• Title/Summary/Keyword: biliary tract

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Bioequivalence of Alpit Tablet to Algiron Tablet (Cimetropium Bromide 50 mg) (알기론 정(브롬화 시메트로피움 50 mg)에 대한 알피트 정의 생물학적 동등성)

  • Cho, Hea-Young;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.32 no.1
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    • pp.47-54
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    • 2002
  • Cimetropium bromide, a quaternary ammonium compound which is chemically related to scopolamine, exhibits its antispasmodic activity by competing with acetylcholine for the muscarinic receptors of the smooth muscle of gastrointestinal tract. The drug has been used for the treatment of various disorders involving spasms of the musculature of the gastrointestinal, biliary and genitourinary tracts. The purpose of the present study was to evaluate the bioequivalence of two cimetropium bromide tablets, $Algiron^{TM}$ (Boehringer Ingelheim Korea Ltd.) and $Alpit^{TM}$ (Hana Pharmaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KFDA). The cimetropium bromide release from the two cimetropium bromide tablets in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty normal male volunteers, $25.25{\pm}2.10$ years in age and $65.76{\pm}6.39$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three tablets containing 50 mg of cimetropium bromide per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of cimetropium bromide in serum were determined using HPLC method with UV detector. The dissolution profiles of two cimetropium bromide tablets were very similar at all dissolution media. Besides, 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 non-transformed and logarithmically transformed $AUC_t\;and\;C_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on the $Algiron^{TM}$ were 2.19%, -5.97% and 3.49%, respectively. Minimum detectable differences $({\Delta})\;at \;{\alpha}=0.05\;and\;1-{\beta}=0.8$ were less than 20% (e.g., 13.71 %, 19.05% and 15.11% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively). The powers $(1-{\beta})\;at\;{\alpha}=0.05,\;{\Delta}=0.2\;for\;AUC_t$, $C_{max}\;and\;T_{max}$ were 97.79%, 83.22% and 95.60%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-5.84{\sim}10.21,\;-17.11{\sim}5.18\;and\;-5.35{\sim}12.33\;for\;AUC_t,\;C_{max}\;and\;T_{max}$, respectively). There were no sequence effect between two tablets in logarithmically transformed $AUC_t\;and\;C_{max}$. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., $0.94{\sim}1.10\;and\;0.85{\sim}1.05\;for\;AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that $Alpit^{TM}$ tablet is bioequivalent to $Algiron^{TM}$ tablet.

Clinical Evaluation of Syndromic and Nonsyndromic Intrahepatic Bile Duct Paucity (증후군성 및 비증후군성 간내담도부족증의 임상적 고찰)

  • Han, Soo-Jin;Choi, Bo-Hwa;Kang, Kyung-Hoon;Kim, Kyung-Mo
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.2 no.2
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    • pp.178-184
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    • 1999
  • Purpose: The aims of this study were to evaluate the clinical manifestations and prognosis of the syndromic and nonsyndromic intrahepatic bile duct paucity (IHBDP). Methods: We studied histology of 42 infants with neonatal cholestasis. Fourteen patients were diagnosed as IHBDP. We evaluated the clinical manifestations, courses and prognosis retrospectively. Results: Underlying disease of the 42 infants with neonatal cholestasis were biliary atresia in 23, intrahepatic bile duct paucity in 14 (Alagille syndrome in 4 and nonsyndromic IHBDP in 10), neonatal hepatitis in 5 infants. The mean ratio of the bile ducts per portal tract was 0.087 (range: 0~0.5). The manifestations in 4 patients with Alagille syndrome demonstrated as follows: characteristic face in 3, chronic cholestasis in 4, posterior embryotoxon in 2, vertebral anomalies in 2, peripheral pulmonary stenosis in 2. One of 4 patients of Alagille syndrome improved cholestasis and the other 3 patients were remained their cholestasis and growth retardation. All patients of the nonsyndromic IHBDP were idiopathic. Seven out of 8 patients of nonsyndromic IHBDP showed improvement of cholestasis, and one patient received liver transplantation due to cirrhosis. Conclusion: This study suggested that IHBDP should be considered in the differential diagnosis of neonatal cholestasis. The outcome of idiopathic IHBDP was better than predicted.

