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Preparation and Bioequivalence Test of Acetaminophen Liquid Suppository (아세트아미노펜 액상좌제의 제초 및 생물학적 동등성 평가)

  • 김종국;최한곤;이사원;고종호;이미경
    • Biomolecules & Therapeutics
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    • v.6 no.2
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    • pp.213-218
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    • 1998
  • A novel in situ-gelling and mucoadhesive acetaminophen liquid suppository was developed to improve the patient compliance of conventional solid suppository. In this study, acetaminophen liquid suppository, Likipe $n_{R}$, [aminophen/Poloxamer 407/Poloxamer 188/so4ium alginate (5/15/19/0.6%)] with relation temperature at 30-36 "C and suitable gel strength and bioadhesive force, dissolution pattern similar to conventional solid type suppository, Suspe $n_{R}$, was developed. Furthermore, the bioequivalence of two acetaminophen products was evaluated in 16 normal male volunteers (age 22-27 yr, body weight 56-72 kg) following sidle rectal administration. Test product was Likipe $n_{R}$ suppository (Dong-Wha Pharm. Corp., Korea)and reference product was Suspe $n_{R}$204-212 suppository (Hanmi Pharm. Corp., Korea). Both products contain 125 mg of acetaminophen. Four Suppositories of the test and the reference product were administered to the volunteers, respectively, by randomized two period cross-over study (2$\times$2 Latin square method). The determination of acetaminophen was accomplished using HPLC. Average drug concentrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products (p>0.05); the area under the curve to last sampling time (24 hr) (AU $Co_{-2}$4h/) (30.14$\pm$8.64 vs 27.98$\pm$ 6.53 $\mu$g .h/ml), maximum plasma concentration ( $C_{max}$) (3.29$\pm$0.87 vs 3.60$\pm$0.66 $\mu$g/ml) and time to maximum plasma concentration ( $T_{max}$) (2.91 $\pm$0.55 vs 2.69$\pm$0.60 h). The differences of mean AUCo $_{24h}$, C-a. and T-between the two products (7.18%, 9.58% and 7.53%, respectively) were less than 20%. The power (1-7) and treatment difference ($\Delta$) for AU $Co_{24h}$, $C_{max}$ and $T_{max}$ were more than 0.8 and less than 0.2, respectively at $\alpha$=0.1. The confidence limits for AU $Co_{24h}$, $C_{max}$ and $T_{max}$ (-0.81 ~13.55%, -1.56~ 17.60 and -3.81 ~18.87%, respectively) were less than $\pm$ 20% at $\alpha$=0.1. These results suggest that the bioavailability of Likipe $n_{R}$ suppository is not significantly different from that of Suspe $n_{R}$ suppsitory. Therefore, two products are bio-equivalent based on the current results.results.lts.sults.results.lts.

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Medical Care Utilization Status and Associated Factors with Extended Hospitalization of Psychiatric Patients in Korea (우리나라 정신질환자의 의료이용 현황과 장기입원 관련 요인)

  • Suh, Soo-Kyung;Kim, Yoon;Park, Jong-Ik;Lee, Myung-Soo;Jang, Hong-Suk;Lee, Sun-Young;Lee, Jin-Seok
    • Journal of Preventive Medicine and Public Health
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    • v.42 no.6
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    • pp.416-423
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    • 2009
  • Objectives : This study was performed to examine medical care utilization of psychiatric patients and to explore patients' characteristics associated with extended hospitalization. Methods : Data were extracted from information of Korean Health Insurance Review and Assessment Service. All data associated with admission and outpatient clinic visit were analysed by patient characteristics. We selected first psychiatric admission patients who diagnosed mental and behavioral disorders due to use of alcohol (main disease code: F10), schizophrenia and related disorders (F20-29) and mood disorders (F30~33) from January to June 2005. We analysed status of admission, mean length of stay, regular access to outpatient clinic and rates of extended hospitalization during 3 years. Bivariate and multivariate analyses were conducted to identify factors associated with extended hospitalization. Results : The number of psychiatric patients during the first six month of 2005 was 30,678. The mean length of stay was longest for schizophrenia and related disorders but shortest for mood disorders. Patients who experienced an extended hospitalization were 18.8% of total subjects. An extended hospitalization was more common in schizophrenia and related disorders than other diagnostic groups. The factors associated with the extended hospitalization were age, sex, diagnostic group, type of insurance and medical care utilization groups. Conclusions : The study indicates the problem of an extended hospitalization for psychiatric patients in Korea. It is suggested that variations in rates of extended hospitalization among medical care utilization group may need an active early intervention system in psychiatric treatment service. Particular attention needs to be devoted to planning and funding for reducing extended hospitalization.

