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1.
JAMA Surg ; 2024 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-38630471

RESUMO

Importance: Current short-term evidence has shown that uncomplicated acute appendicitis can be treated successfully with oral antibiotics alone, but longer-term results are lacking. Objective: To assess the treatment effectiveness of oral antibiotic monotherapy compared with combined intravenous (IV) and oral antibiotics in computed tomography-confirmed uncomplicated acute appendicitis at a longer-term follow-up. Design, Setting, and Participants: This secondary analysis of a predefined year 3 follow-up of the Appendicitis Acuta II (APPAC II) noninferiority, multicenter randomized clinical trial compared oral moxifloxacin with combined IV ertapenem plus oral levofloxacin and metronidazole for the treatment of uncomplicated acute appendicitis. The trial was conducted at 9 university and central hospitals in Finland from April 2017 to November 2018, with the last follow-up in November 2022. Participants included patients aged 18 to 60 years, who were randomized to receive either oral antibiotics monotherapy (n = 301) or combined IV and oral antibiotics (n = 298). Interventions: Antibiotics monotherapy consisted of oral moxifloxacin, 400 mg/d, for 7 days. Combined IV and oral antibiotics consisted of IV ertapenem sodium, 1 g/d, for 2 days plus oral levofloxacin, 500 mg/d, and metronidazole, 500 mg 3 times/d, for 5 days. Main Outcomes and Measures: The primary end point was treatment success, defined as the resolution of acute appendicitis and discharge from hospital without the need for surgical intervention and no appendicitis recurrence at the year 3 follow-up evaluated using a noninferiority design. The secondary end points included late (after 1 year) appendicitis recurrence as well as treatment-related adverse events, quality of life, length of hospital stay, and length of sick leave, which were evaluated using a superiority design. Results: After exclusions, 599 patients (mean [SD] age, 36 [12] years; 336 males [56.1%]) were randomized; after withdrawal and loss to follow-up, 582 patients (99.8%) were available for the year 3 follow-up. The treatment success at year 3 was 63.4% (1-sided 95% CI, 58.8% to ∞) in the oral antibiotic monotherapy group and 65.2% (1-sided 95% CI, 60.5% to ∞) in the combined IV and oral antibiotics group. The difference in treatment success rate between the groups at year 3 was -1.8 percentage points (1-sided 95% CI, -8.3 percentage points to ∞; P = .14 for noninferiority), with the CI limit exceeding the noninferiority margin. There were no significant differences between groups in treatment-related adverse events, quality of life, length of hospital stay, or length of sick leave. Conclusions and Relevance: This secondary analysis of the APPAC II trial found a slightly higher appendectomy rate in patients who received oral antibiotic monotherapy; however, noninferiority of oral antibiotic monotherapy compared with combined IV and oral antibiotics could not be demonstrated. The results encourage future studies to assess oral antibiotic monotherapy as a viable treatment alternative for uncomplicated acute appendicitis. Trial Registration: ClinicalTrials.gov Identifier: NCT03236961.

2.
PLoS One ; 17(10): e0276007, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36240181

RESUMO

BACKGROUND: Uncomplicated and complicated acute appendicitis seem to be two different forms of this common abdominal emergency. The contribution of appendiceal microbiota to appendicitis pathogenesis has been suggested, but differences between uncomplicated and complicated appendicitis are largely unknown. We compared the appendiceal microbiota in uncomplicated and complicated acute appendicitis. METHODS: This prospective single-center clinical cohort study was conducted as part of larger multicenter MAPPAC trial enrolling adult patients with computed tomography or clinically confirmed uncomplicated or complicated acute appendicitis. The microbial composition of the appendiceal lumen was determined using 16S rRNA gene amplicon sequencing. RESULTS: Between April 11, 2017, and March 29, 2019, 118 samples (41 uncomplicated and 77 complicated appendicitis) were available. After adjusting for age, sex, and BMI, alpha diversity in complicated appendicitis was higher (Shannon p = 0.011, Chao1 p = 0.006) compared to uncomplicated appendicitis. Microbial compositions were different between uncomplicated and complicated appendicitis (Bray-Curtis distance, P = 0.002). Species poor appendiceal microbiota composition with specific predominant bacteria was present in some patients regardless of appendicitis severity. CONCLUSION: Uncomplicated and complicated acute appendicitis have different appendiceal microbiome profiles further supporting the disconnection between these two different forms of acute appendicitis. STUDY REGISTRATION: ClinicalTrials.gov NCT03257423.


