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A comparative evaluation of transdermal diclofenac patch with oral diclofenac sodium as an analgesic drug following periodontal flap surgery: A randomized controlled clinical study.
Diwan, V, Srinivasa, TS, Ramreddy, KY, Agrawal, V, Nagdeve, S, Parvez, H
Indian journal of dental research : official publication of Indian Society for Dental Research. 2019;(1):57-60
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Abstract
BACKGROUND Pain is an inevitable outcome of any periodontal surgery. Controlling postoperative pain is of utmost importance so as to increase patient compliance. The present study aims to compare the degree of postoperative analgesia with the use of oral diclofenac sodium and transdermal diclofenac patch following periodontal flap surgery in patients with chronic periodontitis. MATERIALS AND METHODS A total of 20 patients requiring full mouth flap surgery were selected for this study. Flap surgery was performed quadrant-wise and transdermal diclofenac patch was applied on the right arm following surgery of one of the quadrants and 100 mg oral diclofenac sodium twice daily was prescribed following surgery of the subsequent quadrant. The postoperative pain was recorded on visual analog scale and pain intensity scale 24 h after the surgery. RESULTS Both the statistical and clinical observation showed that diclofenac sodium administered transdermally has equal efficacy as compared to drug administered orally. CONCLUSION The study concludes that the diclofenac administered transdermally has equal potency in relieving postoperative pain as compared to orally administered diclofenac sodium following modified flap surgery. Transdermal patch has an added advantage of better patient compliance as it does not cause gastric disturbance.
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Gle1 mediates stress granule-dependent survival during chemotoxic stress.
Glass, L, Wente, SR
Advances in biological regulation. 2019;:156-171
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Abstract
Stress granules (SGs) are non-membrane bound organelles that form in response to multiple different stress stimuli, including exposure to sodium arsenite. SGs are postulated to support cells during periods of stress and provide a protective effect, allowing survival. Gle1 is a highly conserved, essential modulator of RNA-dependent DEAD-box proteins that exists as at least two distinct isoforms in human cells. Gle1A is required for proper SG formation, whereas Gle1B functions in mRNA export at the nuclear pore complex. Since Gle1A is required for SG function, we hypothesized that SG-dependent survival responses would also be Gle1-dependent. We describe here an experimental system for quantifying and testing the SG-associated survival response to sodium arsenite stress in HeLa cells. Gle1A was required for the sodium arsenite survival response, and overexpression of Gle1A supported the survival response. Overexpression of the SG-component G3BP also enabled the response. Next, we analyzed whether cells undergoing multiple rounds of stress yield a subpopulation with a higher propensity for SG formation and an increased resistance to undergoing apoptosis. After ten doses of sodium arsenite treatment, cells became resistant to sodium arsenite and to diclofenac sodium (another SG-inducing drug). The sodium arsenite-resistant cells exhibited changes in SG biology and had an increased survival response that was conferred in a paracrine manner. Changes in secreted factors occurred including a significantly lower level of MCP-1, a known regulator of stress granules and stress-induced apoptosis. This study supports models wherein SGs play a role in cell evasion of apoptosis and further reveal Gle1A and SG functions as targets for clinical approaches directed at chemoresistant/refractory cells.
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Comparison of the Effects of Piroxicam and Diclofenac Sodium as Treatments for Primary Dysmenorrhea.
Camlibel, M, Erdur, B, Yilmaz, A, Ozen, M, Uyanik, A
Medical science monitor : international medical journal of experimental and clinical research. 2019;:157-164
Abstract
BACKGROUND NSAIDs are the most common agents used in dysmenorrhea treatment. They reduce menstrual pain by reducing uterine pressure and PGF2alpha levels in the menstrual fluid. The aim of this study was to compare the effects of piroxicam and diclofenac sodium as treatments for primary dysmenorrhea. MATERIAL AND METHODS The study was conducted using a randomized and double-blind method. Patients with Visual Analogue Scale (VAS) scores greater than 5 were accepted into the study. The patients who were suitable for inclusion were randomized into 2 groups and received either intramuscular piroxicam or diclofenac sodium. The patients' pain levels were measured at baseline and at 15, 30, 45, and 60 min. A VAS of 10 cm, a numeric scale, a verbal scale, and additional symptoms, as well as pain relapse after 24 hours and required analgesics, were recorded. RESULTS The study included 400 patients. Overall, 200 patients (50%) were in the proxicam group, and 200 patients were in the diclofenac sodium group. The average decrease on the VAS after piroxicam or diclofenac administration was measured as 7.9±1.8 cm and 7.9±1.7 cm (median ± standard deviation), respectively. The pain-reducing efficiency of all the treatments was compared using the Mann-Whitney U test (p=0.929). Rescue medication was needed for 25 patients in the proxicam group (p=0.014). Overall, 30 patients in the proxicam group and 41 patients in the proxicam group needed analgesics again in the 24-hour period after treatment (p=0.150). CONCLUSIONS At the end of our study, it was observed that there was no difference in the results of primary dysmenorrhea treatment with 20 mg piroxicam or 75 mg diclofenac sodium.
