The ESG performance influence mechanism analysis-based on empirical analysis.

ESG has emerged as a prominent method for evaluating enterprises, gaining increasing importance in recent years. It assesses a company's ability to promote sustainable economic development and fulfill its social responsibilities, encompassing three non-financial dimensions: environmental, social, and corporate governance. Regulatory authorities, industry associations, and investment institutions worldwide have placed growing emphasis on a company's ESG performance. From the perspective of career concern, this study conducted a multiple regression analysis using data from Chinese A-share companies listed in Shanghai and Shenzhen from 2011 to 2020. It used CEO shareholding and CEO political affiliation as moderating variables to examine the impact of CEO career concerns on the corporate environment, society, and corporate governance performance. Empirical testing of whether CEO career concerns promote or suppress the ESG performance in enterprises. The findings of this study reveal that CEOs with heightened career concerns tend to impede the ESG performance of their respective enterprises. Additionally, CEO shareholding and political affiliations exert a negative moderating influence on the relationship between CEO career concerns and ESG performance. This research significantly extends the investigation into factors influencing ESG performance, offering fresh perspectives that could inform improved CEO oversight, foster corporate transformation, and enhance ESG performance.

Effects of Bacillus coagulans TBC169 on gut microbiota and metabolites in gynecological laparoscopy patients.

Objective: The primary objective of this study is to investigate the mechanism by which Bacillus coagulans TBC169 accelerates intestinal function recovery in patients who have undergone gynecological laparoscopic surgery, using metabolomics and gut microbiota analysis. Methods: A total of 20 subjects were selected and randomly divided into two groups: the intervention group (n = 10) receiving Bacillus coagulans TBC169 Tablets (6 pills, 1.05 × 108 CFU), and the control group (n = 10) receiving placebos (6 pills). After the initial postoperative defecation, fecal samples were collected from each subject to analyze their gut microbiota and metabolic profiles by high-throughput 16S rRNA gene sequencing analysis and untargeted metabonomic. Results: There were no statistically significant differences observed in the α-diversity and ß-diversity between the two groups; however, in the intervention group, there was a significant reduction in the relative abundance of unclassified_Enterobacteriaceae at the genus level. Furthermore, the control group showed increased levels of Holdemanella and Enterobacter, whereas the intervention group exhibited elevated levels of Intestinimonas. And administration of Bacillus coagulans TBC169 led to variations in 2 metabolic pathways: D-glutamine and D-glutamate metabolism, and arginine biosynthesis. Conclusion: This study demonstrated that consuming Bacillus coagulans TBC169 after gynecological laparoscopic surgery might inhibit the proliferation of harmful Enterobacteriaceae; mainly influence 2 pathways including D-glutamine and D-glutamate metabolism, and arginine biosynthesis; and regulate metabolites related to immunity and intestinal motility; which can help regulate immune function, maintain intestinal balance, promote intestinal peristalsis, and thus accelerate the recovery of intestinal function.

Solid-State Anion Exchange Enabled by Pluggable vdW Assembly for In Situ Halide Manipulation in Perovskite Monocrystalline Film.

The fabrication of perovskite single crystal-based optoelectronics with improved performance is largely hindered by limited processing techniques. Particularly, the local halide composition manipulation, which dominates the bandgap and thus the formation of heterostructures and emission of multiple-wavelength light, is realized via prevalent liquid- or gas-phase anion exchange with the utilization of lithography, while the monocrystalline nature is sacrificed due to polycrystalline transition in exchange with massive defects emerging, impeding carrier separation and transportation. Thus, a damage-free and lithography-free solid-state anion exchange strategy, aiming at in situ halide manipulation in perovskite monocrystalline film, is developed. Typically, CsPbCl3 working as medium to deliver halide is van der Waals (vdW) assembled to specific spots of CsPbBr3, followed by the removal of CsPbCl3 after anion exchange, with the halide composition in contact area modulated and monocrystalline nature of CsPbBr3 preserved. CsPbBr3-CsPbBrxCl3-x monocrystalline heterostructure has been achieved without lithography. Device based on the heterostructure shows apparent rectification behavior and improved photo-response rate. Heterostructure arrays can also be constructed with customized medium crystal. Furthermore, the halide composition can be accurately tuned to enable full coverage of visible spectra. The solid-state exchange enriches the toolbox for processing vulnerable perovskite and paves the way for the integration of monocrystalline perovskite optoelectronics.

