托品卡胺/利多卡因/去氧肾上腺素(Tropicamide/Lidocaine/Phenylephrine) - 药物靶点：SCNA x mAChRs_在研适应症：瞳孔缩小，麻醉_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Fydrane、Lidocaine/phenylephrine/tropicamide、Mydane

+ [4]

靶点

SCNA x mAChRs

作用机制

SCNA调节剂(钠通道α亚基家族调节剂)、mAChRs拮抗剂(毒蕈碱型乙酰胆碱受体家族拮抗剂)

治疗领域

神经系统疾病眼部疾病其他疾病

在研适应症

瞳孔缩小麻醉

非在研适应症

白内障

原研机构

Laboratoires Théa SAS

在研机构

Laboratoires Théa SAS

非在研机构-

最高研发阶段批准上市

首次获批日期

英国 (2016-06-16),

麻醉

最高研发阶段(中国)-

特殊审评-

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结构

分子式C9H13NO2

InChIKeySONNWYBIRXJNDC-VIFPVBQESA-N

CAS号59-42-7

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关联

5

项与托品卡胺/利多卡因/去氧肾上腺素相关的临床试验

CTIS2023-504173-21-00 / Not yet recruitingIIT

MyKid-study: efficacy and systemic side effects of intracameral Mydrane® injections in children undergoing cataract surgery. - EDGE1169

开始日期2023-07-01

申办/合作机构

Antwerp University Hospital

NCT04396301 / Completed临床3期IIT

Effect of Intracameral Injection of Preservative Free, Fixed Concentration of Combined Mydriatic Plus Anaesthetic Formulation on Corneal Endothelial Cell Count in Phacoemulsification

Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery.

开始日期2019-02-01

申办/合作机构

Cairo University

EUCTR2017-003277-34-ES / Not yet recruiting临床4期

Phase IV, open-label, randomized clinical trial to evaluate the effects of Fydrane® and standard topical mydriatics and anaesthetics protocol on ocular surface after cataract surgery. - EFOS

开始日期2018-01-15

申办/合作机构

Laboratoires Théa SAS

100 项与托品卡胺/利多卡因/去氧肾上腺素相关的临床结果

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100 项与托品卡胺/利多卡因/去氧肾上腺素相关的转化医学

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100 项与托品卡胺/利多卡因/去氧肾上腺素相关的专利（医药）

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28

项与托品卡胺/利多卡因/去氧肾上腺素相关的文献（医药）

2024-03-01·European Journal of Ophthalmology

Pain experience in patients undergoing topical anesthesia alone versus topical plus intracameral anesthesia during cataract surgery

Article

作者: Ricci, Francesco ; Ripa, Matteo ; Rizzo, Stanislao

Purpose To evaluate and compare the pain experience and discomfort during cataract surgery and over the 24 hours after surgery in patients undergoing either topical anesthesia alone or topical anesthesia plus intracameral anesthesia, provided by using a standard topical anesthesia regimen and a 0.2-mL dose of Mydrane®. Methods Prospective study involving 100 patients who underwent cataract surgery receiving either topical anesthesia alone (group 1, n = 50) or topical anesthesia plus intracameral anesthesia (group 2, n = 50) between January 2021 and March 2022. The pain experienced by patients during and after surgery was assessed using a pain scale and a questionnaire. One hour after surgery, patients were asked to rate the intensity of discomfort they experienced throughout the procedure by pointing to a 0–100 Visual Analogue Scale (VAS). Results According to VAS measurements, patients who underwent surgery under topical anesthesia reported more significant pain than those who underwent surgery under topical anesthesia plus intracameral anesthesia during and over the 24 hours after surgery. ( p = 0.02 and p = 0.01, respectively). Patients undergoing topical anesthesia had 2.34-fold greater odds of having pain during surgery [95% Confidence Interval (CI): 1.58–5.25, p = 0.03]. Conclusions Topical anesthesia plus intracameral anesthesia lower intraoperative and postoperative pain levels, improving patient cooperation and representing a useful analgesic delivery method in cataract surgery.

