[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.

Objective: To analyze the prevalence and the risk factors of fungal sepsis in 25 neonatal intensive care units (NICU) among preterm infants in China, and to provide a basis for preventive strategies of fungal sepsis. Methods: This was a second-analysis of the data from the "reduction of infection in neonatal intensive care units using the evidence-based practice for improving quality" study. The current status of fungal sepsis of the 24 731 preterm infants with the gestational age of <34⁺⁰ weeks, who were admitted to 25 participating NICU within 7 days of birth between May 2015 and April 2018 were retrospectively analyzed. These preterm infants were divided into the fungal sepsis group and the without fungal sepsis group according to whether they developed fungal sepsis to analyze the incidences and the microbiology of fungal sepsis. Chi-square test was used to compare the incidences of fungal sepsis in preterm infants with different gestational ages and birth weights and in different NICU. Multivariate Logistic regression analysis was used to study the outcomes of preterm infants with fungal sepsis, which were further compared with those of preterm infants without fungal sepsis. The 144 preterm infants in the fungal sepsis group were matched with 288 preterm infants in the non-fungal sepsis group by propensity score-matched method. Univariate and multivariate Logistic regression analysis were used to analyze the risk factors of fungal sepsis. Results: In all, 166 (0.7%) of the 24 731 preterm infants developed fungal sepsis, with the gestational age of (29.7±2.0) weeks and the birth weight of (1 300±293) g. The incidence of fungal sepsis increased with decreasing gestational age and birth weight (both P<0.001). The preterm infants with gestational age of <32 weeks accounted for 87.3% (145/166). The incidence of fungal sepsis was 1.0% (117/11 438) in very preterm infants and 2.0% (28/1 401) in extremely preterm infants, and was 1.3% (103/8 060) in very low birth weight infants and 1.7% (21/1 211) in extremely low birth weight infants, respectively. There was no fungal sepsis in 3 NICU, and the incidences in the other 22 NICU ranged from 0.7% (10/1 397) to 2.9% (21/724), with significant statistical difference (P<0.001). The pathogens were mainly Candida (150/166, 90.4%), including 59 cases of Candida albicans and 91 cases of non-Candida albicans, of which Candida parapsilosis was the most common (41 cases). Fungal sepsis was independently associated with increased risk of moderate to severe bronchopulmonary dysplasia (BPD) (adjusted OR 1.52, 95%CI 1.04-2.22, P=0.030) and severe retinopathy of prematurity (ROP) (adjusted OR 2.55, 95%CI 1.12-5.80, P=0.025). Previous broad spectrum antibiotics exposure (adjusted OR=2.50, 95%CI 1.50-4.17, P<0.001), prolonged use of central line (adjusted OR=1.05, 95%CI 1.03-1.08, P<0.001) and previous total parenteral nutrition (TPN) duration (adjusted OR=1.04, 95%CI 1.02-1.06, P<0.001) were all independently associated with increasing risk of fungal sepsis. Conclusions: Candida albicans and Candida parapsilosis are the main pathogens of fungal sepsis among preterm infants in Chinese NICU. Preterm infants with fungal sepsis are at increased risk of moderate to severe BPD and severe ROP. Previous broad spectrum antibiotics exposure, prolonged use of central line and prolonged duration of TPN will increase the risk of fungal sepsis. Ongoing initiatives are needed to reduce fungal sepsis based on these risk factors.
Infant ; Infant, Newborn ; Humans ; Birth Weight ; Intensive Care Units, Neonatal ; Retrospective Studies ; Tertiary Care Centers ; Infant, Extremely Low Birth Weight ; Gestational Age ; Infant, Extremely Premature ; Sepsis/epidemiology* ; Retinopathy of Prematurity/epidemiology* ; Bronchopulmonary Dysplasia/epidemiology*

