预约演示
更新于：2025-10-19
Lidocaine/Tetracaine
利多卡因/丁卡因
更新于：2025-10-19
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2005-06-23), |
最高研发阶段(中国)临床申请批准 |
特殊审评- |
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结构/序列
分子式C29H46N4O3 |
InChIKeyLWNPNOFGINFGGV-UHFFFAOYSA-N |
CAS号444093-81-6 |
关联
39
项与 利多卡因/丁卡因 相关的临床试验CTRI/2025/03/081845
A multicenter, randomized, double blind, placebo-controlled, three-arm, prospective, Phase 3 study to evaluate the efficacy, safety, and tolerability of IMP1 and IMP2, potentized formulations, in the treatment of patients with Hypothyroidism. - Nil
CTR20244197
利多卡因丁卡因乳膏用于成人浅层皮肤手术前对完整皮肤的局部麻醉的有效性及安全性的多中心、随机、双盲、阳性药自身对照、等效性临床研究
CTR20242317
多中心、随机、双盲、阳性药自身对照、等效性临床试验评价利多卡因丁卡因乳膏用于面部激光美容术前皮肤局部麻醉的有效性和安全性
100 项与 利多卡因/丁卡因 相关的临床结果
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100 项与 利多卡因/丁卡因 相关的转化医学
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100 项与 利多卡因/丁卡因 相关的专利（医药）
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32
项与 利多卡因/丁卡因 相关的文献（医药）2025-08-01Journal of Cosmetic Dermatology
Efficacy and Safety of Combined Topical Lidocaine and Tetracaine Cream for Facial Fractional Laser Resurfacing Compared With Its Reference Product in Chinese Adults: A Multicenter, Randomized, Double‐Blind Phase 3 Study
Article
作者: Zhang, Aijun ; Lin, Xiaoxi ; Wang, Haiying ; Li, Yong ; Zhu, Hanjie ; Zhao, Yi ; Chen, Xiaosong ; Luo, Zhongling ; Tao, Juan ; Hu, Zhiqi ; Chen, Liying ; Yu, Wenxin
ABSTRACT:
Background:
As a potentially effective anesthetic, CU‐30101 is comprised of 7% lidocaine and 7% tetracaine and is a generic drug of Pliaglis. This study aimed to investigate the equivalence between CU‐30101 and Pliaglis as topical anesthetics for fractional laser.
Methods:
This Phase 3 trial recruited Chinese adults scheduled for facial fractional laser resurfacing. Participants were randomized to receive opposite treatment sequences of CU‐30101 and Pliaglis on contralateral sides of the face prior to laser application. Visual Analog Scale (VAS), participant and investigator satisfaction ratings, local tolerability, and safety were assessed.
Results:
Two hundred eighty‐four participants completed the study, with mean VAS scores of 35.3 ± 24.51 for CU‐30101 and 37.3 ± 24.17 for Pliaglis. The 95% confidence interval of −3.78 to −0.13 for the VAS difference laid within the predefined equivalence margin of ±4.7, confirming equivalence in efficacy. The results in the per‐protocol set further corroborated the equivalence. Both participants and investigators expressed consistently high satisfaction with CU‐30101 and Pliaglis. Furthermore, both treatments were well tolerated and exhibited favorable safety profiles.
Conclusion:
This study demonstrated the equivalent efficacy of CU‐30101 to its reference product, Pliaglis, among Chinese adults undergoing facial fractional laser resurfacing. CU‐30101 showed commendable local tolerability and safety profiles, consistent with those of Pliaglis.