2023-05-01·European Journal of Ophthalmology

Efficacy of the intracamerally administered mydriatics for cataract surgery in patients with primary open-angle glaucoma

Article

作者: Savastano, Maria Cristina ; Rizzo, Stanislao ; Ripa, Matteo ; Ricci, Francesco ; Grieco, Giulia ; Cuffaro, Giovanni

Purpose To compare Mydrane®, mydriatic eye drops, and Mydriasert® in terms of pupil site stability, surgical time, visual field, and anterior chamber configuration modifications among patients with primary open-angle glaucoma (POAG) during cataract extraction surgery. Methods Retrospective analysis of sixty patients with POAG and cataract who underwent elective cataract extraction. All patients underwent routine ophthalmic examinations, including automatic visual field examination, anterior chamber configuration, specular microscopy, and arterial blood pressure measurement prior to surgery, and 24 h and 30 days postoperatively. All cataract surgeries were video-recorded and all measurements were performed using a media player. Patients divided into groups 1, 2, and 3 (n = 20 in each group) received topical mydriatic eye drops, Mydriasert®, and an intracameral injection of Mydrane®, respectively, immediately after the first incision. Results The mean change in pupil size from just before capsulorhexis to the end of surgery was 0.43 ± 0.09, 0.42 ± 0.08, and 0.36 ± 0.02 mm in groups 1, 2, and 3, respectively. The mean surgery duration was similar among all the groups. The baseline main cell density slightly decreased at 24 h and remained stable for 30 days postoperatively. The mean deviation and pattern standard deviation remained stable at 1 month after surgery. At 24 h after surgery, the nasal irido-corneal angle, temporal-iridocorneal angle, and anterior chamber depth increased compared with the baseline, remaining stable for 30 days after surgery. Conclusions Mydrane® produced adequate and stable mydriasis as effectively as produced by Mydriasert® and topical eye drops.

2023-02-01·Acta Ophthalmologica

Pupil diameter during cataract surgery after intracameral injection of the first ready‐to‐use combination of mydriatics and anaesthetic at the beginning of surgery in patients with a preoperative pupil diameter <6 mm

Article

作者: Szaflik, Jerzy ; Omulecki, Wojciech ; Jurowski, Piotr ; Kęcik, Dariusz ; Szaflik, Jacek P. ; Romanowska–Dixon, Bożena ; Mianowska, Katarzyna ; Romaniuk, Wanda ; Kopacz, Dorota ; Mrukwa–Kominek, Ewa ; Grabska‐Liberek, Iwona

AbstractPurposeWe evaluated, in a real‐life setting, the effect of Mydrane® (ready‐to‐use combination of tropicamide, phenylephrine hydrochloride and lidocaine, injected into the anterior chamber at the beginning of cataract surgery to induce mydriasis and intraocular anaesthesia) on the pupil diameter during cataract surgery in patients with a preoperative pupil diameter <6 mm after the use of topical mydriatics.MethodsWe collected and analysed the data of 59 consecutive patients whose pupils dilated to a diameter <6 mm after the administration of mydriatic eye drops during the preoperative visit and who received Mydrane® during cataract surgery.ResultsIn the group of 59 patients with a preoperative pupil diameter <6 mm after topical mydriatics, cataract surgery was performed in 36 patients (61.0%) using only Mydrane® to obtain mydriasis, with no additional drug or medical device. The mean pupil diameters in this group (36 of 59) during the preoperative assessment after topical mydriatics and just before capsulorhexis when Mydrane® was injected during surgery were 5.1 ± 0.74 and 6.15 ± 1.14 mm. Additional drugs were used in 23 patients (39%). In this group, the mean pupil diameters after topical mydriatics and just before capsulorhexis using Mydrane® were 4.58 ± 1.06 and 5.6 ± 1.26 mm, respectively.ConclusionIn a real‐life setting, the mean pupil diameter achieved during cataract surgery after the intracameral injection of Mydrane® in patients with a preoperative pupil diameter <6 mm was over 1 mm larger than the mean pupil diameter after topical mydriatics, despite the trauma caused by the operation.

100 项与托品卡胺/利多卡因/去氧肾上腺素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	S01FA56	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
瞳孔缩小	英国	Laboratoires Théa SAS	2016-07-24
麻醉	英国	Laboratoires Théa SAS	2016-06-16

未上市

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
白内障	临床1期	法国	Laboratoires Théa SAS	2011-06-01

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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


ARVO2019	N/A	-	69	Mydrane alone	(願鹽築衊醖鹽壓範窪選) = 獵醖憲衊糧簾醖艱網獵選繭夢夢艱窪簾膚鬱壓 (壓壓積獵願餘製簾範齋 ) 更多	不佳	2019-07-01
				Tropicamide plus Mydrane	(願鹽築衊醖鹽壓範窪選) = 醖廠衊觸範積艱蓋糧範選繭夢夢艱窪簾膚鬱壓 (壓壓積獵願餘製簾範齋 ) 更多