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1.
Clin Orthop Surg ; 16(5): 836-844, 2024 Oct.
Article in English | MEDLINE | ID: mdl-39364103

ABSTRACT

Background: Fracture healing or nonunion refers to a process in which many factors interact. In this study, we aimed to evaluate the radiological, histological, and biomechanical effects of phenyramidol and diclofenac, which are frequently used to treat post-fracture ture pain worldwide, on fracture healing and nonunion in a rat femur fracture model. Methods: In this study, 72 male Wistar-Albino rats aged 2-3 months and weighing 250 ± 30 g were divided into 4 main groups. The rats were divided into 12 subgroups according to the early, middle, and late periods. A fracture model was created in rat femurs, and surgical fixation was performed. Postoperative analgesic treatment protocols included phenyramidol, diclofenac, phenyramidol + diclofenac, and the control group. The rats were sacrificed on the fifteenth, thirtieth, and forty-fifth days and were evaluated radiologically, histopathologically, and biomechanically. Results: Scoring was conducted independently by 2 orthopedists not involved in the study. When the results were analyzed statistically, no statistically significant difference was observed between the fifteenth and thirtieth day radiology score values of the control, diclofenac, phenyramidol, and Phenyramidol + diclofenac groups (p > 0.05), but there was a statistically significant difference (p < 0.05) between the forty-fifth day radiology score values of the control, diclofenac, phenyramidol, and phenyramidol + diclofenac groups. Conclusions: Our study shows that the use of diclofenac or phenyramidol alone negatively affects postoperative fracture healing. However, this effect was less pronounced in the combined treatment group. Histologic examination revealed that neither treatment had a significant effect on healing. There were statistical differences in biomechanical and radiologic properties between the phenyramidol and diclofenac groups; in particular, the diclofenac group had lower biomechanical properties.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal , Diclofenac , Fracture Healing , Rats, Wistar , Animals , Diclofenac/therapeutic use , Diclofenac/pharmacology , Male , Rats , Fracture Healing/drug effects , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Femoral Fractures/drug therapy , Femoral Fractures/surgery
2.
Pain Res Manag ; 2024: 6687987, 2024.
Article in English | MEDLINE | ID: mdl-39205668

ABSTRACT

Background: Rheumatoid arthritis (RA) is one of the most common forms of arthritis. Extracorporeal shockwave therapy (ESWT) has been identified as a viable alternative therapeutic approach in light of the present protracted clinical course of pharmacological treatment, and changes in levels of marker proteins in the blood samples of RA patients can be utilized to assess treatment outcomes. Methods: A randomized controlled trial was conducted involving forty patients diagnosed with rheumatoid arthritis (RA) who were assigned randomly to two groups. The first group received a combination of diclofenac and methotrexate (MTX) consisting of 25 mg of diclofenac administered thrice daily and 15 mg of MTX administered once weekly. Individual follow-up assessments were carried out after 7 and 14 days. Meanwhile, patients in the second group underwent two sessions of Extracorporeal Shockwave Therapy (ESWT), with a 7-day interval between sessions. Evaluations were conducted on day 7 and day 14. Patients who displayed pain control and stability were advised to continue the treatment, whereas those who had inflammation and discomfort were administered specific medications, and their progress was closely monitored until day 28. Blood samples were collected from both groups prior to treatment, after the first treatment, and after the second treatment. Four marker proteins (NRP-1, CELF-6, COX-2, and RGS-1) and two inflammatory cytokines (IL-6 and IL-17) were measured using western blot and RT-PCR techniques. A statistical analysis was conducted on the levels of specific proteins and inflammatory factors before and after treatment to evaluate its impact. Result: Both groups exhibited statistically significant differences in the serum level of target biomarkers before and after the intervention. However, the ESWT group demonstrated a more noticeable effect, while the diclofenac + MTX group exhibited a delayed anti-inflammatory effect compared to ESWT. Conclusion: Both treatments significantly improved joint function, relieved pain, and reduced inflammation in patients. However, ESWT demonstrated a more prominent clinical analgesic effect compared to the combination treatment of diclofenac and MTX. Furthermore, ESWT produced a more immediate and noteworthy anti-inflammatory impact by regulating NRP-1 expression, a trophic factor receptor that facilitates vascular endothelial cell migration and tissue repair through angiogenesis, and regulating RGS-1 to limit inflammatory signal transmission and immune cell activation.


Subject(s)
Arthritis, Rheumatoid , Biomarkers , Diclofenac , Extracorporeal Shockwave Therapy , Methotrexate , Humans , Methotrexate/therapeutic use , Methotrexate/administration & dosage , Diclofenac/therapeutic use , Diclofenac/administration & dosage , Arthritis, Rheumatoid/blood , Arthritis, Rheumatoid/therapy , Arthritis, Rheumatoid/drug therapy , Male , Female , Middle Aged , Extracorporeal Shockwave Therapy/methods , Adult , Biomarkers/blood , Antirheumatic Agents/therapeutic use , Antirheumatic Agents/administration & dosage , Treatment Outcome , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Combined Modality Therapy , Analgesics/therapeutic use , Aged
3.
Bull Exp Biol Med ; 177(2): 217-220, 2024 Jun.
Article in English | MEDLINE | ID: mdl-39093473

ABSTRACT

PT1 peptide isolated from the venom of spider Geolycosa sp. is a modulator of P2X3 receptors that play a role in the development of inflammation and the transmission of pain impulses. The anti-inflammatory and analgesic efficacy of the PT1 peptide was studied in a model of complete Freund's adjuvant-induced paw inflammation in CD-1 mice. The analgesic activity of PT1 peptide was maximum after intramuscular injection at a dose of 0.01 mg/kg, which surpassed the analgesic effect of diclofenac at a dose of 1 mg/kg. The anti-inflammatory activity was maximum after intramuscular injection at a dose of 0.0001 mg/kg; a decrease in paw thickness was observed as soon as 2 h after the administration of the PT1 peptide against the background of inflammation development. All tested doses of PT1 peptide showed high anti-inflammatory activity 4 and 24 h after administration. PT1 peptide at a dose of 0.01 mg/kg when injected intramuscularly simultaneously produced high anti-inflammatory and analgesic effects compared to other doses of the peptide. Increasing the dose of PT1 peptide led to a gradual decrease in its analgesic and anti-inflammatory activity; increasing the dose of intramuscular injection to 0.1 and 1 mg/kg is inappropriate.


