MISTRAL (Mouthwash In Sore Throat Relief: Antiinflammatory vs. Local Anesthetic Therapy) "Efficacy and Tolerability of Ketoprofen Lysine Salt as a Mouthwash in Acute Phlogosis of the Pharyngeal Cavity; Multicentre, Randomized, Single-blind, Parallel-group Comparison Versus Benzidamine Hydrochloride"

A study to in order to verify any differences between the 2 treatment groups in terms of duration of analgesic effects after the first drug intake and time to remission of symptoms and signs of pharyngitis

开始日期1998-09-01

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 Gabapentin/Ketoprofen 相关的临床结果

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100 项与 Gabapentin/Ketoprofen 相关的转化医学

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100 项与 Gabapentin/Ketoprofen 相关的专利（医药）

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项与 Gabapentin/Ketoprofen 相关的文献（医药）

2024-10-01·Journal of Ethnopharmacology

Long-term oral administration of Kelisha capsule does not cause hepatorenal toxicity in rats

Article

作者: Li, Chunying ; Han, Jiayin ; Liu, Suyan ; Lu, Xiao ; Zhao, Yong ; Su, Yan ; Meng, Jing ; Liang, Aihua ; Wang, Lianmei ; Pan, Chen ; Liu, Chenyue ; Yi, Yan ; Zhang, Yushi ; Tian, Jingzhuo

ETHNOPHARMACOLOGICAL RELEVANCEKelisha capsules (KLS) are often used to treat acute diarrhoea, bacillary dysentery, heat stroke, and other diseases. One of its components, Asarum, contains aristolochic acid I which is both nephrotoxic and carcinogenic. However, the aristolochic acid (AA) content in KLS and its toxicity remain unclear.AIM OF THE STUDYThe aims of this study were to quantitatively determine the contents of five aristolochic acid analogues (AAAs) in Asarum and KLS, and systematically evaluate the in vivo toxicity of KLS in rats.MATERIALS AND METHODSUltra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) was used to determine the content of the five AAAs in Asarum and KLS. Sprague-Dawley rats were administered KLS at 0, 0.75, 1.5, and 3.0 g/kg respectively, and then sacrificed after 4 weeks of administration or after an additional 2 weeks of recovery. The endpoints assessed included body weight measurements, serum biochemistry and haematology indices, and clinical and histopathological observations.RESULTSThe AAAs content in Asarum sieboldii Miq. (HB-ESBJ) were much lower than those of the other Asarums. The contents of AA I, AA IVa, and aristolactam I in KLS were in the ranges of 0.03-0.06 μg/g, 1.89-2.16 μg/g, and 0.55-1.60 μg/g, respectively, whereas AA II and AA IIIa were not detected. None of the rats showed symptoms of toxic reactions and KLS was well tolerated throughout the study. Compared to the control group, the activated partial thromboplastin time values of rats in the 1.5 and 3.0 g/kg groups significantly reduced after administration (P < 0.05). In addition, the serum triglycerides of male rats in the 0.75 and 1.5 g/kg groups after administration, and the 0.75, 1.5, 3.0 g/kg groups after recovery were significantly decreased (P < 0.01 or P < 0.001). No significant drug-related toxicological changes were observed in other serum biochemical indices, haematology, or histopathology.CONCLUSIONSThe AA I content in KLS met the limit requirements (<0.001%) of the Chinese Pharmacopoeia. Therefore, it is safe to use KLS in the short-term. However, for safety considerations, attention should be paid to the effects of long-term KLS administration on coagulation function and triglyceride metabolism.

