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Background: Radiation therapy has become an important treatment for many malignant tumours after surgery and for palliative tumour care. Although modern radiotherapy technology is constantly improving, radiation damage to normal tissues is often difficult to avoid, and radiation-induced skin injury (RSI) is a common complication, manifested as skin erythema, peeling, ulceration, and even bone and deep organ damage, seriously affect the quality of life for patients. Basic research and clinical trials related to RSI have achieved certain results, while no researchers have conducted comprehensive bibliometric studies. Objective: A comprehensive bibliometric analysis of publications on RSI published between 2004 and 2023 was conducted to identify current hotspots and future directions in this area of study. Methods: RSI-related publications published between January 1, 2004, and December 31, 2023, were retrieved from the Web of Science Core Collection (WoSCC) database for analysis using VOSviewer and CiteSpace analytics. Results: A total of 1009 publications on RSI from 2004 to 2023 were included in the WoSCC database. The United States had the highest productivity with 299 papers, accounting for 29.63% of the total production, followed by China with 193 papers (19.13%) and Japan with 111 papers (11.00%). In terms of research institutions and journals, the University of Toronto and Journal of Supportive Care in Cancer published the highest number of papers. Professor Edward Chow published the most articles, while Professor Shuyu Zhang was the most cited. The top ten most-cited papers focused on the pathogenesis, prevention, and management of RSI. Keyword co-occurrence analysis and the top 25 keywords with the strongest citation bursts suggest that current research focuses on the pathogenesis, prevention, and treatment management of RSI. Conclusion: This study conducted a systematic bibliometric analysis of RSI publications from 2004 to 2023; identified the trends in RSI publications, major research countries, major research institutions, major research journals, major research authors, and major research keywords; and revealed the future development direction and research hotspots of this field. This study provides a valuable reference for future RSI research.

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Severe burns related to fires and explosions of lithium-ion batteries of electric motorcycles have not been reported to date. We retrospectively studied 419 patients admitted to our burn intensive care unit from January 2016 to December 2021. Of these 419 patients, 26 (22 male, 4 female; median age, 42 years) had burns related to lithium-ion battery fires and explosions, and all of their injury characteristics were similar to those of traditional flame burns. Lithium-ion battery-related burns were the eighth most common cause of burn injuries among all hospitalized patients. The 26 patients comprised 10 unemployed and 16 employed individuals. Twenty-three patients were injured at home during the battery charging process, and three were injured outdoors (one by a fire while the electric motorcycle was stationary and the others two by a fire while riding the motorcycle). The burn sites were distributed over the whole body; the burn area ranged from 10 % to 100 % of the total body surface area, and the burn depth ranged from superficial second-degree burns to third-degree burns. Twenty-three patients had inhalation injuries, and ten underwent prophylactic tracheostomy and intubation. Multiple operations were required for wound repair. Although convenient, lithium-ion electric motorcycles can also cause severe burns. To prevent these injuries, we must increase public safety awareness and education, develop new battery energy storage systems and battery management systems, and ensure the safety of batteries. Consumers should be aware of the potential dangers of lithium-ion batteries and comply with related security measures.

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In children with large soft tissue defects of the foot and ankle, it is difficult to cover the wound completely using a local skin flap, and skin grafting of the donor area for repair causes secondary damage. Free skin flaps require good vascular anastomoses and are prone to vascular crises. The authors evaluated the effectiveness and safety of cross-inguinal flaps for the repair of large soft tissue defects of the foot and ankle in children. The records of 15 children who underwent cross-groin flap transplantation between June 2017 and June 2021 were analyzed retrospectively. All the flaps survived without infection, necrosis, or other complications. The flap shape was good, the donor area was sutured directly, and the damage was minimal. This surgical method is simple, effective, and safe and can replace microsurgery, making it suitable for use in primary-level hospitals that are not equipped for microscopic surgery.

