Effect of LED therapy for the treatment nipple fissures: Study protocol for a randomized controlled trial.

INTRODUCTION: Poor positioning of the child in relation to the breast and improper suckling are the main causes of nipple fissure. Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses, and silicone nipple shields. Studies involving light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair process, and the control of pain. As it does not cause discomfort, is relatively inexpensive and may impede the discontinuation of breastfeeding, phototherapy could be a viable option for the treatment of nipple fissures. AIM: The principal objective of the proposed study is to evaluate the effectiveness of LED therapy for the treatment of nipple fissures in postpartum mothers. MATERIALS AND METHODS: One hundred patients treated with a medical diagnosis of bilateral nipple trauma classified as nipple fissures or cracks will participate in the study, randomized into 2 groups: The control group will receive orientation regarding breast care and adequate breastfeeding techniques. The experimental group will receive the same orientation and phototherapy sessions using a device developed especially for the treatment of nipple trauma. Both groups will be followed up for 6 consecutive weeks.

Effect of led photobiomodulation on analgesia during labor: Study protocol for a randomized clinical trial.

BACKGROUND: Labor pain is one of the most intense pains experienced by women, which leads to an increase in the number of women opting to undergo a cesarean delivery. Pharmacological and nonpharmacological analgesia methods are used to control labor pain. Epidural analgesia is the most commonly used pharmacological analgesia method. However, it may have side effects on the fetus and the mother. Light-emitting diode (LED) photobiomodulation is an effective and noninvasive alternative to pharmacological methods. OBJECTIVES: To evaluate the effects of LED photobiomodulation on analgesia during labor. METHODS: In total, 60 women in labor admitted to a public maternity hospital will be selected for a randomized controlled trial. The participants will be randomized into 2 groups: intervention group [analgesia with LED therapy (n = 30)] and control group [analgesia with bath therapy (n = 30)]. The perception of pain will be assessed using the visual analogue scale (VAS), with a score from 0 to 10 at baseline, that is, before the intervention. In both the groups, the procedures will last 10 minutes and will be performed at 3 time points during labor: during cervical dilation of 4 to 5 cm, 6 to 7 cm, and 8 to 9 cm. At all 3 time points, pain perception will be evaluated using VAS shortly after the intervention. In addition, the evaluation of membrane characteristics (intact or damaged), heart rate, uterine dynamics, and cardiotocography will be performed at all time points. EXPECTED OUTCOMES: The use of LED photobiomodulation will have an analgesic effect superior to that of the bath therapy.

Correlation between indoleamine 2,3 dioxygenase mRNA and CDKN2A/p16 mRNA: a combined strategy to cervical cancer diagnosis.

Cervical cancer (CC) is one of the most common cancers among women worldwide. The relation of the human papillomavirus (HPV) with CC and its precursor lesions was first suspected for over 40 years. The indoleamine 2,3 dioxygenase (IDO) is an immune modulator enzyme responsible for the immune system tissue protection mechanism, which may be the key to the tumoural persistence. HPV oncoprotein E7 promotes the increase in cyclin-dependent kinase inhibitor p16 (CDKN2A/p16). The isolated and combined analysis of CDKN2A/p16 mRNA to CC diagnosis was done with promising results. The aim of this study is to evaluate the correlation between IDO mRNA and CDKN2A/p16 mRNA. We will explore the potential of both as diagnostic tools. RNA was extracted from tissue samples. cDNA was generated with High Capacity RNA-to-cDNA kit. The real-time PCR results were analysed using nonlinear curve estimation, ROC curve, Chi-squared test, the proportion of variance explained and Galen and Gambino formulas. From 270 patients attended, colposcopy examination was performed in 110 and the biopsy in 75 patients. We found a positive correlation in patients older than 28 years old with low-risk lesions, but the correlation is lost in high-risk lesions. Although cytology, IDO mRNA and CDKN2A/p16 mRNA could not differentiate the risk groups, IDO combined with CDKN2A/p16 mRNA results could (p = 0.028). The best diagnostic result was achieved by IDO coupled with CDKN2A/p16 mRNA, which may considerably increase the sensitivity of screening for CC.