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A Study on the Comparison of One Step Method and Two Step Method to Improve Reporting of CA 19-9 Results (CA 19-9 결과보고 개선을 위한 One step 방식과 Two step 방식의 비교에 관한 연구)

  • Jae-Seok An;Ji-Na Kim;Kwang-Seo Park;Eun-Bit Joo;Sang-Hyuk Yoon;Yoon-Cheol Kim
    • The Korean Journal of Nuclear Medicine Technology
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    • v.28 no.1
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    • pp.81-87
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    • 2024
  • Purpose: CA 19-9 is the most widely used tumor marker for the diagnosis of digestive system tumor, especially pancreatic and biliary tract cancer. This study was conducted to improve the result value near reference range by comparing the reagents of CA 19-9 one step method and two step method. In addition, it was intended to establish a standard for selecting reagents. Material and Methods: 120 patients who visited the National Cancer Center in 2023 were selected as subjects for this study. The reagents used in the study were CA 19-9 IRMA kits (Shinjin, Korea) and three types of reagents were compared. Two step method reagent that is currently being used (A), one step method reagent (B) and two step method reagent improved by request (C) were compared and regression analysis was performed on their data. And we also performed recovery test, linearity test and hook effect test for each reagent. Result: There were 46 cases of reagent B in which the concentration value was lower than the result measured in reagent A that was previously used, and 77 cases of reagent C. As a result of regression analysis of reagents A, B, and C, the coefficients of determination of reagents A and B, reagents A and C, and reagents B and C were 0.653, 0.577, and 0.875. In the recovery rate test and the linearity test, the results of all reagents were good, and in the hook effect test, reagent B showed a hook effect at a low value. Conclusion: The improved reagent C appears to have been improved based on the concentration value of reagent B, which the manufacturer judged to be more stable at low concentrations. The hook effect in reagent B can be a fatal reason for disqualification when selecting reagents in general patient samples which high-concentration samples appear frequently. The first improved reagent C will be able to be used once it is confirmed that it has more stability for various concentration values.

The Gastric-Bile Juice Reflux in Patients from Hepatobiliary Scan with Subtotal Gastrectomy (위 부분절제술 환자의 간담도 스캔에서 위-담즙역류)

  • Kwak, Dong-Woo;Kim, Ji-Hyeon;Kim, Kyung-Hun;Lee, Kyung-Jae;Park, Young-Jae;Lee, In-Won
    • The Korean Journal of Nuclear Medicine Technology
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    • v.14 no.2
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    • pp.17-20
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    • 2010
  • Purpose: The hepatobiliary scan is the examination which is the possibility of knowing the function of liver, gall bladder and closing of the biliary tract. Also, after subtotal gastrectomy, the increased gastric-bile reflux is known as the primary reason of reflux gastritis. In this study, according to changing the acquisition method, we tried to prove the reflux time and reflux index in patients who underwent subtotal gastrectomy. Materials and Methods: From Oct 2008 to Jan 2009, 72 patients with subtotal gastrectomy who took the hepatobiliary scan (man: 52, woman: 20, age range: 31-77, mean age: $60.5{\pm}7$) in our department. We used the radiopharmaceutical $^{99m}Tc$-mebrofenin 185 MBq/0.5 cc. After 5 minutes, we acquired 300,000 counts anterior image on supine, and then we acquired right lateral and $45^{\circ}$ LAO position by using the time setting method. We acquired 30 min, 60 min, 90 min, 120 min and fatty meal by the same method. We painted the ROI of liver, GB and CBD on 30 min anterior image and LAO image in patients had occurred the bile juice reflux. And then we painted the ROI of stomach on others image. We calculated the reflux index from those values. Results: According to this study, we found out 40 patients (55.6%) who had occurred the gastric-bile juice reflux (1 person from 30 min, 7 persons from 60 min, 4 persons from 90 min, 28 persons from after fatty meal). Hourly, the bile reflux highest level is 6 persons from 60 min, 2 persons from 90 min, 32 persons from fatty meal among those people. The reflux index of anterior is 0.85-23.36% (mean 6.53%). The reflux index of LAO is 1-29.13% (mean 8.89%). By visual assessment, we can distinguish that there were 26 of the 40 patients (65%) had occurred the reflux on LAO image more than anterior image. Conclusion: We find out that the patients with subtotal gastrectomy had occurred gastric-bile juice reflux more than 50% from hepatobiliary scan. And after eating fatty meal, we can know that it's the most possible to occur the gastric-bile juice reflux. When it happened, we have to change the acquisition method to reduce the overlap between colon and stomach. This study will be more valuable in diagnosis.

