[Effectivity and security of vildagliptin as additional treatment for Type 2 diabetes mellitus in real-life conditions in Mexico. EDGE Study subanalysis]. / Efectividad y seguridad de vildagliptina como tratamiento adicional para la diabetes mellitus de tipo 2 (DMT2) en condiciones de vida real en México. Sub-análisis del estudio EDGE.

BACKGROUND: The multinational EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study assessed the effectiveness and tolerability of vildagliptin versus other oral antihyperglycemic drugs (OAD) when added to monotherapy in patients in the real-world setting. METHODS: Prospective, real-world observational study. The primary endpoint (PEP) was the proportion of patients achieving a reduction in HbA1c > 0.3% without peripheral edema, hypoglycemia, discontinuation, dueto gastrointestinal event, or weight gain > 5%. The secondary endpoint (SEP) was the proportion of patient achieving HbA1c < 7% (at month 12), without proven hypoglycemia or weight gain (≥ 3%). RESULTS: Of the 3,523 patients enrolled in Mexico, 2,847 were in the vildagliptin and 676 in the comparator cohort. The PEP was reached in 61.8 and 53.2% in the vildagliptin and comparator cohorts, respectively. The unadjusted odds ratio was 1.42 (95% CI: 1.19-1.68) in favor of vildagliptin. A similar advantage for vildagliptin-based therapies was seen for the SEP. The percentage was lower in the vildagliptin (n = 145; 5.0%) than in the comparator group (n = 95; 14.0%). CONCLUSION: Vildagliptin, added to a first-line OAD monotherapy, allows patients to reach target HbA1c without experiencing significant adverse events.

Placenta Accreta Spectrum Prenatal Diagnosis Performance: Are Ultrasound False-positive Results Acceptable in Limited-resources Settings?

OBJECTIVE: The immediate referral of patients with risk factors for placenta accreta spectrum (PAS) to specialized centers is recommended, thus favoring an early diagnosis and an interdisciplinary management. However, diagnostic errors are frequent, even in referral centers (RCs). We sought to evaluate the performance of the prenatal diagnosis for PAS in a Latin American hospital. METHODS: A retrospective descriptive study including patients referred due to the suspicion of PAS was conducted. Data from the prenatal imaging studies were compared with the final diagnoses (intraoperative and/or histological). RESULTS: A total of 162 patients were included in the present study. The median gestational age at the time of the first PAS suspicious ultrasound was 29 weeks, but patients arrived at the PAS RC at 34 weeks. The frequency of false-positive results at referring hospitals was 68.5%. Sixty-nine patients underwent surgery based on the suspicion of PAS at 35 weeks, and there was a 28.9% false-positive rate at the RC. In 93 patients, the diagnosis of PAS was ruled out at the RC, with a 2.1% false-negative frequency. CONCLUSION: The prenatal diagnosis of PAS is better at the RC. However, even in these centers, false-positive results are common; therefore, the intraoperative confirmation of the diagnosis of PAS is essential.

OBJETIVO: Recomenda-se o encaminhamento imediato de pacientes com fatores de risco para espectro placentário acreta (PAS, na sigla em inglês) para centros especializados, favorecendo assim o diagnóstico precoce e o manejo interdisciplinar. No entanto, erros diagnósticos são frequentes, mesmo em centros de referência (CRs). Buscou-se avaliar o desempenho do diagnóstico pré-natal para PAS em um hospital latino-americano. MéTODOS: Um estudo descritivo retrospectivo incluindo pacientes encaminhados por suspeita de SAP foi realizado. Os dados dos exames de imagem do pré-natal foram comparados com os diagnósticos finais (intraoperatórios e/ou histológicos). RESULTADOS: Foram incluídos 162 pacientes no presente estudo. A idade gestacional mediana no momento da primeira ultrassonografia suspeita de PAS foi de 29 semanas, mas as pacientes chegaram ao CR de PAS com 34 semanas. A frequência de resultados falso-positivos nos hospitais de referência foi de 68,5%. Sessenta e nove pacientes foram operadas com base na suspeita de PAS com 35 semanas e houve 28,9% de falso-positivos no CR. Em 93 pacientes, o diagnóstico de PAS foi descartado no CR, com frequência de falso-negativos de 2,1%. CONCLUSãO: O diagnóstico pré-natal de PAS é melhor no CR. Entretanto, mesmo nestes centros, resultados falso-positivos são comuns; portanto, a confirmação intraoperatória do diagnóstico de SAP é essencial.

