Objective To explore the clinical effect of clinical observation of supplemented wendan decoction combined with Western medicine in treating insomnia accompanied by anxiety and depression in phlegm-heat internal disturbance syndrome.Methods A total of 120 cases of insomnia with anxiety and depression comorbiditis with phlegm heat disturbance syndrome were randomly divided into control group and treatment group,60 cases in each group.The control group was given escitalopram oxalate tablet combined with dexzopiclonone tablet,and the observation group was given added Wendan decoction on the basis of the control group.Both groups were treated continuously for 6 weeks.Polysomnography monitoring parameters and heart rate variability were compared between the two groups during baseline period and visit 2(baseline period+3 months).Scale scores of the two groups were compared during baseline period,visit 1(baseline period+6 weeks)and visit 2.The content of heart rate variability includes:time domain analysis(standard deviation of normal interval(SDNN),square root of the square sum of the mean of the difference between adjacent normal interval(RMSSD)and frequency domain analysis(LF,HF,LF/HF).The scale scores included the Pittsburgh Sleep Quality Index(PSQI)and Insomnia Severity Index(ISI)to assess sleep status,and the Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Self-assessment Scale for Depression(PHQ-9)and Generalized Anxiety Disorder Scale(GAD-7)to assess anxiety and depression status.Results(1)Polysomnography monitoring:the wake time of observation group was significantly shorter than that of control group,the number of awakenings was significantly less than that of control group,and the percentage of N3 and REM was significantly higher than these of control group(P＜0.05).(2)Heart rate variability:RMSSD and HF values in the observation group were significantly higher than those in the control group,and LF/HF values were significantly lower than those in the control group(P＜0.05).(3)In terms of sleep:during the interview,PSQI total score,sleep quality,hypnotic drugs and daytime dysfunction in the observation group were significantly lower than those in the control group(P＜0.05);At the 3 months,the sleep quality,hypnotic drugs and daytime dysfunction in the observation group were significantly lower than those in the control group(P＜0.05).In terms of emotion:HAMA,HAMD and GAD-7 scores were significantly lower than those of control group at 6 weeks(P＜0.05);At the 3 months,HAMA and GAD-7 scores were significantly lower than those of control group(P＜0.05).Conclusion Supplemented Wendan decoction combined with western medicine can obviously optimize the sleep structure of insomnia patients with anxiety and depressionof phlegm-heat disturbance syndrome,improve sleep continuity and deepen sleep depth,and improve parasympathetic functional activities,contribute to sympathetic parasympathetic balance,can improve insomniaand depression symptoms recently,and significantly improve anxiety symptoms in the short term,with good safety.

Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.

Objective To investigate the clinical characteristics of 16 patients with connective tissue diseases associated interstitial lung disease(CTD-ILD)complicated with lung cancer,and to improve the cognition of the disease.Methods Clinical data of 16 patients diagnosed as CTD-ILD associated with lung cancer,who were admitted to our center,were retrospectively analyzed,including general conditions,clinical characteristics,auxiliary examinations,pathological classification of lung cancer,TNM type,treatment and clinical outcome.Results Among the 16 CTD-ILD patients with lung cancer,there were 12 males and 4 females.The mean age at diagnosis of CTD-ILD was(64.7±9.2)years,and the mean age at diagnosis of lung cancer was(66.6±8.7)years.Lung occupying space on imaging(62.5%)was the most common initial symptom in lung cancer patients,followed by cough and phlegm(12.5%)and chest pain(12.5%).Of patients with lung cancer,adenocarcinoma(8 cases,50.0%)was the most common pathological type,followed by small cell lung cancer(4 cases,25.0%).The diagnosis time of CTD-ILD was earlier than that of lung cancer in 8 cases(50.0%),with a median time of 36.0(11.3,57.0)months,followed by 7 cases(43.8%)of CTD-ILD diagnosed with lung cancer at the same time.The diagnosis time of lung cancer was earlier than that of CTD-ILD in 1 case(6.3%).The most common TNM stage for lung cancer was stage Ⅳ(9 cases,56.25%).Sixteen patients were followed up from 1 to 64 months,with a median of 8.5(1.5,14.3)months.Eleven patients(68.8%)died,including 8 patients(72.7%)died of infection and 3 patients(27.3%)died of end-stage lung cancer.Conclusion For CTD-ILD patients,close follow-up and regular imaging monitoring are necessary to help early detection of lung cancer and improve prognosis.

