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1.
Nutrients ; 16(11)2024 May 22.
Artículo en Inglés | MEDLINE | ID: mdl-38892494

RESUMEN

OBJECTIVE: Medical nutrition therapy provides the opportunity to compensate for muscle wasting and immune response activation during stress and trauma. The objective of this systematic review is to assess the safety and effectiveness of early enteral nutrition (EEN) in adults with sepsis or septic shock. METHODS: The MEDLINE, Embase, CENTRAL, CINAHL, ClinicalTrials.gov, and ICTRP tools were searched from inception until July 2023. Conference proceedings, the reference lists of included studies, and expert content were queried to identify additional publications. Two review authors completed the study selection, data extraction, and risk of bias assessment; disagreements were resolved through discussion. Inclusion criteria were randomized controlled trials (RCTs) and non-randomized studies (NRSs) comparing the administration of EEN with no or delayed enteral nutrition (DEE) in adult populations with sepsis or septic shock. RESULTS: Five RCTs (n = 442 participants) and ten NRSs (n = 3724 participants) were included. Low-certainty evidence from RCTs and NRSs suggests that patients receiving EEN could require fewer days of mechanical ventilation (MD -2.65; 95% CI, -4.44-0.86; and MD -2.94; 95% CI, -3.64--2.23, respectively) and may show lower SOFA scores during follow-up (MD -1.64 points; 95% CI, -2.60--0.68; and MD -1.08 points; 95% CI, -1.90--0.26, respectively), albeit with an increased frequency of diarrhea episodes (OR 2.23, 95% CI 1.115-4.34). Even though the patients with EEN show a lower in-hospital mortality rate both in RCTs (OR 0.69; 95% CI, 0.39-1.23) and NRSs (OR 0.89; 95% CI, 0.69-1.13), this difference does not achieve statistical significance. There were no apparent differences for other outcomes. CONCLUSIONS: Low-quality evidence suggests that EEN may be a safe and effective intervention for the management of critically ill patients with sepsis or septic shock.


Asunto(s)
Nutrición Enteral , Sepsis , Choque Séptico , Humanos , Nutrición Enteral/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Respiración Artificial , Sepsis/terapia , Sepsis/mortalidad , Choque Séptico/terapia , Choque Séptico/mortalidad , Factores de Tiempo , Resultado del Tratamiento
2.
Cancers (Basel) ; 16(11)2024 May 26.
Artículo en Inglés | MEDLINE | ID: mdl-38893140

RESUMEN

This study aimed to investigate prognosis and survival differences in 82 breast cancer patients with germline pathogenic/likely pathogenic variants (PVs) treated and followed at the Breast Unit of the Instituto Nacional de Cancerología, Colombia (INC-C) between 2018 and 2021. Median age at diagnosis was 46 years, with 62.2% presenting locally advanced tumors, 47.6% histological grade 3, and 35.4% with triple-negative breast cancer (TNBC) subtype. Most carriers, 74.4% (61/82), had PVs in known breast cancer susceptibility genes (i.e., "associated gene carriers" group, considered inherited breast cancer cases): BRCA2 (30), BRCA1 (14), BARD1 (4), RAD51D (3), TP53 (2), PALB2 (2), ATM (2), CHEK2 (1), RAD51C (1), NF1 (1), and PTEN (1). BRCA1-2 represented 53.7%, and homologous recombination DNA damage repair (HR-DDR) genes associated with breast cancer risk accounted for 15.9%. Patients with PVs in non-breast-cancer risk genes were combined in a different category (21/82; 25.6%) (i.e., "non-associated gene carriers" group, considered other breast cancer cases). Median follow-up was 38.1 months, and 24% experienced recurrence, with 90% being distant. The 5-year Disease-Free Survival (DFS) for inherited breast cancer cases was 66.5%, and for other breast cancer cases it was 88.2%. In particular, for carriers of PVs in the BRCA2 gene, it was 37.6%. The 5-year Overall Survival (OS) rates ranged from 68.8% for those with PVs in BRCA2 to 100% for those with PVs in other HR-DDR genes. Further studies are crucial for understanding tumor behavior and therapy response differences among Colombian breast cancer patients with germline PVs.

