Objective:To establish a method for the detection of bacterial endotoxin in terbutaline sulfate active pharmaceutical ingredients(API).Methods:The method of terbutaline sulfate was verified by gel method,and interference test and bacterial endotoxin test were performed on three batches of samples.Results:The limit for terbutaline sulfate API that can be used for bacterial endotoxin test was set as"the amount of endotoxin contained in terbutaline sulfate should be less than 0.50 EU per 1 mg".Conclusion:Limulus gel method can be used to detect bacterial endotoxin of terbutaline sulfate API.

Objective:To analyze the clinical features and follow-up data in children with neuropsychiatric lupus erythematosus (NPSLE), and provide reference for the diagnosis and treatment of NPSLE.Methods:The clinical data of 22 children with NPSLE who were admitted to the Department of Rheumatology Immunology and Allergy, Children′s Hospital of Zhejiang University School of Medicine from January 2019 to March 2022 were included and were followed-up for 24~60 months. The data were analyzed retrospectively. Statistical descriptive analysis was performed using the SPSS 23.0.Results:Twenty-two (26.8%, 22/82) children with NPSLE occurred in the hospitalized children with SLE during the study period. The ratio of male to female was 1∶4.5, and the onset age was (10.7±2.0) years. Among these cases, 86.4% (19/22) patients were newly diagnosed and had severe disease activity and 16 cases (72.7%) occurred within 1 month after disease onset. Nineteen cases (86.4%) had mucocutaneous involvement, 16 cases (72.7%) had lupus nephritis, 14 cases (63.2%) had hematological system involvement, 13 cases (59.1%) had skeletal muscle involvement, 10 cases (45.5%) had serositis, 10 cases (45.5%) were complicated with hypertension, and 8 cases (36.5%) with macrophage activation syndrome (MAS). The main clinical symptoms of the nervous system included headache (11/19, 57.9%), dizziness (10/19, 52.6%), listlessness (7/19, 36.8%), blurred vision (4/19, 21.1%), convulsions (3/19, 15.8%), lethargy (2/19, 10.5%). Twenty patients (20/22, 90.9%) demonstrated abnormal signals on brain MRI, 7 cases (7/12, 45.5%) showed abnormal signals on brain CT, 10 cases (10/22, 45.5%) showed abnormal waves on EEG, and 6 cases (6/20, 30.0%) demonstrated abnormal results of cerebrospinal fluids analysis. The follow-up duration was 34 (28, 48) months. Clinical remission or low disease activity was found in 19 patients (86.4%), and no death were observed. Three cases had residual cerebral infarction lesions, no neurological sequelae were found in all patients.Conclusion:The most common symptoms of NPSLE in children are headache and dizziness, which are more likely to occur in patients with initial onset and severe disease activity, and approximately 36.5% children with NPSLE may complicated by MAS.The results of 24-60 months follow-up showed that the prognosis of the disease is good.

Temporomandibular joint (TMJ) diseases are common clinical conditions. The number of patients with TMJ diseases is large, and the etiology, epidemiology, disease spectrum, and treatment of the disease remain controversial and unknown. To understand and master the current situation of the occurrence, development and prevention of TMJ diseases, as well as to identify the patterns in etiology, incidence, drug sensitivity, and prognosis is crucial for alleviating patients′suffering.This will facilitate in-depth medical research, effective disease prevention measures, and the formulation of corresponding health policies. Cohort construction and research has an irreplaceable role in precise disease prevention and significant improvement in diagnosis and treatment levels. Large-scale cohort studies are needed to explore the relationship between potential risk factors and outcomes of TMJ diseases, and to observe disease prognoses through long-term follw-ups. The consensus aims to establish a standard conceptual frame work for a cohort study on patients with TMJ disease while providing ideas for cohort data standards to this condition. TMJ disease cohort data consists of both common data standards applicable to all specific disease cohorts as well as disease-specific data standards. Common data were available for each specific disease cohort. By integrating different cohort research resources, standard problems or study variables can be unified. Long-term follow-up can be performed using consistent definitions and criteria across different projects for better core data collection. It is hoped that this consensus will be facilitate the development cohort studies of TMJ diseases.

Objective:To explore the genetic basis and clinical phenotype of a Chinese pedigree affected with Focal segmental glomerulosclerosis (FSGS).Methods:A male patient who was admitted to the First Affiliated Hospital of Zhengzhou University on July 26, 2018 was selected as the study subject. Clinical data of the patient was collected. Next generation sequencing and Sanger sequencing were carried out to detect the variant sites. Bioinformatic software was used to simulate the effect of candidate variants on the protein functions.Results:Ultrasound exam of the patient showed enhanced echo for the renal parenchyma. Kidney biopsy had confirmed the pathological diagnosis of FSGS (non-specific). Electronic microscopy displayed segmental sclerosis of the glomeruli, mild hyperplasia of mesangial cells and matrix. The proband was found to harbor two novel variants of the PLCE1 gene, namely c. 3199delA (p.N1067Mfs*15) and c.4441_4443delATC (p.1481_1481del), which were respectively inherited from his mother and father. Based on the guidelines from the American College of Medical Genetics and Genomics (ACMG), both variants were rated as pathogenic (PVS1+ PM2_Supporting+ PP3; PM2_Supporting+ PM3+ PP3). Bioinformatic simulation suggested that both variants could significantly affect the tertiary structure of the PLCE1 protein. Conclusion:The c. 4441_4443delATC and c. 3199delA variants of the PLCE1 gene probably underlay the pathogenesis of the FSGS in this pedigree.