Subject(s)
Analgesics , Anti-Inflammatory Agents , Inflammation , Peptides , Animals , Mice , Analgesics/pharmacology , Analgesics/therapeutic use , Inflammation/drug therapy , Inflammation/pathology , Anti-Inflammatory Agents/pharmacology , Anti-Inflammatory Agents/administration & dosage , Male , Peptides/pharmacology , Peptides/administration & dosage , Peptides/therapeutic use , Injections, Intramuscular , Freund's Adjuvant , Spider Venoms/pharmacology , Diclofenac/pharmacology , Diclofenac/therapeutic use , Diclofenac/administration & dosage , Disease Models, Animal , Pain/drug therapy
4.
Scand J Pain ; 24(1)2024 Jan 01.
Article in English | MEDLINE | ID: mdl-39175232

ABSTRACT

OBJECTIVES: The aim of this study was to understand profiles of topical Voltaren gel diclofenac (VGD) 2.32 and 1.16% consumers through analyzing prescription patterns and to characterize treatment satisfaction, functional impairment, and pain relief after over-the-counter (OTC) VGD use in Sweden under real-world conditions. METHODS: This observational, real-world study conducted in Sweden had retrospective and prospective segments. The retrospective secondary data segment utilized 12-month diclofenac gel prescription data from the Swedish eHealth Agency (E-hälsomyndigheten). The prospective segment included electronic surveys completed at baseline and weeks 4 and 12 by adult consumers who purchased OTC VGD to treat their pain. RESULTS: Secondary data analyses (n = 12,145) showed that 56.7% of patients receiving diclofenac gel were females ≥70 years old. Most patients did not switch pain treatments; the mean time between diclofenac gel refills was about 2.5 months. From the surveys (n = 264), VGD provided pain relief, indicated by improvement in 11-point pain numeric rating scale scores. Average pain severity at baseline was 5.8 - improving by a mean of 1.3 and 1.9 points at weeks 4 and 12, respectively. The majority of consumers reported improvement in daily functioning (i.e., health-related quality of life [HRQoL]), and most were at least somewhat satisfied with VGD treatment results. CONCLUSIONS: This real-world study provides important insights into the prescription patterns of diclofenac gel and the consumer experience with OTC VGD in Sweden. Patients rarely switched to other topical nonsteroidal anti-inflammatory drugs, and VGD consumers reported pain relief and improved HRQoL compared to baseline - resulting in treatment satisfaction.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal , Diclofenac , Gels , Patient Satisfaction , Humans , Diclofenac/administration & dosage , Diclofenac/therapeutic use , Female , Sweden , Male , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Middle Aged , Aged , Adult , Retrospective Studies , Prospective Studies , Nonprescription Drugs/therapeutic use , Nonprescription Drugs/administration & dosage , Pain/drug therapy
5.
J Endod ; 50(9): 1213-1220, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38925367

ABSTRACT

AIM: This prospective, randomized, double-blind clinical trial investigated the impact of diclofenac potassium, prednisolone, and placebo as oral premedication on postendodontic pain and pulpal interleukin (IL)-8 expression in patients with irreversible pulpitis. METHODS: Thirty-six patients undergoing conventional endodontic treatment were assigned into one of 3 groups (n = 12). Pulpal blood samples were taken after access cavity preparation and stored until they were analyzed using enzyme-linked immunosorbent asssay for quantification of IL-8. Postendodontic pain was scored using the visual analogue scale. Outcome data were statistically analyzed using one-way analysis of variance, Kruskal-Wallis, Friedman's, Dunn's, Chi-square, and Fisher's exact tests and Spearman's correlation coefficient. The significance level (α) was set at 0.05. RESULTS: Apart from preoperative pain scores, all groups had similar baseline characteristics (P > .05). Immediate postendodontic pain scores had a significant difference between all groups (P < .05) where placebo group showed the highest score. There was no significant difference between all groups at 6 and 12 hours postoperatively (P > .05). Furthermore, there was no significant difference in the incidence of postendodontic pain and in mean IL-8 levels between the 3 groups (P > .05). CONCLUSIONS: The only impact the premedications had was on the immediate postendodontic pain intensity, and they had no influence on the later time points, incidence of postendodontic pain or pulpal IL-8 levels.