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Chronic wounds have gradually evolved into a global health challenge, comprising long-term non-healing wounds, local tissue necrosis, and even amputation in severe cases. Accordingly, chronic wounds place a considerable psychological and economic burden on patients and society. Chronic wounds have multifaceted pathogenesis involving excessive inflammation, insufficient angiogenesis, and elevated reactive oxygen species levels, with bacterial infection playing a crucial role. Hydrogels, renowned for their excellent biocompatibility, moisture retention, swelling properties, and oxygen permeability, have emerged as promising wound repair dressings. However, hydrogels with singular functions fall short of addressing the complex requirements associated with chronic wound healing. Hence, current research emphasises the development of multifunctional antibacterial hydrogels. This article reviews chronic wound characteristics and the properties and classification of antibacterial hydrogels, as well as their potential application in chronic wound management.

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The anatomic position of the patella is superficial, making it vulnerable to injuries. Treatment of patella infection after internal fixation surgery remains a big challenge due to minimal soft tissue coverage and vital tissue exposure. Forty-two patients aged 10 to 59 years were admitted to the institution's burn unit between January 2010 and December 2019. Each presented with infection after patellar fracture surgery. Twenty-seven infections were superficial, whereas 15 were deep with pyogenous arthritis of the knee. Negative pressure wound therapy (NPWT) was applied after radical debridement to remove necrotic subcutaneous tissues and internal fixation devices. In addition, cases with septic arthritis were irrigated continuously with normal saline. After 5 to 10 days of NPWT treatment and irrigation, wound infection was well controlled. Afterward, 42 wounds were resurfaced with pedicled flaps, the 42 patients received 17 reverse-flow anterolateral thigh (ALT) perforator flap, 12 medial sural artery perforator flaps, 7 gastrocnemius musculocutaneous flaps, as well as 6 saphenous artery flaps. Thirty-seven flaps survived uneventfully. However, 3 flaps developed venous congestion in the distal end. Two flaps developed tip necrosis. All patients were followed up between 3 and 48 months. Infection beneath the flap occurred in 3 patients and healed after an additional debridement surgery. The staged NPWT and flap surgery strategy focus on thorough debridement and immediate internal fixation devices removal, effective fracture fixation, efficient NPWT application, targeted administration of antibiotics, and adequate soft tissue coverage. This study established that the procedure was effective in infection control after patellar internal fixation surgery.

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Type III electrical burns on the wrist are characterized by circumferential wounds, three dimensional with sandwich-like necrosis, and progressive blood circulation disturbances. Limb salvage is challenging, and success in meeting this challenge depends on vascular reconstruction and wound coverage. This article is intended for the following purposes: to investigate the principles of wound debridement, the management of involved blood vessels, and the clinical effects of the extended paraumbilical perforator flap pedicled with the inferior epigastric artery for coverage of type III circumferential electrical burns of the wrist. A total of 13 male patients (age, 20 to 43 years; average, 29 years) were enrolled in the study. After early escharotomy, debridement, and vascular reconstruction, all wounds were repaired with the extended paraumbilical perforator flap pedicled with the inferior epigastric artery. Flap survival was achieved in all 13 patients. Subcutaneous liquefaction necrosis and infection beneath the flap occurred in three patients. Radial or ulnar artery reconstruction via the great saphenous vein (GSV) graft was performed in 12 cases. All patients had a mean follow-up of 6 to 36 months, and the flaps demonstrated satisfactory flexibility and texture. Hand function was preserved in eight patients, and no patients developed abdominal hernia. Thorough debridement, early vascular reestablishment, and wound coverage are essential for the overall limb salvage effort for type III circumferential electrical burns of the wrist. The extended paraumbilical perforator flap may provide a new and appropriate option for the primary repair of extensive soft tissue defects.

