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1.
Medicine (Baltimore) ; 98(38): e17190, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31567962

RESUMO

AIM: Effects of azithromycin on asthma reported in clinical trials are less consistent. We aimed to further clarify the efficacy and safety of azithromycin in treatment of asthma. METHODS: The protocol registration number was CRD42017074318 (http://www.crd.york.ac.uk/Prospero). We searched PubMed, EMBASE, Cochrane databases, China National Knowledge Internet (CNKI), and Wanfang databases for the randomized controlled trials (RCTs) with prolonged treatment of azithromycin for more than 3 weeks. Random-effects or fixed-effects model was applied to calculate risk ratio (RR) and mean difference (MD) for dichotomous and continuous data respectively. RESULTS: A total of eight studies were included for analysis. The pooled result of adjunctive azithromycin therapy in asthma showed a small, but statistically significant increase in forced expiratory volume in one second (FEV1) (MD = 0.06, 95% confidence interval [CI]: 0.01-0.12, P = .02), but no significant differences in exacerbation frequency (MD = -0.42, 95%CI: -1.13 to 0.30, P = .25) and peak expiratory flow (PEF) (MD = 0.20, 95% CI: -0.05 to 0.44, P = .12), fractional exhaled nitric oxide (FeNO) (MD = 4.12, 95% CI: -2.06 to 10.30, P = .19), asthma quality of life questionnaire (AQLQ) (MD: 0.05, 95% CI: -0.17 to 0.28, P = .65), asthma control questionnaire (ACQ) (MD: -0.03, 95% CI: -0.21 to 0.15, P = .75). The subgroup analysis revealed that azithromycin could decrease FeNO among Asian asthma (MD = 15.04, 95% CI: 6.18-23.90, P = .0009). CONCLUSIONS: Add-on therapy of azithromycin in asthma patients could improve the FEV1, but failed to improve asthma exacerbations, PEF, ACQ, AQLQ, and FeNO. Subgroup analysis indicated that azithromycin could improve FeNO in Asian group asthmatics.


Assuntos
Antibacterianos/uso terapêutico , Asma/tratamento farmacológico , Azitromicina/uso terapêutico , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Azitromicina/administração & dosagem , Azitromicina/efeitos adversos , Humanos , Resultado do Tratamento
2.
Rev Med Liege ; 74(7-8): 382-387, 2019 Jul.
Artigo em Francês | MEDLINE | ID: mdl-31373450

RESUMO

Sotalol is a bêta-blocker and class 3 anti-arrhythmic. Ciprofloxacin is a fluoroquinolone antibiotic used against Gram - germs. Both drugs have a common adverse effect : they increase QT interval with a risk of torsade de pointe. The risk increases even more if other risk factors are present such as old age, female gender, renal failure, high blood pressure and ionic disturbances. Because a long QT interval is not associated with symptoms, only an electrocardiogram can establish the diagnosis. However, it's not rare that a torsade de pointe will reveal it. We report a clinical case of a long QT interval due to the association of sotalol and ciprofloxacin, which led to a torsade de pointe. Intravenous magnesium sulphate is the recommended treatment if haemodynamic parameters are good. If not, an external electric shock may be needed.


Assuntos
Ciprofloxacino , Interações de Medicamentos , Sotalol , Torsades de Pointes , Antiarrítmicos/efeitos adversos , Antibacterianos/efeitos adversos , Ciprofloxacino/efeitos adversos , Eletrocardiografia , Feminino , Humanos , Sotalol/efeitos adversos , Torsades de Pointes/induzido quimicamente
3.
Praxis (Bern 1994) ; 108(10): 693-697, 2019 Aug.
Artigo em Alemão | MEDLINE | ID: mdl-31387493

RESUMO

Fatal Outcome of Agranulocytosis after Re-Exposure to Metamizole and Cefepime-Induced Encephalopathy Abstract. We present the case of an 83-year-old female patient who died as a result of likely drug-induced complications, namely agranulocytosis caused by metamizole and cefepime-induced encephalopathy. Agranulocytosis precipitated a cascade of events that eventually led to death. As prescription of metamizole has increased over the past decades, it is important to keep in mind its serious adverse drug reactions. Metamizole must be stopped immediately at the onset of symptoms such as fever, mucositis and sore throat, and re-exposure in patients who have previously developed leukopenia under metamizole must be avoided. This can be achieved by meticulous documentation in the medical records and the use of an emergency or allergy alert card which the patient carries at all times. When using cefepime, renal function should be closely monitored, especially in multimorbid geriatric patients, and the dose should be adjusted accordingly.


