Academic Hospitals In China Research Articles

Practice Standards in International Medical Departments of Public Academic Hospitals in China: Cross-Sectional Study.

Improving health care in cities with a diverse, international population is crucial for ensuring health equity, particularly for foreigners facing challenges due to cultural and language barriers. This situation is especially relevant in China, a major destination for expatriates and travelers, where optimizing health care services and incorporating international standards in the public sector are vital. Achieving this involves understanding the operational details, cultural and linguistic nuances, and advancing medical digitalization. A strategic approach focusing on cultural competence and awareness of health care systems is essential for effectively navigating health care for foreigners and expatriates in China. The aim of this study was to perform an in-depth analysis of the subjective and objective experiences of local and international patients in public hospitals in China to provide a basis for enhancing the medical experience of all patients. A structured questionnaire was provided to patients at an international outpatient service of a top-tier university hospital in China. Qualitative analysis of the survey responses was performed to methodically categorize and analyze medical treatment, focusing on patient demand and satisfaction across four main category elements ("high demand, high satisfaction"; "high demand, low satisfaction"; "low demand, high satisfaction"; and "low demand, low satisfaction"), enabling a detailed cross-sectional analysis to identify areas for improvement. Elements falling under "high demand, high satisfaction" for both Chinese and international patients were primarily in the realms of medical quality and treatment processes. In contrast, elements identified as "high demand, low satisfaction" were significantly different between the two patient groups. The findings highlight the importance of systematic, objective research in advancing the quality of international health care services within China's leading academic medical centers. Key to this improvement is rigorous quality control involving both patients and providers. This study highlights the necessity of certifying such centers and emphasizes the role of digital platforms in disseminating information about medical services. This strategy is expected to cater to diverse patient needs, enhancing the overall patient experience. Furthermore, by developing comprehensive diagnosis and treatment services and highlighting the superior quality and costs associated with international health care, these efforts aim to foster a sense of belonging among international patients and increase the attractiveness of China's medical services for this demographic.

Early enteral nutrition versus early supplemental parenteral nutrition in patients undergoing major abdominal surgery: a secondary analysis of 2 randomized clinical trials

BackgroundThe effect of early isoenergetic feeding routes [early enteral nutrition (E-EN) or early supplemental parenteral nutrition (E-SPN)] on the outcome of patients undergoing major abdominal surgery is controversial. ObjectivesThe aim of this study was to investigate the impact of early isoenergetic EN compared with early isoenergetic SPN on nosocomial infections in patients undergoing major abdominal surgery. MethodsThis study is a secondary, post hoc analysis of data from 2 open-label randomized clinical trials. Participants were recruited from the general surgery department of 11 academic hospitals in China undergoing major abdominal surgery and with Nutritional Risk Screening 2002 score ≥3. All eligible patients were categorized into 2 groups based on their achievement of the 100% energy target on postoperative day (POD) 3: the E-EN group (n = 199) and the E-SPN group (n = 115). The primary outcome was the incidence of nosocomial infections between POD 3 and hospital discharge. ResultsIn total, 314 patients [mean (SD) age, 59.2 (11.4) y; 113 (36.0%) females] were included. Patients in the E-EN group showed no significant difference in nosocomial infections compared with those in the E-SPN group {17/199 [8.5%] compared with 10/115 [8.7%], risk difference, 0.2% [95% confidence interval (CI): –6.3, 6.6]}. The hematological nutritional status of the E-EN group showed a significant improvement at discharge compared with the E-SPN group (albumin: 38.0 ± 6.0 g/L compared with 35.5 ± 7.6 g/L; mean difference, –2.5 g/L; 95% CI: –4.0, –1.0 g/L; prealbumin: 200.0 ± 8.0 mg/L compared with 158.4 ± 38.1 mg/L; mean difference, –41.6 mg/L; 95% CI: –41.7, –36.1 mg/L). Other indicators were comparable between groups. ConclusionE-EN compared with isoenergetic SPN may not be associated with a reduced rate of nosocomial infection in patients undergoing major abdominal surgery, but may be associated with improved hematological nutritional status. Trial registration numberThis trial was registered at clinicaltrials.gov as NCT03115957 (https://clinicaltrials.gov/ct2/show/NCT03115957) and NCT03117348 (https://clinicaltrials.gov/ct2/show/NCT03117348).

Phase II clinical study evaluating the efficacy and safety of disitamab vedotin combined with sintilimab and S-1 in the conversion treatment of HER2-overexpression unresectable gastric cancer.

