Efficacy of Local Delivery of MicroRNAs and MicroRNA Inhibitors in Promoting Osteogenesis and Modulating Local Inflammation: A Pilot Clinical Trial Using the Tooth Socket Model
To evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAs, and/or microRNA inhibitors, in the promotion of osteogenesis and modulation of the inflammatory response on the basis of different clinical, radiographic, histologic and biomolecular outcomes in post-extraction socket defects in humans.
EFFICACY OF ULTRASOUND GUIDED RHOMBOID INTERCOSTAL NERVE BLOCK AND SUBSERRATUS BLOCK(RISS) IN PAEDIATRIC PATIENTS UNDERGOING THORACOTOMY. - RISS
100 项与 XEL-006LG 相关的专利（医药）
项与 XEL-006LG 相关的文献（医药）
2023-08-25·Pediatric emergency care
Applying Topical Anesthetic on Pediatric Lacerations in the Emergency Department: A Quality Improvement Project.
作者: Nagham Faris ; Mohamad Mesto ; Sandra Mrad ; Ola El Kebbi ; Noor Asi ; Rasha D Sawaya
Caring for pediatric lacerations in the emergency department (ED) is typically painful because of irrigation and suturing. To improve this painful experience, we aimed to increase the use of a topical anesthetic, Eutectic Mixture of Local Anesthetics (EMLA) on eligible pediatric lacerations with an attainable, sustainable, and measurable goal of 60%. The baseline rate of applying topical anesthetic to eligible lacerations was 23% in our ED. We aimed to increase the use of topical anesthetics on eligible pediatric lacerations to a measurable goal of 60% within 3 months of implementing our intervention.
We conducted a prospective, single-center, interrupted time series, ED quality improvement project from November 2019 to July 2020. A multidisciplinary team of physicians and nurses performed a cause-and-effect analysis identifying 2 key drivers: early placement of EMLA and physician buy-in on which we built our Plan, Do, Study, and Act (PDSA) cycles. We collected data on number of eligible patients receiving EMLA, as well as patient and physician feedback via phone calls within 2 days after encounter. Balancing measures included ED length of stay (LOS), patient and physician satisfaction with EMLA, and adverse effects of EMLA.
We needed 3 PDSA cycles to reach our goal of 60% in 3 months, which was also maintained for 5 months. The PDSA cycles used educational interventions, direct provider feedback about noncompliance, and patient satisfaction results obtained via phone calls. Balancing measures were minimally impacted: 75% good patient satisfaction, no adverse events but an increase in LOS of patients who received EMLA compared with those who did not (1.79 ± 0.66 vs 1.41 ± 0.83 hours, P < 0.001). The main reasons for dissatisfaction for physicians were the increased LOS and the preference for procedural sedation or intranasal medications.
With a few simple interventions, our aim of applying EMLA to 60% of eligible pediatric lacerations was attained and maintained.
2023-08-23·Journal of the American Association for Laboratory Animal Science : JAALAS
Comparison of Systemic Extended-release Buprenorphine and Local Extended-release Bupivacaine-Meloxicam as Analgesics for Laparotomy in Mice.
作者: Peggy Yang ; Gerry Hish ; Patrick A Lester
Extended-release (ER) local anesthetics can be used in multi-modal analgesia or in situations in which systemic analgesics may alter animal physiology and thus introduce interpretational confounds. In this study, we compared the analgesic efficacy of an ER buprenorphine formulation with that of a synergistic combination of ER bupivacaine and meloxicam. Female and male CD1 mice were randomly assigned to receive subcutaneous buprenorphine (3.25 mg/kg) preemptively, subcutaneous infiltration of bupivacaine-meloxicam (0.03 mL at incision closure (bupivacaine, 35 mg/kg; meloxicam, 1 mg/kg), or saline (10 mL/kg SC) after induction of anesthesia. After laparotomy, mice were assessed for changes in daily body weight, rearing frequency, nest consolidation scores, time-to-integrate-nest test (TINT), and response to von Frey testing at 4, 8, 24, 48, and 72 h after surgery. Daily weight, nest consolidation scores and rearing frequency were not significantly different among the 3 groups. TINT had fallen significantly response at 24 and 48 h after injection in the ER buprenorphine group as compared with the saline and ER bupivacaine-meloxicam groups. Nociceptive thresholds, as assessed with von Frey testing, differed between saline controls and both analgesic groups at 4, 8, 24, 48, and 72 h after surgery. None of the mice in thebupivacaine-meloxicam group developed signs of neurotoxicity, a potential side effect of high-dose local anesthetics. Thisstudy demonstrates that local ER bupivacaine-meloxicam may be a useful alternative to systemic, ER buprenorphine forthe relief of pain after laparotomy in mice.
