The bioequivalence and pharmacokinetics of alendronate sodium tablets were examined by determining the plasma concentration of alendronate. Two groups, consisting of 24 healthy volunteers, each received a 70 mg reference alendronate sodium tablet and a test tablet in a $2{\times}2$ crossover study. There was a 6-day washout period between doses. The plasma alendronate concentration was monitored for 7 h after the dose, using HPLC-Fluorescence Detector (FD). The area under the plasma concentration-time curve from time 0 to the last sampling time at 7 h $(AUC_{0-7h})$ was calculated using the linear-log trapezoidal rule. The maximum plasma drug concentration $(C_{max})$ and the time to reach $C_{max}(T_{max})$ were derived from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_{0-7h}\;and\;C_{max}$, and untransformed $T_{max}$. For the test medication versus the reference medication, the $AUC_{0-7h}\;were\;87.63{\pm}29.27\;vs.\;102.44{\pm}69.96ng\;h\;mL^{-1}$ and the $C_{max}$ values were $34.29{\pm}13.77\;vs.\;38.47{\pm}24.39ng\;mL^{-1}$ respectively. The $90\%$ confidence intervals of the mean differences of the logarithmic transformed $AUC_{0-7h}$ and $C_{max}$ values were log 0.8234-log 1.1597 and log 0.8222-log 1.1409, respectively, satisfying the bioequivalence criteria guidelines of both the US Food and Drug Administration and the Korea Food and Drug Administration. The other pharmacokinetic parameters for the test drug versus reference drug, respectively, were: $t_{1/2},\;1.87{\pm}0.62\;vs.\;1.77{\pm}0.54\;h;\;V/F,\;2061.30{\pm}986.49\;vs.\;2576.45{\pm}1826.05\;L;\;CL/F,\;835.32{\pm}357.35\;vs.\;889.48{\pm}485.87\;L\;h^{-1}; K_{el},\;0.42{\pm}0.14\;vs.\;0.40{\pm}0.18\;h^{-1};\;Ka,\;4.46{\pm}3.63\;vs.\;3.80{\pm}3.64\;h^{-1};\;and\;T_{lag},\;0.19{\pm}0.09\;vs.\;0.18{\pm}0.06\;h$. These results indicated that two alendronate formulations(70-mg alendronate sodium) were biologically equivalent and can be prescribed interchangeably.
Proceedings of the Plant Resources Society of Korea Conference
/
2019.04a
/
pp.111-111
/
2019
Glycyrrhizae radix is one of the most frequently prescribed ingredients in Oriental medicine, and G. radix extract has been shown to exert anti-cancer effects. However, the cellular and molecular mechanisms of apoptosis by G. radix are poorly defined. In the present study, it was examined the biochemical mechanisms of apoptosis by water extract of G. radix (WEGR) in human bladder T24 cancer cells. It was found that WEGR could inhibit the cell growth of T24 cells in a dose-dependent manner, which was associated with the induction of apoptotic cell death, as evidenced by the formation of apoptotic bodies, DNA fragmentation and increased populations of annexin-V positive cells. The induction of apoptotic cell death by WEGR was connected with an up-regulation of pro-apoptotic Bax protein expression and down-regulation of anti-apoptotic Bcl-2 and Bcl-xL proteins, and inhibition of apoptosis family proteins (XIAP, cIAP-1 and cIAP-2). In addition, apoptosis-inducing concentrations of WEGR induced the activation of caspase-9, an initiator caspase of the mitochondrial-mediated intrinsic pathway, and caspase-3, accompanied by proteolytic degradation of poly (ADP-ribose)-polymerase. WEGR also induced apoptosis via a death receptor-mediated extrinsic pathway by caspase-8 activation, resulting in the down-regulation of total Bid and suggesting the existence of cross-talk between the extrinsic and intrinsic pathways. Taken together, the present results suggest that WEGR may be a potential chemotherapeutic agent for the control of human bladder cancer cells.
