Microsatellite instability (MSI) as a result of deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR) is a key contributor to the development of tumors with a high mutation rate and cancer-specific neoantigens. dMMR identification can be beneficial for selection of immune checkpoint inhibitor (ICI) therapy-eligible patients. While multiple studies have focused on dMMR prevalence in colorectal cancer (CRC), fewer investigate the prevalence of dMMR in tumor types besides CRC, especially in Chinese patients. In this study, we aimed to determine the prevalence of dMMR in China across five gastrointestinal and gynecological tumor types. Tissue samples from Chinese patients with advanced endometrial, ovarian, cervical, biliary tract, or gastric metastatic or unresectable solid tumors were tested for dMMR status using immunohistochemistry with the Ventana MMR RxDx panel. Data were analyzed to determine the prevalence of dMMR for each tumor type. A total of 748 patients were included in the study, representing five tumor types. Prevalence of dMMR varied across tumor types, with an overall prevalence of 9.4%. Patients with endometrial tumors had the highest proportion of patients with dMMR at 49/164 (29.9%). Patients with cervical tumors had the lowest prevalence of dMMR with 6/221 (2.7%) patients. The prevalence of dMMR was similar across most demographic characteristics. In the dMMR population, co-occurring MLH1 and PMS2 protein loss across all tumor types was observed most commonly, in 48/70 (68.6%) patients. These data highlight the importance of dMMR testing in patients with advanced solid tumors in China to optimize biomarker testing and treatment decisions.

Bailing Capsules (BLC) and YongChongCao Capsules (YChCC) share similar medicinal components, but Yong Chong Cao benefit from more advanced cultivation and large-scale production. This study systematically compared their therapeutic effects in patients with mild-to-severe Chronic Obstructive Pulmonary Disease (COPD). This study was designed as a multicenter, single-blinded, randomized, active-controlled trial. 240 COPD patients were randomized 1:1 to receive YChCC or BLC for 24 weeks, followed by a 24‑week follow‑up. The primary endpoints were number of acute exacerbations. Secondary outcomes included, time to first exacerbation, and exacerbation duration, forced expiratory volume in 1 s (FEV1), FEV1%, forced vital capacity (FVC), FVC%, FEV1/FVC%, modified Medical Research Council dyspnea scale (mMRC), Chronic Obstructive Pulmonary Disease Assessment Test (CAT), and Chronic Obstructive Pulmonary Disease Clinical Questionnaire (CCQ). A total of 208 patients completed the trial (full analysis set, FAS), and 178 comprised the per‑protocol set (PPS). Compared with BLC, YChCC significantly reduced the number of acute exacerbations (FAS: p=0.002; PPS: p=0.003) and prolonged time to first exacerbation. No significant between‑group differences were observed in lung function parameters or mMRC, CAT, and CCQ scores. YChCC represent a promising adjuvant therapy for patients with stable COPD, ranging from mild to severe. They significantly prolong the time to the first acute exacerbation and reduce the frequency of acute exacerbations, thereby offering potential benefits in managing COPD. This trial has been registered at ClinicalTrials.gov under the registration number NCT03745261. NCT0374526.

Percutaneous transhepatic cholangioscopy (PTCS) is a minimally invasive treatment for biliary diseases; however, postoperative biliary drainage can impair quality of life and cause complications. We developed a biodegradable blockage (BB) for tract embolization to replace drainage; this is the first study investigating this approach after PTCS. In this prospective study, 10 patients with bile duct stones underwent PTCS with BB embolization (June-August 2024). Outcomes and complications were recorded over 3 months. A 1:1 propensity-matched control group from historical PTCS patients with standard drainage was established for comparison of hemoglobin levels and complications. BB placement was successful in all patients with no procedure-related deaths. No significant differences were found between the embolization and drainage groups in operative time, hemoglobin changes, or complication rates, though the small sample size warrants caution. One patient in the embolization group had a Grade II complication, versus three complications (two Grade I, one Grade II) in the drainage group. The embolization group had no serious adverse events during follow-up. Tract embolization with BB appears to be a safe and feasible alternative to conventional drainage after PTCS. Larger randomized trials are needed for validation.

To develop a core outcome set (COS) for clinical trials on post COVID-19 condition (PCC), that is, what, when, and how to measure PCC. A comprehensive collection of outcomes (including their measurement methods and phases) was launched via literature review and clinician and patient surveys. Two rounds of Delphi surveys were conducted under the predefined criteria for rating, followed by a consensus meeting to finalize the COS for PCC (COS-PCC). Fifty-two outcomes within 7 categories and 206 measurement methods were identified. Sixty participants from five stakeholder groups completed the first round of the Delphi survey and 41 the second. Consensus was reached among 36 representatives on four domains of respiratory, physical, neuropsychological, and health conditions, including nine core outcomes and their respective measurement methods of priority: dyspnea (modified Medical Research Council scale), cough (Leicester Cough Questionnaire), exercise capacity (6-min walk test), fatigue (Fatigue Severity Scale), pain (Numerical Rating Scale), sleeping disturbance (Pittsburgh Sleep Quality Index), anxiety (Generalized Anxiety Disorder Scale-7), depression (Patient Health Questionnaire-9), and health status (36-itemShortFormHealthSurvey); 16 optional measurement methods achieved consensus for supplement. Measuring phases of each core outcome were prioritized by importance through short and long terms of PCC. The COS-PCC highlights the key PCC concerns and provides an essential outcome set for PCC assessment in clinical trials and evidence synthesis. With improving the understanding of PCC and accumulating research evidence, the COS-PCC needs to be continuously updated and improved in practice.