Objective:To investigate the clinical characteristics and treatment strategies of patients with connective tissue disease (CTD) related lymphatic duct obstruction.Methods:The clinical data, laboratory tests results, imaging data, and treatment of CTD patients associated with lymphatic vessel obstruction were retrospectively collected from January 2008 to December 2020 at Beijing Shijitan Hospital. Lymphatic duct obstruction was confirmed by thoracic duct ultrasound or thoracic duct MRI or lymphoscintigraphy or direct lymphangiography. SLE and RA patients were matched with gender and age in a 1∶2 ratio, and SLE and RA patients without lymphatic reflux disorder admitted at the same time were randomly selected as the control group. When comparing the data between the two groups, t-test or rank sum test was used to test continuous variables, and chi-square test or Fisher′s exact probability method was used to test categorical variables. Results:Forty-four patients with CTD complicated with thoracic duct obstruction were included, with a male-to-female ratio of 7∶37, including 14 cases of rheumatoid arthritis (RA), 21 cases of systemic lupus erythematosus (SLE), 8 cases of primary Sjogren's syndrome (pSS), and 1 case of systemic sclerosis (SSc). The onset age of CTD ranged from 14 to 68 years, the mean age was (37±15) years and the median duration of CTD was 66 (range 1~480) months. The median age at the onset of lymphatic duct obstruction such as limb edema or thoracoabdominal effusion was (42±17) years, and the median duration of lymphatic duct obstruction symptoms was 12 (range 3~480) months. 59%(26/44) of patients were diagnosed with CTD followed by the diagnosis of thoracic duct obstruction, and 41%(18/44) of patients had lymphatic duct obstruction symptoms as the initial presentation of CTD. Thoracic duct-related imaging was performed in 44 patients and showed thoracic duct obstruction (64%, 28/44), thoracic duct malformation or variation (36%, 16/44), limb lymphatic reflux disorder (34%, 15/44), and small bowel lymphatic duct dilatation or intestinal protein loss (18%, 8/44), respectively. Compared with the control group, among these patients, patients with RA complicated with lymphatic involvement had a younger onset age [(34±14)years old vs. (44±13)years old, t=-2.15, P=0.037)] and longer RA course [(17±11)months vs. (7±7)months, t=3.38, P=0.002] and presented with limb swelling (12/14). While compared with the control group, SLE patients complicated with lymphatic duct obstruction presented with celiac multi-plasmatic effusion (20/21), more patients presented with multiple serous cavity effusion [95%(20/21) vs. 62%(25/42), χ2=7.63, P=0.006], but the prevalence of lupus nephritis [(60%(12/21) vs. 86%(36/42), χ2=4.87, P=0.027] and lupus encephalopathy [0%(0/21) vs. 16.7%(17/42), χ2=6.11, P=0.013] was lower. 27% (12/44) of patients improved with aggressive glucocorticoids combined with immunosuppressive therapy, 54%(24/44) of patients were performed with lymphatic duct reconstruction surgery on top of medical treatment, 5 patients were lost of follow-up, and 2 patients deceased. Conclusion:CTD patients may develop lymphatic duct obstruction during the disease course, while lymphatic duct obstruction can also be the initial presentation of CTD. Rheumatologists and surgeons should be alert to this rare situation. Young women with refractory polyserositis or lymphedema should be examined for the possibility of combined CTD. Lymphatic duct obstruction may be associated with long-term chronic inflammation in CTD. Glucocorticoids combined with immunosuppressive agents and surgery can be used to treat lymphatic duct obstruction in patients with CTD.