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Rectal Diclofenac administration for prevention of post-Endoscopic Retrograde Cholangio-Pancreatography (ERCP) acute pancreatitis. Randomized prospective study.
Geraci, G, Palumbo, VD, D'Orazio, B, Maffongelli, A, Fazzotta, S, Lo Monte, AI
La Clinica terapeutica. 2019;(5):e332-e336
Abstract
INTRODUCTION Post-Endoscopic Retrograde Cholangio-Pancreatography pancreatitis (PEP) is a relevant (1-4%) complication of biliopancreatic operative endoscopy. Rectal nonsteroidal anti-inflammatory drugs (specifically, 100 mg of diclofenac) have shown promising prophylactic activity in PEP. The aim of our prospective study is to report whether prophylactic oral versus rectal suppository versus intramuscular diclofenac versus placebo are able to reduce the incidence and the severity of ERCP-induced pancreatitis. MATERIALS AND METHODS In this randomized, double-blinded, prospective study, 100 patients (49 male, 51 female), similar with regard to indication for ERCP, were enrolled between January 2016 and November 2017 to undergo ERCP in the Section of General and Thoracic Surgery of University Hospital of Palermo. They were randomized into five groups, respectively 20 patients with placebo by mouth; 20 patients with 50 mg diclofenac sodium enteric-coated capsules by mouth; 20 with 100 mg rectal suppository diclofenac, 20 with 75 mg/3 ml intramuscular diclofenac sodium, 20 with 75 mg/3 ml intramuscular diclofenac sodium and 20 with 75 mg/3 ml intravenous diclofenac. All drugs were administered 30 to 90 minutes before ERCP. All clinical data were collected one day before and 2, 12 and 24 hour after ERCP. RESULT Data were prospectively collected and to demonstrate the preventive effect of rectal diclofenac on PEP, a two-by-two table and chi-square test with Yates correction were used: the incidence of PEP was significantly lower (p < 0.001) in the rectal diclofenac group respect to other groups and, in the same way, the incidence of post-ERCP pain was significantly lower in the rectal diclofenac group than in the other groups (p = 0.001) and patients discharge was consequently earlier (p < 0.01). CONCLUSION 100 mg dose rectal diclofenac administered 30-60 minutes before ERCP can effectively prevent PEP.
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Possible use of a Nicotiana tabacum 'Bright Yellow 2' cell suspension as a model to assess phytotoxicity of pharmaceuticals (diclofenac).
Svobodníková, L, Kummerová, M, Zezulka, Š, Babula, P
Ecotoxicology and environmental safety. 2019;:109369
Abstract
Growth and developmental changes in plants induced by pharmaceuticals reflect changes in processes at the cellular and subcellular levels. Due to their growth and cellular characteristics, plant cell suspension cultures can be a suitable model for assessing toxicity. In this study, 10-1000 μg/L of the non-steroidal anti-inflammatory drug diclofenac (DCF) decreased the viability of Nicotiana tabacum BY-2 cells after 24 h of treatment. Further, 0.1-10 mg/L DCF diminished the density of the cell suspension by 9-46% after 96 h of treatment, but at 1 and 10 μg/L, DCF increased the density by 13% and 5%, respectively, after 120 h. These changes were accompanied by increased production of total reactive oxygen species (ROS) and mitochondrial superoxide (up to 17-fold and 5-fold, respectively), and a decrease in the mitochondrial membrane potential (by ∼64%) especially at 1000 μg/L DCF. The increased ROS production was accompanied by decrease in level of reactive nitrogen species (RNS; by 36%) and total thiols (by 61%). Damage to BY-2 cells was evidenced by accumulation of neutral red in acidic compartments (up to 10-fold at 1000 μg/L DCF), and increase of autophagic vacuole formation (up to 8-fold at 1000 μg/L DCF). Furthermore, irregular or stretched nuclei were observed in nearly 27% and 50% of cells at 100 and 1000 μg/L DCF, respectively. Highest levels of chromatin condensation (11% of cells) and apoptotic DNA fragmentation (7%) were found at 10 μg/L DCF. The results revealed a significant effect of DCF on BY-2 cells after 24 h of exposure. Changes in the growth and viability parameters were indisputably related to ROS and RNS production, changes in mitochondrial function, and possible activation of processes leading to cell death.
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Clay nanotubes as a novel multifunctional excipient for the development of directly compressible diclofenac potassium tablets in a SeDeM driven QbD environment.
