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1.
BMC Infect Dis ; 20(1): 834, 2020 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-33176727

RESUMO

BACKGROUND: Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care. METHODS: StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4-10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4-10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks. DISCUSSION: Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence. TRIAL REGISTRATION: The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111-1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true ).


Assuntos
Antibacterianos/uso terapêutico , Clindamicina/uso terapêutico , Metronidazol/uso terapêutico , Parceiros Sexuais , Vaginose Bacteriana/tratamento farmacológico , Administração Intravaginal , Administração Oral , Antibacterianos/administração & dosagem , Austrália , Clindamicina/administração & dosagem , Feminino , Seguimentos , Humanos , Masculino , Metronidazol/administração & dosagem , Nova Zelândia , Pênis/microbiologia , Estudos Prospectivos , Recidiva , Resultado do Tratamento , Vaginose Bacteriana/microbiologia
2.
Gastroenterol. hepatol. (Ed. impr.) ; 43(8): 426-430, oct. 2020. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-196893

RESUMO

OBJETIVOS: La tendencia actual en el tratamiento de la diverticulitis aguda no complicada es el manejo ambulatorio de los pacientes con pautas cortas de antibiótico o incluso con antiinflamatorios en casos seleccionados. Presentamos una comparativa de los resultados obtenidos en nuestro hospital con distintos protocolos aplicados en 2016 y 2017. MATERIAL Y MÉTODOS: Todos los pacientes seleccionados para este estudio fueron diagnosticados de diverticulitis grado Ia de la clasificación de Hinchey, según los hallazgos radiológicos en la TC abdominal. Hemos analizado dos cohortes retrospectivas: 100 pacientes tratados en 2016 según protocolo antiguo y 104 pacientes tratados en 2017 con protocolo nuevo. En el año 2016 los pacientes candidatos a tratamiento ambulatorio permanecieron en observación durante 24 horas antes de ser dados de alta. El tratamiento consistió en 14 días de ciprofloxacino y metronidazol. En 2017 solo se observaron durante 24 horas los pacientes con sintomatología más aguda y se prescribió amoxicilina-clavulánico durante solo cinco días. RESULTADOS: La persistencia de la enfermedad en 2016 fue del 6% y en 2017 solo alcanzó el 5,77% (p = 0,944). La recidiva durante el primer año fue del 13% en el primer grupo, mientras que en el segundo fue del 5,7%, aunque esta diferencia no fue estadísticamente significativa. Asimismo, se consiguió una significativa reducción del coste sanitario. CONCLUSIONES: El tratamiento ambulatorio de la diverticulitis aguda no complicada con pauta corta de antibiótico oral parece ser una estrategia terapéutica segura y efectiva en pacientes seleccionados con escasa comorbilidad


GOALS: The current trend in the treatment of non-complicated diverticulitis is the outpatient management with antibiotic or even anti-inflammatory regimens in selected cases. We present a comparison of the results in our hospital with different protocols applied in 2016 and 2017. MATERIAL AND METHODS: All patients selected for this study were diagnosed with diverticulitis grade Ia of Hinchey's classification according to radiological findings on abdominal CT. We have analyzed two retrospective cohorts: 100 patients treated in 2016 according to the old protocol and 104 patients treated in 2017 with a new protocol. In 2016, the candidates for ambulatory treatment remained under observation for 24 hours before being discharged. The treatment consisted of 14 days of ciprofloxacin and metronidazole. In 2017, only patients with more acute symptoms were observed 24 hours and amoxicillin-clavulanic acid was prescribed for only 5 days. RESULTS: The persistence of the disease in 2016 was 6% and in 2017 was only 5.77% (p = 0.944). Recurrence during the first year was 13% in the first group, while in the second it was 5.7%, although this difference was not statistically significant. Likewise, a significant reduction in health costs was achieved. CONCLUSIONS: Outpatient treatment of acute uncomplicated diverticulitis with oral treatment seems to be a safe and effective therapeutic strategy in selected patients with low comorbidity


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Diverticulite/tratamento farmacológico , Resultado do Tratamento , Assistência Ambulatorial/métodos , Estudos de Coortes , Estudos Retrospectivos , Ciprofloxacino/administração & dosagem , Metronidazol/administração & dosagem , Combinação Amoxicilina e Clavulanato de Potássio/administração & dosagem
3.
BMC Infect Dis ; 20(1): 669, 2020 Sep 14.
Artigo em Inglês | MEDLINE | ID: mdl-32928130

RESUMO

BACKGROUND: The parasite Entamoeba histolytica is the causal agent of amoebiasis, a worldwide emerging disease. Amebic brain abscess is a form of invasive amebiasis that is both rare and frequently lethal. This condition always begins with the infection of the colon by E. histolytica trophozoites, which subsequently travel through the bloodstream to extraintestinal tissues. CASE PRESENTATION: We report a case of a 71-year-old female who reported an altered state of consciousness, disorientation, sleepiness and memory loss. She had no history of hepatic or intestinal amoebiasis. A preliminary diagnosis of colloidal vesicular phase neurocysticercosis was made based on nuclear magnetic resonance imaging (NMRI). A postsurgery immunofluorescence study was positive for the 140 kDa fibronectin receptor of E. histolytica, although a serum analysis by ELISA was negative for IgG antibodies against this parasite. A specific E. histolytica 128 bp rRNA gene was identified by PCR in biopsy tissue. The final diagnosis was cerebral amoebiasis. The patient underwent neurosurgery to eliminate amoebic abscesses and was then given a regimen of metronidazole, ceftriaxone and dexamethasone for 4 weeks after the neurosurgery. However, a rapid decline in her condition led to death. CONCLUSIONS: The present case of an individual with a rare form of cerebral amoebiasis highlights the importance of performing immunofluorescence, NMRI and PCR if a patient has brain abscess and a poorly defined diagnosis. Moreover, the administration of corticosteroids to such patients can often lead to a rapid decline in their condition.