Assuntos
Apendicite , Microbiota , Doença Aguda , Adulto , Apendicectomia , Apendicite/complicações , Estudos de Coortes , Humanos , Estudos Prospectivos , RNA Ribossômico 16S/genética
3.
Scand J Surg ; 111(3): 31-38, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36000748

RESUMO

BACKGROUND AND OBJECTIVE: The prevalence of bacteremia in acute appendicitis is unknown. We aimed to assess prevalence and predictive factors of bacteremia in adult patients with appendicitis. METHODS: In this prospective propensity score-matched cohort study, patients were recruited as part of one single-center prospective observational study assessing appendicitis microbiology in concurrence with two randomized controlled trials on non-operative treatment of uncomplicated acute appendicitis. All patients evaluated for enrollment in these three trials between April 2017 and December 2018 with both a confirmed diagnosis of appendicitis and available blood culture on admission were included in this study. Potential predictive factors of bacteremia (age, sex, body mass index (BMI), body temperature, C-reactive protein (CRP), leukocyte count, comorbidities, symptom duration, and appendicitis severity) were assessed. Prevalence of bacteremia was determined by all available blood cultures followed by propensity score matching using sex, age, BMI, CRP, leukocyte count, and body temperature of the patients without available blood culture. RESULTS: Out of the 815 patients with appendicitis, 271 patients had available blood culture and the prevalence of bacteremia was 12% (n = 33). Based on propensity score estimation, the prevalence of bacteremia in the whole prospective appendicitis cohort was 11.1%. Bacteremia was significantly more frequent in complicated acute appendicitis (15%; 29/189) compared with uncomplicated acute appendicitis (5%; 4/82) (p = 0.015). Male sex (p = 0.024) and higher body temperature (p = 0.0044) were associated with bacteremia. CONCLUSIONS: Estimated prevalence of bacteremia in patients with acute appendicitis was 11.1%. Complicated appendicitis, male sex, and higher body temperature were associated with bacteremia in acute appendicitis.


Assuntos
Apendicite , Bacteriemia , Doença Aguda , Adulto , Apendicite/complicações , Apendicite/diagnóstico , Apendicite/cirurgia , Bacteriemia/diagnóstico , Bacteriemia/epidemiologia , Bacteriemia/etiologia , Biomarcadores , Hemocultura , Proteína C-Reativa/análise , Proteína C-Reativa/metabolismo , Estudos de Coortes , Humanos , Contagem de Leucócitos , Masculino , Pontuação de Propensão , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
Br J Surg ; 109(6): 503-509, 2022 05 16.
Artigo em Inglês | MEDLINE | ID: mdl-35576384

RESUMO

BACKGROUND: Non-operative management of uncomplicated acute appendicitis is an option, but omission of antibiotics from the regimen has not been tested. METHODS: A double-blind, placebo-controlled, superiority RCT in adults with CT-confirmed uncomplicated acute appendicitis was designed to compare placebo with antibiotics (intravenous ertapenem followed by oral levofloxacin and metronidazole). The primary endpoint was treatment success (resolution resulting in discharge without appendicectomy within 10 days); secondary outcomes included pain scores, complications, hospital stay, and return to work. RESULTS: From May 2017 to September 2020, 72 patients with a mean(s.d.) age of 37.5 (11.1) years were recruited at five hospitals. Six were excluded after randomization (5 early consent withdrawals, 1 randomization protocol violation), 35 were assigned to receive antibiotics, and 31 to receive placebo. Enrolment challenges (including hospital pharmacy resources in an acute-care surgery setting) meant that only the lowest sample size of three predefined scenarios was achieved. The 10-day treatment success rate was 87 (95 per cent c.i. 75 to 99) per cent for placebo and 97 (92 to 100) per cent for antibiotics. This clinical difference of 10 (90 per cent c.i. -0.9 to 21) per cent was not statistically different for the primary outcome (1-sided P = 0.142), and secondary outcomes were similar. CONCLUSION: The lack of antibiotic superiority statistically suggests that a non-inferiority trial against placebo is warranted in adults with CT-confirmed mild appendicitis. Registration number: EudraCT 2015-003634-26 (https://eudract.ema.europa.eu/eudract-web/index.faces), NCT03234296 (http://www.clinicaltrials.gov).


