• Title/Summary/Keyword: First-In-Man dose

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A Study of clinical trial method for safety of herb-acupuncture (약침제제(藥鍼製劑)의 안전성(安全性)을 위한 임상시험방법(臨床試驗方法)에 대한 연구(硏究))

  • Jun Kum-Sun;Nam Sang-Soo;Lee Jae-Dong;Choi Do-Young;Ahn Byoung-Choul;Park Dong-Seok;Lee Yun-Ho;Choi Yong-Tae
    • Journal of Acupuncture Research
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    • v.15 no.2
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    • pp.183-198
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    • 1998
  • This study was done in order to present clinical trial method for safety of herb-acupuncture. The results were summerized as follow: In case of western medicine, clinical trial divides into four phase 1. Phase I: Investigate safety and drug movement for health people. 2. The first phase II: Investigate safety, effectiveness for the limited patient. The late phase II: Investigate propriety of an applicable disease, the way to use and dose. 3. Phase III: Through the comparative, public trial, investigate a final, applicable disease and side effect. 4. Phase IV: After NDA, investigate safety and effectiveness for the wide patients. In case of herb-acupuncture, we have to investigate the following for safety and effectiveness 1. Drug dose: Decide with 1/2 or 1/3 of oral dosage or a basis of animal's of maximum dosage or a ratio of man and animal. 2. Toxicity: Examine blood, urine, liver function, EKG, after herb-acupuncture during acertain period of time. 3. Regional response: Estimate response of swelling, redness, pruritus. etc 4. Treatment effectiveness: After exactly diagnosis, estimate effectiveness with a objective guide post.

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Effects of Sambutoxin on the Rabbit Platelet Aggregation (Sambutoxin이 토끼의 혈소판 응집에 미치는 영향)

  • Hong, Choong-Man;Cho, Myung-Haeng
    • Toxicological Research
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    • v.14 no.3
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    • pp.333-339
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    • 1998
  • Sambutoxin, a newly purified mycotoxin in Koea, caused hemorrhage in the stomach and intestine of rats. To elucidate the mechanism of hemorrhage, effects of sambutoxin on rabbit platelet aggregation were investigated. First of all, the effects of sambutoxin on the platelet aggregation response and ATP release from platelet by various appregating factors were investigated. And then the role of $Ca^{2+}$ on the platelet aggregation was investigated by flow cytometer. Finally, morphological effect of sambutoxin on platelet ultrastructure was examined by transmission electron microscope. Sambutoxin inhibited aggregation induced by ADP, collagen, thrombin, and arachidonic acid and decreased platelet activating factor-induced disaggregation time in a dose dependent manner. Sambutoxin also decreased thrombin and arachidonic acid-induced ATP release, but increased all factors induced $Ca^{2+}$ release. Sambutoxin showed severe ultrastructural changes of platelet such as appearance of disorganization debri of cellular organelle in intercellular space. Our results indicate that sambutoxin inhibitis rabbit platelet aggregation, and it may be party due to the decrease of ATP release. However, it is not clear whether the antiaggregating effect of sambutoxin is related to $Ca^{2+}$ increase.

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Studies on Intestinal Trematodes in Korea VIII. A Human Case of Echinostoma hortense Infection (한국의 장흡충에 관한 연구 Vlll. 호르텐스 극구흡충(Echinostomu hoytense)의 인체감염 1예)

  • 서병고;홍성태채종일이순형
    • Parasites, Hosts and Diseases
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    • v.21 no.2
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    • pp.219-223
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    • 1983
  • Echinostomatid eggs were found from a 21year old man, whose native village is Munkyong-gun, Kyongsangnam-do during fecal examination in October 1983. The eggs were detected again one week later concommitantly with the eggs of Clonorchis sinensis. He had no subjective symptoms related with these fluke infections. He was treated with praziquantel ($Distocide^{\circledR}$) 20 mg/kg in single dose and purgated with magnesium salt. One echinostomatid fluke and 4 adults of C. sinensis were collected from the diarrheal stools. After morphological observation, the echinostomatid fluke was identified as Echinostoma hortense Asada, 1926. This is the first record on human E. hortense infection in Korea.

