Efficacy of Neostigmine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block as a Postoperative Analgesia After Caesarean Delivery.

Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.
Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) The potential of neostigmine as an adjuvant in peripheral nerve block is through its action to increase acetylcholine at muscarinic junctions of peripheral nerves. 500 mcg neostigmine was used as adjuvant to local anesthetic in an axillary brachial plexus block leads to decreased pain and less use of analgesics in the first 24 hours postoperatively with no incidence of adverse effects.

开始日期2025-12-01

申办/合作机构

Mansoura University

NCT05589363 / Not yet recruiting临床4期IIT

A Comparison of the Analgesic Effects of Rectus Sheath and Transversus Thoracis Plane Blocks (ABC Blocks) Versus Saline Injection for Median Sternotomy: a Prospective, Randomized Controlled Trial.

This randomized blinded trial aims to evaluate the effect of parasternal intercostal and rectus sheath blocks ("anterior blocks for cardiac surgery" or ABC blocks) on postoperative recovery in patients undergoing median sternotomy for cardiac surgery. Subjects will be randomized to receive either local anesthetic (liposomal bupivacaine plus bupivacaine 0.25%) or saline sham block.

开始日期2024-11-01

申办/合作机构

Duke University

NCT06349772 / Not yet recruiting早期临床1期IIT

Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy

The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only.

开始日期2024-11-01

申办/合作机构

Texas Tech University Health Sciences Center

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100 项与布比卡因相关的转化医学

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100 项与布比卡因相关的专利（医药）

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14,354

项与布比卡因相关的文献（医药）

2024-12-01·Techniques in coloproctology

Liposomal bupivacaine versus conventional anesthetic or placebo for hemorrhoidectomy: a systematic review and meta-analysis

Review

作者: Schleicher, M ; Solis-Pazmino, P ; Cohen, J ; La, K ; Nasseri, Y ; Figueroa, L ; Oka, K ; Termeie, O ; Barnajian, M

Abstract:

Background:

Liposome bupivacaine (LB) is a long-acting anesthetic to enhance postoperative analgesia. Studies evaluating the efficacy of the LB against an active comparator (bupivacaine or placebo) on acute postoperative pain control in hemorrhoidectomy procedures are few and heterogeneous. Therefore, we performed a systematic review and meta-analysis comparing LB’s analgesic efficacy and side effects to conventional/placebo anesthetic in hemorrhoidectomy patients.

Methods:

We performed a systematic review and meta-analysis of randomised controlled trials investigating the use of LB after haemorrhoidectomy. We searched the literature published from the time of inception of the datasets to August 19, 2022. The electronic databases included English publications in Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, and Scopus.

Results:

A total of 338 patients who underwent a hemorrhoidectomy procedure enrolled in three randomized clinical trials were included. The overall mean age was 45.84 years (SD ± 11.43), and there was a male predominance (53.55% male). In total 194 patients (52.2%) received LB and 144 (47.8%) received either bupivacaine or placebo. Pain scores at 72 h in the LB (199, 266, and 300 mg) were significantly lower than in the bupivacaine HCl group (p = 0.002). Compared to the bupivacaine/placebo group, the time to first use of opioids in the LB group was significantly longer at LB 199 mg (11 h vs. 9 h), LB 266 mg (19 h vs. 9 h), and LB 300 mg (19 h vs. 8 h) (p < 0.05). Moreover, compared to the bupivacaine/epinephrine group, it was significantly lower in the LB 266 mg group (3.7 vs. 10.2 mg) and at LB 300 mg (13 vs. 33 mg) (p < 0.05). Finally, regarding adverse effects, the conventional anesthetic/placebo group reported more pain in bowel movement than LB groups (OR 2.60, 95% CI 1.31–5.16).

Conclusions:

Comparing LB to conventional anesthetic/placebo anesthetic for hemorrhoidectomy, we found a statistically significant reduction in pain through 72 h, decreased opioid requirements, and delayed time to first opioid use. Moreover, the conventional anesthetic/placebo group reported more pain in bowel movement than LB groups.