TPS428 Background: Gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA) is the fifth commonest cancer and the fourth leading cause of cancer deaths worldwide. In about 30% to 40% of patients with advanced gastric cancer have lost the opportunity for radical surgery at the first diagnosis, and the overall 5-year survival rate is less than 50%. In recent years, conversion therapy has shown great promise. Disitamab vedotin is an antibody-drug conjugate comprising a novel HER2-directed monoclonal antibody, In previous study C008, RC48 showed a good safety profile and promising activity towards GC, and showed equivalent efficacy for HER2 IHC 2+ or HER2 IHC 3+ tumors. Methods: This study is a single-arm, phase II trial carry out at 16 academic hospitals in China, and will evaluate DV combined with Sintilimab and S-1 in patients with HER2-expressing unresectable gastric cancer. Eligible patients are at ≥ 18 to ≤ 75 years old; histologically confirmed, unresectable stage IV GC or GEJA; Single initial unresectable factor. For example, peritoneal metastasis (P1), Intraperitoneal free cancer cells positive (CY1), Paraaortic lymph node metastasis, liver metastasis (≤ 3 lesions, and ≤ 5 cm for a single lesion), ovarian metastasis; and documented histologically confirmed HER2 IHC 3+ or 2+; ECOG 0-1; at least one unresectable, measurable tumor lesion according to the RECIST version 1.1; adaptable function of the heart, liver, and kidney. 30 patients will be enrolled in this trial and receive Disitamab Vedotin(2.5mg/kg, IV, Q3W), Sintilimab (200 mg, IV, Q3W) and S-1 (twice daily on D1-14 are given at a dose calculate according to the body surface area and repeated every 3 weeks), until patients assessed by MDT to meet the criteria for surgical resection undergo gastrectomy. And the patients with peritoneal dissemination will combine with intraperitoneal administration of paclitaxel (60mg / m2, Q3W). The primary endpoint is R0 resection rate, Secondary endpoints include cORR, OS, RFS and safety. Seven patients have been enrolled in this study. Clinical trial information: NCT05627414 .

Effect of percutaneous cerebral oximetry-guided anaesthetic management on postoperative delirium in older adults undergoing off-pump coronary artery bypass grafting: study protocol for a single-centre prospective randomised controlled trial in a tertiary academic hospital in China

IntroductionPostoperative delirium is a prominent and clinically important complication in older adults after coronary artery bypass grafting (CABG) surgery, resulting in prolonged hospital stay, long-term cognitive impairment and increased morbidity...

Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): a randomized, double-blind, placebo-controlled trial

Glibenclamide alleviates brain edema and improves neurological outcomes in experimental models of stroke. We aimed to assess whether glibenclamide improves functional outcomes in patients with acute ischemic stroke treated with recombinant tissue plasminogen activator (rtPA). In this randomized, double-blind, placebo-controlled trial, patients with acute ischemic stroke were recruited to eight academic hospitals in China. Patients were eligible if they were aged 18-74 years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4-25, and had been treated with rtPA within 4.5h of symptom onset. We used web-based randomization (1:1) to allocate eligible participants to the glibenclamide or placebo group, stratified according to endovascular treatment and baseline stroke severity. Glibenclamide or placebo was taken orally or via tube feeding at a loading dose of 1.25mg within 10h after symptom onset, followed by 0.625mg every 8h for 5 days. The primary outcome was the proportion of patients with good outcomes (modified Rankin Scale of 0-2) at 90 days, assessed in all randomly assigned patients who had been correctly diagnosed and had begun study medication. The study is registered with ClinicalTrials.gov, NCT03284463, and is closed to new participants. Between January 1, 2018, and May 28, 2022, 305 patients were randomly assigned, of whom 272 (142 received glibenclamide and 130 received placebo) were included in the primary efficacy analysis. 103 (73%) patients in the glibenclamide group and 94 (72%) in the placebo group had a good outcome (adjusted risk difference 0.002, 95% CI-0.098 to 0.103; p=0.96). 12 (8%) patients allocated to glibenclamide and seven (5%) patients allocated to placebo died from any cause at 90 days (p=0.35). The number and type of adverse events were similar between the two groups. There were no drug-related adverse events and no drug-related deaths. The addition of glibenclamide to thrombolytic therapy did not increase the proportion of patients who achieved good outcomes after stroke compared with placebo, but it did not lead to any safety concerns. Southern Medical University and Nanfang Hospital.

Effect of early achievement of energy target by different nutritional support strategies on nosocomial infections in patients undergoing major abdominal surgery: a secondary analysis of two randomized clinical trials.

The effect of early achievement of energy targets (EAETs) using different nutritional support strategies in patients undergoing major abdominal surgery is unclear. This study determined the impact of EAETs on the incidence of nosocomial infections in patients undergoing major abdominal surgery. This was a secondary analysis of two open-label randomized clinical trials. Patients from the general surgery department of 11 academic hospitals in China undergoing major abdominal surgery and at nutritional risk (Nutritional risk screening 2002≥3) were divided into two groups based on whether they met the 70% energy targets, the EAET (521 EAET and non-achievement of energy target (114 NAET) groups. The primary outcome was the incidence of nosocomial infections between postoperative day 3 and discharge, and the secondary outcomes were actual energy and protein intake, postoperative noninfectious complications, intensive care unit admission, mechanical ventilation, and hospital stay. Overall, 635 patients [mean (SD) age, 59.5 (11.3) years] were included. The EAET group received more mean energy between days 3 and 7 than the NAET group (22.7±5.0 vs. 15.1±4.8kcal/kg/d; P <0.001). The EAET group had significantly fewer nosocomial infections than the NAET group [46/521(8.8%) vs. 21/114(18.4%); risk difference, 9.6%; 95% CI, 2.1-17.1%; P =0.004]. A significant difference was found in the mean (SD) number of noninfectious complications between the EAET and NAET groups [121/521(23.2%) vs. 38/114(33.3%); risk difference, 10.1%; 95% CI, 0.7-19.5%; P =0.024]. The nutritional status of the EAET group was significantly improved at discharge compared with the NAET group ( P <0.001), and other indicators were comparable between groups. EAETs was associated with fewer nosocomial infections and improved clinical outcomes, regardless of the nutritional support strategy (early enteral nutrition alone or combined with early supplemental parenteral nutrition).

