An analysis from clinico-epidemiological data of the principal adverse events from the COX-2 selective NSAID, nimesulide, with particular reference to hepatic injury

Introduction: Leaving a foreign object (retained the surgical item, or RSI) during surgery involving the abdominal cavity and pelvis minor is a relatively frequent, underestimated phenomenon which is dangerous to the health of the patient and the legal security of medical personnel. These adverse events are easy to avoid through the use of appropriate means of prevention. The aim of the present paper is the collection of epidemiological data and determination of risk factors, symptomatology, health effects, and prevention methods associated with RSIs. Material and methods: Analysis of global scientific publications in the databases PubMed, ClinicalKey, Google Scholar, ScienceDirect, and Scopus related to the subject of RSIs. Results: The frequency of RSI incidents ranges from 1 to 10 in 10,000 intra-abdominal surgeries, which results in at least one case in an average multispeciality hospital on a yearly basis. The items most frequently left behind include soft foreign objects, such as swabs and bandages (90%). Risk factors include emergency surgical procedures, high patient BMI, significant loss of blood during surgery, and neglect in counting material and surgical tools. The postoperative course, although in many cases asymptomatic, may be complicated by inflammation, bleeding, or perforation, leading to the necessity of a second operation and, in 2 to 4% of cases, even ending in death. Imaging tests are effective diagnostic tools. Effective methods of preventing RSIs are based on checklists and systems for counting and monitoring the location of material and tools. Conclusions: The globally occurring problem of RSIs requires the education of operating block personnel regarding risk factors and the identification and elimination of adverse events of this type. Diagnostics based on imaging should take into account non-specific complaints resulting from a possible oligosymptomatic course. An RSI should not be regarded as a medical error. Changes in the perception of the phenomenon are aimed at minimizing the legal liability of staff in the event of leaving a foreign object in the patient’s body.

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Diethylcarbamazine Reduces Chronic Inflammation and Fibrosis in Carbon Tetrachloride- (CCl4-) Induced Liver Injury in Mice

Mediators of Inflammation ◽

10.1155/2014/696383 ◽

2014 ◽

Vol 2014 ◽

pp. 1-15 ◽

Cited By ~ 17

Author(s):

Sura Wanessa Santos Rocha ◽

Maria Eduarda Rocha de França ◽

Gabriel Barros Rodrigues ◽

Karla Patrícia Sousa Barbosa ◽

Ana Karolina Santana Nunes ◽

...

Keyword(s):

Chronic Inflammation ◽

Inflammatory Process ◽

Hepatic Injury ◽

Treated Group ◽

Inos Mrna ◽

Hepatic Inflammation ◽

Liver Necrosis ◽

Cox 2 ◽

Anti Inflammatory ◽

Mrna Expression Levels

This study investigated the anti-inflammatory effects of DEC on the CCl4-induced hepatotoxicity in C57BL/6 mice. Chronic inflammation was induced by i.p. administration of CCl40.5 μL/g of body weight through two injections a week for 6 weeks. DEC (50 mg/kg) was administered by gavage for 12 days before finishing the CCl4induction. Histological analyses of the DEC-treated group exhibited reduced inflammatory process and prevented liver necrosis and fibrosis. Immunohistochemical and immunofluorescence analyses of the DEC-treated group showed reduced COX-2, IL1β, MDA, TGF-β, andαSMA immunopositivity, besides exhibiting decreased IL1β, COX-2, NFκB, IFNγ, and TGFβexpressions in the western blot analysis. The DEC group enhanced significantly the IL-10 expression. The reduction of hepatic injury in the DEC-treated group was confirmed by the COX-2 and iNOS mRNA expression levels. Based on the results of the present study, DEC can be used as a potential anti-inflammatory drug for chronic hepatic inflammation.

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Temporal effects of a COX-2-selective NSAID on bone ingrowth

Journal of Biomedical Materials Research Part A ◽

10.1002/jbm.a.30231 ◽

2005 ◽

Vol 72A (3) ◽

pp. 279-287 ◽

Cited By ~ 41

Author(s):

Stuart B. Goodman ◽

Ting Ma ◽

Lance Mitsunaga ◽

Keita Miyanishi ◽

Mark C. Genovese ◽

...

