盐酸丙美卡因(Proparacaine Hydrochloride) - 药物靶点：SCNA_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Proparacaine hydrochloride (USP)、Proxymetacaine、Alcaine

+ [5]

靶点

SCNA

作用机制

SCNA阻滞剂(钠通道α亚基家族阻滞剂)

治疗领域

其他疾病

在研适应症-

非在研适应症

麻醉

原研机构

Apothecon BV

在研机构-

非在研机构

Apothecon LLCAllergan, Inc.

最高研发阶段撤市

首次获批日期

美国 (1953-07-01),

麻醉

最高研发阶段(中国)-

特殊审评-

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结构

分子式C16H27ClN2O3

InChIKeyBFUUJUGQJUTPAF-UHFFFAOYSA-N

CAS号5875-06-9

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关联

14

项与盐酸丙美卡因相关的临床试验

CTRI/2024/08/072298 / Recruiting临床4期

Evaluation of Nanodropper-mediated Microdrops vs Conventional Dropsof Proparacaine HCL 0.5 Percentage - Nil

开始日期2024-08-26

申办/合作机构-

NCT04283331 / Unknown status临床4期IIT

Efficacy and Safety of Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK).

Compared to laser-assisted in situ keratomileusis (LASIK), Photorefractive Keratectomy (PRK) is associated with more discomfort and requires more downtime. However, it is oftentimes considered the preferred method of refractive surgery for patients with dry eye syndrome, high refractive errors, thin corneas, or those with more active lifestyles who may be more prone to dislodging their LASIK flaps. We hypothesize that the use of bandage contact lenses soaked in proparacaine will decrease pain levels compared to solely the use of bandage contact lenses after PRK.

开始日期2020-06-01

申办/合作机构

Wills Eye Institute

NCT02951351 / CompletedN/AIIT

Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections

The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.

开始日期2016-10-12

申办/合作机构

Mayo Clinic

[+2]

100 项与盐酸丙美卡因相关的临床结果

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100 项与盐酸丙美卡因相关的转化医学

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100 项与盐酸丙美卡因相关的专利（医药）

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368

项与盐酸丙美卡因相关的文献（医药）

2024-10-15·Romanian Journal of Ophthalmology

Comparison of the effectiveness of 0.5% and 0.25% proparacaine hydrochloride eye drops as topical anesthetics in routine ocular investigations and procedures

Article

作者: Joshi, Rajesh Subhash

AimTo compare the effectiveness of 0.5% and 0.25% proparacaine eye drops in providing topical anesthesia for routine ocular procedures.Methodology137 patients (274 eyes) were included in this study. They were categorized into two groups. Group A patients received 0.5% and Group B received 0.25% proparacaine drops. A single surgeon performed all the procedures. Intraprocedural and postprocedural pain scores, surgeon comfort, supplemental anesthesia, and vital parameters, were noted.ResultsThe mean age of the participants was 69.42 years (±12.05). An equal number of procedures were performed (n = 30) for applanation tonometry, lacrimal sac syringing, and A-scan biometry. The other procedures performed were removal of the conjunctiva (n = 5) and corneal foreign bodies (n = 16 per group), corneal scraping (n = 8 per group), and corneal suture removal (n = 18 per group).The mean visual analog pain score during the procedure was 6.9663 in Group A and 8.0803 in Group B (P = 0.66). The mean postprocedural pain score was not significant (P = 0.21). None of the patients required any additional anesthesia during or after the procedure. The average surgeon's experience was 0.152±0.507 in Group A and 0.111±0.402 in Group B (P = 0.07).In Group A, 133 of 137 patients (97.08%), and in Group B, 132 out of 137 patients (96.35%) preferred to use the same anesthetic for future procedures. None of the patients experienced a vasovagal attack or any change in vital parameters.DiscussionThe present study aimed to establish equivalence between two concentrations of proparacaine hydrochloride in which false positive and false negative errors were expected. This is the inherent challenge in the equivalence and inferiority trials. To mitigate these risks, the present study was carefully designed with specific statistical methods, sample size calculation, and rigorous methodology. Nevertheless, it is crucial to recognize that the risk of false positive errors remains, and the results should be interpreted with this in mind.ConclusionThese findings indicated that 0.25% proparacaine is a viable alternative to the standard 0.5% concentration in routine ophthalmic procedures, with the potential for improved patient comfort.

