Background: Conventional spinal saddle block is performed with the patient in a sitting position, keeping the patient sitting for between 3 to 10 min after injection of a drug. This amount of time, however, is long enough to cause prolonged postoperative urinary retention. The trend in this block is to lower the dose of local anesthetics, providing a selective segmental block; however, an optimal dose and method are needed for adequate anesthesia in variable situations. Therefore, in this study, we evaluated the question of whether only 1 min of sitting after drug injection would be sufficient and safe for minor anorectal surgery. Methods: Two hundred and sixteen patients undergoing minor anorectal surgery under spinal anesthesia remained sitting for 1 min after completion of subarachnoid administration of 1 ml of a 0.5% hyperbaric bupivacaine solution (5 mg). They were then placed in the jack-knife position. After surgery, analgesia levels were assessed using loss of cold sensation in the supine position. The next day, urination and 11-point numeric rating scale (NRS) for postoperative pain were assessed. Results: None of the patients required additional analgesics during surgical manipulation. Postoperative sensory levels were T10 [T8-T12] in patients, and no significant differences were observed between sex (P = 0.857), height (P = 0.065), obesity (P = 0.873), or age (P = 0.138). Urinary retention developed in only 7 patients (3.2%). In this group, NRS was $5.0{\pm}2.4$ (P = 0.014). Conclusions: The one-minute sitting position for spinal saddle block before the jack-knife position is a safe method for use with minor anorectal surgery and can reduce development of postoperative urinary retention.
Objectives: This study evaluated the single-dose toxicity of Saeng Maek San (SMS) in rats. Methods: All experiments were conducted at Biotoxtech (Chungwon, Korea), an institute authorized to perform non-clinical studies under the regulations of Good Laboratory Practice (GLP). A single-dose intravenous toxicity study was carried out on 40 6-week-old Sprague-Daley rats. The animals were randomly divided into the following four groups of ten animals each: Group 1 (G1) was the control group, with each animal receiving an intravenous injection of 1.0 mL of saline, and Groups 2, 3 and 4 (G2, G3 and G4) were the experimental groups, with the animals in the groups receiving an injection of 0.1, 0.5 and 1.0 mL of SMS, respectively. Mortality, clinical signs, body-weight changes and gross pathological findings were observed for 14 days following a single administration of SMS or saline. Organ weights, clinical chemistry and hematology were analyzed at 14 days. This study was conducted with the approval of the Institutional Animal Ethics Committee. Results: No deaths occurred in any of the four groups, indicating that the lethal dose of SMS in rats is greater than 1.0 mL/animal. Some changes in weights of male rats between the control group and the experimental groups were observed, but no significant changes in the weights of female rats were noted. To identify abnormalities in organs and tissues, we stained representative sections of each specified organ with hematoxylin and eosin for examination with a light microscope. No significant abnormalities were observed in any of the organs or tissues. Conclusion: The results suggest that intravenous injection of SMS is a safe method of treatment.
Bae, Jung Ah;Choi, Yoon Hee;Kim, Ah Jin;Lee, Sun Hwa
Journal of The Korean Society of Clinical Toxicology
/
v.14
no.1
/
pp.9-15
/
2016
Purpose: In most emergency department (ED), sedation is required before carrying out an invasive procedure on a pediatric patient. In the ED setting, it is essential to determine the optimal dose and administration route of CH for successful sedation. The aim of this study was to determine the optimal dose of CH for an invasive procedure and to examine the effectiveness of the drug's different administration routes. Furthermore, in this study, we performed simple survey using questionnaire which composed of Likert-scale to evaluate satisfaction of medical staffs in ED with administration routes. Methods: This study was conducted prospectively. The study participants were pediatric patients under 8 years old who visited the ED in two tertiary hospitals in South Korea within a period of 12 months. Results: Overall, 300 patients were included in this study. The age, sex, and weight of the patients were not shown to influence the sedation time. Chloral hydrate dosage is the independent factor to influence the both sedation and discharge time (p<0.01). In the comparison of the groups, groups 1, 2, and 5 showed no significant difference. On the other hand, groups 3 and 4 were shown to be statistically significantly different from group 1. Conclusion: Up to 100 mg/kg CH is safe to use in the emergency department for pediatric patients, but the initial dose of 50 mg/kg for oral administration should be considered in advance because it can provide safe and effective sedation with a lower possibility of causing an adverse effect.