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Treatment of primary cutaneous anaplastic large cell lymphoma

  • Baik, Bong Soo;Lee, Wu Seop;Ji, So Young;Park, Ki Sung;Yang, Wan Suk;Kim, Sun Young
    • Archives of Craniofacial Surgery
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    • v.20 no.3
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    • pp.207-211
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    • 2019
  • Primary cutaneous anaplastic large cell lymphoma (C-ALCL) is a rare subtype of primary cutaneous lymphoma with a favorable prognosis. Primary cutaneous CD30+ lymphoproliferative disorders, which include C-ALCL and lymphomatoid papulosis, are the second most common group of cutaneous T-cell lymphomas. C-ALCL is comprised of large cells with anaplastic, pleomorphic, or immunoblastic cytomorphology, and indeed, more than 75% of the tumor cells express the CD30 antigen. C-ALCL clinically presents with solitary or localized reddish-brown nodules or tumors, and sometimes indurated papules, and they may be with ulceration covering with dark eschar. Multifocal lesions are seen in 20% of the patients. Extracutaneous dissemination, which mainly involves the regional lymph nodes, occurs in 10% of patients. A 69-year-old man noticed a mild elevated cutaneous lesion containing central ulceration covering with brownish black necrotic tissue on the right lower lip, and the lesion was surgically removed. After the first operation, another skin lesion was developed and the histological examination confirmed the diagnosis, C-ALCL. Eight specimens were excised during the 7-month follow-up period. The patient started the treatment with low-dose oral methotrexate (15 mg/wk) and there was no recurrence for 11 months.

A Review of Personal Radiation Dose per Radiological Technologists Working at General Hospitals (전국 종합병원 방사선사의 개인피폭선량에 대한 고찰)

  • Jung, Hong-Ryang;Lim, Cheong-Hwan;Lee, Man-Koo
    • Journal of radiological science and technology
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    • v.28 no.2
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    • pp.137-144
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    • 2005
  • To find the personal radiation dose of radiological technologists, a survey was conducted to 623 radiological technologists who had been working at 44 general hospitals in Korea's 16 cities and provinces from 1998 to 2002. A total of 2,624 cases about personal radiological dose that were collected were analyzed by region, year and hospital, the results of which look as follows : 1. The average radiation dose per capita by region and year for the 5 years was 1.61 mSv. By region, Daegu showed the highest amount 4.74 mSv, followed by Gangwon 4.65 mSv and Gyeonggi 2.15 mSv. The lowest amount was recorded in Chungbuk 0.91 mSv, Jeju 0.94 mSv and Busan 0.97 mSv in order. By year, 2000 appeared to be the year showing the highest amount of radiation dose 1.80 mSv, followed by 2002 1.77 mSv, 1999 1.55 mSv, 2001 1.50 mSv and 1998 1.36 mSv. 2. In 1998, Gangwon featured the highest amount of radiological dose per capita 3.28 mSv, followed by Gwangju 2.51 mSv and Daejeon 2.25 mSv, while Jeju 0.86mSv and Chungbuk 0.85 mSv belonged to the area where the radiation dose remained less than 1.0 mSv In 1999, Gangwon also topped the list with 5.67 mSv, followed by Daegu with 4.35 mSv and Gyeonggi with 2.48 mSv. In the same year, the radiation dose was kept below 1.0 mSv. in Ulsan 0.98 mSv, Gyeongbuk 0.95 mSv and Jeju 0.91 mSv. 3. In 2000, Gangwon was again at the top of the list with 5.73 mSv. Ulsan turned out to have less than 1.0 mSv of radiation dose in the years 1998 and 1999 consecutively, whereas the amount increased relatively high to 5.20 mSv. Chungbuk remained below the level of 1.0 mSv with 0.79 mSv. 4. In 2001, Daegu recorded the highest amount of radiation dose among those ever analyzed for 5 years with 9.05 mSv, followed by Gangwon with 4.01 mSv. The area with less than 1.0 mSv included Gyeongbuk 0.99 mSv and Jeonbuk 0.92 mSv. In 2002, Gangwon also led the list with 4.65 mSv while Incheon 0.88 mSv, Jeonbuk 0.96 mSv and Jeju 0.68 mSv belonged to the regions with less than 1.0 mSv of radiation dose. 5. By hospital, KMH in Daegu showed the record high amount of average radiation dose during the period of 5 years 6.82 mSv, followed by GAH 5.88 mSv in Gangwon and CAH 3.66 mSv in Seoul. YSH in Jeonnam 0.36 mSv comes first in the order of the hospitals with least amount of radiation dose, followed by GNH in Gyeongnam 0.39 mSv and DKH in Chungnam 0.51 mSv. There is a limit to the present study in that a focus is laid on the radiological technologists who are working at the 3rd referral hospitals which are regarded to be stable in terms of working conditions while radiological technologists who are working at small-sized hospitals are excluded from the survey. Besides, there are also cases in which hospitals with less than 5 years since establishment are included in the survey and the radiological technologists who have worked for less than 5 years at a hospital are also put to survey. We can't exclude the possibility, either, of assumption that the difference of personal average radiological dose by region, hospital and year might be ascribed to the different working conditions and facilities by medical institutions. It seems therefore desirable to develop standardized instruments to measure working environment objectively and to invent device to compare and analyze them by region and hospital more accurately in the future.