Assuntos
Agranulocitose , Antibacterianos , Anti-Inflamatórios não Esteroides , Cefepima , Dipirona , Idoso de 80 Anos ou mais , Agranulocitose/induzido quimicamente , Antibacterianos/efeitos adversos , Anti-Inflamatórios não Esteroides/efeitos adversos , Encefalopatias , Cefepima/efeitos adversos , Dipirona/efeitos adversos , Evolução Fatal , Feminino , Humanos
5.
Medicine (Baltimore) ; 98(32): e16775, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31393400

RESUMO

BACKGROUND: The benefit of a procalcitonin (PCT)-guided antibiotic strategy in acute exacerbation of chronic obstructive pulmonary disease (AECOPD) remains uncertain. OBJECTIVES: This updated meta-analysis was performed to reevaluate the therapeutic potential of PCT-guided antibiotic therapy in AECOPD. DATA SOURCES: We searched PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov up to February 2019 to identify randomized controlled trials (RCTs) investigating the role of PCT-guided antibiotic strategies in treating adult patients with AECOPD. Relative risk (RR) or mean differences (MD) with accompanying 95% confidence intervals (CIs) were calculated with a random-effects model. RESULTS: Eight RCTs with a total of 1376 participants were included. The results suggested that a PCT-guided antibiotic strategy reduced antibiotic prescriptions (RR: 0.55; 95% CI: 0.39-0.76; P = .0003). However, antibiotic exposure duration (MD: -1.34; 95% CI: -2.83-0.16; P = .08), antibiotic use after discharge (RR: 1.61; 95% CI: 0.61-4.23; P = .34), clinical success (RR: 1.02; 95% CI: 0.96-1.08; P = .47), all-cause mortality (RR: 1.05; 95% CI: 0.72-1.55; P = .79), exacerbation at follow-up (RR: 0.97; 95% CI: 0.80-1.18; P = .78), readmission at follow-up (RR: 1.12; 95% CI: 0.82-1.53; P = .49), length of hospital stay (MD: -0.36; 95% CI: -1.36-0.64; P = .48), and adverse events (RR: 1.33; 95% CI: 0.79-2.23; P = .28) were similar in both groups. IMPLICATIONS OF KEY FINDINGS: A PCT-guided antibiotic strategy is associated with fewer antibiotic prescriptions, and has similar efficacy and safety compared with standard antibiotic therapy in AECOPD patients.


Assuntos
Antibacterianos/uso terapêutico , Pró-Calcitonina/sangue , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Protocolos Clínicos , Esquema de Medicação , Uso de Medicamentos , Humanos , Readmissão do Paciente , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
Ther Umsch ; 75(1): 29-31, 2019 07.
Artigo em Alemão | MEDLINE | ID: mdl-31282838

RESUMO

Drug allergy in children: more often suspected than real Abstract. Adverse drug reactions are frequent in the pediatric population. However, only a small proportion of all adverse reactions are drug allergic reactions. About 10 % of the parents report a suspected drug allergy in their children. Even though, no accurate epidemiological data are available, studies suggested that as few as 10 % of those reported an allergy really are. The most common drug allergy among children is a drug hypersensitivity to antibiotics, especially to betalactam antibiotics.In children, one of the major difficulty in the diagnosis of drug allergies, and especially to antibiotics, is the differentiation of maculopapular eruption as an allergic reaction from a viral exanthema, which is very common among children. Therefore, a high number of children are inappropriately labeled as "drug allergic". In case of suspicion of an allergy, it is recommended to perform a complete allergy workup.