Assuntos
Abscesso Encefálico/diagnóstico , Abscesso Encefálico/parasitologia , Infecções Parasitárias do Sistema Nervoso Central/diagnóstico , Entamebíase/diagnóstico , Idoso , Animais , Abscesso Encefálico/tratamento farmacológico , Abscesso Encefálico/cirurgia , Ceftriaxona/administração & dosagem , Infecções Parasitárias do Sistema Nervoso Central/tratamento farmacológico , Infecções Parasitárias do Sistema Nervoso Central/patologia , Infecções Parasitárias do Sistema Nervoso Central/cirurgia , Terapia Combinada , DNA de Protozoário/análise , Dexametasona/administração & dosagem , Quimioterapia Combinada , Entamoeba histolytica/genética , Entamoeba histolytica/imunologia , Entamoeba histolytica/isolamento & purificação , Entamebíase/tratamento farmacológico , Entamebíase/patologia , Entamebíase/cirurgia , Evolução Fatal , Feminino , Humanos , Metronidazol/administração & dosagem , Procedimentos Neurocirúrgicos , Testes Sorológicos
4.
BMC Infect Dis ; 20(1): 491, 2020 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-32650729

RESUMO

BACKGROUND: Bacterial vaginosis (BV) increases HIV risk and adverse reproductive outcomes. Standard-of-care (SOC) for BV are antibiotics; however, cure rates are low. Probiotics for vaginal health may be useful in improving cure and recurrence although the regulatory framework governing probiotics and the conduct of randomized clinical trials to evaluate these has not been established in South Africa. We performed an exploratory single-blind trial evaluating a commercial oral-vaginal-combination probiotic as adjunct to SOC for BV treatment. METHODS: Women with symptomatic vaginal discharge were screened for BV and common sexually transmitted infections (STIs). BV+ (Nugent 7-10) but STI- women were randomized to vaginal metronidazole alone (n = 12) or to metronidazole followed by a commercial oral/vaginal probiotic (n = 18). The primary qualitative outcome was to test the regulatory landscape for conducting randomized probiotic trials in South Africa; and acceptability of vaginal application by women. BV cure at 1 month (Nugent≤3) was the primary quantitative endpoint. Secondary quantitative endpoints were BV recurrence, symptoms, vaginal microbiota and genital cytokine changes over 5 months post-treatment. RESULTS: The  South African Health Products Regulatory Authority (SAHPRA) reviewed and approved this trial. As probiotics continue to be regulated as health supplements in South Africa, SAHPRA required a notification application for this trial. Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules. 44.8% of women cleared BV one-month post-treatment, and no significant differences in BV cure (RR = 0.52, 95% CI = 0.24-1.16), recurrence, vaginal pH, symptoms, microbiota or vaginal IL-1α concentrations were found between SOC and intervention groups in this pilot study with an over-the-counter product. CONCLUSION: Navigation of the SAHPRA registration process for evaluating a commercial probiotic in a randomised trial laid the foundation for planned larger trials of improved probiotic products for vaginal health in South Africa. Although adherence to the vaginally delivered probiotic was high, women preferred oral application and we recommend that improvements in the content and method of application for future probiotics for vaginal health should be considered. TRIAL REGISTRATION: This trial was registered on 17 October 2017 with the South African National Clinical Trial Register ( http://www.sanctr.gov.za/ ; BV-trial1; DOH-27-1117-5579 ).


Assuntos
Probióticos/uso terapêutico , Vaginose Bacteriana/microbiologia , Vaginose Bacteriana/terapia , Administração Intravaginal , Adulto , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Suplementos Nutricionais , Aprovação de Drogas , Feminino , Humanos , Interleucina-1alfa/metabolismo , Adesão à Medicação , Metronidazol/administração & dosagem , Metronidazol/uso terapêutico , Microbiota , Projetos Piloto , Recidiva , Método Simples-Cego , África do Sul , Resultado do Tratamento , Adulto Jovem
5.
Ann Afr Med ; 19(2): 103-112, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32499466