The objective of study was to identify perceived medication administration Competence of senior nursing students. A total of 128 students were recruited. The instruments for this study were self-efficacy for drug dosage calculation, anxiety for drug dosage calculation and perceived medication administration competence. The data were collected from November 2018 to January 2019, analyzed by descriptive analysis, chi-square, t-test, Scheffe test, correlation coefficients, and multiple regression using the SPSS 25.0 program. The main predictors of perceived medication administration competence were identified as confidence in drug dosage calculation (${\beta}=.463$, p<.001), Attitude of participation at clinical practice (${\beta}=.168$, p=.040). These two factors explained about 29% of variance in perceived medication administration competence (F=26.93, p<.001). It can contribute to improve their ability to administrate medication in practice, with the accuracy of prescription, recalculation of prescribed drug dose, and observation of adverse reactions in clinical practice and simulation with collaborative approach.
[ $\underline{Purpose}$ ]: For the first time, a nationwide survey in the Republic of Korea was conducted to determine the basic parameters for the treatment of esophageal cancer and to offer a solid cooperative system for the Korean Pattern of Care Study database. $\underline{Materials\;and\;Methods}$: During $1998{\sim}1999$, biopsy-confirmed 246 esophageal cancer patients that received radiotherapy were enrolled from 23 different institutions in South Korea. Random sampling was based on power allocation method. Patient parameters and specific information regarding tumor characteristics and treatment methods were collected and registered through the web based PCS system. The data was analyzed by the use of the Chi-squared test. $\underline{Results}$: The median age of the collected patients was 62 years. The male to female ratio was about 91 to 9 with an absolute male predominance. The performance status ranged from ECOG 0 to 1 in 82.5% of the patients. Diagnostic procedures included an esophagogram (228 patients, 92.7%), endoscopy (226 patients, 91.9%), and a chest CT scan (238 patients, 96.7%). Squamous cell carcinoma was diagnosed in 96.3% of the patients; mid-thoracic esophageal cancer was most prevalent (110 patients, 44.7%) and 135 patients presented with clinical stage III disease. Fifty seven patients received radiotherapy alone and 37 patients received surgery with adjuvant postoperative radiotherapy. Half of the patients (123 patients) received chemotherapy together with RT and 70 patients (56.9%) received it as concurrent chemoradiotherapy. The most frequently used chemotherapeutic agent was a combination of cisplatin and 5-FU. Most patients received radiotherapy either with 6 MV (116 patients, 47.2%) or with 10 MV photons (87 patients, 35.4%). Radiotherapy was delivered through a conventional AP-PA field for 206 patients (83.7%) without using a CT plan and the median delivered dose was 3,600 cGy. The median total dose of postoperative radiotherapy was 5,040 cGy while for the non-operative patients the median total dose was 5,970 cGy. Thirty-four patients received intraluminal brachytherapy with high dose rate Iridium-192. Brachytherapy was delivered with a median dose of 300 cGy in each fraction and was typically delivered $3{\sim}4\;times$. The most frequently encountered complication during the radiotherapy treatment was esophagitis in 155 patients (63.0%). $\underline{Conclusion}$: For the evaluation and treatment of esophageal cancer patients at radiation facilities in Korea, this study will provide guidelines and benchmark data for the solid cooperative systems of the Korean PCS. Although some differences were noted between institutions, there was no major difference in the treatment modalities and RT techniques.
