Icotinib has been previously shown to be non-inferior to gefitinib in non-selected advanced non-small-cell lung cancer patients when given as second- or further-line treatment. In this open-label, ...randomized, phase 3 CONVINCE trial, we assessed the efficacy and safety of first-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutation.
Eligible participants were adults with stage IIIB/IV lung adenocarcinoma and exon 19/21 EGFR mutations. Participants were randomly allocated (1 : 1) to receive oral icotinib or 3-week cycle of cisplatin plus pemetrexed for up to four cycles; non-progressive patients after four cycles were maintained with pemetrexed until disease progression or intolerable toxicity. The primary end point was progression-free survival (PFS) assessed by independent response evaluation committee. Other end points included overall survival (OS) and safety.
Between January 2013 and August 2014, 296 patients were randomized, and 285 patients were treated (148 to icotinib, 137 to chemotherapy). Independent response evaluation committee-assessed PFS was significantly longer in the icotinib group (11.2 versus 7.9 months; hazard ratio, 0.61, 95% confidence interval 0.43-0.87; P = 0.006). No significant difference for OS was observed between treatments in the overall population or in EGFR-mutated subgroups (exon 19 Del/21 L858R). The most common grade 3 or 4 adverse events (AEs) in the icotinib group were rash (14.8%) and diarrhea (7.4%), compared with nausea (45.9%), vomiting (29.2%), and neutropenia (10.9%) in the chemotherapy group. AEs (79.1% versus 94.2%; P < 0.001) and treatment-related AEs (54.1% versus 90.5%; P < 0.001) were significantly fewer in the icotinib group than in the chemotherapy group.
First-line icotinib significantly improves PFS of advanced lung adenocarcinoma patients with EGFR mutation with a tolerable and manageable safety profile. Icotinib should be considered as a first-line treatment for this patient population.
Abstract Objective Hepatic steatosis can cause substantial problems for both donors and recipients in living donor liver transplantation (LDLT). The aim of this study is to evaluate the accuracy of ...the magnetic resonance IDEAL (iterative decomposition of water and fat with echo asymmetry and least squares estimation) sequence in quantifying the liver fat during LDLT. Materials and Methods A total of 63 liver donors (29 men and 34 women ranging from 18 to 47 years old with a mean age of 30) who received both magnetic resonance imaging (MRI) and intraoperative liver biopsy were enrolled in this study. MR IDEAL IQ sequences were performed by 1.5-T MRI (Discovery 450; GE Healthcare, Milwaukee, Wis, United States) to estimate the liver fatty content. Accuracy was assessed through linear regression between fat fraction image and pathology grading. Sensitivity and specificity of MR IDEAL IQ fat fractions were also calculated. Results A total of 63 LDLTs were performed and with pathology grading. No fatty content was found in 48 donors (76.2%; group 1), 5% to 10% fatty liver in 11 donors (17.4%; group 2), 11% to 15% fatty liver in 2 donors (3.2%; group 3), and >16% fatty change in 2 donors (3.2%; group 4). MR IDEAL fat fraction results were excellent in prediction of the normal and fatty content and with good correlation with the pathology grading (2.9 ± 0.9, 8.3 ± 4.2, P < .0001). Linear regression between IDEAL image and pathology grading indicated a high accuracy rate ( R2 = 0.813, R2 = 0.9286) for all 4 groups. The sensitivity and specificity for detection of liver steatosis in MRI fat fraction image were 100% and 77.1% ( P < .0001, 95% confidence interval 0.000–1.000). Conclusion MR IDEAL IQ sequencing is a highly precise and accurate method in quantifying hepatic steatosis for the living donor.
The functional restoration of Brown class III maxillary defects is a challenging endeavour in oral and maxillofacial surgery. Conventional reconstruction techniques with osseous free flaps have ...certain limitations, such as the need for multiple operations and greater patient morbidity. This study introduces a single-stage computer-assisted approach for tumour resection and functional restoration of these defects using titanium mesh, zygomatic implants, and a vascularized anterolateral thigh flap (ALTF). Virtual surgical planning was used to simulate tumour resection, titanium mesh placement, and zygomatic implant insertion. Surgery was performed under the guidance of mixed reality and surgical navigation. The tumour was resected by total hemimaxillectomy, and the reconstruction was performed using a pre-bent patient-specific titanium mesh for the orbital floor and two zygomatic implants placed and exposed through tunnels in an ALTF. The ALTF survived without any perioperative complications. A fixed prosthesis with built-in titanium frame was delivered 4 months postoperatively. At the 1-year follow-up, there was no tumour recurrence, the implants were osseointegrated, and aesthetics and masticatory function were satisfactory. An occlusal force of 155 N was attained on the reconstructed side, compared to 127 N on the non-surgical side.
