ObjectiveTo evaluate the efficacy and safety of Xiaoji Hufei Formula in protecting children with close contact exposure to influenza， and to provide reference and evidence-based support for better clinical prevention and treatment of influenza in children. MethodsA multicenter， prospective， non-randomized， parallel， controlled trial was conducted from October 2021 to May 2022 in five hospitals， including Dongfang Hospital of Beijing University of Chinese Medicine. Confirmed influenza cases and influenza-like illness （ILI） cases were collected， and eligible children with close contact exposure to these cases were recruited in the outpatient clinics. According to whether the enrolled close contacts were willing to take Xiaoji Hufei formula for influenza prevention， they were assigned to the observation group （108 cases） or the control group （108 cases）. Follow-up visits were conducted on days 7 and 14 after enrollment. The primary outcomes were the incidence of ILI and the rate of laboratory-confirmed influenza. Secondary outcomes included traditional Chinese medicine （TCM） symptom score scale for influenza， influenza-related emergency （outpatient） visit rate， influenza hospitalization rate， and time to onset after exposure to influenza cases. ResultsA total of 216 participants were enrolled， with 108 in the observation group and 108 in the control group. Primary outcomes： （1） Incidence of ILI： The incidence was 12.0% （13/108） in the observation group and 23.1% （25/108） in the control group， with the observation group showing a significantly lower incidence （χ²=4.6， P<0.05）. （2） Influenza confirmation rate： 3.7% （4/108） in the observation group and 4.6% （5/108） in the control group， with no statistically significant difference. Secondary outcomes： （1） TCM symptom score scale： after onset， nasal congestion and runny nose scores differed significantly between the two groups （P<0.05）， while other symptoms such as fever， sore throat， and cough showed no significant differences. （2） Influenza-related emergency （outpatient） visit rate： 84.6% （11 cases） in the observation group and 96.0% （24 cases） in the control group， with no significant difference. （3） Time to onset after exposure： The median onset time after exposure to index patients was 7 days in the observation group and 4 days in the control group， with a statistically significant difference （P<0.05）. ConclusionIn previously healthy children exposed to infectious influenza cases under unprotected conditions， Xiaoji Hufei formula prophylaxis significantly reduced the incidence of ILI. Xiaoji Hufei Formula can be recommended as a specific preventive prescription for influenza in children.

ObjectiveTo evaluate the efficacy and safety of Xiaoji Hufei Formula in protecting children with close contact exposure to influenza， and to provide reference and evidence-based support for better clinical prevention and treatment of influenza in children. MethodsA multicenter， prospective， non-randomized， parallel， controlled trial was conducted from October 2021 to May 2022 in five hospitals， including Dongfang Hospital of Beijing University of Chinese Medicine. Confirmed influenza cases and influenza-like illness （ILI） cases were collected， and eligible children with close contact exposure to these cases were recruited in the outpatient clinics. According to whether the enrolled close contacts were willing to take Xiaoji Hufei formula for influenza prevention， they were assigned to the observation group （108 cases） or the control group （108 cases）. Follow-up visits were conducted on days 7 and 14 after enrollment. The primary outcomes were the incidence of ILI and the rate of laboratory-confirmed influenza. Secondary outcomes included traditional Chinese medicine （TCM） symptom score scale for influenza， influenza-related emergency （outpatient） visit rate， influenza hospitalization rate， and time to onset after exposure to influenza cases. ResultsA total of 216 participants were enrolled， with 108 in the observation group and 108 in the control group. Primary outcomes： （1） Incidence of ILI： The incidence was 12.0% （13/108） in the observation group and 23.1% （25/108） in the control group， with the observation group showing a significantly lower incidence （χ²=4.6， P<0.05）. （2） Influenza confirmation rate： 3.7% （4/108） in the observation group and 4.6% （5/108） in the control group， with no statistically significant difference. Secondary outcomes： （1） TCM symptom score scale： after onset， nasal congestion and runny nose scores differed significantly between the two groups （P<0.05）， while other symptoms such as fever， sore throat， and cough showed no significant differences. （2） Influenza-related emergency （outpatient） visit rate： 84.6% （11 cases） in the observation group and 96.0% （24 cases） in the control group， with no significant difference. （3） Time to onset after exposure： The median onset time after exposure to index patients was 7 days in the observation group and 4 days in the control group， with a statistically significant difference （P<0.05）. ConclusionIn previously healthy children exposed to infectious influenza cases under unprotected conditions， Xiaoji Hufei formula prophylaxis significantly reduced the incidence of ILI. Xiaoji Hufei Formula can be recommended as a specific preventive prescription for influenza in children.

Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.

It is believed that wind pathogen is one of the core pathogenic factors of small cell lung cancer （SCLC）. The nature and pathogenic characteristics of wind pathogen are closely related to the occurrence and metastasis of SCLC. Mainly manifested as deficiency of both qi and yin， healthy qi deficiency of SCLC makes it susceptible to invasion of external wind. Simultaneously， there are internal wind pathogenesis such as yin deficiency causing wind， blood deficiency causing wind， phlegm， stasis and toxin causing wind， liver yang transforming into wind. The internal and external winds together lead to the disease. Therefore， it is proposed to treat SCLC from wind theory， that is， boosting qi and nourishing yin to extinguish wind with taizishen （Radix Pseudostellariae）， wuweizi （Fructus Schisandrae Chinensis） and others； resolving phlegm and moving stasis to dispel wind with wind-dispelling and phlegm-resolving medicinals such as jiangcan （Bombyx Batryticatus）， muhudie （Semen Oroxyli）， fangfeng （Radix Saposhnikoviae）， tianma （Rhizoma Gastrodiae）， quanxie （Scorpio） and blood-invigorating and wind-dispelling medi-cinals such as danggui （Radix Angelicae Sinensis）， chuanxiong （Rhizoma Chuanxiong） and danshen （Radix et Rhizoma Salviae Miltiorrhizae）； attacking toxin and dissipating masses to dispel wind with shuizhi （Hirudo）， dilong （Pheretima）， fengfang （Nidus Vespae）， quanxie， baihuashe （Agkistrodon）， jiuxiangchong （Aspongopus） and other drastic medicinals； calming liver and extinguishing wind to prevent brain metastasis of SCLC with Tianma Gouteng Beverage （天麻钩藤饮） modification.

Objective:To establish Wistar rat models of acute radiation esophagitis, and observe the histopathological changes at different time points after modeling.Methods:Wistar rats were locally irradiated with different doses of 6 MV X-rays, and the rats were sacrificed on the 3 rd, 5 th, 7 th, and 14 th days after irradiation. The full-length esophagus tissue was taken for paraffin embedding, sectioning, and hematoxylin and eosin (HE) staining for pathological assessment. The pathological changes of the esophagus of the rats were observed at the 3 rd, 5 th, 7 th, and 14 th days after 25 Gy and 30 Gy irradiation. The changes of daily dietary intake of rats in different irradiation groups within 1-2 weeks after radiation exposure were observed. Results:No rat died in two groups after being irradiated with 25 Gy and 30 Gy rays. All the rats in the 30 Gy group had esophagus injury. On the 7 th day, the degree of injury was the most serious, with a pathological score of 5.00±0.75 and a food intake of 0 g. On the 14 th day, the degree of injury was relieved, and the food intake was restored to the level before irradiation. Conclusions:The Wistar rat model of acute radiation esophagitis can be established by a single dose of 6 MV X-ray 30 Gy irradiation to the esophagus. The 7 th day after irradiation is an ideal observation time for the acute injury phase, which is gradually alleviated after the 7 th day. The time can be chosen from 7-14 days after irradiation as the observation point for the healing repair phase.