Abeliophyllum distichum Nakai is a deciduous shrub of a flowering plant in Oleaceae. It is an important plant resource and consists of only one species in the entire world. A. distichum Nakai is well known an edible, medicinal herb in its habitat districts, but the toxicological evaluation for the safe use of its extract is still insufficient. The study characterized the toxicity of an Abeliophyllum distichum Nakai ethanol extract in Sprague-Dawley (SD) rats and determined the safe dosage levels in a 13 weeks toxicity study. Abeliophyllum distichum Nakai ethanol extract was orally administered once daily for 2 weeks at 0, 500, 1,000 and 2,000 mg/kg/day to male and female SD rats. while recording the clinical signs of toxicity, body weight, food intake/consumption, eye test and urine analysis. Only the total protein frequency in the urine of male SD rats (p<0.05), the right ovary of the 500 mg/kg group (p<0.01) and the right adrenal gland of the 1,000 mg/kg group (p<0.05) in the female rats showed statistically significant changes. But no toxic effects were noted from repeated-dose administration of the Abeliophyllum distichum Nakai ethanol extract in the SD rats during the observation period. The post-mortem examinations showed no test substance-mediated changes. The hematological analysis and clinical blood chemistry data demonstrated no toxic effects from repeated-dose administration of Abeliophyllum distichum Nakai ethanol extract in the SD rats during the observation period. Based on these results, this data suggests that a dose of 1,000 mg/kg/day is a highest treatment to administer when conducting a further 13 weeks toxicity study.
Objectives: Anaphylactic shock can be fatal to people who become hypersensitive when bee venom pharmacopuncture (BVP) is used. Thus, sweet bee venom (SBV) was developed to reduce these allergic responses. SBV is almost pure melittin, and SBV has been reported to have fewer allergic responses than BVP. BVP has been administered only into acupoints or intramuscularly, but we thought that intravenous injection might be possible if SBV were shown to be a safe medium. The aim of this study is to evaluate the intravenous injection toxicity of SBV through a single-dose test in Sprague-Dawley (SD) rats. Methods: Male and female 6-week-old SD rats were injected intravenously with SBV (high dosage: 1.0 mL/animal; medium dosage: 0.5 mL/animal; low dosage: 0.1 mL/animal). Normal saline was injected into the control group in a similar method. We conducted clinical observations, body weight measurements, and hematology, biochemistry, and histological observations. Results: No death was observed in any of the experimental groups. Hyperemia was observed in the high and the medium dosage groups on the injection day, but from next day, no general symptoms were observed in any of the experimental groups. No significant changes due to intravenous SBV injection were observed in the weights, in the hematology, biochemistry, and histological observations, and in the local tolerance tests. Conclusion: The results of this study confirm that the lethal dose of SBV is over 1.0 mL/animal in SD rats and that the intravenous injection of SBV is safe in SD rats.
