RESUMO
BACKGROUND: Between 62 and 90% of cases of acute generalized exanthematous pustulosis are caused by drugs. Its onset is rapid with generalized pustules, fever, and blood neutrophil count over 7000; pustules resolve spontaneously in less than 15 days. A case associated with piroxicam described. CASE REPORT: A 36-year-old with initial erythema of the thorax and abdomen, accompanied by burning, without fever, which later spread to his forearms, upper arms, and thighs, with face edema. A week earlier he had taken piroxicam for low back pain; at the time of hospitalization he received antihistamines, and topical and systemic steroids. Full blood count showed leukocytes at 8920, eosinophils at 600, neutrophils at 6600, total serum IgE at 188 UI, C-reactive protein at 2.9 mg/L, and no liver, kidney, or lung involvement. Treatment was initiated with intravenous antihistamines and ranitidine, saline, topical Vaseline plus topical mupirocin, and systemic steroids. On the second day of hospitalization neutrophils increased to 9000 and PCR to 3.3. The score to evaluate acute exanthematous pustulosis in the patient was 8, giving a definitive diagnosis. CONCLUSIONS: The differential diagnosis should be established primarily with pustular psoriasis. The prognosis is generally good, as reported.
Antecedentes: Entre 62 y 90% de los casos de pustulosis exantemática generalizada aguda son causados por medicamentos. Su inicio es rápido con pústulas generalizadas, fiebre, conteo de neutrófilos en sangre mayor de 7000; la resolución de las pústulas es espontánea en menos de 15 días. Se describe un caso asociado a piroxicam. Caso clínico: Hombre de 36 años de edad con eritema inicial en tórax y abdomen, acompañado de ardor, sin fiebre, que posteriormente se extendió a antebrazos, brazos y muslos; con edema de cara. Una semana antes había consumido piroxicam por dolor lumbar; al momento de su hospitalización recibía antihistamínicos, esteroides tópicos y sistémicos. El hemoleucograma mostró leucocitos de 8920, eosinófilos de 600, neutrófilos de 6600, IgE sérica total de 188 mg/L, proteína C reactiva de 2.9 mg/L, sin compromiso hepático, renal ni pulmonar. Se inició tratamiento con antihistamínicos y ranitidina intravenosos, solución salina, vaselina tópica más mupirocina tópica y esteroides sistémicos. Al segundo día de hospitalización, los neutrófilos aumentaron a 9000 y la proteína C reactiva a 3.3 mg/L. La puntuación para validar pustulosis exantemática aguda en el paciente fue de 8, indicativa de diagnóstico definitivo. Conclusiones: El diagnóstico diferencial debe establecerse principalmente con psoriasis pustulosa. El pronóstico en general es bueno, como sucedió con el caso informado.
Assuntos
Pustulose Exantematosa Aguda Generalizada/etiologia , Anti-Inflamatórios não Esteroides/efeitos adversos , Piroxicam/efeitos adversos , Pustulose Exantematosa Aguda Generalizada/diagnóstico , Pustulose Exantematosa Aguda Generalizada/patologia , Adulto , Diagnóstico Diferencial , Humanos , MasculinoRESUMO
OBJECTIVE: To determine the effect of treatment with honey in piroxicam-induced gastric ulcer in Holtzman rats. MATERIALS AND METHODS: 48 eight-week old female Holtzman rats, weights between 100 and 200 grams, were divided into 6 treatment groups as follow: Group A: water; Group B: piroxicam (30 mg/kg); Group C: omeprazole (5 mg/kg) and piroxicam (30 mg/kg); Group D: honey (2.5 g/kg) and piroxicam (30 mg/kg); Group E: honey (5 g/kg) and piroxicam (30 mg/kg); Group F: honey (7.5 g/kg) and piroxicam (30 mg/kg). Macroscopic studies, using Scion Image, and microscopic histological section of gastric mucosa were performed after the interventions. RESULTS: The results of the macroscopic studies showed statistically significant differences for both doses of honey at 6 g/kg and 7.5 g/kg when compared to piroxicam (p=0.016 and p=0.001 respectively) and the gastroprotective effect was similar when compared to omeprazole (p>0.05). Microscopic studies showed statistically significant differences only for dose at 7.5 g/kg when compared to piroxicam (p=0.0018) and the gastroprotective effect was similar to omeprazole (p=1). CONCLUSION: Dose of honey at 7.5 g/kg showed gastroprotective effect at microscopic and macroscopic studies when compared to omeprazole.
