Air Pollutants ; toxicity ; China ; epidemiology ; Hospitals, Public ; Humans ; Patient Admission ; Respiratory Tract Diseases ; etiology ; physiopathology ; Temperature ; Weather

The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.
Clinical Trials as Topic ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; adverse effects ; chemistry ; economics ; therapeutic use ; Herbal Medicine ; economics ; legislation & jurisprudence ; Humans ; Patents as Topic ; Product Surveillance, Postmarketing ; Quality Control

OBJECTIVETo investigate the expression of chemokine receptor CCR7 in oral squamous cell carcinoma (OSCC) and its possible role in directional neck lymph node metastasis.

METHODSThe expression of chemokine receptor CCR7 was examined in 85 cases of OSCC, normal oral mucosa, and Tca8113 and adenoid cystic carcinoma (ACC-M) cell lines using immunohistochemistry, RT-PCR and Western blotting. The relationship between the expression and clinicopathological factors of OSCC was analyzed. After treatment with or without CCR7 antibody, in vitro adhesion assay was performed to compare the adhesion of Tca8113 and ACC-M cells to lymph nodes.

RESULTSCCR7 was expressed in 66% (56/85) of OSCC cases, and there was a significant difference in CCR7 expression between metastasis group (31/39, 79%) and non-metastasis group (25/46, 54%). RT-PCR and Western blotting also confirmed the presence of positive CCR7 expression in OSCC. Tca8113 cells expressing CCR7 showed stronger ability to adhere to lymph nodes as compared to CCR7-negative ACC-M cells and could be actively inhibited by CCR7 antibody.

CONCLUSIONSCCR7 may play an important role in the development and lymph node metastasis of oral squamous cell carcinoma.

Adult ; Aged ; Carcinoma, Squamous Cell ; metabolism ; pathology ; Female ; Humans ; Lymph Nodes ; pathology ; Lymphatic Metastasis ; Male ; Middle Aged ; Mouth Neoplasms ; metabolism ; pathology ; Receptors, CCR7 ; metabolism

Objective To investigate the current staffing of nurses and need of hospital nursing human resources in China.Methods Data were collected from 181 secondary and tertiary hospitals and 9774 nurses in mainland China by questionnaires.Results The average doctor-nurse ratio was 1 ∶ 1.39 in tertiary hospitals and 1 ∶ 1.31 in secondary hospitals.The doctor-nurse ratios in 164 hospitals (97.6％) and the proportion of nurses in health care staff in 105 hospitals (61.8％) had not reached the standard set by the Ministry of Health of China.62.3％ nurses held secondary diploma for their initial nursing education.The constituent ratio of nurses held secondary diploma decreased,while the ratio of nurses held advanced diploma and bachelor degree increased in the last 5 years from 2003 to 2007.Sixty percent of newly employed nurses were contract nurses in 2003.The proportion increased to 78％ in 2007,and in some regions it accounted for more than 90％ of new nurses.The needs and constituent ratio of nurses with.secondary diploma and advanced diploma would decrease while nurses with bachelor degree and master degree would increase in the next 5 years (from 2009 to 2013).Conclusions The nursing shortage is still severe in China,and nursing staff mainly held secondary diploma for their initial nursing education.Most of new nurses were employed as conwact nurses.The need of hospitals for nurses has increased,especially for nurses with higher educational level such as bachelor degree and master degree,while the need for secondary diploma hold ers have decreased.The need for advanced diploma holders has increased in the last 5 years and would decrease in the next 5 years,but they would still be the majority of employed nurses.The authors suggested that the staffing of nursing manpower,the work environments and career development of contract nurses should be improved,and the initial nursing education should be upgraded to meet the needs of hospitals.

OBJECTIVETo determine the differential protein expressions of epithelial mesenchymal transition (EMT) markers E-cadherin and vimentin in hepatocellular carcinorma (HCC) and to investigate their correlation to the molecular mechanisms of metastasis to explore their potential utility as prognostic indicators of HCC.

