Azvudine and nirmatrelvir/ritonavir (Paxlovid) are recommended for COVID-19 treatment in China, but their safety and efficacy in the elderly population are not fully known. In this multicenter, retrospective, cohort study, we identified 5131 elderly hospitalized COVID-19 patients from 32,864 COVID-19 patients admitted to nine hospitals in Henan Province, China, from December 5, 2022, to January 31, 2023. The primary outcome was all-cause death, and the secondary outcome was composite disease progression. Propensity score matching (PSM) was performed to control for confounding factors, including demographics, vaccination status, comorbidities, and laboratory tests. After 2:1 PSM, 1786 elderly patients receiving azvudine and 893 elderly patients receiving Paxlovid were included. Kaplan-Meier and Cox regression analyses revealed that compared with Paxlovid group, azvudine could significantly reduce the risk of all-cause death (log-rank P = 0.002; HR: 0.71, 95% CI: 0.573-0.883, P = 0.002), but there was no difference in composite disease progression (log-rank P = 0.52; HR: 1.05, 95% CI: 0.877-1.260, P = 0.588). Four sensitivity analyses verified the robustness of above results. Subgroup analysis suggested that a greater benefit of azvudine over Paxlovid was observed in elderly patients with primary malignant tumors (P for interaction = 0.005, HR: 0.32, 95% CI: 0.18-0.57) compared to patients without primary malignant tumors. Safety analysis revealed that azvudine treatment had a lower incidence of adverse events and higher lymphocyte levels than Paxlovid treatment. In conclusion, azvudine treatment is not inferior to Paxlovid treatment in terms of all-cause death, composite disease progression and adverse events in elderly hospitalized COVID-19 patients.

Objective To review clinical trial registration status of TCM treatment for coronary microvascular disease;To analyze the effectiveness and safety of TCM in treating coronary microvascular disease.Methods The clinical trials of TCM in the treatment of coronary artery microvascular disease included in the Chinese Clinical Trials Registry and the US Clinical Trials Registry from the establishment of the database to January 31,2024 were retrieved,and the general characteristics(time,region,funding source),design type,intervention regimen and outcome indicators of the included clinical trials were extracted and analyzed using Excel 2019 software.Results A total of 17 clinical trials were included,including 16 pre-registrations.The registered units were distributed in 5 provinces across the country,involving 17 registration institutions.The two regions with the most distribution were Shanghai(6 studies,35.29%)and Beijing(5 studies,29.41%).The types of studies were mainly interventional studies,and most of the study designs were randomized parallel controlled studies(16 studies,94.12%).A total of 8 interventions were reported,including Chinese patent medicine,TCM decoction,TCM intravenous preparation,and acupuncture and moxibustion.A total of 143 outcome indicators were designed,including 10 first-level indicators,including coronary artery microcirculation,clinical efficacy,symptoms and signs,TCM syndromes,quality of life,exercise tolerance,cardiac function,physical and chemical testing,safety,and pharmacoeconomic evaluation.Conclusion The registration of clinical trials by TCM in the treatment of coronary microvascular diseases has been gradually receiving attention from researchers,but the overall number is still small.At present,the study needs to be optimized in terms of study design and index selection.

Objective:To evaluate the clinical efficacy of percutaneous balloon pulmonary valvuloplasty (PBPV) via antegrade venous-arterial loop in neonates with critical pulmonary stenosis with intact ventricular septum (CPS-IVS).Methods:A retrospective case review was conducted. Fifteen neonates with CPS-IVS who underwent PBPV via antegrade venous-arterial loop at the Women and Children′s Hospital, Qingdao University between September 2020 and September 2023 were included. Pre-and post-operative right ventricular functional parameters, surgical complications, and follow-up outcomes were analyzed. Paired-sample t-test was used to compare changes in right ventricular systolic pressure (RVSP), percutaneous oxygen saturation (SpO 2), and echocardiographic findings pre-and post-operatively, as well as during the follow-up period. Results:Among the 15 neonates (9 males and 6 females) with CPS-IVS, the surgical age was (3.6±0.5) d. All neonates underwent successful PBPV via antegrade venous-arterial loop under general anesthesia. The immediate post-operative trans-pulmonary valve pressure gradient was (35±6) mmHg (1 mmHg=0.133 kPa), with a significant reduction in RVSP from (96±16) mmHg to (59±14) mmHg ( t=6.70, P<0.001). SpO 2 (with an inspired oxygen concentration of 0.48) increased from 0.86±0.07 pre-operatively to 0.97±0.03 post-operatively ( t=4.81, P<0.001). One month postoperatively, SpO 2 (without oxygen supplementation) normalized in all patients, with a statistically significant difference compared to pre-operative values ( t=0.16, P<0.001). Immediately postoperative, mild to moderate diastolic pulmonary valve regurgitation was observed in 8 patients, with no cases of severe regurgitation. Additionally, the severity of tricuspid valve regurgitation decreased from severe to mild-to-moderate in 6 patients. Three months postoperatively, one patient underwent a second PBPV due to an increased trans-pulmonary valve pressure gradient of 74 mmHg, which decreased to 27 mmHg immediately after the procedure, with subsequent good recovery. Over a one-year follow-up period, all 15 patients demonstrated improvements in right ventricular indices. The Z-score of the tricuspid valve annulus significantly improved from -1.9±0.8 pre-operatively to -0.4±0.1 post-operatively ( t=6.88, P<0.001). At the last follow-up, mild to moderate pulmonary valve regurgitation was observed in 3 patients, and mild tricuspid regurgitation in 2 patients, with no cases of moderate or severe regurgitation. Conclusion:Intervention via antegrade venous-arterial loop for the treatment of CPS-IVS in neonates is safe and effective.

