The regulatory requirements of 3D printing products were introduced.The risks during the production of 3D printed navigational template for orthopedic surgery were summarized in terms of data acquisition,medical-industrial intera-ction design,3D printing,post-processing and sterilization.Some quality control measures were proposed from the aspects of quality control of raw materials,validation of data and software,verification of printing process parameters,post-processing method and verification,sterilization verification and testing of semi-finished and final products,so as to enhance the safety and effectiveness of 3D printed navigational template for orthopedic surgery.[Chinese Medical Equipment Journal,2024,45(5):80-85]

This study developed an optimal pre-processing technique for the reference substance of the classic formula Gualou Xiebai Banxia Decoction(GXBD) and established a comprehensive quality control method for GXBD reference substance to provide a reference for its overall quality evaluation. The authors prepared 15 batches of GXBD samples and innovatively used the extracted ion chromatogram under the base peak chromatogram mode to establish a liquid chromatography-mass spectrometry(LC-MS) fingerprint, identify characteristic peaks, and perform quantitative analysis of indicator components. The yield of the 15 batches of GXBD samples ranged from 50.28% to 76.20%. In the positive ion mode, 12 common characteristic peaks were detected in the LC-MS fingerprint, and the structures of five common peaks were identified by comparison with reference standards. The similarity between the fingerprint profiles of different batches of samples and the reference fingerprint profile ranged from 0.920 to 0.984. Finally, liquid chromatography-triple quadrupole mass spectrometry(LC-QQQ/MS) in multiple reaction monitoring(MRM) mode was used to determine the content of eight indicator components in GXBD, including loliolide, chrysoeriol, rutin, cucurbitacin D, macrostemonoside Ⅰ, 25S-timosaponin B Ⅱ, 25R-timosaponin B Ⅱ, and peptide proline-tryptophan-valine-proline-glycine(PWVPG). The method established in this study can reduce matrix interference in the compound, and it has good accuracy, stability, and practical value. It effectively reflects the quality attributes of GXBD samples and can be used for the comprehensive quality control of GXBD.
Chromatography, Liquid ; Tandem Mass Spectrometry/methods* ; Drugs, Chinese Herbal/chemistry* ; Proline ; Chromatography, High Pressure Liquid/methods*