Prenatal Diagnosis of Pfeiffer Syndrome Patient with FGFR2 C.940-1G>C Variant: A Case Report.

BACKGROUND: Pfeiffer syndrome (PS) is an autosomal dominant disorder caused by mutations in fibroblast growth factor receptor FGFR1 and FGFR2 genes, occurring in approximately 1:100,000 live births. PS has a wide range of clinical expression and severity, so early prenatal diagnosis is difficult and genetic counseling is desirable. We describe a PS newborn with her ultrasound and molecular studies. CASE REPORT: We describe a female term newborn with cloverleaf-shaped skull, facial hypoplasia, low ears, exophthalmos and wide, broad and deviated thumbs and hallux. The patient was diagnosed by ultrasound at 29 WGA and referred to a tertiary care hospital for her follow-up. Molecular test revealed a heterozygous pathogenic variant in intron 8 of the FGFR2 gene (FGFR2: c.940-1G>C). It was a de-novo mutation. At 17 days of life, craniosynostosis correction and a Lefort-III frontomaxillary advancement were performed. CONCLUSION: Pfeiffer syndrome is a devastating genetic disorder. Prenatal diagnosis according PS morphological features in prenatal ultrasound allows timely genetic counseling, early referral to third-level centers, and close follow-up in the prenatal and postnatal stages.

Maternal transfer of anti HPV 6 and 11 antibodies upon immunization with the 9-valent HPV vaccine.

BACKGROUND: This exploratory analysis was conducted to characterize the level of HPV types 6/11 antibodies in peripartum maternal blood and in cord blood of infants born to women who received 9-valent HPV (9vHPV) vaccine or quadrivalent HPV (qHPV) vaccine in a pivotal efficacy study (V503-001, NCT 00543543). METHODS: A total of 21 mother-infant pairs had evaluable HPV 6/11 results available for analysis. HPV6/11 antibodies were assessed using competitive Luminex immunoassay. The distribution of the ratios of infant to mother anti-HPV antibodies (i.e., infant-anti-HPV/mother- anti-HPV) was summarized. RESULTS: All mothers and infants were seropositive to HPV 6 and HPV 11. Anti-HPV 6/11 geometric mean titers (GMTs) in peripartum maternal blood and in cord blood of infant born to study participants were highly correlated. A 100% of infants born to seropositive mothers were also seropositive. The GMT ratios of peripartum maternal blood vs. those in cord blood were HPV 6: 1.23 [0.43, 3.49] and HPV 11: 1.29 [0.54, 3.07] in the 9vHPV vaccine group and HPV 6: 1.33 [0.41, 4.29] and HPV 11: 1.19 [0.45, 3.13] in the qHPV vaccine group, respectively. CONCLUSIONS: These results indicate that antibodies induced by the 9vHPV vaccine cross the placenta, which could potentially be beneficial against HPV6/11 infection and related disease such as recurrent respiratory papillomatosis.

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women.

BACKGROUND: A 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine. METHODS: Efficacy, immunogenicity, and safety outcomes were assessed in Latin American participants enrolled in 2 international studies of the 9vHPV vaccine, including a randomized, double-blinded, controlled with qHPV vaccine, efficacy, immunogenicity, and safety study in young women aged 16-26 years, and an immunogenicity and safety study in girls and boys aged 9-15 years. Participants (N=5312) received vaccination at Day 1, Month 2, and Month 6. Gynecological swabs were collected regularly in young women for cytological and HPV DNA testing. Serum was analyzed for HPV antibodies in all participants. Adverse events (AEs) were also monitored in all participants. RESULTS: The 9vHPV vaccine prevented HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical, vulvar, and vaginal dysplasia with 92.3% efficacy (95% confidence interval 54.4, 99.6). Anti-HPV6, 11, 16, and 18 geometric mean titers at Month 7 were similar in the 9vHPV and qHPV vaccination groups. Anti-HPV antibody responses following vaccination were higher among girls and boys than in young women. Most (>99%) 9vHPV vaccine recipients seroconverted for all 9 HPV types at Month 7. Antibody responses to the 9 HPV types persisted over 5 years. The most common AEs were injection-site related, mostly of mild to moderate intensity. CONCLUSIONS: The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Latin American young women, girls, and boys. These data support 9vHPV vaccination programs in Latin America, a region with substantial cervical cancer burden.