Assuntos
Anti-Inflamatórios não Esteroides/efeitos adversos , Mel , Piroxicam/efeitos adversos , Úlcera Gástrica/prevenção & controle , Animais , Antiulcerosos/uso terapêutico , Feminino , Omeprazol/uso terapêutico , Distribuição Aleatória , Ratos , Ratos Sprague-Dawley , Úlcera Gástrica/induzido quimicamente , Resultado do TratamentoRESUMO
AIM: To assess the safety of lornoxicam with particular focus on gastrointestinal (GI) events. METHODS: Data on adverse drug reactions (ADRs) were pooled from 60 comparative studies of lornoxicam. RESULTS: A total of 6420 patients received lornoxicam, 1192 received placebo and 3770 received a comparator analgesic. ADRs were reported by 21% of lornoxicam-treated patients, with GI events the most frequent (14 vs 8% with placebo). Across 15 studies that compared lornoxicam (n = 1287) with another NSAID (n = 1010), there was a reduced risk of a GI ADR with lornoxicam (0.78 [95% CI: 0.64-0.96]; p = 0.017). CONCLUSION: Lornoxicam was well tolerated with the type of GI events observed consistent with the known safety profile of NSAIDs.
Assuntos
Artrite Reumatoide/complicações , Inibidores de Ciclo-Oxigenase/efeitos adversos , Gastroenteropatias/induzido quimicamente , Dor/tratamento farmacológico , Piroxicam/análogos & derivados , Adulto , Ensaios Clínicos como Assunto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor/etiologia , Piroxicam/efeitos adversos , Resultado do TratamentoRESUMO
ABSTRACTBACKGROUND AND OBJECTIVES:Tenoxicam is widely used in osteoarthritis treatment and we aimedto compare the effectivity of oral and intra-articular administration of tenoxicam in osteoarthri-tis treatment.METHODS: This study was performed between 2011 and 2012 by retrospectively analyzing andcomparing the findings of 60 patients who were clinically and radiologically diagnosed with kneedegenerative osteoarthritis in Bünyan state hospital pain policlinic. 60 patients included in thestudy were divided into two groups. The first group (tenoxicam IA, n = 30) included patientfindings of those subjected to intra-articular injection of 20 mg tenoxicam to the knee oncea week for three weeks and the second group (oral tenoxicam, n = 30) included patients whowere administered 20 mg oral tenoxicam once a day for three weeks. All patients were clini-cally evaluated pre-treatment and in the 1st week, 1st month and 3rd month post-treatmentaccording to specified criteria.RESULTS AND CONCLUSIONS: Twenty two of 60 patients included in the study were male and 38were female. In both groups significant improvements were detected in all of the observedparameters: visual analog scale, Western Ontario McMaster Osteoarthritis Index (pain, physicalactivity, knee stiffness) and Lequesne index scores and in the evaluations performed in 1st week,1st month and 3rd month with respect to pre-treatment values. Besides, a better complianceto treatment and gastrointestinal system tolerability in tenoxicam IA group was also observed.Intra-articular tenoxicam administration could be thought as an alternative treatment methodin patients with knee osteoarthritis who cannot use oral tenoxicam especially due to systemicgastrointestinal system side effects and those who have difficulties in adapting to treatment.