Edge-by-Edge Lateral Heterostructure through Interfacial Sliding.

van der Waals heterostructures (vdWHs) based on two-dimensional (2D) semiconductors have attracted considerable attention. However, the reported vdWHs are largely based on vertical device structure with large overlapping area, while the realization of lateral heterostructures contacted through 2D edges remains challenging and is majorly limited by the difficulties of manipulating the lateral distance of 2D materials at nanometer scale (during transfer process). Here, we demonstrate a simple interfacial sliding approach for realizing an edge-by-edge lateral contact. By stretching a vertical vdWH, two 2D flakes could gradually slide apart or toward each other. Therefore, by applying proper strain, the initial vertical vdWH could be converted into a lateral heterojunction with intimately contacted 2D edges. The lateral contact structure is supported by both microscope characterization and in situ electrical measurements, exhibiting carrier tunneling behavior. Finally, this approach can be extended to 3D thin films, as demonstrated by the lateral 2D/3D and 3D/3D Schottky junction.

Safety analysis of immediate breast reconstruction with a deep inferior epigastric perforator (DIEP) flap in the post-COVID-19 era: a comparison between pre- and post-pandemic cohorts.

Background: The demand for immediate breast reconstruction with a deep inferior epigastric perforator (DIEP) flap is recovering as coronavirus disease 2019 (COVID-19) transitions from a pandemic to an endemic. This study sought to evaluate the safety of resuming DIEP flap reconstruction in the post-COVID-19 era. Methods: Consecutive breast cancer patients who underwent immediate breast reconstruction with a DIEP flap at the Comprehensive Breast Health Center, Ruijin Hospital were retrospectively included in the study. The patients were divided into a post-pandemic group (Group A) and a pre-pandemic group (Group B). The clinicopathological factors, surgical procedures, and rates of post-operative complications were compared between the two groups using the Mann-Whitney U test and Chi-squared test. Results: A total of 167 patients were included in the study, of whom 119 (71.3%) were in Group A and 48 (28.7%) were in Group B. The two groups had similar clinicopathological features, including age (P=0.988), body mass index (P=0.504), and tumor, node, metastasis (TNM) stage (P=0.932). The Group A patients were more likely to receive single perforator DIEP flap transplantation than the Group B patients (n=28, 22.8% vs. n=3, 5.8%, P=0.007). There was a numerical decrease in the mean operating time of Group A patients compared to Group B patients (9.82 vs. 10.12 hours, P=0.172). The mean length of stay after the surgery was significantly shorter after the pandemic than before the pandemic (11.2 vs. 14.3 days, P<0.001). The complication rates between the two groups were similar. Conclusions: This study provides evidence that resuming DIEP reconstruction is safe in the post-COVID-19 era.

Pd Clusters Loaded with Multivalent Cu Foam for Superior Electrochemical Nitrate Reduction and Selective N≡N Bond Formation.

The electrochemical denitrification of nitrate (NO3 - ) in actual wastewater to nitrogen (N2 ) is an effective approach to reversing the current imbalance of the nitrogen cycle and the eutrophication of water. However, electrostatic repulsion between NO3 - and the cathode results in the low efficiency of NO3 - reduction reaction (NO3 RR). Here, density functional theory (DFT) calculations are used as a theoretical guide to design a Pd cluster-loaded multivalent Cu foam (Pd/Cu2 O-CF) electrocatalyst, which achieves a splendid 97.8% NO3 - removal rate, 97.9% N2 selectivity, 695.5 mg N g-1 Pd h-1 reduction efficiency, and 60.0% Faradaic efficiency at -1.3 V versus SCE. The projected density of states (pDOS) indicates that NO3 - and Pd/Cu2 O-CF are bonded via strong complexation between the O 2p (in NO3 - ) and Cu 3d (in Cu2 O) with the input of voltage, which reduces the electrostatic repulsion and enhances the enrichment of NO3 - on the cathode. In-situ characterizations demonstrate that Pd[H] can reduce Cu2 O to Cu, and subsequently Cu reduces NO3 - to nitrite (NO2 - ) accompanied by in situ reconfiguration of multivalent Cu foam. NO2 - is then transferred to the surface of Pd clusters by the cascade catalysis and accelerates the breaking of N─O bonds to form Pd─N, and eventually achieves the N≡N bond formation.

