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Introduction Neovascular glaucoma is characterized by neovascularization of the iris and anterior angle chamber. Intravitreal anti-vascular endothelial growth factor agents may decrease intraocular pressure (IOP) and improve neovascularization. The VENERA study assessed the efficacy and safety of intravitreal aflibercept (IVT-AFL) in patients with neovascular glaucoma. Methods This was a 5-week, single-arm, nonrandomized, open-label, phase 3 study performed at 7 study sites in Japan that enrolled Japanese patients with anterior segment neovascularization and IOP > 25 mmHg who had not undergone (within 30 days prior), nor were imminently scheduled to undergo (within 8 days following) intraocular surgeries, including panretinal photocoagulation (PRP). Patients received background therapy plus 2 mg IVT-AFL at baseline. Background therapy with systemic IOP-lowering drugs was prohibited for 3 days before day 1 and until IOP evaluation at week 1. The primary endpoint was the change in IOP from baseline to week 1 and the secondary endpoint was the proportion of patients with an improvement of ≥ 1 grade of neovascularization of the angle (NVA) from baseline to week 1. Results Sixteen patients received treatment (full analysis set); the per-protocol set comprised 15 patients. The mean IOP decreased from 34.1 mmHg at baseline to 25.8 mmHg at week 1 (mean change, −8.3 mmHg [95% confidence interval; CI −12.2 to −4.4; P = 0.0004]). At week 1, 81.3% of patients had an improvement in the grade of neovascularization of the iris (NVI) and 50.0% of patients had an improvement in NVA grade. The proportion of patients with controlled IOP (≤ 21 mmHg) was 43.8% (95% CI 19.8–70.1) at week 1, and increased to 56.3% at week 2 and 86.7% at week 5. The most common ocular treatment-emergent adverse event was eye pain, which occurred in 4 patients (25.0%). Conclusions IVT-AFL was associated with statistically significant and clinically meaningful IOP reductions, without concomitant use of systemic IOP-lowering drugs or PRP. The safety profile was consistent with the known safety profile of IVT-AFL. These findings supplement those from the previous VEGA study, and suggest that IVT-AFL may be a potential treatment option for patients with neovascular glaucoma. Trial Registration Clinicaltrials.gov identifier NCT03639675. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-020-01580-y.

We aimed to investigate the impact of the controlling nutritional status (CONUT) score, an immuno-nutritional biomarker, on the prognosis of patients with hepatocellular carcinoma (HCC) treated with lenvatinib (LEN). This retrospective study enrolled 164 patients with HCC and treated with LEN (median age 73 years, Barcelona Clinic Liver Cancer (BCLC) stage B/C 93/71). Factors associated with overall survival (OS) were evaluated using multivariate and decision tree analyses. OS was calculated using the Kaplan&ndash, Meier method and analyzed using the log&ndash, rank test. Independent factors for OS were albumin&ndash, bilirubin grade 1, BCLC stage B, and CONUT score &lt, 5 (hazard ratio (HR) 2.9, 95% confidence interval (CI) 1.58&ndash, 5.31, p &lt, 0.001). The CONUT score was the most important variable for OS, with OS rates of 70.0% and 29.0% in the low and high CONUT groups, respectively. Additionally, the median survival time was longer in the low CONUT group than in the high CONUT group (median survival time not reached vs. 11.3 months, p &lt, 0.001). The CONUT score was the most important prognostic variable, rather than albumin&ndash, bilirubin grade and BCLC stage, in patients with HCC treated with LEN. Accordingly, immuno-nutritional status may be an important factor in the management of patients with HCC treated with LEN.

Aim: To evaluate the effect of antenatal corticosteroids (ANS) on short- and long-term outcomes in small-for-gestational age (SGA) infants. Methods: A retrospective database analysis was performed. A total of 1,931 single infants (birth weight

To evaluate the short- and long-term outcomes among very low birth weight (VLBW) preterm infants after histologic chorioamnionitis (HCA).We performed a retrospective analysis of 5849 single infants (birth weight1500 g) born at a gestational age between 22 + 0 and 33 + 6 weeks. Clinical data were obtained from the Neonatal Research Network Japan between 2003 and 2007. Multivariable logistic regression analyses were performed to assess the effect of HCA on short- and long-term outcome.According to logistic regression analysis, HCA was associated with lower incidence of respiratory distress syndrome (odds ratio [OR] = 0.54; p 0.001), increased chronic lung disease (OR = 1.68; p 0.001) and sepsis (OR = 1.71; p 0.001) and as a short-term outcomes. There was no significant association with intraventricular hemorrhage (OR = 1.11; p = 0.33), periventricular leukomalacia (OR = 1.07; p = .070) and death before discharge (OR = 0.97; p = 0.084). HCA was associated with increased home oxygen therapy (OR = 3.09; p 0.001), but not with cerebral palsy (CP; OR = 0.91; p = 0.63), develop quotient 70 (OR = 1.27; p = 0.17), visual impairment (OR = 1.08; p = 0.77), severe hearing impairment (OR = 1.28; p = 0.62) and death (OR = 0.98; p = 0.91) before three years of age.In this retrospective population-based study in Japan, HCA was not a risk factor for death, neurodevelopmental impairment and CP in VLBW three-year-old preterm infants.

