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 explore the clinical efficacy and safety of transarterial chemoembolization(TACE)combined with immune checkpoint inhibitor(ICI)and molecular targeted therapy for Child-Pugh grade B hepatocellular carcinoma(HCC).Methods The patients with Child-Pugh grade B HCC,who received TACE combined with ICI and molecular targeted therapy(combination group)or TACE monotherapy(monotherapy group)at the three medical centers including the Affiliated Zhongda Hospital of Southeast University of China between January 2018 and May 2021,were enrolled in this study.The primary outcome was overall survival(OS),and the secondary outcomes included progression-free survival(PFS),objective response rate(ORR),and clinical safety.Results A total of 126 patients were enrolled in this study,including 64 patients in the combination group and 62 patients in the monotherapy group.No statistically significant difference in median OS existed between the combination group and the monotherapy group[17.7 months(95％CI:11.9-29.9 months)vs.13.2 months(95％CI:7.8-19.9 months);P=0.160].In the combination group,the patients having a Child-Pugh score of 7 points obtained a significantly better OS[19.0months(95％CI:13.6-NR)vs.13.2 months(95％CI:8.0-NR),P=0.024].The differences in the median PFS and ORR between the two groups were not statistically significant(P=0.720 and P=0.960 respectively).Grade Ⅲ/Ⅳ adverse events occurred in 19 patients(14.1％)of the combination group and in 6 patients(9.7％)of the monotherapy group.Conclusion In treating patients with Child-Pugh grade B HCC,TACE combined with ICI and molecular targeted therapy does not show a better prognosis than TACE monotherapy,however,the patients having a Child-Pugh score of 7 points in the combination group can have a much better OS.

Objective:To construct assessment and evaluation system of clinical research and its application in practice. To explore the reliability, validity and discrimination of this index system, and evaluate its effect.Methods:The cluster was randomly sampled from 54 clinical departments. Taking the department as units, all individuals in each department was conducted a questionnaire survey for empirical analysis. Cronbach's coefficient and factor analysis were used to verify the reliability and validity of the index system. The correlation coefficient method was used to analyze the discrimination. The t-test method was used to calculate the discrimination. Extreme grouping method was used to compare the difference between high grouping and low grouping to validate the difference of each index.Results:Cronbach′s α of the whole index system is 0.840. Through exploratory factor analysis, four common factors were extracted, and the cumulative contribution rate is 56.278%. Through correlation coefficient method and t-test method, results show that except for the " concluding situation" , " number of visitors to clinical scientists workstation" and " personnel selected into talent category clinical research program" , the differences of other indicators were statistically significant ( P<0.05), and the distinguish index was between 0.31 and 0.64. Conclusions:The clinical research assessment system has good reliability and validity. And the discrimination is good. The index system can accurately assess the clinical research situation. It can be used for reference in assessment of clinical efficiency.

According to multicenter randomized controlled trials, laparoscopic radical resection of colon cancer has the same short and long term clinical efficacy as traditional open surgery. In laparoscopic radical resection of right semicolon cancer, it is important to separate the embryonic plane of the root, and to ligate and cut off the central vascular roots. Only by separation along the membrane space can one achieve minimally invasive operation with no bleeding, and ensure the integrity of the excision of the mesangium and avoid damage of internal fascia and other organs. The mesangial distribution of the right semicolon is adjacent to the mesangium of the stomach and is connected to the mesentery of the small intestine. The pancreaticoduodenum locates between the right semicolon mesentery and the retroperitoneal subperitoneal fascia. In particular, the relationship between the anterior and posterior Treitz fascia of the pancreaticoduodenum and the Toldt space is complex, which is closely related to the feasibility of complete mesocolic excision(CME). This article introduces the distribution of intermembranous space and mesangial bed in the right semicolon, presenting the problem in CME surgery. In addition, there are key points in identifying the gap between the membranes based on the author’s experience and we propose a new evaluation criteria for membrane surgical specimens, which has certain guiding significance for radical CME surgery for right semicolon cancer.