Continuous palliative sedation in terminally ill patients with cancer: a retrospective observational cohort study from a Chinese palliative care unit

ObjectiveThis study aimed to describe a 4-year practice of continuous palliative sedation (CPS) in a palliative medicine ward of an academic hospital in China. To compare the survival time of...

INCREASE IN CHLORIDE IS ASSOCIATED WITH MAJOR ADVERSE KIDNEY EVENTS IN CRITICALLY ILL PATIENTS.

Purpose: This study aimed to identify the association between hyperchloremia at intensive care unit (ICU) admission and/or the increase of blood chloride levels and the incidence of major adverse kidney events within 30 days (MAKE30) in critically ill adults. Methods: We conducted a retrospective study to analyze the data of all adult patients admitted to the ICU of a tertiary academic hospital in China between April 2020 and April 2022. Patients were categorized based on their admission chloride levels (hyperchloremia ≥110 mmol/L and nonhyperchloremia <110 mmol/L) and stratified on the increased chloride levels 48 h after ICU admission (∆Cl ≥5 mmol/L and ∆Cl <5 mmol/L). The primary outcome was the MAKE30 incidence, including in-hospital death, new receipt of renal replacement therapy (RRT), and persistent renal dysfunction (PRD). Association between hyperchloremia at ICU admission and/or the increase of chloride and the incidence of MAKE30 were assessed using logistic regression. Result: A total of 2,024 patients with a median age of 67 years (interquartile range [IQR], 55-76 years) and a median Acute Physiology and Chronic Health Evaluation II score of 22 (IQR, 17-28) were included. Hyperchloremia occurred in 30.9% (n = 625), and ΔCl ≥5 mmol/L occurred in 18.5% (n = 375) of all ICU patients. The overall MAKE30 incidence was 33.6% (n = 680), including a 10.9% of 30-day hospital mortality (n = 220; as well as overall in-hospital mortality, 11.8% [n = 238]), a 20.2% (n = 408) of PRD, and a 18.0% (n = 365) of new RRT. After adjusted for confounders, it was found that ΔCl ≥5 mmol/L (odds ratio [OR], 1.46; 95% confidence interval [CI], 1.096-1.93; P = 0.010), but not hyperchloremia (OR, 0.99; 95% CI, 0.77-1.28; P = 0.947), was associated with increased incidence of MAKE30. Conclusion: An increased chloride level in the first 48 h of ICU admission was an independent risk factor for MAKE30, whereas hyperchloremia at ICU admission was not associated with an increased incidence of MAKE30. Large-scale prospective studies are needed to verify our findings.

Does the Geriatric Nutritional Risk Index Play a Predictive Role in Postoperative Atrial Fibrillation and Outcomes in Cardiac Surgery?

<h3>Objectives</h3> Malnutrition is associated with adverse surgical outcomes. The Geriatric Nutritional Risk Index, a nutritional screening tool, could be a predictor of postoperative atrial fibrillation and outcomes in cardiac surgery. <h3>Design</h3> The authors enrolled 292 patients who underwent cardiac surgery and showed postoperative atrial fibrillation during hospitalization, and assessed mortality and readmission during a 90-day follow-up period. <h3>Setting</h3> A large academic hospital in China. <h3>Participants</h3> Participants were divided into low-risk (Geriatric Nutritional Risk Index <98) and no-risk malnutrition groups (Geriatric Nutritional Risk Index ≥98). <h3>Interventions</h3> Univariate and multivariate logistic regression analyses were used to validate the role of the Geriatric Nutritional Risk Index in predicting postoperative atrial fibrillation. Kaplan–Meier analysis was used to examine the effect of Geriatric Nutritional Risk Index scores on mortality and readmission after cardiac surgery. <h3>Measurements and Main Results</h3> A total of 136 patients were in the low-risk malnutrition group. Postoperative atrial fibrillation was more common in the low-risk group (63.2% <i>v</i> 28.8%, p < 0.001). Duration of intensive care unit stays and hospitalization were significantly longer than in the no-risk group (44 [43] <i>v</i> 39 [47] hours, p < 0.001; 18 [7] <i>v</i> 15 [6] days, p < 0.001). Multivariate analysis showed that Geriatric Nutritional Risk Index, age, and NYHA class independently predicted postoperative atrial fibrillation. Kaplan–Meier analysis showed that 90-day all-cause readmission, but not 90-day all-cause mortality, was different between groups based on the Geriatric Nutritional Risk Index (log-rank p < 0.001, log-rank p = 0.09). <h3>Conclusions</h3> The easily accessible Geriatric Nutritional Risk Index used for nutritional assessment before cardiac surgery has a predictive role in postoperative atrial fibrillation, and is related to short-term readmission.