Appendicitis was the most common reason for emergency surgery, but we now know that mild and severe acute appendicitis are two different diseases. Severe appendicitis still necessitates removal of the appendix but antibiotics alone are an option for mild disease. This small study found that most cases of mild appendicitis to resolve even without antibiotics. Larger studies (more patients) would be needed to show that omitting antibiotics is safe and no worse than antibiotic therapy for milder acute appendicitis.


Assuntos
Apendicite , Doença Aguda , Adulto , Antibacterianos/uso terapêutico , Apendicectomia , Apendicite/diagnóstico por imagem , Apendicite/tratamento farmacológico , Apendicite/cirurgia , Ertapenem/uso terapêutico , Humanos , Tomografia Computadorizada por Raios X , Resultado do Tratamento
5.
Br J Surg ; 108(12): 1483-1490, 2021 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-34761262

RESUMO

BACKGROUND: Contrast-enhanced CT is the reference standard used in diagnostic imaging for acute appendicitis in adults. The radiation dose has been of concern. This study aimed to assess whether a lower radiation dose would affect the diagnostic accuracy of CT. METHODS: This was a prospective single-centre cohort study of patients (aged over 16 years) with suspected appendicitis evaluated for enrolment in concurrent APPAC II-III trials. The diagnostic accuracy of contrast-enhanced low- and standard-dose CT was compared with study protocols guiding imaging based on BMI; this enabled direct CT imaging comparison only in patients with a BMI below 30 kg/m2. The on-call CT diagnosis was compared with the final clinical diagnosis. RESULTS: Among all 856 patients investigated, the accuracy of low-dose (454 patients) and standard-dose (402 patients) CT in identifying patients with and without appendicitis was 98·0 and 98·5 per cent respectively. In patients with a BMI under 30 kg/m2, respective values were 98·2 per cent (434 patients) and 98·6 per cent (210 patients) (P = 1·000). The corresponding accuracy for differentiating between uncomplicated and complicated acute appendicitis was 90·3 and 87·6 per cent in all patients, and 89·8 and 88·4 per cent respectively among those with a BMI below 30 kg/m2 (P = 0·663). The median radiation dose in the whole low- and standard-dose CT groups was 3 and 7 mSv respectively. In the group with BMI below 30 kg/m2, corresponding median doses were 3 and 5 mSv (P < 0·001). CONCLUSION: Low- and standard-dose CT were accurate both in identifying appendicitis and in differentiating between uncomplicated and complicated acute appendicitis. Low-dose CT was associated with a significant radiation dose reduction, suggesting that it should be standard clinical practice at least in patients with a BMI below 30 kg/m2.


Assuntos
Apendicite/diagnóstico , Apêndice/diagnóstico por imagem , Doses de Radiação , Tomografia Computadorizada por Raios X , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Índice de Massa Corporal , Estudos de Coortes , Meios de Contraste , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
7.
JAMA ; 325(4): 353-362, 2021 01 26.
Artigo em Inglês | MEDLINE | ID: mdl-33427870