RESUMO

Background: Postcesarean wound infection is a leading cause of prolonged hospital stay. Considerable debates still exist regarding choice of antibiotics, dose, and duration of use. Objectives: The objective is to compare the efficacy of 2 doses of amoxicillin-clavulanic acid versus a 7 days combination of amoxicillin-clavulanic acid and metronidazole as prophylactic antibiotics following cesarean section (CS). Methodology: It was a randomized controlled trial that was conducted among 160 women undergoing CS at Aminu Kano Teaching Hospital. Women were randomized into two groups. Group I (study group) received 2 doses of 1.2 g amoxicillin-clavulanic acid. Group II (control group) received a 7 days course of amoxicillin-clavulanic acid and metronidazole. The data obtained were analyzed using SPSS version 17. Categorical (qualitative) variables were analyzed using Chi-square test and Fisher's exact test as appropriate while continuous (quantitative) variables were analyzed using independent sample t-test. P < 0.05 was considered statistically significant. Results: There was no statistically significant association in the occurrence of fever (12.8% vs. 15.8%, P = 0.6), wound infection (6.4% vs. 10.5%, P = 0.36), endometritis (7.7% vs. 11.8%, P = 0.38), UTI (6.4% vs. 5.3%, P = 1.00), mean duration of hospital stay (129.7 vs. 134.2 h, P = 0.48), and neonatal outcomes between the two groups. There was statistically significant difference in the mean cost of antibiotics (₦2883/US$9.5 vs. ₦7040/US$23.1, P < 0.001) and maternal side effects (10.3% vs. 26.3%, P < 0.001) between the study and the control groups, respectively. Conclusion: This study found no statistically significant difference in infectious morbidity, duration of hospital stay, and neonatal outcomes when two doses of amoxicillin-clavulanic acid was compared with a 7 days course of prophylactic antibiotic following CS. The use of two doses of amoxicillin-clavulanic acid has the advantages of reduced cost and some maternal side effects. The two doses were cheaper with minimal side effects.


Assuntos
Amoxicilina/administração & dosagem , Antibacterianos/administração & dosagem , Antibioticoprofilaxia/métodos , Infecções Bacterianas/prevenção & controle , Cesárea/efeitos adversos , Ácido Clavulânico/administração & dosagem , Metronidazol/administração & dosagem , Infecção Puerperal/prevenção & controle , Adulto , Antibioticoprofilaxia/efeitos adversos , Infecções Bacterianas/tratamento farmacológico , Relação Dose-Resposta a Droga , Esquema de Medicação , Quimioterapia Combinada , Feminino , Hospitais de Ensino , Humanos , Nigéria , Gravidez , Infecção da Ferida Cirúrgica/tratamento farmacológico , Infecção da Ferida Cirúrgica/prevenção & controle , Resultado do Tratamento
6.
PLoS One ; 15(5): e0232905, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32442163

RESUMO

Antibiotic administration can be a cause of gastrointestinal disease in horses, creating a disruption in the normal population and function of bacteria found in the hindgut. The objective of this study was to describe the changes in the cecal and fecal microbiomes and metabolomes of clinically healthy horses before and after metronidazole administration. Metronidazole (15 mg/kg BID PO) was given to five horses with cecal cannulas. The study was suspended on Day 3 due to adverse gastrointestinal effects. Cecal and fecal samples were obtained before (Days minus52, m28, m14, and 0) and after (Days 7, 14, 28, and 52) metronidazole administration. DNA was extracted from the cecal and fecal samples, and 16S rRNA genes were sequenced. Richness and evenness indices were significantly decreased by metronidazole administration in both cecal and fecal samples, but the overall composition was only significantly changed in fecal samples on Day 3 (ANOSIM, p = 0.008). The most dominant phyla were Bacteroidetes and Firmicutes in all groups examined. In fecal samples, significant changes of the phyla Actinobacteria, Spirochaetes, Lentisphaerae, and Verrucomicrobia occurred on Day 3, which correlated with clinical signs of gastrointestinal disease. The metabolome was characterized by mass spectrometry-based methods and only named metabolites were included in the analysis. Fecal, but not cecal, metabolites were significantly affected by metronidazole. The fecal metabolites affected represent diverse metabolic pathways, such as the metabolism of amino acids, carbohydrates, lipids, nucleic acids and cofactors and vitamins. Metronidazole administration has potential to cause adverse effects in horses, alters the bacterial composition of the horse's cecal and fecal content, and the metabolome of fecal samples.


Assuntos
Antibacterianos/administração & dosagem , Microbioma Gastrointestinal/efeitos dos fármacos , Cavalos , Metaboloma/efeitos dos fármacos , Metronidazol/administração & dosagem , Animais , Biodiversidade , Ceco/efeitos dos fármacos , Ceco/metabolismo , Ceco/microbiologia , Fezes/química , Fezes/microbiologia , Microbioma Gastrointestinal/genética , Cavalos/metabolismo , Cavalos/microbiologia , Masculino , RNA Ribossômico 16S
7.
BMC Surg ; 20(1): 112, 2020 May 24.
Artigo em Inglês | MEDLINE | ID: mdl-32448287