Assuntos
Antibacterianos/efeitos adversos , Hipersensibilidade a Drogas , Exantema , Antibacterianos/imunologia , Criança , Hipersensibilidade a Drogas/diagnóstico , Humanos , Testes Cutâneos , Viroses/diagnóstico , Viroses/patologia
8.
Ther Umsch ; 75(1): 13-21, 2019 Jul.
Artigo em Alemão | MEDLINE | ID: mdl-31282834

RESUMO

Allergies to non-betalactam antibiotics: a challenge in practice Abstract. The heterogeneous group of non-betalactam antibiotics can in part trigger very severe immunologically mediated hypersensitivity reactions. The risks are very differently distributed among the different representatives and a genetic predisposition to the development of Stevens-Johnson syndrome / toxic epidermal necrolysis or Drug rash with eosinophilia and systemic symptoms (DRESS syndrome) can be observed. Individual patient groups are particularly frequently affected, including patients with HIV or cystic fibrosis. In this overview, the individual drug groups and corresponding risk situations as well as the available diagnostic means are discussed.


Assuntos
Antibacterianos/efeitos adversos , Antibacterianos/imunologia , Hipersensibilidade a Drogas , Eosinofilia , Humanos , Síndrome de Stevens-Johnson
10.
Expert Opin Drug Saf ; 18(9): 795-802, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31305171

RESUMO

Introduction: Antibiotics have saved and are still saving countless human lives from the burden of infectious diseases. However, as with all other drugs, they can cause adverse events. Generally, these are uncommon, mild and spontaneously resolving. However, in some cases, they can cause relevant clinical problems. Compared with adults, children, particularly in the first years of life, have a higher risk of antibiotic-related adverse events for several reasons. Areas covered: In this paper, the conditions that can contribute to the elevated risk of antibiotic-related adverse events in children are discussed. Expert opinion: Antibiotic stewardship can be a solution to limit antibiotic abuse and misuse and consequently the incidence of antibiotic-related adverse events in children. Moreover, most of the antibiotic-associated adverse events can be avoided with more extensive pre-marketing medicine investigations, improved postmarket safety surveillance system, increased transparency throughout the clinical research enterprise, increased training of clinical pharmacologists and paediatric researchers, expanded pool of paediatric patients, and providing additional funding and incentives for paediatric drug development.


Assuntos
Antibacterianos/administração & dosagem , Gestão de Antimicrobianos/métodos , Desenvolvimento de Medicamentos/métodos , Fatores Etários , Antibacterianos/efeitos adversos , Criança , Pré-Escolar , Humanos , Lactente , Infecção/tratamento farmacológico , Vigilância de Produtos Comercializados , Fatores de Risco
11.
Yakugaku Zasshi ; 139(7): 1055-1061, 2019.
Artigo em Japonês | MEDLINE | ID: mdl-31257252

RESUMO

Linezolid (LZD), an antimicrobial agent against methicillin-resistant Staphylococcus aureus, demonstrates good bone and joint penetration, and is used for prosthetic bone and joint infections. Recently, we observed vomiting in several patients administered LZD. However, there are few reports on the incidence rate of, and risk factors for, LZD-induced nausea and vomiting. In this study, we aimed to verify the relationship between LZD administration and vomiting. Patients administered LZD at the Department of Orthopedic Surgery of Hokkaido University Hospital between November 2008 and December 2017 were enrolled in the study. The primary endpoint was the comparison of the vomiting rate between patients administered LZD (LZD group) and those administered other antibiotics (non-LZD group). For the secondary endpoint, to verify the risk factors of vomiting, a univariate logistic regression analysis was performed. In total, 130 patients were included in this study; 77 patients in the LZD group, and 53 in the non-LZD group. Vomiting occurred in 18 patients in the LZD group and 4 patients in the non-LZD group (23.4% and 7.5%, respectively); this was significantly higher in the LZD group. In the univariate logistic regression analysis, LZD administration, gender (female), age ≥65 years, renal impairment (creatinine clearance <60 mL/min) and concomitant use of rifampicin were extracted as potential risk factors of vomiting. The results of this study reveal a possible relationship between LZD administration and vomiting.


