Τετάρτη 4 Νοεμβρίου 2020

Effects of Yinzhihuang Granules on Serum Liver Enzymes in Jaundice Patients: A Real-World Study Based on HIS Data

Alexandros G.Sfakianakis shared this article with you from Inoreader

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Objective. Our aim was to analyze the influence of Yinzhihuang granules on serum liver enzymes in jaundice patients and to provide real-world evidence for the efficacy evaluation of Yinzhihuang granules in treating jaundice. Methods. We constructed a data warehouse which integrates real-world electronic medical records from the hospital information system of multiple 3A hospitals in China and used a descriptive statistical method to analyze the changes in the serum liver enzymes of the jaundice patients treated with Yinzhihuang granules and then used Wilcoxon signed-rank to test the changes in the indicators caused by the treatment. Results. After being treated with Yinzhihuang granules, the jaundice patients had a decrease in the average serum levels of total bilirubin, indirect bilirubin, aspartate amino transferase, glutamyl transpeptidase, and alkaline phosphatase, and the differences were statistically significant () but had no significant changes in the average serum levels of direct bilirubin and alanine aminotransferase ().Conclusion. The data analysis on the real-world electronic medical records demonstrate that Yinzhihuang granules help to reduce jaundice patients' serum levels of total bilirubin, indirect bilirubin, aspartate aminotransferase, glutamyl transpeptidase, and alkaline phosphatase, but there is no evidence that Yinzhihuang granules help to reduce the jaundice patients' serum levels of direct bilirubin and alanine aminotransferase.
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Palbociclib Plus Exemestane with GnRH Agonist versus Capecitabine in Premenopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer: A Prospective, Open-Label, Randomized Phase ll Trial (KCSG-BR 15-10)

Alexandros G.Sfakianakis shared this article with you from Inoreader
Μέσω Cancers

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Cancers, Vol. 12, Pages 3265: Patient-Reported Outcomes of Palbociclib Plus Exemestane with GnRH Agonist versus Capecitabine in Premenopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer: A Prospective, Open-Label, Randomized Phase ll Trial (KCSG-BR 15-10)

Cancers doi: 10.3390/cancers12113265

Authors: Soohyeon Lee Seock-Ah Im Gun Min Kim Kyung Hae Jung Seok Yun Kang In Hae Park Jee Hyun Kim Kyoung Eun Lee Hee Kyung Ahn Moon Hee Lee Hee-Jun Kim Han Jo Kim Jong In Lee Su-Jin Koh Yeon Hee Park

In the era of CDK4/6 inhibitors in hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, few trials have been specifically studied to compare quality of life between palbociclib plus endocrine therapy (ET) and cytotoxic chemotherapy exclusively in premenopausal women. We aimed to evaluate differences of patient report outcomes (PROs) between palbociclib plus ET and capecitabine. PROs were assessed using EORTC QLQ-C30 at baseline, every 6 weeks, and the end of treatment. All EORTC QLQ-30 scores were maintained from baseline to the end of treatment. Patients treated palbociclib plus ET arm experienced delay in time-to-deterioration of physical functioning (HR = 0.58, 95% CI, 0.36 to 0.84, p = 0.0058), nausea and vomiting (HR = 0.48; 95% CI, 0.32 to 0.73, p = 0.0005), and diarrhea (HR = 0.42; 95% CI, 0.27 to 0.65, p = 0.001). There was a numeric trend for worsening of insomnia (HR = 1.43; 95% CI, 0.96 to 2.16, p = 0.079) and favoring of appetite loss (HR = 0.69, 95 % CI, 0.44 to 1.07, p = 0.09) in the palbociclib plus ET arm. Premenopausal patients with palbociclib plus ET maintained QoL without compromising treatment efficacy.

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Effectiveness of Perindopril/Indapamide Single-Pill Combination in Uncontrolled Patients with Hypertension: A Pooled Analysis of the FORTISSIMO, FORSAGE, ACES and PICASSO Observational Studies

Alexandros G.Sfakianakis shared this article with you from Inoreader

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Abstract

Introduction

Our objective was to determine the effectiveness of a perindopril/indapamide (Per/Ind) single-pill combination (SPC) in a broad range of patient profiles, including subgroups with varying hypertension severity, age and cardiovascular risk profiles.

Methods

Patient data from four large prospective observational studies (FORTISSIMO, FORSAGE, PICASSO, ACES) were pooled. In each study, patients already treated for hypertension were switched to Per/Ind 10/2.5 mg SPC and systolic and diastolic blood pressure (SBP/DBP) measured at the 1-month (M1) and 3-month (M3) visits. Study endpoints included change in SBP and DBP from baseline to M1 and M3 and the percentage of patients achieving BP control (SBP/DBP < 140/90 mmHg for patients without diabetes or < 140/85 mmHg for patients with diabetes).

