This study was aimed to evaluate the absorbed dose in brain of dental radiography. For radiographic exposure, PLD(photoluminescence dosimetry) chips placed in Rando phantom to measurement the absorbed dose to pituitary gland, orbit, maxillary sinus and submandibular glands, thyroid gland, esophagus. Equipments were used Kodak 2200, Kodak 8000C dental radiographic systems and computed tomography(Lightspeed VCT). The absorbed doses were measured at the same exposure parameters and distance by the clinical factor(kV, mA, sec). The result were as follows ; The absorbed dose for intra-oral radiography were 0.02~2.47cGy, the greatest absorbed dose was 2.47cGy for thyroid gland in maxillary right molar projection. the lowest adsorbed dose was 0.02cGy for submandibular glands in lower anterior projection. The absorbed dose for extra-oral radiography were 0.36~3.44cGy of cephalometric method, 0.14~12.82cGy of panoramic method, 8.17~253.63cGy of computed tomography, the greatest adsorbed dose was 253.63cGy for submandibular glands in maxillary CT scan. the lowest adsorbed dose was 0.14cGy for orbit in panoramic method. As a result, extra-oral radiography was measured more than intra-oral radiography. In particular, method which used computed tomography was measured more than 100 times than intra-oral radiography highly. Therefore, you must show a guideline in extra-oral radiography and an effort to reduce absorbed dose is demanded.
Background: Medication policy development in Thailand is continually promoting rational drug use. Letrozole, an endocrine therapy drug, is usually prescribed for post-menopausal status early and advanced stage breast cancer. After Ministry of Public Health announced Letrozole as compulsory licensed drug in 2009, more breast cancer patients can access to this drug at low cost especially those within universal coverage schemes. To ensure that Letrozole is rationally prescribed, the drug utilization study was conducted. Objectives: The aim of this study was to describe the appropriate use of Letrozole in breast cancer and the relationship between appropriate use and health benefit schemes. Materials and Methods: A retrospective study to evaluate use of Letrozole in breast cancer patients was performed for six months between January - June 2010 in seven regional cancer hospitals, Thailand. All prescriptions of Letrozole were identified from pharmacy dispensing databases and prescription papers. A medical record review was also performed to evaluate appropriate use referring to the drug use evaluation criteria. The approved criterion of this study was referred from the guideline of Thai National Formulary version 2010. Results: There were 681 prescriptions of Letrozole for 254 breast cancer patients with an average age of $58.6{\pm}10.0years$. The patients in universal coverage scheme (UCS), civil servant medication benefit scheme (CSMBS) and social security scheme (SSS) were 77.7%, 18.5% and 8.7% respectively. 10.6% were prescribed Letrozole for the first time. Letrozole were prescribed by oncologists (82.8%). The average number of tablets per prescription was $58{\pm}10$. Calcium supplements were prescribed concomitant with Letrozole for 19.4%. To assess drug use evaluation criteria, 45 prescriptions were excluded because of uncompleted clinical data, 636 prescriptions were evaluated. The study showed 86 prescriptions (13.5%) with inappropriate use including 6 (0.9%) not prescribed for estrogen receptor (ER) and/or progesterone receptor (PR) positive, 31 (4.9%) not prescribed for post-menopausal and 49 (7.7%) not prescribed for an appropriate duration. Appropriate use percentages in different health benefit schemes were similar, 85.7% of CSMBS, 86.4% of SSS and 86.7% of UCS. The relationship between health benefit scheme and appropriate use of Letrozole was not significantly different, ${\chi}^2$ (2, N = 636) = 0.081, p > 0.05. Conclusions: The study showed inappropriate use in breast cancer patients because of non-compliance with duration, menopausal status and hormone receptor requirements. To prescribe appropriate indication did not referred to the appropriate practice along the treatment. Drug use evaluation proved very useful for detecting the sign of inappropriate use and allows immediate feedback to the stakeholder for developing medication policy in the future. Importantly, there was no significantly difference in appropriate use of Letrozole across health benefit schemes.
