BACKGROUND: Valvular heart disease (VHD) has become increasingly common with the aging in China. This study aimed to evaluate regional differences in the clinical features, management strategies, and outcomes of patients with VHD across different regions in China. METHODS: Data were collected from the China-VHD Study. From April 2018 to June 2018, 12,347 patients who presented with moderate or severe native VHD with a median of 2 years of follow-up from 46 centers at certified tertiary hospitals across 31 provinces, autonomous regions, and municipalities in Chinese mainland were included in this study. According to the locations of the research centers, patients were divided into five regional groups: eastern, southern, western, northern, and central China. The clinical features of VHD patients were compared among the five geographical regions. The primary outcome was all-cause mortality or rehospitalization for heart failure. Kaplan-Meier survival analysis was used to compare the cumulative incidence rate. RESULTS: Among the enrolled patients (mean age, 61.96 years; 6877 [55.70%] male), multiple VHD was the most frequent type (4042, 32.74%), which was mainly found in eastern China, followed by isolated mitral regurgitation (3044, 24.65%), which was mainly found in northern China. The etiology of VHD varied significantly across different regions of China. The overall rate of valve interventions was 32.67% (4008/12,268), with the highest rate in southern China at 48.46% (205/423). In terms of procedure, the proportion of transcatheter valve intervention was relatively low compared to that of surgical treatment. Patients with VHD in western China had the highest incidence of all-cause mortality or rehospitalization for heart failure. Valve intervention significantly improved the outcome of patients with VHD in all five regions (all P  <0.05). CONCLUSIONS: This study revealed that patients with VHD in China are characterized by significant geographic disparities in clinical features, treatment, and clinical outcomes. Targeted efforts are needed to improve the management and prognosis of patients with VHD in China according to differences in geographical characteristics. REGISTRATION ClinicalTrials.gov , NCT03484806.
Aged ; Female ; Humans ; Male ; Middle Aged ; China/epidemiology* ; Heart Valve Diseases/therapy* ; Kaplan-Meier Estimate ; Tertiary Care Centers ; Treatment Outcome

Objective:To develop an artificial intelligence (AI)-based platelet review strategy to identify abnormal platelet histograms with no significant difference between initial impedance platelet count (PLT-I) and PLT-F results.Methods:This study included 5 119 routine blood analysis in Nanfang Hospital of Southern Medical University and its Ganzhou branch from July 2023 and March 2024. Specimens exhibiting abnormal platelet histograms and an initial platelet count >40×10?/L underwent review using the fluorescent platelet count (PLT-F) channel. Consistency of the results was defined as a difference between impedance platelet count (PLT-I) and PLT-F less than ±20% of the PLT-F results. A deep learning model was developed using platelet and red blood cell histogram data from a training set of 3 807 specimens. The model′s diagnostic performance was evaluated on an independent external validation set ( n=805) using receiver operating characteristic (ROC) curve analysis. Changes in the number of reviewed samples and sample turnaround time were analyzed to assess its clinical utility. Results:The deep learning model based on platelet and red blood cell histograms achieved an area under the ROC curve (AUC) of 0.854 in the training set. At a cutoff value of 0.1, the sensitivity was 0.954 and specificity was 0.358. The model could reduce review by 16.80% (190/1 131). In the validation set, the AUC was 0.805, with a sensitivity of 0.955 and specificity of 0.307, corresponding to a reduction of 17.41% (47/270) in reviewed specimens.Conclusion:The platelet review prediction model developed based on deep learning technology can efficiently identify samples with consistent results before and after review, reducing unnecessary reviews and shortening specimen testing time, thereby improving the efficiency of platelet test.

Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.

Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.

Objective:To develop an artificial intelligence (AI)-based platelet review strategy to identify abnormal platelet histograms with no significant difference between initial impedance platelet count (PLT-I) and PLT-F results.Methods:This study included 5 119 routine blood analysis in Nanfang Hospital of Southern Medical University and its Ganzhou branch from July 2023 and March 2024. Specimens exhibiting abnormal platelet histograms and an initial platelet count >40×10?/L underwent review using the fluorescent platelet count (PLT-F) channel. Consistency of the results was defined as a difference between impedance platelet count (PLT-I) and PLT-F less than ±20% of the PLT-F results. A deep learning model was developed using platelet and red blood cell histogram data from a training set of 3 807 specimens. The model′s diagnostic performance was evaluated on an independent external validation set ( n=805) using receiver operating characteristic (ROC) curve analysis. Changes in the number of reviewed samples and sample turnaround time were analyzed to assess its clinical utility. Results:The deep learning model based on platelet and red blood cell histograms achieved an area under the ROC curve (AUC) of 0.854 in the training set. At a cutoff value of 0.1, the sensitivity was 0.954 and specificity was 0.358. The model could reduce review by 16.80% (190/1 131). In the validation set, the AUC was 0.805, with a sensitivity of 0.955 and specificity of 0.307, corresponding to a reduction of 17.41% (47/270) in reviewed specimens.Conclusion:The platelet review prediction model developed based on deep learning technology can efficiently identify samples with consistent results before and after review, reducing unnecessary reviews and shortening specimen testing time, thereby improving the efficiency of platelet test.