Kim, Kang-Min;Park, Chul-Kee;Chung, Hyun-Tai;Paek, Sun-Ha;Jung, Hee-Won;Kim, Dong-Gyu
Journal of Korean Neurosurgical Society
/
v.42
no.4
/
pp.286-292
/
2007
Objective : Gamma Knife Stereotactic Radiosurgery (GK SRS) has become an important treatment modality for vestibular schwannomas. We evaluated the tumor control rate, patterns of tumor volume change and preservation of hearing following low-dose radiation for vestibular schwannomas in a homogeneous cohort group in which the mean marginal dose was 12 Gy. Methods : A total of 59 patients were enrolled in this study. All enrolled patients were followed-up for at least 5 years and the radiation dose was 11-13 Gy. Regular MRI, audiometry and clinical evaluations were done and tumor volumes were obtained from MRI using the OSIRIS program. Results : The tumor control rate was 97%. We were able to classify the patterns of change in tumor volume into three categories. Transient increases in tumor volume were detected in 29% of the patients and the maximum transient increase in tumor volume was identified at 6 to 30 months after GK SRS. The transient increases in tumor volume ranged from 121% to 188%. Hearing was preserved in 4 of the 12 patients who had serviceable hearing prior to treatment. There were no other complications associated with GK SRS. Conclusion : Low-dose GK SRS was an effective and safe mode of treatment for vestibular schwannomas in comparison to the previously used high-dose GK SRS. Transient increases in tumor volume can be identified during the follow-up period after low-dose GK SRS for vestibular schwannomas. Physicians should be aware that these increases are not always indicative of treatment failure and that close observation is required following treatments. Unfortunately, a satisfactory hearing preservation rate was not achieved by reducing the radiation dose. It is thought that hearing preservation is a more sophisticated problem and further research is required.
Objectives: The aim of the study is to investigate both the single-dose intramuscular injection toxicity and the approximate lethal dose of water-soluble Carthami-flos and Cervi cornu parvum pharmacopuncture (WCFC) in male and female Sprague-Dawley (SD) rats. Methods: The study was conducted at Biotoxtech Co. according to the Good Laboratory Practice (GLP) regulation and the toxicity test guidelines of the Ministry of Food and Drug Safety (MFDS) after approval of the Institutional Animal Care and Use Committee. Dosages for the control, high dose, middle dose and low dose groups were 0.5 mL/animal of saline and 0.5, 0.25 and 0.125 mL/animal of WCFC, respectively. WCFC was injected into the muscle of the left femoral region by using a disposable syringe (1 mL, 26 gauge). The general symptoms and mortality were observed 30 minutes, 1, 2, 4, and 6 hours after the first injection and then daily for 14 days after the injection. The body weights of the SD rats were measured on the day of the injection (before injection) and on the third, seventh, and fourteenth days after the injection. Serum biochemical and hematologic tests, necropsy examinations, and histopathologic examinations at the injection site were performed after the observation period. Results: No deaths, abnormal clinical symptoms, or significant weight changes were observed in either male or female SD rats in the control or the test (0.125, 0.25, and 0.5 mL/animal) groups during the observation period. No significant differences in hematology and serum biochemistry and no macroscopic abnormalities at necropsy were found. No abnormal reactions at injection sites were noted on the topical tolerance tests. Conclusion: The results of this single-dose toxicity study show that WCFC is safe, its lethal doses in male and female SD rats being estimated to be higher than 0.5 mL/animal.
Moon, Kyung Pil;Kim, Beom Joon;Lee, Kyu Jin;Oh, Jin Hee;Han, Ji Whan;Lee, Kyung Yil;Lee, Soon Ju
Clinical and Experimental Pediatrics
/
v.59
no.4
/
pp.178-182
/
2016
Purpose: Medium-dose (1 g/kg) intravenous immunoglobulin (IVIG) is effective in the majority of patients with Kawasaki disease (KD) but some patients who do not respond to medium-dose IVIG are at high risk for the development of coronary artery lesions (CALs). The purpose of this study was to identify the clinical predictors associated with unresponsiveness to medium-dose IVIG and the development of CALs. Methods: A retrospective study was performed in 91 children with KD who were treated with mediumdose IVIG at our institution from January 2004 to December 2013. We classified the patients into responders (group 1; n=68) and nonresponders (group 2; n=23). We compared demographic, laboratory, and echocardiographic data between the 2 groups. Results: Multivariate logistic regression analysis identified 6 variables as predictors for resistance to medium-dose IVIG. We generated a predictive scoring system assigning 1 point each for percentage of neutrophils ${\geq}65%$, C-reactive protein ${\geq}100mg/L$, aspartate aminotransferase ${\geq}100IU/L$, and alanine aminotransferase ${\geq}100IU/L$, as well as 2 points for less than 5 days of illness, and serum sodium level ${\leq}136mmol/L$. Using a cutoff point of ${\geq}4$ with this scoring system, we could predict nonresponsiveness to medium-dose IVIG with 74% sensitivity and 71% specificity. Conclusion: If a patient has a low-risk score in this system, medium-dose IVIG can be recommended as the initial treatment. Through this process, we can minimize the adverse effects of high-dose IVIG and incidence of CALs.