Objectives: This study was conducted to examine the preferences and needs of typical Korean females adults for food and nutrition information provided by the mass media. Methods: A total of 343 females (77 in their 20s, 85 in their 30s, 88 in their 40s and 93 in their 50s) residing in the Seoul/Gyeonggido area was surveyed on general characteristics, main sources of food and nutrition information and needs for sources and contents of nutrition information. Results: The survey showed that typical Korean females obtained knowledge of food and nutrition mainly through the Internet (30.4%) and broadcasting (29.0%). Typical Korean females were interested in 'dietary management for weight control' (21.9%), 'the prevention and treatment of disease' (20.0%), 'food safety' (16.8%), 'proper dietary habits' (14.6%), 'cookery' (11.8%), 'functional foods' (9.6%), 'restaurant details' (3.5%) and 'life-cycle-specific dietary guideline' (1.6%). Needs for food and nutrition program forms on TV were 'educational programs' (34.3%), 'documentaries' (20.8), 'expert lecture-style' (13.0%), 'entertainment programs' (11.9%), 'expert conversation' (11.4%), 'news-style' (4.6%) and 'public campaign advertisements' (4.0%). On the Internet, 38.6% of the respondents preferred to get information provided by food and nutrition-related institutions (38.6%) while 26.1% preferred webtoons for nutritional information. The favored forms in mobile applications were 'monitoring their diets' (29.5%), 'data-based texts information' (21.4%), 'experts feedback' (20.6%), 'communities' (15.1%) and 'games' (13.1%). The rates of the preference to obtain information from experts such as nutritionists and dietitians and doctorsor dietitian turned reporters increased markedly with older ages. Conclusions: Since the mass media is a main source of food and nutrition information for the general public, the effectiveness and accuracy of the information provided should be enhanced by taking the needs of the public into account. The quality of information should be improved by involving more nutrition experts.
The number of CT scans is increasing every year due to the improvement of the medical standards of the public, and thus the annual dose of medical radiation is also increasing. In this study, we evaluated the effective dose of the human body exposed to CT scans and estimated LAR. First, five region were selected from the CT diagnostic reference level guideline, and the effective dose of human body exposed to each examination was evaluated by clinical CT device. Second, the human organs and effective dose were calculated using the ALARA-CT program under the same conditions. Third, lifetime attributable risk (LAR) estimated by the effective dose exposed through the previous CT scan was estimated. As a result, the most effective dose was 21.18 mSv during the abdomen 4 phase scan, and the dose level was below DRL for all other tests except for the abdominal examination. As a result of evaluating effective dose using a dose calculation program under the same conditions, the results showed about 1.1 to 1.9 times higher results for each examination. In the case of organ dose, the closer the organ to the scan site, the higher the scattering ray. The lifetime attributable risk to CT radiation dose in adults was gradually decreased with age, and the results were somewhat different according to gender.
Han, Hyoung-Yun;Kim, Soo Nam;Yang, Young-Su;Han, Su-Cheol;Seok, Ji-Hyeon;Roh, Hang Sik;Lee, Jong-Kwon;Jeong, Jayoung;Jeong, Yeon Woo;Kim, Jeong Ah;Min, Byung Sun
Korean Journal of Pharmacognosy
/
v.46
no.1
/
pp.44-51
/
2015
The objective of this study is to characterize a toxicity of Polygalae Radix (PR) in F344 rats and to find a dose levels for the 13 weeks toxicity study. PR is well known as medicinal herb in many Asian countries for treatment of expectorant, tonic, tranquillizer, antipsychotic agent and functional diet for improving memory. However, there is insufficient background information on toxicological evaluation of PR extract to support its safe use. Therefore, we conducted toxicological evaluation of this drug in compliance with OECD and KFDA guideline in this study. The extract of PR was administered orally to F344 rats at dose levels of 0, 500, 1000, 2000, 3500 and 5000 mg/kg/day for 2 weeks. Each group was composed to five male and five female rats. In the result, there were no treatment PR-related adverse changes in food consumption, hematology, clinical chemistry, urinalysis, gross finding at necropsy, organ weight examination. Four males at 5000 mg/kg/day were found dead during the treatment period. These animals showed salivation. The cause of death is still under investigation. The animals treated at 500, 1000, 2000, 3500 and 5000 mg/kg/day showed salivation and all animals at 5000 mg/kg/day exhibited lower body weight and cumulative weight gain in compared to those of control animals. Therefore, we recommend that a dose group of 3500 mg/kg/day is a highest treatment group in 13-week exposure study.