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Dose dependent effects of Jungsongouhyul Pharmacopuncture on Low Back Pain (요통환자에서 중성어혈 약침 사용 용량에 따른 효과)

  • Jeong, Man-Jin;Kwon, O-Gon;Woo, Chang-Hoon;An, Hee-Duk
    • Journal of Pharmacopuncture
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    • v.14 no.2
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    • pp.45-52
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    • 2011
  • Objectives : The object of this study is to analyse about Low Back Pain's intensity according to dosage of Jungsongouhyul pharmacopuncture. Method : Three groups were made with 15 patients in Po-Hang Oriental Hospital, which is affiliates to Daegu Haany University. They were observed August 1st, 2010 to September 30th. 2010. Each group was treated by based on acupuncture, herb and other therapy and differential dosage of Jungsongouhyul pharmacopuncture 0,4, 0.8, and 1.2cc. We had measured pain threshold and Visual Analog Scale during first week of their admission. The statistical analysis was performed by using the oneway ANOVA and Tukey's test. Result : Change of VAS was not statistically significant. Change of pain threshold was statistically significant. Multiple comparisons of pain threshold between the group1,2 was not statistically significant. Multiple comparisons of pain threshold between the group1,3 and group2,3 was statistically significant. Conclusions : Jungsongouhyul Pharmacopuncture 1.2cc was more effective than 0.4 and 0.8cc.

Status Epilepticus Caused by Nefopam

  • Park, Yong-Sook;Kim, Young-Baeg;Kim, Jeong-Min
    • Journal of Korean Neurosurgical Society
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    • v.56 no.5
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    • pp.448-450
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    • 2014
  • Nefopam, a centrally acting analgesic, has been used to control postoperative pain. Reported adverse effects are anticholinergic, cardiovascular or neuropsychiatric. Neurologic adverse reactions to nefopam are confusion, hallucinations, delirium and convulsions. There are several reports about fatal convulsive seizures, presumably related to nefopam. A 71-year-old man was admitted for surgery for a lumbar spinal stenosis. He was administered intravenous analgesics : ketorolac, tramadol, orphenadrine citrate and nefopam HCl. His back pain was so severe that he hardly slept for several days; he even needed morphine and pethidine. At 4 days of administration of intravenous analgesics, the patient suddenly started generalized tonic-clonic seizures for 15 seconds, and subsequently, status epilepticus; these were not responsive to phenytoin and midazolam. After 3 days of barbiturate coma therapy the seizures were controlled. Convulsive seizures related to nefopam appear as focal, generalized, myoclonic types, or status epilepticus, and are not dose-related manifestations. In our case, the possibility of convulsions caused by other drugs or the misuse of drugs was considered. However, we first identified the introduced drugs and excluded the possibility of an accidental misuse of other drugs. Physicians should be aware of the possible occurrence of unpredictable and serious convulsions when using nefopam.