In the European Guideline on Management of Major Bleeding and Coagulopathy Following Trauma updated recently, there are 39 clinical practice recommendations that follow an approximate temporal path for management of the bleeding trauma patient, with recommendations grouped behind key decision points, including initial resuscitation and prevention of further bleeding, diagnosis and monitoring of bleeding, rapid control of bleeding, initial management of bleeding and coagulopathy, further goal-directed coagulation management, management of antithrombotic agents, thromboprophylaxis, guideline implementation and quality control, as welll as the management of tissue oxygenation, volume, fluids and temperature. In this paper, we introduce the recommendations and rationale of the guideline and add some newly published clinical study evidence. These information would be very helpful to the development and training of the guidelines or protocols for the management of the trauma patient with major haemorrhage and coagulopathy in China.

Evidenced based and practical guidelines have important role in the decrease of mobility and mortality of the patients with major haemorrhage. Recently, British Society for Haematology updated a guideline on haematological management of major haemorrhage, which provides the recommendations in general and on alternatives to transfusion, obstetric haemorrhage, gastrointestinal haemorrhage, trauma and surgery, and the good practice statements for laboratory/organisational support. The comprehensive and instructive recommendations presented in the guideline will be good references for and assist in the education and development of the guidelines or protocols for the management of the patient with major haemorrhage in China.

Purpose: This study aims to comprehensively evaluate the clinical efficacy of chemotherapy or endocrine therapy maintenance in metastatic breast cancer (MBC) patients. Materials and Methods: The meta-analysis of randomized clinical trials (RCTs) and propensity score matching of multicenter cohort study evaluated MBC patients who underwent first-line chemotherapy or endocrine therapy maintenance. This study is registered with PROSPERO: CRD42017071858 and ClinicalTrials.gov: NCT04258163. Results: A total of 2,867 patients from 15 RCTs and 760 patients from multicenter cohort were included. The results from meta-analysis showed that chemotherapy maintenance improved progression-free survival (PFS) (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.54 to 0.73; p < 0.001; moderate-quality evidence) and overall survival (OS) (HR, 0.87; 95% CI 0.78 to 0.97; p=0.016; high-quality evidence) than observation. In the cohort study, for hormone receptor–positive MBC patients, chemotherapy maintenance improved PFS (HR, 0.67; 95% CI, 0.52 to 0.85; p < 0.001) and OS (HR, 0.55; 95% CI 0.42 to 0.73; p < 0.001) compared with observation, and endocrine therapy maintenance also improved PFS (HR, 0.65; 95% CI, 0.53 to 0.80; p < 0.001) and OS (HR, 0.55; 95% CI, 0.44 to 0.69; p < 0.001). There were no differences between chemotherapy and endocrine therapy maintenance in PFS and OS (all p > 0.05). Regardless of the continuum or switch maintenance therapy, showed prolonged survival in MBC patients who were response to first-line treatment. Conclusion This study provided evidences for survival benefits of chemotherapy and endocrine therapy maintenance in MBC patients, and there was no difference efficacy between chemotherapy and endocrine therapy maintenance for hormone receptor–positive patients.