Epitaxy of a Monocrystalline CsPbBr3 -SrTiO3 Halide-Oxide Perovskite p-n Heterojunction with High Stability for Photodetection.

Perovskite heterojunctions are essential components of perovskite optoelectronics, but their construction and investigation have been impeded by the instability and severe anion interdiffusion. This work epitaxially deposits p-type CsPbBr3 on n-type Nb:SrTiO3 (STO) to construct a functional perovskite heterojunction with high stability. The lattice match allows epitaxial growth of CsPbBr3 to occur over large scale, resulting in a monocrystalline thin film with excellent crystallinity and uniformity. The highly stable STO prevents the anion migration frequently happening in halide perovskites, forming a sharp interface of two perovskite with opposite conduction type, with which a diode is fabricated and a current rectification ratio of 374 is obtained. The diode is able to work as a photodetector with dark current of 2.01 × 10-12 A at -1 V and responsivity (R) of 8.26 A W-1 , rendering a detectivity (D*) of 2.98 × 1013 Jones. Owing to the all-inorganic architecture, effective photoresponse at temperature as high as 150 °C is guaranteed with D* of ≈1.52 × 1013 Jones. Combining the unique optoelectrical properties of halide perovskite and the rigidity of oxide perovskite, the epitaxy of CsPbBr3 on n-type STO opens up a new method to construct functional perovskite heterojunction for optoelectronics.

Comparation of time-course, dose-effect, influencing factors and adverse events of biologics in the treatment of adults with moderate to severe plaque psoriasis.

Introduction: Biologics is used for treating moderate to severe plaque psoriasis (MSPP), which represent one of the foremost therapeutic advancements in disease of dermatology. Up to now, the relative efficacy and safety across approved andinvestigational biologics for MSPP is still unclear. Methods: This study aimed to comparative effectiveness of various biological treatments for MSPP measured by PASI75, PASI90 and PASI100 (The ratio of patients whose Psoriasis Area and Severity Index score (PASI) decreased by ≥ 75%, 90% and 100% compared with baseline, respectively). In addition, random models were used together with a Bayesian method to compare direct and indirect Adverse Events (AEs) of biologics with placebo, to make probabilistic statements and predictions on their AEs. The analytic data set was made up of summarized data from 54 trials, including 27,808 patients, with treatment of 17 biologics. Three mathematic models with nonparametric placebo evaluations were established to characterize the longitudinal direction profile for the three efficacy measures as above mentioned. Results: Our results showed significant differences among treatments. Bimekizumab, sonelokimab, and ixekizumab were found to be the most effective treatments among the biologics. The effects of covariate were further evaluated, patients' age, body weight, duration of disease and percentage of patients previously treated with a biological therapy showed impact on the efficacy. In addition, we found that ixekizumab and risankizumab displayed relatively stable as for efficacy and safety. Discussion: Our findings provide valuable insights into the comparative effectiveness and safety of biologics for MSPP treatment. These results may aid in clinical decision-making and ultimately improve patient outcomes.

Transient Receptor Potential Channel Vanilloid 1 Contributes to Facial Mechanical Hypersensitivity in a Mouse Model of Atopic Asthma.