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With the coverage of sensor-rich smart devices (smartphones, iPads, etc.), combined with the need to collect large amounts of data, mobile crowd sensing (MCS) has gradually attracted the attention of academics in recent years. MCS is a new and promising model for mass perception and computational data collection. The main function is to recruit a large group of participants with mobile devices to perform sensing tasks in a given area. Task assignment is an important research topic in MCS systems, which aims to efficiently assign sensing tasks to recruited workers. Previous studies have focused on greedy or heuristic approaches, whereas the MCS task allocation problem is usually an NP-hard optimisation problem due to various resource and quality constraints, and traditional greedy or heuristic approaches usually suffer from performance loss to some extent. In addition, the platform-centric task allocation model usually considers the interests of the platform and ignores the feelings of other participants, to the detriment of the platform's development. Therefore, in this paper, deep reinforcement learning methods are used to find more efficient task assignment solutions, and a weighted approach is adopted to optimise multiple objectives. Specifically, we use a double deep Q network (D3QN) based on the dueling architecture to solve the task allocation problem. Since the maximum travel distance of the workers, the reward value, and the random arrival and time sensitivity of the sensing tasks are considered, this is a dynamic task allocation problem under multiple constraints. For dynamic problems, traditional heuristics (eg, pso, genetics) are often difficult to solve from a modeling and practical perspective. Reinforcement learning can obtain sub-optimal or optimal solutions in a limited time by means of sequential decision-making. Finally, we compare the proposed D3QN-based solution with the standard baseline solution, and experiments show that it outperforms the baseline solution in terms of platform profit, task completion rate, etc., the utility and attractiveness of the platform are enhanced.

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Background and Objectives: Osteoporosis is characterized by low bone mass and high bone fragility. Findings regarding the association of coffee and tea intake with osteoporosis have been inconsistent. We conducted this meta-analysis to investigate whether coffee and tea intake is associated with low bone mineral density (BMD) and high hip fracture risk. Materials and Methods: PubMed, MEDLINE, and Embase were searched for relevant studies published before 2022. Studies on the effects of coffee/tea intake on hip fracture/BMD were included in our meta-analysis, whereas those focusing on specific disease groups and those with no relevant coffee/tea intake data were excluded. We assessed mean difference (MD; for BMD) and pooled hazard ratio (HR; for hip fracture) values with 95% confidence interval (CI) values. The cohort was divided into high- and low-intake groups considering the thresholds of 1 and 2 cups/day for tea and coffee, respectively. Results: Our meta-analysis included 20 studies comprising 508,312 individuals. The pooled MD was 0.020 for coffee (95% CI, -0.003 to 0.044) and 0.039 for tea (95% CI, -0.012 to 0.09), whereas the pooled HR was 1.008 for coffee (95% CI, 0.760 to 1.337) and 0.93 for tea (95% CI, 0.84 to 1.03). Conclusions: Our meta-analysis results suggest that daily coffee or tea consumption is not associated with BMD or hip fracture risk.

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The use of electric bicycles (e-bikes) has increased in China. Alongside this increased use of e-bikes, reports of injuries related to e-bikes have also increased. However, few studies have explored electrical burns from short circuits in e-bike batteries, especially among children. Our study aimed to describe the epidemiology and prognosis of e-bike-related electrical flash burns in children. This retrospective analysis examined the injury patterns and prognosis of flash burn injuries from e-bike batteries among children presenting to the emergency department of a hospital in northern China from 2009 to 2020. Data collected included demographics, mechanism of injury, time of injury, injury site, burn depth, healing time, and patient prognosis. During the study period, 82 children presented to our emergency department with these injuries (boys: n = 64, 78%; girls: n = 18, 22%). The children's mean age was 3.5 (2.5) years. Burns occurred in all months of the year but peaked from May to August (spring and summer). Most burns were to the fingers. All burns were minor injuries that healed within 2 weeks with wound care. With the growing popularity of e-bikes, electric flash burns among children caused by e-bike batteries are increasingly common. Doctors should be aware of this special injury type to offer the correct diagnosis and treatment and provide parents with appropriate information.