METHODSTumor tissues and patient-matched adjacent non-tumor tissues were collected from individuals diagnosed with HCC. E-cadherin and vimentin protein expressions in the tissue specimens were quantified by western blot with densitometry of fluorescence emission and comparatively analyzed to determine the associations with molecular and clinical features. The expressions of E-cadherin and vimentin, as well as the other EMT-related protein Twist, were also detected in the tissue specimens by immunohistochemistry. Statistical analyses were carried out by paired-samples t-test, Mann-Whitney test, and Spearman rank correlation analysis.

RESULTSE-cadherin expression was significantly lower in tumor tissues (0.082 +/- 0.063 vs. adjacent non-tumor tissues: 0.226 +/- 0.215, t = -4.050, P less than 0.01), lower in patients with portal vein tumor thrombus (vs. non-thrombic HCC patients, P = 0.001), and correlated with TNM stage (III/IV > I/II, P = 0.003). Vimentin expression was significantly higher in tumor tissues (vs. adjacent non-tumor tissues, P = 0.002), negatively correlated with E-cadherin expression (t = -0.509, P = 0.004), and closely associated with some clinical parameters, such as portal vein tumor thrombus (P less than 0.01), TNM stage (P less than 0.01), and Milan criteria (P = 0.005). Immunohistochemistry showed that E-cadherin expression was very weak in tumors but very strong in the cell membranes of non-tumor tissues, and that vimentin and Twist expressions were strong in tumors but undetectable in non-tumor tissue.

CONCLUSIONExpression levels of the EMT markers E-cadherin and vimentin in HCC are related to clinical parameters, including portal vein tumor thrombus and TNM stage, and may represent useful prognostic markers of metastasis.

Biomarkers, Tumor ; Cadherins ; Carcinoma, Hepatocellular ; Epithelial-Mesenchymal Transition ; Humans ; Liver Neoplasms ; Vimentin

BACKGROUNDThe neurogenic bladder dysfunction caused by spinal cord injury is difficult to treat clinically. The aim of this research was to establish an artificial bladder reflex arc in rats through abdominal reflex pathway above the level of spinal cord injury, reinnervate the neurogenic bladder and restore bladder micturition.

METHODSThe outcome was achieved by intradural microanastomosis of the right T13 ventral root to S2 ventral root with autogenous nerve grafting, leaving the right T13 dorsal root intact. Long-term function of the reflex arc was assessed from nerve electrophysiological data and intravesical pressure tests during 8 months postoperation. Horseradish peroxidase (HRP) tracing was performed to observe the effectiveness of the artificial reflex.

RESULTSSingle stimulus (3 mA, 0.3 ms pulses, 20 Hz, 5-second duration) on the right T13 dorsal root resulted in evoked action potentials, raised intravesical pressures and bladder smooth muscle, compound action potential recorded from the right vesical plexus before and after the spinal cord transaction injury between L5 and S4 segmental in 12 Sprague-Dawley rats. There were HRP labelled cells in T13 ventral horn on the experimental side and in the intermediolateral nucleus on both sides of the L6-S4 segments after HRP injection. There was no HRP labelled cell in T13 ventral horn on the control side.

CONCLUSIONUsing the surviving somatic reflex above the level of spinal cord injury to reconstruct the bladder autonomous reflex arc by intradural microanastomosis of ventral root with a segment of autologous nerve grafting is practical in rats and may have clinical applications for humans.