Assuntos
Antibacterianos/efeitos adversos , Linezolida/efeitos adversos , Náusea/induzido quimicamente , Vômito/induzido quimicamente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/administração & dosagem , Quimioterapia Combinada/efeitos adversos , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Náusea/epidemiologia , Rifampina/administração & dosagem , Rifampina/efeitos adversos , Fatores de Risco , Vômito/epidemiologia , Adulto Jovem
12.
Medicine (Baltimore) ; 98(30): e16581, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31348293

RESUMO

RATIONALE: A number of medicines are associated with edema. However, only 2 cases of edema of both lower legs, associated with levofloxacin, have been reported. PATIENT: We report the case of levofloxacin-associated bilateral leg edema in an 81-year-old male. The patient was referred to the Division of Nephrology due to edema limited to both lower legs, which had developed 1 day before. He had undergone supraglottic laryngectomy due to supraglottic cancer in our institution 6 months ago. He had been admitted to the Department of Otolaryngology due to persistent aspiration and general weakness 5 days ago. DIAGNOSIS: The patient had no underlying diseases that could result in edema. No abnormalities were detected in several diagnostic tests. He strongly denied using other medications including herbal or traditional remedies, recreational drugs, or drugs of abuse. The patient had been intravenously administered levofloxacin at 750 mg per day 5 days earlier; on this basis levofloxacin-induced edema was suspected. INTERVENTIONS AND OUTCOMES: Levofloxacin was immediately withdrawn and conservative management (salt restriction and withdrawal of intravenous fluid) was initiated. His edema was completely restored within 3 weeks after withdrawal of levofloxacin. OUTCOMES: The patient stopped taking levofloxacin and he did not have any recurrent edema until his death due to uncontrolled pneumonia. LESSONS: Levofloxacin should be added to the list of drugs associated with the development of bilateral leg edema. This might obviate the need for time-consuming studies for diagnostic purposes and application of ineffective or harmful treatments.


Assuntos
Antibacterianos/efeitos adversos , Edema/induzido quimicamente , Levofloxacino/efeitos adversos , Idoso de 80 Anos ou mais , Humanos , Levofloxacino/administração & dosagem , Masculino
13.
Yakugaku Zasshi ; 139(6): 917-922, 2019.
Artigo em Japonês | MEDLINE | ID: mdl-31155536

RESUMO

The use of a drug administration plan and therapeutic drug monitoring (TDM) based on pharmacokinetic-pharmacodynamic (PK-PD) analysis is important for the effective use of antimicrobial agents to treat infections. We focused on the use of beta-lactam agents, anti-methicillin-resistant Staphylococcus aureus (MRSA) agents, and an antifungal agent as antimicrobial agents and examined their efficacy in patients under special clinical conditions from the viewpoint of safety and TDM. Our PK-PD analysis of the use of an administration plan to set an optimum serum level for beta-lactam agents or anti-MRSA drugs for the treatment of pneumonia, acute renal failure during continuous hemodialysis filtration, febrile neutropenia, or malignant tumors confirmed the necessity of managing the optimal serum level. PK-PD analysis was also useful for TDM of voriconazole and intubation administration in long-term use from the viewpoint of preventing the onset of side effects. PK-PD analysis appears to be a useful tool in antibiotic therapy and TDM for developing a pharmacokinetic "individual difference" for "individualization therapy" under special clinical conditions. PK-PD analysis utilizes the restrictive information that is obtained by a clinic to the maximum and allows coordination with the mission of hospital pharmacists to provide adequate antibiotic therapy.


