Zaltoprofen, (2-(10,11-dihydro-10-oxodibenzo[b,f]thiepin-2-yl)propionic acid) is an NSAID with powerful anti-inflammatory effects as well as an analgesic action on inflammatory pain. The purpose of the present study was to evaluate the bioequivalence of two zaltoprofen tablets, $Soleton^{\circledR}$ (CJ Corp.) and SCD Zaltoprofen (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of zaltoprofen from the two zatoprofen formulations in vitro was tested using KP Vlll Apparatus ll method with various dissolution media. Twenty six healthy male subjects, $23.2{\pm}2.26$ years in age and$64.7{\pm}8.08$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 80 mg as zaltoprofen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of zaltoprofen in serum were determined using HPLC with 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 ANOVA test was 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, $Soleton^{\circledR}$ were 6.33, 5.91 and 17.7% for $AUC_t$, $C_{max}$ and untransformed $T_{max}$, 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 $1.01{\sim}1og\;1.11$ and log $0.928{\sim}1og\;1.18$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating SCD Zaltoprofen tablet was bioequivalent to $Soleton^{\circledR}$ tablet.
Purpose : Ascending cholangitis is the most common complication after Kasai operations. The aim of this study is to evaluate the therapeutic efficacy of cefotaxime as an empirical antibiotic on ascending cholangitis after Kasai operations. Methods : Thirty-nine episodes of cholangitis in twenty-nine children who underwent Kasai operations at Seoul National University Children's Hospital from January 1991 to December 2000 were included in this study. Empirical cefotaxime treatments were divided into three groups : cefotaxime and amikacin treatment group(CA group), cefotaxime and gentamicin treatment group(CG group) and cefotaxime treatment group(C group). A diagnosis of cholangitis was made on the basis of unexplained fever(>$38^{\circ}C$) and either development of acholic stool or elevation of serum total bilirubin (>1.5 mg/dL). Therapeutic efficacy was judged by elimination of fever up to 72 hours, 120 hours, and 168 hours after antibiotic treatment. Results : There were therapeutic responses in 51%(20/39) up to 72 hours after antibiotic treatment : 54%(13/24) in CA group, 43%(3/7) in CG group and 50%(4/8) in C group. There were therapeutic responses in 69%(27/39) up to 120 hours, in 79%(31/39) up to 168 hours and in 82%(32/39) up to 2 weeks. There were no differences in therapeutic efficacy among the three regimens. In 12 of 39 episodes, the etiologic pathogens including Escherichia coli and enterococcus were cultured from the blood. Conclusion : Cefotaxime can be tried as an initial antibiotic in Korean children with ascending cholangitis after Kasai operation prior to the identification of microorganism on culture. However, further evaluation of pathogen and its resistant strain to cefotaxime should be done.
In order to study the effects of supplementary $Safmannan^(R)$(Beta-glucan & MOS complex) and $World-Labs^(R)$ (multiple probiotics) on the performance, nutrient availability, small intestinal microflora and immune response in broiler chicks, one thousand hatched broilers ($Ross^(R)$ were assigned to 4 treatments: control(basal diet), $BMD^(R),\;Safmannan^(R)\;and\;World-Labs^(R)$. There were no significant differences in the performance and in serum IgG, ND titre. However parameters of leukocytes and erythrocytes were significantly different among treatments (p<0.05). Leukocytes and RBC of $World-Labs^(R)\;and\;Safmannan^(R)$ were mostly lower than $BMD^(R)$ and control whereby MCH and MCHC of $World-Labs^(R)\;and\;Safmannan^(R)$ were higher than other treatments. The cfu of intestinal microflora had no significant differences among treatments. The $BMD^(R)$ treatment was higher than others in amino acid and crude fat availability and $World-Labs^(R)$ was higher than others in crude fiber availability. It was concluded that supplements used in the present experiment did not significantly affect the production parameters. However, significant impact on blood parameters, especially on leucocytes, may need further investigation.
Hwang-Bo, Jeon;Jang, Kyung Ok;Chung, Hayoung;Park, Jong-Hwa;Lee, Tae Hoon;Kim, Jiyoung;Chung, In Sik
The Korean Journal of Food And Nutrition
/
v.29
no.6
/
pp.998-1007
/
2016
The objective of this study was to investigate the effects of a lettuce (Lactuca sativa L.) extract on the inflammation of human umbilical vein endothelial cell (HUVEC) and blood lipid improvement in hypercholesterolemic mice fed a high cholesterol diet. The lettuce extract (100% ethanol extract) inhibited the expression of intercellular adhesion molecule-1 and vascular cell adhesion molecule-1 in HUVEC treated with tumor necrosis factor-${\alpha}$ (TNF-${\alpha}$). The lettuce extract suppressed the adhesion of THP-1 to TNF-${\alpha}$-treated HUVEC. The lettuce extract decreased the TNF-${\alpha}$-stimulated production of proinflammatory cytokine interleukin-6, interleukin-8 and chemokine monocyte chemotactic protein 1. In hypercholesterolemic mice, the lettuce extract reduced serum total cholesterol, triglyceride, and low-density lipoprotein-cholesterol level, while the lettuce extract elevated high-density lipoprotein-cholesterol level, resulting in the decrease of atherogenic index and cardiac risk factor level. These results suggested that lettuce extract can be an useful resource to show an anti-inflammatory effect and improve lipid metabolism.