Results

A total of 16,763 patients were enrolled and received Per/Ind (94% received the full dose of 10/2.5). Mean patient age was 61.4 years (36% were ≥ 65 years old), 57% were women, and 16% had isolated systolic hypertension (ISH). Mean baseline office SBP/DBP was 162/94 mmHg, and mean duration of hypertension was 11 years. Cardiovascular risk factors and comorbid conditions were common in this population. Significant mean reductions in SBP (− 23 mmHg) and DBP (− 11 mmHg) were observed at M1 compared with baseline (P < 0.001), which were maintained at M3 (− 30 mmHg and − 14 mmHg, respectively). At M3, BP control was achieved by 70% of patients (78% for ISH). In patients with SBP ≥ 180 mmHg at baseline (grade III hypertension), the mean SBP/DBP decrease was − 51/− 20 mmHg and 53% achieved BP control. Per/Ind was well tolerated with an overall rate of adv erse events of 1.3%, most frequently cough and dizziness at rates of 0.3% and 0.2%, respectively.

Conclusion

In this hypertensive population including difficult-to-control patient subgroups, switching to Per/Ind 10/2.5 mg SPC led to rapid and important reductions in BP. BP control was achieved in 70% of patients overall in an everyday practice context.

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Cinacalcet as a First-Line Treatment in Neonatal Severe Hyperparathyroidism Secondary to Calcium Sensing Receptor (CaSR) Mutation

Alexandros G.Sfakianakis shared this article with you from Inoreader
Introduction: Neonatal severe hyperparathyroidism (NSHPT) is a rare cause of neonatal hypercalcemia caused by a loss of function mutation in the calcium-sensing receptor (CaSR). Hypercalcemia in NSHPT can be life-threatening. Maintenance of serum calcium within a safe range is the primary goal of treatment through hydration, forced diuresis, and bisphosphonate treatment, nevertheless most cases require parathyroidectomy. We report a case with NSHPT diagnosed on the first day of life (DoL) and successfully treated with cinacalcet as the first-line treatment from the 2nd DoL up to the age of 18 months. Case Report: A full-term baby evaluated for weight loss at postnatal 14th hour and found to have hypercalcemia (14.4 mg/dL, reference range [RR]: 8.0–11.3). Despite hydration and diuresis, hypercalcemia persisted. Further evaluation revealed a parathyroid hormone (PTH) level of 1,493 pg/mL (RR: 15–65) and urine Ca/Cr of 0.09 mg/mg (RR: 0.03– 0.81). Cinacalcet treatment was initiated on the 2nd DoL with the diagnosis of NSHPT due to hypocalciuric hypercalcemia and elevated PTH level. Ca levels decreased to normal levels on the 7th DoL. She was discharged from hospital at postnatal day 15 on cinacalcet treatment and still continued at 18 months of age. Sequencing of CaSR revealed a novel homozygous c.1836G#x3e;A (p.G613E) mutation in the patient, for which the parents and sister were heterozygous. Conclusion: This case represents the youngest age at cinacalcet initiation and the longest duration without parathyroidectomy in a homozygous NSHPT and demonstrates that cinacalcet is an effective first-line treatment in patients who are responsive to this treatment modality and allows avoiding/delay in surgical intervention in NSHPT.
Horm Res Paediatr
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Assessment of D-Shaped Annulus of Mitral Valve in Patients with Severe MR Using Semi-Automated 4-Dimensional Analysis: Implications for Transcatheter Interventions

Alexandros G.Sfakianakis shared this article with you from Inoreader

JCDD, Vol. 7, Pages 48: Assessment of D-Shaped Annulus of Mitral Valve in Patients with Severe MR Using Semi-Automated 4-Dimensional Analysis: Implications for Transcatheter Interventions

Journal of Cardiovascular Development and Disease doi: 10.3390/jcdd7040048

Authors: N. Mai Vo Suzanne E. van Wijngaarden Nina Ajmone Marsan Jeroen J. Bax Victoria Delgado