RESUMO

Importance: Antibiotics are an effective and safe alternative to appendectomy for managing uncomplicated acute appendicitis, but the optimal antibiotic regimen is not known. Objective: To compare oral antibiotics with combined intravenous followed by oral antibiotics in the management of computed tomography-confirmed uncomplicated acute appendicitis. Design, Setting, and Participants: The Appendicitis Acuta (APPAC) II multicenter, open-label, noninferiority randomized clinical trial was conducted from April 2017 until November 2018 in 9 Finnish hospitals. A total of 599 patients aged 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis were enrolled in the trial. The last date of follow-up was November 29, 2019. Interventions: Patients randomized to receive oral monotherapy (n = 295) received oral moxifloxacin (400 mg/d) for 7 days. Patients randomized to receive intravenous antibiotics followed by oral antibiotics (n = 288) received intravenous ertapenem (1 g/d) for 2 days followed by oral levofloxacin (500 mg/d) and metronidazole (500 mg 3 times/d) for 5 days. Main Outcomes and Measures: The primary end point was treatment success (≥65%) for both groups, defined as discharge from hospital without surgery and no recurrent appendicitis during 1-year follow-up, and to determine whether oral antibiotics alone were noninferior to intravenous and oral antibiotics, with a margin of 6% for difference. Results: Among 599 patients who were randomized (mean [SD] age, 36 [12] years; 263 [44%] women), 581 (99.7%) were available for the 1-year follow-up. The treatment success rate at 1 year was 70.2% (1-sided 95% CI, 65.8% to ∞) for patients treated with oral antibiotics and 73.8% (1-sided 95% CI, 69.5% to ∞) for patients treated with intravenous followed by oral antibiotics. The difference was -3.6% ([1-sided 95% CI, -9.7% to ∞]; P = .26 for noninferiority), with the confidence limit exceeding the noninferiority margin. Conclusion and Relevance: Among adults with uncomplicated acute appendicitis, treatment with 7 days of oral moxifloxacin compared with 2 days of intravenous ertapenem followed by 5 days of levofloxacin and metronidazole resulted in treatment success rates greater than 65% in both groups, but failed to demonstrate noninferiority for treatment success of oral antibiotics compared with intravenous followed by oral antibiotics. Trial Registration: ClinicalTrials.gov Identifier: NCT03236961; EudraCT Identifier: 2015-003633-10.


Assuntos
Antibacterianos/uso terapêutico , Apendicite/tratamento farmacológico , Doença Aguda , Administração Intravenosa , Administração Oral , Adulto , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Apendicectomia , Apendicite/diagnóstico por imagem , Apendicite/cirurgia , Quimioterapia Combinada , Ertapenem/uso terapêutico , Feminino , Seguimentos , Humanos , Levofloxacino/uso terapêutico , Masculino , Metronidazol/uso terapêutico , Pessoa de Meia-Idade , Moxifloxacina/uso terapêutico , Tomografia Computadorizada por Raios X , Adulto Jovem
9.
JAMA Surg ; 155(4): 283-289, 2020 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-32074268

RESUMO

Importance: Long-term results support antibiotics for uncomplicated acute appendicitis as an alternative to appendectomy. To our knowledge, treatment-related long-term patient satisfaction and quality of life (QOL) are not known. Objective: To determine patient satisfaction and QOL after antibiotic therapy and appendectomy for treating uncomplicated acute appendicitis. Interventions: Open appendectomy vs antibiotics with intravenous ertapenem, 1 g once daily, for 3 days followed by 7 days of oral levofloxacin, 500 mg once daily, and metronidazole, 500 mg 3 times per day. Design, Setting, and Participants: This observational follow-up of the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotics included 530 patients age 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or receive antibiotics (257 [49%]). The trial was conducted from November 2009 to June 2012; the last follow-up was May 9, 2018. The data were analyzed in February 2019. Main Outcomes and Measures: In this analysis, post hoc secondary end points of postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference were evaluated. Results: Of the 530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent appendectomy. Of the 206 patients taking antibiotics, 81 (39%) had undergone appendectomy. The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96). Patients who underwent appendectomy were more satisfied in the treatment than patients taking antibiotics (68% very satisfied, 21% satisfied, 6% indifferent, 4% unsatisfied, and 1% very unsatisfied in the appendectomy group and 53% very satisfied, 21% satisfied, 13% indifferent, 7% unsatisfied, and 6% very unsatisfied in the antibiotic group; P < .001) and in a subgroup analysis this difference was based on the antibiotic group patients undergoing appendectomy. There was no difference in patient satisfaction after successful antibiotic treatment compared with appendectomy (cumulative odds ratio [COR], 7.8; 95% CI, 0.5-1.3; P < .36). Patients with appendectomy or with successful antibiotic therapy were more satisfied than antibiotic group patients who later underwent appendectomy (COR, 7.7; 95% CI, 4.6-12.9; P < .001; COR, 9.7; 95% CI, 5.4-15.3; P < .001, respectively). Of the 81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment. Conclusions and Relevance: In this analysis, long-term QOL was similar after appendectomy and antibiotic therapy for the treatment of uncomplicated acute appendicitis. Patients taking antibiotics who later underwent appendectomy were less satisfied than patients with successful antibiotics or appendectomy. Trial Registration: Clinicaltrials.gov Identifier: NCT01022567.


