This study was conducted to evaluate the safety of a recombinant human Factor VIII(GC-$\gamma$ AHF) manufactured by Korea Green Cross Company with different technology according to the Regulation of Korean Food and Drug Administration (l 998. 12. 3). In acute toxicity test, both genders of Sprague-Dawley rats and Beagle dogs were administered intravenously with GC-$\gamma$ AHF of three doses (3,125, 625 and 125 IU/kg), and single dose of 3,125 IU/kg, respectively. No dead animal and abnormal autopsy findings were found in Control and GC-$\gamma$ AHF treated group. Therefore, the 50% lethal dose ($LD_{50}$) of GC-$\gamma$ AHF was conidered to be higher than 3,125 IU/kg in rats and dogs. In the four weeks repeated intravenous toxicity study, GC-$\gamma$ AHF was administrated intravenosly to both genders of rats and dogs with 3 doses (500, 150, 50 IU/kg). There were neither dead animals nor significant changes of body weights during the experimental Period. In addition, no significant GC-$\gamma$ AHF related changes were found in clinical sign, urinalysis and other finding. Statistically changes were observed in hematological, biochemical and organ weight parameters of treated groups: however these changes were not dose dependent. No histopathological lesion were observed in both control and treated animals. Above data suggest that no observed adverse effect level of test materials in rats and dogs might be over 500 IU/kg/day in this study. In ocular irritation test, any injury on iris, conjunctiva and cornea in rabbits were not observed. The acute ocular irritation index (A.O.I.), mean ocular irritation index (M.O.I.) and Day-7 individual ocular irritation Index (I.O.I.) of GC-$\gamma$ AHF were 0. In the primary skin Irritation test, the primary irritation index (P.I.I.) oj GC-$\gamma$ AHF were 0. Therefore, the GC-$\gamma$ AHF is considered not to have the primary skin and eye toxicity in rabbits. In active systemic anaphylaxis (ASA) test, GC-$\gamma$ AHF and GC-$\gamma$ AHF emulsified with Freund's complete adjuvant (FCA) did not induce any symptom of anaphylactic shock in guinea pigs. In passive cutaneous anaphylxis (PCA) test, after sensitization with antisera of GC-$\gamma$ AHF sensitized mice, blue spots were observed on the hypodermis of back of rats, but diameter of each spot was smaller than 5 mm in each test groups except the positive control group. Based on the results of this study, GC-$\gamma$ AHF is not conidered to have any antigenic potential. In conclusion, at levels of up to 500 IU/kg, GC-$\gamma$ AHF did not produce treatment-related toxicity under the conditions of these acute-, four week repeated-toxicity, primary skin and eye toxicity, and antigenicity test.
Park, Hyeong-Jun;Chae, Jean;Lee, Jin-Soo;Jung, Hyun-Sik;Lee, Sang-Hun;Choi, Won-Cheol;Kim, Kyung-Suk
Journal of Korean Traditional Oncology
/
v.16
no.1
/
pp.55-61
/
2011
Objectives : Epidermal growth factor receptor-inhibitors have demonstrated improved overall survival in patients with non-small cell lung cancer, but their use is associated with dermatologic adverse reactions that often require symptomatic treatment. Methods : A 44-year-old woman, who started the chemotherapy of Iressa$^{(R)}$ on August 2010, developed cutaneous symptoms such as papulopustular rash, dry skin, and pruritus on her face and scalp after taking Iressa$^{(R)}$ for four weeks. The patient visited our clinic with such symptoms on March 2011 and underwent herebal remedy targeted to alleviate the skin reactions. The severity of dermatologic symptoms was evaluated with the numeric rating scale and the Common Terminology Criteria for Adverse Events version 4.0. Results : Noticeable changes on the skin lesion were observed after the two months of treatment, without any dose modification of the Iressa$^{(R)}$. The cutaneous symptoms as papulopustular rash, dry skin and pruritus were improved and there was no adverse event induced by the treatment with herbal medicine. Conclusions : This case report suggests that the treatment with a herbal medicine, Samultang-gagambang be considered as a useful treatment to relieve EGFR-inhibitor induced dermatologic adverse reactions.