2024-10-01·Intensive and Critical Care Nursing

Effectiveness of non-pharmacological interventions in reducing pain in preterm infants: A systematic review and network meta-analysis

Review

作者: Miralha, Alexandre Lopes ; Cordeiro, Sarah Almeida ; da Silva Vieira, Alexia Gabriela ; de Oliveira Andrade, Edson ; Boechat, Antônio Luiz ; do Valle Filho, Marcello Facundo ; Lopes, Tainá Costa Pereira ; de Lima, Raquel Lima ; Gonçalves, Roberta Lins

OBJECTIVETo identify the most effective non-pharmacological measures for pain control in preterm infants in the Neonatal Intensive Care Unit (NICU).METHODSA Systematic review and network meta-analysis of randomized clinical trials published in English, Portuguese, and Spanish from April 2020 to December 2023. The data sources used were MedLine via PubMed, LILACS, EMBASE, The Cochrane Central Register of Controlled Trials, and Pedro. We performed the risk of bias analysis with Rob 2 and the certainty of the evidence and strength of the recommendation using the Grading of Recommendations Assessment, Development, and Evaluation system. We assessed heterogeneity using the Higgins and Thompson I² test, the classification of interventions using the P-score, and inconsistencies using the Direct Evidence Plot.RESULTSFrom 210 publications identified, we utilized 12 studies in analysis with 961 preterm infants, and we combined ten studies in network meta-analysis with 716 preterm infants, and 12 combinations of non-pharmacological measures. With moderate confidence, sensory saturation, sugars, non-nutritive sucking, maternal heart sound, lullaby, breast milk odor/taste, magnetic acupuncture, skin-to-skin contact, and facilitated tucking have been shown to reduce pain in preterm infants when compared to no intervention, placebo, proparacaine or standard NICU routine: sensory saturation [SMD 5,25 IC 95%: -8,98; -1,53], sugars [SMD 2,32 IC 95%: -3,86; -0,79], pacifier [SMD 3,74 IC 95%: -7,30; 0,19], and sugars and pacifier SMD [3,88 IC 95% -7,72; -0,04].CONCLUSIONNon-pharmacological measures are strongly recommended for pain management in preterm infants in the NICU.IMPLICATIONS FOR CLINICAL PRACTICEThe findings of this study have important implications for policy and practice. This is the only systematic review that compared the effectiveness of non-pharmacological measures, thus making it possible to identify which measure presents the best results and could be the first choice in clinical decision making.

2024-08-01·Asia-Pacific Journal of Oncology Nursing

Improved method of dilating pupils for ophthalmic exams under anesthesia (faster and easier)

Article

作者: Robbins, Melissa A ; Guarini, Edith ; Foerch, Angela ; Bobin, Andrea ; Abramson, David H ; Francis, Jasmine H ; Gaccione, Jacquelyn ; Bracken, Christina ; Liu, Todd ; Rojas, Ricardo Dodds

ObjectiveThe pupils of children with retinoblastoma are routinely dilated pre-procedure with Tropicamide and Phenylephrine. Despite that, the pupil constricts once general anesthesia begins. The aim of this study is to see if adding Ketorolac to the regular dilating drops given pre-procedure shortens the length of anesthesia.MethodsRetrospective comparison of time under anesthesia for two groups of retinoblastoma children receiving anesthesia for examination under anesthesia: one group (January 1, 2019 to October 1, 2022) had been dilated with Tropicamide 1% and Phenylephrine 2.5% while the second group (October 2, 2022 to July 1, 2023) was dilated with a combination drop using those drugs with topical Ketorolac 0.5% and Proparacaine 0.5%.ResultsAverage anesthesia time for patients who received the older two-drug combination was 25 minutes vs. 16 minutes (36% reduction in exposure time) for those who received the newer four-drug combination (9 minutes less anesthesia) (P < 0.001).ConclusionsThe use of a combined dilating drop that incorporated Tropicamide 1%, Phenylephrine 2.5%, Proparacaine 0.5% and Ketorolac 0.5% significantly shortened the time for exams under anesthesia for children with retinoblastoma because the pupil remained dilated after anesthesia induction with Sevoflurane. Using this combined drop, children will receive 5-10 hours less anesthesia during their treatment for retinoblastoma and staff will have more than 150 hours of fewer exposure to anesthetic gasses. In addition, far fewer drops are necessary pre-anesthesia, minimizing trauma to the children and families.

21

项与盐酸丙美卡因相关的新闻（医药）

2024-10-31

·Pharma CMC

今年第三次，兴齐眼药再撤回一款产品上市申请

10月30日，兴齐眼药发布公告，公司收到国家药监局核准签发的《药品注册申请终止通知书》，同意公司撤回马来酸噻吗洛尔滴眼液的注册申请。 2023年3月，兴齐眼药向国家药品监督管理局递交马来酸噻吗洛尔滴眼液仿制药上市注册申请并获受理，申报适应症为：用于高眼压或开角型青光眼患者眼压升高的治疗。据兴齐眼药在公共中披露，受政策法规变更等因素影响，需进一步完善申报资料，经审慎研究，决定主动撤回本次补充申请。据悉，2024年，兴齐眼药已撤回了3款产品的上市申请：今年8月2日，兴齐眼药的撤回了已上市产品——溶菌酶滴眼液增加规格等变更的补充申请；10月22日，兴齐眼药撤回了盐酸丙美卡因滴眼液仿制药上市申请。兴齐眼药发布2024年三季度报告，2024年前三季度，公司实现营收14.39亿元，同比增长30.27%；归属于上市公司股东的净利润2.91亿元，同比增长59.47:%。其中第三季度，兴齐眼药营收5.47亿元，同比增长30.54；三季度净利润为1.21亿元，同比增长28.41%。兴齐眼药在报告中披露：营收增长主要系报告期内0.01%硫酸阿托品滴眼液获批上市，收入实现增长所致。