Kay Chul Seung;Yoon Sei Chul;Chung Su Mi;Ryu Mi Ryung;Kim Yeon Sil;Suh Tae Suk;Choi Kyuho;Son Byung Chul;Kim Moon Chan
Radiation Oncology Journal
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v.19
no.2
/
pp.81-86
/
2001
Prupose : To evaluate the role of linac based radiosurgery (RS) in the treatment of meningiomas, we retrospectively analyzed the results of clinical and follow up CT/MRI studies. Methods and Materials : From the 1988 July to 1998 April, twenty patients of meningioma had been treated with 6 MV linear accelerator based radiosurgery. Of the 20 patients, four $(20\%)$ were male and 16 $(80\%)$ were female. Mean age was 51 years old ($22\~78$ years old). Majority of intracranial location of tumor for RS were parasagittal and sphenoid wing area. RS was done for primary treatment in 6 $(30\%)$, postoperative residual lesions in 11 $(55\%)$ and regrowth after surgery in 3 $(15\%)$. Mean tumor volume was $5.72\;cm^3\;(0.78\~15.1\;cm^3)$ and secondary collimator size was 2.04 cm $(1\~3\;cm)$. The periphery of tumor margin was prescribed with the mean dose of 19.6 Gy $(9\~30\;Gy)$ which was $40\~90\%$ of the tumor center dose. The follow up duration ranged from 2.5 to 109 months (median 53 months). Annual CT/MRI scan was checked. Results : By the follow up imaging studies, the tumor volume was reduced in 5 cases $(25\%)$, arrested growth in 14 cases $(70\%)$, and increased size in 1 case $(15\%)$. Among these responsive and stable 19 patients by imaging studies, there showed loss of contrast enhancement after CT/MRI in four patients. In clinical response, nine $(45\%)$ patients were considered improved condition, 10 $(50\%)$ patients were stable and one $(5\%)$ was worsened to be operated. This partly resulted in necrosis after surgery. Conclusion : The overall control rate of meningiomas with linac based RS was $95\%$ by both imaging follow-up and clinical evaluation. With this results, linac based RS is considered safe and effective treatment method for meningioma.
Purpose: Ceftriaxone, a potent parenteral third-generation semisynthetic cephalosporin is widely used for the treatment of a variety of bacterial infections in both children and adult. Review of recent data indicates that ceftriaxone treatment has been associated with the development of reversible biliary pseudolithiasis and that is thought by many to be a benign process. Despite, several reports describe patients with ceftriaxone pseudolithiasis who required cholecystectomy for presumed acute cholecystitis. In this study we evaluated the incidence, risk factors, and prognosis of gallbladder pseudolithiasis after ceftriaxone treatment. Methods: Between march, 1997 and January, 1998, any child admitted to the Children's hospital of National University of Seoul and prescribed ceftriaxone for probable or definite bacterial infection were eligible for the study. 21 of them had ultrasound examination on the 2~12 days later after the start of ceftriaxone treatment, 8 of whom documented gallbladder precipitates or pseudolithiasis during treatment by serial abdominal ultrasound. Repeat abdominal ultrasound was performed 10~80 days later after the end of ceftriaxone treatment. The children with underlying liver disease or decreased renal function were excluded in this study. Results: 1) 21 children had ultrasound examinations of gallbladder during ceftriaxone treatment and 8 (38%) of them acquired pseudolithiasis. 2) The patients who developed gallbladder pseudolithiasis were significantly older ($6.3{\pm}2.9$ yr. vs $2.2{\pm}3.1$ yr.)(p<0.05), and older than 24 months were probably the significant risk associated with this phenomenon (p<0.05). However, no significant differences in sex, type of infection, fasting, and ceftriaxone treatment regimen (dose, duration of therapy). 3) The abnormality found on gallbladder ultrasonography was a strikingly hyperechogenic material with post-acoustic shadowing in 5 patients without post-acoustic shadowing in 3 patients 4) Follow up of gallbladder ultrasound was performed in 6 patients after cessation of ceftriaxone treatment. Sonographic abnormalities completely resolved within 14 days post cessation of therapy in 2 patients; 30 days, 1 patient; 80 days, 3 patients. Conclusions: We suggest that routine abdominal ultrasound should be considered in all children who received high dose ceftriaxone in more than 24 months of age and developed hepatobiliary symptoms during or just after ceftriaxone treatment.