RESUMO

BACKGROUND: Metronidazole (MNZ) has been clearly established as a medication for amebic liver abscess. In uncomplicated cases, surgical drainage should be avoided. We report a case of amebic liver abscess refractory to MNZ that was successfully treated using preoperative computed tomography (CT) and percutaneous and surgical drainage with intraoperative ultrasonography (IOUS). CASE PRESENTATION: A 53-year-old man with high-grade fever was diagnosed with a cystic lesion on his right hepatic lobe using CT. Percutaneous drainage was performed, and antibacterial drugs were administered. However, the infection and condition of the patient worsened. Entamoeba histolytica was detected from pus within the mediastinal cavity. Hence, the patient was diagnosed with amebic liver abscess. After the diagnosis was established, we administered MNZ for 10 days. Despite this, the patient's physical condition did not improve. Blood tests suggested impending disseminated intravascular coagulation (DIC). We performed surgical intervention to drain the amebic liver abscess refractory to conservative treatment. During surgery, imaging information from preoperative CT and IOUS enabled us to recognize the anatomical structures and determine the incision lines of the hepatic capsule and hepatic tissue. The patient's DIC immediately regressed after surgery. Unfortunately, malnutrition and disuse syndrome contributed to the patient's long recovery period. He was discharged 137 days post-surgery. CONCLUSIONS: We reported a case of amebic liver abscess refractory to conservative treatment. Surgical drainage with preoperative CT and IOUS allowed us to safely and effectively perform complex abscess decompression.


Assuntos
Drenagem/métodos , Entamoeba histolytica/isolamento & purificação , Abscesso Hepático Amebiano/cirurgia , Humanos , Masculino , Metronidazol/administração & dosagem , Pessoa de Meia-Idade , Tomografia Computadorizada por Raios X , Ultrassonografia
8.
Braz. J. Vet. Res. Anim. Sci. (Online) ; 57(2): e166204, mai. 2020. ilus, graf
Artigo em Inglês | LILACS, VETINDEX | ID: biblio-1122176

RESUMO

Medical management of abdominal abscesses in horses requires prolonged antibiotic therapy and presents varied success rates. A 6-year-old male horse with a history of colic and multiple abdominal punctures to relieve gas was attended. At admission, tachycardia, tachypnea, hyperthermia, mucosal congestion, dehydration, and rigid gait were observed. The association of physical examination, laboratory and ultrasonographic findings allowed the diagnoses of peritonitis and abdominal abscess. Supporting treatment plus broad spectrum antibiotic therapy was performed: daily intraperitoneal ceftriaxone (25 mg/kg, 7 days); daily intravenous gentamicin (6.6 mg/kg, 7 days); per os metronidazole three times a day (15 mg/kg 12 days), followed by the same dose twice a day (15 mg/kg 33 days), totaling 45 days of treatment. Plasma fibrinogen and ultrasonographic examination were the most effective tools to evaluate abscess evolution. There was normalization of the physical examination 24 h after beginning the treatment, consecutive regression of the nucleated cell count in the peritoneal fluid, and regression of plasma fibrinogen and size of the abscess. On the 10th treatment day, the animal was discharged from the hospital, maintaining oral therapy with metronidazole every 12 h (15 mg / kg). When the animal returned on the 30th day, an abscess size regression was observed. However, there was no resolution, and therapy with metronidazole was maintained. On the 45th day of treatment, a new hospital evaluation was performed, where the abscess resolved, and metronidazole was suspended. It is highlighted that the therapeutic association used in the treatment of abdominal infection and abscess resulted in a rapid clinical response.(AU)


O tratamento conservativo dos abscessos abdominais em equinos requer antibioticoterapia prolongada e apresenta variadas taxas de sucesso. Foi atendido um cavalo de seis anos de idade, com histórico de cólica e múltiplas punções abdominais por agulha para esvaziamento de gás. Na admissão, foram observados taquicardia, taquipnéia, hipertermia, congestão mucosa, desidratação e marcha rígida. A associação do exame físico, achados laboratoriais e ultrassonográficos permitiu o diagnóstico de peritonite e abscesso abdominal. Foi realizado tratamento suporte e antibioticoterapia de amplo espectro: ceftriaxona intraperitoneal diária (25 mg/kg, 7 dias); gentamicina intravenosa diária (6,6 mg/kg, 7 dias); metronidazol oral três vezes ao dia (15 mg/kg, 12 dias), seguido de mesma dose duas vezes ao dia, por mais 33 dias, totalizando 45 dias de tratamento. O fibrinogênio plasmático e o exame ultrassonográfico foram os recursos mais eficazes para a avaliação da evolução do abscesso. Após 24 horas do início do tratamento foi constatada a normalização do exame fisico, regressão progressiva da contagem de células nucleadas no líquido peritoneal, do fibrinogênio plasmático e do tamanho do abscesso. No 10° dia de tratamento o animal recebeu alta hospitalar, mantendo-se a terapia oral com metronidazol a cada 12 horas (15 mg/Kg). Em retorno, ao 30° dia, observou-se regressão do tamanho do abscesso, entretanto, não houve resolução, tendo sido mantida a terapia com metronidazol. No 45º dia de tratamento, realizou-se nova avaliação hospitalar, onde foi observada a resolução do abscesso e a admnistração do metronidazol foi suspensa. Destaca-se, que a associação terapêutica utilizada no tratamento de infecção abdominal e abscesso resultou em rápida resposta clínica.(AU)


Assuntos
Animais , Peritonite/veterinária , Ceftriaxona/administração & dosagem , Gentamicinas/administração & dosagem , Abscesso Abdominal/veterinária , Cavalos , Metronidazol/administração & dosagem , Ultrassom , Fibrinogênio , Injeções Intraperitoneais/veterinária
10.
Lancet Gastroenterol Hepatol ; 5(8): 729-738, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32325012