Keyword(s):

Bone Ingrowth ◽

Temporal Effects ◽

Cox 2 ◽

Selective Nsaid

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Dehydration-induced increase in aquaporin-2 protein abundance is blocked by nonsteroidal anti-inflammatory drugs

AJP Renal Physiology ◽

10.1152/ajprenal.90202.2008 ◽

2010 ◽

Vol 298 (4) ◽

pp. F1051-F1058 ◽

Cited By ~ 13

Author(s):

Erin Baggaley ◽

Søren Nielsen ◽

David Marples

Keyword(s):

Wistar Rats ◽

Hydration Status ◽

Free Access ◽

Protein Abundance ◽

Aquaporin 2 ◽

Male Wistar Rats ◽

Access To Water ◽

Inflammatory Drugs ◽

Cox 2 ◽

Selective Nsaid

It is now well established that the antidiuretic response to vasopressin is modulated by changes in aquaporin-2 (AQP2) expression in response to hydration status. While vasopressin itself is one signal driving expression, other signals also play a part. In this study, we planned to investigate whether prostaglandins, known to modulate AQP2 trafficking, may play a role in this process. Male Wistar rats were kept in metabolic cages, with either free access to water and food, or were given 15 g of food gelled with water, such that they were fluid restricted or fluid loaded. The effects of oral administration of two structurally different NSAIDs, indomethacin and ibuprofen, and a COX-2-selective NSAID, meloxicam, on urine output and AQP2 expression were investigated in kidneys removed under terminal anesthesia. All the NSAIDs decreased AQP2 expression significantly in water-restricted rats but did not significantly alter PGE excretion. In water-loaded rats, the effects were less marked, and meloxicam had no significant effect. Consistent with this, ibuprofen prevented the increase in AQP2 expression seen in response to dehydration. These results demonstrate that NSAIDs decrease AQP2 protein abundance, particularly during adaptation during dehydration. This may be of particular significance in older and critically ill patients, who are prone to dehydration.

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Analgesic Effect Study of Young Coconut Water (Cocos nucifera L.) on Mice (Mus musculus) Induced with Pain using Acetic Acid

Biomolecular and Health Science Journal ◽

10.20473/bhsj.v4i2.30176 ◽

2021 ◽

Vol 4 (2) ◽

pp. 94

Author(s):

Dini Indah Berlianti ◽

Danti Nur Indiastuti ◽

Gondo Mastutik ◽

Shaohong Lai

Keyword(s):

Acetic Acid ◽

Analgesic Effect ◽

Cocos Nucifera ◽

Effect Study ◽

Coconut Water ◽

Natural Minerals ◽

Recorded Data ◽

Cox 2 ◽

Cocos Nucifera L ◽

Selective Nsaid

Introduction: Pain signals tissue damage that is capable of reducing thequality of life. Non-Steroidal Anti-inflammatory Drugs (NSAIDs) are known as effective analgesic drugs which have various side effects, therefore natural minerals are used as an alternative medicine for pain and inflammation, one of which is known to be coconut water. Hence this research was conducted to find out the differences of the analgesic effect between young coconut water (Cocos nucifera L.) with non-selective and COX-2 selective NSAID on mice induced with pain from acetic acid 0.6% 1 ml/100gBW of mice.Methods: True experimental, conducted at the Pharmacology Laboratory in Faculty of Medicine of Airlangga University involving the sample of 48 mice (6 groups). The recorded data was tested using the oneway ANOVA methodology before then continued with the posthoc test of LSD.Results: The addition of young coconut water (Cocos nucifera L.) with the dosage of 3 ml/100gBW, 4 ml/100gBW, and 4.5 ml/100gBW of mice doesn't give any significant analgesic effect even though the analgesic protection percentage increases accordingly to its dosage (12.32%, 18.72%, 26.88%), but non-selective and COX-2 selective NSAID give significant analgesic effect (p<0.05) on mice induced with pain from acetic acid 0.6% 1 ml/100gBW of mice.Conclusion: There are differences in the analgesic effect of young coconut water (C. nucifera L.) with non-selective and COX-2 selective NSAID on mice induced with pain from acetic acid 0.6% 1 ml/100gBW of mice.