Meningeal Hemangiopericytomas : Clinical Features, Treatment and Long-term Outcome (수막 혈관주위세포종의 임상상, 치료 및 장기 추적 결과)

  • Lee, June-Ho;Hwang, Sung-Kyun;Gwak, Ho-Shin;Paek, Sun Ha;Kim, Dong Gyu;Kim, Hyun Jib;Jung, Hee-Won
    • Journal of Korean Neurosurgical Society
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    • v.30 no.7
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    • pp.876-882
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    • 2001
  • Objectives : Meningeal hemangiopericytoma is a rare tumor. Clinical and radiological features are similar to those of an ordinary meningioma. But its biological behavior is quite different from those of a meningioma as it brings profuse bleeding in the operation field, frequent recurrence and metastasis to other systemic organs even in the case of gross total resection. In order to find out the prognostic factors and to compare longterm outcome after various treatment modalities, the authors reviewed consecutive 20 operated cases of meningeal hemangiopericytoma to characterize their clinical features, surgical outcomes and effectiveness of the radiation therapy. Methods : Twenty patients with a hemangiopericytoma were treated between 1982 and 1999 in our department. They are composed of 13 patients of hemangiopericytoma and 7 patients who were initially diagnosed as angioblastic type meningioma and then confirmed as a hemangiopericytoma after review of their previous histopathology slides. The mean follow-up period was 99 months(1-256 months). The long-term outcomes after various treatment modalities were evaluated according to recurrence-free survival and image follow-up. Recurrence-free survival curves are compared between the patient groups according to the extent of removal and radiation therapy. Results : There were 10 cases of recurrence and 4 cases of distant metastases ; lung, liver and femur(2 cases) respectively. The 5-year recurrence rate was 37%, while the 10-year recurrence rose to 77%. There was also statistically significant difference of median recurrence-free survival between the completely-resected group(Simpson grade 1 or 2) and partially-resected group(Simpson grade 3 or 4 or 5) ; 137 months compared to 47 months, respectively(p=0.009). The median recurrence-free period after subtotal resection of tumor and postoperative radiotherapy was 47 months compared to 117 months of the patients who underwent gross total resection of tumor and did not receive radiotherapy. But radiation therapy alone did not show significant difference in recurrence-free survival. Marked tumor volume reduction and easy removal of tumors without bleeding were found in 2 recurred cases. Conclusion : The extent of tumor resection and presence of metastasis are the most important factors related to long-term outcome of the patients with hemangiopericytoma. Radiation therapy after the first operation did not have a role in extending the recurrence-free survival, but it affected favorably to decrease the size of residual mass and intraoperative bleeding during the second operation.

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Does Breast Cancer Drive the Building of Survival Probability Models among States? An Assessment of Goodness of Fit for Patient Data from SEER Registries

  • Khan, Hafiz;Saxena, Anshul;Perisetti, Abhilash;Rafiq, Aamrin;Gabbidon, Kemesha;Mende, Sarah;Lyuksyutova, Maria;Quesada, Kandi;Blakely, Summre;Torres, Tiffany;Afesse, Mahlet
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.12
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    • pp.5287-5294
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    • 2016
  • Background: Breast cancer is a worldwide public health concern and is the most prevalent type of cancer in women in the United States. This study concerned the best fit of statistical probability models on the basis of survival times for nine state cancer registries: California, Connecticut, Georgia, Hawaii, Iowa, Michigan, New Mexico, Utah, and Washington. Materials and Methods: A probability random sampling method was applied to select and extract records of 2,000 breast cancer patients from the Surveillance Epidemiology and End Results (SEER) database for each of the nine state cancer registries used in this study. EasyFit software was utilized to identify the best probability models by using goodness of fit tests, and to estimate parameters for various statistical probability distributions that fit survival data. Results: Statistical analysis for the summary of statistics is reported for each of the states for the years 1973 to 2012. Kolmogorov-Smirnov, Anderson-Darling, and Chi-squared goodness of fit test values were used for survival data, the highest values of goodness of fit statistics being considered indicative of the best fit survival model for each state. Conclusions: It was found that California, Connecticut, Georgia, Iowa, New Mexico, and Washington followed the Burr probability distribution, while the Dagum probability distribution gave the best fit for Michigan and Utah, and Hawaii followed the Gamma probability distribution. These findings highlight differences between states through selected sociodemographic variables and also demonstrate probability modeling differences in breast cancer survival times. The results of this study can be used to guide healthcare providers and researchers for further investigations into social and environmental factors in order to reduce the occurrence of and mortality due to breast cancer.