Objective:To improve the understanding of patients with connective tissue diseases(CTD) associated with lung cancer.Methods:The clinical manifestations of in-patients diagnosed as CTD associated with lung cancer in our center from January 2011 to May 2022 were retrospectively analyzed,including demographic information,pathological classification of lung cancer,TNM stage,the time sequence of the diagnosis of CTD and lung cancer, treatment and clinical outcomes. The mean±standard deviation was used for the numeric variables and the number of cases (%) was used in the counting data. Fifty patients were cofirmed to have squamous cell carcinoma, adenocarcinoma and small-cell carcinoma group. Chi-square test was used to compare the differences between groups.Results:Fifty-six patients with CTD were complicated with lung cancer, of whom 27 were male, and 29 were female. The age of CTD at diagnosis was (58±15) years. The age of lung cancer at diagnosis was (69±10) years. Of patients with CTD, rheumatoid arthritis was the most common type of rheumatic disease, followed by polymyositis/dermatomyositis, systemic sclerosis and systemic lupus erythematosus. Of patients with CTD, 24 cases (42.9%) had interstitial pulmonary disease. Of patients with lung cancer, mass ( n=26, 46.4%) was the most common initial presentation, followed by cough and expectoration ( n=19, 33.8%). Non small cell lung cancer, the most common pathological type, was found in 47 cases (83.9%), followed by small cell lung cancer in 6 cases(10.7%). Stage Ⅳ was the most common stage in 36 cases(65.5%) by TNM staging. The diagnosis of CTD was earlier than that of lung cancer in 42 cases (42/56), with an median of 90 (45, 244) months, ranged between 7 months and 50 years. The diagnosis of lung cancer was earlier than that of CTD in 2 cases (2/56), with the interval of 7 and 15 months respecticely. Twelve cases (12/56) were diagnosed with CTD at the same time, and the interval between CTD and lung cancer was within 6 months. Fifty-five patients were followed up with an median of 10 (2, 24) months. In 15 patients (26.8%) with stable conditions, stageⅠ( n=10, 66.7%) cancer was the most common stage, followed by stage Ⅱ( n=2, 13.3%). Thirty-seven patients (66.1%) died of end stage lung cancer ( n=21, 56.8%) or infection ( n=16, 43.2%). The most lethal was stage Ⅳ ( n=32, 86.5%) lung cancer. There were significant differences in sex [male 9 cases (90.0%), 13 cases (38.2%) vs 4 cases (66.7%), χ2=8.88, P=0.012], smoking [8 cases (80.0%), 11 cases (32.4%) vs 4 cases (66.7%), χ2=8.24, P=0.016] and TNM stage [stage I for 0 case (0), 12 cases(35.3%) vs 0 case (0), stage Ⅱ-Ⅲ for 4 cases (40.0%), 3 cases (8.8%) vs 0 cases (0), stage Ⅳ for 6 cases (60.0%), 19 cases (55.9%) vs 6 cases (100%), χ2=13.58, P=0.009] among squamous cell carcinoma, adenocarcinoma and small-cell carcinoma groups. Conclusion:The prognosis of patients with CTD complicated with lung cancer is poor and the mortality rate is high. Therefore, close follow-up and regularly imaging are necessary for CTD patients.