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Selective COX-2 inhibitors and risk of thromboembolic events – regulatory aspects

Thrombosis and Haemostasis ◽

10.1160/th06-08-0462 ◽

2006 ◽

Vol 96 (10) ◽

pp. 423-432 ◽

Cited By ~ 9

Author(s):

Karl Broich ◽

Hans-Karl Heim

Keyword(s):

Skin Toxicity ◽

Epidemiological Data ◽

Arterial Disease ◽

European Medicines Agency ◽

Established Coronary Heart Disease ◽

Cox 2 ◽

Anti Inflammatory ◽

Peripheral Arterial ◽

Cox 2 Inhibitors ◽

The Eu

SummaryIn the 1990s, the pharmaceutical industry developed selective COX-2 inhibitors (coxibs) as alternatives to conventional nonsteroidal anti-inflammatory drugs (NSAIDs), with the expectation of similar analgetic and anti-inflammatory efficacy but a reduced risk of adverse gastrointestinal (GI) effects. Marketing authorisation (MA) was granted for rofecoxib and celecoxib as first representatives of this new pharmacological class at the end of the 1990s in the EU. In the following years MAs were granted for the ´second generation` coxibs etoricoxib, parecoxib/valdecoxib and lumiracoxib. However, data from large clinical ´outcome studies` as well as epidemiological data raised concerns about the cardiovascular (CV) safety of the coxibs. In consequence, two comprehensive review processes (referrals) were initiated by the European Medicines Agency (EMEA).As a result, in the EU the use of coxibs has been contraindicated in patients with established coronary heart disease, cerebrovascular disease and peripheral arterial disease and a number of warning statements concerning CV, GI and skin toxicity have been introduced in the coxib product informations. This article provides a description of the regulatory actions taken and discusses some specific aspects of the past and future regulatory assessment of coxibs.

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Randomized double-blind, placebo-controlled study of topical diclofenac in prevention of hand-foot syndrome in patients receiving capecitabine.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.tps12135 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. TPS12135-TPS12135

Author(s):

Atul Batra ◽

Akhil P. Santosh ◽

Raja Pramanik ◽

Ajay Gogia ◽

R. M. Pandey ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Phase Iii ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Patient Reported ◽

Hand Foot Syndrome ◽

Cox 2 ◽

Topical Diclofenac

TPS12135 Background: The pathophysiology of capecitabine induced hand-foot syndrome (HFS) includes activation of cyclooxygenase (COX)-2, leading to an upregulation of the inflammatory cascade. Prophylaxis with oral celecoxib was previously reported to be associated with a significantly lower frequency of HFS (grade 1 [29.0% vs. 72.0%, p < 0.001] and grade 2 [11.8% vs. 30.0%, p=0.024]) (1). The findings were confirmed in a phase III trial (2). However, the associated systemic adverse events limit routine prophylactic use. Till date, no clinical trials have assessed the role of topical non-steroidal anti-inflammatory drugs (NSAIDs) in preventing HFS. Methods: In this investigator-initiated randomised phase III double-blind, placebo controlled, parallel group trial, a total of 264 patients with any stage breast or gastrointestinal cancer planned to receive capecitabine as a single agent or in combination with other chemotherapy will be randomised (1:1) to 1% topical diclofenac or placebo (base for 1% topical diclofenac) arm at a single tertiary care cancer centre in India. Randomization will be done by stratified (male vs female, and capecitabine mono therapy vs combination) permuted block method using a computer generated random sequence and allocation concealment will be done by using sealed opaque envelopes. In both the arms, patients will be asked to apply 1 fingertip unit (FTU) of topical medication on both surfaces of bilateral hands twice daily for a total duration of 12 weeks or till development of grade 2 or higher HFS, whichever is earlier. The primary objective is to compare the effect of topical diclofenac with placebo in preventing clinically significant HFS (incidence of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 2 or higher HFS). The secondary objectives include comparison of topical diclofenac with placebo on (i) incidence of NCI CTCv5.0 all grade HFS, (ii) time to develop grade ≥2 HFS from start of capecitabine, (iii) patient-reported outcomes using HFS-14 questionnaire (iv) adherence with topical application using self-reported adherence diary, (v) capecitabine dose reductions, delays and cessation due to HFS and (vi) safety profile (NCICTCv5.0). The tertiary correlative endpoint is to correlate the occurrence and severity of HFS with serum COX-2 levels and polymorphism of dihydropyrimidine dehydrogenase (DPPD) enzyme. The trial is registered at the Clinical Trial Registry of India (CTRI/2021/01/030592). Till date, we have enrolled 12/264 patients. (1) Zhang RX et al. J Cancer Res Clin Oncol. 2011;137(6):953-957. (2) Zhang RX et al. Annals of oncology. 2012;23(5):1348-1353. Clinical trial information: CTRI/2021/01/030592.

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