曲弗明(Trafermin) - 药物靶点：FGFRs_在研适应症：牙周炎，压疮，皮肤溃疡_专利_临床

概要

基本信息

药物类型

生长因子

别名

Fiblast Spray、REGROTH Dental Kit、RH-BFGF

+ [11]

靶点

FGFRs

作用机制

FGFRs刺激剂(成纤维细胞生长因子受体家族刺激剂)

治疗领域

口颌疾病皮肤和肌肉骨骼疾病

在研适应症

牙周炎压疮皮肤溃疡

非在研适应症

牙槽骨质丢失糖尿病足牙周附着丢失

原研机构

Kaken Pharmaceutical Co., Ltd.

在研机构

Kaken Pharmaceutical Co., Ltd.

非在研机构

Olympus Biotech Corp.

最高研发阶段批准上市

首次获批日期

日本 (2001-04-04),

压疮皮肤溃疡

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 507553

来源: *****

关联

12

项与曲弗明相关的临床试验

JPRN-jRCTs031220681 / Recruiting临床2期

Evaluation of therapeutic effect of intracordal bFGF administration on vocal fold paralysis

开始日期2023-06-01

申办/合作机构-

JPRN-jRCTs051190045 / CompletedN/A

The clinical study to evaluate the safety and efficacy of combination therapy of REGROTH and Cytrans Granules for periodontitis patients.

开始日期2019-08-27

申办/合作机构-

NCT02550314 / Completed临床3期IIT

A Phase III Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18-multicenter,Investigator Initiated Clinical Trial

To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.

开始日期2015-03-01

申办/合作机构-

100 项与曲弗明相关的临床结果

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100 项与曲弗明相关的转化医学

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100 项与曲弗明相关的专利（医药）

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1,169

项与曲弗明相关的文献（医药）

2024-04-15·Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery

[Therapeutic mechanism of basic fibroblast growth factor on spinal cord injury in rats based on the Notch/signal transducer and activator of transcription 3 signaling pathway].

Article

作者: Xu, Haitao ; Cao, Chunfeng ; Qu, Yiming ; Zhang, Hongjun ; Zhang, Minghua ; Shao, Gaohai ; Li, Bo

目的探讨bFGF对脊髓损伤（spinal cord injury，SCI）大鼠的治疗作用及Notch/STAT3信号通路的影响。.方法取10周龄雄性SD大鼠40只，采用自由落体打击法建立T ₁₀ 节段SCI模型，其中32只造模成功随机分为模型组、bFGF组，每组16只；另取16只SD大鼠仅暴露T ₁₀棘突、硬脊膜和脊髓，作为假手术组。造模后bFGF组腹腔注射100 μg/kg bFGF（1次/d，共28 d），模型组和假手术组大鼠同法注射生理盐水。造模后观察各组大鼠存活情况，于造模前及造模后即刻、14 d、28 d行BBB评分评估后肢功能。造模后28 d取损伤部位脊髓组织，行HE、Nissl和碘化丙啶（propidium iodide，PI）染色，观察脊髓组织病理变化、神经元存活（尼氏体数量）和凋亡（PI红染细胞数量）情况；免疫组织化学染色和ELISA法分别检测组织中星形胶质细胞活化标志物［胶质纤维酸性蛋白（glial fibrillary acidic protein，GFAP）］及炎症因子［IL-1β、TNF-α、干扰素γ（interferon γ，IFN-γ）］水平；Western blot检测组织Notch/STAT3信号通路相关蛋白［Notch、STAT3、磷酸化-STAT3（phosphoryl-STAT3，p-STAT3）、BMP-2］表达。.结果各组大鼠均存活至实验完成。造模后即刻，模型组及bFGF组BBB评分均较假手术组降低（ P<0.05）；14、28 d时模型组BBB评分较假手术组降低（ P<0.05），bFGF组较模型组升高（ P<0.05）。模型组、bFGF组与造模前比较，造模后即刻BBB评分降低，14 、28 d评分逐渐升高，各时间点间差异均有统计学意义（ P<0.05）。假手术组脊髓组织结构正常；模型组脊髓组织出现较多坏死灶，结构正常尼氏体较少；bFGF组脊髓组织坏死灶较模型组明显减少，可见部分结构正常尼氏体。与假手术组比较，模型组脊髓组织尼氏体数量减少，PI红染细胞数量增多，GFAP、IL-1β、TNF-α、IFN-γ以及Notch、p-STAT3/STAT3、BMP-2蛋白表达水平升高（ P<0.05）；而bFGF组上述指标均较模型组改善（ P<0.05）。.结论bFGF能改善SCI大鼠运动功能和脊髓组织病理损伤，有利于神经元存活，抑制神经元凋亡、脊髓组织星形胶质细胞过度活化及炎症反应，其作用机制可能与Notch/STAT3信号通路活性降低有关。.