The development of transcatheter mitral valve replacement therapies requires accurate post-processing analysis tools to provide D-shaped mitral annulus dimensions from 3-dimensional (3D) data. The agreement between two semi-automated, software packages to process 3D transesophageal echocardiography (TEE) data for the measurement of the mitral valve annulus dimensions was evaluated. 3DTEE data of patients with moderate&ndash;severe mitral regurgitation (MR) were postprocessed with semi-automated, vendor-independent (VI) software and vendor-specific (VS) software. Both post-processing software provided key measurements for the selection of transcatheter valve prosthesis size: annulus area, annulus circumference and the septal-to-lateral distance of the annulus. The intertrigonal distance was provided only by the VS software. The inter- and intra-observer agreements were assessed with Bland&ndash;Altman analysis. Of 105 patients (63.8 &plusmn; 11 years, 66% male) with MR , 28 had secondary MR, 45 fibroelastic deficiency, and 32 Barlow&rsquo;s disease. Using VS software, the dimensions for the overall population were 16.1 &plusmn; 4.6 cm2 for annulus area, for circumference 14.4 &plusmn; 1.9 cm, intertrigonal distance 3.4 &plusmn; 0.5 cm and septal-to-lateral distance 3.8 &plusmn; 0.6 cm. Similar dimensions were obtained using VI software: 15.7 &plusmn; 4.6 cm2 for annulus area, 14.5 &plusmn; 2.0 cm for circumference, and 4.1 &plusmn; 0.6 cm for septal-to-lateral distance. The inter- and intra-observer agreement for both software programs was excellent. In conclusion, current post-processing software programs for 3DTEE data of the mitral valve annulus provide good reproducibility of key measurements to select the transcatheter prosthesis size.

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Anatomy of Mitral Valve Complex as Revealed by Non-Invasive Imaging: Pathological, Surgical and Interventional Implications

Alexandros G.Sfakianakis shared this article with you from Inoreader

JCDD, Vol. 7, Pages 49: Anatomy of Mitral Valve Complex as Revealed by Non-Invasive Imaging: Pathological, Surgical and Interventional Implications

Journal of Cardiovascular Development and Disease doi: 10.3390/jcdd7040049

Authors: Laura Anna Leo Vera Lucia Paiocchi Susanne Anna Schlossbauer Elisa Gherbesi Francesco F. Faletra

Knowledge of mitral valve (MV) anatomy has been accrued from anatomic specimens derived by cadavers, or from direct inspection during open heart surgery. However, today two-dimensional and three-dimensional transthoracic (2D/3D TTE) and transesophageal echocardiography (2D/3D TEE), computed tomography (CT) and cardiac magnetic resonance (CMR) provide images of the beating heart of unprecedented quality in both two and three-dimensional format. Indeed, over the last few years these non-invasive imaging techniques have been used for describing dynamic cardiac anatomy. Differently from the &ldquo;dead&rdquo; anatomy of anatomic specimens and the &ldquo;static&rdquo; anatomy observed during surgery, they have the unique ability of showing &ldquo;dynamic&rdquo; images from beating hearts. The &ldquo;dynamic&rdquo; anatomy gives us a better awareness, as any single anatomic arrangement corresponds perfectly to a specific function. Understanding normal an atomical aspects of MV apparatus is of a paramount importance for a correct interpretation of the wide spectrum of patho-morphological MV diseases. This review illustrates the anatomy of MV as revealed by non-invasive imaging describing physiological, pathological, surgical and interventional implications related to specific anatomical features of the MV complex.

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The Mesenchymal Cap of the Atrial Septum and Atrial and Atrioventricular Septation

Alexandros G.Sfakianakis shared this article with you from Inoreader

JCDD, Vol. 7, Pages 50: The Mesenchymal Cap of the Atrial Septum and Atrial and Atrioventricular Septation

Journal of Cardiovascular Development and Disease doi: 10.3390/jcdd7040050

Authors: Ray Deepe Emily Fitzgerald Renélyn Wolters Jenna Drummond Karen De Guzman Maurice J.B. van den Hoff Andy Wessels

In this publication, dedicated to Professor Robert H. Anderson and his contributions to the field of cardiac development, anatomy, and congenital heart disease, we will review some of our earlier collaborative studies. The focus of this paper is on our work on the development of the atrioventricular mesenchymal complex, studies in which Professor Anderson has played a significant role. We will revisit a number of events relevant to atrial and atrioventricular septation and present new data on the development of the mesenchymal cap of the atrial septum, a component of the atrioventricular mesenchymal complex which, thus far, has received only moderate attention.

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Muscularization of the Mesenchymal Outlet Septum during Cardiac Development

Alexandros G.Sfakianakis shared this article with you from Inoreader

JCDD, Vol. 7, Pages 51: Muscularization of the Mesenchymal Outlet Septum during Cardiac Development

Journal of Cardiovascular Development and Disease doi: 10.3390/jcdd7040051

Authors: Maurice J. B. van den Hoff Andy Wessels

After the formation of the linear heart tube, it becomes divided into right and left components by the process of septation. Relatively late during this process, within the developing outflow tract, the initially mesenchymal outlet septum becomes muscularized as the result of myocardialization. Myocardialization is defined as the process in which existing cardiomyocytes migrate into flanking mesenchyme. Studies using genetically modified mice, as well as experimental approaches using in vitro models, demonstrate that Wnt and TGF&beta; signaling play an essential role in the regulation of myocardialization. They also show the significance of the interaction between cardiomyocytes, endocardial derived cells, neural crest cells, and the extracellular matrix. Interestingly, Wnt-mediated non-canonical planar cell polarity signaling was found to be a crucial regulator of myocardialization in the outlet septum and Wnt-mediated canonical &beta;-catenin signaling is an essential r egulator of the expansion of mesenchymal cells populating the outflow tract cushions.