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Lower Extremity Edema in Terminal Cancer Patients (말기 암 환자에서의 하지 부종)

  • Shim, Byoung-Yong;Hong, Seok-In;Park, Ji-Chan;Hong, Sug-Hui;Choi, Gang-Heun;Cho, Hong-Joo;Kim, Seon-Young;Han, Sun-Ae;Lee, Ok-Kyung;Kim, Hoon-Kyo
    • Journal of Hospice and Palliative Care
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    • v.8 no.2
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    • pp.152-155
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    • 2005
  • Purpose: The lower extremity edema (LEE) is a common distressful symptom in advanced cancer patients and is hard to manage. We analyze the characteristics of LEE in patients with advanced cancer to provide the basic information of causes and adequate management. Methods: Physical examination, assessment of the location and severity of edema, blood chemistry (albumin, creatinine), Doppler Sono for patients with suspecting deep vein thrombosis (DVT), and abdomen CT scan for patient with suspecting lymph edema were performed. Severity of edema was classified according to NCI lymph edema scaling and improvement was defined as lowering at least 1 grade of edema after management. Results: Among 154 patient who had been admitted to Hospice Ward from Mar 2003 to Jan 2004, 33 had LEE, and 6 had both upper extremity edema and LEE except generalized edema. Their underlying cancers were stomach (7), lung (6), biliary tract (5), liver (5), colorectal (5), pancreas (2), and others (9). There were 12 patient with grade I, 20 patients with grade II, and 7 patients with grade III edema. The causes were hypoalbuminemia (11), lymph edema (10), DVT (7), obstruction of inferior vena cava (IVC) or portal vein (6), and dependent edema (5). The common managements were including leg elevation and diuretics. Elastic stocking was applied for patients with DVT and leg massage and pneumatic compression was used for lymph edema. The 2/3 patients were improved after management. Conclusion: The incidence of LEE in terminal cancer pts was high (25.3%) and their causes were variable including lymph edema, DVT, hypoalbuminemia and dependent edema. Active noninvasive management according to causes could result in good palliation.

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DNR (Do-Not-Resuscitate) Order for Terminal Cancer Patients at Hospice Ward (호스피스 병동에서 시행되는 말기 암 환자의 DNR (Do-Not-Resuscitate) 동의)

  • Shim, Byoung-Yong;Hong, Seok-In;Park, Jin-Min;Cho, Hong-Joo;Ok, Jong-Sun;Kim, Seon-Young;Han, Sun-Ae;Lee, Ok-Kyung;Kim, Hoon-Kyo
    • Journal of Hospice and Palliative Care
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    • v.7 no.2
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    • pp.232-237
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    • 2004
  • Purpose: DNR order is generally accepted for cancer patients near the end of life at Hospice Ward. It means not only no CPR when cardiopulmonary arrest develops but no aggressive meaningless medical interventions. Usually on admission, we discuss with the patients' family about DNR order at the Hospice Ward. Recently, we experienced a terminal lung cancer patient who had been on the ventilator for two months after pulmonary arrest. CPR and artificial ventilation were performed because patient's family refused DNR order. There is no consensus when, who, and how DNR order could be written for terminal cancer patients in Korea, yet. Methods: Hospice charts of 60 patients who admitted between Jan and Jun 2003 to Hospice Ward were reviewed retrospectively. Results: The median age was 66(range $31{\sim}93$) and there were 31 males and 29 females. Their underlying cancers were lung (12), stomach (12), biliary tract (7), colon (6), pancreas (4) and others (19). The persons who signed DNR order were son (22), spouse(19), daughter (16) and others (3). But, there was no patients who signed DNR order by oneself. Thirty families of 60 patients signed on day of admission and 30 signed during hospitalization when there were symptom aggravation (19), vital sign change (4), organ failure (3) and others (4). There were 13 patients who died within 5 days after DNR order. Most of patients died at our hospice ward, except in 1 patient. The level of care was mostly 1, except in 2 patients. (We set level of care as 3 categories. Level 1 is general medical care: 2 is general nursing care: 3 is terminal care.) Conclusion: We have to consider carefully discussing DNR order with terminal cancer patients in the future & values on withholding futile intervention.

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