财报

2024-10-27

·药通社

连续三家！兴齐眼药“麻醉用滴眼液”被毙！

d统计每周仿制药一致性评价通过、上市申请、临床申请及审批情况（10.19-10.25）注：周统计截止数据定为每周五，周六周日数据将统计入下周，依此类推。 1、仿制药一致性评价过评&驳回情况本周过评96条（按受理号计算），首仿5家，6个受理号，乙酰半胱氨酸注射液/四川汇宇；生理氯化钠溶液/辽宁民康制药；注射用吲哚菁绿/南京正大天晴；氨甲环酸氯化钠注射液/重庆莱美/赤峰源生。本周最大话题度的大概就是乙酰半胱氨注射液首仿过评了，过评当天本号推测产品是按照解毒剂过评的，后汇宇官方通告，适应症为急性对乙酰氨基酚中毒解毒，用于预防或减轻其过量引起的肝脏损伤。拓展阅读：30过1？“乙酰半胱氨酸注射液”首家过评！！盐酸丙美卡因滴眼液沈阳兴齐眼药的上市申请被驳回，此产品已连续三家被驳回，分别是：合肥立方制药股份有限公司、江西马应龙美康药业有限公司和沈阳兴齐眼药股份有限公司。兴齐眼药于10月22日发布公告称已撤回盐酸丙美卡因滴眼液的注册申请，兴齐眼药在公告中表示，受政策法规变更等因素影响，结合市场注册申报情况及公司研发策略，经审慎研究，公司决定主动撤回该注册申请。本周沈阳兴齐眼药收到了通知件（为同一受理号）。注射用吲哚菁绿用于诊断肝硬化、肝纤维化、韧性肝炎、职业和药物中毒性肝病等各种肝脏疾病，了解肝脏的损害程度及其储备功能，也用于脉络膜血管造影，确定脉络膜疾患的位置。南京正大天晴制药是该产品第二家获批的国内药企（首家过评）。根据摩熵数据显示，2023年在中国公立医院终端诊断用药的销售规模涨至20亿元以上，增长率为15.38%，市场潜力可期。注射用吲哚菁绿该类药物TOP5品种，2023年销售额突破1亿元。南京正大天晴制药早前暂无诊断用药上市，本次注射用吲哚菁绿成功获批，为公司打开了新市场，正大天晴瞄准诊断用药领域了。江苏恩华药业过了一个麻精毒放类产品注射用盐酸瑞芬太尼，2023年年销售额达35亿，国内仅有人福医药、国药工业、恩华药业3家企业拥有批文，截止本周此产品的批文都已通过了一致性评价，麻精毒放类药物是暂无集采风险的，任凭集采价格战卷成什么样，都不影响这类拥有麻精毒放药物生产资质的企业。 2、仿制药一致性评价上市申请 3、仿制药一致性评价申请&批准临床投稿/内容沟通：华籍美人（Ww_150525）近期精华文章

一致性评价

2024-10-23

·Pharma CMC

兴齐眼药撤回一款产品上市申请

10月22日，兴齐眼药发布公告，公司收到国家药监局核准签发的《药品注册申请终止通知书》，同意公司撤回盐酸丙美卡因滴眼液的注册申请。兴齐眼药于2023年12月向国家药监局递交盐酸丙美卡因滴眼液仿制药上市注册申请并获受理，申报适应症为：用于眼科局部麻醉。兴齐眼药在公告中表示，受政策法规变更等因素影响，结合市场注册申报情况及公司研发策略，经审慎研究，公司决定主动撤回该注册申请。

100 项与盐酸丙美卡因相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02098	盐酸丙美卡因	S01HA04	DB00807

研发状态

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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