Objectives: To investigated the safety and efficacy of treating patients with acute non-ST-segment elevation myocardial infarction (NSTEMI) and elevated levels of N-terminal pro-hormone B-type natriuretic peptide (NT-proBNP) with levosimendan within 24 hours of first medical contact (FMC). Methods: This multicenter, open-label, block-randomized controlled trial (NCT03189901) investigated the safety and efficacy of levosimendan as an early management strategy of acute heart failure (EMS-AHF) for patients with NSTEMI and high NT-proBNP levels. This study included 255 patients with NSTEMI and elevated NT-proBNP levels, including 142 males and 113 females with a median age of 65 (58-70) years, and were admitted in the emergency or outpatient departments at 14 medical centers in China between October 2017 and October 2021. The patients were randomly divided into a levosimendan group (n=129) and a control group (n=126). The primary outcome measure was NT-proBNP levels on day 3 of treatment and changes in the NT-proBNP levels from baseline on day 5 after randomization. The secondary outcome measures included the proportion of patients with more than 30% reduction in NT-proBNP levels from baseline, major adverse cardiovascular events (MACE) during hospitalization and at 6 months after hospitalization, safety during the treatment, and health economics indices. The measurement data parameters between groups were compared using the t-test or the non-parametric test. The count data parameters were compared between groups using the χ² test. Results: On day 3, the NT-proBNP levels in the levosimendan group were lower than the control group but were statistically insignificant [866 (455, 1 960) vs. 1 118 (459, 2 417) ng/L, Z=-1.25,P=0.21]. However, on day 5, changes in the NT-proBNP levels from baseline in the levosimendan group were significantly higher than the control group [67.6% (33.8%,82.5%)vs.54.8% (7.3%,77.9%), Z=-2.14, P=0.03]. There were no significant differences in the proportion of patients with more than 30% reduction in the NT-proBNP levels on day 5 between the levosimendan and the control groups [77.5% (100/129) vs. 69.0% (87/126), χ²=2.34, P=0.13]. Furthermore, incidences of MACE did not show any significant differences between the two groups during hospitalization [4.7% (6/129) vs. 7.1% (9/126), χ²=0.72, P=0.40] and at 6 months [14.7% (19/129) vs. 12.7% (16/126), χ²=0.22, P=0.64]. Four cardiac deaths were reported in the control group during hospitalization [0 (0/129) vs. 3.2% (4/126), P=0.06]. However, 6-month survival rates were comparable between the two groups (log-rank test, P=0.18). Moreover, adverse events or serious adverse events such as shock, ventricular fibrillation, and ventricular tachycardia were not reported in both the groups during levosimendan treatment (days 0-1). The total cost of hospitalization [34 591.00(15 527.46,59 324.80) vs. 37 144.65(16 066.90,63 919.00)yuan, Z=-0.26, P=0.80] and the total length of hospitalization [9 (8, 12) vs. 10 (7, 13) days, Z=0.72, P=0.72] were lower for patients in the levosimendan group compared to those in the control group, but did not show statistically significant differences. Conclusions: Early administration of levosimendan reduced NT-proBNP levels in NSTEMI patients with elevated NT-proBNP and did not increase the total cost and length of hospitalization, but did not significantly improve MACE during hospitalization or at 6 months.
Male ; Female ; Humans ; Aged ; Natriuretic Peptide, Brain ; Simendan/therapeutic use* ; Non-ST Elevated Myocardial Infarction ; Heart Failure/drug therapy* ; Peptide Fragments ; Arrhythmias, Cardiac ; Biomarkers ; Prognosis

Benzodiazepines(BDZs)are used in clinics for anxiolysis,anticonvulsants,sedative hypnosis,and muscle relaxation.They have high consumptions worldwide because of their easy availability and potential addiction.They are often used for suicide or criminal practices such as abduction and drug-facilitated sexual assault.The pharmacological effects of using small doses of BDZs and their detections from complex biological matrices are challenging.Efficient pretreatment methods followed by accurate and sensitive detections are necessary.Herein,pretreatment methods for the extraction,enrichment,and preconcentration of BDZs as well as the strategies for their screening,identification,and quantitation developed in the past five years have been reviewed.Moreover,recent advances in various methods are summarized.Characteristics and advantages of each method are encompassed.Future directions of the pretreatment and detection methods for BDZs are also reviewed.

Objective:To establish an effective classification and identification method for sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) maps of Rana dybowskii,its analogues and counterfeits based on cluster analysis and multivariate statistical analysis. Method:SDS-PAGE maps of 18 batches of R. dybowskii,its analogues and 2 counterfeits were obtained by SDS-PAGE method. SDS-PAGE maps were transformed into data matrix. NTSYSpc 2.10e statistical analysis software was used for cluster analysis,and SMICA-P 14.1 software was used for multivariate statistical analysis. Unsupervised Principal Component Analysis (PCA),Supervised Partial Least Squares Discriminant Analysis (PLS-DA) and Orthogonal Partial Least Squares Discriminant Analysis (OPLS-DA) were performed for multivariate analysis and evaluation. Result:SDS-PAGE maps technology combined with cluster analysis and multivariate statistical analysis could accurately classify and identify R. dybowskii,its analogues and counterfeits. Cluster analysis could cluster four kinds of medicinal materials into four branches except No.1 medicinal materials. PCA results were superior to cluster analysis. Supervised PLS-DA and OPLS-DA results in multivariate statistical analysis were superior to unsupervised PCA. The classification and identification efficiencies of OPLS-DA were better than those of unsupervised PCA. OPLS-DA aggregated R. dybowskii,its analogues and 2 counterfeits into four groups. Six different protein components were obtained by comprehensive analysis of variable importance in projection (VIP) value, and OPLS-DA Bi load diagram,with relative molecular weights were 51.363,35.838,14.565,17.563,15.358 and 21.696 kDa,respectively. Conclusion:SDS-PAGE maps combined with cluster analysis and multivariate statistical analysis can be used as an effective method to classify and identify R. dybowskii,its analogues and counterfeits. This study provides a reference for the quality evaluation and screening of R. dybowskii.