Hemiplegic Migraine Presenting with Unilateral Facial Palsy: A case report (편측안면마비로 발현한 편마비편두통 1예)

  • Yeon, Gyu Min
    • Journal of the Korean Child Neurology Society
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    • v.26 no.4
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    • pp.288-291
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    • 2018
  • Hemiplegic migraine (HM) is a rare subtype of migraine with aura and is accompanied by a fully reversible motor aura. HM can occur in two forms: familial or sporadic. Currently, three genes are related to familial HM. Typically, HM occurs in the first or second decade of life and involves gradually progressing aura symptoms in succession, accompanied by headaches. The aura includes visual, sensory, motor, aphasic and often basilar-type symptoms. Motor aura (weakness) is related to the regions where the sensory aura is involved, and it usually starts at the hand before spreading to the arm and face. Aphasia is a common form of speech aura, but does not typically present as a difficulty in understanding. In this case report, the sensory-motor aura started at the right face and then gradually progressed to the right leg without any symptoms in the ipsilateral upper extremity. To the best of my knowledge, there has been no previous case report for the presentation of a hemiplegic migraine, as in this case report. As there is a possibility of misdiagnosis of Bell's palsy at the early stage of this case, this case report suggests that a physician should consider the rare possibility of stroke or HM when a patient presents with unilateral facial palsy.

A Case of Multiple System Atrophy-Parkinsonism Type (MSA-P) with Gait Disturbance and Posture Instability Treated with Korean Medicine (보행 장애와 자세 이상 등을 호소하는 다계통 위축증(MSA-P) 한의 치험 1례)

  • Lee, Sang-hwa;Shin, Hee-yeon;Jeong, Hye-seon;Kim, Seo-young;Yang, Seung-bo;Cho, Seung-yeon;Park, Jung-mi;Ko, Chang-nam;Park, Seong-uk
    • The Journal of Internal Korean Medicine
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    • v.40 no.5
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    • pp.743-751
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    • 2019
  • This case report suggests the potential effects of Korean medicine for the gait disturbance and posture instability of Multiple System Atrophy-Parkinsonism (MSA-P). A patient with MSA-P who had gait disturbance and posture instability was given a series of Korean medicine, including acupuncture, pharmacopuncture, electro-acupuncture, moxibustion, and herbal medicine, for 15 days of hospitalization. During the hospitalization period, the severity and progression of the disease was measured with the Unified Multiple System Atrophy Rating Scale (UMSARS) and a video recording of a 20-meter round timed walking test. The UMSARS Part I and II scores decreased from 14 to 5 and 9 to 5, respectively. An improvement was also noted in standing and walking posture, and the walking time was shortened from 30 to 25 seconds in the 20-meter round-trip walking test. Dysarthria, dysphagia, and non-motoring symptoms like sleep behavioral disorders and constipation were also improved. The findings of this case study suggest that this series of Korean medicine has potential therapeutic effects for patients with MSA-P with motor and non-motor symptoms.

Sudden Deafness (돌발적난청)

  • 조중환;류태현
    • Proceedings of the KOR-BRONCHOESO Conference
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    • 1976.06a
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    • pp.85.3-86
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    • 1976
  • Sudden deafness requires immediate investigation and treat if there is to be any prospect of salvaging the hearing. It present an otological emergency and a diagnostic challenge. Sn Sudden sensorineural deafness can be caused by a wide variety of pathologies. A battery of tests and investigations must be performed forthwith if treatment is to be started without further delay. The concept that nothing can be done for the patient with sensori-neural deafness must be abandoned. Some pathologies causing sudden deafness are not amenable to therapy or can show only partial reversibility. But there are several causes, showing little or no spontaneous recovery, which do responed to appropriate treatment. It is important to identify them and concentrate on their management. The age and sex ratios and the unilaterral or bilateral nature of the lesion are related to the etiology and depend upon which type of case is included in the series. Though individually rare, collecting for about 2.5 per cent of new otoloical patients. Some 70 per cent of cases are unilateral. Viral, bacterial and treponemal infections accounted for about 30 per cent of the cases. Some 16 per cent were due to vascular lesions of the cochlea. In almost 22 per cent there was no obvious cause (idiopathic), they occurred in young adult and were either sensory or neural. About 12 per cent were traumatic and 9 per cent were ototoxic in origin. The remaining 11 per cent were due to a group of rarities. The two vital factors are the site of the lesion and the duration of the hearing loss. The earlier these are diagnosed and treated the better the response. The etiology, pathology and treatment are reviewed.