Assuntos
Antibacterianos/administração & dosagem , Antibacterianos/farmacocinética , Antifúngicos/administração & dosagem , Antifúngicos/farmacocinética , Monitoramento de Medicamentos , Medicina de Precisão , Antibacterianos/efeitos adversos , Antifúngicos/efeitos adversos , Neutropenia Febril , Humanos , Neoplasias , Diálise Renal
14.
J Agric Food Chem ; 67(27): 7569-7586, 2019 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-31198037

RESUMO

The abundant use of antibiotics leads to antibiotic residues in frequently consumed foods. Residual antibiotics in food may have adverse effects on humans by directly causing disease via low-dose exposure and indirect harm via antibiotic resistance. However, the current methods for antibiotic extraction and analysis in food have not yet formed a uniform standard, and only a few data exist regarding the residual antibiotic condition in various types of foods. Hence, we review the literature since 2008 to summarize analytical methods and residue status of antibiotics in food. Then, we discuss the causes of antibiotic residues in food and the possible hazards to human health. We hope that the joint efforts of the scientific community and political circles will lead to the formation of a unified standard for the extraction and analysis of antibiotics in food, to allow for comprehensive monitoring of residual antibiotics and ensure human health.


Assuntos
Antibacterianos/efeitos adversos , Antibacterianos/análise , Resíduos de Drogas/análise , Contaminação de Alimentos/análise , Animais , Cromatografia Líquida/métodos , Resistência Microbiana a Medicamentos , Ovos/análise , Peixes , Nível de Saúde , Humanos , Espectrometria de Massas/métodos , Carne/análise , Leite/química , Produtos Avícolas/análise , Fatores de Risco , Sensibilidade e Especificidade , Verduras/química
15.
Nat Commun ; 10(1): 2712, 2019 06 20.
Artigo em Inglês | MEDLINE | ID: mdl-31221971

RESUMO

Clostridium difficile (C. difficile) incidence has tripled over the past 15 years and is attributed to the emergence of hypervirulent strains. While it is clear that C. difficile toxins cause damaging colonic inflammation, the immune mechanisms protecting from tissue damage require further investigation. Through a transcriptome analysis, we identify IL-33 as an immune target upregulated in response to hypervirulent C. difficile. We demonstrate that IL-33 prevents C. difficile-associated mortality and epithelial disruption independently of bacterial burden or toxin expression. IL-33 drives colonic group 2 innate lymphoid cell (ILC2) activation during infection and IL-33 activated ILC2s are sufficient to prevent disease. Furthermore, intestinal IL-33 expression is regulated by the microbiota as fecal microbiota transplantation (FMT) rescues antibiotic-associated depletion of IL-33. Lastly, dysregulated IL-33 signaling via the decoy receptor, sST2, predicts C. difficile-associated mortality in human patients. Thus, IL-33 signaling to ILC2s is an important mechanism of defense from C. difficile colitis.


Assuntos
Clostridium difficile/imunologia , Enterocolite Pseudomembranosa/imunologia , Imunidade Inata , Interleucina-33/metabolismo , Linfócitos/imunologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Animais , Antibacterianos/efeitos adversos , Toxinas Bacterianas/imunologia , Toxinas Bacterianas/metabolismo , Clostridium difficile/patogenicidade , Colo/citologia , Colo/imunologia , Colo/microbiologia , Colo/patologia , Modelos Animais de Doenças , Enterocolite Pseudomembranosa/microbiologia , Enterocolite Pseudomembranosa/mortalidade , Enterocolite Pseudomembranosa/terapia , Transplante de Microbiota Fecal , Feminino , Microbioma Gastrointestinal/efeitos dos fármacos , Microbioma Gastrointestinal/imunologia , Perfilação da Expressão Gênica , Humanos , Interleucina-33/imunologia , Linfócitos/metabolismo , Masculino , Camundongos Endogâmicos C57BL , Camundongos Knockout , Pessoa de Meia-Idade , Regulação para Cima/efeitos dos fármacos , Regulação para Cima/imunologia , Virulência/imunologia , Adulto Jovem
19.
Medicine (Baltimore) ; 98(19): e15399, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31083168