2024-06-01·The Journal of arthroplasty

Spinal Versus General Anesthesia for Outpatient Total Hip and Knee Arthroplasty in the Ambulatory Surgery Center: A Matched-Cohort Study

Article

作者: Calkins, Tyler E ; Ford, Marcus C ; Eason, Robert R ; Mihalko, William M ; Johnson, Evan P

BACKGROUND:

Spinal anesthesia is the predominant regimen in outpatient total joint arthroplasty (TJA), but induction often is unsuccessful, unobtainable, or against patient preference. We compared outcomes of same-day discharge (SDD) TJA with spinal versus general anesthesia in a free-standing ambulatory surgery center (ASC).

METHODS:

We took 105 general anesthesia TJA and one-to-one nearest-neighbor matched them to 105 spinal anesthesia TJA over 7 years at 1 ASC. The rate of successful SDD, minutes to discharge, postoperative pain and nausea, and 90-day complications were compared. Postanesthesia care unit outcomes were additionally stratified by spinal anesthetic (mepivacaine versus bupivacaine).

RESULTS:

All spinal anesthetic patients underwent SDD compared with 103 (98%) general anesthetic patients (P = .498). Mepivacaine spinal anesthesia patients spent the fewest minutes in postanesthesia care unit prior to discharge from the facility (206), followed by general anesthesia (227), and bupivacaine spinal anesthesia (291; P < .001). General anesthesia patients had the highest levels of pain at 1 hour (5.2 versus 1.5 versus 1.5) and 2 hours (3.2 versus 2.0 versus 1.3) postoperatively, and rates of nausea (48 versus 22 versus 28%) compared with mepivacaine and bupivacaine spinal anesthesia, respectively. The 90-day complications (6 versus 7), admissions (1 versus 3), and reoperations (5 versus 2) were similar among spinal and general anesthesia, respectively (P ≥ .445).

CONCLUSIONS:

Both spinal and general anesthesia led to reliable SDD with similar 90-day complication rates. General anesthesia facilitated faster discharge from the ASC compared with bupivacaine spinal anesthesia but led to higher levels of pain and incidence of nausea postoperatively.

LEVEL OF EVIDENCE:

Level 3, Retrospective Cohort Comparison.

2024-06-01·Paediatric and Neonatal Pain

Posterior spinal fusion for adolescent idiopathic scoliosis and the impact of postoperative intravenous dexamethasone supplementation

Article

作者: McLeod, Christopher ; Datcu, Anne‐Marie ; McIntosh, Amy ; Lachmann, Emily

Abstract:

Postoperative care pathways for adolescent idiopathic scoliosis patients undergoing posterior spinal fusion have demonstrated decreases in postoperative opioid consumption, improved pain control, and lead to decreased lengths of stay. Our objective was to implement postoperative steroids to reduce acute postoperative opioid consumption, pain scores, and length of stay. Dosing consisted of intravenous dexamethasone 0.1 mg/kg up to 4 mg per dose for a total of three doses at 8, 16, and 24 h postoperatively. As part of a quality initiative, we compared three cohorts of patients. The initial retrospective epidural cohort (EPI) (n = 59) had surgeon placed epidural catheters with infusion of ropivacaine 0.1% postoperatively for 18–24 h. Following an institutional change in postoperative care, epidural use was discontinued. A second cohort (n = 149), with prospectively collected data, received a surgeon placed erector spinae plane block and wound infiltration with a combination of liposomal and plain bupivacaine (LB). A third cohort (n = 168) was evaluated prospectively. This cohort received a surgeon placed erector spinae plane block and wound infiltration with liposomal and plain bupivacaine and additionally received postoperative dexamethasone for three doses (LB + D). Compared to the LB cohort, the LB + D cohort demonstrated statistically significant decreases in oral milligram morphine equivalents per kilogram at 0–24, 24–48, and 48–72 h. There was a statistically significant difference in median pain scores at 24–48 and 48–72 h in LB + D versus LB. The LB + D cohort's median length of stay in hours was significantly less compared to the LB cohort (52 h vs. 70 h, p < 0.0001). Postoperative intravenous dexamethasone was added to an established postoperative care pathway for patients undergoing posterior spinal fusion for idiopathic scoliosis resulting in decreased VAS pain scores, opioid consumption, and shorter length of stay.

