• Title/Summary/Keyword: rhEGF

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The safety and efficacy of EGF-based cream for the prevention of radiotherapy-induced skin injury: results from a multicenter observational study

  • Kang, Hyun-Cheol;Ahn, Seung-Do;Choi, Doo-Ho;Kang, Min Kyu;Chung, Woong-Ki;Wu, Hong-Gyun
    • Radiation Oncology Journal
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    • v.32 no.3
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    • pp.156-162
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    • 2014
  • Purpose: This study was designed to evaluate the efficacy and safety of topically applied recombinant human epidermal growth factor (rhEGF) for the prevention of radiation-induced dermatitis in cancer patients. Materials and Methods: From December 2010 to April 2012, a total of 1,172 cancer patients who received radiotherapy (RT) of more than 50 Gy were prospectively enrolled and treated with EGF-based cream. An acute skin reaction classified according to the Radiation Therapy Oncology Group 6-point rating scale was the primary end point and we also assessed the occurrence of edema, dry skin, or pruritus. Results: The percentage of radiation dermatitis with maximum grade 0 and grade 1 was 19% and 58% at the time of 50 Gy, and it became 29% and 47% after completion of planned RT. This increment was observed only in breast cancer patients (from 18%/62% to 32%/49%). Adverse events related to the EGF-based cream developed in 49 patients (4%) with mild erythema the most common. Skin toxicity grade >2 was observed in 5% of the patients. Edema, dry skin, and pruritus grade ${\geq}3$ developed in 9%, 9%, and 1% of the patients, respectively. Conclusion: Prophylactic use of an EGF-based cream is effective in preventing radiation dermatitis with tolerable toxicity. Further studies comparing EGF cream with other topical agents may be necessary.

A Phase II, double-blinded, randomized, multicenter clinical trial for evaluation of efficacy and safety of rhEGF in patients with diabetic foot ulcer (제 2 상, 이중맹검, 무작위배정, 다기관 공동임상시험의 결과 : 당뇨병성 족부궤양에 대한 표피 성장인자(Epidermal Growth Factor, EGF)의 치료 효과를 평가)

  • Choi Ji-Hyeon;Jung Kui-Oak;Sohn Ho-Young;Kim Young-Sul;Lee Hong-Gyu;Lee Kui-Up;Lee Hyun-Chul;Lee Byung-Doo;Park Byung-Joo
    • 대한예방의학회:학술대회논문집
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    • 2001.10a
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    • pp.305-307
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    • 2001
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Skin regeneration by spray of fibrin gel containing keratinocytes and epidermal growth factor

  • Gwak, So-Jung;Kim, Sang-Soo;Choi, Cha-Yong;Kim, Byung-Soo
    • 한국생물공학회:학술대회논문집
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    • 2003.10a
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    • pp.356-358
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    • 2003
  • The use of cultured epidermal sheet grafts for large full-thickness wound has been tempered by weak points such as long culture periods, difficulty in handling the fragile sheets, high costs and the detachment of the skin cells from the culture dishes by enzymatic digestion. To overcome the drawback of epidermal sheet grafts, we have developed a transplantation method to spray the cultured human keratinocytes with the mixtures of rhEGF and fibrin gel matrix to the full-thickness wounds on the dorsum of the athymic mice to regenerate epithelial layers. Wound biopsies were retrieved at 7, 14 and 21 days after transplantation and retrieved biopsies were analyzed by histology and immunohistochemistry. Transplanted keratinocytes and EGF-fibriin gel accelerated wound regeneration compared with control groups. The technique developed in this study overcomes the drawbacks of the current cultured epidermal sheet grafts and accelerates epidermal wound healing.

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Influence of Human Follicular Fluid and Gonadotropins in the Culture Medium on the In Vitro Maturation, Fertilization and Development of Human Immature Oocytes (배양액 내 인간 난포액 및 성선자극호르몬 첨가가 인간 미성숙 난자의 체외성숙, 수정 및 체외 배발달에 미치는 영향)