2023-08-22·Clinical oral investigations
Analgesic effect of a lidocaine-ropivacaine mixture for extraction of impacted mandibular third molars: a randomized controlled trial.
The painless postoperative period can be significantly prolonged by using long-acting local anesthetics such as ropivacaine, though these local anesthetics are known for their slower onset of action. To compensate for this, a mixture of short-onset (e.g., lidocaine) and long-acting local anesthetics is used. However, the efficacy of such an anesthetic cocktail has not been elucidated in the field of oral and maxillofacial surgery.
MATERIALS AND METHODS:
To address the research purpose, this prospective randomized controlled trial included 56 patients scheduled for impacted mandibular third molar extraction. All patients received the inferior alveolar nerve block (IANB) using either 2% lidocaine with epinephrine or a 1:1 mixture of 2% lidocaine with epinephrine and 0.75% ropivacaine.
Patients anesthetized using the lidocaine-ropivacaine mixture showed significantly prolonged postoperative analgesia and pain control than those anesthetized using lidocaine only.
IANB using a lidocaine-ropivacaine mixture can provide prolonged postoperative anesthesia and pain control with extraction of mandibular third molars.
This method can be a noteworthy addition to existing methods of local anesthesia for the extraction of mandibular third molars. Trial registration number University Hospital Medical Information Network (No. UMIN000044315).
CRYSTAL LAKE, Ill., June 20, 2023 (GLOBE NEWSWIRE) -- 20/20 Imaging, a division of Konica Minolta Healthcare Americas, Inc. and a leader in veterinary imaging solutions, announced today a distribution agreement with Medovate Ltd., a medical device development company based in Cambridge, UK, to bring the pioneering SAFIRA® system for regional anesthesia to the US veterinary market. Konica Minolta's ultrasound systems are an excellent complement to the SAFIRA system as ultrasound is optimally used to guide the exact placement of local/regional anesthetic as well as provide real-time assessment of the needle advancement. This agreement will further expand the use of regional anesthesia with ultrasound imaging in veterinary practices. 20/20 Imaging is a leading provider of Konica Minolta Healthcare’s advanced ultrasound systems, such as the SONIMAGE® HS2 Portable Ultrasound System and the SONIMAGE® MX1 Platinum Compact Ultrasound System, to the US veterinary market. Ultrasound is widely considered the gold standard for safety and efficacy in regional anesthesia1,2,3. In human studies, regional anesthesia has demonstrated better post-operative analgesia, decreased opioid consumption and length of stay, early rehabilitation, fewer anesthesia-related side effects and high patient satisfaction compared to general anesthesia4,5. Ultrasound-guided regional anesthesia is increasingly being used in veterinary practices due to these benefits and the improved quality of patient recovery compared to general anesthesia. Nerve injury for instance, is harder to ascertain in animals. Small animals, such as cats, also have increased sensitivity to local anesthetics when compared with other species, necessitating much lower maximum doses be used6. SAFIRA (Safer Injection for Regional Anesthesia) is a medical device designed to limit injection pressure and automatically stop injection at high pressures, helping to reduce the risk of nerve injury and improving patient safety. The solution also transforms regional anesthesia into a one-person procedure by allowing a single veterinarian to conduct the entire procedure. Previously, an assistant was required to inject the anesthetic solution at the required pressure while the practitioner inserted the needle tip using ultrasound guidance. Bob Salzman, President 20/20 Imaging says, “20/20 Imaging is proud to be the appointed veterinary distributor for SAFIRA and bring the unique benefits and safety profile of this technology to our US customers. As with human patients, regional anesthesia delivers numerous advantages to animal patients and by enabling a one-person procedure, more veterinarians will be able to utilize this capability. SAFIRA is the perfect complement