Sensitive skin, a common pathophysiological feature of allergic diseases, is defined as an unpleasant sensation in response to stimuli that normally should not provoke such sensations. However, the relationship between allergic inflammation and hypersensitive skin in the trigeminal system remains to be elucidated. To explore whether bronchial allergic inflammation affects facial skin and primary sensory neurons, we used an ovalbumin (OVA)-induced asthma mouse model. Significant mechanical hypersensitivity was observed in the facial skin of mice with pulmonary inflammation induced by OVA sensitization compared to mice treated with adjuvant or vehicle as controls. The skin of OVA-treated mice showed an increased number of nerve fibers, especially rich intraepithelial nerves, compared to controls. Transient receptor potential channel vanilloid 1 (TRPV1)-immunoreactive nerves were enriched in the skin of OVA-treated mice. Moreover, epithelial TRPV1 expression was higher in OVA-treated mice than in controls. Trigeminal ganglia of OVA-treated mice displayed larger numbers of activated microglia/macrophages and satellite glia. In addition, more TRPV1 immunoreactive neurons were found in the trigeminal ganglia of OVA-treated mice than in controls. Mechanical hypersensitivity was suppressed in OVA-treated Trpv1-deficient mice, while topical skin application of a TRPV1 antagonist before behavioral testing reduced the reaction induced by mechanical stimulation. Our findings reveal that mice with allergic inflammation of the bronchi had mechanical hypersensitivity in the facial skin that may have resulted from TRPV1-mediated neuronal plasticity and glial activation in the trigeminal ganglion.

Developing Chinese race-specific warfarin dose prediction algorithms.

BACKGROUND: Numerous genotype-guided warfarin dosing algorithms have been developed to individualize warfarin doses, but they can only explain 47-52% of the variability. AIM: This study aimed to develop new warfarin algorithms suitable to predict the stable warfarin dose for the Chinese population and to compare their prediction performance with those of the most commonly used algorithms. METHOD: Multiple linear regression analysis with the warfarin optimal dose (WOD), logarithm (log) WOD, 1/WOD, and [Formula: see text], respectively, as the dependent variables were performed to deduce a new warfarin algorithm (NEW-Warfarin). WOD was the stable dose that maintained the international normalized ratio (INR) within the target range (2.0-3.0). Three major genotype-guided warfarin dosing algorithms were selected and compared against NEW-Warfarin predictive performance using the mean absolute error (MAE). Furthermore, patients were divided into five groups according to warfarin indications [atrial fibrillation (AF), pulmonary embolism (PE), cardiac-related disease (CRD), deep vein thrombosis (DVT), and other diseases (OD)]. Multiple linear regression analyses were also performed for each group. RESULTS: The regression equation with [Formula: see text] as the dependent variable had the highest coefficient of determination (R2 = 0.489). The NEW-Warfarin had the best predictive accuracy compared to the three algorithms selected. Group analysis, according to indications, showed that the R2 of the five groups were PE (0.902) > DVT (0.608) > CRD (0.569) > OD (0.436) > AF (0.424). CONCLUSION: Dosing algorithms based on warfarin indications are more suitable for predicting warfarin doses. Our research provides a novel strategy to develop indication-specific warfarin dosing algorithms to improve the efficacy and safety of warfarin prescribing.

State Recognition of Multi-Nozzle Electrospinning Based on Image Processing.

The online monitoring of a multi-jet electrospinning process is critical to the achievement of stable mass electrospinning for industrial applications. In this study, the construction of an ejection state recognition system of a multi-jet electrospinning process based on image processing is reported. The ejection behaviors regarding multi-nozzle electrospinning were recorded by CMOS industrial cameras in real time. The characteristic information regarding the multi-jet cone tip was obtained by processing the images regarding Roberts operator edge detection, Hough transform line detection, and mask histogram analysis. The jet anomalies of the hanging droplets in the nozzle outlet area could be obtained and identified by the vision. The identification accuracy towards the target hanging droplets was more than 85%. This work reports the intelligent control of large-scale multi-nozzle electrospinning equipment.

Increased GLUT1 expression and localization to Golgi apparatus of acinar cells in the parotid gland of Goto-Kakizaki diabetic rats.

OBJECTIVE: Patients with diabetes are known to have high salivary glucose levels. But the mechanisms are still unclear. We hypothesized that the topological changes of glucose transporters affect the salivary glucose level. METHODS: We used adult Goto-Kakizaki (GK) rats, an animal model of advanced diabetes, and Wistar rats as a control, with or without glucose load. The sections of salivary glands from the animals were processed for standard histological, immunohistochemical, and immunofluorescent staining. RESULTS: Parotid acinar cells of GK rats appeared like mucous filled with low-eosin-stained granules and possessing a flat nucleus located basally, whereas those of Wistar rats appeared as a typical serous gland with eosin-rich cytoplasm and a spherical nucleus. Cytoplasmic granules of GK rat parotid acinar cells showed no reaction of polysaccharide staining. In acinar cell cytoplasm of GK rats, intense GLUT1 immunoreactivity was observed compared to Wistar rats. By double immunostaining for GLUT1 and Golgi apparatus-specific markers, it was determined that GLUT1 was localized to the Golgi apparatus. By glucose loading in starved GK rats, the distribution of GLUT1-immunoreactive signals was spread out clearly from the apical side of the nucleus to the basolateral side. CONCLUSIONS: In rat model of diabetes, highly localized GLUT1 at Golgi apparatus in acinar cells seems to increase taking up cytoplasmic glucose to form exocytotic vesicles. This phenomenon may transform parotid glands from serous to mucous-like and result in saccharide-rich saliva.