The Journal of Korean Society for Radiation Therapy
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v.23
no.1
/
pp.13-19
/
2011
Purpose: It's essential to minimize the tumor motion and identify the exact location of the lesions to achieve the improvement in radiation therapy efficiency during SBRT. In this study, we made the established compression belt to reduce respiratory motion and evaluated the usefulness of clinical application in SBRT. Materials and Methods: We analyzed the merits and demerits of the established compression belt to reduce the respiratory motion and improved the reproducibility and precision in use. To evaluate the usefulness of improved compression belt for respiratory motion reduction in SBRT, firstly, we reviewed the spiral CT images acquired in inspiration and expiration states of 8 lung cancer cases, respectively, and analyzed the three dimensional tumor motion related to respiration. To evaluate isodose distribution, secondly, we also made the special phantom using EBT2 film (Gafchronic, ISP, USA) and we prepared the robot (Cartesian Robot-2 Axis, FARARCM4H, Samsung Mechatronics, Korea) to reproduce three dimensional tumor motion. And analysis was made for isodose curves and two dimensional isodose profiles with reproducibility of respiratory motion on the basis of CT images. Results: A respiratory motion reduction compression belt (Velcro type) that has convenient use and good reproducibility was developed. The moving differences of three dimensional tumor motion of lung cancer cases analyzed by CT images were mean 3.2 mm, 4.3 mm and 13 mm each in LR, AP and CC directions. The result of characteristic change in dose distribution using the phantom and rectangular coordinates robot showed that the distortion of isodose has great differences, mean length was 4.2 mm; the differences were 8.0% and 16.8% each for cranio-caudal and 8.1% and 10.9% each for left-right directions in underdose below the prescribed dose. Conclusion: In this study, we could develop the convenient and efficient compression belt that can make the organs' motion minimize. With this compression belt, we confirmed that underdose due to respiration can be coped with when CTV-PTV margins of mean 6 mm would be used. And we conclude that the respiratory motion reduction compression belt we developed can be used for clinical effective aids along with the gating system.
Jo, Sun-Mi;Chun, Mi-Son;Kim, Mi-Hwa;Oh, Young-Taek;Kang, Seung-Hee;Noh, O-Kyu
Radiation Oncology Journal
/
v.28
no.3
/
pp.177-183
/
2010
Purpose: Simulation using computed tomography (CT) is now widely available for radiation treatment planning for breast cancer. It is an important tool to help define the tumor target and normal tissue based on anatomical features of an individual patient. In Korea, most patients have small sized breasts and the purpose of this study was to review the margin of treatment field between conventional two-dimensional (2D) planning and CT based three-dimensional (3D) planning in patients with small breasts. Materials and Methods: Twenty-five consecutive patients with early breast cancer undergoing breast conservation therapy were selected. All patients underwent 3D CT based planning with a conventional breast tangential field design. In 2D planning, the treatment field margins were determined by palpation of the breast parenchyma (In general, the superior: base of the clavicle, medial: midline, lateral: mid - axillary line, and inferior margin: 2 m below the inframammary fold). In 3D planning, the clinical target volume (CTV) ought to comprise all glandular breast tissue, and the PTV was obtained by adding a 3D margin of 1 cm around the CTV except in the skin direction. The difference in the treatment field margin and equivalent field size between 2D and 3D planning were evaluated. The association between radiation field margins and factors such as body mass index, menopause status, and bra size was determined. Lung volume and heart volume were examined on the basis of the prescribed breast radiation dose and 3D dose distribution. Results: The margins of the treatment field were smaller in the 3D planning except for two patients. The superior margin was especially variable (average, 2.5 cm; range, -2.5 to 4.5 cm; SD, 1.85). The margin of these targets did not vary equally across BMI class, menopause status, or bra size. The average irradiated lung volume was significantly lower for 3D planning. The average irradiated heart volume did not decrease significantly. Conclusion: The use of 3D CT based planning reduced the radiation field in early breast cancer patients with small breasts in relation to conventional planning. Though a coherent definition of the breast is needed, CT-based planning generated the better plan in terms of reducing the irradiation volume of normal tissue. Moreover it was possible that 3D CT based planning showed better CTV coverage including postoperative change.