OBJECTIVE: To evaluate the efficacy of Wen-Luo-Tong Granules (WLT) local administration in the treatment of patients with peripheral neuropathy (PN) induced by chemotherapy or target therapy. METHODS: This study is a randomized, double-blinded, and placebo-controlled trial. Seventy-eight patients with PN induced by chemotherapy or target therapy were enrolled from China-Japan Friendship Hospital between July 2019 and January 2020. They were randomly assigned to WLT (39 cases) and control groups (39 cases) using a block randomization method. The WLT group received WLT (hand and foot bath) plus oral Mecobalamin for 1 week, while the control group received placebo plus oral Mecobalamin. The primary endpoint was PN grade evaluated by the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE). The secondary endpoints included quantitative touch-detection threshold, neuropathy symptoms, Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy (QLQ-CIPN20), and Quality of Life Questionnaire-Core30 (QLQ-C30). RESULTS: After treatment, the PN grade in the WLT group was significantly lower than that in the control group (1.00 ± 0.29 vs. 1.75 ± 0.68, P<0.01). The total effective rate in the WLT group was significantly higher than that in the control group (82.05% vs. 51.28%, P<0.01). Compared with the control group, the touch-detection thresholds at fingertips, neuropathy symptom score, QLQ-CIPN 20 (sensory scale, motor scale, autonomic scale, and sum score), and QLQ-C30 (physical functioning, role functioning, emotional functioning, and global health) in the WLT group significantly improved after treatment (P<0.01 or P<0.05). CONCLUSION WLT local administration was significantly effective in the treatment of patients with PN induced by chemotherapy or target therapy. (Trial registration No. ChiCTR1900023862).
Antineoplastic Agents/adverse effects* ; China ; Humans ; Japan ; Peripheral Nervous System Diseases/drug therapy* ; Quality of Life/psychology* ; Surveys and Questionnaires

Objective:To investigate the efficacy and safety of plasma exchange(PE) in the treatment of autoimmune hemolytic anemia in children.Methods:The data from 8 hospitals in China during November 2014 to April 2017 were collected, and the clinical characteristics of PE in children with AHA were analyzed retrospectively.Results:A total of 21 children with AHA were included in the study, including 17 cases from PICU and 4 cases from pediatric kidney ward, with 11 boys and 10 girls, and the median age was 3.64(0.25, 11.10)years old, and median hospital stay was 12(4, 45)days.There were 15 cases(71.4%) with infection, 2 cases(9.5%)with autoimmune diseases, 4 cases(19.0%) with unknown.Consciousness disturbance occurred in 4 patients before replacement and recovered to normal after PE.The volume of blood decreased in two cases(9.5%) and completely relieved.There were 20 cases of anemia (95.2%), 15 cases were normal after PE, and 5 cases were improved.Jaundice occurred in 18 cases (85.7%), 12 cases were normal after PE, 6 cases were improved.Hepatosplenomegaly was found in 11 cases, 10 cases were normal after PE, 1 case was improved.After PE, the hemoglobin and red blood cell count increased, while the total bilirubin, indirect bilirubin, urea nitrogen and lactate dehydrogenase decreased, there were significant differences between pre-and post-replacement ( P<0.05). Only 1 case had allergic reaction, which was improved after symptomatic treatment, and PE was continued.After PE, 2 cases (9.5%) had complete remission, 16 cases (76.2%) had partial remission and 3 cases (14.3%) had been discharged. Conclusion:PE therapy can obviously improve the clinical symptoms and laboratory indexes of children with AHA who have failed to respond to conservative treatment.It can be used as a treatment measure for children with severe AHA and has a good safety.