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The Factors that Predict Using Mechanical Ventilation for Patients with Organophosphate Intoxication (유기인계 농약 중독환자에서 기계환기 필요성에 대한 예측인자 분석)

  • Park, Dong-Chan;Park, Jung-Bae;Kim, Yun-Jeong;Shin, Soo-Jeong;Mun, You-Ho;Park, Sin-Ryul;Ryoo, Hyun-Wook;Seo, Kang-Suk;Chung, Jae-Myung
    • Journal of The Korean Society of Clinical Toxicology
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    • v.8 no.2
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    • pp.106-112
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    • 2010
  • Purpose: The purpose of this study is to investigate the factors that predict using mechanical ventilation for patients with organophosphate intoxication. Methods: We retrospectively reviewed the medical records of 111 patients with acute organophosphate intoxication and who were treated in our emergency center from January 2000 to December 2008. We compared the toxicologic characteristics, the laboratory findings and the APACHE II scores between the Mechanical Ventilation group (MV group) and the non-Mechanical Ventilation group (the non MV group). Results: Sixty three patients were in the MV group and 48 patients were in the non MV group. In the MV group, the patients had an older age (p<0.001), a larger amount of ingestion (p<0.001), a lower initial serum cholinesterase level (p=0.003), a higher APACHE II score (p<0.001) and they ingested a more toxic agent (p=0.001). There were no significant differences in gender, the type of visit and the arrival time between the MV group and the non MV group. Conclusion: We suggest that the patient's age, the amount of organophosphate ingestion, the toxicity of the agent, the initial serum cholinesterase level and the APACHE II score are important factors to determine if mechanical ventilation will be applied for patients with organophosphate intoxication.

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Association between Depression and Sociodemographic Factors of Elderly Welfare Facility Users in a City (일도시 노인복지시설 이용자들에서 우울증과 인구사회학적 요인과의 연관성)

  • Shin, Ae Rin;Lee, Kang Joon;Kim, Hyun
    • Korean Journal of Psychosomatic Medicine
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    • v.24 no.2
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    • pp.133-139
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    • 2016
  • Objectives : As the prevalence of elderly depression increases, it becomes urgent problem to provide preventive and management measures. But in practice, it is difficult to detect depression in early stage. The purpose of this study is to evaluate the association between sociodemographic factors and depression in elderly welfare facility users in a city. Methods : In this research, the severity of depression and sociodemographic factors(gender, age, education, co-morbid disease, housing type, number of children, number of family members living with the subjects) was evaluated through PHQ-9 and interview. Using the data, the associations of depression and sociodemographic factors were analyzed. Based on PHQ-9 depression cut-off value(10 points), the subjects were divided into two groups, and the difference of the variables between groups were analyzed statistically. Results : 'Own house'(YES/NO), education(less than elementary school graduation/more than elementary school graduation) were sociodemographic factors which showed significance difference in mean PHQ-9 scores. Group with Over PHQ-9 10 points showed less 'having their own house' and less education level than group with less PHQ-9 10 points. Conclusions : With this research, it is expected that the risk factors for the elderly depression can be understood and the measures for early detection and invention of elderly depression would be provided.

Necessity of Mandatory Records on Radiological Examination (방사선검사에 관한 기록 의무화의 필요성)

  • Hong, Dong-Hee;Lim, Cheong-Hwan;Kim, Yon-Min;Kim, Eun-Hye;Yoo, Se-Jong;Yoon, Yong-Su;Lim, Woo-Taek;Jung, Young-Jin;Jung, Hong-Ryang;Joo, Young-Cheol;Choi, Ji-Won;Kang, Byung-Sam;Park, Myeong-Hwan;Back, Geum-Mun;Yang, Oh-Nam;Rhim, Jae-Dong;Jeong, Bong-Jae
    • Journal of radiological science and technology
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    • v.44 no.4
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    • pp.399-407
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    • 2021
  • This study discussed the validity and necessity of compulsory recording of radiographic examination performed by radiological technologist on patients in medical institutions related to radiation exposure. Also, this study provided reasonable evidence of radiographic examination related medical records can contribute to the improvement of public health. Based on overseas cases of implementing a radiographic examination record system, the essential items to be included in medical record are the exposure date, exposure time, exposure method, exposure conditions that is tube voltage, tube current. Name and license number of the radiological technologist who performed the examination should be include in medical record. It is expected that the medical record of the total amount of radiation exposure per year would be in giving the maximum benefit with the minimum exposure to the medical radiation examination of the patient. In addition, interventional radiography medical record should also include exposure time, type and dose of the contrast medium.