Preoperative NT-proBNP and LVEF for the prediction of acute kidney injury after noncardiac surgery: a single-centre retrospective study

BackgroundAcute kidney injury (AKI) is one of the most common postoperative complications in noncardiac surgical patients, has an important impact on prognosis and is difficult to predict. Whether preoperative N-terminal pro-brain natriuretic peptide (NT-proBNP) concentrations and left ventricular ejection fraction (LVEF) levels can predict postoperative AKI in noncardiac surgical patients is unclear.MethodsWe included 3,314 patients who underwent noncardiac surgery and had measurements of preoperative NT-proBNP concentrations and LVEF levels at a tertiary academic hospital in China between 2008 and 2018. Multiple logistic regression analysis was used to construct a postoperative AKI risk prediction model for this cohort. Then, NT-proBNP concentrations and LVEF levels were included in the abovementioned model as independent variables, and the predictive ability of these two models was compared.ResultsPostoperative AKI occurred in 223 (6.72%) patients within 1 week after surgery. Preoperative NT-proBNP concentrations and LVEF levels were independent predictors of AKI after adjustment for clinical variables. The area under the receiver operating characteristic curve (AUROC) of the AKI risk predictive model established with clinical baseline variables was 0.767 (95% CI: 0.732, 0.802). When NT-proBNP concentrations and LVEF levels were added to the base model, the AUROC was 0.811 (95% CI: 0.779, 0.843). The addition of NT-proBNP concentrations and LVEF levels improved reclassification by 22.9% (95% CI 10.5–34.4%) for patients who developed postoperative AKI and by 36.3% (95% CI 29.5–43.9%) for those who did not, resulting in a significant overall improvement in net reclassification (NRI: 0.591, 95% CI 0.437–0.752, P < 0.000). The integral discrimination improvement was 0.100 (95% CI: 0.075, 0.125, P < 0.000).The final postoperative AKI prediction model was constructed, and had a good discriminative ability and fitted to the dataset.ConclusionsPreoperative NT-proBNP concentrations and LVEF levels were independently associated with the risk of AKI after noncardiac surgery, and they could improve the predictive ability of logistic regression models based on conventional clinical risk factors.Trial registrationThe protocol was preregistered in the Chinese Clinical Trial Registry (ChiCTR1900024056).

Comparison of the clinicopathologic features of prostate cancer in US and Chinese populations

BackgroundProstate cancer (PCa) is the most common malignant tumor found among men in the United States. Incidence rates of PCa have recently grown in Asian countries, partially due to the comprehensive implementation of early detection systems. Interestingly, a prospective cohort study showed that adopting a westernized dietary pattern was associated with a higher risk of being diagnosed with PCa among Korean and Japanese men. However, a comparison of current clinicopathological features of PCa between American and Chinese men is lacking. In this study, we report the current clinicopathological features of PCa in Chinese men and compare them to those of patients in the USA. Materials and methodsCase cohorts included, in total, 871 PCa cases with prostatectomy sequentially treated since 2017, including 299 cases from USA and 572 cases from two different academic hospitals in China. The parameters, including patient’s age, preoperative Prostate-Specific Antigen (PSA) level, Gleason score, Grade Group, stage and tumor focality, were collected, analyzed and compared using two sample t-test, Wilcoxon rank sum test, Pearson’s Chi-squared test and Fisher’s exact test. ResultsSignificant differences were demonstrated in the mean age of patients, preoperative PSA levels, extra-prostatic extension, Gleason scores, and Grade Groups (p < 0.05). PCa patients in the Chinese group were older than patients in the USA group (67.81 vs. 63.53, p < 0.01). The preoperative PSA levels in the Chinese group were higher than those in the USA group (11.69 v.s 6.30, p < 0.01). A higher percentage of high Grade Groups (Groups 4 and 5) was observed in the Chinese group (25.7%) compared to the USA cohort (17.11%), while Grade Group 2 was more common in the USA group than in the Chinese group (51.68% vs. 32.52%, p < 0.01). ConclusionsAll these data suggest that the clinicopathologic features of PCa are different between the USA and Chinese populations, which may be influenced by treatment strategies (including surgical case selection criteria).

Barriers to prescribing oral anticoagulants to inpatients aged 80 years and older with nonvalvular atrial fibrillation: a cross-sectional study