Total implanted central venous port (TIAP, Chemoport) is widely used in oncology patients because it does not require external dressing and restricts patient activity. Chemoport only requires monthly flushes of heparinized saline to keep the patency of the catheter and probably less prone to infectious complications than tunneled catheter. Despite the extensive use of permanent central venous access in oncology patients, there are only few reports about clinical experience of the Groshong catheter. The purpose of this study is to compare the complication rate between the traditional open-ended (non-valved) chemoports and valved chemoports (Groshong catheter connected to TIAP). During 5 years (Jan 2006 to May 2010), 438 patients received chemoport insertion procedure in our interventional radiology department. Among them 30 patients was referred to our department for problematic chemoports. We compared the cause of problematic chemoports between two types of chemoports (valved, vs. non-valved). Valved chemoports had higher referral rates than non-valved chemoports. When there is a need to insert valved port, different method of insertion and maintenance procedure seems to be necessary. More than 20 ml of flusing with heparinized saline after blood sampling could be a good suggestion. Adequate care of chemoport is essential for long patency. Also following the guideline from the manufacturing company is necessary.
Purpose: Submandibular gland tumor is rare, less than 6% of head and neck tumor. The purpose of this article is to analysis the clinical experience and treatment outcomes of malignant submandibular gland tumor, suggesting a guideline of management. Methods: We retrospectively evaluated 26 patients who underwent operation for malignant submandibular gland tumor at Severence hospital between 1986 and 2004. Statistical analysis was performed by Kaplan-Meier method, log rank test, Chi-square test, Fisher's exact test using SPSS v12.0 for Windows. Results: They consisted of 18 males and 8 females whose median age was 47 years(range: 20-71). 10 cases of adenocystic carcinoma, 8 cases of carcinoma ex pleomorphic adenoma, 4 cases of mucoepidermoid carcinoma, 1 case each for acinic cell carcinoma, undifferentiated carcinoma, adeno carcinoma, epithelioid hemangioendothelioma. Sialoadenectomy only was performed in 10 cases(36.5%) and sialoadenectomy with neck node dissection was performed in 16 cases(63.5%). Adjuvant radiotherapy was done in 22 cases(84.6%). 10 year disease free survival rate for malignant submandibular gland tumor was 63.1 % and 10 year overall survival rate for malignant submandibular gland tumor was 70.1%. In univariate analysis, prognostic factors affecting recurrence of malignant submandibular gland tumor was initially papable lateral neck node in physical examination and metastasis of lateral neck node in pathologic confirmation. The prognostic factors affecting survival of malignant submandibular gland tumor was tumor size, TNM stage, recurrence and type of recurrence. Conclusion: In this study, prognostic factors affecting recurrence of malignant submandibular gland tumor was initially papable lateral neck node in physical examination and metastasis of lateral neck node in pathologic confirmation. The prognostic factors affecting survival of malignant submandibular gland tumor was tumor size, TNM stage, recurrence and type of recurrence. To prevent recurrence and to improve survival, early diagnosis and aggressive surgery must be considered.
The bioequivalence study of two tiropramide products was evaluated in 16 health male volunteers following intra-muscular injection. Test product was Tiram$^{(R)}$ injection (S Pharm. Co, Ltd.) and reference product was Tiropa$^{(R)}$ injection(D Pharm. Co., Ltd.). The drug concentration in plasma was determined by GC/MS for over a period of 8 hours after injection. Analysis of variance reveal that there are no differences in AUC (area under the plasma concentration-time curve from time zero to infinity), Cmax (maximum plasma concentration) and Tmax (time to reach Cmax). The differences of mean AUC, Cmax and Tmax between two products were 0.73, -1.385 and -12.994%, respectively. Minimum detectable differences (%) at ${\alpha}=0.05$ were all less than 20% given as a guideline (10.05, 17.90 and 19.01% for AUC, Cmax and Tmax, respectively). From these results, the two formulations of tiropramide are bioequivalent and thus, may be prescribed interchangeably.