Objectives: The goals of this research were to evaluate acute (single-dose) and sub-acute (repeated-dose) toxicity profiles of methanolic extract of Pistacia integerrima J. L. Stewart ex Brandis (PI) for Wistar rats and to assess the safety profile of PI by observing physiological changes, mortality, changes in body weight, the histopathology of body organs, the hematology and the biochemistry of the animals. Methods: The toxicity profile of PI was evaluated using Wistar rats of both sexes. Animals were divided into four groups: Group 1; control group (normal saline), Group 2; PI-1 (250 mg/kg), Group 3; PI-2 (500 mg/kg), Group 4; PL-3 (1,000 mg/kg). An acute-toxicity study in which animals received a single dose of PI extract (2,000 mg/kg) and were then observed for 14 days for changes in skin, fur, eye color, mucous membrane secretions and excretions, gait, posture, and tonic or clonic movements was performed according to guideline 425 of the Organization of Economic and Corporation Development (OECD). In the repeated-dose toxicity study (OECD - 407) animals received a daily dose of PI extract for 28 days (4 weeks). The parameters observed in this study include body weight, hematology and biochemistry of the animals. Results: In the acute toxicity study, no mortalities or changes in behavior were noted in the animals. The repeated-dose toxicity study was also devoid of any toxicity in the animals during the 28 days of testing with PI extract. The extract did not alter- the body weight, hematology or biochemistry of the animals. The methanolic extract of PI was to be found safe to the no-observed-adverse-effect-level (NOAEL) for the single-dose and repeated-dose toxicity tests in rats. Conclusion: The methanolic extract of PI was devoid of toxicity; hence, it can be used for various ayurvedic preparations and treatments of diseases.
Brachytherapy is an essential part of radiotherapy for uterine cervical cancer. The low dose rate (LDR) regimen has been the major technique of intracavitary therapy for cervical cancer. However, there has been an expansion in the last 20 years of high dose rate (HDR) machines using Ir-192 sources. Since 1979, HDR brachytherapy has been used for the treatment of uterine cervical cancer in Korea. The number of institutions employing HDR has been increasing, while the number of low dose rate system has been constant. In 1995, there was a total 27 HDR brachytherapy units installed and 1258 cases of patients with cervical cancer were treated with HDR Most common regimens of HDR brachytherapy are total dose of 30-39 Gy at point A with 10-13 fractions in three fractions per week. 24-32 Gy with 6-8 fractions in two fractions per week, and 30-35 Gy with 6-7 fractions in two fractions per week. The average fractionation regimen of HDR brachytherapy is about 8 fractions of 4.1 Gy each to Point A. In Korea, treatment results for HDR brachytherapy are comparable with the LDR series and appears to be a safe and effective alternative to LDR therapy for the treatment of cervical carcinoma. Studies from the major centers report the five-year survival rate of cervical cancer as. 78-86$\%$ for Stage 1, 68-85$\%$ for stage 11, and 38-56$\%$ for Stage III. World-wide questionnaire study and Japanese questionnaire survey of multiple institutions showed no survival difference in any stages and dose-rate effect ratio (HDR/LDR) was calculated to be 0.54 to 0.58. However the optimum treatment doses and fractionation schemes appropriate to generate clinical results comparable to conventional LDR schemes have yet to be standardized. In conclusion, HDR intracavitary radiotherapy is increasingly practiced in Korea and an effective treatment modality for cervical cancer. To determine the optimum radiotherapy dose and fractionation schedule, a nation-wide prospective study is necessary in Korea. In addition, standardization of HDR application (clinical, computer algorithms, and dosimetric aspects) is necessary.
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