According to multicenter randomized controlled trials, laparoscopic radical resection of colon cancer has the same short and long term clinical efficacy as traditional open surgery. In laparoscopic radical resection of right semicolon cancer, it is important to separate the embryonic plane of the root, and to ligate and cut off the central vascular roots. Only by separation along the membrane space can one achieve minimally invasive operation with no bleeding, and ensure the integrity of the excision of the mesangium and avoid damage of internal fascia and other organs. The mesangial distribution of the right semicolon is adjacent to the mesangium of the stomach and is connected to the mesentery of the small intestine. The pancreaticoduodenum locates between the right semicolon mesentery and the retroperitoneal subperitoneal fascia. In particular, the relationship between the anterior and posterior Treitz fascia of the pancreaticoduodenum and the Toldt space is complex, which is closely related to the feasibility of complete mesocolic excision(CME). This article introduces the distribution of intermembranous space and mesangial bed in the right semicolon, presenting the problem in CME surgery. In addition, there are key points in identifying the gap between the membranes based on the author’s experience and we propose a new evaluation criteria for membrane surgical specimens, which has certain guiding significance for radical CME surgery for right semicolon cancer.

According to multicenter randomized controlled trials, laparoscopic radical resection of colon cancer has the same short and long term clinical efficacy as traditional open surgery. In laparoscopic radical resection of right semicolon cancer, it is important to separate the embryonic plane of the root, and to ligate and cut off the central vascular roots. Only by separation along the membrane space can one achieve minimally invasive operation with no bleeding, and ensure the integrity of the excision of the mesangium and avoid damage of internal fascia and other organs. The mesangial distribution of the right semicolon is adjacent to the mesangium of the stomach and is connected to the mesentery of the small intestine. The pancreaticoduodenum locates between the right semicolon mesentery and the retroperitoneal subperitoneal fascia. In particular, the relationship between the anterior and posterior Treitz fascia of the pancreaticoduodenum and the Toldt space is complex, which is closely related to the feasibility of complete mesocolic excision(CME). This article introduces the distribution of intermembranous space and mesangial bed in the right semicolon, presenting the problem in CME surgery. In addition, there are key points in identifying the gap between the membranes based on the author’s experience and we propose a new evaluation criteria for membrane surgical specimens, which has certain guiding significance for radical CME surgery for right semicolon cancer.

Objective To compare the prognostic ability of Hong Kong Liver Cancer (HKLC) staging system with that of Barcelona Clinic Liver Cancer (BCLC) staging system for Chinese patients with hepatocellular carcinoma (HCC) after receiving transarterial chemoembolization (TACE).Methods The clinical data of 180 Chinese patients with primary HCC,who were treated with TACE during the period from August 2008 to December 2015,were retrospectively analyzed.HCC staging of each patient was scored by two staging methods separately.Kaplan-Meier analysis was adopted to separately calculate the median survival time of each stage that was judged by the two staging methods.The likelihood ratio (LR) x2 values,the Akaike information criterion (AIC) value and Harrell's C value of the two staging methods were calculated.Results Statistically significant differences in the survival time of each period existed between the two staging systems.AIC value,LRx2 value and Harrell's C value of HKLC staging system were 1360,66.6,and 0.813 respectively,while those of BCLC staging system were 1365,61.8,and 0.772 respectively.Conclusion Compared with BCLC staging,HKLC staging is more suitable for predicting the survival time of Chinese patients with primary liver cancer treated with TACE.

A sandwich format immunochromatographic assay for detecting foot-and-mouth disease virus (FMDV) serotypes was developed. In this rapid test, affinity purified polyclonal antibodies from Guinea pigs which were immunized with sucking-mouse adapted FMD virus (A/AV88(L) strain) were conjugated to colloidal gold beads and used as the capture antibody, and affinity purified polyclonal antibodies from rabbits which were immunized with cell-culture adapted FMD virus (A/CHA/09 strain) were used as detector antibody. On the nitrocellulose membrane of the immunochromatographic strip, the capture antibody was laid on a sample pad, the detector antibody was printed at the test line(T) and goat anti-guinea pigs IgG antibodies were immobilized to the control line(C). The lower detection limit of the test for a FMDV 146S antigen is 11.7ng/ml as determined in serial tests after the strip device was assembled and the assay condition optimization. No cross reactions were found with FMDV serotype C, Swine vesicular disease (SVD), Vesicular stomatiti svirus (VSV) and vesicular exanthema of swine virus (VES) viral antigens with this rapid test. Clinically, the diagnostic sensitivity of this test for FMDV serotypes A was 88.7% which is as same as an indirect-sandwich ELISA. The specificity of this strip test was 98.2% and is comparable to the 98.7% obtained with indirect-sandwich ELISA. This rapid strip test is simple, easy and fast for clinical testing on field sites;no special instruments and skills are required, and the result can be obtained within 15 min. To our knowledge, this is the first rapid immunochromatogarpic assay for serotype A of FMDV.