Purpose: The risk stratification of pediatric anaplastic large cell lymphoma (ALCL) has not been standardized. In this study, new risk factors were included to establish a new risk stratification system for ALCL, and its feasibility in clinical practice was explored. Materials and Methods: On the basis of the non-Hodgkin’s lymphoma Berlin–Frankfurt–Munster 95 (NHL-BFM-95) protocol, patients with minimal disseminated disease (MDD), high-risk tumor site (multiple bone, skin, liver, and lung involvement), and small cell/lymphohistiocytic (SC/LH) pathological subtype were enrolled in risk stratification. Patients were treated with a modified NHL-BFM-95 protocol combined with an anaplastic lymphoma kinase inhibitor or vinblastine (VBL). Results: A total of 136 patients were enrolled in this study. The median age was 8.8 years. The 3-year event-free survival (EFS) and overall survival of the entire cohort were 77.7% (95% confidence interval [CI], 69.0% to 83.9%) and 92.3% (95% CI, 86.1% to 95.8%), respectively. The 3-year EFS rates of low-risk group (R1), intermediate-risk group (R2), and high-risk group (R3) patients were 100%, 89.5% (95% CI, 76.5% to 95.5%), and 67.9% (95% CI, 55.4% to 77.6%), respectively. The prognosis of patients with MDD (+), stage IV cancer, SC/LH lymphoma, and high-risk sites was poor, and the 3-year EFS rates were 45.3% (95% CI, 68.6% to 19.0%), 65.7% (95% CI, 47.6% to 78.9%), 55.7% (95% CI, 26.2% to 77.5%), and 70.7% (95% CI, 48.6% to 84.6%), respectively. At the end of follow-up, one of the five patients who received maintenance therapy with VBL relapsed, and seven patients receiving anaplastic lymphoma kinase inhibitor maintenance therapy did not experience relapse. Conclusion This study has confirmed the poor prognostic of MDD (+), high-risk site and SC/LH, but patients with SC/LH lymphoma and MDD (+) at diagnosis still need to receive better treatment (ClinicalTrials.gov number, NCT03971305).

Acute respiratory infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had caused a global pandemic since 2019, and posed a serious threat to global health security. Traditional Chinese medicine (TCM) has played an indispensable role in the battle against the epidemic. Many components originated from TCMs were found to inhibit the production of SARS-CoV-2 3C-like protease (3CLpro) and papain-like protease (PLpro), which are two promising therapeutic targets to inhibit SARS-CoV-2. This study describes a systematic investigation of the roots and rhizomes of Sophora tonkinensis, which results in the characterization of 12 new flavonoids, including seven prenylated flavanones (1-7), one prenylated flavonol (8), two prenylated chalcones (9-10), one isoflavanone (11), and one isoflavan dimer (12), together with 43 known compounds (13-55). Their structures including the absolute configurations were elucidated by comprehensive analysis of MS, 1D and 2D NMR data, and time-dependent density functional theory electronic circular dichroism (TDDFT ECD) calculations. Compounds 12 and 51 exhibited inhibitory effects against SARS-CoV-2 3CLpro with IC₅₀ values of 34.89 and 19.88 μmol·L^-1, repectively while compounds 9, 43 and 47 exhibited inhibitory effects against PLpro with IC₅₀ values of 32.67, 79.38, and 16.74 μmol·L^-1, respectively.
Flavonoids/chemistry* ; SARS-CoV-2 ; Rhizome ; COVID-19 ; Peptide Hydrolases ; Antiviral Agents/chemistry*

[This corrects the article DOI: 10.1016/j.apsb.2021.07.006.].

Objective:To compare the efficacy of the Preterm Infant Oral Feeding Readiness Assessment Scale (PIOFRA) and Preterm Infant Oral Feeding Ability Readiness Assessment Scale (POFARA) in predicting the outcome of first oral feeding in preterm infants.Methods:This study was a cross-sectional study. From February 2021 to February 2022, 276 premature infants treated in the Neonatal Intensive Care Unit of the Second Affiliated Hospital of Air Force Medical University of People's Liberation Army and the Second Affiliated Hospital of Shaanxi University of Chinese Medicine were selected by convenience sampling method. According to the outcome of the first oral feeding, the premature infants were divided into a successful first oral feeding group ( n=227) and a failed first oral feeding group ( n=49). PIOFRA and POFARA were used to evaluate premature infants. The area under the receiver operating characteristic curve ( AUC), sensitivity, specificity, Youden index and other indicators were used to compare the predictive efficacy of the two scales for the first oral feeding outcome of premature infants. Results:The success rate of first oral feeding for premature infants was 82.25% (227/276). The PIOFRA and POFARA scores of the successful first oral feeding group were higher than those of the failed first oral feeding group ( P<0.01). The AUC of PIOFRA was 0.830. When the total score of PIOFRA was 27.00, the sensitivity was 78.40%, the specificity was 75.50%, and the Youden index was 0.539 ( P<0.01), and its prediction efficiency was the highest. The AUC of POFARA was 0.928. When the total score of POFARA was 33.00, the sensitivity was 79.70%, the specificity was 95.90%, and the Youden index was 0.757 ( P<0.01), and its prediction efficiency was the highest. The AUC, sensitivity, specificity and Youden index of POFARA were higher than those of PIOFRA. Conclusions:The predictive efficacy of POFARA is higher than that of PIOFRA. It is recommended to use POFARA for the evaluation and prediction of the outcome of first oral feeding in premature infants.