Subject(s)
Dental Pulp , Diclofenac , Interleukin-8 , Pain, Postoperative , Prednisolone , Pulpitis , Humans , Pulpitis/metabolism , Double-Blind Method , Male , Female , Adult , Diclofenac/therapeutic use , Prednisolone/therapeutic use , Prospective Studies , Pain, Postoperative/drug therapy , Dental Pulp/drug effects , Dental Pulp/metabolism , Young Adult , Pain Measurement , Middle Aged , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Root Canal Therapy/methods , Anti-Inflammatory Agents/therapeutic use
6.
BMC Biotechnol ; 24(1): 26, 2024 May 09.
Article in English | MEDLINE | ID: mdl-38724967

ABSTRACT

BACKGROUND: Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease, and it leads to irreversible inflammation in intra-articular joints. Current treatment approaches for RA include non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying anti-rheumatic drugs (DMARDs), corticosteroids, and biological agents. To overcome the drug-associated toxicity of conventional therapy and transdermal tissue barrier, an injectable NSAID-loaded hydrogel system was developed and explored its efficacy. RESULTS: The surface morphology and porosity of the hydrogels indicate that they mimic the natural ECM, which is greatly beneficial for tissue healing. Further, NSAIDs, i.e., diclofenac sodium, were loaded into the hydrogel, and the in vitro drug release pattern was found to be burst release for 24 h and subsequently sustainable release of 50% drug up to 10 days. The DPPH assay revealed that the hydrogels have good radical scavenging activity. The biocompatibility study carried out by MTT assay proved good biocompatibility and anti-inflammatory activity of the hydrogels was carried out by gene expression study in RAW 264.7 cells, which indicate the downregulation of several key inflammatory genes such as COX-2, TNF-α & 18s. CONCLUSION: In summary, the proposed ECM-mimetic, thermo-sensitive in situ hydrogels may be utilized for intra-articular inflammation modulation and can be beneficial by reducing the frequency of medication and providing optimum lubrication at intra-articular joints.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal , Arthritis, Rheumatoid , Hydrogels , Hydrogels/chemistry , Animals , Mice , Arthritis, Rheumatoid/drug therapy , RAW 264.7 Cells , Anti-Inflammatory Agents, Non-Steroidal/pharmacology , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/chemistry , Extracellular Matrix/metabolism , Extracellular Matrix/drug effects , Diclofenac/pharmacology , Diclofenac/therapeutic use , Drug Liberation
7.
Ann Med ; 56(1): 2357235, 2024 Dec.
Article in English | MEDLINE | ID: mdl-38813682

ABSTRACT

OBJECTIVE: Tension-type headache is the most common type of primary headache and results in a huge socioeconomic burden. This network meta-analysis (NMA) aimed to compare the efficacy and safety of simple analgesics for the treatment of episodic tension-type headache (ETTH) in adults. METHODS: We searched the Cochrane Library, PubMed, Web of Science, Embase, Chinese BioMedical Literature database and International Clinical Trials Registry Platform databases for eligible randomized clinical trials reporting the efficacy and/or safety of simple analgesics. A Bayesian NMA was performed to compare relative efficacy and safety. The surface under the cumulative ranking curve (SUCRA) was calculated to rank interventions. PROSPERO registration number: CRD42018090554. RESULTS: We highlighted six studies including 3507 patients. For the 2 h pain-free rate, the SUCRA ranking was ibuprofen > diclofenac-K > ketoprofen > acetaminophen > naproxen > placebo. All drugs except naproxen reported a higher 2 h pain-free rate than placebo, with a risk ratio (RR) of 2.86 (95% credible interval, CrI: 1.62-5.42) for ibuprofen and 2.61 (1.53-4.88) for diclofenac-K. For adverse events rate, the SUCRA ranking was: metamizol > diclofenac-K > ibuprofen > lumiracoxib > placebo > aspirin > acetaminophen > naproxen > ketoprofen. The adverse event rates of all analgesics were no higher than those of placebo, except for ketoprofen. Moreover, all drugs were superior to placebo in the global assessment of efficacy. In particular, the RR of lumiracoxib was 2.47 (1.57-4.57). Global heterogeneity I2 between the studies was low. CONCLUSIONS: Simple analgesics are considered more effective and safe as a placebo for ETTH in adults. Our results suggest that ibuprofen and diclofenac-K may be the two best treatment options for patients with ETTH from a comprehensive point of view (both high-quality evidence).


To our knowledge, this is the first network meta-analysis comparing the available data on adult patients with episodic tension-type headache (ETTH) treated with different simple analgesics recommended by the current guidelines.Ibuprofen (400 mg) and diclofenac-K (12.5 mg, 25 mg) are potentially the most effective and safe treatment options, supported by high-quality evidence.


Subject(s)
Analgesics , Ibuprofen , Network Meta-Analysis , Tension-Type Headache , Humans , Tension-Type Headache/drug therapy , Analgesics/adverse effects , Analgesics/therapeutic use , Analgesics/administration & dosage , Adult , Ibuprofen/adverse effects , Ibuprofen/administration & dosage , Ibuprofen/therapeutic use , Acetaminophen/therapeutic use , Acetaminophen/adverse effects , Acetaminophen/administration & dosage , Bayes Theorem , Treatment Outcome , Diclofenac/adverse effects , Diclofenac/therapeutic use , Diclofenac/administration & dosage , Randomized Controlled Trials as Topic , Naproxen/therapeutic use , Naproxen/adverse effects , Naproxen/administration & dosage , Ketoprofen/adverse effects , Ketoprofen/therapeutic use , Ketoprofen/administration & dosage , Ketoprofen/analogs & derivatives , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Female , Male
8.
Rheumatol Int ; 44(6): 1061-1069, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38581450