Journal of Physiology & Pathology in Korean Medicine
/
v.30
no.2
/
pp.109-115
/
2016
Hataedock is a Korean medical treatment that administers herbal extracts orally to newborn infants. This method is used for alleviating harmful heat and excreting fetal wastes by meconium. The purpose of this study was to evaluate anti-inflammatory effect of Hataedock method with Douchi on 2,4-dinitrofluorobenzene (DNFB)-induced atopic dermatitis (AD). The 3-week-old NC/Nga mice were divided into 3 groups: the control group (Ctrl), the AD-induced group (AE), and the Hataedock-treated group (GT). Only the GT group was treated with Hataedock at the 3rd week. After 28 days from Hataedock treatment, we induced AD-like dermatitis to the AE and GT group by DNFB. The effects of Hataedock were evaluated by immunohistochemical method. In the epithelium, PKC-positive reaction of the GT group was decreased by 57%. In the dermal papillae, IL-4-positive reaction was decreased by 34%. In the dermis, the distribution of degranulated mast cells was decreased and substance P-positive reaction was decreased by 49%. In the skin tissue, edema was decreased and MMP-9-positive reaction was decreased by 71%. Tissue damage such as epithelial cell hyperplasia, infiltration of granulocyte and lymphocyte, and capillary distribution were also decreased. The Hataedock method with Douchi maintained skin barrier and inhibited skin-damaging factors via regulating Th2 differentiation. In conclusion, Hataedock has a potential for preventative treatment of AD. Further studies are necessary to investigate the immune-regulating mechanism and verify the safety and efficacy of the Hataedock method.
Journal of Physiology & Pathology in Korean Medicine
/
v.24
no.2
/
pp.290-295
/
2010
Gamigunggui-tang (GMGGT) is one of the important prescriptions that has been used in oriental medicine. We investigated the inhibitory effect of an oral administration of hot water extract of GMGGT on the development of atopic dermatitis (AD) by using Balb/c mice. The induction of atopic dermatitis-like lesion was conducted by the removal of the back hairs and topical application of 2,4-Dinitrochlorobenzene (DNCB) on to the back skin repeatedly. GMGGT was orally administered at a different dose (10.0 mg/kg, 50.0 mg/kg). Skin reactions, consisting of increased ear thickness and the presence of ear inflammation, were observed in mice over three weeks. Oral administration of GMGGT significantly suppressed the skin lesions, ear swelling, spleen weight, total serum IgE in a concentration dependent manner, and also inhibited the infiltration of mast cells in the dorsal skin. In the present study, these results suggested that GMGGT extract inhibits inflammatory response atopic dermatitis. Therefore, GMGGT may be effective substances for the management of AD in human.
Background : Central poststroke pain(CPSP) can occur as a result of lesion or dysfunction of the brain from stroke and may cause many difficulty in the social activities and daily life. In this study, we evaluate the clinical effectiveness of east-west medical management for CPSP through VAS(visual analogue scale), infrared themography, MBI(Moderfied Barthel Index) and Rankin scale. Methods : We treated thirty patients with oriental medical treatment method and western & oriental medical treatment method. Each group has fifteen patients of the CPSP. We evaluated their pain(characterizes tingling and burning sensation, aching, hyperalgesia, and allodynia) through VAS(visual analog scale) pain score, the skin temperature of pain site by infrared thermography and assessed their mobility & rehabilitation ability through MBI(Moderfied Barthel Index), Rankin scale before and after pain treatment. Results : The skin temperature of pain site was lower than non-pain site. The difference of skin temperature improved from $0.65{\pm}0.45^{\circ}C$ to $0.39{\pm}0.25^{\circ}C$ after oriental medical treatment and $0.68{\pm}0.54^{\circ}C$ to $0.27{\pm}0.24^{\circ}C$ after western & oriental medical treatment VAS scores improved from $7.9{\pm}1.4$ to $4.7{\pm}1.6$ after oriental medical treatment and $8.1{\pm}1.3$ to $4.6{\pm}1.2$ after western & oriental medical treatment. MBI scores improved from $61.40{\pm}13.58$ to $85.00{\pm}13.85$ after oriental medical treatment and $52.26{\pm}13.52$ to $77.13{\pm}12.04$ after western & oriental medical treatment. And Rankin scale scores improved from $3.33{\pm}0.72$ to $2.46{\pm}0.74$ after oriental medical treatment and $3.60{\pm}0.82$ to $2.66{\pm}0.81$ after western & oriental medical treatment Conclusion : The difference of skin temperature and Rankin scale scores more significantly improved after western & oriental medical treatment than oriental medical treatment. According to the results, we thought east-west medical management is very useful treatment for CPSP and rehabilitation of the patients with stroke.