Placenta Accreta Spectrum Prenatal Diagnosis Performance: Are Ultrasound False-positive Results Acceptable in Limited-resources Settings? / Desempenho do diagnóstico pré-natal do espectro da placenta acreta: Os resultados falso-positivos do ultrassom são aceitáveis em ambientes com recursos limitados?

Abstract Objective The immediate referral of patients with risk factors for placenta accreta spectrum (PAS) to specialized centers is recommended, thus favoring an early diagnosis and an interdisciplinary management. However, diagnostic errors are frequent, even in referral centers (RCs). We sought to evaluate the performance of the prenatal diagnosis for PAS in a Latin American hospital. Methods A retrospective descriptive study including patients referred due to the suspicion of PAS was conducted. Data from the prenatal imaging studies were compared with the final diagnoses (intraoperative and/or histological). Results A total of 162 patients were included in the present study. The median gestational age at the time of the first PAS suspicious ultrasound was 29 weeks, but patients arrived at the PAS RC at 34 weeks. The frequency of false-positive results at referring hospitals was 68.5%. Sixty-nine patients underwent surgery based on the suspicion of PAS at 35 weeks, and there was a 28.9% false-positive rate at the RC. In 93 patients, the diagnosis of PAS was ruled out at the RC, with a 2.1% false-negative frequency. Conclusion The prenatal diagnosis of PAS is better at the RC. However, even in these centers, false-positive results are common; therefore, the intraoperative confirmation of the diagnosis of PAS is essential.

Resumo Objetivo Recomenda-se o encaminhamento imediato de pacientes com fatores de risco para espectro placentário acreta (PAS, na sigla em inglês) para centros especializados, favorecendo assim o diagnóstico precoce e o manejo interdisciplinar. No entanto, erros diagnósticos são frequentes, mesmo em centros de referência (CRs). Buscou-se avaliar o desempenho do diagnóstico pré-natal para PAS em um hospital latino-americano. Métodos Um estudo descritivo retrospectivo incluindo pacientes encaminhados por suspeita de SAP foi realizado. Os dados dos exames de imagem do pré-natal foram comparados com os diagnósticos finais (intraoperatórios e/ou histológicos). Resultados Foram incluídos 162 pacientes no presente estudo. A idade gestacional mediana no momento da primeira ultrassonografia suspeita de PAS foi de 29 semanas, mas as pacientes chegaram ao CR de PAS com 34 semanas. A frequência de resultados falso-positivos nos hospitais de referência foi de 68,5%. Sessenta e nove pacientes foram operadas com base na suspeita de PAS com 35 semanas e houve 28,9% de falso-positivos no CR. Em 93 pacientes, o diagnóstico de PAS foi descartado no CR, com frequência de falso-negativos de 2,1%. Conclusão O diagnóstico pré-natal de PAS é melhor no CR. Entretanto, mesmo nestes centros, resultados falso-positivos são comuns; portanto, a confirmação intraoperatória do diagnóstico de SAP é essencial.

Do electrocardiographic changes with adenosine myocardial perfusion imaging predict ischaemia in patients with left ventricular hypertrophy?