3.
Gynecol Oncol ; 169: 4-11, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-36459858

RESUMEN

OBJECTIVE: To assess the rate of pathological response rate, and the oncological outcomes of preoperative brachytherapy (PBT) in early-stage cervical cancer. METHODS: A systematic literature review was conducted according to the Preferred Reporting Items for Systematic Reviews and meta-analyses (PRISMA) statement. MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Scopus databases were searched from inception until April 2022. Only English and French articles were included. Studies containing data about pathology response or oncological outcomes among patients who received PBT as compared to those who underwent up-front surgery in early-stage cervical cancer were included. This study was registered in PROSPERO (CRD42022319036). RESULTS: Thirteen studies met the inclusion criteria, 3 randomized controlled trials (RCT), and 10 non-randomized studies (NRS). The 5-year survival was significantly higher in the PBT group compared with the up-front surgery group (OR 1.78, 95% CI 1.11-2.84, I2 = 0%) in the NRS. Recurrence rate was significantly lower in the PBT group compared with in up-front surgery group in the analysis of the RCT but not in NRS, (OR 0.34, 95% CI 0.13-0.91, I2 not applicable) and (OR 0.72, 95% CI 0.26-1.95, I2 = 51%) respectively. PBT was associated with a statistically significant lower rate of positive margins (OR 0.28, 95% CI 0.09-0.89; I2 = 42%) in the RCT and with a significantly higher rate of complete pathology response (CPR) in the RCT analysis (OR 2.55, 95% CI 1.11-5.85, I2 = 0%) and in the NRS (OR 9.64, 95% CI 1.88-49.48, I2 = 76%) compared with the up-front surgery group. CONCLUSION: Preoperative brachytherapy in patients with early-stage cervical cancer could improve pathologic and oncologic outcomes, but it should be assessed in high-quality randomized controlled trials before its implementation in clinical practice.


Asunto(s)
Braquiterapia , Neoplasias del Cuello Uterino , Femenino , Humanos , Neoplasias del Cuello Uterino/radioterapia , Neoplasias del Cuello Uterino/cirugía
4.
Cochrane Database Syst Rev ; 1: CD011708, 2020 01 29.
Artículo en Inglés | MEDLINE | ID: mdl-31995238

RESUMEN

BACKGROUND: Chlamydia trachomatis (C trachomatis) is one of the most frequent sexually transmitted infections and a source of deleterious effects on the reproductive health of men and women. Because this infection is likely asymptomatic and is associated with subfertility, ectopic pregnancy, and chronic pain, its presence needs to be confirmed. Technologies available for the diagnosis of C trachomatis infection can be classified into tests performed in a laboratory and rapid tests at the point of care (POC tests). Laboratory-based tests include culture, nucleic acid amplification tests, enzyme immunoassays (EIA), direct fluorescent antibody, nucleic acid hybridization, and transformation tests. Rapid tests include solid-phase EIA and solid-phase optical immunoassay. POC tests can be performed within 30 minutes without the need for expensive or sophisticated equipment. The principal advantage of this technology is the immediate presentation of results with the subsequent possibility to start the treatment of infected patients immediately. OBJECTIVES: To determine the diagnostic accuracy of rapid point-of-care (POC) testing for detecting urogenital C trachomatis infection in nonpregnant women and men of reproductive age, as verified with nucleic acid amplification tests (NAATs) as the reference standard. SEARCH METHODS: In November 2019 we searched CENTRAL, MEDLINE, Embase and LILACS. We also searched Web of Science, two trials registries and an abstract database. We screened reference lists of included studies for additional references. SELECTION CRITERIA: We included diagnostic accuracy studies of symptomatic or asymptomatic nonpregnant women and men reproductive age. Included trials should have prospectively enrolled participants without previous diagnostic testing, co-infections or complications and consecutively or through random sampling at primary or secondary care facilities. Only studies reporting that all participants received the index test and the reference standard and presenting 2 x 2 data were eligible for inclusion. We excluded diagnostic case-control studies. DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles and abstracts for relevance. Two review authors independently, and in duplicate, assessed eligibility, extracted data, and carried out quality assessment. We resolved differences through consensus or by involving a third review author. We assessed studies for methodological quality using QUADAS-2 and used meta-analysis to combine the results of studies using the bivariate approach to estimate the expected sensitivity and specificity values. We assessed the quality of the evidence using GRADE criteria and explored sources of heterogeneity. MAIN RESULTS: We included a total of 19 studies, with 13,676 participants, that assessed the diagnostic accuracy of POC tests for C trachomatis infection in nonpregnant women and men of reproductive age, as verified with NAATs as the reference standard. Rapid tests were provided by the distributors in nine studies. Seven studies recruited a predominantly high risk or symptomatic population; the studies were conducted in America, Asia, Africa, Europe and Oceania, with a median prevalence of 10% (range 8% to 28%); nine different brands were assessed. The mean sensitivity for rapid tests for detecting urogenital infection was 0.48 (95% confidence interval (CI) 0.39 to 0.58; low-quality evidence) with a mean specificity of 0.98 (95% CI 0.97 to 0.99; moderate-quality evidence). We explored sources of heterogeneity by looking into differences in diagnostic accuracy according to the specimen (endocervical versus urine or vaginal), symptoms among participants (symptomatic versus asymptomatic), and setting (low/middle-income versus high-income countries). Likelihood ratio tests were not significantly different in terms of sensitivity or specificity by specimen (P = 0.27) or setting (P = 0.28); for this reason, these covariates do not appear to explain the observed variability. Included studies did not provide enough information to assess the 'presence of symptoms' covariate. We downgraded the quality of evidence because of some limitations in applicability and heterogeneity. AUTHORS' CONCLUSIONS: Based on the results of this systematic review, the POC test based on antigen detection has suboptimal sensitivity but good specificity. Performance of this test translates, on average, to a 52% chance of mistakenly indicating absence of infection and a 2% chance of mistakenly pointing to the presence of this condition. Because of its deleterious consequences for reproductive health, and considering the current availability of safe and effective interventions to treat C trachomatis infection, the POC screening strategy should not be based on a rapid diagnostic test for antigen detection. Research in this topic should focus on different technologies.