Choi, Soo Jong;Bae, Yong Chan;Moon, Jae Sul;Nam, Su Bong;Oh, Chang Gun;Kwak, Hee Suk;Kim, Chang Won
Archives of Plastic Surgery
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v.34
no.5
/
pp.557-561
/
2007
Purpose: Malignant melanoma is a fatal tumor arising in the melanocytic systems of the skin. The incidence of malignant melanoma, formerly considered a rare tumor in Korea, is observed to increase. The aim of this study is to analyze the clinical and histopathological pattern of malignant melanoma in one institute. Methods: Thirty patients with ages ranging from 33 to 80 years, diagnosed as malignant melanoma at our skin tumor department, were enrolled in a retrospective study over a 6 year period(2000. 9-2006. 7). The analyzed data included age, sex, location, duration before diagnosis, clinical type, level of invasion, and stage. Results: The cases were identified and analyzed by clinical and histopathologic study. The male to female ratio was 1:1.7. Lower extremities(especially, feet) were favored sites. The majority of cases were acral lentiginous melanoma(40%), followed by nodular melanoma (36.7%), superficial spreading melanoma(20%) in this study. Clark level IV was predominant in histopathologic study. There was merely narrow gap among each stage by AJCC. Conclusion: The clinicopathological characteristic of melanoma in our patients is quite different with that in the West. In this retrospective study, primary lesions of the foot were predominant with melanoma, and a high percentage of these were classified pathologically as acral lentiginous melanomas. Patients had a more advanced stage of disease at first presentation and a more deeply invasive primary lesion than Western patients. These suggest that malignant melanoma has a worse prognosis in our patients than in the West. So, further organized prospective studies are needed to approach the prudent and accurate diagnosis and management of melanoma in Korea.
Cutaneous squamous cell carcinoma is the second-most common skin cancer and represents 20% of all skin cancers. Cutaneous squamous cell carcinoma often spreads to the parotid gland through lymph nodes, but, direct invasion of an adjacent organ may also occur. We present the case of 78-year-old man with ulcerated mass on the right infra-auricular area. The histopathologic finding was squamous cell carcinoma. There was no evidence of distant metastasis, but the mass was found to invade the superficial lobe of the right parotid gland. The mass was widely excised and superficial parotidectomy was performed while preserving the facial nerve. The defect was covered by primary closure. Postoperative radiotherapy was performed. At 20 months after surgery, our patient had no facial palsy, local recurrence, or metastasis. Cutaneous squamous cell carcinoma involving the parotid gland is an aggressive, rapidly advancing lesion, which if not recognized and treated early will result in high morbidity and mortality. Squamous cell carcinoma of the parotid gland has shown that patients who receive adjuvant radiotherapy have a lower recurrence rate and a higher survival rate than patients treated with surgery alone. The role of elective neck dissection remains controversial.