  • Kim, Eun-Kuk;Kim, Dong-Won;Jeong, Byung-Jun
    • Journal of Embryo Transfer
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    • v.24 no.3
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    • pp.145-150
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    • 2009
  • This study was conducted to examine the effects of human follicular fluid and gonadotropin (FSH+HCG+rhEGF) on in vitro maturation, fertilization and development of human immature oocytes. Cumulus-oocyte complexes (COCs) were collected following for in vitro fertilization and embryo transfer (IVF-ET) cycles of the patients. At the time of oocytes collection, oocytes were classified into MII, MI and GV in accordance with their appearance (MII: Fully mature oocyte at metaphase II of meiosis; MI: Nearly mature oocytes at metaphase I of meiosis; GV: Immature oocytes at prophase I of meiosis). After controlled ovarian stimulation using gonadotropin(FSH) and human chorionic gonadotropin (HCG) in 70 ICSI cycles, 158 MI to MII matured oocytes were intracytoplasmic sperm injection (ICSI) ${\sim}4$ h after in vitro culture and 553 MII oocytes were ICSI after denudation. The aspirated MI and GV oocytes were cultured in culture medium containing 10% (v/v) serum protein substitute (SPS), 10% (v/v) human follicular fluid (hFF) and 10% (v/v) serum protein substitute (SPS)+1 IU/ml FSH+10 IU/ml HCG+10 ng/ml recombinant human epidermal growth factor (rhEGF). The maturation rate of immature oocytes was similar among the three group. When maturation medium was supplemented with 10% SPS, 10% hFF or gonadotropins, the fertilization rate of in vitro matured oocytes was higher in 10% SPS (80.0%), but there was no statistical significance (78.2%; hFF, 76.9%; gonadotropin, p>0.05). The development rate of human embryos developed to $6{\sim}8$ cells were not significant difference in the medium containing SPS, hFF and gonadotropins (65.6%, 65.9% and 66.7%). The results of these study suggest that human follicular fluid and gonadotropins supplemented in the culture medium was not effected on the in vitro maturation, fertilization and development of human immature oocytes.

A Prospective Comparison of Fertilizability of in vitro Matured Human Oocytes Obtained from Stimulated Cycle: Conventional Versus ICSI (과배란유도 주기에서 얻어진 체외성숙 난자의 수정능: 고식적 체외수정시술과 세포질내정자주입법의 비교)

  • Jee, Byung-Chul;An, So-Jung;Moon, Jeong-Hee;Hwang, Eun-Ju;Suh, Chang-Suk;Kim, Seok-Hyun;Moon, Shin-Yong
    • Clinical and Experimental Reproductive Medicine
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    • v.36 no.4
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    • pp.249-254
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    • 2009
  • Objective: The aim of this study was to compare the fertilization and cleavage rates of human in vitro matured oocytes after fertilized by conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Methods: A total of 135 GV stage oocytes were obtained from 59 women who received ovarian stimulation and IVF during Jan 2007 to Oct 2008. Ovarian hyperstimulation was performed using hMG or recombinant FSH with GnRH antagonist and then ovulation triggered by recombinant hCG. The immature oocytes obtained from stimulation cycles were cultured in IVM medium up to 48 hrs; commercial medium supplemented with rFSH 75 mIU/mL, rhCG 0.5 IU/mL and rEGF 10 ng/mL. The in vitro matured oocytes were fertilized by conventional IVF (41 GV oocytes) or ICSI method (94 GV oocytes). Results: Maturation rate were 51.2% and 59.6% in conventional IVF group and ICSI group, respectively. There was no significant difference in fertilization rates between two groups; 71.4% and 80.4%, respectively. The cleavage rate was also similar in two groups. Conclusion: The presented data suggest that conventional IVF has comparable fertilization and cleavage potential compared with ICSI as the insemination method of immature human oocytes obtained from stimulated cycle.

A 13 Week Subcutaneous Toxicity Study of Recombinant Human Epidermal Growth Factor (DWP401) in Mice (Recombinant Human Epidermal Growth Factor (DWP401)의 마우스를 이용한 피하투여 아급성독성시험)

  • 송시환;강부현;신천철;김희연;강진석;심점순;한상섭;노정구
    • Biomolecules & Therapeutics
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    • v.4 no.2
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    • pp.138-147
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    • 1996
  • DWP401, a recombinant human epidermal growth factor, was subcutaneously administered to ICR mice at the dose levels of 0, 0.04, 0.2 and 1.0 mg/kg/day (15rats/sex/group) in order to evaluate the subchronic toxicity. General observations, examinations for food and water consumption, ophthalmoscopy and urinalysis were carried out during the study. For the complete gross and microscopic examinations, 10 mice/ sex/group were sacrificed at the ends of the dosing period, and the remaining animals were sacrificed with a 5 week recovery period. Examinations for hematology and blood biochemistry were also carried out at the time of recovery period. Based on the results, it was thought that the target tissue or organs were mesothelial cell, injection site, spleen, adrenal gland, ovary and transitional epithelial cell of urinary tract, and no observed toxic level of DWP401 was 0.04 mg/kg while definite toxic dose level might be 0.2 mg/kg.

