部份中文曲弗明基因重组处方资料（仅供参考）
商品名：Fiblast Spray
英文名: Trafermin
中文名: 曲弗明基因重组喷雾剂
生产商: 科研制药
药品简介
Fiblast Spray（Trafermin 曲弗明）喷雾剂是重组形式的人成纤维细胞生长因子，用于治疗压力性溃疡以及包括烧伤性溃疡和黑色溃疡的其他皮肤溃疡。
在六周时间内对罹患慢性糖尿病性神经性溃疡患者每日施用曲弗明或安慰剂后，通过每周临床检查和计算机化照片评估足部溃疡大小。溃疡周长和面积的每周减少，以及从进入第六周治疗的线性进展速率在两组中是相同的。
フィブラストスプレー250/フィブラストスプレー500
药效分类名称
压疮/皮肤溃疡的治疗
批准日期：2001年6月
FIBLAST Spray 250
FIBLAST Spray 500
一般名
Trafermin（genetical recombination）
（トラフェルミン（遺伝子組換え））
本質
ヒト由来の塩基性線維芽細胞成長因子ゲノム遺伝子の発現により組換え体で産生される154個（C764H1201N217O219S6；分子量：17,122.42）及び153個（C761H1196N216O218S6；分子量：17,051.35）のアミノ酸残基からなるたん白質（N末端；Ala-Ala：65％以上、Ala：35％以下）
药效药理
1.在病理模型中促进伤口愈合的作用
在以下伤口愈合延迟的病理模型中已观察到药理作用。
（1）促进遗传性糖尿病小鼠和遗传性肥胖小鼠的全层皮肤缺损伤口的愈合（减少面积的作用或缩短完全愈合天数）。
（2）恢复了肝损伤大鼠全层皮肤切口皮肤撕裂张力的降低。
（3）促进遗传性糖尿病小鼠和营养不良大鼠的三度烧伤创面愈合（缩短完全愈合天数）。
（4）促进遗传性糖尿病小鼠中细菌感染的皮肤全层伤口的愈合（减少面积的作用）。
（5）促进遗传性糖尿病小鼠中压疮的愈合（增加完全治愈的病例数）。
2.血管生成作用
它与血管内皮细胞（ACE细胞）的FGF（成纤维细胞生长因子）受体特异性结合，具有细胞增殖促进作用，细胞迁移促进作用，纤溶酶原激活物产生促进作用和管腔形成作用。 。此外，在健康小鼠和遗传性糖尿病小鼠的全层皮肤缺损伤口中，通过使用兔角膜的微口袋法，健康大鼠的纸盘法和血红蛋白水平测量法已观察到血管生成作用。体内）。
3.造粒促进作用
它与成纤维细胞（BHK-21细胞）的FGF受体特异性结合，并已显示出可促进细胞增殖（体外）。另外，在健康小鼠和遗传性糖尿病小鼠中，通过纸盘法和棉丸法在健康大鼠和伤口愈合受损（类固醇治疗，阿霉素给药，X射线照射）的大鼠中观察到成粒促进作用。还发现通过纸盘法（体内）对造粒具有显着的促进作用。
4.其他影响
遗传性糖尿病小鼠增加了全层皮肤缺损伤口渗出液的数量和炎性细胞的数量。
5.作用机制
该药物与血管内皮细胞，成纤维细胞等中存在的FGF受体特异性结合，并通过显示血管生成和促进颗粒形成的作用，对压力性溃疡和皮肤溃疡表现出治疗作用。
适应症
褥疮、皮肤溃疡（热伤溃疡、下腿溃疡）
用法与用量
使用时每1 mL附着的溶液溶解100μgtrafermin（基因重组），擦拭溃疡表面，然后如果溃疡的最大直径在6cm以内，则每天使用一次专用于该药物的喷雾器，在距溃疡表面约5 cm处进行5次喷雾（30μgtrafermin（基因重组）。如果溃疡的最大直径超过6厘米，则在距溃疡表面约5厘米的距离处重复相同的操作，以便将药物喷洒在同一溃疡表面上5次。
包装
喷雾剂
250微克：（冻干产品/附着溶液）x 1，5
500 微克：（冻干产品/附着溶液）x 1，5
科研製薬株式会社
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/2699710R1028_1_09
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FIBLAST Spray（Trafermin(genetical recombination)）
FIBLAST Spray 250（フィブラストスプレー250）
Brand name : FIBLAST Spray 250
　Active ingredient: Trafermin(genetical recombination)
　Dosage form: liquid
　Print on wrapping: フィブラストスプレー250μg
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Effects of this medicine
This medicine binds specifically to FGF (fibroblast growth factor) receptor in vascular endothelial cell or fibroblast cell that plays an important role in process to heal wounds. It shows vascularization or granulation to prompt pressure ulcer or skin ulcer healing.
It is usually used to treat pressure ulcer (bedsore) and skin ulcer.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have malignant tumor at the applied site.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, apply the following dose at a time, once a day, about 5cm apart from the affected area using a special device. If the maximum diameter of the ulcer (wound) is less than 6cm, apply 5 sprays (30 mcg of the active ingredient). If the maximum diameter of the ulcer is more than 6cm, apply 5 sprays to the same site of ulcer and repeat the application. Strictly follow the instructions.
•Apply this medicine after sterilizing or cleaning up the affected area.
•If you miss a dose, apply a dose as soon as possible when you noticed. You should not apply two doses at one time.
•If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop using this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include stimulating feeling/pain on sprayed site, redness, itch and increase of effusion. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
No pertinent entries.
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Store at 10℃ or below in a cold dark place such as refrigerator in a storage bag with put the lucent cap on. Store away from freezing. Do not use any medicine that has stored for more than 2 weeks after opening for the stability.
•Discard the remainder. Do not store them.
Kaken Pharmacetical Co.,LtdExternal
Revised: 7/2007
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.