Vitellogenin(Vg) is a sex specific serum protein present in sexually maturing female blood of oviparous vertebrates. Estrogen($E_2$) is a main inducer of hepatic Vg synthesis. We investigated the effects of androgen and growth hormone(GH) on regulation of Vg and estrogen receptor(ER) genes in Japanese eel. Immature eels($200{\sim}250\;g$) were given a single injection of $E_2(5{\sim}5,000\;{\mu}g/kg\;bw)$ alone, or in combination with eel recombinant GH(eGH, $1{\sim}10\;{\mu}g/kg$) or methyltestosterone(MT, $1{\sim}5\;mg/kg$) and sacrificed 10 days after the hormone treatments. Expression levels of ER and Vg genes from the liver were determined by means of reverse transcription and polymerase chain reaction(RT-PCR). Administration of $E_2$ stimulated Vg gene expression in a dose dependent manner. Levels of Vg mRNA after the injection of $E_2(500\;{\mu}g/kg)$ with MT(5mg/kg) or eGH($10\;{\mu}g/kg$) were much higher than in that of $E_2$ alone($500\;{\mu}g/kg$). Whereas, injection of either vehicle, eGH ($10\;{\mu}g/kg$) or MT(5mg/kg) alone did not induce the expression of Vg gene in the liver. ER mRNA was detected from the fish treated with vehicle alone. $E_2$ injection($5{\sim}500\;{\mu}g/kg\;bw$) increased this ER expression but dose dependent response was not clear. Addition of MT(5mg/kg) or eGH($10\;{\mu}g/kg$) did not affect $E_2-stimulated$ ER mRNA expression. This study confirms the necessity of $E_2$ as the primary factor for Vg gene expression and requirement of additional hormones such as MT or GH for the full expression of Vg mRNA, and suggests that the additive effect of MT or GH on Vg gene expression would be mediated by some unknown factors other than ER.
Hong Ihn Hee;Ko Cheol Woo;Koo Ja Hoon;Kim Ji-Hong;Kim Pyung-Kil;Cho Byoung Soo
Childhood Kidney Diseases
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v.3
no.1
/
pp.48-56
/
1999
Purpose : This multicenter collaboratory study was conducted to see the therapeutic efficacy and side effect of cyclosporine A (Cipol-$N^{(R)}$, Chong Kun Dang) on children with idiopathic nephrotic syndrome who experienced frequently relapsing (FR), steroid dependent (SD), or steroid resistant (SR) pattern. Patients and methods : Thirty-nine children with SD/FR NS and 3 children with SR NS were enrolled in the study. After induction of remission (SD/FR NS) with steroid or after 4 weeks of steroid therapy (SR NS), cyclosporine A was started in a dose of 4-5 mg/Kg/day in two divided dose and steroid (prednisolone or equivalent dose of deflazacort) was tapered slowly. During 16 weeks of study period, monthly check up of physical examination and various laboratory tests including BUN, creatinine, Ccr and cyclosporine blood level were done. Results : Out of 39 children with SD/FR NS, 35($89.7\%$) maintained sustained remission and at 4 weeks after therapy, values of serum protein, albumin, cholesterol, and 24 hours urinary protein excretion showed normal values. Two out of 3 children with SR NS showed and sustained remission with cyclosporine A therapy. Side reaction to cyclosporine A therapy showed hypertrichosis in 8 cases and hyperuricemia in 5 cases. However, other laboratory tests including CBC, liver profile, BUN, creatinine and GFR (creatinine clearance utilizing 24 hour urine) did not show any abnormalities during the 16 weeks of study period. Conclusion : Cyclosporine A (Cipoi-$N^{(R)}$ Chong Kun Dang) can be utilized quite effectively on children with SD/FR or SR NS and further trial of cyclosporine A on long-term basis (1-2 year period) is needed to determine it's efficacy and side effect (especially nephrotoxicity) of long-term administration of cyclosporine A.