Background: The current maximal recommended doses of lidocaine are 7 mg/kg with $5\;{\mu}g/ml$ of epinephrine. But in clinical practice, sometimes more doses of lidocaine are required to produce adequate regional anesthesia. Method: Twenty-two healthy women patients were divided into two groups and pretreated with valium 5 mg p.o., morphine 5 mg i.m., and midazolam 2 mg i.v. before operation. Of these, 7 mg/kg of 2% lidocaine with $5\;{\mu}g/ml$ of epinephrine were given to 11 patients epidurally. Initial 3 ml of epinephrine mixed lidocaine was given as a test dose and remaining doses were given 5 ml/30 sec with 3 min intervals. Radial arterial blood were drawn at 5, 10, 15, 20, 30, 45, 60, 90, 120 min to measure plasma lidocaine concentrations. After confirming all of the peak plasma concentrations of 7 mg/kg lidocaine were absolutely under $5\;{\mu}g/ml$, the other 11 patients were given 10 mg/kg of 2% lidocaine with $5\;{\mu}g/ml$ of epinephrine epidurally and blood samplings were taken according to the same method of 7 mg/kg group. The peak plasma concentration ($C_{max}$), time to reach to $C_{max}$ ($T_{max}$), time to reach to $T_4$, maximal sensory block level, systemic toxicity, and vital sign changes were investigated. Result: $C_{max}$ was significantly higher in 10 mg/kg group ($5.1{\pm}1.3\;{\mu}g/ml$) than 7 mg/kg group($3.3{\pm}0.5\;{\mu}g/ml$), but $T_{max}$ ($10.5{\pm}2.7$ min vs $10.9{\pm}3.1$ min) was not different. Time to reach $T_4$ was significantly shorter in 10 mg/kg group ($9.5{\pm}2.7$ min) than 7 mg/kg group ($12.7{\pm}3.2$ min) but maximal sensory block level ($T_{3.7{\pm}0.7}$ vs $T_{2.7{\pm}1.0}$) was not different. In four patients of 10 mg/kg group, peak plasma concentrations exceeded $5\;{\mu}g/ml$, but no systemic toxicities appeared. No significant vital sign changes were observed. Conclusion: The current maximal recommended doses of lidocaine, merely based on body weight are not always appropriate. Further studies are needed to determine more precise guideline of maximal doses that include various pharmacokinetic components.
Ibudilast, 3-isobutyryl-2-isopropyrazolo[1,5-a]pyridine, is a nonselective inhibitor of cyclic nucleotide phosphodiesterase (PDE). It preferentially inhibits PDE 3A, PDE4, PDE10 and PDE11 as well as a number of the other PDE families, albeit to a lesser extent. Ibudilast is used clinically to treat bronchial asthma and cerebrovascular disorders. Thes e clinical uses are based on the ability of ibudilast to inhibit platelet aggregation, improve cerebral blood flow and attenuate allergic reactions. The purpose of the present study was to evaluate the bioequivalence of two ibudilast capsules, Ketas capsule (Handok Pharmaceuticals Co., Ltd.) and Pinatos capsule (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of ibudilast from the two ibudilast formulations was tested using KP Apparatus method with various dissolution media. Twenty six healthy male subjects, 23.31${\pm}$1.09 years in age and 70.45${\pm}$8.51 kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single capsule containing 10 mg as ibudilast was orally administered, blood samples were taken at predetermined time intervals and the concentrations of ibudilast in serum were determined using HPLC/UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Ketas, were 6.99%, -2.48% and 9.93% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.8791~log 1.1861 and log 0.8347~log 1.1199 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Pinatos capsule was bioequivalent to Ketas capsule.
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