2024-05-01Journal of the American Academy of Dermatology
Comparative effectiveness of short contact (30-minute) lidocaine-prilocaine vs lidocaine-tetracaine topical anesthetic mixtures for cutaneous pain relief: A randomized controlled trial
Article
作者: Iyengar, Sanjana ; Ma, Melissa S ; Alam, Murad ; Shi, Victoria J ; Haq, Misha ; Schlessinger, Daniel ; Cahn, Brian A ; Clark, Melanie ; Pearlman, Ross ; Ahmed, Areeba ; Poon, Emily ; Maisel-Campbell, Amanda ; Koza, Eric ; Weil, Alexandra
Current topical anesthetics used in dermatol. are typically a mixture of multiple agents, commonly 7% lidocaine-7% tetracaine topical anesthetic (LTTA) and 2.5% lidocaine-2.5% prilocaine topical anesthetic (LPTA).The main objective of this study was to assess at various anat. sites the effectiveness of short-contact (30-min application) topical LTTA and LPTA for pain relief prior to laser treatment.A concurrent objective was to determine whether short-contact LTTA and/or LPTA could provide adequate pain relief relative to placebo.Participants were pretreated with 2.5%-2.5% LPTA (EMLA, Astra Pharmaceuticals, L.P.), 7%-7% LTTA (Pliaglis, Taro Pharmaceuticals, Inc), or placebo (Vanicream, Pharmaceutical Specialties, Inc) under occlusion on the right and left forehead, cheek, and upper inner arm.After 30 min, the topical preparations were removed, and the 6 areas were treated with Q- switched 532 nm laser.Mean visual analog scale pain scores for Q-switched laser treatment after LPTA, LTTA, and placebo treatments were significantly different across the treatment areas on the forehead (3.3 vs 2.4 vs 5.0; P - .005), cheek (2.2 vs 1.9 vs 7.1; P < .001), and arm (4.1 vs 2.6 vs 4.8; P - .05).LTTA provided adequate pain relief at all 3 anat. sites, while LPTA only provided adequate pain relief on the cheek.Although LTTA is more expensive than LPTA, its effectiveness at more anat. sites compared to placebo may make the extra expense worthwhile in select cases.Short-contact anesthetic treatment may reduce inconvenience for patients and physicians, while still providing effective pain relief.Future studies could investigate whether application times of 60 min resulted in greater pain reduction than 30 min.
2023-06-01Neoplasma
Topical application of local anesthetics to melanoma increases the efficacy of anti-PD-1 therapy.
Article
作者: Blasko, Filip ; Tibensky, Miroslav ; Mravec, Boris ; Vargovic, Peter ; Jakubechova, Jana ; Cholujova, Dana ; Jakubikova, Jana
Experimental and clinical data have shown that the nervous system can significantly stimulate the initiation and progression of melanoma. In support of this, approaches that reduce the transmission of signals from peripheral nerves to effector tissues reduce the recurrence of melanoma. Therefore, we investigated the effect of topical application of the local anesthetic Pliaglis (7% lidocaine and 7% tetracaine) on the growth of melanoma induced by intradermal application of B16F0 cells in mice without treatment and in mice treated with the anti-PD-1 antibody. We found that application of Pliaglis to melanoma significantly reduced its growth and this effect was even pronounced in mice treated with the anti-PD-1 antibody. To determine the mechanisms and pathways responsible for the observed effect, the in vitro effect of incubating melanoma cells with lidocaine and/or tetracaine and the in vivo gene expression of cancer and immune-related factors, percentage of immune cells, gene expression of selected neurotransmitter receptors and nerve growth factors in melanoma tissue were studied. We found that lidocaine and tetracaine significantly reduced the viability of B16F0 cells in vitro. In mice with melanoma, Pliaglis potentiated the effect of anti-PD-1 antibody on gene expression of COX-2, IL-1β, IL-6, CCL11, F4/80, CD206, and NCR1. In addition, Pliaglis increased the gene expression of α9nACHR and 5-HT2a receptors and decreased the gene expression of nerve growth factor receptor (p75NTR) and p53. We also observed Pliaglis-mediated changes in myeloid populations. Topical application of this local anesthetic cream decreased the CD11b+Gr1- population and increased the CD11b+Gr1high population. Our data suggest that Pliaglis reduces melanoma growth through a direct effect on melanoma cells as well as through modulation of the immune response. The involvement of nervous system-related signaling in the inhibitory effect of Pliaglis on melanoma is inconclusive from our data.
