The aspects that describe the pre-clinical studies of aceclofenac, as an instrument of registration of a generic drug

2020 ◽  
Author(s):  
Natalia A. Anisimova ◽  
Natalia O. Selizarova ◽  
Grigory A. Plisko ◽  
Evgeny D. Semivelichenko ◽  
Svetlana M. Napalkova

The paper presents the aspects of the toxicity, specific activity, pharmacokinetics and pharmacodynamics of aceclofenac, given in various sources describing its preclinical studies. The search for information sources for the study was carried out using domestic and international databases: elibrary and PubMed using contextual queries, including terms of the international nonproprietary name, preclinical studies of pharmacokinetics, pharmacodynamics, and animal species. Aceclofenac is one of the most prescribed drugs for acute and chronic pain. It refers to non-steroidal anti-inflammatory drugs, considered as drugs of first choice in the treatment of inflammation and pain. On the pharmaceutical market of the Russian Federation, aceclofenac is presented in the form of tablets, powder for suspension preparation, cream for external use, which allows it to be prescribed for various diseases. It has shown itself to be highly effective in the symptomatic treatment of diseases of the musculoskeletal system, for the relief of acute and chronic pain. A review of preclinical studies materials cited in various literature sources and including aspects of studying the toxicity, specific activity, pharmacokinetics and pharmacodynamics of aceclofenac, in our opinion, will allow using the data obtained in our study as one of the tools for further registration of generics.

2019 ◽  
Vol 14 (8) ◽  
pp. 644-653 ◽  
Author(s):  
Jinxuan Ren ◽  
Na Liu ◽  
Na Sun ◽  
Kehan Zhang ◽  
Lina Yu

Chronic pain is a common condition that seriously affects the quality of human life with variable etiology and complicated symptoms; people who suffer from chronic pain may experience anxiety, depression, insomnia, and other harmful emotions. Currently, chronic pain treatments are nonsteroidal anti-inflammatory drugs and opioids; these drugs are demonstrated to be insufficient and cause severe side effects. Therefore, research into new therapeutic strategies for chronic pain is a top priority. In recent years, stem cell transplantation has been demonstrated to be a potent alternative for the treatment of chronic pain. Mesenchymal stem cells (MSCs), a type of pluripotent stem cell, exhibit multi-directional differentiation, promotion of stem cell implantation, and immune regulation; they have also been shown to exert analgesic effects in several chronic pain models. Exosomes produced by MSCs have been demonstrated to relieve painful symptoms with fewer side effects. In this review, we summarize the therapeutic use of MSCs in various chronic pain studies. We also discuss ways to enhance the treatment effect of MSCs. We predict in the future, cell-free therapies for chronic pain will develop from exosomes secreted by MSCs.


2021 ◽  
pp. 1-23
Author(s):  
Ömer Elma ◽  
Elien Lebuf ◽  
Arturo Quiroz Marnef ◽  
Sevilay Tümkaya Yilmaz ◽  
Iris Coppieters ◽  
...  

2021 ◽  
pp. 107846
Author(s):  
Ya-Qun Zhou ◽  
Wei Mei ◽  
Xue-Bi Tian ◽  
Yu-Ke Tian ◽  
Dai-Qiang Liu ◽  
...  

2015 ◽  
Vol 82 (3) ◽  
Author(s):  
Pier Luigi Temporelli ◽  
Giovanni Battista Zito ◽  
Roberto Franco Pedretti ◽  
Francesco Iachini Belisarii ◽  
Giuseppe Putortì ◽  
...  

Non steroid anti-inflammatory drugs (NSAIDs) are largely used for treatment of acute and chronic pain, even for long periods of time (months or years). While it is known that their use is frequently associated with gastrointestinal damage, including major bleedings from peptic ulcer, the risk of cardiovascular events related to NSAID has received much less attention. However, there is a large body of evidence showing that NSAIDs (both “traditional”, such as diclofenac or indobufen, and selective cyclooxygenase inhibitors, COX-2) are associated with a significant increase of risk of cardiovascular events, both fatal and nonfatal. Consequently, several options have been proposed for the treatment of pain, including the use of analgesic drugs with different mechanisms of action, such as the opiates. Of interest, the Italian Drug Agency (AIFA) published a few years ago a warning (Nota 66) on the careful prescription of NSAIDs in patients with overt heart disease, such as coronary artery disease and heart failure. Aim of this paper is to present the current status of knowledge on the proper use of NSAIDs and other analgesic drugs in the management of acute and chronic pain.