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China has been reported as the world's largest carbon emitter, facing a tough challenge to meet its carbon peaking goal by 2030. Reducing the carbon intensity of energy-intensive industries (EIICI) is a significant starting point for China to achieve its emission reduction targets. To decompose the overall target into regions, understanding the spatiotemporal differences and drivers of carbon intensity is a solid basis for the scientific formulation of differentiated regional emission reduction policies. In this study, the spatiotemporal differences of EIICI are described using the panel data of 30 provinces in China from 2000 to 2019, and a spatial econometric model is further adopted to analyze its drivers. As indicated by the results: (1) from 2000 to 2019, China's EIICI tended to be reduced continuously, and the spatial differences at the provincial and regional levels expanded continuously, thus revealing the coexistence of "high in the west and low in the east" and "high in the north and low in the south" spatial patterns. (2) There is a significant spatial autocorrelation in the EIICI, characterized by high and high agglomeration and low and low agglomeration types. Moreover, the spatial spillover effects are denoted by a 1% change in the local EIICI, and the adjacent areas will change by 0.484% in the same direction. (3) Technological innovation, energy structure, and industrial agglomeration have direct and indirect effects, thus affecting the local EIICI and the adjacent areas through spatial spillover effects. Economic levels and firm sizes only negatively affect the local EIICI. Environmental regulation merely has a positive effect on adjacent areas. However, the effect of urbanization level on EIICI has not been verified, and the effect of urbanization level on the EIICI has not been verified. The results presented in this study show a scientific insight into the reduction of EIICI in China. Furthermore, policymakers should formulate differentiated abatement policies based on dominant drivers, spatial effects, and regional differences, instead of implementing similar policies in all provinces.

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BACKGROUND: One of the procedures for treating chronic osteomyelitis is the management of dead space resulting from aggressive débridement of the marrow cavity. To fill the void created by débridement, various muscle flaps have been recommended by many surgeons for their convenience and antiinfective properties. The objective of this study was to evaluate the efficacy of island perforator muscle flaps for the reconstruction of chronic osteomyelitis débridement defects of the lower extremities and provide indications for the selection of the muscle flap. METHODS: A retrospective review of consecutive patients with chronic osteomyelitis of the lower extremities who underwent reconstruction using the island perforator muscle flap procedure from 2015 through 2018 was conducted. Data were collected on characteristics of the patients, wound site, wound size, surgical procedure, muscle choice, and wound healing. RESULTS: For the 21 patients included in the study, all muscle flaps survived. Wounds healed completely within 4 weeks. No infection relapses were identified during the follow-up period of at least 12 months. Simple primary closure, with no additional incision in the donor site, was achieved in five patients. In eight patients, an additional incision was made to harvest a muscle flap, but both the wound and donor site were closed primarily. CONCLUSION: The results showed that the island perforator muscle flap is less invasive, easy to harvest, and effective, and can be a good choice for the management of dead space resulting from débridement for chronic osteomyelitis in the lower extremity. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

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BACKGROUND: We found by accident that stem cells could still be isolated from adipose tissue stored for 14 days in sealed tubes, which was distinct from previous protocols. The morphology of these hypoxia-tolerant stem cells also differs from that of conventional adipose-derived stem cells (ADSCs). In this study, we aim to define the newly found subsets. MATERIALS AND METHODS: Stem cells were isolated from adipose tissue that was aspirated immediately or stored for 14 days. The stem cells were then harvested for flowcytometric analysis and differentiation potentials. The expression of hypoxia-inducible factor 1 alpha (HIF-1α) was assayed to confirm the hypoxia-tolerant ability. RNA sequencing (RNA-seq) was performed to find the common signatures of the hypoxia-tolerant cells. The result of bioinformatics was tested by quantitative real-time reverse transcription-polymerase chain reaction (qPCR) and western blotting. RESULTS: Certain subsets of ADSCs can be isolated from adipose tissue stored for 14 days. These survived cells were positive for CD90, CD105, and CD73 and showed multilineage differentiation potentials. The hypoxic condition was evidenced by up-regulation of HIF-1α for 2.0-fold changes (p < 0.05). The hypoxia-tolerant stem cells were distinct from multilineage-differentiating stress-enduring (Muse) cells, previously found stress-enduring stromal cells. RNA-seq suggested that integrin beta 3 (ITGB3) was highly expressed in hypoxia-tolerant subpopulations. The result was further confirmed at transcription and translation levels by qPCR and western blotting (mRNA: 2.9 ± 0.4, p < 0.05; protein: 1.5 ± 0.2, p < 0.05; respectively). The conventional ADSCs are positive for ITGB3, which implies that ITGB3+ cells are subpopulations of heterogeneous ADSCs. CONCLUSIONS: Our study reveals the ITGB3+ subsets with potent hypoxia tolerance, which has significant implications for improving fat retention rates and curing obesity-related diseases.