BACKGROUND: Electrocardiographic (ECG) changes during adenosine myocardial perfusion imaging (MPI) correlate with severe coronary artery disease and the presence of collaterals. However, the significance of these changes during adenosine MPI in patients with left ventricular hypertrophy (LVH) on baseline electrocardiogram is less well understood. OBJECTIVE: To evaluate whether ECG changes on adenosine MPI predict ischaemia in patients with LVH. METHODS: We reviewed retrospectively 454 consecutive patients who had undergone adenosine MPI at our institution. The baseline electrocardiogram was reviewed to determine whether or not LVH was present. All patients were administered adenosine at 140 microg x kg x min for a total of 6 min and Tc-sestamibi was injected at 3 min into the protocol. None of the patients underwent any form of exercise during the stress test. RESULTS: Of the 146 patients with LVH, 10 had stress ECG changes suggestive of ischaemia and 40 had evidence of ischaemia on MPI. Similarly, of the 308 patients without LVH, 43 had stress ECG changes suggestive of ischaemia and 68 had ischaemia on MPI. The sensitivity and specificity of stress ECG changes in predicting ischaemia on perfusion in patients with LVH were 12.5% and 95.3%, respectively, with a positive predictive value of 50% and a negative predictive value of 74.3%. CONCLUSION: ECG changes suggestive of ischaemia in patients with LVH are very specific for ischaemia on MPI, and their significance is similar to that in patients without LVH.

A Comparative in Vitro Study of Apical Microleakage with Five Obturation Techniques: Lateral Condensation, Soft-Core®, Obtura II®, Guttaflow® and Resilon®.

AIM: A comparison was made between the root canal lateral condensation technique and other condensation techniques in which physical (temperature: Soft-Core®, Obtura II®) or chemical changes (condensation: Guttaflow®, Resilon®) may affect the dimensional stability of obturation and thus favor apical microleakage. MATERIALS AND METHODS: A total of 212 single-root teeth removed for orthodontic or periodontal reasons were randomized to 5 groups of 40 teeth each. Six samples were used as positive controls, and another 6 as negative controls. The teeth were worked with the Hero 642 system, and each group was obturated using a different technique: lateral condensation, Obtura II®, Soft-Core®, Guttaflow® or Resilon®. The samples were immersed in black ink, and after 72 hours the teeth were transparentized using the technique described by Robertson. Filtration of the ink was measured under the stereoscopic microscope. Analysis of variance and post-hoc testing were used for the statistical analysis. RESULTS: The Soft-Core® obturated group showed significantly greater microleakage than the other groups, with no differences among the rest of the groups. CONCLUSIONS: Under the conditions of this study, the teeth obturated with the Soft-Core® technique showed greater apical microleakage than the other systems.

Patología vulvar en pacientes post-menopáusicas del Hospital militar: un tamizaje con test de Collins

Objetivo: Identificar el tipo de frecuencia de la patología vulvar en pacientes post-menopáusicas, sintomáticas o no, que consultaron al HMC. Evaluar la sensibilidad y especifidad del test de Collins. Determinar la correlación clínico diagnóstico-patológica de la vulva. Material y Metodos: Tuvimos 73 pacientes remitidos a "Clínica de Vulva" a las cuales se les practicó Test de Collins y Biopsia dirigida, enviando este material a análisis histopatológico. Resultados:La edad de las pacientes osciló entre 45 y 73 años, con promedio de 53.3. El síntoma predominante fue prurito (50.5); asintomáticas (23 por ciento) y otros (26.5 por ciento). Las lesiones encontradas clasificadas como levantadas y no levantadas (69.86 por ciento), y sin lesión 9.5 por ciento. El diagnóstico histopatológico fue: lesiones Malignas (2.7 por ciento) discriminadas así: Carcinoma escamocelular infiltrante e In Situ, las lesiones no neoplásicas:(97.3 por ciento): Liquen escleroso (1.4 por ciento) Hiperplasia de células escamosas (2.7 por ciento) y otras dermatosis (93.2 por ciento). De éstas: Eccema, Liquenificación, Liquen simple, Condiloma. Para el test de Collins obtuvimos: sensibilidad de 33 por ciento y una especificidad no medible. Conclusiones: la patología maligna de la vulva es poco frecuente. Dentro de los trastornos no neoplásicos encontramos varios que deben ser de conocimiento para el Ginecólogo con miras a un tratamiento específico. El Test de Collins es útil para el diagnóstico de patología maligna vulvar no así para transtornos no neoplásicos