Objective To determine the trend of emergency department (ED)mortality of a tertiary general hospital from 2004 to 2014 in order to find the factors that may impact on ED mortality.Methods Mortality in ED was estimated according to the ratio of ED visiting patients to ED deaths.And the data of all ED deaths in 2004,2009 and 2014 were collected.Variance analysis and chi-square test were used for data analysis.Results During the past decade,ED visiting patients was increased significantly by 38.0% in 2014,compared with those in 2004,and the mortality was also increased accordingly from 0.7% in 2004, to 0.9% in 2009,to 1.2% in 2014 (P <0.01).Finally,a total of 1,091 deaths occurred in these three years were included for further evaluation.There were no significant changes in average age and gender distribution,and the average age was 61.9 and the male /female ratio was 1.36∶1 during past decade.The number of adults under 40 years old (18 -39)increased from 7.5% in 2004,to 10.6% in 2009,to 14.4% in 2014 (P <0.05).Both the facilities were upgraded and the number of staffs in ED increased markedly.The cardiovascular illness,cerebrovascular diseases,and sudden death were the leading causes of ED death during past decade.The incidences of trauma and tumor remained unchanged.Average time consumed from onset of illness to arrival to ED didn’t vary significantly during past decade.The study showed no changes in use of ambulance,but remarkable increases in number of non-compliant patients or their family from 18.3% in 2004,to 25.6% in 2009,to 38.3% in 2014 (P <0.01).The percentage of patients in the night time was higher,but there were no significant changes in number of emergency patients in the night time and during holidays in the past decade,but the mean ED stay time increased obviously from 22.4 h in 2004 to 53.3 h in 2014 (P <0.05 ).Conclusions During the past decade,although ED facilities and number of staffs have been improved apparently,ED mortality rate still keeps on escalating. The increase in ED mortality rate may be related to the severely ill patients presenting to ED,the obvious decrease in compliance of patients and the prolonged ED stay time.

In 2013, the first dengue fever (DF) outbreak in central China was reported in the central of Henan province, northern temperate regions, although they have been sequentially recorded in Southern China. 106 suspected DF cases were reported and 73 patients were confirmed dengue virus type 3 (DEN-3) infections. 62/392 (15.8%) local health persons showed DEN antibodies positive. To this day Henan is the northernmost province in China which has been reported about outbreak of DF and what is important is that it warns us the endemic range of DF has been expanded geographically in China.
Adolescent ; Adult ; Aged ; Antibodies, Viral ; blood ; Child ; Child, Preschool ; China ; epidemiology ; Dengue ; epidemiology ; virology ; Dengue Virus ; isolation & purification ; Disease Outbreaks ; statistics & numerical data ; Female ; Humans ; Immunoglobulin G ; blood ; Immunoglobulin M ; blood ; Infant ; Male ; Middle Aged ; Serologic Tests ; Young Adult

OBJECTIVETo analyze and summarize the clinical characteristics, experience of diagnosis and treatment of cases infected by new bunyavirus, which occurred in Henan province in 2010.

METHODSThe clinical characteristics and effect of diagnosis and treatment of 5 cases were analyzed using descriptive epidemiological method. Blood specimens were detected by RT-PCR and pathogen separation.