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OBJECTIVE: The totality-of-evidence approach requires that similarity between a proposed biosimilar and a reference biologic is demonstrated across a range of analytical, preclinical, and clinical parameters to establish biosimilarity. We describe the totality of evidence for Sandoz biosimilar pegfilgrastim (LA-EP2006 [marketed as Ziextenzo]) that supported its regulatory approval in Europe and the United States. METHODS: Analytical similarity to the reference biologic [marketed by Amgen as Neulasta] was first investigated with regard to physiochemical quality attributes such as primary structure, pegylation, higher-order structures, variants and impurities, molecular size variants, and formulation (protein content, pH, excipients, etc.). In vitro biological activity studies were performed to examine the primary mechanism of action of pegfilgrastim. Bioequivalence (clinical pharmacokinetics [PK] and pharmacodynamics [PD]) of Sandoz biosimilar pegfilgrastim to the reference biologic was studied in healthy volunteers; efficacy, safety, and immunogenicity were assessed during confirmatory clinical efficacy studies in patients undergoing treatment for breast cancer. RESULTS: No meaningful or relevant differences were identified between Sandoz biosimilar pegfilgrastim and the reference biologic during analytical testing. Similar receptor binding and induction of cellular proliferation in vitro confirmed no functional differences between the biologics. Clinical studies in healthy adult participants demonstrated PK/PD biosimilarity and a similar safety profile between biosimilar and reference pegfilgrastim. Clinical studies in a sensitive patient population also demonstrated similar efficacy, safety, and immunogenicity between Sandoz biosimilar pegfilgrastim and the reference biologic. CONCLUSIONS: The totality of evidence confirms that Sandoz biosimilar pegfilgrastim matches the reference biologic and will therefore provide equivalent efficacy and safety in all eligible indications.

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Infections secondary to Pasteurella multocida frequently occur in patients who have been exposed to domestic pets. Human infections caused by Pasteurella multocida vary in severity, and clinical features include localised cellulitis, osteomyelitis, systemic bacteraemia, meningitis and pneumonia. No vaccine has been developed against Pasteurella multocida; it is treated with antibacterial agents and, in most cases, surgical intervention. This article discusses the authors' experience in treating a woman with severe cellulitis and osteomyelitis on her hand caused by Pasteurella multocida. She refused surgical intervention and was successfully treated with honey-containing dressings and antibiotics after failure to heal following conservative treatment using conventional wound dressings combined with antibiotics.

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Objective: This study was performed to describe the epidemiology of patients with severe burns hospitalized in a burn intensive care unit (BICU), explore the risk factors associated with the patients' outcomes and evaluate the ability of prognostic scoring systems as risk prediction of mortality. Methods: The data for this study were derived from patients with severe burns in the BICU of Beijing Jishuitan Hospital from 2015 to 2019. The following epidemiological information and outcomes were collected for retrospective analysis: sex, age, date of injury, etiology of burn, admission time after injury, extent of burn, inhalation injury, length of stay, and outcome. Abbreviated Burn Severity Index (ABSI), prognostic burn index (PBI), the burn index (BI), Belgian Outcome in Burn Injury (BOBI) scores and the revised Baux (rBaux) scores were calculated. Results: Of the 243 patients included in this study, the median age was 41.00 (22.00) years and the male: female ratio was 4.28:1.00. Most of the burns had occurred from March to July. Flame was the main cause of the burns (77.37%), followed by electricity (14.40%). In total, 78.19% of all patients sustained third-degree burns, and the median burn area and third-degree burn area of patients were 40% (53%) and 15.0% (43.0%) of the total body surface area, respectively. The incidence of inhalation injury was 69.14%. Tracheotomy was performed in 53.89% of the patients with inhalation injuries, and the rate of tracheostomy showing a rising trend. The median length of stay was 37 (40) days, and the case fatality rate was 8.64%. Multivariable logistic regression model indicated that age and third-degree burn area were risk factors for death, and the area under the receiver operating characteristic curve for the full prediction model was 0.921 (95% CI = 0.874-0.967). Conclusions: The majority of severe burns are flame-related accidents in middle-aged men. Risk prediction model combining age and third-degree burn area has better mortality predictive value.