ABSTRACT

Gout attacks are treated with uric-lowering and anti-inflammatory drugs. In patients with gout, non-steroidal anti-inflammatory drugs (NSAIDs) could be both cardiovascular beneficial, due to their anti-inflammatory actions, and cardiovascular hazardous, due to their prothrombotic, hypertensive, and proarrhythmic side effects. We, therefore, examined the risk of cardiovascular events associated with NSAID use in patients with gout. We conducted a nationwide, population-based case-crossover study of all Danes ≥ 18 years of age with first-time gout during 1997-2020, who experienced a cardiovascular event (myocardial infarction, ischemic stroke, congestive heart failure, atrial fibrillation/flutter, or cardiovascular death) (n = 59,150). The exposure was use of NSAIDs, overall and according to type (ibuprofen, naproxen, or diclofenac). We used the dates 300, 240, 180, and 120 before the outcome date as reference dates. We used the Mantel-Haenszel method to calculate odds ratios (ORs) with 95% confidence intervals (CIs) of the association between NSAID use and cardiovascular events. NSAID use was overall associated with 12% decreased odds of a cardiovascular event (OR = 0.88, 95% CI: 0.85-0.91). This decreased odds ratio was observed for the use of ibuprofen (OR = 0.92, 95% CI: 0.88-0.97) and naproxen (OR = 0.85, 95% CI: 0.74-0.97), but not for the use of diclofenac (OR = 0.97, 95% CI: 0.90-1.05). Overall, use of NSAIDs was associated with decreased odds of all the individual components of the composite outcome. NSAIDs were not associated with an increased cardiovascular event rate when used in gout patients. Ibuprofen and naproxen appeared to have better cardiovascular risk profiles than diclofenac.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal , Cardiovascular Diseases , Cross-Over Studies , Gout , Ibuprofen , Naproxen , Humans , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Gout/drug therapy , Gout/epidemiology , Male , Female , Middle Aged , Aged , Denmark/epidemiology , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/chemically induced , Naproxen/adverse effects , Naproxen/therapeutic use , Ibuprofen/adverse effects , Ibuprofen/therapeutic use , Adult , Diclofenac/adverse effects , Diclofenac/therapeutic use
9.
Swiss Med Wkly ; 154: 3535, 2024 Feb 05.
Article in English | MEDLINE | ID: mdl-38579298

ABSTRACT

OBJECTIVE: To investigate claims patterns for metamizole and other non-opioid analgesics in Switzerland. To characterise users of these non-opioid analgesics regarding sex, age, comedications and canton of residence. METHODS: We conducted a retrospective descriptive study using administrative claims data of outpatient prescribed non-opioid analgesics of the Swiss health insurance company Helsana between January 2014 and December 2019. First, we evaluated the number of claims and defined daily doses  per year of metamizole, ibuprofen, diclofenac and paracetamol in adults aged 18 years or over. Second, we characterised new users of these non-opioid analgesics in terms of sex, age, claimed comedications and canton of residence. RESULTS: From 2014 to 2019, among the investigated non-opioid analgesics, metamizole showed the highest increase in claims (+9545 claims, +50%) and defined daily doses (+86,869 defined daily doses, +84%) per 100,000 adults. Metamizole users had the highest median age (62 years [IQR: 44-77]) compared to ibuprofen (47 years [IQR: 33-62]), diclofenac (57 years [IQR: 43-71]) and paracetamol (58 years [IQR: 39-75]) users. Metamizole users also more frequently claimed proton pump inhibitors, anticoagulants, platelet aggregation inhibitors and antihypertensive drugs than users of other non-opioid analgesics. While metamizole was most frequently claimed in German-speaking regions of Switzerland, ibuprofen and paracetamol were most frequently claimed in the French-speaking regions and diclofenac in German- and Italian-speaking regions. CONCLUSION: In Switzerland, metamizole was increasingly claimed between 2014 and 2019. Metamizole was most frequently claimed by older adults and patients with comedications suggestive of underlying conditions, which can be worsened or caused by use of nonsteroidal anti-inflammatory drugs. The lack of studies regarding the effectiveness and safety of metamizole in this population warrants further investigation.


Subject(s)
Analgesics, Non-Narcotic , Humans , Aged , Adult , Middle Aged , Dipyrone/therapeutic use , Acetaminophen/therapeutic use , Switzerland , Ibuprofen/therapeutic use , Diclofenac/therapeutic use , Retrospective Studies , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Analgesics, Opioid , Insurance, Health
10.
Mymensingh Med J ; 33(2): 440-445, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38557523

ABSTRACT

The incidence of first trimester pregnancy loss is around 10.0-20.0% of registered pregnancies. Manual vacuum aspiration is a safe, effective and acceptable option of treatment for patients diagnosed with first trimester pregnancy loss. Main disadvantage of MVA is the pain caused by manipulation of the cervix, the uterine suction and the cervical dilatation. This study showed the way how the pain and discomfort might be reduced. This was a cross-sectional comparative study was conducted at the obstetrics and Gynecological Department of Sadar hospital, Manikganj, Bangladesh from January 2017 to December 2017. All the consecutive women admitted and diagnosed as incomplete abortion, missed abortion and anembryonic pregnancy (blighted ovum) were included in this study. Sampling technique was purposive sampling. The objective of this study was to compare the effectiveness of paracervical block anesthesia with non-steroidal anti inflammatory drug (NSAID) for relief of pain during the manual vacuum aspiration procedure for the treatment of first trimester pregnancy loss. Total 120 cases were included in this study. Assigned study population were divided into two groups like Group A and Group B. 60 of the study population were included in Group A who were given paracervical block anesthesia 3 minutes before the procedure. Another 60 study population was included in Group B who was given diclofenac 75mg intramuscular injection, 30 minutes before the procedure. Both intraoperative and postoperative pain level was evaluated by using visual analog scale ranged from (0-10 points) 30 minutes after the procedure. At the same time the satisfaction level of the study population were measured by 5 points lickert scale. Regarding clinical profile of the study population it showed no significant difference in case of mean age, mean gestational age and mean duration of the procedure between two groups. The mean intraoperative pain score in Group A was 4.0±1.3, in Group B it was 5.4±1.5 (p=0.001) which was significant. So it showed that paracervical block anesthesia significantly reduced the pain in relation to diclofenac 75mg intramuscular injection. Mean postoperative pain level 30 minutes after procedure in Group A was 2.2±0.4 and in Group B was 2.4±0.4 (p=0.343), where post-operative pain is lower in Group A than Group B. Though this difference is not statistically significant (p=0.343). In Group A 73.0% (n=44) and in Group B 43.0% (n=26) study population were agreed that the procedure was easy. Most common adverse effect was epigastric pain which was 1.7% (n=1) in Group A and 10.0% (n=7) in Group B. Paracervical block significantly reduces intraoperative pain during Manual Vacuum Aspiration (MVA) procedure in the treatment of first trimester pregnancy loss in comparison to intramuscular injection of diclofenac. In conclusion it might be mentioned that regarding paracervical block anesthesia, efficacy is higher and side effects are less. Moreover paracervical block anesthesia is cost effective.


