The mortality and changes in body weight, clinical signs, gross observation, organ weight and histopathology of principle organs were monitored 14 days after treatment with PR extract. We could not find any mortalities, clinical signs, changes in the body and organ weights, gross and histopathological findings except for dose-dependent increases in the hepatic fatty change frequencies detected in PR extract 2000 and 1000mg/kg treated in both male and female mice. The results obtained in this study suggest that LD$_{50}$ and approximate LD in mice after single oral dose of PR extracts were considered over 2000 mg/kg in both and female male mice, but more than 1000mg/kg of PR extracts treatment could induce slight hepatotoxicity the fatty changes in mice.

Comparisons of Adherence, Efficacy and Price between Sitagliptin/Metformin Fixed-dose Combination Tablets and Concomitant Administration of Sitagliptin and Metformin in Type 2 Diabetes Mellitus Patients (제2형 당뇨병 환자에서 시타글립틴과 메트포민 고정 복합제 투여와 단일제 병용간의 복약 순응도, 효과 및 약가에 대한 비교 연구)

  • Park, Ji Hye;Lee, Byung Koo;Kim, Jae Youn;Gwak, Hye Sun
    • Korean Journal of Clinical Pharmacy
    • /
    • v.24 no.3
    • /
    • pp.193-198
    • /
    • 2014
  • Objective: This study was conducted to compare the adherence, clinical and economical utility of fixed-dose combination tablets of sitagliptin/metformin with concomitant administration of sitagliptin and metformin in patients with type 2 diabetes mellitus. Methods: Adherence was measured as the medication possession ratio (MPR) of ${\geq}80%$, and MPR was calculated as the number of total prescription days divided by the total treatment period. Hemoglobin $A_{1C}$ ($HbA_{1c}$) differences between baseline and predetermined periods were analyzed. Proportions of patients who achieved $HbA_{1c}$ less than 6.5% for three or more consecutive times were compared. To evaluate cost-effectiveness, prices of sitagliptin, metformin and sitagliptin/metformin tablets were investigated. Results: More than 90% of patients showed adherence in both groups (92.0% in fixed-dose combination group vs 95.9% in concomitant administration group), and there was no statistically significant difference (P = 0.113). Proportion of patients with HbA1c less than 6.5% for three or more consecutive times tended to be somewhat higher in fixed dose combination group than in concomitant administration group without a statistically significant difference (32.6% vs. 28.0%, P = 0.344). Total price of metformin and sitagliptin was cheaper up to 222 KRW in the case of fixed-dose combination tablets compared to the case of concomitant administration. Conclusion: The sitagliptin/metformin fixed-dose combination tablet had a similar patient adherence and was not significantly different in efficacy to the concomitant administration of each component. In terms of drug prices, fixed-dose combination tablets were cheaper than concomitant administration of each tablet.

Evaluation of Radiation Dose to Patients according to the Examination Conditions in Coronary Angiography (심장동맥 조영 검사 시 검사 조건에 따른 환자 선량 평가)

  • Yong-In Cho
    • Journal of radiological science and technology
    • /
    • v.46 no.6
    • /
    • pp.509-517
    • /
    • 2023
  • This study analyzed imaging conditions and exposure index through clinical information collection and dose calculation programs in coronary angiography examinations. Through this, we aim to analyze the effective dose according to examination conditions and provide basic data for dose optimization. In this study, ALARA(As Low As Reasonably Achievable)-F(Fluoroscopy), a program for evaluating the radiation dose of patients and the collected clinical data, was used. First, analysis of imaging conditions and exposure index was performed based on the data of the dose report generated after coronary angiography. Second, after evaluating organ dose according to 9 imaging directions during coronary angiography, with the LAO fixed at 30°, dose evaluation was performed according to tube voltage, tube current, number of frames, focus-skin distance, and field size. Third, the effective dose for each organ was calculated according to the tissue weighting factors presented in ICRP(International Commission on Radiological Protection) recommendations. As a result, the average sum of air kerma during coronary angiography was evaluated as 234.0±112.1 mGy, the dose-area product was 25.9±13.0 Gy·cm2, and the total fluoroscopy time was 2.5±2.0 min. Also, the organ dose tended to increase as the tube voltage, milliampere-second, number of frames, and irradiation range increased, whereas the organ dose decreased as the FSD increased. Therefore, medical radiation exposure to patients can be reduced by selecting the optimal tube voltage and field size during coronary angiography, maximizing the focal-skin distance, using the lowest tube current possible, and reducing the number of frames.