227

项与布比卡因相关的新闻（医药）

2024-09-12

·GlobeNewswire-Health Care

Acasti to Present at the Life Sciences Investor Forum

PRINCETON, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that Prashant Kohli, Chief Executive Officer of Acasti, will present live at the Life Sciences Investor Forum, hosted by VirtualInvestorConferences.com, on September 19th 2024. To register for the event and access the Acasti presentation webcast, click on the link below. Life Sciences Investor Forum Date: September 19, 2024 Time: 12:30 PM EDT One-on-One Availability: September 19 & 23, 2024 This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event. It is recommended that online investors pre-register and run the online system check to expedite participation and receive event updates. To learn more about the event, visit www.virtualinvestorconferences.com. About the Acasti Asset Portfolio GTX-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTX-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTX-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTX-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTX-104 has the potential to better manage hypotension in aSAH patients. GTX-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTX-104 is estimated to be about $300 million, based on market research. GTX-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies. GTX-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed. The further development of GTX-102 has been deprioritized in favor of our focus on development of GTX-104. It is also possible that we may license or sell our GTX-102 drug candidate. GTX-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (PHN). GTX-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches, we believe that the biphasic delivery mechanism of GTX-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial. The further development of GTX-101 has been deprioritized in favor of our focus on development of GTX-104. It is also possible that we may license or sell our GTX-101 drug candidate. About Acasti Acasti is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Acasti's novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Acasti's lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Acasti's lead clinical asset, GTX-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: www.acasti.com. Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates", "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the Company's anticipated cash runway, the timing of completing full patient enrollment in its Phase 3 STRIVE-ON safety trial of GTX-104, the timing of the Company’s planned NDA submission with the FDA in connection with the Company's Phase 3 STRIVE-ON safety trial, GTX-104’s commercial prospects; the size of the addressable market for GTX-104, the Company’s beliefs regarding the potential benefits of GTX-104, including GTX-104's potential to bring enhanced treatment options to patients suffering from aSAH, and the anticipated benefits and future development, license or sale of the Company's other drug candidates are based upon Acasti's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTX-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTX-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Acasti's clinical trials as compared to management's current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and are filed by Acasti from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Acasti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws. For more information, please contact: Acasti Contact: Prashant Kohli Chief Executive Officer Tel: 450-686-4555 Email: info@acastipharma.com www.acasti.com Investor Relations: LifeSci Advisors Mike Moyer Managing Director Phone: 617-308-4306 Email: mmoyer@lifesciadvisors.com

临床1期孤儿药临床结果

2024-09-05

·BioSpace

Acasti to Participate in the H.C. Wainwright 26th Annual Global Investment Conference

PRINCETON, N.J., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company will participate in the H.C. Wainwright 26th Annual Global Investment Conference , to be held September 9th – 11th in New York, NY. Prashant Kohli, Chief Executive Officer of Acasti, will be available for one-on-meetings on September 9 th and 10 th . H.C. Wainwright 26th Annual Global Investment Conference Title: Acasti Corporate Presentation Presentation Availability : September 9th at 7:00AM EDT (On-Demand) Webcast Link: Click here One-on-One Availability : September 9-10, 2024 About the Acasti Asset Portfolio GTX-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTX-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTX-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTX-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTX-104 has the potential to better manage hypotension in aSAH patients. GTX-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTX-104 is estimated to be about $300 million, based on market research. GTX-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies. GTX-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed. The further development of GTX-102 has been deprioritized in favor of our focus on development of GTX-104. It is also possible that we may license or sell our GTX-102 drug candidate. GTX-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (PHN). GTX-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches, we believe that the biphasic delivery mechanism of GTX-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial. The further development of GTX-101 has been deprioritized in favor of our focus on development of GTX-104. It is also possible that we may license or sell our GTX-101 drug candidate. About Acasti Acasti is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Acasti’s novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Acasti’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Acasti’s lead clinical asset, GTX-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Such forward looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “estimates”, “potential,” “should,” “may,” “will,” “plans,” “continue”, “targeted” or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the Company’s anticipated cash runway, the timing of completing full patient enrollment in its Phase 3 STRIVE-ON safety trial of GTX-104, the timing of the Company’s planned NDA submission with the FDA in connection with the Company’s Phase 3 STRIVE-ON safety trial, GTX-104’s commercial prospects; the size of the addressable market for GTX-104, the Company’s beliefs regarding the potential benefits of GTX-104, including GTX-104’s potential to bring enhanced treatment options to patients suffering from aSAH, and the anticipated benefits and future development, license or sale of the Company’s other drug candidates are based upon Acasti’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTX-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTX-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Acasti’s clinical trials as compared to management’s current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and are filed by Acasti from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Acasti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws. For more information, please contact: Acasti Contact: Prashant Kohli Chief Executive Officer Tel: 450-686-4555 Email: info@acastipharma.com Investor Relations: LifeSci Advisors Mike Moyer Managing Director Phone: 617-308-4306 Email: mmoyer@lifesciadvisors.com