Objective:To study the surveillance results of soil-transmitted nematode (STN) disease at the national surveillance site in Nanchang City, so as to scientifically formulate prevention and control strategies for parasitic diseases in Nanchang City.Methods:From 2016 to 2020, in Nanchang County, the national surveillance site of STN disease in Nanchang City, no less than 1 000 fecal samples and 25 soil samples of permanent residents over 3 years of age were investigated annually. The improved Kato-Katz thick smear method was used to detect the eggs of STN in the population, species identification of hookworm was carried out by test-tube filter paper incubation, the Enterobius vermicularis eggs of 3 - 9 years old children were detected by cellophane anal swab method, and the soil samples were used to identify hookworm larvae and of Ascaris lumbricoides eggs. Results:The total infection rate of STN was 0.93% (47/5 054) from 2016 to 2020 in the national surveillance site of Nanchang City. The annual infection rates were 0.10% (1/1 000), 2.94% (30/1 021), 0.79% (8/1 008), 0.50% (5/1 002) and 0.29% (3/1 023), respectively; the infection rates of hookworm, Ascaris lumbricoides and Trichuris trichiura were 0.42% (21/5 054), 0.02% (1/5 054) and 0.49% (25/5 054), respectively. Totally 97.87% (46/47) of the infected persons were mild infection. The population distribution characteristics showed that there was significant difference in STN infection rate among different education levels (χ 2 = 18.06, P = 0.001), but there was no significant difference in infection rate among different sex, age and occupation (χ 2 = 0.92, 2.01, 13.60, P > 0.05). Among them, the infection rate of junior high school cultural was the highest (1.84%, 24/1 301). The culture of hookworm larvae showed that 90.48% (19/21) were Necator americanus; the infection rate of Enterobius vermicularis in 3 - 9 years old children, the contamination rate of soil hookworm larvae and Ascaris lumbricoides eggs, were all 0. Conclusion:STN disease shows a low prevalence trend at the national monitoring site in Nanchang City, Trichuris trichiura and hookworm are the key insect species for STN disease control in Nanchang City in the future.

Objective:To explore the value of machine learning models based on multiple structural MRI features for diagnosis of Parkinson disease (PD).Methods:The clinical and imaging data of 60 PD patients (PD group) diagnosed in the Neurology Department of the Second Affiliated Hospital of Soochow University from November 2017 to August 2019 and 56 normal elderly people (NC group) recruited from the community were retrospectively analyzed. All subjects underwent brain MR imaging. Multiple structural MRI features were extracted from cerebellum, deep nuclei and of brain cortex based on different partition templates. The Mann-Whitney U test, as well as least absolute shrinkage and selection operator regression were used to select the most discriminating features. Finally, logistic regression (LR) and linear discriminant analysis (LDA) classifier combined with the 5-fold cross-validation scheme were used to construct the models based on structural features of cerebellum, deep nuclei and cortex, and a combined model based on all features. The receiver operating characteristic curves were drawn, and the diagnostic performance and clinical net benefit of each model were evaluated by the area under curve (AUC) and the decision curve analysis (DCA). Results:In total, four cerebellum (asymmetry index of Lobule Ⅵ volume, asymmetry index of Lobule ⅦB cortical thickness, asymmetry index of total gray matter volume and absolute value of right Lobule Ⅵ gray matter volume), 3 deep nuclei (absolute value of right nucleus accumbens volume, absolute and relative value of total nucleus accumbens volume) and 3 cortex features (local gyration index of left PFm, local fractal dimension of right superior frontal gyrus and sulcal depth of left superior occipital gyrus) were selected as the most discriminating features, and the related models were constructed. In validation set, the AUC of cerebellum, deep nuclei, cortex and combined models for diagnosis of PD based on LR classifier were 0.692, 0.641, 0.747 and 0.816; the AUC of cerebellum, deep nuclei, cortex and combined models for diagnosis of PD based on LDA classifier were 0.726, 0.610, 0.752 and 0.818. The diagnostic efficiency of the combined models based on LR and LDA classifiers were significantly better than those of other models ( P<0.05). The DCA curve demonstrated that the combined models based on LR and LDA classifiers showed the highest clinical net benefit. Conclusion:The combined models with all structural features of cerebellum, deep nuclei and cortex included based on LR and LDA classifiers showed favorable performance and clinical net benefit for diagnosis of PD, which have the potential application value in clinical diagnosis.

The acute combination fractures of the atlas and axis in adults have a higher rate of neurological injury and early death compared with atlas or axial fractures alone. Currently, the diagnosis and treatment choices of acute combination fractures of the atlas and axis in adults are controversial because of the lack of standards for implementation. Non-operative treatments have a high incidence of bone nonunion and complications, while surgeries may easily lead to the injury of the vertebral artery, spinal cord and nerve root. At present, there are no evidence-based Chinese guidelines for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults. To provide orthopedic surgeons with the most up-to-date and effective information in treating acute combination fractures of the atlas and axis in adults, the Spinal Trauma Group of Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field of spinal trauma to develop the Evidence-based guideline for clinical diagnosis and treatment of acute combination fractures of the atlas and axis in adults ( version 2023) by referring to the "Management of acute combination fractures of the atlas and axis in adults" published by American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) in 2013 and the relevant Chinese and English literatures. Ten recommendations were made concerning the radiological diagnosis, stability judgment, treatment rules, treatment options and complications based on medical evidence, aiming to provide a reference for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults.