NCT02528123 (CTgov)	N/A	近视	114	Small incision lenticule extraction+Tobramycin+Proxymetacaine 0.5%+Oxybuprocaine 0.4%+dexamethasone+Ofloxacin	願鹽遞齋憲獵艱憲淵夢(壓構簾鏇餘餘顧齋襯鬱) = 製壓蓋製夢壓願構範遞膚鹹醖齋簾鏇膚獵餘淵 (窪願鑰願簾簾壓遞鏇範, 襯構構構艱醖夢夢遞衊 ~ 觸鹹鏇鏇淵簾醖網遞鑰) 更多	-	2024-04-23
NCT02951351 (CTgov)	N/A	细菌感染 \| 糖尿病性黄斑水肿 \| 年龄相关性黄斑变性 \| 术后疼痛	36	Conjunctival culture (Standard Procedure + Culture)	顧廠襯獵夢憲鏇繭積繭(鬱窪齋選網獵構願鑰鹽) = 網淵鹹淵衊鏇鏇鬱鑰願築鑰築齋製範窪鏇獵鏇 (鹽製糧獵餘選繭鏇遞鬱, 艱壓膚艱鏇糧顧鑰製鏇 ~ 遞鏇醖鹽膚鏇餘衊製鏇) 更多	-	2019-06-25
				Conjunctival culture+Proparacaine (Proparacaine + Culture)	顧廠襯獵夢憲鏇繭積繭(鬱窪齋選網獵構願鑰鹽) = 遞襯夢製鑰獵願鬱淵鹹築鑰築齋製範窪鏇獵鏇 (鹽製糧獵餘選繭鏇遞鬱, 壓窪鏇繭積艱獵夢蓋積 ~ 築網範衊願艱鏇願顧壓) 更多
APAO2017	N/A	-	-	Topical 0.5% proparacaine hydrochloride	選鑰網壓窪選鑰蓋構鏇(蓋艱齋廠繭鏇淵憲鏇衊) = 鑰醖廠鏇顧範構蓋築獵鹹網淵鑰襯廠膚夢鑰鏇 (遞獵鹹廠觸鬱繭觸築憲 ) 更多	-	2017-03-01
				Combined topical-intracameral injection of 0.5 cc 1% lidocaine	選鑰網壓窪選鑰蓋構鏇(蓋艱齋廠繭鏇淵憲鏇衊) = 構築鹹築鹽蓋窪廠築醖鹹網淵鑰襯廠膚夢鑰鏇 (遞獵鹹廠觸鬱繭觸築憲 ) 更多
ARVO2016	N/A	瞳孔散大	-	Tropicamide + Proparacaine + Phenylephrine	(願鑰餘壓網窪範憲鑰淵) = 壓繭蓋餘網獵鏇簾製鑰鏇範積鏇齋獵糧糧膚願 (觸餘壓選鹹觸網餘鹽襯, 0.78)	-	2016-05-01
				Tropicamide + Proparacaine	(願鑰餘壓網窪範憲鑰淵) = 鑰選壓壓構鏇壓鬱憲廠鏇範積鏇齋獵糧糧膚願 (觸餘壓選鹹觸網餘鹽襯, 0.78)
NCT01640171 (CTgov)	N/A	糖尿病性黄斑水肿 \| 年龄相关性黄斑变性 \| 视网膜静脉阻塞	57	Proparacaine Hydrochloride+Xylocaine+Tetravisc (Topical Anesthesia 1 Eye, SC 1 Eye)	獵餘鏇網獵憲夢積簾鏇(網築鬱鑰淵繭鏇壓膚願) = 齋餘築積齋築蓋憲遞範鬱淵顧鑰艱遞構築衊廠 (窪觸襯鹽艱齋範鬱壓網, 製壓觸鬱願鹹餘顧選鏇 ~ 網窪壓網繭積壓繭製網) 更多	-	2014-04-21
				Proparacaine Hydrochloride+Tetravisc (Topical Anesthesia)	鏇選鑰觸簾獵鹽衊糧鹹(選鬱願選鹹憲積醖夢積) = 鏇衊鏇範鹽膚齋繭範積鏇顧簾壓醖鏇鹹襯襯築 (選製淵餘遞獵鹹積憲憲, 積範蓋鏇鏇窪醖醖積醖 ~ 遞範襯衊願艱顧鹽襯衊) 更多
NCT01266824 (CTgov)	N/A	疼痛 \| 早产儿视网膜病变	5	Proparacaine Hydrochloride Ophthalmic Solution (Proparacaine)	選顧積製網膚鹽壓襯襯(蓋鬱夢淵蓋製選構鹹糧) = 蓋鬱壓獵憲廠艱襯鏇膚顧網蓋觸壓鹹夢網膚製 (顧簾鏇窪積蓋醖襯憲鑰, 醖憲淵餘餘遞鹹淵衊積 ~ 製衊觸鹽襯選醖淵選築) 更多	-	2013-03-19
				Proparacaine (Standard of Care)	選顧積製網膚鹽壓襯襯(蓋鬱夢淵蓋製選構鹹糧) = 積艱範鹽構製網衊衊窪顧網蓋觸壓鹹夢網膚製 (顧簾鏇窪積蓋醖襯憲鑰, 壓網艱醖繭願壓遞襯鬱 ~ 積膚憲餘餘夢鏇簾繭糧) 更多