Anastomosis, Surgical ; Animals ; Atropine ; pharmacology ; Male ; Models, Theoretical ; Rats ; Rats, Sprague-Dawley ; Reflex, Abdominal ; drug effects ; physiology ; Trimethaphan ; pharmacology ; Urinary Bladder, Neurogenic ; physiopathology

Objective To explore the effect of lactoferrin fortified formula milk on growth and blood erythrocyte indices among infants.Methods In this prospective multi -center controlled intervention study,a total of 260 infants were selected from six maternal and children's health care hospitals in the area.All subjects were divided into two groups with the sequence of outpatient:lactoferrin fortified formula milk group (fortified group,FG,containing lactoferrin 38 mg/100 g milk and iron element 4mg/100 g milk)and no lactoferrin fortified milk (control group,CG,containing lactoferrin 0 mg/100 g milk and iron element 4.2 mg/100 g milk)for 3 months.The levels of weight,height and head circumference and the concentration of hemoglobin (Hb),serum ferritin (SF),red blood cell count (RBC),hematocrit(Hct),mean corpuscular volume (MCV ), mean corpuscular hemoglobin (MCH ), mean corpuscular hemoglobin concentration (MCHC),red blood cells volume distribution width (RDW)and HAZ,WAZ and WHZ were recorded before and after intervention,respectively.Results A total of 213 (including 115 in FG,and 98 in CG)infants were included in the intervention trial and all measurement of biochemical indicators were detected.There were no significant difference in the average amount of daily intake of formula milk (94.3 ±9.8 g vs.88.2 ±8.7 g for FG and CG,P >0.05)and iron element (3.8 ±0.4 mg vs.3.7 ±0.6 mg for FG and CG,P >0.05).The average amount of daily intake of lactoferrin for infants in FG group was 35.8 ±3.7 mg.The levels of weight,WAZ,WHZ,Hb,SF,MCV and MCHC of infants in FG after intervention were all significantly higher than those of infants in CG [weight,(8723 ±245)g vs.(8558 ±214)g;WAZ,(1.02 ±0.31)vs.(0.44 ±0.18);WHZ,(0.98 ±0.31)vs.(0.41 ±0.12);Hb,(125.5 ±15.4)g/L vs. (116.9 ±13.1)g/L;SF,(44.7 ±17.2)μg/L vs.(31.6 ±18.4)μg/L,but significantly lower for the prevalence of anemia (4.35% vs.7.14%)and iron deficiency (13.91% vs.24.49%)(P <0.05).Conclusion The intervention of lactoferrin fortified formula milk presented significant effects on iron metabolic homeostasis and erythrocyte indices of infant with breastfeeding.