to our portfolio of leading ultrasound solutions, further enabling our veterinary customers to deliver the best care to their patients.” Stuart Thomson, Managing Director at Medovate says, “With a significant number of regional anesthesia blocks performed in veterinary practice each year globally, SAFIRA can play a significant role in the future of veterinary regional anesthesia practice. We are delighted to be partnering with 20/20 Imaging as our new distributor partner for SAFIRA in the veterinary market in the US and we look forward to working with them. It is a very exciting time for our company and we look forward to helping veterinarians across the US elevate the quality and safety of interventions and treatments.” Developed in collaboration with consultant anesthesiologists in the UK National Health Service (NHS), SAFIRA has been successfully launched in the human healthcare field in the USA, UK, Europe, Australia, New Zealand, Singapore and the Middle East. Griffin J, Nicholls B. Ultrasound in regional anaesthesia. Anaesthesia. 2010;65 Suppl 1:1-12.Sites BD, Antonakakis JG. Ultrasound guidance in regional anesthesia: state of the art review through challenging clinical scenarios. Local Reg Anesth. 2009;2:1-14.Andrew T. Gray, David C. Warltier; Ultrasound-guided Regional Anesthesia: Current State of the Art. Anesthesiology 2006; 104:368–373.Cozowicz C, Poeran J, Zubizarreta N, et al. Trends in the Use of Regional Anesthesia: Neuraxial and Peripheral Nerve Blocks. Regional Anesthesia & Pain Medicine 2016;41:43-49.Albrecht, E. and Chin, K.J. Advances in regional anaesthesia and acute pain management: a narrative review. Anaesthesia, 2020; 75: e101-e110.Regional Anesthesia and Pain Management in Veterinary Medicine (asra.com) About 20/20 Imaging 20/20 Imaging, a division of Konica Minolta Healthcare, is a leading provider of healthcare IT and digital imaging solutions tailored for specialties such as podiatry, chiropractic and veterinary medicine. Utilizing its broad healthcare IT and imaging expertise, and new economical DR, ultrasound and PACS solutions, 20/20 Imaging provides comprehensive digital imaging & IT solutions and services to a large variety of small to medium size clinical specialties. About Medovate www.medovate.co.uk Medovate is a medical device company dedicated to the development and commercialisation of innovative medical technologies created within the NHS and beyond. Medovate identifies and works with high potential medtech innovations, providing the specialist management and technical resources to guide medical technologies through development, clinical trials, regulatory approval, into manufacture and on through to successful market launch. Medovate accelerates medical device innovations to market in order to benefit patient care and healthcare delivery. The company has a strong portfolio relating to specialisms in anesthesia, airway management, critical care and surgery. Medovate provides commercial returns to the NHS organisations and inventors that created the technologies helping to support further NHS innovation. Contact:Mary Beth Massatmbmassat@massatmedia.com224.578.2388www.2020imaging.net A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c5b4a85e-1a91-44ae-9aff-2d078b0ddf41
Subjects in Bunionectomy Study Dosed
Data Presented at American Society for Pharmacology and Experimental Therapeutics Shows Similar Ropivacaine Pharmacokinetic Curves From CPL-01 Across Multiple Surgeries; Minimal Variability as Compared to Liposomal Bupivacaine
SAN DIEGO, June 5, 2023 /PRNewswire/ -- Cali Biosciences Co., Ltd. (hereinafter referred to as "Cali" or "Cali Biosciences"), a biopharmaceutical company focused on the research and development of innovative drugs in the peri-operative space, announced that its second Phase III study of its core product, CPL-01 (long-acting ropivacaine), has begun with dosing in bunion patients. This study is in addition to the hernia repair study initiated last month, and is expected to help fulfill regulatory requirements of a broad indication.
CPL-01 is an extended-release injectable version of Naropin® (ropivacaine hydrochloride), developed by Cali to treat post-operative surgical pain and reduce or eliminate the need for opioids.
