ObjectiveTo establish the fingerprint of seven commercially available Yangyin Qingfei preparations， to quantitatively analyze the index components， to evaluate their quality uniformity with multivariate statistical analysis， and to explore the quality differences among different dosage forms. MethodA total of 33 batches of commercially available 7 kinds of Yangyin Qingfei preparations were analyzed by high performance liquid chromatography（HPLC）， the fingerprints were established and the common peaks were identified. Paeoniflorin， verbascoside， harpagoside， glycyrrhizic acid and paeonol were selected as the indicators of quality attributes to quantitatively analyze 33 batches of preparations. Based on the administration methods of Yangyin Qingfei preparations， the daily intake was calculated and the radar charts were poltted， and cluster analysis and principal component analysis were used to explore the quality differences of 7 kinds of Yangyin Qingfei preparations and the quality uniformity among different batches of the same dosage form. ResultThe similarity of fingerprints of 7 dosage forms was 0.248-0.956， suggesting that there were significant differences among different dosage forms of Yangyin Qingfei preparations， and a total of 15 common peaks were calibrated， of which peak 7， peak 8， peak 11， peak 13 and peak 15 were paeoniflorin， verbascoside， harpagoside， glycyrrhizic acid and paeonol， respectively. The radar plots showed that the average total daily intake of large honeyed pills and water honeyed pills was the highest， and the uniformity of pill components was better. The quality of 33 batches of samples was divided into poor quality and high quality by cluster analysis. Principal component analysis showed that the uniformity and dosage form of different dosage forms were significantly different， the oral liquid had the best quality homogeneity with the minimum dispersion. And the content of paeonol in different dosage forms was significantly different， which was the key component of quality control of Yangyin Qingfei preparations. ConclusionYangyin Qingfei large honeyed pills and water honeyed pills show high content and good uniformity， which are relatively preferred dosage forms. Different preparation processes have a great influence on the content of paeonol， and its quality control should be emphasized during production. This study provides a scientific method for the comparison of product quality of different dosage forms of traditional Chinese medicine prescriptions， which is helpful for the development of preferred dosage forms of different prescriptions， and provides a reference for efficient use of medication in the clinical practice.

Objective:To explore the current status of rumination in inpatients with metastatic prostate cancer (mPCa) under the disease coping mechanism, and analyzing its influencing factors.Methods:From March 2021 to December 2022, 267 mPCa inpatients at the Tenth People's Hospital of Tongji University were selected as the study subject using convenience sampling. The survey was conducted using the General Information Questionnaire, Chinese Version of Event Relate Rumination Inventory (C-ERI), Medical Coping Modes Questionnaire (MCMQ), International Prostate Symptom Score (IPSS), and Social Support Revalued Scale (SSRS), and the factors influencing the rumination in patients were analyzed.Results:This study collected 260 valid questionnaires, with an effective response rate of 97.4% (260/267). The total score of rumination in 260 mPCa patients was (31.08±6.46), with invasive rumination and purposeful rumination scores of (14.13±4.44) and (16.95±4.55), respectively. The initial prostate-specific antigen index, confrontation medical coping modes were the influencing factors of invasive rumination in mPCa patients ( P<0.05). The initial prostate-specific antigen index, course of disease, social support, and confrontation medical coping style were the influencing factors of purposeful rumination in mPCa patients ( P<0.05) . Conclusions:The rumination of mPCa patients is above the medium level, and is influenced by multiple factors under the disease coping mechanism. Clinical medical and nursing staff should combine the clinical situation and characteristics of mPCa patients, provide personalized interventions as early as possible, and assist patients in improving their positive cognitive processing abilities.