RESUMO

RATIONALE: Tigecycline is a broad-spectrum antimicrobial agent structurally belong to tetracyclines and covers against many multidrug-resistant organisms. Arising clinical cases reporting its adverse drug reactions have emerged alongside with the increasing off label use globally. By literature review, delirium caused by tigecycline has not been reported yet. We present what we believe to be the first case of tigecycline-induced delirium. PATIENT CONCERNS: A 77-year-old male patient with end-stage renal disease was hospitalized due to acute exacerbation of chronic obstructive pulmonary disease. DIAGNOSIS: The patient developed delirium after infused with a loading dose of tigecycline for pulmonary infection. INTERVENTIONS: All potential causes inducing delirium were evaluated and the symptoms improved soon after discontinuation of tigecycline. He experienced delirium once again after reusing tigecycline for the exacerbation of the pulmonary infection even without a loading dose. Tigecycline was discontinued and the symptoms quickly relieved. OUTCOMES: According to the Naranjo adverse drug reaction probability scale, tigecycline was the probable cause of his delirium. LESSONS: Clinicians should be aware of this potential adverse effect of tigecycline. We recommend that clinicians monitor patients for signs and symptoms of delirium during treatment with tigecycline.


Assuntos
Infecções por Acinetobacter/tratamento farmacológico , Acinetobacter baumannii , Antibacterianos/efeitos adversos , Delírio/etiologia , Pneumopatias/tratamento farmacológico , Tigeciclina/efeitos adversos , Idoso , Antibacterianos/uso terapêutico , Delírio/diagnóstico , Diagnóstico Diferencial , Humanos , Masculino , Tigeciclina/uso terapêutico
20.
Cochrane Database Syst Rev ; 4: CD004827, 2019 04 30.
Artigo em Inglês | MEDLINE | ID: mdl-31039287