This review aimed at evaluating the effectiveness of reconstructive procedures for treating peri-implantitis. Searches of electronic databases and cross-referencing were performed for human ...comparative clinical trials with ≥10 implants for ≥12 months of follow-up, reporting radiographic defect fill and at least one of the following parameters: probing depth reduction, clinical attachment level gain, bleeding on probing reduction, and mucosal recession. The searches retrieved 430 citations. Only 1 randomized controlled trial was identified, which compared reconstructive therapy and open flap debridement. Case series studies were also included to evaluate the overall performance of the reconstructive procedures. Twelve studies were finally included. Meta-analysis revealed that the weighted mean radiographic defect fill was 2.17 mm (95% confidence interval CI: 1.46-2.87 mm), probing depth reduction was 2.97 mm (95% CI: 2.38-3.56 mm), clinical attachment level gain was 1.65 mm (95% CI: 1.17-2.13 mm), and bleeding on probing reduction was 45.8% (95% CI: 38.5%-53.3%). Great variability in reparative outcomes was found, attributed to patient factors, defect morphology, and reconstructive agents used. Currently, there is a lack of evidence for supporting additional benefit of reconstructive procedures to the other treatment modalities for managing peri-implantitis.
A high precision calibration of the nonlinearity in the energy response of the Daya Bay Reactor Neutrino Experiment’s antineutrino detectors is presented in detail. The energy nonlinearity originates ...from the particle-dependent light yield of the scintillator and charge-dependent electronics response. The nonlinearity model is constrained by γ calibration points from deployed and naturally occurring radioactive sources, the β spectrum from 12B decays, and a direct measurement of the electronics nonlinearity with a new flash analog-to-digital converter readout system. Less than 0.5% uncertainty in the energy nonlinearity calibration is achieved for positrons of kinetic energies greater than 1 MeV.
Elizabethkingia species are ubiquitous bacteria but uncommonly cause human infection. An outbreak of Elizabethkingia anophelis bacteraemia was observed in a respiratory care center of a tertiary ...hospital in Taiwan from 2015 to 2018.
Clinical and environmental isolates were collected for the outbreak investigation. Pulsed-field gel electrophoresis (PFGE) and complete-genome sequencing were conducted to elucidate the mechanism of transmission.
The three-year outbreak involved 26 patients with E. anophelis bacteraemia and the incidence significantly increased during the outbreak period compared with that observed from 2010 to 2014 (P<0.05). All 26 clinical isolates during the outbreak period belonged to a cluster by PFGE analysis. In contrast, the PFGE pattern was heterogeneous among comparative historical strains. Hospital tap water was highly contaminated by Elizabethkingia species (18/34, 52.9%); among that, five E. anophelis belonged to the outbreak cluster (5/18, 27.8%). As for the inanimate surface survey, 3.4% sites (4/117) revealed positive growth of E. anophelis including two from feeding tubes/bags and two from sputum suction regulators. All four isolates belonged to the outbreak clone. The outbreak strain had no apparent relationship to currently known E. anophelis strains worldwide through complete-genome sequencing analysis. Specific infection control strategies aimed at water source control and environmental disinfection were implemented subsequently and the outbreak ended in mid-2018.
A specific E. anophelis strain was identified from a three-year outbreak. The elucidation of the mechanism of dominance and intra-hospital transmission is crucial for development of corresponsive infection control policies and outbreak control.
Please cite this paper as: Chen C‐H, Xirasagar S, Lin C‐C, Wang L‐H, Kou Y, Lin H‐C. Risk of adverse perinatal outcomes with antithyroid treatment during pregnancy: a nationwide population‐based ...study. BJOG 2011;118:1365–1373.
Objective To compare, using two large nationwide population‐based data sets, the risk of adverse pregnancy outcomes (low birthweight LBW, preterm birth, small for gestational age SGA and congenital anomalies) among pregnant women with hyperthyroidism classified into three groups: receiving propylthiouracil (PTU) treatment during pregnancy, receiving methimazole/carbimazole (MMI) treatment, and no antithyroid treatment during pregnancy.
Design A matched case–control study.
Setting Taiwan.
Sample A total of 2830 mothers with hyperthyroidism and 14 150 age‐matched randomly selected mothers without hyperthyroidism were included.