28
项与 利多卡因/丁卡因 相关的新闻（医药）2025-09-21
·信狐药迅
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2025-08-31
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细胞疗法疫苗免疫疗法ASH会议申请上市
100 项与 利多卡因/丁卡因 相关的药物交易
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外链
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 疼痛 | 美国 | 2005-06-23 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 镇痛 | 临床3期 | 中国 | 2023-04-03 | |
| 麻醉 | 临床3期 | 中国 | 2023-03-29 | |
| 麻醉 | 临床3期 | 中国 | 2023-03-29 | |
| 膝关节炎 | 临床2期 | 美国 | 2013-09-01 | |
| 肌筋膜疼痛综合征 | 临床2期 | 美国 | 2010-06-01 | |
| 腕管综合征 | 临床2期 | 美国 | 2009-09-01 | |
| 疱疹后神经痛 | 临床2期 | 美国 | 2008-01-01 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 100 | (EMLA Cream) | 繭築糧構獵鏇餘廠窪齋 = 鏇鬱願構艱觸齋壓顧憲 築蓋鹹構積淵衊製鬱襯 (齋鏇襯襯選積遞繭範膚, 蓋糧齋網顧齋積範鑰獵 ~ 範蓋製鬱鏇願願網遞網) 更多 | - | 2018-08-31 | ||
(Synera Patch) | 繭築糧構獵鏇餘廠窪齋 = 艱蓋鏇襯繭鹹願醖願鏇 築蓋鹹構積淵衊製鬱襯 (齋鏇襯襯選積遞繭範膚, 鬱築衊醖壓積鹹鑰網窪 ~ 築艱糧膚範夢夢範遞顧) 更多 | ||||||
临床4期 | 30 | 醖觸觸獵製鏇鹽淵築廠(齋鬱繭鑰衊蓋範構鏇襯) = 範壓蓋淵觸範夢觸範積 衊膚醖夢鏇齋獵簾積蓋 (糧繭膚範夢蓋糧觸獵獵, 3.2) 更多 | - | 2018-03-13 | |||
临床4期 | 64 | (Benzocaine) | 範構鬱鑰願鹹簾鹽積憲(廠顧製襯構夢網鏇網窪) = 製範夢顧築繭壓範鑰選 選廠衊憲襯蓋夢膚醖糧 (鏇鑰積窪簾簾鏇壓憲艱, 遞壓製衊蓋廠淵網製鏇 ~ 鏇選醖鹽蓋製廠鑰衊構) 更多 | - | 2016-07-22 | ||
範構鬱鑰願鹹簾鹽積憲(廠顧製襯構夢網鏇網窪) = 壓網鹽鹹鬱糧築夢鏇鹹 選廠衊憲襯蓋夢膚醖糧 (鏇鑰積窪簾簾鏇壓憲艱, 餘餘鑰顧範廠築淵膚築 ~ 夢壓網範簾膚願衊積鹹) 更多 | |||||||
临床1/2期 | 40 | (Synera) | 遞艱膚膚顧獵鹹網醖鹽(鹽夢顧遞鹹願襯鏇艱壓) = 選餘膚艱構醖獵簾顧築 繭繭願廠遞積鹽襯蓋淵 (範餘鹽糧蓋遞選鏇遞鏇, 2.242) 更多 | - | 2014-11-10 | ||
Inactive patch (Inactive Patch) | 遞艱膚膚顧獵鹹網醖鹽(鹽夢顧遞鹹願襯鏇艱壓) = 艱築憲製鑰醖範繭餘鹽 繭繭願廠遞積鹽襯蓋淵 (範餘鹽糧蓋遞選鏇遞鏇, 2.253) 更多 | ||||||
临床2期 | - | 25 | Heated lidocaine/tetracaine patch (Synera) | 壓窪壓餘窪衊壓鬱膚選(網蓋網鹽獵構壓願齋壓) = anesthesia lasted at least 100 mins after patch removal 襯鹽獵艱廠糧襯廠齋範 (顧遞積顧繭衊遞積鹹廠 ) | - | 2010-12-31 |
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