A 59-year-old male patient had 5-month history of gait disturbance and memory impairment. His initial brain computed tomography scan showed $3.5{\times}2.8cm$ sized mass with high density in the pineal region. The tumor was hypointense on T2 weighted magnetic resonance images and hyperintense on T1 weighted magnetic resonance images with heterogenous enhancement of central portion. The tumor was totally removed via the occipital transtentorial approach. Black mass was observed in the operation field, and after surgery, histopathological examination confirmed the diagnosis of malignant melanoma. Whole spine magnetic resonance images and whole body 18-fluoro-deoxyglucose positron emission tomography could not demonstrate the primary site of this melanoma. Scrupulous physical examination of his skin and mucosa was done and dark pigmented lesion on his left leg was found, but additional studies including magnetic resonance images and skin biopsy showed negative finding. As a result, final diagnosis of primary pineal malignant melanoma was made. He underwent treatment with the whole brain radiotherapy and extended local boost irradiation without chemotherapy. His preoperative symptoms were disappeared, and no other specific neurological deficits were founded. His follow-up image studies showed no recurrence or distant metastasis until 26 weeks after surgery. Primary pineal malignant melanomas are extremely rare intracranial tumors, and only 17 cases have been reported since 1899. The most recent case report showed favorable outcome by subtotal tumor resection followed by whole brain and extended local irradiation without chemotherapy. Our case is another result to prove that total tumor resection with radiotherapy can be the current optimal treatment for primary malignant melanoma in the pineal region.
Objective : The main purpose of this study was to evaluate the effect of Jasinwhalhyul-tang (Zishenhuoxue-tang, JWT) on MRL/MpJ-Ipr/Ipr mouse model with systemic lupus erythematosus. Methods: The effect of JWT on MRL/MpJ-Ipr/Ipr mice that have autoimmune disease similar to SLE in humans was evaluated after JWT per oral in the present study. Mice were administered with Jasinwhalhyul-tang (Zishenhuoxue-tang, JWT) (80 or 400mg/kg) or distilled water for control group from experimental week 10 for 22 weeks. Results : The amount of erythematosus skin lesion and proteinuria were significantly decreased. The size and weight of cervical lymph nodes and spleen were significantly reduced. The ratio between activated $CD3^+CD69^+$ T-cells and undifferentiated $CD3^+CD4^-CD8^-$ T-cells in lymph nodes, spleen and kidney was effectively reduced. The gene expression of TGF-$\beta$ in spleen and kidney was increased. The amount of anti-dsDNA IgG in blood was decreased. The gene expression of TGF-$\beta$ in normal mouse spleen cells was increased depending on concentration by treatment of with T cell stimulating agent. In the histological examination of skin and kidney, the amount of infiltration of immune cells involved in the inflammatory response was decreased. Conclusions : According to the above results, JWT should be considered as an applicable therapeutic agent to SLE in clinical practice. Further research is required to investigate other efficacies of JWT on SLE.
Roh, Sang Hoon;Sohn, Hyung Bin;Jung, Young Jin;Hong, In Pyo
Archives of Plastic Surgery
/
v.36
no.3
/
pp.361-364
/
2009
Purpose: Sebaceous carcinoma is a rare malignant tumor derived from the adnexal epithelium of sebaceous glands. This tumor usually occurs on the eyelids, but uncommonly it may occur on the extraocular sites. It is characterized by a tendency of local recurrence and occasional metastasis. Surgical excision is appropriate treatment for patients with sebaceous carcinoma. Because this kind of case is rare, we report two cases of sebaceous carcinoma developed on scalp. Methods: Case 1 was a 69 - year - old woman. She visited the hospital with a $1.5{\times}2.5cm$ sized reddish yellow - colored, slowly growing mass on left parietal scalp. The mass began at birth and started growing at 5 years ago. Case 2 was a 67 - year - old woman. She had $2.5{\times}3.0cm$ sized yellow - colored mass on right parietal scalp. It occured at birth and started growing at 3 years ago. And the masses had erythematous ulcer with sanguineous discharge. In the beginning, the masses were miliary nodule. Results: CT scan and fine needle biopsy were done. Case 1 and 2 were diagnosed as sebaceous carcinoma. Wide excision with safety margin of 10 mm and split thickness skin graft was done. Histological examination revealed well demarcated, irregular, variable sized tumor lobules. Each lobule was composed of sebaceous and undifferentiated cells. Postoperatively, the patients did well and the lesion had not recurred. Conclusion: Sebaceous carcinoma is an aggressive malignant tumor. It often can be mistaken for other skin tumors. Authors experienced two rare cases of sebaceous carcinoma developed on scalp. We recommend early wide excision with enough safety margin as treatment of sebaceous carcinoma.
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