A Study on the Dose Distribution for Total Body Irradiation using Co-60 Teletherapy Unit (Co-60 Teletherapy Unit를 이용한 전신조사의 선량분포에 관한 고찰)

  • Kim, Sung-Kyu;Shin, Sei-One;Kim, Myung-Se
    • Journal of Yeungnam Medical Science
    • /
    • v.6 no.2
    • /
    • pp.113-119
    • /
    • 1989
  • In recent years there has been a growing interest in total body, hemibody, total lymphoid irradiation. For refractory leukemia or lymphoma patients, various techniques and dose regimens were introduced, including high dose total body irradiation for destruction of leukemic or bone marrow cells and immunosuppression prior to bone marrow transplantation, and low dose total body irradiation for treatment of lymphocytic leukemia or lymphomas. Accurate provision for specified dose and the desired homogeneity are essential before clinical total body irradiation. Purposes of this paper are to discuss calibrating Cobalt Unit in 3m distance using Rando Phantom, to compare calculated dose, calibrated dose, and compensating filters for homogeneous dose distribution in the head and neck, the lung, and the pelvis. Results were following. 1. Measured dose on the lung was 6% higher than on the abdomen. Measured dose on the head (10%) and neck (18%) were higher than the abdomen because of thinness. Pelvic dose was measured 12% less than the abdomen. Those data suggest that compensating filter was essential. 2. Measured dose according to distance was 3% less than calculated dose which suggest that all doses in clinical use should be compared with calculated dose for minimizing error.

  • PDF

Clinical and microbiologic effects of the subantimicrobial dose of doxycycline on the chronic periodontitis (저용량 독시싸이클린 투여가 만성 치주염에 미치는 임상적 미생물학적 효과)

  • Kim, Sang-Jun;Um, Heung-Sik;Chang, Beom-Seok;Lee, Jae-Kwan
    • Journal of Periodontal and Implant Science
    • /
    • v.39 no.1
    • /
    • pp.37-44
    • /
    • 2009
  • Purpose: Tetracycline and its chemically modified non-antibacterial analogues can inhibit certain host-derived tissue destructive collagenases such as matrix metalloproteinases. The purpose of this study was to evaluate clinical and microbiologic effects of the subantimicrobial dose of doxycycline(SDD) in conjunction with scaling and root planing. Materials and methods: A total of 30 patients with chronic periodontitis who were going to receive scaling and root planing were randomly allocated to receive either a doxycycline hyclate for 3 months or nothing. Clinical probing depth, clinical attachment level, gingival recession, and bleeding on probing were measured by one periodontist. After a periodontal examination, microbial samples were collected using sterile paper points. The effect of SDD in conjunction with scaling and root planing on alterations of the periodontal pathogens (Aggregatibacter actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis) were also assessed using l6S rRNA polymerase chain reaction. Results: During the treatment period, clinical parameters for both treatment group and control group were improved. After 3 months, reductions in probing depth and gains in clinical attachment level were significantly greater for the SDD group than control group. Microbial analysis showed that there was no alteration of the periodontal pathogens and no difference between the groups. Conclusion: This study suggested that the subantimicrobial dose of doxycycline as an adjunct therapy with scaling and root planing might be effective and safe in the management of chronic periodontitis.