Objective:To investigate the improved performance of hepatic elastography combined with the serum biomarkers for the diagnosis of biliary atresia.Methods:A total of 193 patients with suspected biliary atresia in Beijing Children′s Hospital from March 2019 to November 2020 were consecutively collected. All patients were randomly divided into the training cohort and validation cohort at a ratio of 7∶3. LASSO regression analysis was used for the selection of the model index based on the data set from the training cohort including the serum biomarkers, demographic features (age and sex) and hepatic elastic measurement, and a diagnostic model for biliary atresia was subsequently developed by weighting on the basis of the dominance ration. The performance of the model was respectively evaluated with respect to the discrimination and calibration in each cohort.Results:Alanine aminotransferase (ALT), glutamyl transferase (GGT) and hepatic elastic measurement were selected to build the model. The area under the ROC curve of the final diagnostic model was 0.943 with a sensitivity of 90.9% and a specificity of 85.7% in the training cohort, and 0.955 in the validation cohort. Hosmer-Lemeshow test ( P=0.292, P=0.951) and calibration curves further validated its satisfactory calibration in both cohorts. As demonstrated by Delong et al.test, employing the model in the training cohort achieved the best diagnostic performance compared with using single model index ( P<0.001, P=0.016, P<0.001). In the validation cohort, the decision curve analysis showed the model had a higher overall net benefit over using hepatic elastography alone in every predicted probability. Conclusions:The diagnostic model for biliary atresia, which incorporates ALT, GGT and hepatic elastic measurement, can improve the performance of hepatic elastography with a higher clinical value.

Objective:To analyze the ultrasonographic images and clinical characteristics of congenital mesoblastic nephroma (CMN), and to investigate the differential performances with Wilm′s tumor (WT).Methods:Twenty-one cases of CMN patients confirmed by pathology from December 2008 to December 2019 in Beijing Children′s Hospital, Capital Medical University were collected as the CMN group, and in the same criterion, 51 cases of WT patients were taken as WT group. Ultrasonographic images and clinical characteristics were collected retrospectively, and then the tumor size, site, echo and age were compared and analyzed between the two groups. ROC curve was used to evaluate the differential performance.Results:The difference analysis showed that except for echo ( P=0.694), there were statistically significant differences in tumor size, site and age between the two groups (all P<0.05). In prenatal, the incidence of CMN was significantly higher than WT (61.9% vs 3.9%, P<0.001), and the specificity was 96.1%. The median age (interquartile range) of CMN after birth was significantly earlier than WT( Z=-4.044, P<0.001). The area under the ROC was 0.949, the best cutoff was 112.5 days, with a sensitivity of 87.5% and a specificity of 93.9%. Conclusions:It is difficult to distinguish CMN and WT by echo, but the diagnosis performance can be improved through combining tumor size with site, especially age.

Objective To explore the value of ultrasound in differential diagnosis of hepatic hilar cyst in neonates and infants. Methods The ultrasonographic characteristics of 93 children with hilar cysts under 6 months of age admitted to the General Surgery Department of Beijing Children′s Hospital. Affiliated to Capital Medical University from January 2014 to December 2018 were retrospectively analyzed. According to the surgical results,they were divided into two groups:cystic biliary atresia ( CBA) group and congenital choledochal cyst (CC) group,21 cases in the CBA group and 72 cases in the CC group. The size of cyst in hepatic portal area,the shape of gallbladder in empty stomach,the expansion of intrahepatic and extrahepatic bile ducts,the deposition of biliary sludge and the communication between cyst and intrahepatic bile duct were observed by ultrasound. Results The cyst volume of CBA group was 0. 4 ( 0. 1, 1. 3 ) cm3 , and that of CC group was 18. 3(5. 4,50. 3) cm3. The cyst volume of CBA group was significantly smaller than that of CC group (P<0. 01);19 cases had abnormal gallbladder morphology in CBA group and 4 cases in CC group (P<0. 01);1 case had biliary sludge in hilar cyst in CBA group and 51 cases had biliary sludge in cyst in CC group ( P <0. 01);no intrahepatic bile duct dilatation was observed in CBA group,and 54 cases had intrahepatic bile duct dilatation in CC group (P<0. 01);no cyst communicated with intrahepatic bile duct in CBA group,and all cysts communicated with intrahepatic bile duct in CC group (P <0. 01). Conclusion Gallbladder shape,cyst size,biliary sludge deposition,intrahepatic bile duct dilatation and the communication between cyst and intrahepatic bile duct can be used as sonographic features to differentiate CBA from CC.