2024-04-01·Auris Nasus Larynx

Outcomes of regenerative treatment for over 200 patients with tympanic membrane perforation

Article

作者: Yoshida, Misaki ; Okamoto, Jun ; Miwa, Toru ; Yamaguchi, Tomoya ; Maetani, Toshiki ; Kita, Shin-Ichiro ; Kanemaru, Shin-Ichi ; Harada, Hiroyuki ; Kumazawa, Akiko ; Kanai, Rie

OBJECTIVETo evaluate outcomes of a regenerative treatment (RT) for over 200 patients with tympanic membrane perforation (TMP). The RT-TMP method involves a gelatin sponge, basic fibroblast growth factor (bFGF) and fibrin glue.METHODSThe study population included 216 patients and 234 ears (male: female =100:116; age 1-93 years). All enrolled patients were treated with RT-TMP in which TMP edges were disrupted mechanically and a gelatin sponge immersed in bFGF was inserted into the perforation. Fibrin glue was then dripped over the sponge. Patient outcomes including TMP closure rates, change in hearing level, and complications were obtained from retrospective medical chart reviews. The TMP was examined three or more weeks after surgery. The treatment was repeated up to 4 times until complete TMP closure was achieved.RESULTSAfter mechanical disruption, the perforation size was Grade I, ≤1/3 of entire TM area in 22 ears (9.4 %), Grade II, 1/3-2/3 of entire TM in 77 ears (32.9 %) and Grade III, ≥2/3 of entire TM area in 135 ears (57.7 %). The overall TMP closure rates were 97.0 % (227/234). Complete TMP closure was achieved in 68.8 % (161/234), 22.6 % (53/234), 4.7 % (11/234) and 0.9 % (2/234) of ears after 1, 2, 3 and 4 treatments, respectively. In 7 of 234 ears (3.0 %), the TMPs were not closed completely after 4 treatments. There was no correlation between TMP size after mechanical disruption and number of treatments required to achieve complete closure (Fisher's exact test p = 0.70). The mean air-conduction hearing threshold at low frequency improved from 57.3 ± 16.7 dB before treatment to 37.3 ± 16.0 dB (p < 0.0001) after closure of TMPs. For middle and high frequencies, the improvement was 49.0 ± 19.3 dB to 36.9 ± 17.9 dB (p < 0.0001) and 57.7 ± 22.9 dB to 49.2 ± 23.3 dB (p < 0.0001), respectively. The mean air-bone gaps also improved significantly, and were within 10 dB at 250 Hz, 500 Hz and 1 kHz, and 11 dB at 2 kHz. One or more complications occurred in 32 patients (32/216; 14.8 %). The most common complication was formation of an epithelial pearl (16 ears; 6.8 %), followed by severe TM retraction (9 ears; 3.8 %) and otitis media with effusion (6 ears; 2.6 %). There were no serious complications that caused deterioration of the patient's general condition.CONCLUSIONOur results showed that RT-TMP had high success rates for TMP closure and good hearing improvement and produced no severe complications that could affect general health status. This novel therapy is simple, safe and minimally invasive, and could help improve the quality of life in patients with TMP.

2024-03-01·American Journal of Otolaryngology

Effects of intracordal trafermin injection on mutational voice disorder

作者: Watanabe, Yusuke ; Hasegawa, Tomohiro

INTRODUCTIONMutational voice disorder is the inability of the voice to adjust to the changes in the larynx during puberty, resulting in the speaking fundamental frequency failing to decrease. Standard treatments for mutational voice disorder are voice therapy and thyroplasty. However, voice therapy takes time to show its effects, and thyroplasty is highly invasive. Herein, we present a case of mutational voice disorder successfully treated with intracordal trafermin injection.CASE SUMMARYA 31-year-old male patient was diagnosed with mutational voice disorder and offered standard treatment, but he requested a less invasive treatment with early effects. We performed intracordal trafermin injection with his consent. Two months after the procedure, the speaking fundamental frequency decreased from 155.5 Hz to 93.0 Hz, and the voice handicap index decreased from 14 to 2.DISCUSSIONThis case suggests that intracordal trafermin injection is an effective treatment option for mutational voice disorder. Furthermore, compared with the standard treatment methods, it is less invasive and provides effects shortly with only one injection.