Objective:To investigate the prognosis of patients with initially resectable gastric cancer liver metastasis (GCLM) who were treated by different modalities, and analyze the influencing factors for prognosis of patients.Methods:The retrospective cohort study was conducted. The clinicopathological data of 327 patients with initially resectable GCLM who were included in the database of a nationwide multicenter retrospective cohort study on GCLM based on real-world data from January 2010 to December 2019 were collected. There were 267 males and 60 females, aged 61(54,68)years. According to the specific situations of patients, treatment modalities included radical surgery combined with systemic treatment, palliative surgery combined with systemic treatment, and systemic treatment alone. Observation indicators: (1) clinical characteristics of patients who were treated by different modalities; (2) prognostic outcomes of patients who were treated by different modalities; (3) analysis of influencing factors for prognosis of patients with initially resectable GCLM; (4) screening of potential beneficiaries in patients who were treated by radical surgery plus systemic treatment and patients who were treated by palliative surgery plus systemic treatment. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M( Q1, Q3), and comparison between groups was conducted using the rank sum test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test. The Kaplan-Meier method was used to calculate survival rate and draw survival curve, and Log-Rank test was used for survival analysis. Univariate and multivariate analyses were conducted using the COX proportional hazard regression model. The propensity score matching was employed by the 1:1 nearest neighbor matching method with a caliper value of 0.1. The forest plots were utilized to evaluate potential benefits of diverse surgical combined with systemic treatments within the population. Results:(1) Clinical characteristics of patients who were treated by different modalities. Of 327 patients, there were 118 cases undergoing radical surgery plus systemic treatment, 164 cases undergoing palliative surgery plus systemic treatment, and 45 cases undergoing systemic treatment alone. There were significant differences in smoking, drinking, site of primary gastric tumor, diameter of primary gastric tumor, site of liver metastasis, and metastatic interval among the three groups of patients ( P<0.05). (2) Prognostic outcomes of patients who were treated by different modalities. The median overall survival time of the 327 pati-ents was 19.9 months (95% confidence interval as 14.9-24.9 months), with 1-, 3-year overall survival rate of 61.3%, 32.7%, respectively. The 1-year overall survival rates of patients undergoing radical surgery plus systemic treatment, palliative surgery plus systemic treatment and systemic treatment alone were 68.3%, 63.1%, 30.6%, and the 3-year overall survival rates were 41.1%, 29.9%, 11.9%, showing a significant difference in overall survival rate among the three groups of patients ( χ2=19.46, P<0.05). Results of further analysis showed that there was a significant difference in overall survival rate between patients undergoing radical surgery plus systemic treatment and patients undergoing systemic treatment alone ( hazard ratio=0.40, 95% confidence interval as 0.26-0.61, P<0.05), between patients undergoing palliative surgery plus systemic treatment and patients under-going systemic treatment alone ( hazard ratio=0.47, 95% confidence interval as 0.32-0.71, P<0.05). (3) Analysis of influencing factors for prognosis of patients with initially resectable GCLM. Results of multivariate analysis showed that the larger primary gastric tumor, poorly differentiated tumor, larger liver metastasis, multiple hepatic metastases were independent risk factors for prognosis of patients with initially resectable GCLM ( hazard ratio=1.20, 1.70, 1.20, 2.06, 95% confidence interval as 1.14-1.27, 1.25-2.31, 1.04-1.42, 1.45-2.92, P<0.05) and immunotherapy or targeted therapy, the treatment modality of radical or palliative surgery plus systemic therapy were independent protective factors for prognosis of patients with initially resectable GCLM ( hazard ratio=0.60, 0.39, 0.46, 95% confidence interval as 0.42-0.87, 0.25-0.60, 0.30-0.70, P<0.05). (4) Screening of potentinal beneficiaries in patients who were treated by radical surgery plus systemic treatment and patients who were treated by palliative surgery plus systemic treatment. Results of forest plots analysis showed that for patients with high-moderate differentiated GCLM and patients with liver metastasis located in the left liver, the overall survival rate of patients undergoing radical surgery plus systemic treatment was better than patients undergoing palliative surgery plus systemic treatment ( hazard ratio=0.21, 0.42, 95% confidence interval as 0.09-0.48, 0.23-0.78, P<0.05). Conclusions:Compared to systemic therapy alone, both radical and palliative surgery plus systemic therapy can improve the pro-gnosis of patients with initially resectable GCLM. The larger primary gastric tumor, poorly differen-tiated tumor, larger liver metastasis, multiple hepatic metastases are independent risk factors for prognosis of patients with initial resectable GCLM and immunotherapy or targeted therapy, the treatment modality of radical or palliative surgery plus systemic therapy are independent protective factors for prognosis of patients with initially resectable GCLM.