RESUMO

BACKGROUND: Previous studies have found that mechanical bowel preparation with oral antibiotics can reduce the incidence of surgical-site infections, but no randomised controlled trial has assessed oral antibiotics alone without mechanical bowel preparation. The aim of this study was to determine whether prophylaxis with oral antibiotics the day before elective colon surgery affects the incidence of postoperative surgical-site infections. METHODS: In this multicentre, pragmatic, randomised controlled trial (ORALEV), patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated. Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated. Participants were randomly assigned (1:1) using online randomisation tables to either administration of oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group). For the experimental group, ciprofloxacin 750 mg was given every 12 h (two doses at 1200 h and 0000 h) and metronidazole 250 mg every 8 h (three doses at 1200 h, 1800 h, and 0000 h) the day before surgery. All patients were given intravenous cefuroxime 1·5 g and metronidazole 1 g at the time of anaesthetic induction. The primary outcome was incidence of surgical-site infections. Patients were followed up for 1 month after surgery and all postsurgical complications were registered. This study was registered with EudraCT, 2014-002345-21, and ClinicalTrials.gov, NCT02505581, and is closed to accrual. FINDINGS: Between May 2, 2015, and April 15, 2017, we assessed 582 patients for eligibility, of whom 565 were eligible and randomly assigned to receive either no oral antibiotics (n=282) or oral antibiotics (n=282) before surgery. 13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention. The incidence of surgical-site infections in the control group (30 [11%] of 269) was significantly higher than in the experimental group (13 [5%] of 267; χ2 test p=0·013). Oral antibiotics were associated with a significant reduction in the risk of surgical-site infections compared with no oral antibiotics (odds ratio 0·41, 95% CI 0·20-0·80; p=0·008). More complications (including surgical-site infections) were observed in the control group than in the experimental group (76 [28%] vs 51 [19%]; p=0·017), although there was no difference in severity as assessed by Clavien-Dindo score. No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications. INTERPRETATION: The administration of oral antibiotics as prophylaxis the day before colon surgery significantly reduces the incidence of surgical-site infections without mechanical bowel preparation and should be routinely adopted before elective colon surgery. FUNDING: Fundación Asociación Española de Coloproctología.


Assuntos
Antibacterianos/uso terapêutico , Ciprofloxacino/uso terapêutico , Colo/cirurgia , Metronidazol/uso terapêutico , Cuidados Pré-Operatórios/normas , Infecção da Ferida Cirúrgica/prevenção & controle , Administração Intravenosa , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/administração & dosagem , Ciprofloxacino/administração & dosagem , Colectomia/efeitos adversos , Colectomia/métodos , Colo/patologia , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Feminino , Humanos , Incidência , Masculino , Metronidazol/administração & dosagem , Pessoa de Meia-Idade , Método Simples-Cego , Espanha/epidemiologia , Infecção da Ferida Cirúrgica/epidemiologia
11.
J Gastroenterol Hepatol ; 35(10): 1731-1737, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32167605

RESUMO

BACKGROUND AND AIM: Concomitant therapy is a recommended first-line treatment for Helicobacter pylori infection in most national or international consensuses. Reverse hybrid therapy is a modified 14-day concomitant therapy without clarithromycin and metronidazole in the final 7 days. This study aims to test whether 14-day reverse hybrid therapy is non-inferior to 14-day concomitant therapy in the first-line treatment of H. pylori infection. METHODS: Helicobacter pylori-infected adult patients were randomly assigned to receive either reverse hybrid therapy (dexlansoprazole 60 mg o.d. plus amoxicillin 1 g b.d. for 14 days, and clarithromycin 500 mg plus metronidazole 500 mg b.d. for initial 7 days) or concomitant therapy (dexlansoprazole 60 mg once o.d. plus amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg b.d. for 14 days). H. pylori status was assessed 6 weeks after the end of treatment. RESULTS: Helicobacter pylori-infected participants (n = 248) were randomized to receive either 14-day reverse hybrid therapy (n = 124) or 14-day concomitant therapy (n = 124). Intention-to-treat analysis demonstrated that the two therapies had comparable eradication rate (95.2% vs 93.5%; 95% confidence interval, -4.0% to 7.4%; P = 0.582). However, reverse hybrid therapy had a much lower frequency of adverse events than concomitant therapy (20.2% vs 38.7%, P = 0.001). The two therapies exhibited comparable drug adherence (93.5% vs 87.9%, P = 0.125). CONCLUSIONS: Fourteen-day reverse hybrid therapy and 14-day concomitant therapy are equivalent in efficacy for the first-line treatment of H. pylori infection. However, reverse hybrid therapy has fewer adverse events compared with concomitant therapy.