A review of Gymnophalloides seoi (Digenea: Gymnophallidae) and human infections in the Republic of Korea

  • Lee, Soon-Hyung;Chai, Jong-Yil
    • Parasites, Hosts and Diseases
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    • v.39 no.2
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    • pp.85-118
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    • 2001
  • Studies on Gymnophalloides seoi (Digenea: Gymnophallidae) and human infections are briefly reviewed. This minute intestinal fluke was first discovered from a Korean woman suffering from acute pancreatitis and gastrointestinal troubles. It was described as a new species by Lee, Chai and Hong in 1993. The southwestern coastal village where the patient resided was found to be a highly endemic area, and additional endemic areas have been identified. The parasite is very small, 0.33-0.50 mm long and 0.23-0.33 mm wide. and characterized by the presence of a ventral pit. The first intermediate host remains unknown, but the second intermediate host has been found to be the oyster Crassostrea gigas. Man and the Palearctic oystercatcher Haematopus ostralegus have been shown to be natural definitive hosts , and wading birds including the Dentish plover Charadrius alexandrinus are highly susceptible to experimental infection. Gerbils, hamsters, cats, and several strains of mice were also susceptible laboratory hosts. In experimentally infected mice, the parasites inhabit the small intestine, pinching and sucking the root of villi with their large oral suckers, but they did not invade beyond the mucosa in immunocompetent mice. However, they were found to invade the submucosa in immunosuppressed mice. Human G. seoi infections have been found in at least 25 localities; 23 islands on the Yellow Sea or the South Sea, and 2 western coastal villages. The highest Prevalence was found in a village on Aphaedo. Shinan-fun (49% e99 Positive rate) : other areas showed 0.8-25.3% prevalence. Infected people complained of variable degrees of gastrointestinal troubles and indigestion. The infection can be diagnosed by recovery of eggs in the feces; however, an expert is needed to identify the eggs. Praziquantel, 10mg/kg in single dose, is effective for treatment of human infections. Eating raw oysters in endemic areas should be avoided.

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A Study on Self-medication Beharior of Four Cautious Drugs. (특정의약품의 자가투약행위에 관한 연구)