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General Pharmacology of DWP 401, a Recombinant Human Epidermal Growth Factor (재조합 인간 상피세포 성장인자(DWP 401)의 일반약리작용)

  • 천선아;김상미;이은방;임승욱;유영효;박명환
    • YAKHAK HOEJI
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    • v.39 no.5
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    • pp.471-479
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    • 1995
  • The recombinant human epidermal growth factor(DWP 401) was investigated on the pharrnacological actions. DWP 401 had no effects on the hexobarbital-induced sleeping time, locomotor activity, rotarod test, body temperature, analgesic action and anticonvulsant action in mice. It also had no influences on the isolated tracheal muscle and ileum of guinea-pig, isolated uterus and fundus strip of rats. Slight hypotensive action with effect on respiration was revealed at a dose of 8 g/kg i.v. of DWP 401 in rabbits. DWP 401 exhibited a weak inhibitory action of glucose tolerance in normal rats, significantly lowered the blood glucose contents in adrenalectomized rats at .a concentration of 160 g,/kg, and produced a significant inhibitory effect on leucocyte migration in CMC-pouch of rats at a concentration of 32 g/rat. Furthermore, DWP 401 showed a significant decrease on gastric juice volume and acidity. However. DWP 401 had no intestinal propulsion rate and influence on urine excretion.

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Pharmacokinetics of Recombinant Human Epidermal Growth Factor (DWP401) after Repeated Subcutaneous Administration to Rats (흰쥐에 재조합 인간 상피세포 성장인자(DWP401)를 연용피하투여했을 때 약물체내동태)

  • Nam, Gwon-Ho;Jo, Jae-Yeol;Jeong, Ju-Yeong;Jang, U-Ik;Gang, Jin-Seok;Yu, Eun-Suk;Park, Seung-Guk;Yu, Yeong-Hyo;Park, Myeong-Hwan;Sim, Chang-Gu
    • YAKHAK HOEJI
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    • v.40 no.5
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    • pp.491-500
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    • 1996
  • The organ distribution and pharmacokinetics of DWP401, a recombinant human epidermal growth factor (rhEGF), were compared after single and repeated subcutaneous administration ( 50${\mu}$/kg, 10${\mu}g$Ci/kg of $^{125}I$-DWP401, twice a day for 7 consecutive days) to rats. The pharmacokinetic parameters such as AUC and terminal half-life were similar between two different administration. During repeated administration, the plasma concentration of DWP401 seemed to be constant when the plasma was collected at 15 min after each dosing. The TCA-precipitated radioactivities in thyroid, liver, kidney, and stomach were higher than those of other organs studied after both single and repeated administration. The TCA-precipitated radioactivities after repeated administration in several organs, such as thyroid, stomach, prostate, adrenal, eye ball, and testis were higher than those after single administration. But, according to the observations using gel filtration chromatography and antibody binding assay, the radioactivities in thyroid and stomach were not primarily due to the intact DWP401 or its metabolites but due to the $^{125}I$-thyroxine binding protein. In conclusion, it can be suggested that DWP401 is metabolized to each amino acid or small polypeptides, and there was no significant changes in pharmacokinetics or any indications for accumulation of DWP401 in rat plasma and organs after repeated treatment.

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Effect of Chlorella Growth Factor on the Proliferation of Human Skin Keratinocyte

  • Yong-Ho Kim;Yoo-Kyeong Hwang;Yu-Yon Kim;Su-Mi Ko;Jung-Min Hwang;Yong-Woo Lee
    • Biomedical Science Letters
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    • v.8 no.4
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    • pp.229-234
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    • 2002
  • Chlorella is rich in chlorella growth factor (CGF). A review of the literature has described that CGF improves the capability of a Th1-based immunity, anticancer, antioxidant antibacterial activity, growth promotion, wound healing and so on, but has not studied the effect for the metabolism and the proliferation of human skin keratinocyte. The aim of this study was to examine the effect of metabolism and the proliferation of human skin keratinocyte in vitro. CGF was extracted with an autoclaving method which is a modified hot-water extraction method from dried chlorella and conformed by means of absorbance 0.22 at 260 nm. We have measured the extracellular acidification rate (ECAR) of the CGF by Cytosensor$^{\circledR}$ Microphysiometer and evaluated responsiveness depending upon the dosage on the HaCaT cell. The ECAR for the concentrations of 0.15, 1.5, 15, 150 $\mu\textrm{g}$/ml of CGF increased as a 103.6, 128.2, 149.0 and 423.9%, respectively compared to control (0.0 $\mu\textrm{g}$/ml, 100% ECAR). The ECAR for ErbBl tyrosine kinase inhibited by 4-anilinoquinazolines, $C_{16}$H$_{14}$BrN$_3$O$_2$.HCl on tile HaCaT cells with the amounts of 10 $\mu\textrm{g}$/ml of the CCF compared with 100 $\mu\textrm{g}$/ml of rhEGF. The conclusion of the study is that CGF might increase human epidermal keratinocyte proliferation through the interaction between the epidermal growth factor receptor and itself.

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