OBJECTIVE: To examine the anti-inflammatory effects and potential mechanisms of polypeptide from Moschus (PPM) in lipopolysaccharide (LPS)-induced THP-1 macrophages and BALB/c mice. METHODS: The polypeptide was extracted from Moschus and analyzed by high-performance liquid chromatography and sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE). Subsequently, LPS was used to induce inflammation in THP-1 macrophages and BALB/c mice. In LPS-treated or untreated THP-1 macrophages, cell viability was observed by cell counting kit 8 and lactate dehydrogenase release assays; the proinflammatory cytokines and reactive oxygen species (ROS) were measured by enzyme-linked immunosorbent assay and flow cytometry, respectively; and protein and mRNA levels were measured by Western blot and real-time quantitative polymerase chain reaction (qRT-PCR), respectively. In LPS-induced BALB/c mice, the proinflammatory cytokines were measured, and lung histology and cytokines were observed by hematoxylin and eosin (HE) and immunohistochemical (IHC) staining, respectively. RESULTS: The SDS-PAGE results suggested that the molecular weight of purified PPM was in the range of 10-26 kD. In vitro, PPM reduced the production of interleukin 1β (IL-1β), IL-18, tumor necrosis factor α (TNF-α), IL-6 and ROS in LPS-induced THP-1 macrophages (P<0.01). Western blot analysis demonstrated that PPM inhibited LPS-induced nuclear factor κB (NF-κB) pathway and thioredoxin interacting protein (TXNIP)/nucleotide-binding oligomerization domain, leucine-rich repeat and pyrin domain containing 3 (NLRP3) inflammasome pathway by reducing protein expression of phospho-NF-κB p65, phospho-inhibitors of NF-κB (Iκ Bs) kinase α/β (IKKα/β), TXNIP, NLRP3, apoptosis-associated speck-like protein containing a caspase recruitment domain (ASC), and pro-caspase-1 (P<0.05 or P<0.01). In addition, qRT-PCR revealed the inhibitory effects of PPM on the mRNA levels of TXNIP, NLRP3, ASC, and caspase-1 (P<0.05 or P<0.01). Furthermore, in LPS-induced BALB/c mice, PPM reduced TNF-α and IL-6 levels in serum (P<0.05 or P<0.01), decreased IL-1β and IL-18 levels in the lungs (P<0.01) and alleviated pathological injury to the lungs. CONCLUSION PPM could attenuate LPS-induced inflammation by inhibiting the NF-κB-ROS/NLRP3 pathway, and may be a novel potential candidate drug for treating inflammation and inflammation-related diseases.

LIN28 is an RNA binding protein with important roles in early embryo development, stem cell differentiation/reprogramming, tumorigenesis and metabolism. Previous studies have focused mainly on its role in the cytosol where it interacts with Let-7 microRNA precursors or mRNAs, and few have addressed LIN28's role within the nucleus. Here, we show that LIN28 displays dynamic temporal and spatial expression during murine embryo development. Maternal LIN28 expression drops upon exit from the 2-cell stage, and zygotic LIN28 protein is induced at the forming nucleolus during 4-cell to blastocyst stage development, to become dominantly expressed in the cytosol after implantation. In cultured pluripotent stem cells (PSCs), loss of LIN28 led to nucleolar stress and activation of a 2-cell/4-cell-like transcriptional program characterized by the expression of endogenous retrovirus genes. Mechanistically, LIN28 binds to small nucleolar RNAs and rRNA to maintain nucleolar integrity, and its loss leads to nucleolar phase separation defects, ribosomal stress and activation of P53 which in turn binds to and activates 2C transcription factor Dux. LIN28 also resides in a complex containing the nucleolar factor Nucleolin (NCL) and the transcriptional repressor TRIM28, and LIN28 loss leads to reduced occupancy of the NCL/TRIM28 complex on the Dux and rDNA loci, and thus de-repressed Dux and reduced rRNA expression. Lin28 knockout cells with nucleolar stress are more likely to assume a slowly cycling, translationally inert and anabolically inactive state, which is a part of previously unappreciated 2C-like transcriptional program. These findings elucidate novel roles for nucleolar LIN28 in PSCs, and a new mechanism linking 2C program and nucleolar functions in PSCs and early embryo development.
Animals ; Cell Differentiation ; Embryo, Mammalian/metabolism* ; Embryonic Development ; Mice ; Pluripotent Stem Cells/metabolism* ; RNA, Messenger/genetics* ; RNA, Ribosomal ; RNA-Binding Proteins/metabolism* ; Transcription Factors/metabolism* ; Zygote/metabolism*