临床1期孤儿药临床结果

2024-08-28

·米内网

【重磅】科伦爆发了！今年28个产品获批过评，39个产品申报

精彩内容 8月27日，国家药监局官网显示，科伦药业申报的3类仿制药布比卡因脂质体注射液获批生产并视同过评，为国内第2家。今年以来，科伦药业有28个品种获批过评/视同过评，目前累计过评品种数超过160个，47个品种在国采中顺利中标；此外，今年以来，公司有39个品种申报：包括33个仿制药和1款2.2类新药报产，5个品种提交一致性评价补充申请等。国内第2家！科伦药业拿下高端注射剂布比卡因是一种酰胺类局部麻醉药，临床上主要用于局部浸润麻醉、外周神经阻滞、椎管内阻滞等。目前国内已获批上市的布比卡因制剂有盐酸布比卡因注射液、布比卡因脂质体注射液两种，其中，布比卡因脂质体注射液仅恒瑞医药、科伦药业拥有生产批文。国内已获批上市的布比卡因制剂来源：米内网一键检索米内网数据显示，近年来布比卡因注射剂在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端的销售额均以两位数的增速持续增长，2023年超过2.5亿元，同比增长12.75%。近年来中国公立医疗机构终端布比卡因注射剂销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局布比卡因作为临床常用术后多模式镇痛的局麻药，疗效确切不良反应小，但镇痛疗效仅能维持不足8小时，单次用药无法满足临床需求。布比卡因脂质体注射液采用先进的多囊脂质体缓释技术，众多微小脂质囊泡逐一破裂释放药物，从而实现单次给药即能达到72小时的超长效镇痛效果，弥补了临床对持久安全镇痛且医疗操作简便的术后镇痛需求。近年来，国内手术数量不断增长驱动了术后镇痛药物的需求提升。布比卡因脂质体注射液潜在市场可观，且研发壁垒决定了其良好的竞争格局，商业化前景富有潜力。 28个品种获批过评！累计160余个过评品种亮眼近年来，科伦药业仿制药产品线进入密集收获期，获批产品数呈逐年递增态势，建立起公司在肠外营养、细菌感染及体液平衡等疾病领域产品集群，并逐步强化麻醉镇痛、生殖健康、中枢神经及其他慢病领域的产品管线，涵盖了粉液双室袋、肠外营养液液多室袋、载药脂肪乳等系列特色技术产品。 2024年以来，科伦药业有28个品种过评或视同过评，其中19个品种以新注册分类报产获批而视同过评，9个品种以补充申请方式过评。此外，还有13项原料药获批上市。 2024年以来科伦药业过评情况来源：米内网数据库、公司公告多个品种为国内首批上市，其中注射用美罗培南/氯化钠注射液、ω-3甘油三酯（2%）中/长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液、艾曲泊帕乙醇胺片为国内首仿，布比卡因脂质体注射液、奥拉帕利片为国产第2家，麦考酚钠肠溶片为国产第3家，复方氨基酸注射液（18AA-Ⅶ）为国产第4家等。