Subject(s)
Anesthesia, Obstetrical , Vacuum Curettage , Pregnancy , Humans , Female , Vacuum Curettage/adverse effects , Vacuum Curettage/methods , Diclofenac/therapeutic use , Anesthesia, Obstetrical/adverse effects , Anesthesia, Obstetrical/methods , Cross-Sectional Studies , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Pregnancy Trimester, First , Pain, Postoperative/drug therapy , Pain, Postoperative/prevention & control
11.
Postgrad Med J ; 100(1188): 741-750, 2024 Sep 22.
Article in English | MEDLINE | ID: mdl-38679808

ABSTRACT

BACKGROUND: Low back pain (LBP) is a leading cause of disability worldwide and has posed numerous health and socioeconomic challenges. This study compared whether nonsteroidal anti-inflammatory drugs (NSAIDs) in combination with tramadol, tizanidine or placebo would be the best treatment regime to improve the Roland Morris Disability Questionnaire (RMDQ) scores at 1 week. METHODS: This was a multi-center, double-blind, randomized, and placebo-controlled trial including adult patients with acute LBP and sciatica in three emergency departments in Hong Kong. Patients were randomized to the receive tramadol 50 mg, tizanidine 2 mg, or placebo every 6 hours for 2 weeks in a 1:1:1 ratio. The RMDQ and other secondary outcomes were measured at baseline, Day 2, 7, 14, 21, and 28. Data were analyzed on an intention to treat basis. Crude and adjusted mean differences in the changes of RMDQ and NRS scores from baseline to Day 7 between tizanidine/tramadol and placebo were determined with 95% confidence intervals. RESULTS: Two hundred and ninety-one patients were analyzed with the mean age of 47.4 years and 57.7% were male. The primary outcome of mean difference in RMDQs on Day 7 (compared with baseline) was non-significant for tizanidine compared with placebo (adjusted mean difference - 0.56, 95% CI -2.48 to 1.37) and tramadol compared with placebo (adjusted mean difference - 0.85, 95% CI -2.80 to 1.10). Only 23.7% were fully compliant to the treatment allocated. Complier Average Causal Effect analysis also showed no difference in the primary outcome for the tizanidine and tramadol versus placebo. CONCLUSION: Among patients with acute LBP and sciatica presenting to the ED, adding tramadol or tizanidine to diclofenac did not improve functional recovery.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal , Clonidine , Diclofenac , Low Back Pain , Pain Measurement , Sciatica , Tramadol , Humans , Clonidine/analogs & derivatives , Clonidine/therapeutic use , Tramadol/therapeutic use , Male , Low Back Pain/drug therapy , Female , Sciatica/drug therapy , Double-Blind Method , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Middle Aged , Treatment Outcome , Adult , Diclofenac/therapeutic use , Diclofenac/analogs & derivatives , Diclofenac/administration & dosage , Analgesics, Opioid/therapeutic use , Drug Therapy, Combination , Hong Kong , Aged
12.
Int J Pharm Compd ; 28(2): 156-160, 2024.
Article in English | MEDLINE | ID: mdl-38604143

ABSTRACT

Diclofenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been found to be effective in treating a variety of acute and chronic pain and inflammatory conditions. A stability study was designed to assess the physical, chemical, and antimicrobial stability of three extemporaneously compounded bracketed Diclofenac Sodium formulations over time using a validated, stability indicating HPLC method. Diclofenac Sodium 1% and 15% were compounded in Medisca VersaPro™ Cream Base, VersaPro™ Gel Base and PLO Gel Mediflo™30 Compound Kit and stored at room temperature, in tightly closed, light resistant, plastic containers for 180 days. The organoleptic properties, pH, viscosity, and Diclofenac Sodium concentration of each formulation were evaluated at predetermined time points. Antimicrobial effectiveness testing of the compounded formulation according to USP <51> was also evaluated at the initial time point and after 180 days. The results demonstrated that all formulations remained within the specified stability criteria for the duration of the study. Therefore, an extended beyond-use-date of 180 days may be assigned to these compounded formulations under the studied conditions.