The association of p16(INK4A) and fragile histidine triad gene expression and cervical lesions.

OBJECTIVE: This cross-sectional study was intended to assess the association between immunohistochemical analysis of p16 and fragile histidine triad (FHIT) and the presence of precancerous cervical lesions. MATERIALS AND METHODS: Women seen at Pérola Byington Hospital, São Paulo, Brazil, with histologically confirmed cervicitis (n = 31), cervical intraepithelial neoplasia (CIN) 1 (n = 30), CIN 2,3 (n = 30), and cervical cancer (n = 7) had also cervical material collected for liquid-based cytology, human papillomavirus Hybrid Capture 2 (HC2) test, and p16 and FHIT immunohistochemical reactions. RESULTS: p16 and FHIT reactions were scored as the following: <1%, 1% to 5%, >5% to 25%, and >25%. Receiver operating curve analysis was used to select p16 and FHIT score cutoffs for further categorical analyses. All but one of the 37 CIN 2,3/cancer cases had a p16 score of greater than 1% to 5%. Among the 61 cervicitis/CIN 1 cases, 46 (75%) had a p16 score lower than 1% to 5%. In contrast, no association of FHIT expression and severity of cervical lesions could be demonstrated in this data set. Receiver operating curve analyses suggested the score of 1% to 5% for p16 as the cutoff that best discriminates CIN 2,3/cancer from cervicitis/CIN 1. No cutoff for FHIT scores could be suggested with data set. CONCLUSIONS: p16, but not FHIT expression, has the potential to be used as complementary diagnostic tool to investigate human papillomavirus-induced cervical lesions, if these results are confirmed in larger studies.

Introdução do Reflex Teste na Rede Pública de Saúde para as estratégias de controle das lesões neoplásicas e pré-neoplásicas do colo uterino

A opção pelo melhor método de rastreamento para lesões neoplásicas e pré-neoplásicas do colo do útero ainda é controversa. Acredita-se que, a Citologia de Base Líquida (CBL) apresenta melhor sensibilidade do que a Citologia Convencional (CC) e oferece a possibilidade do que a Captura Híbrida para HPV (HC2). O método mais utilizado atualmente, nos casos de citologia com resultado de célula de significado indeterminado (ASCUS) é chamado Reflex Teste, que combina a citologia com o HC2. Esta técnica demonstra alta efetividade para elucidar diagnósticos citológicos indeterminados. O objetivo deste estudo prospectivo realizado no Centro de Referência da Saúde da Mulher e Instituto Adolfo Lutz (São Paulo-Brasil) em pacientes de alto risco para o câncer de colo uterino foi analisar a atuação da CBL e CC, comparar os resultados do HC2 para HPV de alto risco com resultados histopatológicos e avaliar se o Reflex Teste define o diagnóstico e condutas em relação aos casos de ASCUS. Foram incluídas no estudo 1095 pacientes. Em todos os casos foram colhidas amostras para CC e CBL em tubos contendo 1 mL de UCMr - e o material residual foi usado para o HC2. Foram encontradas amostras mais adequadas com CBL do que na CC. ASCUS foi diagnosticado significantemente mais com CBL do que com CC...

Introdução do Reflex Teste na Rede Pública de Saúde para as estratégias de controle das lesões neoplásicas e pré-neoplásicas do colo uterino / Introduction of reflex test in public health assistance for strategies of control of pre neoplasic and neoplasic lesions form uterine cervix