Objective:To evaluate the performance of rural practitioners of endoscopic cleaning and disinfection participating in the Early Diagnosis and Treatment Program for Upper Gastrointestinal Cancers and to analyze the influencing factors.Methods:The questionnaires for skill assessment were designed based on the skill scheme and clinical practice of the Early Diagnosis and Treatment Program for Upper Gastrointestinal Cancers in rural China, and the App Early diagnosis, Early treatment was used as the examination platform. The practitioners in 539 county hospitals from 25 provinces participating in the program in 2019 were assessed for techniques and skills for endoscopic cleaning and disinfection and the excellence rate was calculated. Multivariate logistic regression model was used to analyze the influencing factors for the examination. Results:A total of 1 671 endoscopic cleaning and disinfection practitioners participated in the assessment with the score of 73.41±16.60. The passing rate was 85.82%, and the excellence rate was 44.94%. Among all questions, the correct rate of "opportunistic screening flow chart" was the highest (98.21%), and that of "the evaluation index for mass screening" was the lowest (57.89%). The multivariate logistic regression analysis showed that the excellence rate was high in practitioners who had a bachelor degree or above ( OR=1.627,95% CI:1.319-2.007, P<0.001), the career for 5 to <15 years (5 to <10 years: OR=1.329,95% CI:1.045-1.689, P=0.020; 10 to <15 years: OR=1.384,95% CI:1.026-1.867, P=0.033), working in eastern and central regions (eastern regions: OR=3.476,95% CI:2.368-5.103, P<0.001;central regions: OR=4.028,95% CI:2.679-6.057, P<0.001) and with full understanding of the screening scheme ( OR=1.547,95% CI:1.246-1.921, P<0.001) . Conclusion:Practitioners on the Early Diagnosis and Treatment Program for Upper Gastrointestinal Cancers in rural China have mastered the basic screening scheme and skills for endoscopic cleaning and disinfection. The education background, duration of the career, area and understanding of screening scheme are influencing factors for the excellence rate of endoscopic cleaning and disinfection.

Abstract Child abuse is a global public health problem, which has emerged as a neglected yet pressing issue in global development. Early and accurate identification of abuse at a lower-age group is of great significance for treatment, which might reduce the risk of re-maltreatment and promote children s physical and mental health development. Therefore, by reviewing the clinical characteristics, risk factors and existing abuse identification and screening tools of child abuse, the study aims at providing basic evidence for the development of child abuse risk identification tools and the establishment of child maltreatment system in China, so as to take timely intervention measures to prevent adverse outcomes or reduce their severity.

Objective:To evaluate the efficacy and safety of standardized dust mite allergen subcutaneous immunotherapy (SCIT) in children with allergic rhinitis (AR) during treatment.Methods:A total of 283 children with AR diagnosed with definite dust mite allergy and completed 2 to 3 years of SCIT who attended the Department of Otorhinolaryngology Head and Neck Surgery, Xiangya Hospital, Central South University, from August 2019 to October 2021 were included, including 205 males and 78 females, with a mean age of 10.8 years. The total nasal symptoms score (TNSS), symptom medication score (SMS), rhinoconjunctivitis quality of life questionnaire (RQLQ) and visual analogue scale (VAS) before and after 2 to 3 years′ treatment were recorded, and the differences before and after treatment were compared. Adverse reactions during SCIT were recorded to evaluate its safety. SPSS 22.0 software was used for statistical analysis.Results:The overall effectiveness rate during SCIT in 283 children with AR was 89.4% (253/283). Compared with baseline, all symptom scores, medication scores and quality of life scores were significantly lower after 2 to 3 years of SCIT (all P<0.05). Further group comparisons showed positive efficacy in patients with different clinical characteristics, including age, gender, smoking status, family history of AR, symptom severity, mono-or poly-allergy, and second immunization, with no statistically significant differences between groups (all P>0.05). A total of 12 735 injections were administered during the SCIT, and a total of 213 (1.67%) injections of local adverse reactions occurred, mainly in the initial treatment phase, and the diameter of the local air mass was mostly 5 to 20 mm; 71 (0.56%) injections of systemic adverse reactions occurred, mainly in the initial treatment phase, and most of them were grade 1 reactions with no serious systemic adverse reaction such as shock. Conclusion:Standardized dust mite SCIT has a good safety profile and definite efficacy in treating AR children with different clinical characteristics. It can significantly improve all symptoms, reduce the use of symptomatic drugs and improve their quality of life.