2023-11-01·Minerva Pediatrics

Ketoprofen lysine salt treatment in adolescents with acute upper respiratory infections: a primary-care experience

Article

作者: Marseglia, Gian L ; Veraldi, Daniele ; Ciprandi, Giorgio

BACKGROUNDAcute upper respiratory infections (AURI) are widespread in adolescents. Infections are associated with inflammation which in turn is responsible for symptoms and fever occurrence. Ketoprofen lysine salt (KLS) has a potent anti-inflammatory activity associated with effective analgesic and antipyretic effects and has a valuable safety profile. In this regard, KLS could be advantageous in adolescents with AURI.METHODSA group of primary-care pediatricians retrospectively collected data from adolescents with AURI treated with KLS for three days. Fever and symptom perception were assessed by a visual analog scale and were monitored daily for five days. Adolescents (or parents) sent their data to doctors using a phone application (WhatsApp; Meta Platforms, Inc., Menlo Park, CA, USA).RESULTSThis retrospective analysis included sixty-one adolescents (mean age 13.4 years, females and males). KLS treatment markedly and quickly reduced fever and symptoms severity. In addition, the treatment was very well tolerated by all adolescents.CONCLUSIONSAdolescents present peculiar psychological characteristics that may determine some difficulties in prompt management of AURI treatment, while an adolescent with a respiratory infection requires a prompt and adequate cure. KLS, thanks to its pharmacologic profile, could be favorably used in this context. In addition, the treatment was safe, and the acceptability was high.

2023-07-01·Biomedicine & Pharmacotherapy

Ketoprofen, lysine and gabapentin co-crystal magnifies synergistic efficacy and tolerability of the constituent drugs: Pre-clinical evidences towards an innovative therapeutic approach for neuroinflammatory pain

Article

作者: Novelli, Rubina ; Palmerio, Ferdinando ; Tomassetti, Mara ; Lillini, Samuele ; d'Egidio, Francesco ; d'Angelo, Michele ; Castelli, Vanessa ; Allegretti, Marcello ; Aramini, Andrea ; Chierotti, Michele Remo ; Bianchini, Gianluca ; Luongo, Livio ; Cimini, Annamaria ; Dragani, Maria Concetta ; Mattioli, Simone ; Bordignon, Simone ; Brandolini, Laura ; Boccella, Serena ; Canestrari, Daniele ; Maione, Sabatino ; Cocchiaro, Pasquale ; Pacchiarotti, Niccolò

Chronic pain is an enormous public health concern, and its treatment is still an unmet medical need. Starting from data highlighting the promising effects of some nonsteroidal anti-inflammatory drugs in combination with gabapentin in pain treatment, we sought to combine ketoprofen lysine salt (KLS) and gabapentin to obtain an effective multimodal therapeutic approach for chronic pain. Using relevant in vitro models, we first demonstrated that KLS and gabapentin have supra-additive effects in modulating key pathways in neuropathic pain and gastric mucosal damage. To leverage these supra-additive effects, we then chemically combined the two drugs via co-crystallization to yield a new compound, a ternary drug-drug co-crystal of ketoprofen, lysine and gabapentin (KLS-GABA co-crystal). Physicochemical, biodistribution and pharmacokinetic studies showed that within the co-crystal, ketoprofen reaches an increased gastrointestinal solubility and permeability, as well as a higher systemic exposure in vivo compared to KLS alone or in combination with gabapentin, while both the constituent drugs have increased central nervous system permeation. These unique characteristics led to striking, synergistic anti-nociceptive and anti-inflammatory effects of KLS-GABA co-crystal, as well as significantly reduced spinal neuroinflammation, in translational inflammatory and neuropathic pain rat models, suggesting that the synergistic therapeutic effects of the constituent drugs are further boosted by the co-crystallization. Notably, while strengthening the therapeutic effects of ketoprofen, KLS-GABA co-crystal showed remarkable gastrointestinal tolerability in both inflammatory and chronic neuropathic pain rat models. In conclusion, these results allow us to propose KLS-GABA co-crystal as a new drug candidate with high potential clinical benefit-to-risk ratio for chronic pain treatment.

100 项与 Gabapentin/Ketoprofen 相关的药物交易

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