OBJECTIVE: To observe the clinical efficacy of acupoint injection combined with Vitalstim electrical stimulation for post-stroke dysphagia. METHODS: A total of 98 patients with dysphagia after first stroke were randomized into an acupoint injection group (35 cases, 2 cases dropped off), an electrical stimulation group (31 cases, 3 cases dropped off) and a combination group (32 cases, 3 cases dropped off). Injection of mecobalamin into Tunyan point, Vitalstim electrical stimulation and the combination of injection of mecobalamin into Tunyan point and Vitalstim electrical stimulation were applied respectively in the 3 groups, once a day, 10 times as one course, 2 courses were required. Before and after treatment, the tongue muscle thickness and video fluoroscopic swallowing study (VFSS) score were observed in the 3 groups. RESULTS: After treatment, the tongue muscle thickness was decreased (P<0.05), the VFSS scores were increased (P<0.05) compared with before treatment in the 3 groups, and the variation of tongue muscle thickness and VFSS score in the combination group was greater than the acupoint injection group and the electrical stimulation group (P<0.05). CONCLUSION Both acupoint injection of mecobalamin and Vitalstim electrical stimulation have therapeutic effect on dysphagia after stroke, and the two have synergistic effect.
Acupuncture Points ; Acupuncture Therapy ; Deglutition ; Deglutition Disorders/therapy* ; Electric Stimulation ; Humans ; Treatment Outcome

BACKGROUND: The basis of individualized treatment should be individualized mortality risk predictive information. The present study aimed to develop an online individual mortality risk predictive tool for acute-on-chronic liver failure (ACLF) patients based on a random survival forest (RSF) algorithm. METHODS: The current study retrospectively enrolled ACLF patients from the Department of Infectious Diseases of The First People's Hospital of Foshan, Shunde Hospital of Southern Medical University, and Jiangmen Central Hospital. Two hundred seventy-six consecutive ACLF patients were included in the present study as a model cohort (n = 276). Then the current study constructed a validation cohort by drawing patients from the model dataset based on the resampling method (n = 276). The RSF algorithm was used to develop an individual prognostic model for ACLF patients. The Brier score was used to evaluate the diagnostic accuracy of prognostic models. The weighted mean rank estimation method was used to compare the differences between the areas under the time-dependent ROC curves (AUROCs) of prognostic models. RESULTS: Multivariate Cox regression identified hepatic encephalopathy (HE), age, serum sodium level, acute kidney injury (AKI), red cell distribution width (RDW), and international normalization index (INR) as independent risk factors for ACLF patients. A simplified RSF model was developed based on these previous risk factors. The AUROCs for predicting 3-, 6-, and 12-month mortality were 0.916, 0.916, and 0.905 for the RSF model and 0.872, 0.866, and 0.848 for the Cox model in the model cohort, respectively. The Brier scores were 0.119, 0.119, and 0.128 for the RSF model and 0.138, 0.146, and 0.156 for the Cox model, respectively. The nonparametric comparison suggested that the RSF model was superior to the Cox model for predicting the prognosis of ACLF patients. CONCLUSIONS The current study developed a novel online individual mortality risk predictive tool that could predict individual mortality risk predictive curves for individual patients. Additionally, the current online individual mortality risk predictive tool could further provide predicted mortality percentages and 95% confidence intervals at user-defined time points.
Acute-On-Chronic Liver Failure ; Humans ; Prognosis ; Proportional Hazards Models ; ROC Curve ; Retrospective Studies

BACKGROUND: It has been a global trend that increasing complications related to pelvic floor surgeries have been reported over time. The current study aimed to outline the development of Chinese pelvic floor surgeries related to pelvic organ prolapse (POP) over the past 14 years and investigate the potential influence of enhanced monitoring conducted by the Chinese Association of Urogynecology since 2011. METHODS: A total of 44,594 women with POP who underwent pelvic floor surgeries between October 1, 2004 and September 30, 2018 were included from 22 tertiary academic medical centers. The data were reported voluntarily and obtained from a database. We compared the proportion of each procedure in the 7 years before and 7 years after September 30, 2011. The data were analyzed by performing Z test (one-sided). RESULTS: The number of different procedures during October 1, 2011-September 30, 2018 was more than twice that during October 1, 2004-September 30, 2011. Regarding pelvic floor surgeries related to POP, the rate of synthetic mesh procedures increased from 38.1% (5298/13,906) during October 1, 2004-September 30, 2011 to 46.0% (14,107/30,688) during October 1, 2011-September 30, 2018, whereas the rate of non-mesh procedures decreased from 61.9% (8608/13,906) to 54.0% (16,581/30,688) (Z = 15.53, P < 0.001). Regarding synthetic mesh surgeries related to POP, the rates of transvaginal placement of surgical mesh (TVM) procedures decreased from 94.1% (4983/5298) to 82.2% (11,603/14,107) (Z = 20.79, P < 0.001), but the rate of laparoscopic sacrocolpopexy (LSC) procedures increased from 5.9% (315/5298) to 17.8% (2504/14,107). CONCLUSIONS: The rate of synthetic mesh procedures increased while that of non-mesh procedures decreased significantly. The rate of TVM procedures decreased while the rate of LSC procedures increased significantly. TRIAL REGISTRATION NUMBER NCT03620565, https://register.clinicaltrials.gov.
China ; Female ; Gynecologic Surgical Procedures/adverse effects* ; Humans ; Pelvic Floor/surgery* ; Pelvic Organ Prolapse/surgery* ; Surgical Mesh/adverse effects* ; Treatment Outcome ; Vagina