Objective:To evaluate the association of HbA 1C level and variability with annual decline in glomerular filtration rate in elderly patients with type 2 diabetes. Methods:A total of 527 elderly type 2 diabetic patients with baseline estimated glomerular filtration rate(eGFR)≥60 mL·min -1·(1.73 m 2) -1 at the diabetes center of a tertiary hospital in Jiangsu province were included and followed up. The mean value and the variability of HbA 1C, including standard deviation(HbA 1C-SD), variation coefficient(HbA 1C-CV), and adjusted standard deviation(Adj-HbA 1C-SD) were calculated. According to the annual decreased rate of eGFR, the patients were divided into △eGFR>5% group and △eGFR≤5% group. Cox proportional risk regression model was used to evaluate the relationship between HbA 1C variability and the risk of decreased glomerular filtration rate. Results:With a mean follow-up time of 19 months, there were 176 patients whose △eGFR>5%. Compared with △eGFR≤5% group, the HbA 1C-mean and HbA 1C variability were significantly higher in △eGFR>5% group( P<0.05). Cox regression analysis showed that HbA 1C-mean, HbA 1C-SD, HbA 1C-CV, and Adj-HbA 1C-SD were significantly correlated with decreased glomerular filtration rate. After adjustment for age, gender, HbA 1C-mean, and other factors, only Adj-HbA 1C-SD was correlated with renal insufficiency [ HR=3.32(1.68-6.57)]. Conclusions:HbA 1C variability is independently associated with annual decline in glomerular filtration rate in elderly patients with type 2 diabetes. The Adj-HbA 1C-SD is the most sensitive indicator in predicting decreased glomerular filtration rate.

Objective:To investigate the risk factors of moderate to severe cancer-related fatigue (CRF) in patients undergoing chemotherapy of prostate cancer, and to construct a nomogram model to predict the occurrence of CRF.Methods:Using the case data questionnaire, Brief Fatigue Inventory, Social Support Rating Scale and International Prostate Symptom Scores, 724 patients of prostate cancer treated by chemotherapy in Shanghai Tenth People′s Hospital from August 2016 to June 2021 were selected and were treated with 1∶1 ratio, and the indexes of the moderate and severe CRF group (216 cases) and the non-moderate and severe CRF group (216 cases) were compared. According to the ratio of 7∶3, the envelope method was used to divide into training set and validation set. The independent risk factors of moderate and severe CRF were explored by univariate analysis and multivariate Logistic regression analysis, and the risk prediction model was established and the nomogram model was constructed. The C-index and area under ROC curve were used to verify the prediction effect of the model.Results:Multivariate Logistic regression analysis showed that BMI ranged from 24.0 to 27.9 kg/m 2 ( OR=1.733), BMI≥28.0 kg/m 2 ( OR=3.126), neutropenia occurred during chemotherapy ( OR=1.747), chemotherapy course >6 months ( OR=1.893), moderate social support level ( OR=1.244), low social support level ( OR=2.434), mild urinary tract symptoms ( OR=1.264), moderate urinary tract symptoms ( OR=3.371) and severe urinary tract symptoms ( OR=5.297) were independent risk factors for moderate and severe CRF. The nomogram model constructed according to the above risk factors was internally verified by the training set and the validation set, and its C-index was 0.854 and 0.741 respectively. The area under ROC curve training set was 0.823, and the validation set was 0.733. Conclusions:The nomogram model can effectively predict the occurrence of moderate to severe CRF in patients with prostate cancer undergoing chemotherapy.

Antibody-drug conjugates(ADCs)are commonly heterogeneous and require extensive assessment of exposure-efficacy and exposure-safety relationships in preclinical and clinical studies.In this study,we report the generation of a monoclonal antibody against monomethyl auristatin E(MMAE)and the development,validation,and application of sensitive and high-throughput enzyme-linked immunosor-bent assays(ELISA)to measure the concentrations of MMAE-conjugated ADCs and total antibodies(tAb,antibodies in ADC plus unconjugated antibodies)in cynomolgus monkey sera.These assays were suc-cessfully applied to in vitro plasma stability and pharmacokinetic(PK)studies of SMADC001,an MMAE-conjugated ADC against trophoblast cell surface antigen 2(TROP-2).The plasma stability of SMADC001 was better than that of similar ADCs coupled with PEG4-Val-Cit,Lys(m-dPEG24)-Cit,and Val-Cit linkers.The developed ELISA methods for the calibration standards of ADC and tAb revealed a correlation be-tween serum concentrations and the OD450 values,with R2 at 1.000,and the dynamic range was 0.3-35.0 ng/mL and 0.2-22.0 ng/mL,respectively;the intra-and inter-assay accuracy bias％ranged from-12.2％to-5.2％,precision ranged from-12.4％to-1.4％,and the relative standard deviation(RSD)was less than 6.6％and 8.7％,respectively.The total error was less than 20.4％.The development and validation steps of these two assays met the acceptance criteria for all addressed validation parameters,which suggested that these can be applied to quantify MMAE-conjugated ADCs,as well as in PK studies.Furthermore,these assays can be easily adopted for development of other similar immunoassays.