To clarify the association between amniotic neutrophil elastase levels and the development of bronchopulmonary dysplasia (BPD).The database between July 2001 and December 2012 was reviewed for women with amniocentesis on admission for amniotic fluid neutrophil elastase levels and with singleton deliveries between 22 + 0 and 31 + 6 weeks of gestation. Following deliveries, placentas were examined for histologic chorioamnionitis. The peripheral blood of the neonates was analyzed for acute phase reactants.Among 294 infants, no, mild, moderate or severe BPD was observed in 126, 89, 40 and 39 infants, respectively. The medians of gestational age on admission, at premature rupture of membranes and at delivery were significantly smaller in BPD (+) when compared with BPD (-) (p 0.001). The median level of amniotic neutrophil elastase on admission was significantly greater in BPD (+) than that in BPD (-). Histologic chorioamnionitis and funisitis were both detected more frequently in BPD (+) patients than in BPD (-) patients. In a logistic regression model, the only variable that affected an increased chance of BPD was the gestational age at delivery (odds ratio, 0.58; 95% confidence interval, 0.36-0.92; p = 0.021).The level of amniotic neutrophil elastase cannot be a definitive risk factor for BPD.

Aim The aim of this study was to clarify the association between fetal heart rate (FHR) tracing interpretation levels in the second stage of labor and poor fetal acid-base balance. Material and Methods The database at one tertiary hospital in Nagoya, Japan, was retrospectively reviewed for women with singleton fetuses in cephalic presentation and vaginal labor at ≥37 + 0 gestational weeks between 1 June 2011 and 30 April 2012. Continuous FHR tracings in the second stage of labor were subdivided into 15-min intervals, each of which we called a window, from the beginning of labor through delivery, and were assessed according to the five-tier classification proposed by the Japan Society of Obstetrics and Gynecology, in which level 1 is normal, level 2 is subnormal, and levels 3–5 are abnormal patterns. Results In total, 777 parturient women were eligible for the study protocol. The numbers of women with maximal levels of 1, 2, 3, 4, and 5 were 3, 77, 341, 349, and 7, respectively. No cases of severe fetal acidosis (pH

To evaluate the effectiveness of antenatal corticosteroids (AC) therapy on outcomes of very low birthweight infants with histologic chorioamnionitis. We performed a retrospective analysis of 10,935 single infants born at a gestational age between 22 + 0 and 33 + 6 weeks and birth weight

Objective To assess the neonatal and maternal outcomes of pregnancy complicated by previable preterm premature rupture of membranes (PPROM). Design Retrospective study. Setting Tertiary referral hospital. Sample. Forty-five women having aggressive intervention with antibiotics, amnioinfusion, cerclage and tocolysis. Methods The hospital database between July 2001 and December 2009 was reviewed for women with singleton fetuses and PPROM before 23(+0) weeks of gestation. We analysed maternal and neonatal characteristics. Main outcome measures Neonatal survival without major morbidity. Results Thirty-eight infants were delivered alive and seven were stillborn. Ten infants died in the neonatal intensive care unit and one in the labor ward. Twenty-seven live-born infants survived to discharge from hospital. The survival rate of pregnancies with aggressive management was 60% (27 of 45); that of live-born infants was 71.1% (27 of 38). The median gestational age at PPROM and at delivery were significantly lower in the non-surviving group than the surviving group. Thirty-seven women (82.2%) had an amniotic neutrophil elastase level >0.15 μg/mL. Only four women (8.9%) developed clinical chorioamnionitis. Overall, 90.7% of the women showed histological evidence of chorioamnionitis. Eighty-three per cent of the surviving children had bronchopulmonary dysplasia. Nine infants had serious sequelae at a corrected age of one and a half years. Maternal complications were uncommon. Conclusions An aggressive treatment protocol for women with previable PPROM resulted in a high neonatal survival rate. Neonatal survival was associated with higher gestational age at delivery and with more frequent use of antenatal corticosteroids. The prognosis is still bad in PPROM before 22(+0) weeks of gestation.