RESULTSPCR testing was positive for all 5 cases. New bunyavirus were isolated from 2 cases. In 5 cases, fever (5/5), the whole body aches (5/5), fatigue (5/5), anorexia (5/5), nausea (5/5), the chills (4/5), cough (4/5), expectoration (4/5), vomiting (3/5), conjunctival hyperemia (3/5); Leukocyte reduction (5/5), thrombocytopenia (5/5), elevated alanine aminotransferase (4/5), elevated aspartate aminotransferase (4/5), elevated lactate dehydrogenase (5/5), creatine kinase elevations (4/5), urinary protein (3/5). By symptomatic and supportive treatment and prophylactic antibiotics, the first case died and the other 4 cases were cured. The average course of disease was 15.4 days.

CONCLUSIONCases infected by new bunyavirus have complicated clinical feature and multiple organ damage. If symptomatic treatment is in time, prognosis will be good.

Adult ; Bunyaviridae Infections ; diagnosis ; therapy ; virology ; China ; epidemiology ; Female ; Humans ; Male ; Middle Aged ; Orthobunyavirus ; Prognosis ; Young Adult

OBJECTIVETo analyze the epidemiological characteristics of fever thrombocytopenia and leukopenia syndrome (FTLS) in Henan province, China in 2007 - 2011.

METHODSData from specific surveillance system for FTLS in Henan and Information Management System of Chinese Center for Disease Control and Prevention were used to collect the information of the cases.Descriptive epidemiological methods were used to analyze the surveillance data during 2007 - 2011. Patients' sera were collected to detect new bunyavirus using fluorescent RT-PCR and virus isolation.

RESULTSDuring 2007 - 2011, 1021 FTLS cases were reported in Henan province. The fatality rate was 2.25%with 23 deaths. The cases reported in Xinyang city were 1007, accounting for 98.75%.Cases were mainly occurred between April and October, accounting for 96.47% (985/1021). Epidemic peak was May to July, accounting for 59.16% (604/1021). The second peak occurred in September, accounting for 12.05% (123/1021). The age of the cases ranged from 1 to 88 years old with the median age of 59. Sex ratio (male:female) was 1:1.50 (408:613). In all cases, 93.73% (957/1021) were farmers. In 465 patients' sera, the positive rate of new bunyavirus was 69.25% (322/465) using fluorescent RT-PCR. In 164 patients' sera, 67 strains of new bunyavirus were isolated with isolation rate of 40.85% (67/164).

CONCLUSIONFTLS in Henan province is caused mainly by the new bunyavirus and has certain regional and seasonal characteristics. Most cases are female older farmers.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Bunyaviridae Infections ; epidemiology ; Child ; Child, Preschool ; China ; epidemiology ; Female ; Fever ; epidemiology ; virology ; Humans ; Infant ; Male ; Middle Aged ; Orthobunyavirus ; isolation & purification ; Sex Ratio ; Thrombocytopenia ; epidemiology ; virology ; Young Adult

OBJECTIVETo evaluate the effect of placement of urethral catheter combined with lidocaine on urethral irritation caused by postoperative indwelling catheters.

METHODSA total of 120 male surgical patients requiring postoperative indwelling catheters between June 2011 and January 2012 were divided into two equal groups for placement of painless urethral catheter combined with bladder washing with lidocaine on the first postoperative day, or for routine catheter placement only. The symptoms of urethral irritation such as urethral pain, urinary urgency, and perineal discomforts were observed and compared between the two groups.

RESULTSIn patients with painless urethral catheter placement combined with bladder washing with lidocaine, 11 developed urethral irritation symptoms, as compared to 24 in the patients with routine catheter placement only, showing a significant difference between the two groups (P<0.05).

CONCLUSIONPlacement of painless urethral catheter combined with bladder washing with lidocaine can significantly reduce the incidence of urethral irritation due to postoperative indwelling catheters.

Adult ; Humans ; Lidocaine ; Male ; Middle Aged ; Urinary Catheterization ; methods ; Urinary Catheters ; adverse effects ; Urination Disorders ; etiology ; prevention & control ; Young Adult