Objective To investigate the effect of long non-coding RNA (lncRNA) LNC01309 on the proliferation and migration abilities of human hepatocellular carcinoma (HCC) cells and its mechanism of action. Methods HCC samples and corresponding adjacent tissue samples were collected from 12 patients with HCC who underwent surgical treatment in The Sixth Medical Center of PLA General Hospital from February 2018 to June 2019, and quantitative real-time PCR was used to measure the relative expression level of LNC01309. Quantitative real-time PCR was also used to measure the expression level of LNC01309 in human hepatoma cell lines (HepG2, SNU-398, and Hep3B) and the human immortalized normal liver cell line THLE-2. After LNC01309 was overexpressed in HepG2 cells, the cells were divided into plasmid control group (pEXP-control) and overexpression group (pEXP-LNC01309). CCK-8 assay was used to observe the change in cell proliferation, and wound healing assay and Transwell assay were used to observe migration ability. RNA co-immunoprecipitation was used to detect the interaction between LNC01309 with RBM38, with cells divided into IgG group and RBM38 antibody group, and cycloheximide chase assay was used to analyze the effect of LNC01309 on the stability of RBM38 protein. RBM38 was overexpressed in HepG2 cells to conduct the recovery experiment, and CCK-8 assay, wound healing assay, and Transwell assay were used to observe the changes in cell proliferation and migration abilities. The t -test was used for comparison of continuous data between two groups. Results The mean expression level of LNC01309 in HCC tissue was significantly higher than that in adjacent tissue (4.225±2.285 vs 1.541±0.530, t =3.618, P =0.004), and the relative expression level of LNC01309 in hepatoma cells (HepG2, SNU-398, and Hep3B) was also significantly higher than that in normal hepatocytes (THLE-2) ( t =4.231、6.489、14.480, all P < 0.05). Compared with the control group, HepG2 cells with the overexpression of LNC01309 had significant increases in growth rate (OD 450 value at 96 hours: 1.885±0.107 vs 2.527±0.234, t =4.330, P =0.012) and migration ability (11.65%±2.40% vs 35.66%±4.90%, t =9.837, P < 0.001; 100.00%±3.11% vs 161.00%±35.93%, t =4.399, P =0.005); however, the upregulated proliferation and migration abilities of hepatoma cells induced by LNC01309 overexpression were partially inhibited by RBM38 (OD 450 value at 96 hours: 2.500±0.227 vs 1.913±0.282, t =2.812, P =0.048; 168.00%±9.43% vs 117.20%±18.03%, t =6.622, P < 0.001). Compared with the IgG control group, RBM38 antibody significantly enriched the precipitation of LNC01309 ( t =3.846, P =0.031). The results of cycloheximide chase assay showed that the LNC01309 overexpression group had a significant reduction in the stability of RBM38 protein ( t =8.038, P =0.001). Conclusion The newly identified LNC01309 reduces the stability of RBM38 protein through interaction with RBM38 and promotes the proliferation and migration of HCC cells.

Blood glucose fluctuation is gradually becoming an important evaluation index of blood glucose control. Long-term blood glucose fluctuation, which reflects the long-term stability of blood glucose, plays an important role in the long-term outcome of diabetes. Excessive long-term blood glucose fluctuation not only increases the risk of cardiovascular disease, ischemic stroke and accelerates the occurrence and progression of diabetic nephropathy, but also acts as an independent predictor of diabetic retinopathy, peripheral neuropathy and mortality. In the course of diabetes treatment, maintaining long-term stability of blood glucose is the key to avoid adverse outcomes.