Assuntos
Amoxicilina/administração & dosagem , Antibacterianos/administração & dosagem , Claritromicina/administração & dosagem , Dexlansoprazol/administração & dosagem , Gastrite/tratamento farmacológico , Gastrite/microbiologia , Infecções por Helicobacter , Helicobacter pylori , Metronidazol/administração & dosagem , Adulto , Idoso , Amoxicilina/efeitos adversos , Antibacterianos/efeitos adversos , Claritromicina/efeitos adversos , Dexlansoprazol/efeitos adversos , Esquema de Medicação , Quimioterapia Combinada/métodos , Feminino , Humanos , Masculino , Metronidazol/efeitos adversos , Pessoa de Meia-Idade , Resultado do Tratamento
12.
Sci Rep ; 10(1): 3884, 2020 03 03.
Artigo em Inglês | MEDLINE | ID: mdl-32127550

RESUMO

Bacterial vaginosis (BV) is associated with HIV acquisition and adverse pregnancy outcomes. Recurrence after metronidazole treatment is high. HIV-negative, non-pregnant Rwandan BV patients were randomized to four groups (n = 17/group) after seven-day oral metronidazole treatment: behavioral counseling only (control), or counseling plus intermittent use of oral metronidazole, Ecologic Femi+ vaginal capsule (containing multiple Lactobacillus and one Bifidobacterium species), or Gynophilus LP vaginal tablet (L. rhamnosus 35) for two months. Vaginal microbiota assessments at all visits included Gram stain Nugent scoring and 16S rRNA gene qPCR and HiSeq sequencing. All interventions were safe. BV (Nugent 7-10) incidence was 10.18 per person-year at risk in the control group, and lower in the metronidazole (1.41/person-year; p = 0.004), Ecologic Femi+ (3.58/person-year; p = 0.043), and Gynophilus LP groups (5.36/person-year; p = 0.220). In mixed effects models adjusted for hormonal contraception/pregnancy, sexual risk-taking, and age, metronidazole and Ecologic Femi+ users, each compared to controls, had higher Lactobacillus and lower BV-anaerobes estimated concentrations and/or relative abundances, and were less likely to have a dysbiotic vaginal microbiota type by sequencing. Inter-individual variability was high and effects disappeared soon after intervention cessation. Lactobacilli-based vaginal probiotics warrant further evaluation because, in contrast to antibiotics, they are not expected to negatively affect gut microbiota or cause antimicrobial resistance.


Assuntos
Lactobacillus/fisiologia , Metronidazol/farmacologia , Microscopia , Probióticos/farmacologia , Análise de Sequência , Vaginose Bacteriana/microbiologia , Vaginose Bacteriana/prevenção & controle , Administração Intravaginal , Adolescente , Adulto , Antibacterianos/administração & dosagem , Antibacterianos/farmacologia , Feminino , Humanos , Lactobacillus/genética , Metronidazol/administração & dosagem , Pessoa de Meia-Idade , Projetos Piloto , Prevenção Secundária , Adulto Jovem
14.
Eur J Pharm Biopharm ; 149: 85-94, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32001314

RESUMO

Alveolar osteitis is a complication that can occur after tooth extraction, whereby exposed bone results in severe throbbing pain for the patient and can be prone to infection. The current treatment options are widely regarded as sub-optimal. The aim of this project was to investigate in vitro the plausibility of a dual-action monolithic drug-loaded thermosensitive hydrogel that undergoes thermal gelation within the tooth socket and releases both anaesthetic and antimicrobial agents. Hydrogels containing different levels of lidocaine HCl and metronidazole were prepared based upon Carbopol 934P NF and Pluronic F-127 blends. Membrane-less drug release was determined from the set hydrogels into phosphate buffered saline (PBS) at 37 °C as a function of time, following analysis by HPLC. Gelation characteristics and hydrogel dissolution characteristics were also determined. At 23.38% Pluronic F-127, sol-gel transition commenced at 23 °C and gelation was completely at 37 °C (physiological temperature). Setting times varied with Pluronic content and there was an inverse relationship between drug release and Pluronic content. Sustained and dose dependent release of both drugs was observed at therapeutically relevant levels over 24 h, via a combination of diffusion, dissolution and surface erosion processes. Based on the amounts of drugs released, it was determined that hydrogels containing up to 0.5% lidocaine and 0.1% metronidazole exhibited low risk of cytotoxicity to primary human gingival fibroblasts. In an in vivo scenario, the sol-phase formulation would make contact with all inner surfaces of a tooth socket prior to transitioning to monolithic gel-phase and provide sustained release of lidocaine and metronidazole at sub-toxic levels, thereby providing simultaneous pain relief, protection from ingress of debris and pathological bacteria.


Assuntos
Sistemas de Liberação de Medicamentos , Alvéolo Seco/tratamento farmacológico , Lidocaína/administração & dosagem , Metronidazol/administração & dosagem , Acrilatos/química , Anestésicos Locais/administração & dosagem , Anestésicos Locais/farmacologia , Anestésicos Locais/toxicidade , Anti-Infecciosos/administração & dosagem , Anti-Infecciosos/farmacologia , Anti-Infecciosos/toxicidade , Células Cultivadas , Liberação Controlada de Fármacos , Fibroblastos/efeitos dos fármacos , Gengiva/citologia , Gengiva/efeitos dos fármacos , Humanos , Hidrogéis , Lidocaína/farmacologia , Lidocaína/toxicidade , Metronidazol/farmacologia , Metronidazol/toxicidade , Transição de Fase , Poloxâmero/química , Temperatura
15.
Helicobacter ; 25(2): e12683, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32074663