1987 ◽  
Vol 41 (4) ◽  
pp. 392-401 ◽  
Author(s):  
Charles E Inturrisi ◽  
Wayne A Colburn ◽  
Robert F Kaiko ◽  
Raymond W Houde ◽  
Kathleen M Foley

Pain Medicine ◽  
2018 ◽  
Vol 20 (10) ◽  
pp. 1948-1954 ◽  
Author(s):  
Gabrielle F Miller ◽  
Gery P Guy ◽  
Kun Zhang ◽  
Christina A Mikosz ◽  
Likang Xu

Abstract Objective The increased use of opioids to treat chronic pain in the past 20 years has led to a drastic increase in opioid prescribing in the United States. The Centers for Disease Control and Prevention’s (CDC’s) Guideline for Prescribing Opioids for Chronic Pain recommends the use of nonopioid therapy as the preferred treatment for chronic pain. This study analyzes the prevalence of nonopioid prescribing among commercially insured patients with chronic pain. Design Data from the 2014 IBM® MarketScan® databases representing claims for commercially insured patients were used. International Classification of Diseases, Ninth Revision, codes were used to identify patients with chronic pain. Nonopioid prescriptions included nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics/antipyretics (e.g., acetaminophen), anticonvulsants, and antidepressant medications. The prevalence of nonopioid and opioid prescriptions was calculated by age, sex, insurance plan type, presence of a depressive or seizure disorder, and region. Results In 2014, among patients with chronic pain, 16% filled only an opioid, 17% filled only a nonopioid prescription, and 28% filled both a nonopioid and an opioid. NSAIDs and antidepressants were the most commonly prescribed nonopioids among patients with chronic pain. Having prescriptions for only nonopioids was more common among patients aged 50–64 years and among female patients. Conclusions This study provides a baseline snapshot of nonopioid prescriptions before the release of the CDC Guideline and can be used to examine the impact of the CDC Guideline and other evidence-based guidelines on nonopioid use among commercially insured patients with chronic pain.


2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Evangelos Kouremenos ◽  
◽  
Chrysa Arvaniti ◽  
Theodoros S. Constantinidis ◽  
Ermioni Giannouli ◽  
...  

AbstractMore than 0.6 million people suffer from disabling migraines in Greece causing a dramatic work loss, but only a small proportion of migraineurs attend headache centres, most of them being treated by non-experts. On behalf of the Hellenic Headache Society, we report here a consensus on the diagnosis and treatment of adult migraine that is based on the recent guidelines of the European Headache Federation, on the principles of Good Clinical Practice and on the Greek regulatory affairs. The purposes are three-fold: (1) to increase awareness for migraine in Greece; (2) to support Greek practitioners who are treating migraineurs; and (3) to help Greek migraineurs to get the most appropriate treatment. For mild migraine, symptomatic treatment with high dose simple analgesics is suggested, while for moderate to severe migraines triptans or non-steroidal anti-inflammatory drugs, or both, should be administered following an individually tailored therapeutic strategy. A rescue acute treatment option should always be advised. For episodic migraine prevention, metoprolol (50–200 mg/d), propranolol (40–240 mg/d), flunarizine (5–10 mg/d), valproate (500–1800 mg/d), topiramate (25–100 mg/d) and candesartan (16–32 mg/d) are the drugs of first choice. For chronic migraine prevention topiramate (100-200 mg/d), valproate (500–1800 mg/d), flunarizine (5–10 mg/d) and venlafaxine (150 mg/d) may be used, but the evidence is very limited. Botulinum toxin type A and monoclonal antibodies targeting the CGRP pathway (anti-CGRP mAbs) are recommended for patients suffering from chronic migraine (with or without medication overuse) who failed or did not tolerate two previous treatments. Anti-CGRP mAbs are also suggested for patients suffering from high frequency episodic migraine (≥8 migraine days per month and less than 14) who failed or did not tolerate two previous treatments.