Assuntos
Antibacterianos/uso terapêutico , Apendicectomia , Apendicite/terapia , Satisfação do Paciente , Qualidade de Vida , Adolescente , Adulto , Feminino , Finlândia , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade
10.
Ann Surg ; 271(2): 332-338, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-30048324

RESUMO

OBJECTIVE: To compare diagnostic accuracy of contrast enhanced low-dose computed tomography (CT) accomplished in the OPTICAP trial phantom phase to standard CT in patients with suspected acute appendicitis. BACKGROUND: Increasing use of CT as the gold standard in diagnosing acute appendicitis has raised concerns regarding radiation exposure. Unenhanced low-dose CT protocols have shown similar diagnostic accuracy with standard CT for diagnosing appendicitis. To our knowledge, there are no other trials in which the same patient with suspected acute appendicitis underwent both standard and low-dose CT allowing interpatient comparison. METHODS: OPTICAP is an interpatient protocol sequence randomized noninferiority single-center trial performed at Turku University Hospital between November, 2015 and August, 2016. Sixty patients with suspected acute appendicitis and body mass index <30 kg/m were enrolled to undergo both standard and low-dose contrast enhanced CT scans, which were categorized as normal, uncomplicated or complicated appendicitis by 2 radiologists in blinded manner. All patients with CT confirmed appendicitis underwent appendectomy to obtain histopathology. RESULTS: The low-dose protocol was not inferior to standard protocol in terms of diagnostic accuracy; 79% [95% confidence interval (CI) 66%-89%) accurate diagnosis in low-dose and 80% (95% CI 67%-90%) in standard CT by primary radiologist. Accuracy to categorize appendicitis severity was 79% for both protocols. The mean radiation dose of low-dose CT was significantly lower compared with standard CT (3.33 and 4.44 mSv, respectively). CONCLUSION: Diagnostic accuracy of contrast enhanced low-dose CT was not inferior to standard CT in diagnosing acute appendicitis or distinguishing between uncomplicated and complicated acute appendicitis in patients with a high likelihood of acute appendicitis. Low-dose CT enabled significant radiation dose reduction.


Assuntos
Apendicite/diagnóstico por imagem , Tomografia Computadorizada por Raios X/métodos , Adulto , Apendicectomia , Apendicite/cirurgia , Meios de Contraste , Feminino , Finlândia , Humanos , Masculino , Pessoa de Meia-Idade , Doses de Radiação
11.
BMJ Open ; 9(9): e031137, 2019 09 06.
Artigo em Inglês | MEDLINE | ID: mdl-31494621