Aim: To validate a previously developed prediction model for vaginal birth after cesarean (VBAC) using a Japanese cohort. Methods: We performed a cohort study of all term pregnant women with a vertex position, singleton gestation, and one prior low transverse cesarean delivery attempting a trial of labor between April 1985 and March 2010. Variables necessary for the prediction of successful VBAC were maternal age, pre-pregnancy body mass index, ethnicity, prior vaginal delivery, prior VBAC, and indication for prior cesarean delivery. They were extracted from medical records and put into the formula that calculates an individual woman's predicted VBAC success rate. The predicted rates were then partitioned into deciles and compared with the actual VBAC rates. The predictive ability of the model was assessed with a receiver operating characteristic and the area under the curve (AUC) was determined. Results: Seven hundred and twenty-five women who met the inclusion criteria had complete data available, of which 664 (91.6%) had VBAC. The predicted probability of VBAC, as calculated by the regression equation, was significantly higher in those who had a successful trial of labor (median 80.1%, interquartile range 71.5-88.7) than those who did not (median 69.4%, interquartile range 59.9-78.9, P

To evaluate the effect of antenatal corticosteroids (AC) therapy on short- and long-term outcomes among very low birth weight preterm infants after histologic chorioamnionitis (HCA). We performed a retrospective analysis of 5240 single very low birth weight (VLBW) infants born at 22 + 0 and 33 + 6 weeks of gestation between 2003 and 2007, who registered to the Neonatal Research Network Japan. The effects of AC therapy on mortality, neurodevelopmental outcomes at 3 years of age and neonatal morbidities were analyzed in the groups with or without HCA using logistic regression analysis. In the study subjects, 840 were with HCA, 2734 were without HCA, and 1666 were excluded without data for HCA. AC therapy was significantly associated with decreasing mortality before 3 years of age; [0.52 (0.32–0.86)], [odds ratio (95 % confidence intervals]. There were no differences between the two groups regarding neurodevelopmental outcomes, including cerebral palsy [0.90 (0.41–1.99)], development quotient

Septic shock during pregnancy is very rare but has high mortality. We report a case of septic shock in a pregnant woman with ileus, showing that severe ileus in a pregnant woman could be attributed to life-threatening septic shock and that we should give special attention to a nosocomial infection.

To evaluate the five-tier classification of fetal heart rate (FHR) tracings recently proposed by Japan Society of Obstetricians and Gynecologists (JSOG).The database between January and June 2009 was reviewed for women in active labor at ?36 + 0 gestational weeks, with singleton fetuses in cephalic presentation and with umbilical artery blood gas analyses. Continuous FHR tracings were assessed according to the five-tier classification proposed by JSOG, where level 1 is normal, level 2 is subnormal and levels 3?5 are abnormal patterns.A total of 341 parturient women were eligible for this study protocol. The median (range) of the levels in the first and the second stage of labor were 1 (1-4) and 2 (1-4), respectively (p0.001). Both pH and base excess of umbilical artery decreased with higher levels of FHR tracings interpretation (p0.01). Interventions resulting in delivery were more necessary in the first stage of labor than in the second stage of labor in cases of levels 3 and more.Five-tier system for FHR tracing interpretation proposed by JSOG intercorrelates with the fetal acid-base balance well. Categorization of FHR tracings by uniform diagnostic criteria will be useful to standardize therapeutic strategy by sharing common perception among obstetrical staff.

We report a rare case of fetal intraventricular bleeding possibly due to maternal vitamin K deficiency. A 20-year-old woman was admitted to our hospital due to impending premature delivery and loss of dietary intake at 28 weeks of gestation. Her blood examination showed metabolic alkalosis, prolonged prothrombin time, and extremely high level of plasma des-gamma-carboxyprothrombin (protein induced by vitamin K absence, PIVKA-II). Intraventricular hemorrhage was demonstrated by ultrasonography 6 days after admission. She delivered a 2,288-gram girl infant at 40 weeks of gestation. Cranial computerized tomography and magnetic resonance images obtained postnatally demonstrated a reduced cerebral parenchyma adjacent to the interior side of the right lateral ventricle and the deficit of left cerebellum. The infant’s head control was insufficient and central impaired hearing was noted at 6 months of life.

Chorioamnionitis is considered to be one of the main causes of preterm labor and has been associated with an adverse perinatal outcome in preterm infants. The controversy about the benefits/risks of delaying labor is a critical issue concerning the management of chorioamnionitis.The database between July 2001 and March 2006 was reviewed for women with singleton pregnancies between 22 and 28 weeks of gestation and with chorioamnionitis diagnosed on admission by amniotic fluid neutrophil elastase level. Women were classified according to the severity of chorioamnionitis (group A, amniotic fluid neutrophil elastase level of 0.15-1 microg/ml; B, 1-10 microg/ml; and C,or = 10 microg/ml). During expectant management, serum C-reactive protein levels monitored the remission and aggravation of chorioamnionitis. Following deliveries, placentas were examined for histologic chorioamnionitis.One hundred women were enrolled (group A, 38; B, 34; C, 28). The latency period until delivery was significantly longer in group A than in groups B and C. C-reactive protein levels just before delivery were higher than those on admission in 61% of the overall cases. Histologic chorioamnionitis and funisitis were manifested in 90.4% and 65.5%, respectively. Intrauterine fetal demise (4 cases) and neonatal and postneonatal deaths during admission (10 cases) were observed. Bronchopulmonary dysplasia was the most common major morbidity noted in groups B and C.Chorioamnionitis could be controlled but is hard to cure. Higher levels of amniotic fluid neutrophil elastase are associated with a shorter interval from admission to delivery in women with subclinical chorioamnionitis.