Glaucoma in rural China (the Rural Epidemiology for Glaucoma in China (REG-China)): a national cross-sectional study.

OBJECTIVE: This study aimed to investigate the prevalence of glaucoma with associated factors in the rural populations of 10 provinces in China. DESIGN: A population-based cross-sectional study. METHODS: All participants aged 6 years or older from 10 provinces completed visual acuity testing, slit-lamp examination, ophthalmoscopy and non-contact tonometry. Glaucoma suspects underwent fundus photography, Goldmann applanation tonometry, visual field testing and gonioscopy. Glaucoma was determined according to the International Society of Geographical and Epidemiological Ophthalmology classification scheme. Associations of demographics and medical factors with glaucoma were assessed using multiple logistic regression models. RESULTS: From June 2017 to October 2018, 48 398 of 52 041 participants were included in the final analyses. The age-standardised prevalence of glaucoma was 1.7% (95% CI 1.55% to 1.78%) among the participants older than 6 years, which was 2.1% (95% CI 1.93% to 2.23%) in participants aged over 40 years. The constituent ratios of glaucoma were: 44.4% primary angle-closure glaucoma (PACG), 34.7% primary open-angle glaucoma, 2.6% congenital glaucoma and 18.3% other types of glaucoma. Increasing age, smoking, cerebral stroke, type 2 diabetes, higher education (college or more) and higher personal income were significant risk factors for PACG. The unilateral and bilateral blindness rates in the entire study population were 4.692% and 1.068%, respectively. A family history of glaucoma was a significant risk factor for the prevalence of glaucoma and blindness in at least one eye. CONCLUSIONS: Rural populations have a high prevalence of glaucoma, which should be included in chronic disease management programmes in China for long-term care.

Association of tumor immune microenvironment profiling and 21-gene recurrence assay in early breast cancer patients.

INTRODUCTION: Tumor immune microenvironment (TIME) plays a vital role in breast cancer development, treatment resistance, and prognosis. This study evaluates the association of TIME profiling and 21-gene recurrence score (RS) in early Luminal breast cancer patients. METHODS: ER+ /HER2-, pN0 breast cancer patients with available RS results who received surgery between January 2009 and December 2013 were enrolled. TIME markers, including stromal tumor infiltrating lymphocytes (TILs), CD3, CD4, CD8, and tumor PD-L1 expression, were comprehensively analyzed. Association of TIME markers with RS, as well as their correlation with breast cancer-specific survival (BCSS) were tested. RESULTS: Overall, 385 patients were included, of whom 341 (88.6%) had TILs ≤10%. TIME markers were positively but moderately correlated with each other (Spearman r 0.28-0.53, all P < 0.05). Continuous RS showed a weak correlation with continuous TILs, CD3, CD8, and PD-L1. Regarding single gene mRNA level in the 21-gene RS panel, higher expression of TIME markers was related to lower ER group genes expression, but higher proliferation and invasion group genes level. After a median follow-up of 91.67 (range 5.03-134.03) months, TILs (P = 0.049) and PD-L1 (P = 0.034) were inversely associated with BCSS. CONCLUSIONS: Breast cancer TIME markers, including TILs, CD3, CD4, CD8, and PD-L1, were correlated with 21-gene RS score. Lower expression of ER group genes, as well as higher expression of proliferation and invasion group genes were associated with a higher level of these TIME markers, warranting further exploration.

Axilla lymph node dissection can be safely omitted in patients with 1-2 positive sentinel nodes receiving mastectomy: a large multi-institutional study and a systemic meta-analysis.