BackgroundTo investigate the temporal trend of the prevalence of underprescription of anticoagulation treatment and explore the factors associated with underprescription of oral anticoagulants (OACs) among inpatients aged ≥ 80 years with nonvalvular atrial fibrillation (NVAF).MethodsWe retrospectively reviewed the medical records of inpatients with a discharge diagnosis of NVAF from a medical database. We used the Pearson chi-square or Fisher’s exact test to compare categorical variables between patients with and without OAC prescriptions during hospitalization. Logistic regression analysis was used to assess the association between risk factors and underprescription of OACs.ResultsA total of 4375 patients aged ≥ 80 years with AF were assessed in the largest academic hospital in China from August 1, 2016, to July 31, 2020, and 3165 NVAF patients were included. The prevalence of underprescription of OACs was 79.1% in 2017, 71.3% in 2018, 64.4% in 2019, and 56.1% in 2020. Of all participants, 2138 (67.6%) were not prescribed OACs; 66.3% and 68.2% of patients with and without prior stroke did not receive OACs, respectively. Age (85–89 vs 80–84, OR = 1.48, 95% CI (1.25–1.74); 90 + vs 80–84, OR = 2.66, 95% CI: 2.09–3.42), clinical department where patients were discharged (Reference = Cardiology, Geriatrics: OR = 2.97, 95% CI: 2.45- 3.61; neurology: OR = 1.25, 95% CI: 0.96, 1.63; others: OR = 4.23, 95% CI: 3.43- 5.24), use of antiplatelets (OR = 1.69, 95% CI: 1.45- 1.97), and history of stroke (OR = 0.83, 95% CI: 0.71- 0.98 adjusted age), and dementia (OR = 2.16, 95% CI: 1.60- 2.96) were significantly associated with not prescribing OACs. ConclusionsThe prevalence of underprescription of OACs has decreased over the past several years. The rate of underprescription of OACs was higher among NVAF patients who were older, prescribed antiplatelets, discharged from nondepartmental cardiology, and suffered from comorbidities. This study found iatrogenic factors affecting the underprescription of OACs in inpatients aged ≥ 80 years, providing clues and a basis for the standardized use of OACs in inpatients.

Prognostic value of blood urea nitrogen-to-serum albumin ratio for mortality of pneumonia in patients receiving glucocorticoids: Secondary analysis based on a retrospective cohort study

IntroductionPrevious studies have revealed that blood urea nitrogen-to-serum albumin ratio (BUN/ALB) is one of major risk factors of mortality in pneumonia. However, there are fewer scientific research about the correlation between BUN/ALB ratio and outcome of pneumonia in patients receiving glucocorticoids. This study was undertaken to explore the prognostic value of BUN/ALB ratio for mortality of pneumonia in patients receiving glucocorticoids. MethodsThe present study was a retrospective cohort study. 1397 subjects receiving glucocorticoids alone or glucocorticoids and other immunosuppressants from six secondary and tertiary academic hospitals in China were analyzed. The endpoint of the study was 30-day mortality. It was noted that the entire study was completed by Li et al. and uploaded the data to the DATADRYAD website. The author only used this data for secondary analysis. ResultsAfter adjusting potential confounders (age, sex, WBC, persistent lymphocytopenia, PLT, ALT, AST, Cr, high-dose steroid use, and COPD), non-linear relationship was detected between BUN/ALB ratio and 30-day mortality, whose point was 0.753. The effect sizes and the confidence intervals on the left and right sides of inflection point were 23.110 (7.157, 74.623) and 0.410 (0.074, 2.283), respectively. Subgroup analysis revealed the positive association was stronger among subjects with connective tissue disease. ConclusionsThe relationship between BUN/ALB ratio and 30-day mortality of pneumonia in patients receiving glucocorticoids is non-linear. BUN/ALB ratio is positively related with 30-day mortality when BUN/ALB ratio is less than 0.753.

Abstract P2-14-08: Preliminary safety and efficacy results of camrelizumab in combination with apatinib and eribulin in heavily pretreated patients with advanced triple-negative breast cancer: A phase II trial

Abstract Background: Our prior phase II trial (NCT03394287) demonstrated that camrelizumab (an anti-PD-1 antibody) combined with apatinib (an anti-VEGFR2 tyrosine kinase inhibitor) showed a favorable objective response rate (ORR) of 43% in treating patients with advanced triple-negative breast cancer (TNBC), even in those with PD-L1-negative tumors and received 1-2 lines of chemotherapy. However, the progression-free survival (PFS) and overall survival (OS) remained short. Since EMBRACE trial and 301 study found that eribulin monotherapy significantly prolonged OS with relatively low toxicities than other common chemotherapy drugs as multi-line therapy in the treatment of advanced breast cancer, especially for patients with TNBC, we have conducted a phase II trial to study the efficacy and safety of combinational treatment of camrelizumab, apatinib, and eribulin in patients with heavily pretreated advanced TNBC. Methods: Female patients with advanced TNBC who were previously treated with at least one line of systemic therapy were enrolled from three academic hospitals in China to receive camrelizumab 200mg (iv. 3mg/kg for the patient whose weight is below 50kg) on day 1, and apatinib 250mg daily (po, d1-d21), plus eribulin mesylate at 1.4 mg/m2 (iv.) on days 1 and 8 of a 21-day cycle until progression, unacceptable toxicities or patient withdrawal. The primary endpoint was ORR according to RECIST v1.1. Secondary endpoints included disease control rate (DCR), clinical benefit rate (CBR), PFS, time to response (TTR), duration of response (DoR), 12-months OS, toxicities, and potential biomarkers. Results: From March 2020 to May 2021, 46 patients were enrolled. 13 of 46 patients (28.3%) received ≥3 lines of chemotherapy in the advanced setting. And 8 of 46 patients (17.4%) had received PD-1/PD-L1 blockade combined with chemotherapy in the previous treatment for advanced disease. Until May 31th, 2021, 39 and 46 patients were evaluable for overall response and safety, respectively. The ORR was 40.0% (16 of 40, 95% CI: 24.9-56.7), and 3 patients achieved complete response (CR) (intention-to-treat analysis). The DCR was 90.0% (95% CI: 76.3-97.2) (intention-to-treat analysis). The median TTR was 1.5 (95% CI: 1.4-3.0) months. The median PFS was 8.2 (95% CI: 4.9 - not reached) months. 23 patients (50.0%) were still on treatment. Neither PD-L1 status (CPS score) nor lines of prior systemic therapies was correlated with ORR (P=0.782 and 0.651, respectively). All patients suffered from treatment-related adverse events (TRAEs) of any grade, while 34.8% of patients had experienced grade 3 or 4 TRAEs. Key grade 3 or 4 TRAEs were thrombocytopenia (13.0%), leukopenia (13.0%), and elevated aspartate aminotransferase (8.7%). No treatment-related deaths were observed. Conclusions: Camrelizumab in combination with apatinib and eribulin showed favorable efficacy and measurable toxicities in treating heavily pretreated patients with advanced TNBC. This trial is currently ongoing. ClinicalTrials.gov number, NCT04303741. Summary of clinical response in the intention-to-treat population.ParameterOverall (n=40)ORR, %16 (40.0; 24.9-56.7)DCR, %36 (90.0; 76.3-97.2)Median TTR, m1.5 (1.4-3.0)Median PFS, m8.2 (4.9-not reached)The data are presented in the form of n (%; 95% CI), or median time (95% CI). Citation Format: Jieqiong Liu, Zhenluan Tian, Ying Wang, Ying Lin, Hengyu Li. Preliminary safety and efficacy results of camrelizumab in combination with apatinib and eribulin in heavily pretreated patients with advanced triple-negative breast cancer: A phase II trial [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P2-14-08.