Objective:To investigate the feasibility of ductus arteriosus (DA) stent placement through femoral artery approach without guiding catheter.Methods:In this retrospective case study, the birth weight, intervention age, preoperative echocardiography, intraoperative angiography and other clinical data, as well as the follow-up status (Nakata index and final circulatory status, etc.) of 15 patients with congenital heart disease who are dependent on the DA for pulmonary circulation at Women and Children′s Hospital, Qingdao University between January 2018 to June 2023 were collected. All pediatric patients underwent placement of a DA stent without a guiding catheter, the efficacy and safety of this approach were analyzed.Results:Among all 15 cases, there were 9 males and 6 females, with the birth weight of (3.3±0.3) kg and the intervention age of (15.0±0.1) d. Of which, there were 9 cases of pulmonary atresia with intact ventricular septum (PA-IVS), and 6 cases of critical pulmonary stenosis (CPS) with intact ventricular septum. The tricuspid annulus diameter before intervention was (8.8±0.8) mm, and the tricuspid annulus Z-score was -0.7±0.9. There were 3 cases of mild right ventricular dysplasia, 9 cases of moderate dysplasia, and 3 cases of severe dysplasia. All patients successfully completed the intervention without major complications. The narrowest diameter of the DA was (2.2±0.1) mm, the diameter of the DA stent was (3.9±0.3) mm, the preoperative percutaneous oxygen saturation (SpO 2) was 0.83±0.03, and the postoperative SpO 2 was 0.96±0.02. The follow-up time was (7.0±0.5) months. The Nakata index was (163±30) mm 2/m 2 before intervention, and was (173±34) mm 2/m 2 at the last follow-up. Biventricular circulation was successfully achieved in 14 patients, and the other one patient currently under close observation. Conclusion:The placement of a ductus arteriosus stent through femoral artery retrogradely without guiding catheter could serve as an effective and safe plan for neonates with PA-IVS or CPS accompanied by hypoplastic right heart syndrome.

Objective:To evaluate the clinical characteristics and prognosis of transcatheter closure of secundum atrial septal defect (ASD) in infants.Methods:A retrospective analysis was conducted on 83 cases with secundum ASD who underwent transcatheter closure at the Women and Children′s Hospital of Qingdao University from January 2010 to December 2021. The clinical data included general information, pre- and post-operative echocardiography and electrocardiography, surgery records, and follow-up outcomes. The children who underwent successful occlusion were divided into two groups based on the presence or absence of pulmonary hypertension: the normal group and the pulmonary hypertension group. Differences between the two groups in terms of age, weight, right ventricular end-diastolic diameter, maximum ASD diameter, occluder size, and pulmonary-to-systemic flow ratio (Qp/Qs) were compared. Intergroup comparisons were performed using the Wilcoxon test.Results:Among the 83 infants with secundum ASD, 12 were males and 71 were females, with the age of (10.8±1.6) months. There were 29 cases (35%) with weight-for-age below the median level (less than the 25th percentile), 19 cases (23%) with recurrent or refractory pulmonary infections, and 40 cases (48%) with pulmonary hypertension. In this study, 81 cases (97%) successfully completed the procedure, while 2 cases failed due to soft defect margins. Postoperative arrhythmias occurred in 12 cases, of which 11 were transient arrhythmia; one case of atrioventricular block returned to normal rhythm after surgical removal of the occluder. The 81 infants who underwent successful occlusion were divided into normal group (41 cases) and pulmonary hypertension group (40 cases). The pulmonary artery systolic pressure, maximum diameter of ASD, the size of the occluder, and the cardiothoracic ratio were higher in the pulmonary hypertension group compared to those in the normal group, while the Qp/Qs value was lower (all P<0.05). Follow-up results indicated that infants with ASD who underwent transcatheter closure had no new arrhythmias, residual shunts, or intervention-related mortality. Within one year postoperatively, all infants exhibited normalization of right ventricular dimensions and pulmonary artery pressure. During a 3-year follow-up, all 29 cases that originally had a weight-for-age below the median level exhibited catch-up growth, reaching above the median level. Conclusions:Transcatheter closure for secundum ASD in infants is safe and feasible. Follow-up indicates that early transcatheter closure may be necessary for larger ASD diameters combined with pulmonary hypertension, with significant clinical improvement postoperatively.