Ahmed, FR, Shoaib, MH, Yousuf, RI, Ali, T, Geckeler, KE, Siddiqui, F, Ahmed, K, Qazi, F
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. 2019;:214-227
Abstract
Halloysite is a unique biocompatible aluminosilicate clay mineral with powder particles predominantly comprising of concentrically rolled nanotubular aggregates. Some recent studies have also contributed to its prospective case in oral drug delivery and dosage forms albeit with limited commercial viability. In this study, we have investigated the use of halloysite nanotubes (HNTs) as a directly compressible multifunctional tableting excipient using SeDeM diagram expert tool. SeDeM experimentations revealed that ~68% HNTs in the formulations were enough to be used as a directly compressible filler, binder, and disintegrant in diclofenac potassium formulations. In the next phase, a total of 8 formulations blends (IRF1-8) of diclofenac potassium (50 mg) with HNTs and Starch 1500® were prepared in different ratio using simple lattice mixture design and all were found satisfactory for direct compression. Compressed tablets (167 mg) had narrow weight variation (SD = ± 1.78 mg), good hardness (~9-9.5 kg), acceptable friability (<0.7%) and fast disintegration time (<1.5 min). Moreover, the cumulative dissolution at 1 h in phosphate buffer pH 6.8 was found compliant with the compendial criteria (> 92% against 75%). The dissolution profile was best fitted with Peppas-Sahlin model with Fickian diffusion as the only mechanism. f2 similarity test revealed that almost all the tablets were pharmaceutical equivalent to the marketed formulation of the drug. A shelf-life of ~34 months was found upon long-term stability testing of the optimized formulation. This study demonstrates that this novel and economically viable clay material has a strong potential for commercial use in tableting of drug by direct compression.
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Comparison of EMLA and Diclofenac on Reduction of Pain and Phlebitis Caused by Peripheral IV Catheter: A Randomized-Controlled Trial Study.
Babaieasl, F, Yarandi, HN, Saeidzadeh, S, Kheradmand, M
Home healthcare now. 2019;(1):17-22
Abstract
Peripheral venous catheters (PVC) are often used to provide hydration, medications, and blood products when the length of therapy is expected to be less than 1 week. Pain and phlebitis are frequent complications of PVC. Diclofenac and EMLA have been used to minimize these adverse effects; however, conflicting results have been reported regarding which has better outcomes. This double-blind, randomized controlled trial was conducted to compare the efficacy of EMLA and Diclofenac (TDP) in attenuating PVC pain and phlebitis. The inpatient setting was chosen because of the higher frequency of PVC insertions, allowing for a sufficient sample size. One hundred fifty-four subjects were randomly assigned to three groups: EMLA patch (n = 61), a TDP patch (n = 50), or a patch with lubricant gel (n = 46) as a placebo. The pain was measured by Visual Analogue Scale (VAS). Phlebitis was examined based on Boxter criteria in intervals of 6, 12, 18, 24, and 48 hours after PVC insertion. The mean score of VAS was 41.86 ± 22.49 for the control, 39.40 ± 21.60 for TDP, and 38.77 ± 23.28 for the EMLA group, with no significant differences in pain severity between the three groups. The rate of phlebitis in the group with EMLA was significantly higher than the other two groups at 6, 12, and 18 hours (p = 0.02, p = 0.003 and p = 0.04, respectively). In all interval times, the rate of phlebitis in the TDP group was significantly lower than the other groups. Compared with men, women experienced higher rate of phlebitis and intensity of PVC pain. EMLA and TDP had similar analgesic effects, but phlebitis was less frequently observed with TDP, suggesting TDP as a potential medication for reducing pain and phlebitis before PVC insertion.
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Chitosan Film as Eco-Friendly and Recyclable Bio-Adsorbent to Remove/Recover Diclofenac, Ketoprofen, and their Mixture from Wastewater.