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The incidence rate of electrical injury has remained stable, while the absolute case number has increased. Amputations, erosions, occlusions, and delayed blood vessel rupture are the common complications. Ectopic implantation salvage has been performed widely in mechanical trauma patients, to preserve viable or possibly viable tissues and organ, without application in the electrical injury patients to the best of our knowledge. Here, we present a case report involving ectopic implantation salvage of the left thumb before contralateral transplantation to the right hand after high-voltage electrical injury. The patient's left thumb remained viable despite necrosis of the left forearm at 3 weeks postinjury. After debridement, we implanted the left thumb to his thigh where it was anastomosed to the lateral circumflex femoral artery's descending branch and great saphenous vein. We replanted the left thumb on the right hand with fixation 6 weeks later. The reassembled right hand remained well-circulated 11 months postreconstruction. We believe this case supports broadening the indication for ectopic implantation salvage surgeries to patients who sustain electrical injuries.

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Importance: Despite concerns regarding the potential deleterious physical and mental health outcomes among family members of a child with a life-threatening condition (LTC), few studies have examined empirical measures of health outcomes among these family members. Objectives: To examine whether mothers, fathers, sisters, and brothers of children with 1 of 4 types of pediatric LTCs have higher rates of health care encounters, diagnoses, and prescriptions compared with families of children without these conditions. Design, Setting, and Participants: This retrospective cohort study included US families with commercial insurance coverage from a single carrier. Children who had 1 of 4 LTCs (substantial prematurity, critical congenital heart disease, cancer, or a condition resulting in severe neurologic impairment) were identified by a diagnosis in their insurance claim data between July 1, 2015, and June 30, 2016. Each case child and their family was matched with up to 4 control children and their families based on the age of the case and control children. Data were analyzed between August 2020 and March 2021. Exposures: Having a child or sibling with substantial prematurity, critical congenital heart disease, cancer, or a condition resulting in severe and progressive neurologic impairment. Main Outcomes: Rates of occurrence of health care encounters, physical and mental health diagnoses, and physical and mental health medication prescriptions, identified from insurance claims data, were compared between case and control families using a multivariable negative binomial regression model. The statistical analysis adjusted for observed differences between case and control families and accounted for clustering at the family level. Results: The study included 25 528 children (6909 case children [27.1%] and 18 619 control children [72.9%]; median age, 6.0 years [IQR, 1-13 years]; 13 294 [52.1%] male), 43 357 parents (11 586 case parents [26.7%] and 31 771 control parents [73.3%]; mean [SD] age, 40.4 [8.1] years; 22 318 [51.5%] female), and 25 706 siblings (7664 case siblings [29.8%] and 18 042 control siblings [70.2%]; mean [SD] age, 12.1 [6.5] years; 13 114 [51.0%] male). Overall, case mothers had higher rates of the composite outcome of health care encounters, diagnoses, and prescriptions compared with control mothers (incident rate ratio [IRR], 1.61; 95% CI, 1.54-1.68), as did case fathers compared with control fathers (IRR, 1.55; 95% CI, 1.46-1.64). Sisters of children with LTCs had higher rates of the composite outcome compared with sisters of children without LTCs (IRR, 1.68; 95% CI, 1.55-1.82), as did brothers of children with LTCs compared with brothers of children without LTCs (IRR, 1.70; 95% CI, 1.56-1.85). Conclusions and Relevance: In this cohort study, mothers, fathers, sisters, and brothers who had a child or sibling with 1 of 4 types of LTCs had higher rates of health care encounters, diagnoses, and medication prescriptions compared with families who did not have a child with that condition. The findings suggest that family members of children with LTCs may experience poorer mental and physical health outcomes. Interventions for parents and siblings of children with LTCs that aim to safeguard their mental and physical well-being appear to be warranted.