RESUMO

BACKGROUND/AIMS: Conventional second-line, bismuth-containing quadruple therapy is administered four times a day. We aimed to evaluate the efficacy and safety of twice a day administration compared to the four times a day therapy. METHODS: Medical records of consecutive patients with positive 13 C-urea breath tests (UBTs) after first-line eradication were reviewed. From December 2018 to June 2019, 100 consecutive 13 C-UBT-positive patients received tetracycline 1 g, metronidazole 750 mg, bismuth subcitrate 300 mg, and pantoprazole 20 mg twice a day for one week. The same number of consecutive13 C-UBT-positive patients before December 2018 was included as controls. The control group received tetracycline 500 mg and bismuth subcitrate 300 mg four times a day, metronidazole 500 mg three times a day, and pantoprazole 20 mg twice a day for one week. Eradication was confirmed based on a 13 C-UBT performed in the 5th week after taking quadruple therapy. RESULTS: Ninety-eight patients from the twice a day group and 99 patients from the four times a day group were analyzed. The eradication rate did not differ between the twice a day group (92/98, 93.9%) and the four times a day group (92/99, 92.9%). Adverse drug effects were found in 36 patients from the twice a day group and 50 patients from the four times a day group (P = .051). Abdominal pain, discomfort, and distention were more common with four times a day intake (13.1%) than with twice a day intake (4.1%; P = .024). CONCLUSIONS: We determined for the first time that twice a day intake of bismuth-containing quadruple therapy using 2 g/d of tetracycline, 1.5 g/d of metronidazole, and 600 mg/d of bismuth subcitrate for one week is effective and safe as the conventional four times a day therapy. Twice a day intake decreased abdominal pain, discomfort, and distention.


Assuntos
Infecções por Helicobacter/tratamento farmacológico , Helicobacter pylori , Metronidazol/uso terapêutico , Compostos Organometálicos/uso terapêutico , Tetraciclina/uso terapêutico , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Antiulcerosos/administração & dosagem , Antiulcerosos/uso terapêutico , Testes Respiratórios , Quimioterapia Combinada , Feminino , Helicobacter pylori/efeitos dos fármacos , Humanos , Metronidazol/administração & dosagem , Pessoa de Meia-Idade , Compostos Organometálicos/administração & dosagem , Pantoprazol , Inibidores da Bomba de Prótons/administração & dosagem , Inibidores da Bomba de Prótons/uso terapêutico , Tetraciclina/administração & dosagem
16.
Chin Med J (Engl) ; 133(3): 335-343, 2020 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-31929363

RESUMO

The main challenge in the field of Helicobacter pylori (H. pylori) infection is antibiotic resistance, which influences the efficacy of eradication regimens. Bismuth-containing quadruple therapy has been confirmed as an effective regimen for eradicating H. pylori, especially in strains with antibiotic resistance. High-dose proton-pump inhibitor-amoxicillin dual therapy could decrease the use of unnecessary antibiotics, which is a promising alternative approach. Adjuvant therapy (specific probiotic or vitamin) also showed good results, although more evidence is needed. Novel anti-H. pylori drugs are needed, and the establishment of the H. pylori database is an effective way to acknowledge the real-time information of H. pylori management. This review provides the recent progress of H. pylori treatment, and further studies are needed to address the role of different regimens in improving H. pylori eradication rate, especially in strains with antibiotics resistance.


Assuntos
Infecções por Helicobacter/tratamento farmacológico , Helicobacter pylori/efeitos dos fármacos , Amoxicilina/administração & dosagem , Antibacterianos/administração & dosagem , Bismuto/administração & dosagem , Quimioterapia Combinada , Humanos , Metronidazol/administração & dosagem , Probióticos/uso terapêutico , Inibidores da Bomba de Prótons/administração & dosagem , Pirróis/administração & dosagem , Sulfonamidas/administração & dosagem , Vitaminas/uso terapêutico
17.
Clin Oral Investig ; 24(3): 1091-1100, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31938962

RESUMO

BACKGROUND: Gingival recessions inevitably occur during healing after scaling and root planing, but synoptic data on this topic is still lacking. This review compared the recession formation with and without the administration of systemic antibiotics. OBJECTIVES: To evaluate the formation of recession with and without the administration of antibiotics during the healing after scaling and root planing. MATERIALS AND METHODS: This study re-analyzed publications that reported clinical attachment levels (CAL) and probing pocket depths (PD) up to January 2019, including the pivotal review by Zandbergen and co-workers (2013). Whereas these studies traditionally focused on PD and CAL, the present analysis compared recession formation (ΔREC) after adjunctive systemic administration of amoxicillin (amx) and metronidazole (met) during scaling and root planing (SRP) and SRP alone. The mean increase in ΔREC, if not reported, was calculated from CAL and PD values and statistically analyzed. Recession formation was compared after 3 and 6 months after therapy. Results were separately reported for chronic periodontitis (CP) as well as aggressive periodontitis (AP) cases. RESULTS: Recessions increased consistently between baseline and follow-up. In the AP group, median ΔREC was 0.20 mm after 3 months, irrespective of whether antibiotics were administered or not. After 6 months, median ΔREC increased to 0.35 mm after AB and remained stable at 0.20 mm with SRP alone. In the CP group, after 3 months with and without antibiotics, median ΔREC accounted for 0.30 mm and 0.14 mm, respectively. After 6 months, median ΔREC accounted for 0.28 mm (with AB) and 0.20 mm (without AB). The quantitative assessment by meta-analyses also yielded small values (≤ 0.25 mm) for the estimated differences in recession formation between AB and noAB; however, none of them reached statistical significance. CONCLUSIONS: Although a slight tendency towards higher recession formation after SRP in combination with AB could be observed in many studies, quantitative meta-analyses showed no clinically relevant difference in recession formation due to the administration of AB. In general, the description and discussion of recessions in the literature seems not to be a major focus so far. CLINICAL RELEVANCE: Since the preservation of gingival tissues is important by preventive and therapeutic means, e.g., when avoiding postoperative root sensitivity or performing regenerative surgery, these aspects should not be neglected. We thus suggest to report REC measurements along with PD and CAL values for more direct recession formation (ΔREC) assessments in the future.