Asunto(s)
Infecciones por Chlamydia/diagnóstico , Chlamydia trachomatis , Sistemas de Atención de Punto , Adulto , Reacciones Falso Negativas , Reacciones Falso Positivas , Femenino , Humanos , Masculino , Sistemas de Atención de Punto/normas , Ensayos Clínicos Controlados Aleatorios como Asunto , Sensibilidad y Especificidad , Enfermedades Bacterianas de Transmisión Sexual/prevención & control
5.
Cochrane Database Syst Rev ; 2: CD012071, 2019 02 15.
Artículo en Inglés | MEDLINE | ID: mdl-30776081

RESUMEN

BACKGROUND: Congenital syphilis continues to be a substantial public health problem in many parts of the world. Since the first use of penicillin for the treatment of syphilis in 1943, which was a notable early success, it has remained the preferred and standard treatment including for congenital syphilis. However, the treatment of congenital syphilis is largely based on clinical experience and there is extremely limited evidence on the optimal dose or duration of administration of penicillin or the use of other antibiotics. OBJECTIVES: To assess the effectiveness and safety of antibiotic treatment for newborns with confirmed, highly probable and possible congenital syphilis. SEARCH METHODS: We searched the Cochrane STI Group Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, WHO ICTRP, ClinicalTrials.gov and Web of Science to 23 May 2018. We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing antibiotic treatment (any concentration, frequency, duration and route) with no intervention or any other antibiotic treatment for neonates with confirmed, highly probable or possible congenital syphilis. DATA COLLECTION AND ANALYSIS: All review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias in the included studies. We resolved any disagreements through consensus. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: Two RCTs (191 participants) met our inclusion criteria and none of these trials was funded by the industry. One trial (22 participants) compared benzathine penicillin with no intervention for infants with possible congenital syphilis. Low-quality evidence suggested that benzathine penicillin administration may not have decreased the rate of neonatal death due to any cause (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.06 to 11.70), and showed a possible reduction into the proportion of neonates with clinical manifestations of congenital syphilis (RR 0.12, 95% CI 0.01 to 2.09). Penicillin administration increased the serological cure at the third month (RR 2.13, 95% CI 1.06 to 4.27). These results should be taken with caution, because the trial was stopped early because there were four cases with clinical congenital syphilis in the no treatment group and none in the treatment group. Interim analysis suggested this difference was significant. This study did not report neonatal death due to congenital syphilis or the frequency of serious or minor adverse events after therapy. We downgraded the quality of evidence because of imprecision and risk of bias.One trial (169 participants) compared benzathine penicillin versus procaine benzylpenicillin. High- and moderate-quality evidence suggested that there were probably no differences between benzathine penicillin and procaine benzylpenicillin for the outcomes: absence of clinical manifestations of congenital syphilis (RR 1.00, 95% CI 0.97 to 1.03) and serological cure (RR 1.00, 95% CI 0.97 to 1.03). There were no cases of neonatal death due congenital syphilis; all 152 babies who followed up survived. This study did not report on the frequency of serious or minor adverse events after therapy. We downgraded the quality of evidence because of serious risk of bias. AUTHORS' CONCLUSIONS: At present, the evidence on the effectiveness and safety of antibiotic treatment for newborns with confirmed, highly probable or possible congenital syphilis is sparse, implying that we are uncertain about the estimated effect. One trial compared benzathine penicillin with no intervention for infants with possible congenital syphilis. Low-quality evidence suggested penicillin administration possibly reduce the proportion of neonates with clinical manifestations of congenital syphilis, penicillin administration increased the serological cure at the third month. These findings support the clinical use of penicillin in neonates with confirmed, highly probable or possible congenital syphilis. High- and moderate-quality evidence suggests that there are probably no differences between benzathine penicillin and procaine benzylpenicillin administration for the outcomes of absence of clinical manifestations of syphilis or serological cure.