Objective:To investigate the features, changing trend, and rules of pneumoconiosis in Jiangsu Province, China, as well as the health status of patients with pneumoconiosis.Methods:From July to October 2019, the patients with pneumoconiosis, reported up to the end of 2018 in Jiangsu Province, were enrolled as respondents, and follow-up and retrospective investigation were performed. A total of 24405 patients with pneumoconiosis were investigated, and related data were collected from the monitoring system of cause of death for residents, pneumoconiosis network reporting system, occupational disease diagnosis institution, management institutions for the reporting of occupational diseases, and related residents' committee or village committee. The patients with pneumoconiosis, who had been reported, were followed up by telephone or on-site visit to obtain the information on their conditions. A descriptive analysis was performed for age of onset, working years, sex, category of industry, type of pneumoconiosis, annual disease onset, geographic distribution, and medical security.Results:Among the 24405 patients, a male/female ratio was 16.81∶1. Of all 24405 patients, 15948 (65.35%) had stage 1 pneumoconiosis, 5289 (21.67%) had stage 2 pneumoconiosis, and 1637 (6.71%) had stage 3 pneumoconiosis. The mean working years for dust exposure was 16.25±9.95 years for all patients, and the mean working years for dust exposure was 15.80±9.95 years for patients with stage 1 pneumoconiosis, 17.82±9.80 years for patients with stage 2 pneumoconiosis, and 16.31±9.90 years for patients with stage 3 pneumoconiosis. The highest number of cases of pneumoconiosis was reported in Wuxi (5744 cases, accounting for 23.54%) , followed by Zhenjiang (4160 cases, accounting for 17.05%) , Xuzhou (3851 cases, accounting for 15.78%) , Yancheng (3340 cases, accounting for 13.69%) , and Suzhou (2948 cases, accounting for 12.08%) . Major types of pneumoconiosis included silicosis (15392 cases, accounting for 63.07%) and coal workers' pneumoconiosis (5253 cases, accounting for 21.52%) . In this survey, 21115 completed follow-up, among whom 15924 survived and 5191 died, 15924 patients with pneumoconiosis survived, among whom 7461 (46.85%) had an age of ≥70 years and 2515 (15.79%) were exposed to dust for 5-9 years. The industries involved were mainly coal mining and washing industry (5687 cases, accounting for 35.71%) and public management, social security, and social organization (3349 cases, accounting for 21.03%) ; in terms of security, 7999 patients (50.23%) were covered by occupational injury insurance, 946 (5.94%) were compensated by employers, 4537 (28.49%) were covered by basic medical insurance for urban and rural residents, 1590 (9.98%) were covered by critical illness insurance, and 5458 (34.28%) were covered by other types of social security, such as medical assistance and poverty relief.Conclusion:Silicosis and coal worker's pneumoconiosis are the key points for the prevention and treatment of pneumoconiosis in Jiangsu Province, and supervision should be strengthened for industries and regions with serious dust hazards.