  • 황미숙
    • Korean Journal of Health Education and Promotion
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    • v.4 no.2
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    • pp.46-70
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    • 1987
  • The survey with questionnaire were conducted to grasp the actual condition of four cautious drugs-antibiotics, sedative hypnctics, mincr tranquilizer, analeptics-self -medication behavior through drugstore use and to analyze the primary factors connected with it. The following six objectives were established. 1) To catch the reason why the man who medicate himself buy four cautious drugs at a drugstore, and to know the choice motive of each drug purchased. 2) To grasp the distribution of four cautious drug taken by the man who medicate himself and to analyse the reason of taking the drug. 3) To find out whether the buyer has taken the same drug past and to know the duration and the frequency. 4) To grasp the degree of recognition about four cautious drugs and the attitude toward continuous taking them. 5) To analyze the degree of recognition about the influence on human body and the attitude of medication behavior. 6) To know "the experience of side-effects" and to grasp the kind of the side-effects. The data were collected from 15 drugstores with 677 respondents in seoul from August 17 to september 21, 1987. The following results were obtained. 1) The reasons for drugstore use were first, "for easy access and convenience" (53.7%) second, "for the slightness of illness" (19.9%) third "for the cheap price" (13.2%). According to that result, the factor of "the easy access of drugstore" was most influential. In case of the poor, the factor "for the cheap price "was revealed second (37.3%). And "for the slightness of illness" was second reason in the medically insured (22. 9%), "for the cheap price" was second reason in the others (29%). 2) The kind of drugs purchased were antibiotics (62.8%), analeptics(17.2%), minor tranquilizer(13.3%) and sedative hypnotics (6.7%) on the whole. In teenagers, besides antibiotics the percentage of taking analepits came second (42.4%) and it was revealed that the percentage of sedative hypnotics, minor tranquilizer increase with age. But in proportion to the increase of age, the taking of analeptis decreased. 3) The choice motives of each drug purchased were all different. In case of antibiotics "recommendation of pharmacist" was 39.6%, sedative hypnotics "recommendation of pharmacist" and "my own judgement", 28.9%, respectively, minor tranquilizer "my own judgement", 35.2%. and in case of analeptics "my oun judgement" was most common with 53.5%. 4) The reasons for taking drugs were as follows. antibiotics was taken for the inflammation mitigation of a wound and a swelling (38.5%), sedative hypnotics for the removal of insomnia (97.5%), minor tranquilizer because of restlessness and qloominess(39.3%), and analeptics for the shortening of sleeping hours (35.1%). 5) Those experienced in taking four cautious drugs were 78.2% on the average. It was revealed that antibiotics use duration was "from one week to one month" (38.9%), the frequency was "rarely" (62.1%), sedative hypnotics and minor tranquilizer; "More than three years", (35.7%, 30.4%), respectively, "Somtimes", (43.8%, 35%), respectively. analeptics ; "from one year to three years", (27.6%), "Sometimes", (42.7%). 6) In regard to the source of information in taking drugs, 35.3 percent of male were relied on "recommendation of pharmacist", 32.6 percent of female "my own judgement", There was a difference between below the middle school graduates and over the high school graduates Thease were relied on "recommendation of pharmacist" first, those "my own judgement" first. And "my own judgement" was the first source of specialist(40%), labours(41.4%), salesman(43.5%), and jobless men(36.8%), "recommendation of ralatives on friends" was the first source of students (30.4%), "recommendation of pharmacist" was the first soure of teachers, administrative office workers (39%) and housewives (40.7%). 7) The degree of recognition about four cautious drugs was as follows. "know a little" was (43.0%), "don't know" (30.2%), "know" (26.8%), respectively. In regard to the attitude toward continuous taking them, it was revealed that "I will take it according to circumstamces" was first (56.2%), " I will not take it as possible" was first(56.2%), "I dont know well" (12.9%), "I will take it continuously" (8.3%). 8) About the influence on human body, "if proper, it is effect" was common attitude toward antibiotics (43.6%), "Probably bad influence on the health" was first toward the other drugs (46.2%), In terms of the degree of observance to taking-time and dose of drugs, "suitably" was first (37.3%), "relatively correctly" second (27%), "correctly" (17%). 9) The percentage of four cautious drugs side-effects was 27.5 on the average. The kind of side-effects were eruption and urticaria (28.5%), heart acceleration and so forth. (25.4%), headache and Giddiness, dyspepsia (23%), respectively.

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A Case of Delayed Severe Hypersensitivity Reaction during $Genexol-PM^{(R)}$ Infusion (Genexol-$PM^{(R)}$ 항암치료 중 발생한 지연성 중증 과민성반응 1예)

  • Kim, Hyun-Kyung;Kim, Su-Woo;Kang, Hye-Won;Kwon, Kyoung-Joo;Park, Hye-Sung;Ryu, Yon-Ju;Lee, Jin-Hwa;Chun, Eun-Mi;Cho, Young-Joo;Chang, Jung-Hyun
    • Tuberculosis and Respiratory Diseases
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    • v.68 no.5
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    • pp.294-297
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    • 2010
  • Although $Taxo^{(R)}$ is one of the most successful drugs in current cancer chemotherapy against solid tumors, a major problem is hypersensitivity reactions that arises as a consequence of activation of the complement (C) system, "C activation-related pseudo-allergy". Most severe hypersenstivity reactions occur within the first few minutes of $Taxo^{(R)}$ administration, usually after the first or second dose. Here we report a case of a severe hypersensitivity reaction in a 72-year-old man undergoing $Genexol-PM^{(R)}$ infusion. Hypotension and polymorphic pruritic skin rash appeared 2 hours after the start of $Genexol-PM^{(R)}$ infusion (with an appropriate premedication). Treating with methylprednisolone, epinephrine and inotropic agents, reduced the hypotension and the skin rash disappeared. We report this case with a review of the literature.