Asunto(s)
Antibacterianos/uso terapéutico , Penicilina G Benzatina/uso terapéutico , Penicilina G Procaína/uso terapéutico , Sífilis Congénita/tratamiento farmacológico , Humanos , Lactante , Mortalidad Infantil , Recién Nacido , Ensayos Clínicos Controlados Aleatorios como Asunto
6.
Int J Gynaecol Obstet ; 143(1): 19-23, 2018 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-29939397

RESUMEN

BACKGROUND: Medical management of retained placenta could be a safe alternative to manual removal. OBJECTIVE: To evaluate the efficacy of prostaglandin analogues for retained placenta. SEARCH STRATEGY: MEDLINE, EMBASE, CENTRAL, ICTRP, LILACS, and OpenSIGLE were searched without language restrictions from inception to January 31, 2017, by combining terms for retained placenta and prostaglandin analogues. SELECTION CRITERIA: Randomized controlled trials comparing prostaglandin analogues with any other intervention. DATA COLLECTION AND ANALYSIS: Trials were independently assessed for inclusion, data extraction, and risk of bias. Data were extracted for meta-analyses. GRADE was used to evaluate the quality of data. MAIN RESULTS: Seven randomized controlled trials (851 patients) were included. Prostaglandins did not increase the placenta expulsion rate (relative risk [RR] 1.40, 95% confidence interval [CI] 0.83-2.36) or decrease maternal transfusion (RR 0.72, 95% CI 0.43-1.22). In comparison with oxytocin, prostaglandins did not modify the expulsion rate (RR 1.26, 95% CI 0.90-1.78), maternal transfusion (RR 1.05, 95% CI 0.27-4.09), or time for delivery of placenta (mean difference -1.56 minutes, 95% CI, -9.25-6.13). Three trials comparing prostaglandins with oxytocin agonists, ergometrine, and manual removal reported similar results. CONCLUSIONS: Prostaglandin analogues do not offer an effective alternative for management of retained placenta.


Asunto(s)
Oxitócicos/uso terapéutico , Retención de la Placenta/tratamiento farmacológico , Prostaglandinas Sintéticas/uso terapéutico , Ergonovina/uso terapéutico , Femenino , Humanos , Oxitocina/uso terapéutico , Embarazo , Ensayos Clínicos Controlados Aleatorios como Asunto
7.
Cochrane Database Syst Rev ; 12: CD012492, 2017 Dec 11.
Artículo en Inglés | MEDLINE | ID: mdl-29226307

RESUMEN

BACKGROUND: Chancroid is a genital ulcerative disease caused by Haemophilus ducreyi. This microorganism is endemic in Africa, where it can cause up to 10% of genital ulcers. Macrolides may be an effective alternative to treat chancroid and, based on their oral administration and duration of therapy, could be considered as first line therapy. OBJECTIVES: To assess the effectiveness and safety of macrolides for treatment of H ducreyi infection in sexually active adults. SEARCH METHODS: We searched the Cochrane STI Group Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, WHO ICTRP, ClinicalTrials.gov and Web of Science to 30 October 2017. We also handsearched conference proceedings and reference lists of retrieved studies. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing macrolides in different regimens or with other therapeutic alternatives for chancroid. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We resolved disagreements through consensus. We used the GRADE approach to assess the quality of the evidence. MAIN RESULTS: Seven RCTs (875 participants) met our inclusion criteria, of which four were funded by industry. Five studies (664 participants) compared macrolides with ceftriaxone, ciprofloxacin, spectinomycin or thiamphenicol. Low quality evidence suggested there was no difference between the groups after treatment in terms of clinical cure (risk ratio (RR) 1.09, 95% confidence interval (CI) 0.97 to 1.21; 2 studies, 340 participants with syndromic approach and RR 1.06, 95% CI 0.98 to 1.15; 5 studies, 348 participants with aetiological diagnosis) or improvement (RR 0.89, 95% CI 0.52 to 1.52; 2 studies, 340 participants with syndromic approach and RR 0.80, 95% CI 0.42 to 1.51; 3 studies, 187 participants with aetiological diagnosis). Based on low and very low quality evidence, there was no difference between macrolides and any other antibiotic treatments for microbiological cure (RR 0.93, 95% CI 0.74 to 1.16; 1 study, 45 participants) and minor adverse effects (RR 1.34, 95% CI 0.24 to 7.51; 3 studies, 412 participants).Two trials (269 participants) compared erythromycin with any other macrolide type. Low quality evidence suggested that, compared with azithromycin or rosaramicin, long courses of erythromycin did not increase clinical cure (RR 1.00, 95% CI 0.91 to 1.10; 2 studies, 269 participants with syndromic approach and RR 1.04, 95% CI 0.93 to 1.16; 2 studies, 211 participants with aetiological diagnosis), with a similar frequency of minor adverse effects between the groups (RR 1.14, 95% CI 0.63 to 2.06; 1 trial, 101 participants). For this comparison, subgroup analysis found no difference between HIV-positive participants (RR 1.02, 95% CI 0.73 to 1.43; 1 study, 38 participants) and HIV-negative participants (RR 1.04, 95% CI 0.94 to 1.14; 1 study, 89 participants). We downgraded the quality of evidence to low, because of imprecision, some limitations on risk of bias and heterogeneity.None of the trials reported serious adverse events, cost effectiveness and participant satisfaction. AUTHORS' CONCLUSIONS: At present, the quality of the evidence on the effectiveness and safety of macrolides for treatment of H ducreyi infection in sexually active adults is low, implying that we are uncertain about the estimated treatment effect. There is no statistically significant difference between the available therapeutic alternatives for the treatment of sexually active adults with genital ulcers compatible with chancroid. Low quality evidence suggests that azithromycin could be considered as the first therapeutic alternative, based on their mono-dose oral administration, with a similar safety and effectiveness profile, when it is compared with long-term erythromycin use.Due to sparse available evidence about the safety and effectiveness of macrolides to treat H ducreyi infection in people with HIV, these results should be taken with caution.