Abstract P5-16-04: Preliminary safety and efficacy results of KN046 (an anti-PD-L1/CTLA-4 bispecific antibody) in combination with KN026 (a HER2-targeted bispecific antibody) in patients with metastatic HER2-positive breast cancer: A phase II trial

Abstract Background: HER2-targeted therapies combined with chemotherapy have improved survival outcomes for patients with metastatic HER2-positive breast cancer. However, for patients progressed after several lines of anti-HER2 combinational therapies, the overall survival (OS) remained unfavorable. Prior studies showed that immunotherapy in combination with chemotherapy or targeted therapy could significantly prolong OS of metastatic breast cancer patients, especially in patients with triple-negative breast cancer. Reports of immunotherapy combined with HER2-targeted therapy are still limited. Here we reported the preliminary results from an ongoing phase II trial assessing the safety and efficacy for KN046 (a bispecific antibody blocks both PD-L1 interaction with PD-1/CD80 and CTLA-4 interaction with CD80/CD86) in combination with KN026 (a bispecific antibody that binds to two different HER2 epitopes shared by trastuzumab and pertuzumab) in HER2-positive metastatic breast cancer patients, who have progressed after prior anti-HER2 combinational therapies.Methods: Female patients with metastatic HER2-positive breast cancer who were previously treated with at least one line of HER2-targeted combinational therapy were enrolled from multiple academic hospitals in China to receive KN046 (iv. 5 mg/kg Q3W) plus KN026 (iv. 30 mg/kg Q3W) until progression, unacceptable toxicities or patient withdrawal. Efficacy was evaluated Q6W per RECIST 1.1. The primary endpoint was objective response rate (ORR). Results: As of the June 20th, 2021, 36 patients with the median age of 53 years (range: 33-67) were enrolled. 30 of 36 patients (83.3%) received ≥3 lines of HER2-targeted combinational therapies in the metastatic setting. 22 patients were evaluable for overall response and all 36 for safety. The ORR was 50.0% (11 of 22, 95% CI: 28.2-71.8), and one patient achieved complete response (CR). And the disease control rate (DCR) was 81.8% (18 of 22, 95% CI 59.7-94.8). The median progression-free survival (PFS) was 5.6 (95%CI 2.5-not reached) months. 34 of 36 (94.4%) patients had treatment-related adverse events (TRAEs) of any grade, while 4 of 36 (11.1%) patients had experienced ≥grade 3 TRAEs. The most common (≥10%) TEAEs were infusion related reaction (36.1%), rash (16.7%), alanine aminotransferase increased (13.9%), diarrhea (13.9%), pruritus (13.9%), aspartate aminotransferase increased (11.1%), and hypokalemia (11.1%). No treatment-related deaths were observed.Conclusions: The combination of KN046 and KN026, as a chemo free regimen, has shown favorable clinical efficacy with manageable side effects in heavily pre-treated patients with metastatic HER2-positive breast cancer. This trial is currently ongoing. ClinicalTrials.gov number, NCT04521179. Citation Format: Jieqiong Liu, Chuangui Song, Xiangcai Wang, Mingli Ni, Xujuan Wang, Lei Chen, Hongwei Yang, Rusen Zhao, Ting Xu, Lin Shen. Preliminary safety and efficacy results of KN046 (an anti-PD-L1/CTLA-4 bispecific antibody) in combination with KN026 (a HER2-targeted bispecific antibody) in patients with metastatic HER2-positive breast cancer: A phase II trial [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-16-04.