Methods Conditional logistic regression analyses were performed to examine the risk of adverse pregnancy outcomes (LBW, preterm birth, SGA and major congenital anomalies) among these three groups.
Main outcome measures LBW, preterm birth, SGA and major congenital anomalies.
Results Women receiving PTU treatment during pregnancy had a higher risk of giving birth to LBW infants than those not receiving antithyroid treatment (odds ratio = 1.40; 95% CI 1.00–1.96), after adjusting for maternal education, anaemia, hyperlipidaemia, pregestational diabetes, pregestational hypertension, hyperemesis gravidarum and infant’s gender and birth order. However, children of women receiving MMI treatment did not have increased risks of any adverse fetal outcome relative to mothers not receiving antithyroid treatment.
Conclusions Our study finds an increased risk of LBW among babies of mothers with hyperthyroidism receiving PTU treatment during pregnancy relative to untreated mothers with hyperthyroidism.
This Letter reports a measurement of the flux and energy spectrum of electron antineutrinos from six 2.9 GWth nuclear reactors with six detectors deployed in two near (effective baselines 512 and 561 ...m) and one far (1579 m) underground experimental halls in the Daya Bay experiment. Using 217 days of data, 296 721 and 41 589 inverse β decay (IBD) candidates were detected in the near and far halls, respectively. The measured IBD yield is (1.55±0.04) ×10(-18) cm(2) GW(-1) day(-1) or (5.92±0.14) ×10(-43) cm(2) fission(-1). This flux measurement is consistent with previous short-baseline reactor antineutrino experiments and is 0.946±0.022 (0.991±0.023) relative to the flux predicted with the Huber-Mueller (ILL-Vogel) fissile antineutrino model. The measured IBD positron energy spectrum deviates from both spectral predictions by more than 2σ over the full energy range with a local significance of up to ∼4σ between 4-6 MeV. A reactor antineutrino spectrum of IBD reactions is extracted from the measured positron energy spectrum for model-independent predictions.
To evaluate the efficacy of stent placement in the treatment of portal vein (PV) stenosis or occlusion in living donor liver transplant (LDLT) recipients, 468 LDLT records were reviewed. Sixteen (10 ...PV occlusions and 6 stenoses) recipients (age range, 8 months–59 years) were referred for possible interventional angioplasty (dilatation and/or stent) procedures. Stent placement was attempted in all. The approaches used were percutaneous transhepatic (n = 10), percutaneous transsplenic (n = 4), and intraoperative (n = 2). Technical success was achieved in 11 of 16 patients (68.8%). The sizes of the stents used varied from 7 mm to 10 mm in diameter. In the five unsuccessful patients, long‐term complete occlusion of the PV with cavernous transformation precluded catherterization. The mean follow‐up was 12 months (range, 3–24). The PV stent patency rate was 90.9% (10/11). Rethrombosis and occlusion of the stent and PV occurred in a single recipient who had a cryoperserved vascular graft to reconstruct the PV during the LDLT operation. PV occlusion of >1 year with cavernous transformation seemed to be a factor causing technical failure. In conclusion, early treatment of PV stenosis and occlusion by stenting is an effective treatment in LDLT. Percutaneous transhepatic and transsplenic, and intraoperative techniques are effective approaches depending on the situation.
Vascular stents in management of portal venous complications: percutaneous transhepatic and transplenic and intraoperative techniques can be effective in patients with portal venous complications, depending on the situation.
This paper reports an investigation into the effects of collaborative concept mapping in a digital learning environment, in terms of students' overall learning gains, knowledge retention, quality of ...student artefacts (the collaboratively created concept maps), interactive patterns, and learning perceptions. Sixty‐four 12‐year‐old students from two 6th grade classes (32 from each class) participated in the study. Guided by the methodology of quasi‐experimental research, group scribbles 1.0 was adopted in which students carried out collaborative concept mapping activities for social studies in two different settings: (1) 1:1 (one‐device‐per‐student) – students working in pairs with one Tablet PC assigned to each of them; and (2) 1:m (one‐device‐to‐many‐students) – multiple students sharing a Tablet PC. Both settings were evaluated and the interactional patterns of the student groups' concept mapping were identified. The results indicated that in both 1:1 and 1:m settings, students had improved their learning results and retention. Nevertheless, while 1:1 groups had demonstrated more consistency in group participation, improved communication and interaction, the 1:m groups had instead generated superior artefacts as all the notes were well discussed among the group members. The findings suggest that a higher quality of collaborative processes does not necessarily lead to improved student artefacts.
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