Objectives: To explore the efficacy and safety of emergency transcatheter aortic valve replacement (TAVR). Methods: Data of patients who underwent emergency TAVR in eight centers, namely Fuwai Hospital, Wuhan Asia Heart Hospital, Xijing Hospital, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Guangdong Provincial People's Hospital, Zhongshan Hospital Affiliated to Fudan University, the First Affiliated Hospital of Zhengzhou University, the Second Xiangya Hospital of Central South University, between May 2017 and December 2020 were retrospectively analyzed. The use of mechanical circulatory support system (MCS) and the results of laboratory tests (N-terminal B-type natriuretic peptide (NT-proBNP)) and echocardiography (mean aortic valve cross valve pressure difference and left ventricular ejection fraction) before and after operation were collected. The primary endpoint was all-cause death, and the secondary endpoints were stroke, major bleeding, major vascular complications, myocardial infarction, permanent pacemaker implantation, and acute renal injury. Device success was caculated, which refered to absence of procedural mortality and correct positioning of a single prosthetic heart valve into the proper anatomical location and intended performance of the prosthetic heart valve (mean aortic valve gradient<20 mmHg(1 mmHg=0.133 kPa) or peak velocity<3 m/s, with no moderate or severe prosthetic valve regurgitation). Kaplan-Meier survival curve was used to estimate the survival rate of patients during follow-up. Results: This study included 48 patients. The age was (72.5±8.1) years, and 34 patients were males (70.8%). Device success rate was 91.7% (44/48). The mean aortic valve transvalvular pressure was significantly decreased after operation ((12.3±6.4)mmHg vs. (60.2±23.8)mmHg, P<0.000 1). Left ventricular ejection fraction was significantly increased ((41.5±11.7)% vs. (31.0±11.3)%, P<0.000 1). NT-proBNP significantly decreased (3 492.0 (1 638.8, 7 165.5) ng/L vs. 12 418.5 (6 693.8, 35 000.0) ng/L, P<0.000 1). In-hospital all-cause mortality was 8.3% (4/48). During hospitalization, the rate of stroke was 2.1% (1/48), major bleeding was 6.3% (3/48), major vascular complications was 10.4% (5/48), myocardial infarction was 4.2% (2/48), permanent pacemaker implantation was 6.3% (3/48), and the rate of acute renal injury was 12.5% (6/48). MCS was used in 20 patients (41.7%). The median follow-up time was 196 days. During the follow-up, one patient died (due to systemic metastasis of pancreatic cancer), two cases suffered new myocardial infarction and one case received permanent pacemaker implantation. The survival rate of 30 days, 1 year and 2 years after the operation were 91.7% (44/48), 89.6% (43/48), 89.6% (43/48), respectively. Conclusion: Emergency TAVR may be a safe and effective treatment for patients with severe decompensated aortic valve stenosis.
Acute Kidney Injury ; Aged ; Aged, 80 and over ; Aortic Valve/surgery* ; Aortic Valve Stenosis/surgery* ; Female ; Heart Valve Prosthesis ; Humans ; Male ; Middle Aged ; Myocardial Infarction/surgery* ; Retrospective Studies ; Risk Factors ; Stroke ; Stroke Volume ; Transcatheter Aortic Valve Replacement/methods* ; Treatment Outcome ; Ventricular Function, Left

OBJECTIVETo investigate the association between ambient air pollution and hospital emergency admissions in Beijing.

METHODSIn this study, a semi-parametric generalized additive model (GAM) was used to evaluate the specific influences of air pollutants (PM10, SO2, and NO2) on hospital emergency admissions with different lag structures from 2009 to 2011, the sex and age specific influences of air pollution and the modifying effect of seasons on air pollution to analyze the possible interaction.

RESULTSIt was found that a 10 μg/m3 increase in concentration of PM10 at lag 03 day, SO2 and NO2 at lag 0 day were associated with an increase of 0.88%, 0.76%, and 1.82% respectively in overall emergency admissions. A 10 μg/m3 increase in concentration of PM10, SO2 and NO2 at lag 5 day were associated with an increase of 1.39%, 1.56%, and 1.18% respectively in cardiovascular disease emergency admissions. For lag 02, a 10 μg/m3 increase in concentration of PM10, SO2 and NO2 were associated with 1.72%, 1.34%, and 2.57% increases respectively in respiratory disease emergency admissions.

CONCLUSIONThis study further confirmed that short-term exposure to ambient air pollution was associated with increased risk of hospital emergency admissions in Beijing.

Adolescent ; Adult ; Aged ; Air Pollution ; adverse effects ; Cardiovascular Diseases ; epidemiology ; etiology ; Child ; Child, Preschool ; China ; epidemiology ; Cities ; Emergency Medical Services ; Female ; Humans ; Infant ; Male ; Middle Aged ; Respiratory Tract Diseases ; epidemiology ; etiology ; Seasons ; Young Adult