Subject(s)
Anti-Infective Agents , Diclofenac , Diclofenac/therapeutic use , Drug Stability , Anti-Inflammatory Agents, Non-Steroidal , Analgesics , Drug Compounding/methods
13.
J Oral Maxillofac Surg ; 82(7): 840-851, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38615694

ABSTRACT

BACKGROUND: Pain, swelling, and trismus are the most common sequalae following the surgical removal of mandibular third molars. They pose significant challenges for clinicians, prompting the exploration of efficacious management approaches. PURPOSE: The purpose of this study was to assess the efficacy of transbuccal mucoadhesive patch of diclofenac sodium versus an oral tablet in controlling the aforesaid sequelae. STUDY DESIGN, SETTING, SAMPLE: A prospective split-mouth, single-blinded study was conducted in the Department of Oral and Maxillofacial Surgery at AMC Dental College and Hospital, Ahmedabad. The study sample included patients of either sex, aged 18 to 45 years, requiring surgical removal of bilaterally symmetrical mandibular third molars under local anesthesia. Patients who had consumed analgesics within 24 hours prior to the procedure were excluded. PREDICTOR VARIABLE: The primary predictor variable was the route of administration of nonsteroidal anti-inflammatory drug. The study group received transbuccal mucoadhesive patches containing 20 mg diclofenac sodium, whereas the control group received oral tablets of 50 mg. MAIN OUTCOME VARIABLE: Postoperative pain, measured with visual analog scale, was the primary outcome variable, whereas swelling, mouth opening, onset of analgesic effect, and adverse events were assessed as secondary outcome variables. COVARIATES: Two categories of covariates were considered. First, demographic: age and gender. Second, perioperative: pattern of impaction. ANALYSES: Intergroup comparison was made using a paired sample t-test and an independent sample t-test, while intragroup differences were assessed with a one-way ANOVA and a paired t-test. P value ≤ .05 was considered statistically significant. RESULTS: Out of 146 patients screened initially, the final study sample included 37 subjects with a mean age of 26.08 ± 5.09 years (21 (56.75%) males and 16 (43.25%) females). The study group exhibited a significantly lower postoperative pain score compared to the control group on days 0, 1, 2, and 3 postoperatively (P ≤ .05). No statistically significant difference was observed in reduction of facial swelling and improvement in mouth opening on 1st, 2nd, and 3rd days postoperatively between both the groups (P ≥ .05). The mean onset of analgesia was statistically significant in the study group (19.96 ± 5.40 minutes) compared to the control group (52.56 ± 6.33 minutes) (P < .001). CONCLUSION AND RELEVANCE: Transbuccal mucoadhesive patch of diclofenac sodium offers effective pain control with quicker analgesia and fewer side effects compared to an oral tablet.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal , Diclofenac , Molar, Third , Pain, Postoperative , Tooth Extraction , Humans , Diclofenac/administration & dosage , Diclofenac/therapeutic use , Molar, Third/surgery , Female , Adult , Male , Pain, Postoperative/drug therapy , Pain, Postoperative/prevention & control , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Prospective Studies , Single-Blind Method , Adolescent , Young Adult , Middle Aged , Pain Measurement , Administration, Oral , Edema/etiology , Edema/prevention & control , Postoperative Complications/prevention & control , Trismus/prevention & control , Trismus/etiology , Transdermal Patch
14.
J Control Release ; 369: 114-127, 2024 May.
Article in English | MEDLINE | ID: mdl-38521167

ABSTRACT

This research introduces an innovative solution to address the challenges of bacterial keratitis and alkali burns. Current treatments for bacterial keratitis and alkali burns rely on the frequent use of antibiotics and anti-inflammatory eye drops. However, these approaches suffer from poor bioavailability and fluctuating concentrations, leading to limited efficacy and potential drug resistance. Our approach presents an adaptive drug-releasing contact lens responsive to reactive oxygen species (ROS) at ocular inflammation sites, synchronously releasing Levofloxacin and Diclofenac. During storage, minimal drug release occurred, but over 7 days of wear, the lens maintained a continuous, customizable drug release rate based on disease severity. This contact lens had strong antibacterial activity and biofilm prevention, effectively treating bacterial keratitis. When combined with autologous serum, this hydrophilic, flexible lens aids corneal epithelial regeneration, reducing irritation and promoting healing. In summary, this ROS-responsive drug-releasing contact lens combines antibacterial and anti-inflammatory effects, offering a promising solution for bacterial keratitis and alkali burns.


Subject(s)
Anti-Bacterial Agents , Diclofenac , Keratitis , Levofloxacin , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/administration & dosage , Keratitis/drug therapy , Keratitis/microbiology , Animals , Levofloxacin/therapeutic use , Levofloxacin/administration & dosage , Diclofenac/administration & dosage , Diclofenac/therapeutic use , Reactive Oxygen Species/metabolism , Drug Liberation , Biofilms/drug effects , Contact Lenses , Rabbits , Eye Burns/chemically induced , Eye Burns/drug therapy , Humans , Drug Delivery Systems , Eye Infections, Bacterial/drug therapy , Burns, Chemical/drug therapy , Burns, Chemical/therapy
15.
World J Gastroenterol ; 30(8): 811-816, 2024 Feb 28.
Article in English | MEDLINE | ID: mdl-38516233

ABSTRACT

Endoscopic ultrasound (EUS) with fine needle aspiration or fine needle biopsy is the gold standard for sampling tissue to diagnose pancreatic cancer and autoimmune pancreatitis or to analyze cyst fluid. The most common reported adverse event of fine needle aspiration and/or fine needle biopsy is acute pancreatitis, which is likely induced by the same pathophysiological mechanisms as after endoscopic retrograde cholangiopancreatography (ERCP). According to the current European Society of Gastrointestinal Endoscopy guideline, nonsteroidal anti-inflammatory drugs are administered prior to ERCP as a scientifically proven treatment to reduce post-ERCP pancreatitis incidence rate. A single suppository of diclofenac or indomethacin prior to EUS guided tissue acquisition (TA) is harmless in healthy adults. Since it is associated with low costs and, most important, may prevent a dreadsome complication, we strongly recommend the administration of 100 mg diclofenac rectally prior to EUS-TA. We will explain this recommendation in more detail in this review as well as the risk and pathophysiology of post-EUS TA pancreatitis.