Objective:The epidemiological and clinical characteristics of 18 cases of Japanese spotted fever (JSF) in Zigui County were analyzed in order to improve the prevention and treatment of JSF.Methods:This is a case series analysis. The epidemiological and clinical data, laboratory tests and imaging characteristics of 18 JSF cases with median age of 60 years (54, 68) identified by The People′s Hospital of Zigui from April 2021 to August 2022 were collected and analyzed retrospectively.Results:Most (17/18) of the patients were farmers and all had a field exposure history. The patient′s onset was from April to October. Spring and autumn were the seasons with the highest incidence of JSF. The first symptoms of patients were high fever, headache, and fatigue. Of the 18 cases, 15 had a rash and 12 presented an eschar and 3 had neither rash nor eschar. In addition, 10 of 18 cases experienced edema of both lower extremities, and 3 got disturbance of consciousness. Laboratory tests found that 15 patients had abnormal white blood cells and 11 patients had decreased platelets. C-reactive protein, procalcitonin, D-dimer, lactate dehydrogenase, and alpha-hydroxybutyrate dehydrogenase were elevated in all patients; 13 patients with elevated alanine aminotransferase, 14 patients with elevated aspartate transamination. Kidney damage caused by Rickettsia japonica infection showed by abnormal proteinuria in 11 of the patients. Conclusions:The most common clinical manifestations of JSF are non-specific indications such as high fever, chills, fatigue, headache. The eschar and rash, which are the main features of Rickettsia infection, are not present in all patients, resulting delay of diagnosis or misdiagnosis. Medical workers should be more alert to rickettsial infections in patients with fever of unknown origin, especially in seasons of high incidence of spotted fever. Early diagnosis and correct antibiotic treatment shall be given according to the patient′s clinical manifestations, laboratory results and imaging test to control disease progression.

Objective:To investigate the expression levels of peripheral blood lymphocytes in patients with high-grade squamous intraepithelial lesions (HSIL) of the cervix and early cervical cancer, and to analyze their correlation with the clinicopathological characteristics of cervical cancer.Methods:The clinical data of 65 patients with HSIL and 78 patients with early cervical cancer (2018 International Federation of Gynecology and Obstetrics stage ≤ stage Ⅱ A) treated in Shanxi Province Cancer Hospital from October 2020 to November 2021 were retrospectively analyzed, and 31 healthy people undergoing physical examination during the same period were treated as the healthy control group. The expressions of CD3 + T cells, CD4 + T cells, CD8 + T cells, NK cells, NK/T cells and other immune cells in fasting peripheral blood of the patients were detected by using flow cytometry. Results:The expression levels of CD3 + T cells, CD4 + T cells, CD4 +/CD8 + and NK cells were 71±8, 39±7, 1.5±0.5, 16±7, respectively in HSIL group, and 73±9, 41±9, 1.5±0.6, 16±9, respectively in early cervical cancer group, which were lower than those in the healthy control group (76±9, 45±10, 2.0±1.3, 20±7) (all P < 0.05). The expression levels of CD8 + T cells was 28±7, 29±8, respectively in HSIL group and early cervical cancer group, which were higher than those in the healthy control group (24±7) (all P < 0.05). The expression level of total B cells in early cervical cancer group was lower than that in healthy control group (10±4 vs.12±3, P < 0.05). The expression level of CD3 + T cells in peripheral blood of early cervical cancer patients with tumor diameter >4 cm and nerve/vascular invasion was 71±10 and 72±8, which was lower than that of patients with tumor diameter 2-4 cm, ≤2 cm and without nerve/vascular invasion (72±8, 75±8, 78±7); the expression level of CD8 + T cell was 32±8 and 35±4, which was higher than that of patients with tumor diameter 2-4 cm, ≤2 cm, and without nerve/vascular invasion (28±8, 28±7, 29±8) (all P < 0.05). The levels of CD3 + T cells and total B cells were negatively correlated with the tumor diameter (all P < 0.05), while the level of CD8 + T cells was positively correlated with tumor diameter ( P < 0.05); the levels of CD3 + T cells and NK cells were negatively correlated with nerve/vascular invasion (all P < 0.05). Conclusions:The immune function of the body starts to change in the early progression of cervical cancer, and is related to the tumor diameter and nerve/vascular invasion of cervical cancer.