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BACKGROUND: Alpelisib, a PI3Kα-selective inhibitor and degrader, plus fulvestrant showed efficacy in hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer in SOLAR-1; limited data are available in the post-cyclin-dependent kinase 4/6 inhibitor setting. BYLieve aimed to assess alpelisib plus endocrine therapy in this setting in three cohorts defined by immediate previous treatment; here, we report results from cohort A. METHODS: This ongoing, phase 2, multicentre, open-label, non-comparative study enrolled patients with hormone receptor-positive, HER2-negative, advanced breast cancer with tumour PIK3CA mutation, following progression on or after previous therapy, including CDK4/6 inhibitors, from 114 study locations (cancer centres, medical centres, university hospitals, and hospitals) in 18 countries worldwide. Participants aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 2 or less, with no more than two previous anticancer treatments and no more than one previous chemotherapy regimen, were enrolled in three cohorts. In cohort A, patients must have had progression on or after a CDK4/6 inhibitor plus an aromatase inhibitor as the immediate previous treatment. Patients received oral alpelisib 300 mg/day (continuously) plus fulvestrant 500 mg intramuscularly on day 1 of each 28-day cycle and on day 15 of cycle 1. The primary endpoint was the proportion of patients alive without disease progression at 6 months per local assessment using Response Evaluation Criteria in Solid Tumors, version 1.1, in patients with a centrally confirmed PIK3CA mutation. This trial is registered with ClinicalTrials.gov, NCT03056755. FINDINGS: Between Aug 14, 2017, and Dec 17, 2019 (data cutoff), 127 patients with at least 6 months' follow-up were enrolled into cohort A. 121 patients had a centrally confirmed PIK3CA mutation. At data cutoff, median follow-up was 11·7 months (IQR 8·5-15·9). 61 (50·4%; 95% CI 41·2-59·6) of 121 patients were alive without disease progression at 6 months. The most frequent grade 3 or worse adverse events were hyperglycaemia (36 [28%] of 127 patients), rash (12 [9%]), and rash maculopapular (12 [9%]). Serious adverse events occurred in 33 (26%) of 127 patients. No treatment-related deaths were reported. INTERPRETATION: BYLieve showed activity of alpelisib plus fulvestrant with manageable toxicity in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer, after progression on a CDK4/6 inhibitor plus an aromatase inhibitor. FUNDING: Novartis Pharmaceuticals.

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BACKGROUND: In this study, recent trends in the distribution and drug resistance of pathogenic bacteria isolated from patients treated at a burn ward between 2006 and 2019 were investigated. AIM: To develop more effective clinical strategies and techniques for the prevention and treatment of bacterial infections in burn patients. METHODS: Clinical samples with positive bacteria were collected from patients at the burn ward in Beijing Jishuitan Hospital in China between January 2006 and December 2019. The samples were retrospectively analyzed, the distribution of pathogenic bacteria was determined, and the trends and changes in bacterial drug resistance during different period were assessed. Drug resistance in several main pathogenic bacteria from 2006 to 2011 and from 2012 to 2019 was comparatively summarized and analyzed. RESULTS: Samples from 17119 patients were collected and analyzed from 2006 to 2019. Surprisingly, a total of 7960 strains of different pathogenic bacteria were isolated at this hospital. Among these bacteria, 87.98% (7003/7960) of the strains were isolated from burn wounds, and only 1.34% (107/7960) were isolated from the blood of patients. In addition, 49.70% (3956/7960) were identified as Gram-positive bacteria, 48.13% (3831/7960) were Gram-negative bacteria, and the remaining 2.17% (173/7960) were classified as fungi or other pathogens. Importantly, Staphylococcus aureus (21.68%), Pseudomonas aeruginosa (14.23%), and Staphylococcus epidermidis (9.61%) were the top three pathogens most frequently isolated from patients. CONCLUSION: In patients treated at the burn ward in this hospital from 2006 to 2019, Staphylococcus aureus and Pseudomonas aeruginosa were the predominant clinical pathogens responsible for bacterial infections. The circumstantial detection and detailed monitoring of the intensity and growth of different pathogenic bacteria in clinical patients as well as tests of drug sensitivity during burn recovery are particularly important to provide guidelines for the application of antibiotics and other related drugs. Careful collection and correct, standard culture of bacterial specimens are also crucial to improve the efficiency of bacterial infection detection. Effective monitoring and timely clinical treatment in patients may help reduce the possibility and rate of infection as well as alleviate the effects of drug resistance among patients in burn centers.