Objective:To investigate the predictive neutrophil/lymphocyte ratio (NLR) combined with soluble growth stimulating expression gene 2 protein (sST2) on in-hospital major adverse cardiovascular events (MACE) in patients with myocardial injury following moderate-severe acute carbon monoxide poisoning (ACOP).Methods:A single-cente prospective observational approach was conducted. Moderate-severe ACOP patients with myocardial damage from November 2016 to February 2020 in department of emergency medicine of Harrison International Peace Hospital Affiliated to Hebei Medical University were enrolled. The baseline data of the patients, NLR and sST2 (T0 sST2) on admission, sST2 at 3 days after admission (T3 d sST2), and the other myocardial injury and biochemical indicators were collected. According to whether MACE occurred, the patients were divided into MACE group and non-MACE group. The clinical data of the two groups were compared. Pearson correlation analysis was used to analyze the correlation of each index. Binary Logistic regression was used to analyze the independent risk factors of in-hospital MACE in patients with moderate-severe ACOP myocardial injury. The receiver operator characteristic curve (ROC curve) was drawn and area under ROC curve (AUC) was calculated to analyze the predictive value of NLR, sST2, and NLR combined with sST2 for the occurrence of in-hospital MACE in patients with moderate-severe ACOP myocardial injury.Results:A total of 278 patients with moderate-severe ACOP myocardial injury were included in the final analysis, and the incidence of MACE was 11.51% (32/278). Cardiac troponin I (cTnI), lactic acid (Lac), NLR, and T3 d sST2 in the MACE group were significantly higher than those in the non-MACE group [cTnI (μg/L): 0.83±0.15 vs. 0.46±0.37, Lac (mmol/L): 2.96±1.14 vs. 2.43±1.35, NLR: 13.14±4.37 vs. 9.49±4.21, T3 d sST2 (μg/L): 59.88±23.42 vs. 39.83±12.60, all P < 0.05], there was no significant difference in T0 sST2 between the MACE group and the non-MACE group (μg/L: 269.09±90.89 vs. 240.14±113.02, P > 0.05). Pearson correlation analysis showed that there were significantly positive correlations in NLR with acute physiology and chronic health evaluationⅡ(APACHEⅡ), T3 d sST2 with APACHEⅡ, and NLR with T3 d sST2 ( r values were 0.226, 0.209, 0.193, all P < 0.01). Binary Logistic regression analysis showed that T3 d sST2 and NLR were both independent risk factors for MACE in moderate-severe ACOP patients with myocardial injury [odds ratio ( OR) and 95% confidence interval (95% CI) respectively was 1.064 (1.039-1.090), 1.176 (1.066-1.298), both P < 0.01]. ROC curve analysis showed that the predictive efficacy of NLR combined with T3 d sST2 for the occurrence of in-hospital MACE in patients with ACOP myocardial injury (AUC = 0.876) was better than that of NLR (AUC = 0.754) and T3 d sST2 (AUC = 0.813). When the optimal critical value of NLR was 10.02 and that of T3 d sST2 was 43.50 μg/L, the sensitivity of predicting the occurrence of MACE in patients with moderate-severe ACOP myocardial injury was 69.8% and 86.2% respectively, and the specificity was 74.3% and 70.4%, respectively. The specificity and sensitivity of the combined detection was 83.4% and 79.8%, respectively. Conclusions:NLR and T3 d sST2 were independent predictors of in-hospital MACE in moderate-severe ACOP patients with myocardial injury, and combined application of NLR and T3 d sST2 had good predictive value. For patients with moderate-severe ACOP myocardial injury with NLR > 10.02 and T3 d sST2 > 43.50 μg/L, the occurrence of in-hospital MACE should be alert.

Objective:To compare the clinical effects of discectomy combined with transpedicular dynamic stabilization and transforaminal lumbar interbody fusion (TLIF) in treating single-level lumbar disc herniation.Methods:From November 2012 to November 2015, a total of 96 patients with single-level lumbar disc herniation (disc height decreased more than 1/3, the width of the basilar part of the herniated disc >6 mm, massive disc herniation or Modic type I endplate changes) treated by discectomy combined with Dynesys dynamic stabilization (Dynesys group, n=48) or TLIF (fusion group, n=48) were enrolled. Clinical assessments included operation duration, intraoperative blood loss, MacNab score, visual analogue scale (VAS), Oswestry disability index (ODI) and rate of complications. Radiographs were evaluated for lumbar mobility, intervertebral height, etc. Results:A total of 86 patients were included in the final analysis (44 in Dynesys group and 42 in fusion group) and were evaluated after 5 years follow-up. The operation duration of Dynesys group (159.61±37.29 min) was less than that of the fusion group (177.42±39.90 min) significantly ( t=2.140, P=0.035). Intraoperative blood loss in Dynesys group (151.78±50.88 ml) was less than that in fusion group (197.74±76.55 ml) with significant difference ( t=3.293, P=0.001). At 5 years follow-up, there were 2 cases with screw loosening and 5 cases with adjacent segmental degeneration in Dynesys group without symptom. In fusion group, there were 12 cases with adjacent segmental degeneration and two of them with symptom. There were significant differences in the incidence of adjacent segment degeneration between the two groups ( χ2=4.012, P=0.045). According to the MacNab criteria, excellent or good cases accounted for 95% in Dynesys group and 93% in fusion group without significant differences ( Z=0.425, P=0.671). VAS back, VAS leg and ODI scores were improved significantly in both groups after 2 years and 5 years ( P<0.05). However, there were no significant differences between the two groups ( P<0.05). The activity of the surgical segment was 4.59°±0.48° in Dynesys group and 1.00°±0.42° in fusion group at 5 years after surgery. The height of intervertebral space in Dynesys group decreased from 11.19±2.07 mm before surgery to 9.98±2.02 mm at 2 years after surgery and to 9.86±1.64 mm at 5 years after surgery ( F=6.462, P=0.002). However, there was no statistically significant difference between the 2 and 5 years follow-up ( q=0.415, P>0.05). At 5 years after surgery, the activity of the first proximal segment in the two groups was 9.74°±3.29° and 11.69°±3.89°, respectively ( t=2.514, P=0.014). Conclusion:Both discectomy combined with dynamic stabilization and TLIF can achieve satisfied clinical effects in treating single-level lumbar disc herniation. Dynamic stabilization preserves the intervertebral activity of surgical segments and results in a lower incidence of adjacent segment degeneration compared with that in fusion surgery. Furthermore, discectomy combined with dynamic stabilization is a less invasive intervention with shorter operation duration and less blood loss compared with TLIF.