Author(s):  
Chiara Lupi ◽  
Andrea Negro ◽  
Elisabetta Gambassi ◽  
Tommaso Susini ◽  
Pierangelo Geppetti ◽  
...  

Abstract Objective To investigate headache treatment before and during pregnancy. Background Most headaches in pregnancy are primary disorders. Headaches are likely to ameliorate during pregnancy, although they may also begin or worsen. Most headache medications should be avoided during pregnancy because of potential fetal risks. However, only scarce evidence on headache drug consumption during pregnancy is available. Design ATENA was a retrospective, self-administered questionnaire-based, cohort study on women in either pregnancy or who have just delivered and reporting headache before and/or during pregnancy. Results Out of 271 women in either pregnancy or who have just delivered, 100 (37%) reported headache before and/or during pregnancy and constituted our study sample. Before pregnancy, the attitude toward the use of symptomatic drugs was characterized by both a strong focus on their safety and the willingness to avoid possible dependence from them. Compared to the year before, pregnancy led to changes in behavior and therapeutic habits as shown by a higher proportion of patients looking for information about drugs (44/100 [44%] vs. 36/100 [36%]) and a lower proportion of those treating headache attacks (88/100 [88%] vs. 52/100 [52%]) and by a lower use of nonsteroidal anti-inflammatory drugs (68/100 [68%] vs. 5/100 [5%]) and a much higher use of paracetamol (33/100 [33%] vs. 95/100 [95%]). Conclusions Pregnancy changes how women self-treat their headache, and leads to search for information regarding drug safety, mostly due to the perception of fetal risk of drugs. Healthcare providers have to be ready to face particular needs of pregnant women with headache.


Author(s):  
Maximilian Timme ◽  
Lauren Bohner ◽  
Sebastian Huss ◽  
Johannes Kleinheinz ◽  
Marcel Hanisch

(1) Background: Chronic non-bacterial osteomyelitis (CNO) is an autoinflammatory bone disease of finally unknown etiology, which can occur alone or related with syndromes (chronic recurrent multifocal osteomyelitis—CRMO; synovitis, acne, pustulosis, hyperostosis and osteitis syndrome—SAPHO). The involvement of the mandible is rather rare. (2) Methods: We carried out a systematic literature search on CNO with mandibular involvement, according to the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” (PRISMA) guidelines, considering the different synonyms for CNO, with a special focus on therapy. (3) Results: Finally, only four studies could be included. A total of 36 patients were treated in these studies—therefore, at most, only tendencies could be identified. The therapy in the included works was inconsistent. Various therapies could alleviate the symptoms of the disease. A complete remission could only rarely be observed and is also to be viewed against the background of the fluctuating character of the disease. The success of one-off interventions is unlikely overall, and the need for long-term therapies seems to be indicated. Non-steroidal anti-inflammatory drugs (NSAIDs) were not part of any effective therapy. Surgical therapy should not be the first choice. (4) Conclusions: In summary, no evidence-based therapy recommendation can be given today. For the future, systematic clinical trials on therapy for CNO are desirable.


2015 ◽  
Vol 2015 ◽  
pp. 1-12 ◽  
Author(s):  
Caroline Berglund ◽  
Karin Ekströmer ◽  
Jahan Abtahi

Objective.Primary chronic osteomyelitis (PCO) of the jaws in children is associated with pain, trismus, and swelling. In children, temporomandibular joint involvement is rare and few studies have been published due to the relatively low incidence. This paper presents two cases of mandibular PCO in children with the involvement of the collum mandibulae. In addition, a review of the literature regarding demographic data, histological, radiological, and laboratory findings, and treatment strategies of PCO was also performed.Material and Methods.Prospective analyses of two PCO cases. A PubMed search was used and the articles were sorted according to their corresponding key area of focus.Results.Review of the literature revealed twenty-four cases of PCO with two cases of mandibular condyle involvement. The mean age was 18 years; the male to female ratio was 1 : 3. Most of the patients were treated with anti-inflammatory drugs in combination with decortication. Clinical recurrence was seen in 7 cases.Conclusion.A combination of anti-inflammatory drugs and surgical intervention appears to be the first choice of treatment. However, surgical removal of necrotic tissue adjacent to collum mandibulae has its limitations in children. Further investigations are of utmost importance in order to increase our knowledge and understanding of this disease.


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