RESUMO

BACKGROUND: Antibiotics alter the microbial balance commonly resulting in antibiotic-associated diarrhea (AAD). Probiotics may prevent AAD via providing gut barrier, restoration of the gut microflora, and other potential mechanisms of action. OBJECTIVES: The primary objectives were to assess the efficacy and safety of probiotics (any specified strain or dose) used for the prevention of AAD in children. SEARCH METHODS: MEDLINE, Embase, CENTRAL, CINAHL, and the Web of Science (inception to 28 May 2018) were searched along with registers including the ISRCTN and Clinicaltrials.gov. We also searched the NICE Evidence Services database as well as reference lists from relevant articles. SELECTION CRITERIA: Randomized, parallel, controlled trials in children (0 to 18 years) receiving antibiotics, that compare probiotics to placebo, active alternative prophylaxis, or no treatment and measure the incidence of diarrhea secondary to antibiotic use were considered for inclusion. DATA COLLECTION AND ANALYSIS: Study selection, data extraction, and risk of bias assessment were conducted independently by two authors. Dichotomous data (incidence of AAD, adverse events) were combined using a pooled risk ratio (RR) or risk difference (RD), and continuous data (mean duration of diarrhea) as mean difference (MD), along with corresponding 95% confidence interval (95% CI). We calculated the number needed to treat for an additional beneficial outcome (NNTB) where appropriate. For studies reporting on microbiome characteristics using heterogeneous outcomes, we describe the results narratively. The certainty of the evidence was evaluated using GRADE. MAIN RESULTS: Thirty-three studies (6352 participants) were included. Probiotics assessed included Bacillus spp., Bifidobacterium spp., Clostridium butyricum, Lactobacilli spp., Lactococcus spp., Leuconostoc cremoris, Saccharomyces spp., orStreptococcus spp., alone or in combination. The risk of bias was determined to be high in 20 studies and low in 13 studies. Complete case (patients who did not complete the studies were not included in the analysis) results from 33 trials reporting on the incidence of diarrhea show a precise benefit from probiotics compared to active, placebo or no treatment control.After 5 days to 12 weeks of follow-up, the incidence of AAD in the probiotic group was 8% (259/3232) compared to 19% (598/3120) in the control group (RR 0.45, 95% CI 0.36 to 0.56; I² = 57%, 6352 participants; NNTB 9, 95% CI 7 to 13; moderate certainty evidence). Nineteen studies had loss to follow-up ranging from 1% to 46%. After making assumptions for those lost, the observed benefit was still statistically significant using an extreme plausible intention-to-treat (ITT) analysis, wherein the incidence of AAD in the probiotic group was 12% (436/3551) compared to 19% (664/3468) in the control group (7019 participants; RR 0.61; 95% CI 0.49 to 0.77; P <0.00001; I² = 70%). An a priori available case subgroup analysis exploring heterogeneity indicated that high dose (≥ 5 billion CFUs per day) is more effective than low probiotic dose (< 5 billion CFUs per day), interaction P value = 0.01. For the high dose studies the incidence of AAD in the probiotic group was 8% (162/2029) compared to 23% (462/2009) in the control group (4038 participants; RR 0.37; 95% CI 0.30 to 0.46; P = 0.06; moderate certainty evidence). For the low dose studies the incidence of AAD in the probiotic group was 8% (97/1155) compared to 13% (133/1059) in the control group (2214 participants; RR 0.68; 95% CI 0.46 to 1.01; P = 0.02). Again, assumptions for loss to follow-up using an extreme plausible ITT analysis was statistically significant. For high dose studies the incidence of AAD in the probiotic group was 13% (278/2218) compared to 23% (503/2207) in control group (4425 participants; RR 0.54; 95% CI 0.42 to 0.70; P <0.00001; I² = 68%; moderate certainty evidence).None of the 24 trials (4415 participants) that reported on adverse events reported any serious adverse events attributable to probiotics. Adverse event rates were low. After 5 days to 4 weeks follow-up, 4% (86/2229) of probiotics participants had an adverse event compared to 6% (121/2186) of control participants (RD 0.00; 95% CI -0.01 to 0.01; P < 0.00001; I² = 75%; low certainty evidence). Common adverse events included rash, nausea, gas, flatulence, abdominal bloating, and constipation.After 10 days to 12 weeks of follow-up, eight studies recorded data on our secondary outcome, the mean duration of diarrhea; with probiotics reducing diarrhea duration by almost one day (MD -0.91; 95% CI -1.38 to -0.44; P <0.00001; low certainty evidence). One study reported on microbiome characteristics, reporting no difference in changes with concurrent antibiotic and probiotic use. AUTHORS' CONCLUSIONS: The overall evidence suggests a moderate protective effect of probiotics for preventing AAD (NNTB 9, 95% CI 7 to 13). Using five criteria to evaluate the credibility of the subgroup analysis on probiotic dose, the results indicate the subgroup effect based on high dose probiotics (≥ 5 billion CFUs per day) was credible. Based on high-dose probiotics, the NNTB to prevent one case of diarrhea is 6 (95% CI 5 to 9). The overall certainty of the evidence for the primary endpoint, incidence of AAD based on high dose probiotics was moderate due to the minor issues with risk of bias and inconsistency related to a diversity of probiotic agents used. Evidence also suggests that probiotics may moderately reduce the duration of diarrhea, a reduction by almost one day. The benefit of high dose probiotics (e.g. Lactobacillus rhamnosus orSaccharomyces boulardii) needs to be confirmed by a large well-designed multi-centered randomized trial. It is premature to draw firm conclusions about the efficacy and safety of 'other' probiotic agents as an adjunct to antibiotics in children. Adverse event rates were low and no serious adverse events were attributable to probiotics. Although no serious adverse events were observed among inpatient and outpatient children, including small studies conducted in the intensive care unit and in the neonatal unit, observational studies not included in this review have reported serious adverse events in severely debilitated or immuno-compromised children with underlying risk factors including central venous catheter use and disorders associated with bacterial/fungal translocation.


Assuntos
Antibacterianos/efeitos adversos , Diarreia/prevenção & controle , Probióticos/uso terapêutico , Adolescente , Antibacterianos/uso terapêutico , Criança , Pré-Escolar , Diarreia/etiologia , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Resultado do Tratamento
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