Clinical outcomes of asymptomatic low-grade esophagitis: results from a multicenter Chinese cohort.

BackgroundAsymptomatic low-grade (Los Angeles Classification Grades A and B) esophagitis is common in clinical practice with unclear clinical outcomes. This study aimed to explore the clinical outcomes of asymptomatic low-grade esophagitis.MethodsThis was a multicenter cohort study conducted by three academic hospitals in China. Asymptomatic low-grade esophagitis patients between January 2015 and December 2019 were included. Mucosal healing condition 1 year after initial diagnosis, symptom outcomes, and proton-pump inhibitor (PPI) use within 1 year after initial diagnosis were studied and compared.ResultsA total of 248 asymptomatic low-grade esophagitis patients were included. Esophagitis disappeared in 76.2% of patients 1 year after initial diagnosis. In terms of symptom outcomes, 89.9% of patients did not present gastroesophageal reflux disease (GERD) symptoms within 1 year after initial diagnosis. No significant difference was found in the proportion of patients who presented GERD symptoms and in the proportion of patients with persistent esophagitis between the PPI group and the non-PPI group (all P > 0.05). Patients with initial Grade B esophagitis were more likely to present follow-up GERD symptoms (16.0% vs 7.5%, P = 0.041) and had more severe follow-up esophagitis than those with Grade A (P < 0.001). Patients with follow-up GERD symptoms were more likely to have persistent esophagitis than those without.ConclusionsThis study demonstrated that asymptomatic low-grade esophagitis had relatively benign clinical outcomes. Patients with initial Grade B esophagitis and patients with follow-up GERD symptoms were more likely to be those who are in genuine need of further follow-up and treatments.

A neutrophil-to-lymphocyte ratio-based prognostic model to predict mortality in patients with HBV-related acute-on-chronic liver failure

BackgroundAlthough the Asian Pacific Association for the Study of the Liver acute-on-chronic liver failure (ACLF) research consortium (AARC) ACLF score is easy to use in patients with hepatitis b virus-related ACLF (HBV-ACLF), serum lactate is not routinely tested in primary hospitals, and its value may be affected by some interference factors. Neutrophil-to-lymphocyte ratio (NLR) is used to assess the status of bacterial infection (BI) or outcomes in patients with various diseases. We developed an NLR-based AARC ACLF score and compared it with the existing model.MethodsA total of 494 HBV-ACLF patients, enrolled in four tertiary academic hospitals in China with 90-day follow-up, were analysed. Prognostic performance of baseline NLR and lactate were compared between cirrhotic and non-cirrhotic subgroups via the receiver operating curve and Kaplan–Meier analyses. A modified AARC ACLF (mAARC ACLF) score using NLR as a replacement for lactate was developed (n = 290) and validated (n = 204).ResultsThere were significantly higher baseline values of NLR in non-survivors, patients with admission BI, and those with higher grades of ACLF compared with the control groups. Compared with lactate, NLR better reflected BI status in the cirrhotic subgroup, and was more significantly correlated with CTP, MELD, MELD-Na, and the AARC score. NLR was an independent predictor of 90-day mortality, and was categorized into three risk grades (< 3.10, 3.10–4.78, and > 4.78) with 90-day cumulative mortalities of 8%, 21.2%, and 77.5% in the derivation cohort, respectively. The mAARC ACLF score, using the three grades of NLR instead of corresponding levels of lactate, was superior to the other four scores in predicting 90-day mortality in the derivation (AUROC 0.906, 95% CI 0.872–0.940, average P < 0.001) and validation cohorts (AUROC 0.913, 95% CI 0.876–0.950, average P < 0.01), with a considerable performance in predicting 28-day mortality in the two cohorts.ConclusionsThe prognostic value of NLR is superior to that of lactate in predicting short-term mortality risk in cirrhotic and non-cirrhotic patients with HBV-ACLF. NLR can be incorporated into the AARC ACLF scoring system for improving its prognostic accuracy and facilitating the management guidance in patients with HBV-ACLF in primary hospitals.

Clinical characteristics and prognostic risk factors of mortality in patients with interstitial lung diseases and viral infection: a retrospective cohort study.

IntroductionPatients with interstitial lung disease (ILD) who subsequently develop a viral infection have high rates of morbidity and mortality.Hypothesis/Gap statementFew large-scale epidemiological studies have investigated potential prognostic factors for morbidity and mortality in this patient group.AimTo evaluate the risk factors for morbidity and mortality in hospitalized patients with ILD and viral infection, as well as the clinical characteristics.MethodologyThis retrospective cohort study included patients with ILD who were hospitalized for a viral infection in two tertiary academic hospitals in China, between 1 January 2013 and 31 December 2019. We analysed the prevalence of comorbidities, clinical characteristics, 30 day mortality rates, and prognostic risk factors.ResultsA total of 282 patients were included; 195 and 87 were immunocompromised and immunocompetent, respectively. The most common underlying interstitial diseases were idiopathic pulmonary fibrosis (42.9 %) and connective tissue disease (36.9 %). The 30 day mortality rate was 20.6 %. During the influenza season, an increase in influenza virus (IFV) (25.7 %), respiratory syncytial virus (14.9 %) and cytomegalovirus (CMV) (11.3 %) cases was observed in the immunocompromised group. The most frequently detected virus in the immunocompetent group was IFV (44.8 %), followed by respiratory syncytial virus (11.5 %), and human rhinovirus (9.2 %). During the non-influenza season, CMV (34.4 %) was the main virus detected in the immunocompromised group. The 30 day mortality rates of non-IFV patients were higher than those of IFV patients. Older age (>60 years), respiratory failure, persistent lymphocytopenia, invasive mechanical ventilation and non-IFV virus infection were significantly associated with increased 30 day mortality.ConclusionPatients with ILD who develop viral infection have high rates of morbidity and mortality, which are associated with increased age (>60 years), respiratory failure, mechanical ventilation, persistent lymphocytopenia and non-IFV virus infection. These risk factors should be carefully considered when determining treatment strategies for this patient population.