Dr. Grant Garbo, investigator at the site where the first subject was dosed, said, "The importance of CPL-01 in bony surgery cannot be overstated – knowing how well Cali's product has performed in Phase II, I really look forward to helping CPL-01 showcase its excellent results and safety profile in Phase III."
Cali also announced that the poster presentation "CPL-01, A Novel Extended-Release Ropivacaine, Demonstrates Consistent and Predictable Systemic Exposure" was well received at the American Society for Pharmacology and Experimental Therapeutics Annual Meeting this past weekend. Ms. Stevie Pope, lead author on the paper, commented "the fact that CPL-01 showed a similar shaped curve and a predictable median Tmax at 8-12 hours across multiple surgical models should reassure physicians – this contrasts dramatically with data published on liposomal bupivacaine, where the curves are shaped quite differently and the median Tmax can vary from under an hour to more than a day."
Dr. Erol Onel, Chief Medical Officer at Cali Biosciences US, LLC who has developed several other long-acting local anesthetics and is a co-author on the paper, agreed and stated, "Demonstrating consistent and predictable release characteristics directly addresses a frequent concern with available bupivacaine-based products: if the release characteristics in Surgery A are different from those in Surgery B, how can the existing efficacy and safety data from specific surgical procedures be generalized? The data presented resoundingly show that this inconsistency is not present with CPL-01, which clearly supports its applicability across a broad spectrum of procedures."
Mr. PJ Chen, Chief Executive Officer of Cali Biosciences, commented, "Given that ropivacaine is considered safer than bupivacaine, we saw a need for a long-acting ropivacaine rather than the bupivacaines currently available. We are confident that the phase III results in both bunion and hernia will build on our successful Phase II results, so that we can provide a new and better option for doctors and patients seeking post-operative pain management – including opioid reduction or elimination - as quickly as possible. Cali is positioned to be a leader in the peri-operative space as CPL-01 and our other pipeline products proceed, so that we can help patients world-wide."
CPL-01 is an extended-release injectable formulation of Naropin® (ropivacaine hydrochloride), which is a member of the amino amide class of local anesthetics indicated for the production of local or regional anesthesia for surgery and acute pain management. Naropin® (ropivacaine hydrochloride) Injection is approved for local or regional anesthesia for surgery and for acute pain management. However, because of the short duration of effect, frequent injections or infusion by catheter are required if protracted local analgesia is required for postoperative pain management. As a result, Cali Biosciences has developed CPL-01 based on Naropin® Injection and PG-Depot technology platform in order to prolong its duration at the local site, leading to an extended local analgesic effect.
About Cali Biosciences
Cali Biosciences Co., Ltd. was established in Cayman Islands in 2021. Cali Biosciences US, LLC was established in San Diego in 2016, and later Cali Biosciences built its global headquarters in Shenzhen and established a research and development team in Shanghai. Cali Biosciences is an innovative international biopharmaceutical company with a number of licensed independent research and development technology platforms, as well as an international scientific research and management team. It has been committed to R&D, production and sales for innovative clinical drugs in the surgical perioperative field to fully respond to unmet clinical and market needs. Cali Biosciences' product pipeline includes modified formulations and new drugs in the fields of anesthesia, analgesia and anti-inflammatory. The company is committed to serving patients and medical staff around the world.
SOURCE Cali Biosciences
Fresenius Kabi's RFID pre-tagged Rocuronium Bromide Injection is fully compatible with all major RFID kit and tray vendors
LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi, a leading provider of injectable medications, announced today it has launched Rocuronium Bromide Injection with advanced RFID-enabled labels in the United States. Rocuronium Bromide Injection is part of Fresenius Kabi's +RFID™ portfolio of smart-labeled medications, designed to help enhance patient safety and support a more-efficient medication inventory process. This will mark the first +RFID product that is compatible with Bluesight’s KitCheck product, the leading kit and tray solution for American hospitals allowing +RFID products to be used across all major RFID kit and tray vendors.
This press release features multimedia. View the full release here:
Fresenius Kabi Rocuronium Bromide Injection +RFID (Photo: Business Wire)
The use of RFID technology with pharmaceutical products supports a safe, more efficient medication inventory process that eliminates manual product tagging, data entry and may help improve patient safety by reducing medical errors.