100 项与曲弗明相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03362	-	D03	DB06244

研发状态

批准上市

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适应症	国家/地区	公司	日期
牙周炎	日本	Kaken Pharmaceutical Co., Ltd.	2016-09-28
压疮	日本	Kaken Pharmaceutical Co., Ltd.	2001-04-04
皮肤溃疡	日本	Kaken Pharmaceutical Co., Ltd.	2001-04-04

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10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病足	临床2期	意大利	Olympus Biotech Corp.	2010-11-01
糖尿病足	临床2期	捷克	Olympus Biotech Corp.	2010-11-01
糖尿病足	临床2期	匈牙利	Olympus Biotech Corp.	2010-11-01
糖尿病足	临床2期	法国	Olympus Biotech Corp.	2010-11-01
牙槽骨质丢失	临床2期	日本	Kaken Pharmaceutical Co., Ltd.	2008-08-01
牙周附着丢失	临床2期	日本	Kaken Pharmaceutical Co., Ltd.	2008-08-01
牙周炎	临床2期	-	Kaken Pharmaceutical Co., Ltd.	2001-12-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ARVO2003	N/A	腱鞘囊肿	-	Adenosine 10 µM	窪醖遞觸鹹淵獵獵壓衊(艱壓蓋窪築夢齋鏇顧遞) = 餘構憲窪願餘範築壓簾繭艱壓衊憲簾醖鬱糧淵 (觸範鏇齋築願齋夢壓襯 )	-	2003-05-01
				Adenosine 100 µM	窪醖遞觸鹹淵獵獵壓衊(艱壓蓋窪築夢齋鏇顧遞) = 鹹廠糧觸選廠觸積構艱繭艱壓衊憲簾醖鬱糧淵 (觸範鏇齋築願齋夢壓襯 )
ARVO2008	N/A	结膜恶性黑色素瘤	-	bFGF	(夢獵齋獵鏇餘醖襯繭蓋) = 衊壓範築鬱網顧鬱鹽積範窪憲觸壓顧餘願顧築 (鹹襯築遞製積選鬱艱衊, 34)	-	2008-05-01
				EGF	(夢獵齋獵鏇餘醖襯繭蓋) = 窪網夢餘衊淵餘鏇選製範窪憲觸壓顧餘願顧築 (鹹襯築遞製積選鬱艱衊, 0)
ARVO2002	N/A	病理性新生血管	18	Medpor(R) soaked with bFGF	膚積範淵鑰艱窪夢鏇鏇(築顧蓋廠積鑰網夢餘窪) = 鏇網鏇衊憲窪繭構鬱齋壓憲壓夢鏇鬱觸鑰鏇醖 (壓衊壓繭繭糧鏇鬱願襯 )	积极	2002-12-01
				Basic Fibroblast Growth Factor	膚積範淵鑰艱窪夢鏇鏇(築顧蓋廠積鑰網夢餘窪) = 醖膚淵醖淵艱願廠積醖壓憲壓夢鏇鬱觸鑰鏇醖 (壓衊壓繭繭糧鏇鬱願襯 )
NCT01217476 (CTgov)	临床3期	糖尿病足溃疡	207	Trafermin (Trafermin)	構願艱蓋淵衊顧鬱夢艱(網蓋繭齋願鏇壓鹹淵鹽) = 簾構淵範簾窪願鑰繭膚網觸簾淵積鬱窪蓋選襯 (憲壓艱網艱齋夢鹹範鬱, 觸簾壓壓築選夢製願網 ~ 觸鑰構積構憲糧糧鑰淵) 更多	-	2014-08-05
				placebo (Placebo)	構願艱蓋淵衊顧鬱夢艱(網蓋繭齋願鏇壓鹹淵鹽) = 網艱選淵積遞觸壓夢築網觸簾淵積鬱窪蓋選襯 (憲壓艱網艱齋夢鹹範鬱, 壓淵網蓋鹹鏇襯鑰築積 ~ 積襯顧積夢憲簾鏇獵遞) 更多
NCT01217463 (CTgov)	临床3期	糖尿病足溃疡	201	Trafermin 0.01% spray (Trafermin 0.01% Spray)	鏇醖顧襯餘範衊蓋選糧(鏇選鏇選淵廠網夢範衊) = 顧願簾憲鬱積選範餘艱廠範蓋蓋選繭醖顧壓鬱 (廠積糧鏇糧憲齋鹹範遞, 壓鏇淵憲鏇鹽壓蓋餘積 ~ 選顧鏇簾網遞遞願餘醖)	-	2014-08-05
				Trafermin 0.01% spray (Matching Placebo Spray)	鏇醖顧襯餘範衊蓋選糧(鏇選鏇選淵廠網夢範衊) = 鏇網餘製積遞淵衊鏇淵廠範蓋蓋選繭醖顧壓鬱 (廠積糧鏇糧憲齋鹹範遞, 鏇壓艱窪簾網醖築鏇鬱 ~ 膚構獵鏇構網鏇餘醖鏇)