Subject(s)
Pancreatitis , Adult , Humans , Pancreatitis/epidemiology , Pancreatitis/etiology , Pancreatitis/prevention & control , Incidence , Diclofenac/therapeutic use , Acute Disease , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Ultrasonography, Interventional/adverse effects , Endoscopic Ultrasound-Guided Fine Needle Aspiration/adverse effects
16.
Int Immunopharmacol ; 131: 111776, 2024 Apr 20.
Article in English | MEDLINE | ID: mdl-38471363

ABSTRACT

The aim of this study is to explore the potential of repurposing the antiarthritic drug diacerein (DCN) against diclofenac (DCF)-induced acute nephrotoxicity in rats. Rats were divided into four groups: Group I (CTRL) served as the negative control; Group II (DCF) served as the positive control and was injected with DCF (50 mg/kg/day) for three consecutive days (fourth-sixth) while being deprived of water starting on day 5; Group III (DCF + DCN50) and Group IV (DCF + DCN100) were orally administered DCN (50 and 100 mg/kg/day, respectively) for six days and injected with DCF, while being deprived of water as described above. Changes in kidney function biomarkers were assessed. Levels of MDA and GSH along with NO content in kidney tissues were measured as indicators of oxidative stress status. Histopathological changes of the renal cortex and medulla were evaluated. Changes in renal NF-κB and SIRT-1 levels were immunohistochemically addressed. Western blotting was used to estimate the relative expressions of HIF-1α, p53, and active caspase-3. Our results showed that DCN inhibited kidney dysfunction and suppressed oxidative stress, which were reflected in improved kidney architecture, including less tubular degeneration and necrosis in the cortex and medulla. Interestingly, DCN reduced renal HIF-1α, p53, and active caspase-3 expression and NF-κB activation while increasing renal SIRT1 expression. In conclusion, for the first time, DCN counteracts acute kidney injury induced by DCF in rats by its anti-oxidative, anti-inflammatory, antinecrotic, and anti-apoptotic effects in a dose-dependent manner, which are mainly via targeting SIRT1/HIF-1α/NF-κB and SIRT1/p53 regulatory axes.


Subject(s)
Diclofenac , NF-kappa B , Rats , Animals , NF-kappa B/metabolism , Diclofenac/therapeutic use , Caspase 3/metabolism , Tumor Suppressor Protein p53/metabolism , Sirtuin 1/metabolism , Apoptosis , Kidney , Oxidative Stress , Water/metabolism , Water/pharmacology
17.
Toxicon ; 241: 107679, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38447765

ABSTRACT

The search for mechanism-based anti-inflammatory therapies is of fundamental importance to avoid undesired off-target effects. Phospholipase A2 (PLA2) activity is a potential molecular target for anti-inflammatory drugs because it fuels arachidonic acid needed to synthesize inflammation mediators, such as prostaglandins. Herein, we aim to investigate the molecular mechanism by which ß-keto amyrin isolated from a methanolic extract of Cryptostegia grandiflora R. Br. Leaves can inhibit inflammation caused by Daboia russellii viper (DR) venom that mainly contains PLA2. We found that ß-keto amyrin neutralizes DR venom-induced paw-edema in a mouse model. Molecular docking of PLA2 with ß-keto amyrin complex resulted in a higher binding energy score of -8.86 kcal/mol and an inhibition constant of 611.7 nM. Diclofenac had a binding energy of -7.04 kcal/mol and an IC50 value of 620 nM, which predicts a poorer binding interaction than ß-keto amyrin. The higher conformational stability of ß-keto amyrin interaction compared to diclofenac is confirmed by molecular dynamics simulation. ß-keto amyrin isolated from C. grandiflora inhibits the PLA2 activity contained in Daboia russellii viper venom. The anti-inflammatory property of ß-keto amyrin is due to its direct binding into the active site of PLA2, thus inhibiting its enzyme activity.


Subject(s)
Apocynaceae , Daboia , Inflammation , Oleanolic Acid , Viper Venoms , Animals , Mice , Anti-Inflammatory Agents/pharmacology , Apocynaceae/chemistry , Diclofenac/pharmacology , Diclofenac/therapeutic use , Inflammation/chemically induced , Inflammation/drug therapy , Molecular Docking Simulation , Oleanolic Acid/analogs & derivatives , Oleanolic Acid/pharmacology , Oleanolic Acid/therapeutic use , Phospholipases A2/drug effects , Phospholipases A2/metabolism , Viper Venoms/chemistry , Viper Venoms/toxicity
18.
Ann Emerg Med ; 83(6): 542-551, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38441515