Asunto(s)
Antibacterianos/uso terapéutico , Chancroide/tratamiento farmacológico , Haemophilus ducreyi , Macrólidos/uso terapéutico , Adolescente , Adulto , Azitromicina/uso terapéutico , Eritromicina/efectos adversos , Eritromicina/uso terapéutico , Humanos , Leucomicinas/uso terapéutico , Macrólidos/efectos adversos , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
8.
Rev. colomb. anestesiol ; 45(3): 182-199, July-Sept. 2017. graf
Artículo en Inglés | LILACS, COLNAL | ID: biblio-900360

RESUMEN

Abstract Introduction: Critical intraoperative events are rare and may sometimes be managed poorly and too late. Objective: To translate and update the checklists developed by Ariadne Labs for management of critical events in the OR and to adapt the list for managing anesthetic toxicity, based on secondary clinical evidence. Materials and methods : In order to translate and update the checklists, the recommendations given by Ariadne Labs were followed to change the original checklists in accordance with a systematic methodology that comprises three phases: 1) translation of the original lists, 2) systematic literature search, 3) evaluation and selection of evidence, 4) adaptation of the list for managing anesthetic toxicity, 5) changes, deletions, and additions to the translated lists, and 6) layout of the checklists. Results: The 12 original checklists were translated into Spanish and a new list was adapted for managing toxicity from local anesthetic agents. As a result of the systematic literature search, 1407 references were screened, from which 7 articles were selected and included for evidence-based updating of the new checklists. The layout of the new lists was consistent with the design recommendations of the original lists. Conclusion: 12 translated and updated checklists were submitted and a new list was adapted for the management of local anesthetics toxicity, based on a systematic literature review.


Resumen Introducción: Los eventos críticos intraoperatorios son situaciones raras, y su manejo en ocasiones podría ser inoportuno e inadecuado. Objetivo: Traducir y actualizar las listas de chequeo para manejo de eventos críticos en salas de cirugía desarrolladas por Ariadne Labs y adaptar la lista para el manejo de la toxicidad por anestésicos locales, a partir de evidencia clínica secundaria. Materiales y métodos: Para la traducción y actualización de las listas de chequeo se siguieron las recomendaciones de Ariadne Labs para la modificación de las lista de chequeo originales de acuerdo a una metodología sistemática dividida en fases: 1) traducción de las listas originales; 2) búsqueda sistemática de la literatura; 3) evaluación y selección de la evidencia; 4) adaptación de la lista para manejo de toxicidad por anestésicos locales; 5) cambios, sustracciones y adiciones a las listas traducidas, y 6) diagramación de las listas de chequeo. Resultados: Se tradujeron al español las 12 listas de chequeo originales y se adaptó una nueva lista para el manejo de toxicidad por anestésicos locales. Como resultado de la búsqueda sistemática de la literatura se tamizaron 1.407 referencias, de las cuales se seleccionaron e incluyeron 7 artículos con los que se actualizaron las nuevas listas de chequeo con base en la evidencia. Las nuevas listas se diagramaron según las recomendaciones de diseño de las listas originales. Conclusión: Se presentan 12 listas de chequeo traducidas y actualizadas y se adaptó una nueva para el manejo de toxicidad por anestésicos locales. Todo ello a partir de una revisión sistemática de la literatura.