Objective:To investigate the features, changing trend, and rules of pneumoconiosis in Jiangsu Province, China, as well as the health status of patients with pneumoconiosis.Methods:From July to October 2019, the patients with pneumoconiosis, reported up to the end of 2018 in Jiangsu Province, were enrolled as respondents, and follow-up and retrospective investigation were performed. A total of 24405 patients with pneumoconiosis were investigated, and related data were collected from the monitoring system of cause of death for residents, pneumoconiosis network reporting system, occupational disease diagnosis institution, management institutions for the reporting of occupational diseases, and related residents' committee or village committee. The patients with pneumoconiosis, who had been reported, were followed up by telephone or on-site visit to obtain the information on their conditions. A descriptive analysis was performed for age of onset, working years, sex, category of industry, type of pneumoconiosis, annual disease onset, geographic distribution, and medical security.Results:Among the 24405 patients, a male/female ratio was 16.81∶1. Of all 24405 patients, 15948 (65.35%) had stage 1 pneumoconiosis, 5289 (21.67%) had stage 2 pneumoconiosis, and 1637 (6.71%) had stage 3 pneumoconiosis. The mean working years for dust exposure was 16.25±9.95 years for all patients, and the mean working years for dust exposure was 15.80±9.95 years for patients with stage 1 pneumoconiosis, 17.82±9.80 years for patients with stage 2 pneumoconiosis, and 16.31±9.90 years for patients with stage 3 pneumoconiosis. The highest number of cases of pneumoconiosis was reported in Wuxi (5744 cases, accounting for 23.54%) , followed by Zhenjiang (4160 cases, accounting for 17.05%) , Xuzhou (3851 cases, accounting for 15.78%) , Yancheng (3340 cases, accounting for 13.69%) , and Suzhou (2948 cases, accounting for 12.08%) . Major types of pneumoconiosis included silicosis (15392 cases, accounting for 63.07%) and coal workers' pneumoconiosis (5253 cases, accounting for 21.52%) . In this survey, 21115 completed follow-up, among whom 15924 survived and 5191 died, 15924 patients with pneumoconiosis survived, among whom 7461 (46.85%) had an age of ≥70 years and 2515 (15.79%) were exposed to dust for 5-9 years. The industries involved were mainly coal mining and washing industry (5687 cases, accounting for 35.71%) and public management, social security, and social organization (3349 cases, accounting for 21.03%) ; in terms of security, 7999 patients (50.23%) were covered by occupational injury insurance, 946 (5.94%) were compensated by employers, 4537 (28.49%) were covered by basic medical insurance for urban and rural residents, 1590 (9.98%) were covered by critical illness insurance, and 5458 (34.28%) were covered by other types of social security, such as medical assistance and poverty relief.Conclusion:Silicosis and coal worker's pneumoconiosis are the key points for the prevention and treatment of pneumoconiosis in Jiangsu Province, and supervision should be strengthened for industries and regions with serious dust hazards.

Background::Fecal incontinence (FI) has been shown to be a common symptom in Western countries; however, there is few researches focusing on its epidemic condition in Chinese women. We conducted this national population-based epidemiology study to estimate the prevalence and risk factors of FI among adult Chinese women living in urban regions.Methods::This is a subgroup analysis of a national population-based epidemiology study of FI. Total 28,196 adult women from urban regions of six provinces and municipalities participated in this research from 2014 to 2015. They finished the questionnaire under the direction of trained interviewers. FI was defined as accidental leakage of flatus and/or liquid or solid stool at least once in the past. The FI prevalence trend and risk factors were identified by the Cochran-Armitage test, Chi-square test, and multivariable logistic regression.Results::The prevalence of FI in adult females in urban China was 0.43% (95% confidence interval: 0.35%-0.51%). Among women with FI, 42.96%, 82.96%, and 42.22% reported having leakage of solid, liquid stool, and gas, respectively. The overall FI prevalence and the incidence rate of solid stool/liquid stool/gas leakage increased with age. The mean Wexner score was 4.0% and 12.0% FI patients reported Wexner score ≥9. Body mass index ≥24 kg/m 2, pelvic organ prolapses, chronic constipation, chronic cough, alcohol consumption, physical diseases including chronic bronchitis and cancer, gynecological diseases like gynecological inflammation are risk factors for FI. Vaginal delivery was the risk factor for FI in females with labor history. Conclusions::FI was not a common symptom in adult Chinese women living in urban areas and there were some potential modifiable risk factors.Trial Registration::Chinses Clinical Trial Registry: ChiCTR-OCS-14004675; http://www.chictr.org.cn/showproj.aspx?proj=4898