ABSTRACT

STUDY OBJECTIVE: Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are useful for a variety of musculoskeletal injuries. It is not known whether topical NSAIDs should be used for patients presenting with acute nonradicular musculoskeletal low back pain. METHODS: We conducted a randomized, placebo-controlled double-blind study in which patients 18 to 69 years of age visiting the emergency department (ED) with acute, nontraumatic, nonradicular, musculoskeletal low back pain were randomized at the time of discharge to treatment with 400 mg oral ibuprofen + placebo topical gel, 1% diclofenac topical gel + oral placebo, or 400 mg ibuprofen + 1% diclofenac topical gel. We measured outcomes using the Roland Morris Disability Questionnaire (RMDQ), a 24-item yes/no instrument about the effect of back pain on a respondent's daily activities. The primary outcome was change in RMDQ score between ED discharge and 2 days later. Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms. RESULTS: In total, 3,281 patients were screened for participation, and 198 were randomized. Overall, 36% of the population were women, the mean age was 40 years (standard deviation, 13), and the median RMDQ score at baseline was 18 (25th to 75th percentile: 13 to 22), indicating substantial low back-related functional impairment. In total, 183 (92%) participants provided primary outcome data. Two days after the ED visit, the ibuprofen + placebo group had improved by 10.1 (95% confidence interval [CI] 7.5 to 12.7), the diclofenac gel + placebo group by 6.4 (95% CI 4.0 to 8.8), and the ibuprofen + diclofenac gel by 8.7 (95% CI 6.3 to 11.1). The between-group differences were as follows: ibuprofen versus diclofenac, 3.7 (95% CI 0.2 to 7.2); ibuprofen versus both medications 1.4 (95% CI -2.1 to 4.9); and diclofenac versus both medications, 2.3 (95% CI -5.7 to 1.0). Medication-related adverse events were reported by 3/60 (5%) ibuprofen patients, 1/63 (2%) diclofenac patients, and 4/64 (6%) patients who received both. CONCLUSION: Among patients with nontraumatic, nonradicular acute musculoskeletal low back pain discharged from an ED, topical diclofenac was probably less efficacious than oral ibuprofen. It demonstrated no additive benefit when coadministered with oral ibuprofen.


Subject(s)
Administration, Topical , Anti-Inflammatory Agents, Non-Steroidal , Diclofenac , Emergency Service, Hospital , Ibuprofen , Low Back Pain , Humans , Ibuprofen/administration & dosage , Ibuprofen/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Female , Male , Diclofenac/administration & dosage , Diclofenac/therapeutic use , Double-Blind Method , Middle Aged , Adult , Administration, Oral , Low Back Pain/drug therapy , Aged , Young Adult , Adolescent , Treatment Outcome , Drug Therapy, Combination , Acute Pain/drug therapy
19.
Small ; 20(25): e2307281, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38225701

ABSTRACT

Osteoarthritis (OA) is a typical joint degenerative disease that is prevalent worldwide and significantly affects the normal activities of patients. Traditional treatments using diclofenac (DCF) as an anti-inflammatory drug by oral administration and transdermal delivery have many inherent deficiencies. In this study, a lubricating microneedles (MNs) system for the treatment of osteoarthritis with multistage sustained drug delivery and great reduction in skin damage during MNs penetration is developed. The bilayer dissolvable MNs system, namely HA-DCF@PDMPC, is prepared by designating the composite material of hyaluronic acid (HA) and covalently conjugated drug compound (HA-DCF) as the MNs tips and then modifying the surface of MNs tips with a self-adhesive lubricating copolymer (PDMPC). The MNs system is designed to achieve sustained drug release of DCF via ester bond hydrolysis, physical diffusion from MNs tips, and breakthrough of lubrication coating. Additionally, skin damage is reduced due to the presence of the lubrication coating on the superficial surface. Therefore, the lubricating MNs with multistage sustained drug delivery show good compliance as a transdermal patch for OA treatment, which is validated from anti-inflammatory cell tests and therapeutic animal experiments, down-regulating the expression levels of pro-inflammatory factors and alleviating articular cartilage destruction.


Subject(s)
Diclofenac , Drug Delivery Systems , Hyaluronic Acid , Needles , Osteoarthritis , Osteoarthritis/drug therapy , Animals , Diclofenac/administration & dosage , Diclofenac/therapeutic use , Diclofenac/pharmacology , Hyaluronic Acid/chemistry , Lubrication , Humans , Delayed-Action Preparations/chemistry
20.
Int J Med Sci ; 21(1): 37-44, 2024.
Article in English | MEDLINE | ID: mdl-38164348

ABSTRACT

Muscle contusion is an injury to muscle fibers and connective tissues. It commonly happens in impact events, and could result in pain, swelling, and limited range of motion. Diclofenac is one of commonly used nonsteroidal anti-inflammatory drugs to alleviate pain and inflammation after injury. However, it can potentially cause some side effects including gastrointestinal complications and allergy. Betulin is a lupine-type pentacyclic triterpenoid. It is showed to have valuable pharmacological effects, but the physiological effect of betulin on muscle contusion has not been reported. This study aimed to explore the therapeutic effects of betulin on muscle contusion that produced by the drop-mass method in mice. C57BL/6 mice were randomly assigned to control (no injury), only drop-mass injury (Injury), diclofenac treatment (Injury+diclofenac), and betulin treatment (Injury+betulin) groups. Injury was executed on the gastrocnemius of the right hind limb, and then phosphate-buffered saline (PBS), diclofenac, or betulin were oral gavage administrated respectively for 7 days. Results revealed that betulin significantly restored motor functions based on locomotor activity assessments, rota-rod test, and footprints analysis. Betulin also attenuated serum creatine kinase (CK) and lactate dehydrogenase (LDH) levels after muscle injury. Neutrophil infiltration was alleviated and desmin levels were increased after betulin treatment. Our data demonstrated that betulin attenuated muscle damage, alleviated inflammatory response, improved muscle regeneration, and restored motor functions after muscle contusion. Altogether, betulin may be a potential compound to accelerate the repair of injured muscle.


Subject(s)
Contusions , Diclofenac , Mice , Animals , Diclofenac/therapeutic use , Mice, Inbred C57BL , Contusions/drug therapy , Muscle, Skeletal/injuries , Disease Models, Animal
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