Assuntos
Amoxicilina/administração & dosagem , Raspagem Dentária , Retração Gengival , Metronidazol/administração & dosagem , Aplainamento Radicular , Antibacterianos/administração & dosagem , Humanos
18.
Drug Dev Ind Pharm ; 46(2): 296-308, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31944126

RESUMO

Objective: The aim of this study was to develop an emulgel for the treatment of rosacea, applying quality by design (QbD).Methods: An emulgel designed to release the active pharmaceutical ingredients (APIs), metronidazole and niacinamide, via an emollient formulation that favors residence time and attenuates facial redness would be an excellent vehicle to develop to treat rosacea. It was decided to design first a vehicle presenting the attributes established in the quality target product profile, and then, after selecting the best formulation, to load the APIs in it to optimize the final emulgel. A design of experiments was introduced to study the effect of formulation variables on quality attributes (adhesion, phase separation by mechanical stress and viscosity) of the emulgels. Response surface methodology and desirability functions were applied for data analysis. After optimization, the final emulgel was further characterized by assay and in vitro release of APIs, attenuation of facial redness, and compared to commercially available metronidazole products regarding API release.Results: The final emulgel gradually released both APIs, reaching approximately 88% within the first 4 h, and their profiles were well described by the Higuchi model. Only a light attenuation effect to conceal facial redness was achieved.Conclusions: A metronidazole and niacinamide emulgel, also providing cosmetic assistance, was developed using QbD. The emulgel releases metronidazole faster than the creams, but more gradually than the commercially available gel, providing a realistic time frame of drug delivery in accordance with the expected time of residence of the adhesive emulgel over the affected facial area.


Assuntos
Géis/administração & dosagem , Géis/química , Rosácea/tratamento farmacológico , Química Farmacêutica/métodos , Cosméticos/administração & dosagem , Cosméticos/química , Sistemas de Liberação de Medicamentos/métodos , Liberação Controlada de Fármacos , Excipientes/química , Humanos , Metronidazol/administração & dosagem , Metronidazol/química , Niacinamida/administração & dosagem , Niacinamida/química , Viscosidade/efeitos dos fármacos
19.
Int J STD AIDS ; 31(3): 221-229, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31996095
20.
Eur J Clin Microbiol Infect Dis ; 39(1): 75-83, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31482420

RESUMO

This study aimed to evaluate the impact of the intervention targeting the redundant combination of antianaerobic antimicrobials on its incidence and associated antimicrobial consumption. To reveal the characteristics of the combination and the change in the related workload over time was an additional aim of the study. The combinations of metronidazole or clindamycin with antianaerobic antimicrobials were classified into redundant or acceptable, according to the target indications. A pharmacist-based prospective audit and feedback targeting the redundant antianaerobic combination was conducted. Segmented regression analysis was performed to evaluate the impact of the intervention. As a quantitative index of the interventional activity, the change in the number of signed consultation notes was evaluated. After the initiation of the intervention, the median monthly cumulative incidence of the redundant combination decreased from 5.29 (Interquartile range [IQR] 4.94-5.70) to 3.33 (IQR 2.87-3.71) (p < 0.001) per 1000 admissions per month. The consumption of concurrently administered metronidazole and clindamycin decreased from 3.34 (IQR 2.97-4.10) to 1.74 (IQR 1.19-1.93) (p < 0.001) per 1000 patient-days per month. Segmented regression analysis revealed that the monthly cumulative incidence decreased by 28.5% after the initiation of the intervention (change in level - 1.640, p = 0.019) and the monthly consumption decreased by 33.9% (change in level - 1.409, p = 0.009). The number of consultation notes per 1000 admissions per month decreased over time (regression coefficient - 0.004, p < 0.001). The pharmacist-based intervention significantly reduced the incidence and associated antimicrobial consumption of the redundant antianaerobic combination. The overall related workload reduced steadily over time.


Assuntos
Antibacterianos/administração & dosagem , Farmacêuticos , Prescrições/normas , Qualidade da Assistência à Saúde , Bactérias Anaeróbias/efeitos dos fármacos , Clindamicina/administração & dosagem , Humanos , Prescrição Inadequada , Metronidazol/administração & dosagem , Médicos , Estudos Prospectivos
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