A opção pelo melhor método de rastreamento para lesões neoplásicas e pré-neoplásicas do colo do útero ainda é controversa. Acredita-se que, a Citologia de Base Líquida (CBL) apresenta melhor sensibilidade do que a Citologia Convencional (CC) e oferece a possibilidade do que a Captura Híbrida para HPV (HC2). O método mais utilizado atualmente, nos casos de citologia com resultado de célula de significado indeterminado (ASCUS) é chamado Reflex Teste, que combina a citologia com o HC2. Esta técnica demonstra alta efetividade para elucidar diagnósticos citológicos indeterminados. O objetivo deste estudo prospectivo realizado no Centro de Referência da Saúde da Mulher e Instituto Adolfo Lutz (São Paulo-Brasil) em pacientes de alto risco para o câncer de colo uterino foi analisar a atuação da CBL e CC, comparar os resultados do HC2 para HPV de alto risco com resultados histopatológicos e avaliar se o Reflex Teste define o diagnóstico e condutas em relação aos casos de ASCUS. Foram incluídas no estudo 1095 pacientes. Em todos os casos foram colhidas amostras para CC e CBL em tubos contendo 1 mL de UCMr - e o material residual foi usado para o HC2. Foram encontradas amostras mais adequadas com CBL do que na CC. ASCUS foi diagnosticado significantemente mais com CBL do que com CC...

Screening for cervical cancer in high-risk populations: DNA pap test or Hybrid Capture II test alone?

This study was designed to evaluate whether Hybrid Capture II (HC2) test alone refer women to colposcopy as appropriately as DNA Papanicolaou (Pap) test, in the context of a high-risk group of women using the recently validated DNACitoliq LBC system. Women with suspected cervical disease were included in this cross-sectional study at a tertiary center in São Paulo, Brazil, for further workup. All women had cervical material collected for LBC and HC2 for high-risk human papillomavirus (hrHPV)-DNA test. Irrespective of cytology and HC2 results, colposcopy, and cervical biopsy when applicable, was systematically performed. All tests were performed blindly. Sensitivity, specificity, positive and negative predictive values, and overall accuracy of both methods were computed in relation to histology. A total of 1,080 women were included: 36.4% (393/1080) had ACUS+, 10.2% (110/1080) were high-grade squamous intraepithelial lesions (HSIL) or cancer. Mean age was 33.5 years. All women underwent colposcopy, and cervical biopsies were performed in 38.4% (415/1080): 33% (137/415) of the biopsies were negative, 14.4% (155/415) were low-grade squamous intraepithelial lesions (LSIL), 10.7% (116/415) were HSIL, and 0.6% (7/415) were cancer. HC2 sensitivity to diagnose biopsy-proven HSIL was 100%. Because all HSIL cases had a positive HC2 test, sensitivity could not be improved by adding LBC. Specificity and positive and negative predictive values of DNA Pap were not significantly different from HC2 test alone when considering LSIL+ histology as "gold standard" and HSIL+ histology. As a screening strategy for women with high-risk for cervical cancer, DNA Pap test does not seem to add substantially to HC2 alone in terms of appropriately referring to colposcopy.

DCS liquid-based system is more effective than conventional smears to diagnosis of cervical lesions: study in high-risk population with biopsy-based confirmation.

OBJECTIVE: To compare the performances of Papanicolaou test (PapTest) and of a new liquid-based cytology method, DNA-Citoliq System (DCS), in a high-risk population, with histology confirmation. METHODS: Paired specimens of exfoliated cervical cells were collected under split-sample protocol. All patients were submitted to colposcopy and a biopsy taken when any atypical transformation zone was seen. Sensitivity, specificity, positive and negative predictive values, and overall accuracy of both conventional and DCS methods were computed in relation to histology. RESULTS: A total of 1095 patients were analyzed by two cytology methods and, in 425 (38.8%), histologically. There were significantly more adequate samples with DCS (98.63%) than with conventional (89.6%) smears (P < 0.001). ASCUS was diagnosed significantly more with DCS than with conventional Pap (P < 0.001). Conventional Pap misclassified as normal 55.4% (158/285) of cases with either LSIL or HSIL or cancer at histology, whereas DCS misclassified 31.2% (89/285) of cases (P < 0.001). DCS had a significantly higher sensitivity (70% and 91.3%) than the conventional Pap (49.8% and 72.8%) to detect both LSIL+ and HSIL+ at histology, respectively. On the other hand, specificity of conventional smear (88.2% and 85.2%) was significantly higher than DCS (75.4% and 70.9%) considering both LSIL+ and HSIL+ at histology, respectively. CONCLUSIONS: This study confirms the superiority of the liquid-based cytology system DCS to detect cervical lesions. The rate of adequate DSC slides was significantly higher than with conventional cytology.