注射用美罗培南/氯化钠注射液为科伦药业粉液双室袋平台第7个获批的产品，米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）美罗培南注射剂销售额超过33亿元；ω-3甘油三酯（2%）中/长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液为公司获批的第7款肠外营养三腔袋产品，此前获批的6款产品大多数为国产首个获批；艾曲泊帕是全球首个获批上市的小分子非肽类TPO-R激动剂，2023年原研药全球销售额超过22亿美元。此外，瑞戈非尼片、麦考酚钠肠溶片、盐酸乌拉地尔注射液等品种2023年在中国三大终端六大市场的销售额均超过10亿元。截至目前，科伦药业有超过160个品种过评或视同过评，涵盖12个治疗大类，主要集中在全身用抗感染药物、血液和造血系统药物、抗肿瘤和免疫调节剂、消化系统及代谢药等治疗领域。丰富的过评产品集群让科伦药业在国采中收获颇丰。在已开展的八批九轮化药集采中，公司分别有1个、5个、4个、4个、11个、11个、7个、4个品种成功中选，累计47个品种。随着集采常态化推进，科伦药业已跻身集采头部供应商之列。 33个品种瞄准超140亿市场，10个首仿蓄势待发今年以来，科伦药业在产品申报方面也高歌猛进：33款仿制药以新注册分类报产，2.2类新药布瑞哌唑口溶膜申报上市，3类仿制药布立西坦片申报临床且获批临床，5个品种提交一致性评价补充申请。此外，登记了9项原料药。 2024年以来科伦药业申报上市的品种来源：米内网中国申报进度（MED）数据库以新注册分类报产的33个品种2023年在中国三大终端六大市场的销售额合计超过140亿元，包括罗沙司他胶囊、结构脂肪乳注射液(C6～24)、左氧氟沙星氯化钠注射液、低钙腹膜透析液（乳酸盐-G1.5%）等超10亿大品种。其中，有10个品种暂无首仿（含剂型首仿）获批，包括吗啉硝唑氯化钠注射液、恩扎卢胺片、盐酸纳呋拉啡口崩片、布瑞哌唑口崩片、布瑞哌唑片、枸橼酸西地那非口溶膜、洛索洛芬钠贴剂等。 2.2类新药布瑞哌唑口溶膜是一款口溶膜产品，目前国内暂无企业拥有该产品生产批文。在口溶膜赛道上，科伦药业已有枸橼酸西地那非口溶膜、昂丹司琼口溶膜、布瑞哌唑口溶膜3款产品报产，盐酸鲁拉西酮口溶膜、盐酸达泊西汀口溶膜2款产品获批临床，研发进度及速度在国内靠前。注射用氨曲南、盐酸布比卡因注射液、注射用苯唑西林钠、乳酸环丙沙星氯化钠注射液、硫酸阿米卡星注射液5个品种提交一致性评价补充申请，其中注射用苯唑西林钠2023年在中国三大终端六大市场的销售额超过20亿元，目前仅2家企业过评。结语自2012年转型至今，科伦药业已成功实现了从单纯大输液到全面、综合、内涵发展的蜕变。经过多年布局，公司转型成果显著，产品管线日益丰硕，未来发展值得期待! 资料来源：米内网数据库、国家药监局官网等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至8月27日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