Objective To review clinical trial registration status of TCM treatment for coronary microvascular disease;To analyze the effectiveness and safety of TCM in treating coronary microvascular disease.Methods The clinical trials of TCM in the treatment of coronary artery microvascular disease included in the Chinese Clinical Trials Registry and the US Clinical Trials Registry from the establishment of the database to January 31,2024 were retrieved,and the general characteristics(time,region,funding source),design type,intervention regimen and outcome indicators of the included clinical trials were extracted and analyzed using Excel 2019 software.Results A total of 17 clinical trials were included,including 16 pre-registrations.The registered units were distributed in 5 provinces across the country,involving 17 registration institutions.The two regions with the most distribution were Shanghai(6 studies,35.29%)and Beijing(5 studies,29.41%).The types of studies were mainly interventional studies,and most of the study designs were randomized parallel controlled studies(16 studies,94.12%).A total of 8 interventions were reported,including Chinese patent medicine,TCM decoction,TCM intravenous preparation,and acupuncture and moxibustion.A total of 143 outcome indicators were designed,including 10 first-level indicators,including coronary artery microcirculation,clinical efficacy,symptoms and signs,TCM syndromes,quality of life,exercise tolerance,cardiac function,physical and chemical testing,safety,and pharmacoeconomic evaluation.Conclusion The registration of clinical trials by TCM in the treatment of coronary microvascular diseases has been gradually receiving attention from researchers,but the overall number is still small.At present,the study needs to be optimized in terms of study design and index selection.

Objective:To evaluate the clinical efficacy of percutaneous balloon pulmonary valvuloplasty (PBPV) via antegrade venous-arterial loop in neonates with critical pulmonary stenosis with intact ventricular septum (CPS-IVS).Methods:A retrospective case review was conducted. Fifteen neonates with CPS-IVS who underwent PBPV via antegrade venous-arterial loop at the Women and Children′s Hospital, Qingdao University between September 2020 and September 2023 were included. Pre-and post-operative right ventricular functional parameters, surgical complications, and follow-up outcomes were analyzed. Paired-sample t-test was used to compare changes in right ventricular systolic pressure (RVSP), percutaneous oxygen saturation (SpO 2), and echocardiographic findings pre-and post-operatively, as well as during the follow-up period. Results:Among the 15 neonates (9 males and 6 females) with CPS-IVS, the surgical age was (3.6±0.5) d. All neonates underwent successful PBPV via antegrade venous-arterial loop under general anesthesia. The immediate post-operative trans-pulmonary valve pressure gradient was (35±6) mmHg (1 mmHg=0.133 kPa), with a significant reduction in RVSP from (96±16) mmHg to (59±14) mmHg ( t=6.70, P<0.001). SpO 2 (with an inspired oxygen concentration of 0.48) increased from 0.86±0.07 pre-operatively to 0.97±0.03 post-operatively ( t=4.81, P<0.001). One month postoperatively, SpO 2 (without oxygen supplementation) normalized in all patients, with a statistically significant difference compared to pre-operative values ( t=0.16, P<0.001). Immediately postoperative, mild to moderate diastolic pulmonary valve regurgitation was observed in 8 patients, with no cases of severe regurgitation. Additionally, the severity of tricuspid valve regurgitation decreased from severe to mild-to-moderate in 6 patients. Three months postoperatively, one patient underwent a second PBPV due to an increased trans-pulmonary valve pressure gradient of 74 mmHg, which decreased to 27 mmHg immediately after the procedure, with subsequent good recovery. Over a one-year follow-up period, all 15 patients demonstrated improvements in right ventricular indices. The Z-score of the tricuspid valve annulus significantly improved from -1.9±0.8 pre-operatively to -0.4±0.1 post-operatively ( t=6.88, P<0.001). At the last follow-up, mild to moderate pulmonary valve regurgitation was observed in 3 patients, and mild tricuspid regurgitation in 2 patients, with no cases of moderate or severe regurgitation. Conclusion:Intervention via antegrade venous-arterial loop for the treatment of CPS-IVS in neonates is safe and effective.