PURPOSE: This study aimed to evaluate whether axillary lymph node dissection (ALND) can be omitted in patients with 1-2 positive sentinel lymph nodes (SLNs) who received total mastectomy (TM). METHODS: Consecutive breast cancer patients with 1-2 positive SLNs were retrospectively reviewed from a multi-institutional database. Patients were divided into sentinel lymph node biopsy (SLNB) group and ALND group. Administration of adjuvant chemotherapy and survival were compared between groups. To further verify the results, a meta-analysis was also conducted. RESULTS: Among the 1161 enrolled patients, 893 (76.9%) received ALND and 268 (23.1%) underwent SLNB alone. Administration of chemotherapy was comparable between the two groups (91.1% vs. 90.6%, P = 0.798), which was consistent in TM (P = 0.638) and BCS cohort (P = 0.576). After a median follow-up of 36 months, no significant difference was observed between the two groups in recurrence-free survival (P = 0.583) regardless of surgery of breast. During further meta-analysis, 13 out of 4733 relative studies reported the association of axillary surgery and disease-free survival (DFS) or overall survival (OS) in 1-2 positive SLNs patients. Pooled analysis showed no difference in adjusted DFS (HR 0.84, 95% CI 0.70-1.02) or OS (HR 1.02, 95% CI 0.93-1.11) between SLNB and ALND groups. Survival benefit of ALND remained non-significant after restricting the analysis in four studies with patients only receiving BCS, or in three studies with patients only receiving TM. CONCLUSION: Further ALND does not impact adjuvant chemotherapy administration or disease outcome in breast cancer patients with 1-2 positive SLNs treated with TM.

Diatomic Pd-Cu Metal-Phosphorus Sites for Complete N≡N Bond Formation in Photoelectrochemical Nitrate Reduction.

The synergistic effect of bimetallic heterogeneous catalysis in the reaction of nitrate reduction to nitrogen has been widely discussed, but it is still not clear how this effect works at the atomic scale, hindering the rational design of high-performance catalysts. Here, for the first time, 2D phosphorene was used as a giant P ligand to confine high-density PdCu dual-atom to form a unique PdCuP4 coordination structure, and this catalyst achieves 96.3 % NO3 - removal rate and 95.2 % N2 selectivity. In situ characterization combined with density functional theory (DFT) calculations show that the PdCu dual-atom form covalent-like bonds with adjacent P atoms, reducing the adsorption energy of the reactants. The synergistic effect of PdCu dual-atom promotes the breaking of N-O bond, and the short bond length of ≈3 Šbetween PdCu atoms accelerates the transfer of NO2 - , and eventually the two Pd-N adjacent to the surface of Pd rapidly combine to form N2 .

Association of 21-gene recurrence score and locoregional recurrence in early breast cancer patients.

BACKGROUND: The 21-gene recurrence score (RS) assay has been validated to predict the risk of disease-free survival in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer patients. However, its relation with locoregional recurrence (LRR) risk is unclear. OBJECTIVE: This study aimed to explore the ability of RS to predict LRR risk. METHODS: Consecutive ER-positive, HER2-negative, pT1, pN0-1, and M0 early breast cancer patients were analyzed retrospectively. According to RS, patients were divided into low- (RS < 18), intermediate- (RS 18-30), and high-risk (RS ⩾ 31) groups. The primary endpoint was LRR. Subgroup analysis was conducted according to different nodal statuses and surgery types. RESULTS: A total of 1558 patients were enrolled: 354 (22.7%), 788 (50.6%), and 416 (26.7%) patients in the low-, intermediate-, and high-risk groups, respectively. The median follow-up time was 53 months, and 2, 8, and 14 LRR events were observed in the low-, intermediate-, and high-risk groups, respectively (P= 0.004). Both univariate (P= 0.009) and multivariate (P= 0.010) analyses demonstrated that 21-gene RS was correlated with LRR. Compared to low-risk patients, high-risk patients were at greater risk of LRR (HR 5.75, 95% CI 1.30-25.31, P= 0.021). Among pN0 (P= 0.033), pN1 (P= 0.049) and postmastectomy patients (P= 0.012), 21-gene RS remained predictive of the risk of LRR. CONCLUSION: The 21-gene RS assay was significantly associated with the risk of LRR in ER-positive, HER2-negative early breast cancer patients. Among patients with different nodal statuses and patients receiving mastectomy, RS remained predictive of the risk of LRR.