Asunto(s)
Humanos
9.
Cochrane Database Syst Rev ; 10: CD011701, 2016 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-27696372

RESUMEN

BACKGROUND: Bacterial vaginosis (BV) is an infection that has a prevalence between 10% to 50% worlwide. BV results in an imbalance of the normal vaginal flora. Microorganisms associated with BV have been isolated from the normal flora of the male genital tract, and their presence could be related to the recurrence of BV after antibiotic treatment. Therefore, the treatment of sexual partners could decrease the recurrence of infection and possibly the burden of the disease. OBJECTIVES: To assess the effectiveness in women and the safety in men of concurrent antibiotic treatment for the sexual partners of women treated for BV. SEARCH METHODS: We searched the Cochrane Sexually Transmitted Infections Group Specialized Register (23 July 2016), CENTRAL (1991 to 23 July 2016), MEDLINE (1946 to 23 July 2016), Embase (1974 to 23 July 2016), LILACS (1982 to 23 July 2016), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (23 July 2016), ClinicalTrials.gov (23 July 2016) and the Web of Science™ (2001 to 23 July 2016). We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies. SELECTION CRITERIA: Randomized controlled trials (RCTs) that compared the concurrent use of any antibiotic treatment with placebo, no intervention or any other intervention by the sexual partners of women treated for BV. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias in the included studies. We resolved any disagreements through consensus. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: Seven RCTs (1026 participants) met our inclusion criteria, and pharmaceutical industry funded four of these trials. Five trials (854 patients) compared any antibiotic treatment of sexual partners with placebo. Based on high quality evidence, antibiotic treatment does not increase the rate of clinical or symptomatic improvement in women during the first week (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.96 to 1.03; 712 participants, four studies; RR 1.06, 95% CI 1.00 to 1.12; 577 patients, three studies, respectively), between the first and fourth week (RR 1.02, 95% CI 0.94 to 1.11; 590 participants, three studies; RR 0.93, 95% CI 0.84 to 1.03; 444 participants, two studies; respectively) or after the fourth week (RR 0.98, 95% CI 0.90 to 1.07; 572 participants, four studies; RR 1.03, 95% CI 0.90 to 1.17; 296 participants, two studies; respectively). Antibiotic treatment does not led to a lower recurrence during the first and fourth week (RR 1.28, 95% CI 0.68 to 2.43; 218 participants, one study; low quality evidence) or after the fourth week of treatment (RR 1.00, 95% CI 0.67 to 1.52; 372 participants, three studies; low quality evidence) in women, but increases the frequency of adverse events (most frequently gastrointestinal symptoms) reported by sexual partners (RR 2.55, 95% CI 1.55 to 4.18; 477 participants, three studies; low quality evidence). Two trials (172 participants) compared any antibiotic treatment for sexual partners with no intervention. When we compared it with no intervention, the effects of antibiotic treatment on recurrence rate after the fourth week (RR 1.71, 95% CI 0.65 to 4.55; 51 participants, one study), clinical improvement between the first and fourth week (RR 0.93, 95% CI 0.70 to 1.25; 152 participants, two studies) and symptomatic improvement after the fourth week (RR 0.66, 95% CI 0.39 to 1.11; 70 participants, one study) were imprecise and there were no differences between groups. We downgraded the quality of the evidence to low or very low. AUTHORS' CONCLUSIONS: High quality evidence shows that antibiotic treatment for sexual partners of women with BV, compared with placebo, does not increase the rate of clinical or symptomatic improvement during the first, between the first and fourth or after the fourth week into the women. Low quality evidence suggests that antibiotic treatment does not led to a lower recurrence rate during the first and fourth or after the fourth week of treatment into the women, but increases the frequency of adverse events reported by sexual partners. Finally, compared with no intervention, antibiotic treatment does not decrease the recurrence rate after the fourth week and does not increase the frequency of clinical or symptomatic improvement between the first and fourth or after the fourth week into the women, respectively.