Park, Sung-Shin;Chung, Sung-Hoon;Song, Jun-Hyuk;Kim, Sun-Kyoung;Cho, Byoung-Soo;Kim, Sung-Do
Childhood Kidney Diseases
/
v.11
no.1
/
pp.32-40
/
2007
Purpose : We performed this study to determine the incidence of acute renal failure(ARF) in birth asphyxia and to correlate the severity of asphyxia and hypoxic-ischemic encephalopathy (HIE) and ARF in asphyxiated neonates. Methods : Data was retrospectively collected from the medical records of 33 patients with neonatal asphyxia and of 33 neonates with no asphyxia. On the basis the 5-minute Apgar score, the asphyxiated neonates were further grouped into mild(6 or 7), moderate(4 or 5), and severe asphyxia(3 or less). Asphyxiated neonates with HIE were staged by the Sarnat and Sarnat scoring system. We compared serum creatinine, blood urea nitrogen, electrolytes, and urine output on day 3 of life and the incidence and severity of intraventricular hemorrhage(IVH) between each group. Results : ARF occurred in 8(24.2%) asphyxiated neonates. Of these, 3(37.5%) were oliguric, while 1(10.0%) patient with mild asphyxia, 2(18.2%) of moderate asphyxia, and 5(41.7%) with of severe asphyxia had ARF(P>0.05). One(25%) patient with stage I HIE, 4(50%) with stage II HIE, and 3(75%) of HIE with stage III HIE developed ARF(P<0.01). There was no statistical correlation between the severity of asphyxia and HIE stage. One(7.7%) patient with grade 1 IVE, 0(0.0%) with grade 2 IVH, 2(66.7%) with grade 3 IVH, and 2(100.0%) with grade 4 IVH had ARF(P<0.01). Mortality was higher in asphyxiated neonates with ARF(P<0.05). There was no significant difference between the oliguric and non-oliguric renal failure. Conclusion : We found that the greater the degree of HIE, the higher was the incidence of ARF. Asphyxiated neonates with ARF had a poorer prognosis.
Purpose: To assess the relationship between lifestyle and metabolic syndrome in obese children and adolescents. Methods: We retrospectively reviewed the medical records and laboratory results of 109 subjects (7~15 years of age) who visited our pediatric obesity clinic between January 2004 and December 2007. They completed the parent- and self-report questionnaire developed by the Committee on Nutrition of the Korean Pediatric Society to assess lifestyle. The metabolic syndrome was defined as having 3 or more of the following metabolic risk factors: obesity, hypertension, serum triglycerides ${\geq}$110 mg/dL, HDL-cholesterol ${\leq}$40 mg/dL, fasting glucose ${\geq}$110 mg/dL, and insulin ${\geq}20{\mu}IU/mL$. Results: All subjects had at least 1 risk factor (obesity). Sixty-three percent of subjects had 2 or more risk factors, 32% of subjects had 3 or more risk factors, and 10% had 4 or more metabolic risk factors. Hypertriglyceridemia (36%), hypertension (32%), hyperinsulinemia (24%), and HDL-hypocholesterolemia (20%) were observed. Fasting blood glucose levels were normal in all subjects. Hypertension was significantly associated with an unbalanced diet and hyperinsulinemia was significantly associated with parental obesity (p<0.05). Those who ate after 8 PM were at a risk of hypertension (odds ratio, 2.5; 95% CI, 1.0~6.1). Those who did not have a preference for exercise were at a risk of hyperinsulinemia (odds ratio, 10.4; 95% CI, 2~54.1). Those who watched TV for ${\geq}$3 hours/day were at a risk of metabolic syndrome (odds ratio, 4.8; 95% CI, 1.2∼18.8). Conclusion: Lifestyle, such as eating late, no preference for exercise, and TV watching ${\geq}$3 hours/day, were related to metabolic syndrome in obese children and adolescents.
Background: Physician's estimates of patient survival often influence clinical decisions, especially those near the end of life. In addition. clinical decisions frequently reflect trade-offs between morbidity and length of survival. As a result, accurate estimates of survival can be extremely useful in clinical decision. When the episode of acute respiratory failure in chronic obstructive lung disease, evaluation of the severity of the condition and short term prognosis is difficulit based on the available clinical or paraclinical data at the time of admission. Method: In this study, we performed a retrospective study in Chung Ang University Hospital, 74 patients (51 males, 23 females), who were hospitalized with chronic obstructive lung disease with acute respiratory failure from 1980 to 1992. We evaluated these patients to determine lung prognostic factors at time of admission in the Intensive Care Unit (ICU) that predict short term survival, and to determine the possible application of the Simplified Acute Phsiology Score (SAPS) to this population, All patients were treated with similar regimen during the hospitalization. Results: The results were as follows: 1) Hospital mortality was 34%(25/74 patients) and surival rate was 66%(49/74 patients) in COPD with acute respiratory failure. The prognosis of the older age was much poorer than those of the young age. 2) There was no difference in mortality according to the results of basal pulmonary test and arterial blood gas analysis. 3) The SAPS at admission was higher in those patients who expired(10.8) than the survived(6.5), and there was positive correlation between SAPS and mortality (r=0.91, p<0.05). 4) Prognostic factors in acute respiratory failure complicating COPD which were identifiable at time of admission to the ICU were as follows: cachexia, encephalopathy, serum creatinine and phosphate. Conclusion: In conclusion, the SAPS might have a good prognostic value for determination of short term survival among chronic obstructive lung disease with acute respiratory failure.
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.
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