Ulcer and bleeding complications and their relationship with dyspeptic symptoms in NSAIDs users: a transversal multicenter study

Dib, Ricardo; Chinzon, Décio; Fontes, Luiz Henrique de Souza; Teixeira, Ana Cristina de Sá; Navarro–Rodriguez, Tomás

doi:10.3109/00365521.2014.919016

Cited by 8 publications

(4 citation statements)

References 12 publications

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“…Furthermore, opioid addiction may occur and it is unclear whether this substance class can influence fracture healing. In contrast, non‐steroidal anti‐inflammatory drugs (NSAID) that are often prescribed for the treatment of mild to moderate musculoskeletal pain have been shown to exert considerable gastrointestinal side effects . The anti‐inflammatory action of NSAID is based on the selective or non‐selective inhibition of cyclooxygenase (COX)‐2, thus blocking the synthesis of prostaglandins (PGs) from arachidonic acid.…”

mentioning

confidence: 99%

Analgesia via blockade of NGF/TrkA signaling does not influence fracture healing in mice

Rapp

Kroner

Baur

et al. 2015

Journal Orthopaedic Research

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Abatement of fracture-related pain is important in patient welfare. However, the frequently used non-steroidal antiinflammatory drugs are considered to impair fracture healing through blockade of cyclooxygenase-2. An alternative for fracture-related pain treatment may be blockade of nerve growth factor (NGF)/neurotrophic tyrosine kinase receptor type 1 (TrkA) signaling. Because the effect of blocking this signal-pathway on bone healing has not been extensively investigated, we addressed this issue by applying neutralizing antibodies that target NGF and TrkA, respectively, in a mouse fracture model. Mice with a knock-in for human TrkA underwent femur osteotomy and were randomly allocated to phosphate-buffered-saline, anti-NGF-antibody, or anti-TrkA-antibody treatment. The analgesic effect of the antibodies was determined from the activity and the ground reaction force of the operated limb. The effect of antibody administration on fracture healing was assessed by histomorphometry, micro-computed tomography, and biomechanics. NGF/TrkA-signaling blockade had no negative effect on fracture healing as callus formation and maturation were not altered. Mice treated with anti-TrkA antibody displayed significantly greater activity on post-operative day 2 compared to PBS treatment indicating effective analgesia. Our data indicate, that blockade of NGF/TrkA signaling via specific neutralizing antibodies for pain reduction during fracture healing does not influence fracture healing. ß

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mentioning

confidence: 99%

Analgesia via blockade of NGF/TrkA signaling does not influence fracture healing in mice

Rapp

Kroner

Baur

et al. 2015

Journal Orthopaedic Research

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“…However, NSAIDs have limitations as PCA adjuvants. First, NSAIDs may cause digestive ulcer and bleeding 16 . Second, NSAIDs are the drugs most commonly involved in hypersensitivity drug reactions 17 .…”

Section: Discussionmentioning

confidence: 99%

A Randomized Clinical Trial of Nefopam versus Ketorolac Combined With Oxycodone in Patient-Controlled Analgesia after Gynecologic Surgery

Hwang¹,

Kwon²,

Lee³

et al. 2015

Int. J. Med. Sci.

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Objectives: Nefopam is a centrally-acting non-opioid analgesic, which has no effect on bleeding time and platelet aggregation. There has been no study about nefopam and oxycodone combination for postoperative analgesia. In this study, we present efficacy and side effects of nefopam/oxycodone compared with ketorolac/oxycodone in patient-controlled analgesia (PCA) after gynecologic surgery.Methods: 120 patients undergoing gynecologic surgery were divided randomly into two groups: Nefopam group treated with oxycodone 1 mg and nefopam 1 mg bolus; and Ketorolac group treated with oxycodone 1 mg and ketorolac 1.5 mg bolus. After the operation, a blinded observer assessed the pain with a numeric rating scale (NRS), infused PCA dose and sedation score at 1, 4, 24, and 48 h, nausea, vomiting, headache, shivering, pruritus and delirium at 6, 24 and 48 h, and satisfaction at 48 h after the operation.Results: Nefopam group showed less nausea than Ketorolac group within 6 h after the operation. There were no significant differences in demographic data and other complications between both groups. At 48 h after operation, satisfaction and the infused PCA volumes of Nefopam group (34.0± 19.7 ml) showed no significant differences compared to Ketorolac group (30.7± 18.4 ml, P-value= 0.46).Conclusion: Nefopam showed a similar efficacy and lower incidence of nausea within 6 h after the operation to that of ketorolac in PCA. Nefopam may be a useful analgesic drug for the opioid-based PCA after gynecologic surgery. Further evaluation of accurate equivalent dose of nefopam as well as pharmacokinetics of bolus administration is required.