Evaluation of Ovarian Reserve Tests and Age in the Prediction of Poor Ovarian Response to Controlled Ovarian Stimulation-A Real-World Data Analysis of 89,002 Patients.

AimsThis study aimed to explore the value of ovarian reserve tests (ORTs) for predicting poor ovary response (POR) and whether an age cutoff could improve this forecasting, so as to facilitate clinical decision-making for women undergoing in vitro fertilization (IVF).MethodsA retrospective cohort study was conducted on poor ovary response (POR) patients using real-world data from five reproductive centers of university-affiliated hospitals or large academic hospitals in China. A total of 89,002 women with infertility undergoing their first traditional ovarian stimulation cycle for in vitro fertilization from January 2013 to December 2019 were included. The receiver operating characteristic (ROC) curve was performed to estimate the prediction value of POR by the following ORTs: anti-Mullerian hormone (AMH), antral follicle count (AFC), basal FSH (bFSH), as well as patient age.ResultsIn this retrospective cohort, the frequency of POR in the first IVF cycle was 14.8%. Age, AFC, AMH, and bFSH were used as predicting factors for POR, of which AMH and AFC were the best indicators when using a single factor for prediction (AUC 0.862 and 0.842, respectively). The predictive values of the multivariate model included age and AMH (AUC 0.865), age and AFC (AUC 0.850), age and all three ORTs (AUC 0.873). Compared with using a single factor alone, the combinations of ORTs and female age can increase the predictive value of POR. Adding age to single AMH model improved the prediction accuracy compared with AMH alone (AUC 0.865 vs. 0.862), but the improvement was not significant. The AFC with age model significantly improved the prediction accuracy of the single AFC model (AUC 0.846 vs. 0.837). To reach 90% specificity for POR prediction, the cutoff point for age was 38 years old with a sensitivity of 40.7%, 5 for AFC with a sensitivity of 55.9%, and 1.18 ng/ml for AMH with a sensitivity of 63.3%.ConclusionAFC and AMH demonstrated a high accuracy when using ROC regression to predict POR. When testing is reliable, AMH can be used alone to forecast POR. When AFC is used as a prediction parameter, age is suggested to be considered as well. Based on the results of the cutoff threshold analysis, AFC ≤ 5 and AMH ≤ 1.18 ng/ml should be recommended to predict POR more accurately in IVF/ICSI patients.

Characteristics of viral pneumonia in non-HIV immunocompromised and immunocompetent patients: a retrospective cohort study

BackgroundConcerning viral pneumonia, few large-scale comparative studies have been published describing non-HIV immunocompromised and immunocompetent patients, but the epidemiological characteristics of different viruses or underlying diseases in immunocompromised hosts are lacking.MethodsWe retrospectively recruited patients hospitalised with viral pneumonia from six academic hospitals in China between August 2016 and December 2019. We measured the prevalence of comorbidities, coinfections, nosocomial infections, and in-hospital mortalities.ResultsOf the 806 patients, 370 were immunocompromised and 436 were immunocompetent. The disease severity and in-hospital mortality of immunocompromised patients were higher than those of immunocompetent patients. During the influenza season, an increased number of cases of influenza virus (IFV) infection were found in the immunocompromised group, followed by cases of cytomegalovirus (CMV) and respiratory syncytial virus (RSV) infection. During the non-influenza season, CMV was the main virus detected in the immunocompromised group, while RSV, adenovirus (AdV), parainfluenza virus (PIV), and rhinovirus (HRV) were the main viruses detected in the immunocompetent group. Pneumonia caused by Pneumocystis jirovecii (22.4%), Aspergillus spp. (14.1%), and bacteria (13.8%) were the most frequently observed coinfections in immunocompromised patients but not in immunocompetent patients (Aspergillus spp. [10.8%], bacteria [7.1%], and Mycoplasma spp. [5.3%]). CMV infection and infection with two-or-more viruses were associated with a higher in-hospital mortality rate than non-IFV infection. However, patients with IFV and non-IFV infection in immunocompromised patients had similar disease severity and prognosis.ConclusionsImmunocompromised patients have a high frequency of coinfections, and a higher mortality rate was observed among those infected with CMV and two-or-more viruses. In addition, patients with IFV and non-IFV infection in immunocompromised patients had similar same disease severity and prognosis. The type of viral infection varied with seasons.