Bacillus coagulans TBC169 probiotics for the recovery of intestinal function after gynecological laparoscopic surgery: a randomized, placebo-controlled trial.

BACKGROUND: Evidence suggests that Bacillus coagulans TBC169 can improve intestinal motility. AIM: To investigate the effectiveness and safety of Bacillus coagulans TBC169 probiotics in promoting the recovery of intestinal function after gynecological laparoscopic surgery. METHOD: Patients who underwent laparoscopic surgeries due to gynecological diseases were randomly assigned to the high-dose, conventional-dose, and the placebo-control groups (1:1:1 ratio). The primary outcome was the time to the first passage of flatus time (FFT). Secondary outcomes were the time to the first defecation (FDT), the time to the first bowel sounds (TFBS), the duration of hospital stay (DHS), and the incidence of postoperative adverse events (AEs). RESULTS: Compared to the placebo-control group, shorter FFT values were observed in the conventional-dose (23.15 h vs. 29.10 h, P < 0.05) and high-dose (19.15 h vs. 29.10 h, P < 0.001) groups. Similar trends were observed regarding TFBS in the conventional-dose (18.50 h vs. 21.10 h, P < 0.05) and high-dose (15.20 h vs. 21.10 h, P < 0.001) groups. There were no significant differences in FFT and TFBS between the intervention groups. Compared to the placebo-control group, lower incidences of postoperative adverse events were observed in the conventional-dose (12.50% vs. 40.00%, P < 0.05) and the high-dose (5.00% vs. 40.00%, P < 0.001) groups. However, there were no significant differences between these intervention groups. CONCLUSION: Bacillus coagulans TBC169 probiotics can accelerate intestinal function recovery, and reduce postoperative adverse events in patients after gynecological laparoscopic surgery. The study protocol was registered at the Chinese Clinical Trial Registry (ChiCTR2200059518).

The Comparative Safety of Epirubicin and Cyclophosphamide versus Docetaxel and Cyclophosphamide in Lymph Node-Negative, HR-Positive, HER2-Negative Breast Cancer (ELEGANT): A Randomized Trial.

Background: In adjuvant settings, epirubicin and cyclophosphamide (EC) and docetaxel and cyclophosphamide (TC) are both optional chemotherapy regimens for lymph node-negative, hormone receptor (HR)-positive, human epidermal receptor 2 (HER2)-negative breast cancer patients. Neutropenia is one of the most common adverse events (AEs) of these regimens. The rate of grade 3−4 neutropenia varies in different studies, and direct comparisons of safety profiles between EC and TC are lacking. Method: ELEGANT (NCT02549677) is a prospective, randomized, open-label, noninferior hematological safety trial. Eligible patients with lymph node-negative HR+/HER2-tumors (1:1) were randomly assigned to received four cycles of EC (90/600 mg/m2) or TC (75/600 mg/m2) every three weeks as adjuvant chemotherapy. The primary endpoint was the incidence of grade 3 or 4 neutropenia defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 on an intention-to-treat basis. Noninferiority was defined as an upper 95% CI less than a noninferiority margin of 15%. Results: In the intention-to-treat population, 140 and 135 patients were randomized into the EC and TC arms, respectively. For the primary endpoint, the rate of grade 3 or 4 neutropenia is 50.71% (95% CI: 42.18%, 59.21%) in the EC arm and 48.15% (95% CI: 39.53%, 56.87%) in the TC arm (95%CI risk difference: −0.100, 0.151), showing the noninferiority of the EC arm. For secondary endpoints, the rate of all-grade anemia is higher in the EC arm (EC 42.86% versus TC 22.96%, p = 0.0007), and more patients suffer from nausea/vomiting, hair loss, and nail changes (p < 0.01) in the EC arm. No statistically different disease-free survival was observed between the two arms (p = 0.13). Conclusion: EC is not inferior to TC in the rate of grade 3 or 4 neutropenia, but more other AEs were observed in the EC group.