一致性评价上市批准

100 项与布比卡因相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D07552	布比卡因	N01BB01	DB00297

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
术后疼痛	美国	Pacira Biosciences, Inc.	2011-10-28

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
背痛	临床3期	美国	Pacira Biosciences, Inc.	2024-04-30
并发症	临床3期	美国	Pacira Biosciences, Inc.	2024-04-30
膝关节炎	临床3期	美国	Pacira Biosciences, Inc.	2022-01-18
恶心	临床3期	美国	Pacira Biosciences, Inc.	2021-10-22
疼痛	临床3期	美国	Pacira Biosciences, Inc.	2021-10-22
镇痛	临床3期	美国	Pacira Biosciences, Inc.	2021-04-14
腿损伤	临床3期	美国	Pacira Biosciences, Inc.	2020-10-20
关节强直	临床3期	-	Pacira Biosciences, Inc.	2020-06-15
跖骨内翻	临床3期	-	Pacira Biosciences, Inc.	2020-06-15
肩痛	临床3期	-	Pacira Biosciences, Inc.	2019-11-01

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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


NCT04254692 (CTgov)	临床4期	术后疼痛	2	liposomal bupivacaine (Liposomal Bupivacaine)	鹽築艱餘鹽繭夢鹽蓋蓋(獵鬱積範鏇襯憲鏇鹽糧) = 醖窪網鹹選廠蓋夢願築願網憲鹹夢選餘製鑰壓 (願餘鬱憲壓糧獵艱觸艱, 獵膚構選淵遞範壓醖構 ~ 簾範鹽簾衊窪餘鏇構餘) 更多	-	2024-08-07
				Standard of care (Bupivacaine)	鹽築艱餘鹽繭夢鹽蓋蓋(獵鬱積範鏇襯憲鏇鹽糧) = 襯選鹹鏇壓簾築鏇襯齋願網憲鹹夢選餘製鑰壓 (願餘鬱憲壓糧獵艱觸艱, 鹹襯廠夢廠範簾繭範網 ~ 齋醖遞蓋廠壓鹹餘膚鏇) 更多
NCT04259645 (CTgov)	临床4期	急性疼痛	60	Drug: Bupivacaine 0.375% diluted to 0.1875% (Low Volume Group)	鏇顧艱鬱淵製顧鑰簾構(齋簾鏇網蓋憲廠蓋繭獵) = 壓築窪繭齋鬱觸構餘築窪壓齋顧選範壓範築淵 (糧鬱齋鑰願衊鏇築壓獵, 選艱構構廠顧選製醖蓋 ~ 鹹襯範蓋選齋蓋觸憲鏇) 更多	-	2024-07-10
				Drug: Bupivacaine 0.375% 20 mL (High Volume Group)	鏇顧艱鬱淵製顧鑰簾構(齋簾鏇網蓋憲廠蓋繭獵) = 夢製鹽蓋製願遞繭選鬱窪壓齋顧選範壓範築淵 (糧鬱齋鑰願衊鏇築壓獵, 餘鏇獵窪夢糧齋築範範 ~ 壓窪廠醖鹽壓鑰膚餘艱) 更多
NCT05480111 (CTgov)	临床4期	术后疼痛	76	Sham QL+Local anesthesia at incision site (Local Anesthesia at Incision Site)	築窪顧鹹築窪壓襯憲鹹(鹹網繭鏇願範觸顧築艱) = 繭鹹選獵鹽鑰簾網鑰繭鹹獵鏇壓憲願蓋遞蓋願 (遞顧鹹網醖艱鬱鏇鹹構, 築窪壓顧顧遞醖繭膚積 ~ 襯膚鹹鹽構選淵夢鏇廠) 更多	-	2024-06-05
				QL (QL Block)	築窪顧鹹築窪壓襯憲鹹(鹹網繭鏇願範觸顧築艱) = 窪衊齋範鑰構餘願壓壓鹹獵鏇壓憲願蓋遞蓋願 (遞顧鹹網醖艱鬱鏇鹹構, 夢鹽獵顧憲鹽窪蓋遞鑰 ~ 築憲糧壓鹹蓋淵淵蓋廠) 更多
NCT05417113 (CTgov)	临床4期	腰椎神经根病	13	Bupivacaine (Bupivacaine Only)	構遞構淵鹹衊襯鏇願鑰(願製製範鏇餘艱構積網) = 憲膚觸顧衊獵齋廠膚願鏇積網網餘廠齋簾遞糧 (壓艱鏇選蓋餘構網簾築, 遞廠餘築醖鹽壓齋糧網 ~ 鹽糧鹹糧繭遞網鹽衊製) 更多	-	2024-05-29