O impacto do diagnóstico citológico de atipias indeterminadas no sistema público de saúde / The impact of cytological diagnosis of undetermined atypias in public health system

Introdução: as alterações citológicas, de significado indeterminado representam uma importante limitação diagnóstica nos programas de escrutíneo de lesões cérvico-vaginais. A introdução de métodos biomoleculares, como o sistema de captura híbrida para detecção de HPV de alto risco contribui para a otimização da conduta clínica dessas pacientes, indicando colposcopia com precisão. Objetivo: avaliar o significado de lesões de significado indeterminado com relação à infecção pelo HPV, com o uso do teste de DNA para HPV com o método da captura de híbridos II. Métodos: foram estudadas amostras de 236 casos consecutivos examinados no laboratório da DIGENE-BRASIL, de pacientes com diagnóstico citológico prévio de ASCUS. As amostras foram submetidas ao teste de captura híbrida para identificação de DNA-HPV dc alto e baixo riscos. Resultados: dos 236 casos analisados, 183 (77,5 por cento) foram negativos para o teste de captura híbrida, seis (2,6 por cento) foram positivos para HPV de baixo risco e 47 (19,9 por cento) foram positivos para HPV de alto risco. Conclusão: as amostras positivas para HPV de baixo risco representam uma pequena e não-considerável minoria de casos, provavelmente, transientes. Cerca de 20 por cento dos casos foram positivos para HPV de alto risco e deverão ser encaminhados à colposcopia e biópsia, se necessário. Esses casos representam um grande potencial de progressão para lesões cervicais

Pap test in a high-risk population comparison of conventional and liquid-base cytology.

Liquid-based cytology (LBC) is believed to have better sensitivity than conventional smears (CSs) and offers the possibility to perform molecular assay. The goal of this work was to study the performance of CS and LBC in a high-risk population and to compare the results with the hybrid capture (HC) II for high-risk human papillomavirus (HPV). Samples were collected from selected women with clinical suspicions of low genital tract lesion at Pérola Biygnton Hospital (São Paulo, Brazil). After CS preparation, the brush was introduced in the endocervix and a new sample was collected and rinsed in the preservative medium of the system. The residual material was used to HC2. From 925 cases, LBC was unsatisfactory in 4 (1.51%) cases and CS was unsatisfactory in 100 cases (10.81%); among theses cases HC2(+) reactions was observed in 54 (54%) CSs and 3 (21.4%) LBCs. Considering cases with atypia of undetermined significance (squamous and glandular), 85 (77.27%) cases from LBC and 44 (86.4%) from CS were positive for HC2 assay for high-risk DNA-HPV. The difference among the methods was not significant (P < 0.38). The diagnosis improvement of LBC in comparison with CS was 86% in satisfactory samples, 92.76% in undetermined atypical lesions (including glandular), 83% in positive low-grade squamous intraepithelial lesions (LSIL(+)), and 86.84% in high-grade SIL(+) (HSIL(+)). HC2(+) reactions were observed in 144 CS cases and 266 LBC cases with abnormalities. Our results have showed that LBC was superior to CS in a high-risk population to detect lesions with high concordance with HC2(+) reactions; CSs also exhibit a high concordance with HC2 assay but with inferior performance to detect lesions.

Morte unifetal em gestaçäo gemelar: relato de um caso / Single fetal death in multiple gestation: report of a case

Os autores tentam revisar a ocorrência de morte unifetal e sua conduta. A morte unifetal no primeiro trimestre é relativamente comum, com poucos efeitos adversos sobre a mae e o feto sobrevivente. No segundo ou terceiro trimestre ela é mais séria, acarretando risco maior para o gemelar sobrevivente e a possibilidade de distúrbios de coagulaçao. A conduta adequada nao está estabelecida, devido à ausência de um estudo mais abrangente.