Objective:To understand the epidemic characteristics of malaria in Nanchang, and provide a basis for timely adjustment of prevention and control strategies and measures after elimination of malaria in Nanchang.Methods:By retrospective analysis, the malaria case information and epidemiological case questionnaire reported in Nanchang from 2016 to 2020 were collected from the "China Disease Control and Prevention Information System Infectious Disease Report Information Management System" and "Parasitic DiseasePrevention and Control Information Special Report System". General situation of the cases, three distributions (time, region and population distributions) and the source of infection were described and statistically analyzed.Results:A total of 69 malaria cases were reported in Nanchang from 2016 to 2020, including 39 cases of falciparum malaria, 19 cases of vivax malaria, 9 cases of ovale malaria, 1 case of quartan malaria and 1 case of mixed infection. The onset time of 69 malaria cases was not seasonal, and cases were reported every month; they were distributed in 8 districts (counties) of Nanchang, with Jinxian County was most, accounting for 36.2% (25/69); the sex ratio of men and women was 22 ∶ 1 (66 ∶ 3), and the age of the cases was mainly 20 - < 60 years old, accounting for 97.1% (67 cases); the occupation distribution was dominated by workers, accounting for 26.1% (18/69). The 69 malaria cases were all imported cases from abroad, of which 67 cases were imported from Africa, accounting for 97.1%.Conclusions:There is no report of local malaria case in Nanchang from 2016 to 2020, all cases are imported from abroad. In the future, the control and prevention of imported personnel from abroad should be strengthened.

Objective:To investigate and analyze the living conditions of patients with Kaschin-Beck disease in Gansu Province, and to provide scientific basis for accurate treatment of the patients.Methods:From 2018 to 2019, case investigation, clinical examination and X-ray examination of patients with Kaschin-Beck disease were carried out in the Kaschin-Beck disease area of Gansu Province. The contents of the survey included basic information of the patients, clinical diagnosis classification, disease information, surgery and drug treatment, etc.Results:A total of 23 909 patients with Kaschin-Beck disease were diagnosed in 37 counties (districts) of 7 cities (states). The patients with grade Ⅰ, grade Ⅱ and grade Ⅲ accounted for 64.04% (15 312 cases), 26.12% (6 244 cases) and 9.84% (2 353 cases), respectively; 90.74% (21 694 cases) of the patients were over 50 years old, Han nationality was 97.15% (23 228 cases), and peasants were 99.25% (23 729 cases). The patients mainly had multiple joint thickening and deformation (89.30%, 21 350 cases) and pain (87.04%, 20 810 cases). Joint thickening and deformation and pain were more common in finger joint, knee joint and ankle joint. The thickening and deformation of the three joints accounted for 89.97% (21 512 cases), 78.18% (18 692 cases) and 63.81% (15 257 cases), respectively; pain accounted for 80.66% (19 285 cases), 78.75% (18 828 cases) and 64.50% (15 422 cases), respectively; 83.83% (20 044 cases) had joint rest pain, 82.63% (19 757 cases) had joint movement pain and 76.03% (18 177 cases) had joint morning stiffness. Surgical treatment was completed in 1.97% (470 cases). Long-term drug treatment (more than 6 months in the whole year) accounted for 47.78% (11 424 cases); the annual cost of drug treatment was mainly less than 500 yuan, accounting for 57.72% (13 800 cases).Conclusions:The quality of life of patients with Kaschin-Beck disease in Gansu Province is low. We should pay more attention to adult patients with Kaschin-beck disease and strengthen management and treatment.