RESUMO

INTRODUCTION: Based on the epidemiological and clinical data, acute appendicitis can present either as uncomplicated or complicated. The aetiology of these different appendicitis forms remains unknown. Antibiotic therapy has been shown to be safe, efficient and cost-effective for CT-confirmed uncomplicated acute appendicitis. Despite appendicitis being one of the most common surgical emergencies, there are very few reports on appendicitis aetiology and pathophysiology focusing on the differences between uncomplicated and complicated appendicitis. Microbiology APPendicitis ACuta (MAPPAC) trial aims to evaluate these microbiological and immunological aspects including immune response in the aetiology of these different forms also assessing both antibiotics non-responders and appendicitis recurrence. In addition, MAPPAC aims to determine antibiotic and placebo effects on gut microbiota composition and antimicrobial resistance. METHODS AND ANALYSIS: MAPPAC is a prospective clinical trial with both single-centre and multicentre arm conducted in close synergy with concurrent trials APPendicitis ACuta II (APPAC II) (per oral (p.o.) vs intravenous+p.o. antibiotics, NCT03236961) and APPAC III (double-blind trial placebo vs antibiotics, NCT03234296) randomised clinical trials. Based on the enrolment for these trials, patients with CT-confirmed uncomplicated acute appendicitis are recruited also to the MAPPAC study. In addition to these conservatively treated randomised patients with uncomplicated acute appendicitis, MAPPAC will recruit patients with uncomplicated and complicated appendicitis undergoing appendectomy. Rectal and appendiceal swabs, appendicolith, faecal and serum samples, appendiceal biopsies and clinical data are collected during the hospital stay for microbiological and immunological analyses in both study arms with the longitudinal study arm collecting faecal samples also during follow-up up to 12 months after appendicitis treatment. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of the Hospital District of Southwest Finland (Turku University Hospital, approval number ATMK:142/1800/2016) and the Finnish Medicines Agency. Results of the trial will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03257423.


Assuntos
Antibacterianos/administração & dosagem , Apendicite/tratamento farmacológico , Apendicite/microbiologia , Microbioma Gastrointestinal/efeitos dos fármacos , Doença Aguda , Administração Intravenosa , Administração Oral , Antibacterianos/uso terapêutico , Apendicectomia , Apendicite/diagnóstico por imagem , Análise Custo-Benefício , Fezes/microbiologia , Finlândia , Humanos , Tempo de Internação , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Tomografia Computadorizada por Raios X
12.
PLoS One ; 14(7): e0220202, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31344073

RESUMO

BACKGROUND: The efficacy and safety of antibiotic treatment for uncomplicated acute appendicitis has been established at long-term follow-up with the majority of recurrences shown to occur within the first year. Overall costs of antibiotics are significantly lower compared with appendectomy at short-term follow-up, but long-term durability of these cost savings is unclear. The study objective was to compare the long-term overall costs of antibiotic therapy versus appendectomy in the treatment of uncomplicated acute appendicitis in the APPAC (APPendicitis ACuta) trial at 5 years. METHODS AND FINDINGS: This multicentre, non-inferiority randomized clinical trial randomly assigned 530 adult patients with CT-confirmed uncomplicated acute appendicitis to appendectomy or antibiotic treatment at six Finnish hospitals. All major costs during the 5-year follow-up were recorded, whether generated by the initial visit and subsequent treatment or possible recurrent appendicitis. Between November 2009 and June 2012, 273 patients were randomized to appendectomy and 257 to antibiotics. The overall costs of appendectomy were 1.4 times higher (p<0.001) (€5716; 95% CI: €5510 to €5925) compared with antibiotic therapy (€4171; 95% CI: €3879 to €4463) resulting in cost savings of €1545 per patient (95% CI: €1193 to €1899; p<0.001) in the antibiotic group. At 5 years, the majority (61%, n = 156) of antibiotic group patients did not undergo appendectomy. CONCLUSIONS: At 5-year follow-up antibiotic treatment resulted in significantly lower overall costs compared with appendectomy. As the majority of appendicitis recurrences occur within the first year after the initial antibiotic treatment, these results suggest that treating uncomplicated acute appendicitis with antibiotics instead of appendectomy results in lower overall costs even at longer-term follow-up.