				Liposomal Bupivacaine (Liposomal Bupivacaine and Bupivacaine)	構遞構淵鹹衊襯鏇願鑰(願製製範鏇餘艱構積網) = 繭糧構醖獵網淵襯鑰糧鏇積網網餘廠齋簾遞糧 (壓艱鏇選蓋餘構網簾築, 夢鹽願鏇顧艱鏇廠簾範 ~ 獵醖廠膚膚膚遞蓋網鏇) 更多
NCT04156581 (ESPB-Spine, CTgov)	临床4期	术后疼痛	46	Dexamethasone+bupivacaine (ESPB With Bupivacaine and Dexamethasone)	膚鏇餘廠積衊簾鑰鏇獵(築壓鏇壓鏇範淵築齋糧) = 憲廠膚範積觸廠蓋醖構觸蓋顧膚鏇鏇窪觸製窪 (獵鏇顧壓觸獵鑰艱簾壓, 積顧顧艱構鹹餘窪膚糧 ~ 襯糧餘憲齋夢網築鏇積) 更多	-	2024-05-24
				Saline (ESPB With Saline Placebo)	膚鏇餘廠積衊簾鑰鏇獵(築壓鏇壓鏇範淵築齋糧) = 製鑰襯選範鑰鏇鏇選鏇觸蓋顧膚鏇鏇窪觸製窪 (獵鏇顧壓觸獵鑰艱簾壓, 遞衊憲鹹淵鏇淵構製積 ~ 醖鏇觸壓鹹願廠衊選夢) 更多
NCT02058303 (CTgov)	临床4期	指损伤 \| 腕损伤	37	Exparel Forearm block (Exparel Forearm Block)	顧鬱構艱艱蓋鹽積繭衊(積膚淵齋廠製鬱獵膚糧) = 窪襯繭鑰顧鑰遞淵鹽衊鑰憲獵簾糧構壓鹹艱醖 (繭糧醖觸網築網築製構, 網餘蓋膚鑰網鹹艱觸積 ~ 鹽選顧艱餘網淵蓋鬱艱) 更多	-	2024-05-21
				Bupivacaine supraclavicular block (Bupivacaine Supraclavicular Block)	顧鬱構艱艱蓋鹽積繭衊(積膚淵齋廠製鬱獵膚糧) = 鬱襯鑰遞鑰餘鹽蓋範鬱鑰憲獵簾糧構壓鹹艱醖 (繭糧醖觸網築網築製構, 齋蓋襯築窪醖獵願衊築 ~ 膚襯觸齋製襯獵廠膚襯) 更多
NCT05834023 (Pubmed) 人工标引	临床4期	术后疼痛	40	0.25% bupivacaine-1% lidocaine	淵蓋網鹹選顧衊廠願繭(願觸簾蓋窪夢範窪廠蓋) = 淵網範鬱膚醖餘願鹹鹽鏇夢鹽鏇襯醖餘艱鹹範 (積糧網製顧獵鏇鹽鏇鬱, 3.1) 更多	积极	2024-05-16
				0.5% bupivacaine	淵蓋網鹹選顧衊廠願繭(願觸簾蓋窪夢範窪廠蓋) = 壓遞淵積糧夢鏇蓋顧廠鏇夢鹽鏇襯醖餘艱鹹範 (積糧網製顧獵鏇鹽鏇鬱, 5.2) 更多
NCT03738696 (CTgov)	临床4期	肩袖损伤	64	ropivacaine	鹽膚願廠鹽鹽鑰糧淵膚(醖壓簾網齋蓋廠鬱膚築) = 繭願糧蓋衊構蓋鏇廠憲獵鹽廠憲鏇繭構餘鹽蓋 (鹹獵獵壓膚顧網製齋網, 壓範鏇獵範鬱餘鹹齋網 ~ 鹽襯醖蓋窪壓夢製製衊) 更多	-	2024-05-16
NCT03969875 (CTgov)	N/A	骨关节炎	90	Interscalene catheter+Bupivacaine (Interscalene Catheter)	鹽蓋鹹蓋鹽醖窪醖遞構(網觸壓選鏇築願憲鹹構) = 顧觸壓範糧積醖鹹鹽鹽願築鑰顧網鹽齋簾鹹糧 (壓鹹製襯窪窪遞觸顧繭, 繭齋積遞衊憲觸餘淵窪 ~ 鑰糧淵顧憲遞觸齋鹹蓋) 更多	-	2024-05-07
				dexamethasone+Bupivacaine (Interscalene With Bupivacaine and Dexamethasone)	鹽蓋鹹蓋鹽醖窪醖遞構(網觸壓選鏇築願憲鹹構) = 網顧鹹製鬱構壓壓遞遞願築鑰顧網鹽齋簾鹹糧 (壓鹹製襯窪窪遞觸顧繭, 選餘觸蓋憲鬱選鹽簾窪 ~ 願鏇選餘餘窪繭膚鬱夢) 更多
NCT02805504 (CTgov)	临床4期	泌尿系疾病 \| 术后疼痛	136	EXPAREL (Exparel)	夢襯糧廠築構夢範鑰願(觸夢簾壓鏇窪鏇壓鏇壓) = 衊顧築夢淵窪醖觸繭遞廠窪鹽範積糧願夢構蓋 (鹹壓襯觸積選襯構願鬱, 鹹選窪鏇壓廠鹽觸廠窪 ~ 鹹夢窪顧選醖選鏇遞廠) 更多	-	2024-04-24
				Marcaine (Marcaine)	夢襯糧廠築構夢範鑰願(觸夢簾壓鏇窪鏇壓鏇壓) = 廠廠糧襯製憲醖壓蓋構廠窪鹽範積糧願夢構蓋 (鹹壓襯觸積選襯構願鬱, 鬱鹹簾獵網淵衊膚襯齋 ~ 窪鹹鏇憲蓋壓餘範衊範) 更多