RESUMOJUSTIFICATIVA E OBJETIVOS: Tenoxicam é amplamente usado no tratamento da osteoartrite (OA)e o nosso objetivo foi comparar a eficácia de tenoxicam administrado por via oral (VO) e intra-articular (IA) no tratamento da OA.MÉTODOS: Este estudo foi conduzido entre 2011 e 2012 por meio de análise retrospectiva ecomparação dos resultados de 60 pacientes que foram clínica e radiologicamente diagnosticadoscom OA degenerativa de joelhos na Policlínica de Tratamento da Dor do Hospital Estadual deBünyan. Os 60 pacientes incluídos no estudo foram alocados em dois grupos. O primeiro grupo(tenoxicam IA, n = 30) incluiu resultados de pacientes submetidos à injeção nos joelhos porvia IA de 20 mg de tenoxicam uma vez por semana durante três semanas e o segundo grupo(tenoxicam VO, n = 30) incluiu pacientes que receberam 20 mg de tenoxicam por VO uma vezpor dia durante três semanas. Todos os pacientes foram avaliados clinicamente na fase basalpré-tratamento e em uma semana, um mês e três meses pós-tratamento, de acordo com oscritérios especificados.RESULTADOS E CONCLUSÕES: Dos 60 pacientes, 22 eram do sexo masculino e 38 do sexo feminino.Em ambos os grupos, melhorias significativas foram detectadas em todos os parâmetros da escalavisual analógica, do índice Western Ontario and MacMaster (Womac --- dor, atividade física erigidez dos joelhos) e do índice de Lequesne nas avaliações feitas em uma semana, um mês etrês meses e comparadas aos valores basais. Além disso, uma melhor adesão ao tratamento etolerabilidade ao sistema gastrointestinal no grupo tenoxicam IA também foram observadas. Aadministração de tenoxicam IA pode ser considerada como um método opcional de tratamentoem pacientes com OA de joelhos que não podem usar tenoxicam por VO, especialmente porcausa dos efeitos colaterais sobre o sistema gastrintestinal, e naqueles com dificuldades de adaptação ao tratamento.
Assuntos
Humanos , Masculino , Feminino , Idoso , Piroxicam/análogos & derivados , Anti-Inflamatórios não Esteroides/administração & dosagem , Osteoartrite do Joelho/tratamento farmacológico , Piroxicam/administração & dosagem , Piroxicam/efeitos adversos , Administração Oral , Estudos Retrospectivos , Injeções Intra-Articulares , Pessoa de Meia-IdadeRESUMO
BACKGROUND AND OBJECTIVES: Tenoxicam is widely used in osteoarthritis treatment and we aimed to compare the effectivity of oral and intra-articular administration of tenoxicam in osteoarthritis treatment. METHODS: This study was performed between 2011 and 2012 by retrospectively analyzing and comparing the findings of 60 patients who were clinically and radiologically diagnosed with knee degenerative osteoarthritis in Bünyan state hospital pain policlinic. 60 patients included in the study were divided into two groups. The first group (tenoxicam IA, n=30) included patient findings of those subjected to intra-articular injection of 20mg tenoxicam to the knee once a week for three weeks and the second group (oral tenoxicam, n=30) included patients who were administered 20mg oral tenoxicam once a day for three weeks. All patients were clinically evaluated pre-treatment and in the 1st week, 1st month and 3rd month post-treatment according to specified criteria. RESULTS AND CONCLUSIONS: Twenty two of 60 patients included in the study were male and 38 were female. In both groups significant improvements were detected in all of the observed parameters: visual analog scale, Western Ontario McMaster Osteoarthritis Index (pain, physical activity, knee stiffness) and Lequesne index scores and in the evaluations performed in 1st week, 1st month and 3rd month with respect to pre-treatment values. Besides, a better compliance to treatment and gastrointestinal system tolerability in tenoxicam IA group was also observed. Intra-articular tenoxicam administration could be thought as an alternative treatment method in patients with knee osteoarthritis who cannot use oral tenoxicam especially due to systemic gastrointestinal system side effects and those who have difficulties in adapting to treatment.
Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Osteoartrite do Joelho/tratamento farmacológico , Piroxicam/análogos & derivados , Administração Oral , Idoso , Feminino , Humanos , Injeções Intra-Articulares , Masculino , Pessoa de Meia-Idade , Piroxicam/administração & dosagem , Piroxicam/efeitos adversos , Estudos RetrospectivosRESUMO
The preemptive analgesic efficacy and adverse effects of preoperatively administered piroxicam-β-cyclodextrin for post-endoscopic sinus surgery pain was determined in a prospective, double-blind, randomized, clinical study. Seventy-five American Society of Anesthesiologists status I-II patients, aged 18-65 years, were divided into three groups with similar demographic characteristics: group 1 received 20 mg piroxicam-β-cyclodextrin, group 2 received 40 mg piroxicam-β-cyclodextrin and group 3 received placebo orally before induction of general anesthesia. A blinded observer recorded the incidence and severity of pain at admission to the post-anesthesia care unit (PACU), at 15, 30, and 45 min in the PACU, and 1, 2, 4, 6, and 24 h postoperatively. All patients received patient-controlled morphine analgesia during the postoperative period and consumption was recorded for 24 h. During the PACU period, mean visual analogue scale values were significantly lower in groups 1 and 2 compared to group 3 (P < 0.05). During the postoperative period, morphine consumption was 3.03 ± 2.54, 2.7 ± 2.8, and 5.56 ± 3.12 mg for each group, respectively (P < 0.05). As a side effect, bleeding was observed in groups 1 and 3, nausea and vomiting in all groups, and edema only in group 3. However, no significant differences were detected in any of the parameters analyzed, which also included epigastric pain, constipation/diarrhea and headache. Similar hematological test results were obtained for all groups. Preemptive administration of piroxicam-β-cyclodextrin effectively reduced analgesic consumption, and 40 mg of the drug was more effective than 20 mg piroxicam-β-cyclodextrin without side effects during the postoperative period.
Assuntos
Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Anti-Inflamatórios não Esteroides/administração & dosagem , Endoscopia/métodos , Dor Pós-Operatória/prevenção & controle , Piroxicam/administração & dosagem , Sinusite/cirurgia , beta-Ciclodextrinas/administração & dosagem , Anti-Inflamatórios não Esteroides/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Medição da Dor , Cuidados Pré-Operatórios , Estudos Prospectivos , Piroxicam/efeitos adversos , Adulto Jovem , beta-Ciclodextrinas/efeitos adversosRESUMO
The preemptive analgesic efficacy and adverse effects of preoperatively administered piroxicam-beta-cyclodextrin for post-endoscopic sinus surgery pain was determined in a prospective, double-blind, randomized, clinical study. Seventy-five American Society of Anesthesiologists status I-II patients, aged 18-65 years, were divided into three groups with similar demographic characteristics: group 1 received 20 mg piroxicam-beta-cyclodextrin, group 2 received 40 mg piroxicam-beta-cyclodextrin and group 3 received placebo orally before induction of general anesthesia. A blinded observer recorded the incidence and severity of pain at admission to the post-anesthesia care unit (PACU), at 15, 30, and 45 min in the PACU, and 1, 2, 4, 6, and 24 h postoperatively. All patients received patient-controlled morphine analgesia during the postoperative period and consumption was recorded for 24 h. During the PACU period, mean visual analogue scale values were significantly lower in groups 1 and 2 compared to group 3 (P < 0.05). During the postoperative period, morphine consumption was 3.03 +/- 2.54, 2.7 +/- 2.8, and 5.56 +/- 3.12 mg for each group, respectively (P < 0.05). As a side effect, bleeding was observed in groups 1 and 3, nausea and vomiting in all groups, and edema only in group 3. However, no significant differences were detected in any of the parameters analyzed, which also included epigastric pain, constipation/diarrhea and headache. Similar hematological test results were obtained for all groups. Preemptive administration of piroxicam-beta-cyclodextrin effectively reduced analgesic consumption, and 40 mg of the drug was more effective than 20 mg piroxicam-beta-cyclodextrin without side effects during the postoperative period.
Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Endoscopia/métodos , Dor Pós-Operatória/prevenção & controle , Piroxicam/administração & dosagem , Sinusite/cirurgia , beta-Ciclodextrinas/administração & dosagem , Adolescente , Adulto , Idoso , Anti-Inflamatórios não Esteroides/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Piroxicam/efeitos adversos , Cuidados Pré-Operatórios , Estudos Prospectivos , Adulto Jovem , beta-Ciclodextrinas/efeitos adversosRESUMO
BACKGROUND: Piroxicam is an NSAID indicated for the treatment of rheumatoid diseases. Although there are generic formulations of oral piroxicam marketed in Mexico, a literature search did not identify published data concerning the bioavailability of these formulations in the Mexican population. OBJECTIVES: The aims of this study were to determine the bioequivalence of a generic (test) and a reference formulation of oral piroxicam 20 mg and to generate data regarding the oral bioavailability of this drug in a Mexican population. METHODS: This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted in healthy Mexican adult volunteers. Subjects were randomly assigned to receive the test formulation followed by the reference formulation, or vice versa, with a 15-day washout period between doses. Study drugs were administered after a 10-hour overnight fast. For pharmacokinetic analysis, blood samples were drawn at 0 (baseline), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours after administration. Plasma concentrations of piroxicam were determined using HPLC. The test and reference formulations were to be considered bioequivalent if the 90% CIs for the geometric mean test/reference ratios were within a predetermined range of 80% to 125%. Tolerability was determined using clinical assessment, monitoring of vital signs, laboratory analysis, and subject interviews regarding adverse events (AEs). RESULTS: A total of 28 subjects were enrolled (15 men, 13 women; mean [SD] age, 24 [4] years [range, 19-35 years]; weight, 63.0 [8.9] kg [range, 47.5-81.9 kg]; height, 165 [10] cm [range, 149-179 cm]; and body mass index, 23.2 [1.4] kg/m(2) [range, 20.6-26.0 kg/m(2)]). The 90% CIs for piroxicam C(max), AUC(0-infinity), and AUC(0-infinity)) were 89.98% to 101.04%, 91.46% to 101.19%, and 93.51% to 105.86%, respectively. Thirteen subjects reported a total of 17 AEs during the study. None of the AEs were considered serious or related to the administered formulations. The most common AE was local postvenipuncture ecchymosis, reported in 8 subjects (28.6%). CONCLUSIONS: In this small study in healthy Mexican adult subjects, a single 20-mg dose of the test formulation of orally administered piroxicam met the regulatory requirements to assume bioequivalence, based on the rate and extent of absorption. Both formulations were well tolerated. Mexican national registry code: CE-PEC.0875.
Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Anti-Inflamatórios não Esteroides/farmacocinética , Medicamentos Genéricos/administração & dosagem , Medicamentos Genéricos/farmacocinética , Piroxicam/administração & dosagem , Piroxicam/farmacocinética , Administração Oral , Adulto , Anti-Inflamatórios não Esteroides/efeitos adversos , Anti-Inflamatórios não Esteroides/sangue , Disponibilidade Biológica , Cápsulas , Química Farmacêutica , Cromatografia Líquida de Alta Pressão , Estudos Cross-Over , Medicamentos Genéricos/efeitos adversos , Feminino , Humanos , Masculino , México , Piroxicam/efeitos adversos , Piroxicam/sangue , Equivalência Terapêutica , Adulto JovemRESUMO
Third molar extraction is a common procedure frequently accompanied by moderate or severe pain, and involves sufficient numbers of patients to make studies relatively easy to perform. The aim of the present study was to determine the efficacy and safety of the therapeutic combination of 10 mg piroxicam, 1 mg dexamethasone, 35 mg orphenadrine citrate, and 2.5 mg cyanocobalamin (Rheumazin) when compared with 20 mg piroxicam alone (Feldene) in mandibular third molar surgery. Eighty patients scheduled for removal of the third molar were included in this randomized and double-blind study. They received (vo) Rheumazin or Feldene 30 min after tooth extraction and once daily for 4 consecutive days. Pain was determined by a visual analogue scale and by the need for escape analgesia (paracetamol). Facial swelling was evaluated with a measuring tape and adverse effects and patient satisfaction were recorded. There was no statistically significant difference in facial swelling between Rheumazin and Feldene (control group). Both drugs were equally effective in the control of pain, with Rheumazin displaying less adverse effects than Feldene. Therefore, Rheumazin appears to provide a better risk/benefit ratio in the mandibular molar surgery. Since the side effects resulting from nonsteroidal anti-inflammatory drug administration are a severe limitation to the routine use of these drugs in clinical practice, our results suggest that Rheumazin can be a good choice for third molar removal treatment.