Assuntos
Antibacterianos/economia , Apendicectomia/economia , Apendicite/tratamento farmacológico , Apendicite/cirurgia , Doença Aguda , Administração Intravenosa , Adolescente , Adulto , Antibacterianos/uso terapêutico , Apendicectomia/estatística & dados numéricos , Apendicite/economia , Apendicite/epidemiologia , Custos e Análise de Custo , Esquema de Medicação , Quimioterapia Combinada , Estudos de Equivalência como Asunto , Ertapenem/administração & dosagem , Ertapenem/economia , Feminino , Finlândia/epidemiologia , Seguimentos , Humanos , Levofloxacino/administração & dosagem , Levofloxacino/economia , Masculino , Metronidazol/administração & dosagem , Metronidazol/economia , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem
13.
BMJ Open ; 8(11): e023623, 2018 11 03.
Artigo em Inglês | MEDLINE | ID: mdl-30391919

RESUMO

INTRODUCTION: Recent studies show that antibiotic therapy is safe and feasible for CT-confirmed uncomplicated acute appendicitis. Spontaneous resolution of acute appendicitis has already been observed over a hundred years ago. In CT-confirmed uncomplicated acute diverticulitis (left-sided appendicitis), studies have shown no benefit from antibiotics compared with symptomatic treatment, but this shift from antibiotics to symptomatic treatment has not yet been widely implemented in clinical practice. Recently, symptomatic treatment of uncomplicated acute appendicitis has been demonstrated in a Korean open-label study. However, a double-blinded placebo-controlled study to illustrate the role of antibiotics and spontaneous resolution of uncomplicated acute appendicitis is still lacking. METHODS AND ANALYSIS: The APPAC III (APPendicitis ACuta III) trial is a multicentre, double-blind, placebo-controlled, superiority randomised study comparing antibiotic therapy with placebo in the treatment CT scan-confirmed uncomplicated acute appendicitis aiming to evaluate the role of antibiotics in the resolution of uncomplicated acute appendicitis. Adult patients (18-60 years) with CT scan-confirmed uncomplicated acute appendicitis (the absence of appendicolith, abscess, perforation and tumour) will be enrolled in five Finnish university hospitals.Primary endpoint is success of the randomised treatment, defined as resolution of acute appendicitis resulting in discharge from the hospital without surgical intervention within 10 days after initiating randomised treatment (treatment efficacy). Secondary endpoints include postintervention complications, recurrent symptoms after treatment up to 1 year, late recurrence of acute appendicitis after 1 year, duration of hospital stay, sick leave, treatment costs and quality of life. A decrease of 15 percentage points in success rate is considered clinically important difference. The superiority of antibiotic treatment compared with placebo will be analysed using Fisher's one-sided test and CI will be calculated for proportion difference. ETHICS AND DISSEMINATION: This protocol has been approved by the Ethics Committee of Turku University Hospital and the Finnish Medicines Agency (FIMEA). The findings will be disseminated in peer-reviewed academic journals. TRIAL REGISTRATION NUMBER: NCT03234296; Pre-results.


Assuntos
Antibacterianos/uso terapêutico , Apendicite/tratamento farmacológico , Adolescente , Adulto , Apendicectomia , Apendicite/diagnóstico por imagem , Método Duplo-Cego , Estudos de Equivalência como Asunto , Feminino , Finlândia , Custos de Cuidados de Saúde , Hospitalização , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Recidiva , Licença Médica , Tomografia Computadorizada por Raios X , Adulto Jovem
14.
Radiat Prot Dosimetry ; 178(1): 20-28, 2018 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-28591824

RESUMO

The aim was to evaluate effects of voltage, noise input (NI) and iterative reconstruction (IR) on radiation dose and image quality in order to establish a contrast enhanced low-dose protocol for assessment of acute appendicitis. An anthropomorphic abdominal phantom mimicking contrast enhanced abdomen was scanned with 80, 100 and 120 kV, standard and strong IR and 11 NIs (66 protocols). A total of 14 test tubes of increasing iodine dilutions and one tube with an appendicolith were evaluated within the phantom. The dose, HUs, noise, contrast-to-noise ratio (CNR) and figure of merit (FOM) were determined. Visual quality scores were assessed by two readers. A clinically used voltage-IR combination (120 kV, standard IR) was used as a reference. Overall, 100 kV with standard IR (p = 0.002) and 80 kV with both IRs (p < 0.001) showed higher CNR than the reference, but noise was most pronounced at 80 kV (p < 0.001). The highest FOM was found in the 100 kV protocols (p < 0.001). The reference and 100 kV with standard IR had highest image quality scores, where the 100 kV protocol enabled a distinct dose reduction. Lowering the voltage seems to be a more favorable tool than IR changes in optimizing the dose in contrast enhanced abdominal CT. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT01022567.