Objective:To investigate the feasibility of ductus arteriosus (DA) stent placement through femoral artery approach without guiding catheter.Methods:In this retrospective case study, the birth weight, intervention age, preoperative echocardiography, intraoperative angiography and other clinical data, as well as the follow-up status (Nakata index and final circulatory status, etc.) of 15 patients with congenital heart disease who are dependent on the DA for pulmonary circulation at Women and Children′s Hospital, Qingdao University between January 2018 to June 2023 were collected. All pediatric patients underwent placement of a DA stent without a guiding catheter, the efficacy and safety of this approach were analyzed.Results:Among all 15 cases, there were 9 males and 6 females, with the birth weight of (3.3±0.3) kg and the intervention age of (15.0±0.1) d. Of which, there were 9 cases of pulmonary atresia with intact ventricular septum (PA-IVS), and 6 cases of critical pulmonary stenosis (CPS) with intact ventricular septum. The tricuspid annulus diameter before intervention was (8.8±0.8) mm, and the tricuspid annulus Z-score was -0.7±0.9. There were 3 cases of mild right ventricular dysplasia, 9 cases of moderate dysplasia, and 3 cases of severe dysplasia. All patients successfully completed the intervention without major complications. The narrowest diameter of the DA was (2.2±0.1) mm, the diameter of the DA stent was (3.9±0.3) mm, the preoperative percutaneous oxygen saturation (SpO 2) was 0.83±0.03, and the postoperative SpO 2 was 0.96±0.02. The follow-up time was (7.0±0.5) months. The Nakata index was (163±30) mm 2/m 2 before intervention, and was (173±34) mm 2/m 2 at the last follow-up. Biventricular circulation was successfully achieved in 14 patients, and the other one patient currently under close observation. Conclusion:The placement of a ductus arteriosus stent through femoral artery retrogradely without guiding catheter could serve as an effective and safe plan for neonates with PA-IVS or CPS accompanied by hypoplastic right heart syndrome.

Objective:To evaluate the clinical characteristics and prognosis of transcatheter closure of secundum atrial septal defect (ASD) in infants.Methods:A retrospective analysis was conducted on 83 cases with secundum ASD who underwent transcatheter closure at the Women and Children′s Hospital of Qingdao University from January 2010 to December 2021. The clinical data included general information, pre- and post-operative echocardiography and electrocardiography, surgery records, and follow-up outcomes. The children who underwent successful occlusion were divided into two groups based on the presence or absence of pulmonary hypertension: the normal group and the pulmonary hypertension group. Differences between the two groups in terms of age, weight, right ventricular end-diastolic diameter, maximum ASD diameter, occluder size, and pulmonary-to-systemic flow ratio (Qp/Qs) were compared. Intergroup comparisons were performed using the Wilcoxon test.Results:Among the 83 infants with secundum ASD, 12 were males and 71 were females, with the age of (10.8±1.6) months. There were 29 cases (35%) with weight-for-age below the median level (less than the 25th percentile), 19 cases (23%) with recurrent or refractory pulmonary infections, and 40 cases (48%) with pulmonary hypertension. In this study, 81 cases (97%) successfully completed the procedure, while 2 cases failed due to soft defect margins. Postoperative arrhythmias occurred in 12 cases, of which 11 were transient arrhythmia; one case of atrioventricular block returned to normal rhythm after surgical removal of the occluder. The 81 infants who underwent successful occlusion were divided into normal group (41 cases) and pulmonary hypertension group (40 cases). The pulmonary artery systolic pressure, maximum diameter of ASD, the size of the occluder, and the cardiothoracic ratio were higher in the pulmonary hypertension group compared to those in the normal group, while the Qp/Qs value was lower (all P<0.05). Follow-up results indicated that infants with ASD who underwent transcatheter closure had no new arrhythmias, residual shunts, or intervention-related mortality. Within one year postoperatively, all infants exhibited normalization of right ventricular dimensions and pulmonary artery pressure. During a 3-year follow-up, all 29 cases that originally had a weight-for-age below the median level exhibited catch-up growth, reaching above the median level. Conclusions:Transcatheter closure for secundum ASD in infants is safe and feasible. Follow-up indicates that early transcatheter closure may be necessary for larger ASD diameters combined with pulmonary hypertension, with significant clinical improvement postoperatively.

In order to preliminarily evaluate the efficacy and safety of endoscopic intermuscular dissection (EID) for the treatment of rectal neuroendocrine tumors (R-NETs), a retrospective observational study was conducted on 8 consecutive patients with R-NETs confirmed by postoperative pathology at South China Hospital, Medical School, Shenzhen University from January 2022 to October 2023. The therapeutic efficacy, incidence of complications, and follow-up results were mainly analyzed. The results showed that all 8 cases achieved complete resection after EID, with operation times ranging from 40 to 90 minutes. No bleeding, perforation, fever or electrocoagulation syndrome occurred after operation. The hospital stay was 4 to 6 days. During follow-up of 3 to 24 months, there was no local recurrence or metastasis. Therefore, a preliminary conclusion can be drawn that EID is a safe and feasible treatment for R-NETs.