Hypokalemia is a prevalent complication following pituitary adenoma (PA) surgery, adversely impacting patient prognosis. Identifying predictors of early postoperative hypokalemia is crucial for managing patients effectively. This study aims to develop an interpretable predictive model to predict postoperative hypokalemia in patients with PA and recognizes individualized significant parameters contributing to the predictive outcomes, thereby facilitating early intervention. This retrospective cohort study investigated postoperative hypokalemia in 280 patients with PA. We developed a Transformer-based predictive model, CliTab-Transformer, and compared it with an XGBoost-based model and a multilayer perceptron (MLP)-based deep learning model. Model performance was evaluated using metrics such as accuracy, precision, recall, F1 score, and ROC/PR curves, based on five-fold cross-validation. Model interpretability was assessed using a novel Transformer-Explainability method to identify significant parameters contributing to individual predictions. CliTab-Transformer outperformed XGBoost and MLP in predicting postoperative hypokalemia, showing higher accuracy (0.836 vs. 0.775 vs. 0.771), F1 score (0.845 vs. 0.792 vs. 0.766), sensitivity (0.838 vs. 0.833 vs. 0.771), and AUC (0.835 vs. 0.807 vs. 0.676). The model's interpretability analysis revealed that the preoperative factors, including gender, hypertension, serum potassium concentration, and disease duration, are significantly predictive of postoperative hypokalemia. Our model outperforms XGBoost in predicting early postoperative hypokalemia in patients with pituitary adenomas. We systematically explore attention mechanisms in clinical tabular data, demonstrating their effectiveness in capturing complex feature interactions, leading to more individualized, interpretable, and clinically meaningful insights.

Anlotinib, a multi-target small-molecule receptor tyrosine kinase inhibitor, can inhibit tumor angiogenesis proliferation and remains underexplored in metastatic breast cancer (MBC). Therefore, we aimed to analyze the efficacy and safety of anlotinib for MBC treatment in a real-world study. In this multicenter, retrospective study, patients with MBC who received anlotinib at four Chinese centers between January 2021 and December 2022 were enrolled (data cut-off date: February 1, 2025). The primary end point was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate, and adverse events (AEs). Statistical significance was defined at p<0.05. In total, 153 patients were included in this study (median age, 51 years). Median follow-up time was 30.0 months. A total of 86 (56.2%) patients were hormone receptor-positive/human epidermal growth factor receptor 2-negative, whereas the others were human epidermal growth factor receptor 2-positive (9.8%) or triple-negative breast cancer (34.0%). The median PFS and OS were 6.0 months (95% confidence interval [CI] 4.5-7.5) and 28.5 months (95% CI 20.3-36.7). The number of metastatic sites and Eastern Cooperative Oncology Group performance status were significant in Cox multivariate analysis (p=0.012 and p=0.030, respectively) and were significantly associated with PFS of anlotinib. Most AEs were clinically manageable, whereas Grade III/IV AEs included neutropenia (29.4%) and fatigue (6.5%). Anlotinib exhibits effective and safe anti-tumor activity in the treatment of MBC.

This study aimed to describe the incidence, mortality, and disease burden of tracheal, bronchial, and lung cancer (TBL) in both China and worldwide. We extracted estimates of the incidence, mortality, and disability-adjusted life years (DALYs) for TBL from the Global Burden of Disease 2021 database. The age-period-cohort model was employed to explore the impacts of age, period, and birth cohort on TBL. Joinpoint regression analysis examined long-term trends in TBL incidence, mortality, and DALYs. Correlation analysis was conducted to investigate the relationship between TBL disease burden in 2021 and the economic development level of the regions. In 2021, the global age-standardized incidence rate(ASIR), age-standardized mortality rate(ASMR), and age-standardized DALYs rate(ASDR) for TBL were 26 (95% uncertainty intervals [UI]: 24-29), 24 (95% UI: 21-26), and 533 (95% UI: 480-586) per 100,000 population. In all regions, regardless of economic level, male TBL incidence, mortality, and DALYs were significantly higher than those in females. After age 45, the ASIR, ASMR, and ASDR for TBL showed a geometric increase, peaking after age 85. Regions with higher economic levels faced higher TBL incidence and disease burden. In some less developed regions, the disease burden of TBL has shown an upward trend. The heterogeneous long-term trends observed across different sexes and age groups highlight the need for greater attention to issues such as excessive smoking and environmental exposure among middle-aged and elderly populations, particularly women.

The quality of drug clinical trials is crucial for authorizing new drugs and fostering innovations in clinical practice. This study aimed to report the status, trends, and factors of the quality of drug clinical trials in China. This mixed methods study assessed trial quality using quantitative data from public sources and qualitative data from focus groups and interviews with key stakeholders. The No Action Indicated findings issued by the Food and Drug Administration increased from 43% from 2009-2015 to 88% from 2016-2022, whereas the Official Action Indicated findings decreased from 9% to 0% (p = 0.001). The Center for Food and Drug Inspection revealed that 12% of new drug applications in 2015-2017 were suspected of data fabrication, compared to only 0.6% failed to pass the inspection in 2022 (p < 0.001). Number of drug trials published by Chinese institutions in top medical journals increased from 1.3% in 2009 to 4.9% in 2022 (p for trend <0.001). Moreover, the number of clinical trial guidelines increased from approximately 10/year from 2015-2019 to 50-60/year from 2020-2022, number of internationally accredited ethics committees increased from 4 in 2009 to 82 in 2022, and over 130,000 individuals received training on the International Council for Harmonization guidelines. Interviews with stakeholders revealed a consensus on quality improvement, attributed to seven key factors, and highlighted further recommendations to enhance clinical trial quality in China. The quality of drug clinical trials in China has significantly improved over the past decade, yet there remains scope for further enhancement.