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“…A continuación, se presenta una tabla con diferentes ejemplos de desenlaces de eficacia y seguridad, empleados en los ensayos clínicos aleatorizados. (Tabla 1) [9][10][11][12][13][14][15][16][17][18] .…”

Section: Eficacia Y Seguridadunclassified

Clasificación de los desenlaces en los ensayos clínicos

Tabares

Carrillo

Gómez

2019

MedUPB

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RESUMENEl ensayo clínico controlado aleatorizado (ECA) es un experimento planificado, controlado y prospectivo, en el que una o más intervenciones son asignadas a participantes humanos, con el fin de evaluar los efectos sobre los resultados relacionados con la salud, como la eficacia y seguridad de tratamientos, procedimientos o ayudas diagnósticas para diferentes enfermedades. En los ECA se pueden medir diferentes desenlaces, ya sean clínicos, relacionados con el paciente o económicos. Un desenlace es un evento clínico, médico, quirúrgico o de cualquier índole, que busca medir la efectividad y seguridad del tratamiento o intervención que se desea evaluar en un ensayo clínico. La elección de uno o más dependerá de la naturaleza del estudio y de la pregunta que se desea responder. Así mismo, el uso de una amplia gama de ellos tiende a ser más informativo que la medida de uno solo, por lo que es importante reconocer cada uno de estos, para definir su correcta implementación en el ámbito de la investigación. Este estudio tiene como objetivo principal describir los diferentes tipos de desenlaces, los cuales se clasifican en nueve categorías: 1. Eficacia y seguridad; 2. Primario, coprimario, secundario y terciario; 3. Simple y compuesto; 4. Positivo y negativo; 5. Clínicamente significativo y subrogado; 6. Objetivo y subjetivo; 7. Medidas únicas, repetidas y conteos (sucesos); 8. Dicotómico y continuo; y 9. Tiempo fijo y tiempo calendario. Palabras clave: ensayo clínico; eficacia; medidas de asociación, exposición, riesgo o desenlace ABSTRACT A randomized controlled trial (RCT) is a planned and controlled experiment. It is also a prospective study in which one or more interventions are assigned to human participants in order to assess the effects on health outcomes, such as the efficacy and safety of treatments and interventions for different diseases. Different outcomes, whether clinical, patient-related or economic, can be measured in RCTs. An outcome is a clinical, medical, surgical or any other event that seeks to measure the effectiveness and safety of the treatment or intervention to be evaluated in an RCT. The choice of one or more outcomes depends on the nature of the study and the question to be answered. Likewise, the use of a wide range of outcomes tends to be more informative than the measure of one alone. Therefore, it is important to recognize each of these to define their correct implementation in the field of clinical research. This study aims to describe the different types of outcomes, which are classified into nine categories: 1. Efficacy and safety; 2. Primary, coprimary, secondary and tertiary; 3. Simple and compound; 4. Positive and negative; 5. Clinically significant and subrogated; 6. Objective and subjective; 7. Single, repeated measures and counts (events); 8. Dichotomous and continuous; and 9. Fixed time and calendar time.

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Ulcer and bleeding complications and their relationship with dyspeptic symptoms in NSAIDs users: a transversal multicenter study

Cited by 8 publications

References 12 publications

Analgesia via blockade of NGF/TrkA signaling does not influence fracture healing in mice

Analgesia via blockade of NGF/TrkA signaling does not influence fracture healing in mice

A Randomized Clinical Trial of Nefopam versus Ketorolac Combined With Oxycodone in Patient-Controlled Analgesia after Gynecologic Surgery

Clasificación de los desenlaces en los ensayos clínicos

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