Asunto(s)
Antibacterianos/uso terapéutico , Prevención Secundaria , Parejas Sexuales , Vaginosis Bacteriana/prevención & control , Adolescente , Adulto , Antibacterianos/efectos adversos , Clindamicina/uso terapéutico , Femenino , Humanos , Indazoles/uso terapéutico , Lincosamidas/uso terapéutico , Masculino , Metronidazol/uso terapéutico , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Recurrencia , Factores de Tiempo , Tinidazol/uso terapéutico
10.
Cochrane Database Syst Rev ; (11): CD010389, 2014 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-25362229

RESUMEN

BACKGROUND: 30% of people with anogenital warts (AGW) have spontaneous regression of lesions but there is no way to determine whether a specific lesion will remain. There are a wide range of options available for treating people with AGW and selection is based on clinician's experience, patient preferences and adverse effects. The imiquimod could offer the advantages of patient-applied therapies without incurring the limitations of provider-administered treatments. OBJECTIVES: To assess the effectiveness and safety of imiquimod for the treatment of AGW in non-immunocompromised adults. SEARCH METHODS: We searched the Cochrane Sexually Transmitted Infections Group Specialized Register (15 April 2014), CENTRAL (1991 to 15 April 2014), MEDLINE (1946 to 15 April 2014), EMBASE (1947 to 15 April 2014), LILACS (1982 to 15 April 2014), World Health Organization International Clinical Trials Registry (ICTRP) (15 April 2014), ClinicalTrials.gov (15 April 2014), Web of Science (2001 to 15 April 2014) and OpenGrey (15 April 2014). We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing the use of imiquimod with placebo, any other patient-applied or any other provider-administered treatment (excluding interferon and 5-fluorouracil which are assessed in other Cochrane Reviews) for the treatment of AGW in non-immunocompromised adults. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We resolved any disagreements through consensus. The quality of the evidence was assessed using the GRADE approach. MAIN RESULTS: Ten RCTs (1734 participants) met our inclusion criteria of which six were funded by industry. We judged the risk of bias of the included trials as high. Six trials (1294 participants) compared the use of imiquimod versus placebo. There was very low quality evidence that imiquimod was superior to placebo in achieving complete and partial regression (RR 4.03, 95% CI 2.03 to 7.99; RR 2.56, 95% CI 2.05 to 3.20, respectively). When compared with placebo, the effects of imiquimod on recurrence (RR 2.76, 95% CI 0.70 to 10.91), appearance of new warts (RR 0.76, 95% CI 0.58 to 1.00) and frequency of systemic adverse reactions (RR 0.91, 95% CI 0.63 to 1.32) were imprecise. We downgraded the quality of evidence to low or very low. There was low quality evidence that imiquimod led to more local adverse reactions (RR 1.73, 95% CI 1.18 to 2.53) and pain (RR 11.84, 95% CI 3.36 to 41.63).Two trials (105 participants) compared the use of imiquimod versus any other patient-applied treatment (podophyllotoxin and podophyllin). The estimated effects of imiquimod on complete regression (RR 1.09, 95% CI 0.80 to 1.48), partial regression (RR 0.77, 95% CI 0.40 to 1.47), recurrence (RR 0.49, 95% CI 0.21 to 1.11) or the presence of local adverse reactions (RR 1.24, 95% CI 1.00 to 1.54) were imprecise (very low quality evidence). There was low quality evidence that systemic adverse reactions were less frequent with imiquimod (RR 0.30, 95% CI 0.09 to 0.98).Finally, two trials (335 participants) compared imiquimod with any other provider-administered treatment (ablative methods and cryotherapy). There was very low quality of evidence that imiquimod did not have a lower frequency of complete regression (RR 0.84, 95% CI 0.56 to 1.28). There was very low quality evidence that imiquimod led to a lower rate of recurrence during six-month follow-up (RR 0.24, 95% CI 0.10 to 0.56) but this did not translate in to a lower recurrence from six to 12 months (RR 0.71, 95% CI 0.40 to 1.25; very low quality evidence). There was very low quality evidence that imiquimod was associated with less pain (RR 0.30, 95% CI 0.17 to 0.54) and fewer local reactions (RR 0.55, 95% CI 0.40 to 0.74). AUTHORS' CONCLUSIONS: The benefits and harms of imiquimod compared with placebo should be regarded with caution due to the risk of bias, imprecision and inconsistency for many of the outcomes we assessed in this Cochrane Review. The evidence for many of the outcomes that show imiquimod and patient-applied treatment (podophyllotoxin or podophyllin) confer similar benefits but fewer systematic reactions with the Imiquimod, is of low or very low quality. The quality of evidence for the outcomes assessing imiquimod and other provider-administered treatment were of very low quality.