“We’re happy to add Fresenius Kabi to our growing community of partners committed to qualifying and testing RFID products to ensure customers will be able to use them, and we are excited for the portfolio of compatible RFID products to grow. Fresenius Kabi’s use of the registry will provide hospitals the ability to instantly identify recalls and use +RFID products across the hospital system,” said Kevin MacDonald, CEO of Bluesight.
Fresenius Kabi Rocuronium Bromide Injection +RFID is available direct from the company and U.S. wholesalers in a 50 mg per 5 mL multiple dose vial. Utilizing RAIN RFID technology, the smart-labeled medication, following GS1’s open global data, has attained ARC certification by Auburn University’s RFID lab.
According to a recent study by the ASHP Foundation, 87 percent of hospitals surveyed indicate they will evaluate or use RFID in their facility, highlighting the growing demand for RFID technology in the health care industry.1 Fresenius Kabi currently offers four +RFID medications and, to meet the growing need, plans to introduce more +RFID medications in 2023.
"Fresenius Kabi is committed to answering our customers’ call and to support them in their search for improved methods of medication management,” said John Ducker, president and CEO of Fresenius Kabi USA. "Interoperability of our +RFID medications is critical to reducing pain points in the American hospital system.”
Fresenius Kabi produces Rocuronium Bromide Injection in the United States, where the company has invested nearly $1 billion in an advanced manufacturing and distribution network dedicated to serving U.S. hospitals and health systems. To learn more about how Fresenius Kabi is strengthening America’s supply chain of care, visit “More in America.”
INDICATIONS AND USAGE
Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
IMPORTANT SAFETY INFORMATION
Rocuronium Bromide Injection is for intravenous use only. This drug should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. Doses of Rocuronium Bromide Injection should be individualized and a peripheral nerve stimulator should be used to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.
Rocuronium is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents.
Appropriate Administration and Monitoring: Use only if facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available.
Anaphylaxis: Severe anaphylaxis has been reported. Consider cross-reactivity among neuromuscular blocking agents.
Risk of Death due to Medication Errors: Accidental administration can cause death. Store Rocuronium Bromide Injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product.
Need for Adequate Anesthesia: Must be accompanied by adequate anesthesia or sedation.
Residual Paralysis: Consider using a reversal agent in cases where residual paralysis is more likely to occur.
Most common adverse reactions (2%) are transient hypotension and hypertension.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or .
Succinylcholine: Use before succinylcholine has not been studied.
Nondepolarizing muscle relaxants: Interactions have been observed.
Enhanced Rocuronium Bromide Injection activity possible: When used in conjunction with Inhalation anesthetics, certain antibiotics, quinidine, magnesium, lithium, local anesthetics, procainamide.
Reduced Rocuronium Bromide Injection activity possible: When used in patients on chronic anticonvulsant therapy.
Labor and Delivery: Not recommended for rapid sequence induction in patients undergoing Cesarean section.
Pediatric Use: Onset time and duration will vary with dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients.
This Important Safety Information does not include all the information needed to use Rocuronium Bromide Injection safely and effectively. Please see full prescribing information for Rocuronium Bromide Injection at .
About Fresenius Kabi
Fresenius Kabi ( ) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn.
Bluesight solves supply chain inefficiencies and reduces risk by providing actionable analytics for every step of the medication lifecycle. Through our suite of Medication Intelligence™ solutions, Bluesight brings simplicity, visibility, and predictability to the complex world of medication management. To date, more than 1,000 U.S. and Canadian hospitals utilize Bluesight solutions to optimize their hospital’s efficiency.
Bluesight focuses on providing comprehensive, item-level data that empowers providers to make informed, accurate decisions. These solutions include RFID-enabled inventory management, controlled substance diversion prevention software and medication purchasing optimization. To learn more about Bluesight’s suite of Medication Intelligence solutions, visit us at bluesight.com.
+RFID is a registered trademark of Fresenius Kabi USA, LLC.
Advancing Medication Safety Through Technology Innovations: Focus on Radio Frequency Identification Technology. American Society of Health-System Pharmacists Foundation. 2022.