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Survey on Physicians’ Knowledge and Training Needs in Genetic Counseling

Alexandros G.Sfakianakis shared this article with you from Inoreader
Background: In recent years, germline testing of women with a risk of developing breast and ovarian cancer has increased rapidly. This is due to lower costs for new high-throughput sequencing technologies and the manifold preventive and therapeutic options for germline mutation carriers. The growing demand for genetic counseling meets a shortfall of counselors and illustrates the need to involve the treating clinicians in the genetic testing process. This survey was undertaken to assess their state of knowledge and training needs in the field of genetic counseling and testing. Methods: A cross-sectional survey within the European Bridges Study (Breast Cancer Risk after Diagnostic Gene Sequencing) was conducted among physician members (n = 111) of the German Cancer Society who were primarily gynecologists. It was designed to examine their experience in genetic counseling and testing. Results: Overall, the study revealed a need for training in risk communication and clinical recommendations for persons at risk. One-third of respondents communicated only relative disease risks (31.5%) instead of absolute disease risks in manageable time spans. Moreover, almost one-third of the respondents (31.2%) communicated bilateral and contralateral risk-reducing mastectomy as an option for healthy women and unilateral-diseased breast cancer patients without mutations in high-risk genes (e.g. BRCA1 or BRCA2). Most respondents expressed training needs in the field of risk assessment models, the clinical interpretation of genetic test results, and the decision-making process. Conclusion: The survey demonstrates a gap of genetic and risk literacy in a relevant proportion of physicians and the need for appropriate training concepts.
Breast Care
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Therapy Algorithms for the Diagnosis and Treatment of Patients with Early and Advanced Breast Cancer

Alexandros G.Sfakianakis shared this article with you from Inoreader
Background: In order to offer optimal treatment approaches based on available evidence, the Commission Breast of the Working Group Gynecologic Oncology (AGO) of the German Cancer Society developed therapy algorithms for eight complex treatment situations in primary and advanced breast cancer. Summary: Therapy algorithms for the following complex treatment situations are outlined in this paper: (neo)adjuvant therapy of human epidermal growth factor receptor 2 (HER2)-positive breast cancer; axillary surgery and neoadjuvant chemotherapy; adjuvant endocrine therapy in premenopausal patients; adjuvant endocrine therapy in postmenopausal patients; hormone receptor (HR)-positive/HER2-negative metastatic breast cancer: strategies; HR-positive/HER2-negative metastatic breast cancer: endocrine-based first-line treatment; HER2-positive metastatic breast cancer: first to third-line; metastatic triple-negative breast cancer. Key Messages: The therap y options shown in these algorithms are based on the current AGO recommendations updated in January 2020 but cannot represent all evidence-based treatment options. Prior therapies, performance status, comorbidities, patient preference, etc. must be taken into account for the actual treatment choice. Therefore, in individual cases, other evidence-based treatment options not listed here may also be appropriate and justified.
Breast Care
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Multistage Latissimus Dorsi Flap with Implant for Complex Post-Mastectomy Reconstruction: An Old but Still Current Technique

Alexandros G.Sfakianakis shared this article with you from Inoreader
Introduction: The latissimus dorsi (LD) flap has been used for reconstructing mastectomy defects since the early 1900s. Although its popularity has declined over the last decades, it still retains an important role in breast reconstruction. We present our recent experience with the multistage LD flap and implant for extremely complex post-mastectomy defects. Patients and Methods: Between 2011 and 2020, 42 consecutive patients underwent post-mastectomy LD reconstruction with an expander (STAGE 1). Some of them received prior fat-grafting of the mammary region (STAGE 0). All patients were scheduled for an expander-definitive implant change (STAGE 2). Some of them completed the program with fat-grafting, nipple and areola reconstruction, and other refinements (STAGE 3 or 4). Results: Two patients underwent fat-grafting at STAGE 0. Mean age at STAGE 1 was 46.7 years, mean BMI was 23.6, 14.4% of the patients were smokers, and 21.4% had comor bidities. Immediate reconstructions were performed in 35.7% and delayed in 64.3%. Mean surgical time at STAGE 1 was 194.7 min for delayed reconstructions and 242.3 min for immediate ones. Mean hospital stay for STAGE 1 procedures was 3.8 days; all other STAGES were performed as ambulatory surgery. No flap necrosis was observed and only 1 patient required a surgical revision for bleeding. Dorsal seroma occurred in 45.2% of cases. Conclusions: The multistage LD flap with implant is a useful and safe tool within the reconstructive armamentarium for post-mastectomy defects. It combines multiple simple procedures and does not require specific skills and surgical training (level of evidence 4).
Breast Care
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