Asunto(s)
Aminoquinolinas/uso terapéutico , Enfermedades del Ano/tratamiento farmacológico , Enfermedades de los Genitales Femeninos/tratamiento farmacológico , Enfermedades de los Genitales Masculinos/tratamiento farmacológico , Inmunocompetencia , Inductores de Interferón/uso terapéutico , Verrugas/tratamiento farmacológico , Adulto , Aminoquinolinas/efectos adversos , Enfermedades del Ano/virología , Femenino , Enfermedades de los Genitales Femeninos/virología , Enfermedades de los Genitales Masculinos/virología , Humanos , Imiquimod , Inductores de Interferón/efectos adversos , Queratolíticos/uso terapéutico , Masculino , Podofilino/uso terapéutico , Podofilotoxina/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Recurrencia , Autoadministración
11.
Cochrane Database Syst Rev ; (5): CD010312, 2014 May 16.
Artículo en Inglés | MEDLINE | ID: mdl-24833288

RESUMEN

BACKGROUND: Retained placenta affects 0.5% to 3% of women following delivery and it is a major cause of maternal death due to postpartum haemorrhage. Usually, retained placenta has been managed by manual removal or curettage under anaesthesia, which may be associated with haemorrhage, infection and uterine perforation. Medical management to facilitate the delivery of the retained placenta could be a safe alternative avoiding surgical intervention. OBJECTIVES: To assess the effectiveness and safety of prostaglandins for the management of retained placenta. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 December 2013), LILACS (1982 to 1 December 2013), SciELO (1998 to 1 December 2013), Web of Science (2001 to 1 December 2013), openSIGLE (1997 to 1 December 2013), World Health Organization International Clinical Trials Registry Platform (ICTRP) (1 December 2013) and the metaRegister of Controlled Trials (mRCT) (1 December 2013). We also contacted authors of included studies and reviewed the reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled clinical trials comparing the use of prostaglandins (or prostaglandin analogues) with placebo, expectant management, tocolytic drugs, any other prostaglandins or surgical interventions for the management of retained placenta after vaginal delivery of singleton live infants of 20 or more weeks of gestation. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and assessed trial quality. Two review authors independently extracted data. Data were checked for accuracy. Any disagreements were resolved through consensus or consultation with a third review author when required. Authors of the included studies were contacted for additional information. MAIN RESULTS: We included three trials, involving 244 women. The studies were considered to be at high risk of bias.The prostaglandins used were PG E2 analogue (sulprostone) in 50 participants and PG E1 analogue (misoprostol) in 194 participants at a dose of 250 mcg and 800 mcg respectively. The prostaglandins compared with placebo, were not superior in reducing the rate of manual removal of placenta (average risk ratio (RR) 0.82; 95% confidence interval (CI) 0.54 to 1.27), severe postpartum haemorrhage (RR 0.80; 95% CI 0.55 to 1.15), need for blood transfusion (RR 0.72; 95% CI 0.43 to 1.22), mean blood loss (mean difference (MD) -205.26 mL; 95% CI -536.31 to 125.79, random-effects) and the mean time from injection to placental removal (MD -7.00 minutes; 95% CI -21.20 to 7.20). Side-effects were no different between groups (vomiting, headache, pain and nausea between injection and discharge from the labour ward), with the exception of shivering, which was more frequent in women receiving prostaglandins (RR 10.00; 95% CI 1.40 to 71.49). We did not obtain any data for the primary outcomes of maternal mortality and the need to add another therapeutic uterotonic. AUTHORS' CONCLUSIONS: Currently there is limited, very low-quality evidence relating to the effectiveness and the safety using prostaglandins for the management of retained placenta. Use of prostaglandins resulted in less need for manual removal of placenta, severe postpartum haemorrhage and blood transfusion but none of the differences reached statistical significance. Much larger, adequately powered studies are needed to confirm that these clinically important beneficial effects are not just chance findings.Similarly, no differences were detected between prostaglandins and placebo in mean blood loss or the mean time from injection to placental removal (minutes) or side-effects (vomiting, headache, pain and nausea between injection and discharge from the labour ward) except for 'shivering' which was more frequent in women who received prostaglandin. The included studies were of poor quality and there is little confidence in the effect estimates; the true effect is likely to be substantially different. We can not make any recommendations about changes to clinical practice. More high-quality research in this area is needed.


Asunto(s)
Abortivos no Esteroideos/uso terapéutico , Dinoprostona/análogos & derivados , Misoprostol/uso terapéutico , Oxitócicos/uso terapéutico , Retención de la Placenta/tratamiento farmacológico , Abortivos no Esteroideos/efectos adversos , Dinoprostona/efectos adversos , Dinoprostona/uso terapéutico , Femenino , Humanos , Tercer Periodo del Trabajo de Parto , Misoprostol/efectos adversos , Oxitócicos/efectos adversos , Embarazo , Prostaglandinas/efectos adversos , Prostaglandinas/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto
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