Rizzi, V, Romanazzi, F, Gubitosa, J, Fini, P, Romita, R, Agostiano, A, Petrella, A, Cosma, P
Biomolecules. 2019;(10)
Abstract
This paper reported the first example on the use of chitosan films, without further modification, to remove and recover, through bio-sorption processes, the emerging pollutant Diclofenac from water. The latter was adopted as a model, among non-steroidal anti-inflammatory drugs, by obtaining a maximum adsorption capacity, qmax, on chitosan of about 10 mg/g, under the applied experimental conditions of work. The literature gap about the use of chitosan films, which was already used for dyes and heavy metals removal, to adsorb emerging pollutants from water was covered, claiming the wide range application of chitosan films to remove a different class of pollutants. Several parameters affecting the Diclofenac adsorption process, such as the pH and ionic strength of solutions containing Diclofenac, the amount of the bio-sorbent and pollutant, and the temperature values, were investigated. The kinetics and the adsorption isotherms, along with the thermodynamic parameters (ΔG°, ΔH°, and ΔS°) were also evaluated. The process occurred very efficiently, and Chitosan/Diclofenac amounts dependent, remove about the 90% of the pollutant, in 2 h, from the tested solutions, through electrostatic interaction involving the carboxylic moiety of Diclofenac and Chitosan amino groups. This finding was confirmed by the pH and salt effects on the bio-sorption process, including swelling measurements of Chitosan films and by FTIR-ATR analysis. In detail, the maximum adsorption was observed at pH 5, when pollutant and Chitosan were negatively and positively charged, respectively. By reducing or increasing the pH around this value, a reduced affinity was observed. Accordingly, the presence of salts retarded the Diclofenac removal screening its charges, which hinders the interaction with Chitosan. The sorption was spontaneous (ΔG° < 0) and endothermic (ΔH° > 0) following the pseudo-second order kinetic model. The process was Diclofenac and Chitosan amount dependent. In addition, the Freundlich and Temkin isotherms well described the process, which showed the heterogeneous character of the process. Experiments of the complete desorption were also performed by using NaCl solutions 0.25 M (like sea water salt concentration) proposing the reuse of the pollutant and the recycling of the bio-sorbent lowering the associated costs. The versatility of the adsorbent was reported by exploring the possibility to induce the Diclofenac light-induced degradation after the adsorption and by-products adsorption onto chitosan films. To emphasize the chitosan capacity of treating water, the removal of another pollutant such as Ketoprofen and the mixture of Diclofenac and Ketoprofen were investigated. In this way, a green and eco-friendly production-pollution prevention technology for removing emerging pollutants from water was presented, which reduced the overall environmental impact. This illustrated experiments both in static and dynamic conditions for potential industrial applications.
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Continuous intravenous low-dose diclofenac sodium to control a central fever after ischemic stroke in the intensive care unit: a case report and review of the literature.
Giaccari, LG, Pace, MC, Passavanti, MB, Sansone, P, Esposito, V, Aurilio, C, Pota, V
Journal of medical case reports. 2019;(1):373
Abstract
INTRODUCTION Elevation in body temperature within the first 24 hours of ischemic stroke is fairly common and known to be associated with worse outcomes. Only after thoroughly ruling out infection and the noninfectious etiologies and in the appropriate clinical setting should the diagnosis of central fever be made. Acetaminophen and nonsteroidal anti-inflammatory drugs are typical therapeutic options. External cooling is frequently used when pharmacologic interventions are inadequate. However, reports have suggested that neurogenic fevers are somewhat resistant to traditional pharmacologic therapies. CASE PRESENTATION We describe a case of a Caucasian patient with central fever after ischemic stroke not responsive to acetaminophen administration and external cooling. After an initial bolus of diclofenac sodium (0.2 mg/kg in 100 ml of saline solution for 30 minutes), a continuous infusion (75 mg in 50 ml of saline solution) was started. After 5 days of treatment, the patient's body temperature was below 37.5 °C, and the diclofenac sodium infusion was stopped. CONCLUSIONS We observed that a low-dose diclofenac sodium infusion was effective in treating fever without systemic side effects. This treatment may be suggested as an alternative to conventional antipyretic drugs, but additional clinical trials are required.
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Efficient Removal of Diclofenac from Aqueous Solution by Potassium Ferrate-Activated Porous Graphitic Biochar: Ambient Condition Influences and Adsorption Mechanism.
Thi Minh Tam, N, Liu, Y, Bashir, H, Yin, Z, He, Y, Zhou, X
International journal of environmental research and public health. 2019;(1)
Abstract
Porous graphitic biochar was synthesized by one-step treatment biomass using potassium ferrate (K2FeO4) as activator for both carbonization and graphitization processes. The modified biochar (Fe@BC) was applied for the removal of diclofenac sodium (DCF) in an aqueous solution. The as-prepared material possesses a well-developed micro/mesoporous and graphitic structure, which can strengthen its adsorption capacity towards DCF. The experimental results indicated that the maximum adsorption capacity (qmax) of Fe@BC for DCF obtained from Langmuir isotherm simulation was 123.45 mg·L-1 and it was a remarkable value of DCF adsorption in comparison with that of other biomass-based adsorbents previously reported. Thermodynamic quality and effect of ionic strength studies demonstrated that the adsorption was a endothermic process, and higher environmental temperatures may be more favorable for the uptake of DCF onto Fe@BC surface; however, the presence of NaCl in the solution slightly obstructed DCF adsorption. Adsorption capacity was found to be decreased with the increase of solution pH. Additionally, the possible mechanism of the DCF adsorption process on Fe@BC may involve chemical adsorption with the presence of H-bonding and π-π interaction. With high adsorption capacity and reusability, Fe@BC was found to be a promising absorbent for DCF removal from water as well as for water purification applications.