Background : Sustained-release theophylline, which is generally prescribed as a twice-daily equal-dose regimen, is one of the more common asthma treatments. The development of a sustained-release drug delivery technology that enables improved control of the theophylline blood levels represents a significant advancement in both the efficacy and safety of dosing. Method : A crossover study was conducted with 25 adult chronic asthmatic patients requiring daily bronchodilator therapy. The study group included thirteen males and twelve females with ages ranging from 19 to 71 years. The overall approach was to place the patients first on the twice-daily preparation($Etheophyl^{(R)}$) for 28 days at 8 AM and 8 PM, and measure the pulmonary function and theophylline level on the 28th day. The patients were subsequently switched to the once-daily preparation($Uniphyl^{(R)}$) in the same daily dose at 8 PM on the 29th day and the same parameters were measured on the 56th day. Results : The mean serum levels of theophylline were $8.18{\pm}1.66\;{\mu}g/ml$ in the $Etheophyl^{(R)}$-treated period and $8.00{\pm}1.75\;{\mu}g/ml$ in the $Uniphyl^{(R)}$-treated period. ln addition, the $FEV_1$ showed $71.40{\pm}7.48$ percent in the $Etheophyl^{(R)}$-treated and $69.18{\pm}9.00$ percent in the $Uniphyl^{(R)}$-treated period. Thus there were no significant differences between the once-daily and twice-daily preparation. Conclusion : The results indicated little clinical differences between the two medications. The two drugs are equally effective in controlling asthma over the four weeks of treatment.
[ $\underline{Purpose}$ ]: To compare radiation therapy alone to combined modality therapy about survival rate and tolerance of elderly patients ($70=or{\geq}$) with non-small-cell lung cancer (NSCLC). $\underline{Materials\;and\;Methods}$: Between 1998 and 2002, 57 patients given radiation therapy due to NSCLC (Stage III) were analysed retrospectively. Radiation therapy alone (RT), concurrent chemoradiation (CRT), and sequential chemoradiation (SCRT) was done to 33, 16 and 8 patients, respectively. Patients' median age was 74 (range $70{\sim}85$). Male and female are 51 patients and 6 patients, respectively. 23 patients were stage IIIa and 34 were stage IIIb. Patients' characteristic distribution of RT and CRT was not significantly different except mass size that RT has a bigger than CRT. The fraction size of radiation therapy was 1.8 Gy in CRT and $1.8{\sim}3\;Gy$ in other groups. Total radiation dose was $51{\sim}63\;Gy$ according to the fraction size. If the prescribed total radiation dose was successfully irradiated, we stated that it was completion of radiation therapy. $\underline{Results}$: 52 patients were dead. Median period of radiation therapy was as follow: RT, 35 days, CRT, 60.5 days and SCRT, 35 days. Overall median survival time (MST) was 10.1 months. The 1 yr- and 2 yr-overall survival rate was 39.8% and 17.6%, respectively. MST of RT, CRT and SCRT was 8.9, 8.2 and 11.7 months, respectively. The 1 yr survival rate of RT, CRT and SCRT was 38.4%, 37.5% and 50% (not significant). Patients given incomplete radiation therapy were 12 (RT, 5 CRT, 6 SCRT, 1). N stage (p=0.081) and the difference of treatment methods (p=0.079) were the factors affecting incompletion of radiation therapy, but it was not significant. In case of combined-agents chemotherapy, 4 of 8 ceased radiation therapy. T stage ($T{\geq}3$), mass size (${\geq}5\;cm$), Karnofsky performance scale (${\leq}70$) and completion of radiation therapy were the prognostic factors in uni- and multi-variate analysis. $\underline{Conclusion}$: In elderly patients with NSCLC, radiation therapy alone was a treatment method with similar survival period compared with other methods. Generally, patients given radiation therapy alone was tolerable to a treatment. Before planning concurrent chemoirradiation in elderly patients with NSCLC, physicians pay attention to a selection of patients and chemotherapy agents considering general condition and toxicity.
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