Assuntos
Apendicite/diagnóstico por imagem , Doses de Radiação , Tomografia Computadorizada por Raios X/métodos , Meios de Contraste , Humanos , Imagens de Fantasmas , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Radiografia Abdominal
15.
Atherosclerosis ; 263: 369-376, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28457625

RESUMO

BACKGROUND AND AIMS: Uptake of the positron emission tomography (PET) tracer 2-deoxy-2-[18F]-fluoro-d- glucose ([18F]FDG) into macrophages is a sensitive marker of inflammation in atherosclerosis. To assess the anti-inflammatory effects of statins, we studied whether atorvastatin therapy reduces aortic [18F]FDG uptake in hypercholesterolemic mice deficient in low-density lipoprotein receptor (Ldlr), and expressing only apolipoprotein B-100 (Ldlr-/-Apob100/100). METHODS: Thirty-six Ldlr-/-Apob100/100 mice were fed a high-fat diet (HFD) for 12 weeks and then allocated to receive a HFD (n = 13), chow diet (Chow, n = 12), or HFD with added atorvastatin (HFD + A, n = 11), for another 12 weeks. In addition to aortic histopathology, [18F]FDG uptake was studied in vivo using PET/computed tomography (CT), and ex vivo by gamma counting of excised aorta. RESULTS: Total cholesterol levels were lower in the Chow and HFD + A groups than in the HFD group (10 ± 3.2, 23 ± 4.9 and 34 ± 9.2 mmol/l, respectively), with the Chow group also showing a lower plaque burden and lower numbers of macrophages in the lesions. Compared to the HFD group, [18F]FDG uptake in the aorta (normalized for blood) was lower in the Chow group in both in vivo (2.1 ± 0.21 vs. 1.7 ± 0.25, p = 0.018) and ex vivo (5.2 ± 2.3 vs. 2.8 ± 0.87, p = 0.011) analyses, whereas atorvastatin had no effect on uptake (2.1 ± 0.42 in vivo and 3.9 ± 1.8 ex vivo). [18F]FDG uptake correlated with plasma total cholesterol levels. CONCLUSIONS: Atorvastatin therapy did not show cholesterol-independent effects on inflammation in atherosclerotic lesions in Ldlr-/-Apob100/100 mice, as determined by histology and [18F]FDG PET, whereas a cholesterol-lowering diet intervention was effective.


Assuntos
Doenças da Aorta/prevenção & controle , Apolipoproteína B-100/deficiência , Aterosclerose/prevenção & controle , Atorvastatina/farmacologia , Dieta com Restrição de Gorduras , Fluordesoxiglucose F18/administração & dosagem , Inibidores de Hidroximetilglutaril-CoA Redutases/farmacologia , Inflamação/prevenção & controle , Placa Aterosclerótica , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Compostos Radiofarmacêuticos/administração & dosagem , Receptores de LDL/deficiência , Ração Animal , Animais , Doenças da Aorta/sangue , Doenças da Aorta/diagnóstico por imagem , Doenças da Aorta/genética , Apolipoproteína B-100/genética , Aterosclerose/sangue , Aterosclerose/diagnóstico por imagem , Aterosclerose/genética , Dieta Hiperlipídica , Modelos Animais de Doenças , Feminino , Predisposição Genética para Doença , Inflamação/sangue , Inflamação/diagnóstico por imagem , Inflamação/genética , Lipídeos/sangue , Masculino , Camundongos Knockout , Fenótipo , Receptores de LDL/genética , Fatores de Tempo
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