Biomechanical Study of New Biodegradable Esophageal Stent / 中国医疗器械杂志

The radial force of the degradable esophageal stent before and after degradation is one of the important indicators for effective treatment of esophageal stricture. Based on a combination of in vitro experiments and finite element analysis, this paper studies and verifies the biomechanical properties of a new type of degradable esophageal stent under different esophageal stricture conditions. Under radial extrusion conditions, the maximum stress at the port of the stent is 65.25 MPa, and the maximum strain is 1.98%; The peak values of stress and strain under local extrusion and plane extrusion conditions both appear in the extrusion area and the compression expansion area at both ends, which are respectively 48.68 MPa, 46.40 MPa, 0.49%, 1.13%. The maximum radial force of the undegraded stent was 11.22 N, and 97% and 51% of the maximum radial force were maintained after 3 months and 6 months of degradation, respectively. The research results verify the safety and effectiveness of the radial force of the new degradable esophageal stent, and provide a theoretical basis for the clinical treatment of esophageal stricture.

Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial / 中国结合医学杂志

OBJECTIVES@#To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.@*METHODS@#A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.@*RESULTS@#An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).@*CONCLUSIONS@#Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).

Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial / 中国结合医学杂志

OBJECTIVES@#To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.@*METHODS@#A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.@*RESULTS@#An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).@*CONCLUSIONS@#Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).

Investigation of life quality of elderly patients having received percutaneous coronary artery stent implantation / 介入放射学杂志

Objective To investigate the life quality of elderly patients who have received percutaneous coronary artery stent implantation,and to analyze the influence factors.Methods By using SF-12 scale and general information questionnaire,the investigation of the quality of life was conducted in 91elderly patients who had received percutaneous coronary artery stent implantation.Results The total score of the life quality of 91 elderly patients after receiving percutaneous coronary artery stent implantation was (68.06±17.72) points.The factors influencing the quality of life included age (statistic value=4.438,P＜0.05),number of interventional therapy (statistic value=2.916,P＜0.05),number of involved coronary artery vessels (statistic value=4.359,P＜0.05),angina after operation (statistic value=-2.343,P＜0.05),postoperative chest tightness (statistic value=-2.222,P＜0.05) and smoking (statistic value=3.013,P＜0.05).Conclusion The quality of life of the 91 elderly patients who have received percutaneous coronary artery stent implantation is at a moderate level,and it is influenced by many factors.Nursing staff should pay attention to the elderly patients after percutaneous coronary intervention and strengthen the health education guidance so as to provide theoretical basis for improving the quality of life of elderly patients.

The Development and Application of the Orthopaedics Implants Failure Database Software Based on WEB / 中国医疗器械杂志

This article develops a new failure database software for orthopaedics implants based on WEB. The software is based on B/S mode, ASP dynamic web technology is used as its main development language to achieve data interactivity, Microsoft Access is used to create a database, these mature technologies make the software extend function or upgrade easily. In this article, the design and development idea of the software, the software working process and functions as well as relative technical features are presented. With this software, we can store many different types of the fault events of orthopaedics implants, the failure data can be statistically analyzed, and in the macroscopic view, it can be used to evaluate the reliability of orthopaedics implants and operations, it also can ultimately guide the doctors to improve the clinical treatment level.

Study on the release of copper ion and corrosion for intrauterine contraceptive device with two kinds of Cu-containing stent / 中国医疗器械杂志

Two kinds of Cu-containing intrauterine contraceptive device (Cu-IUD) has been evaluated through the study on the release of copper ion and corrosion of copper surface in artificially formulated fluid. The result showed that the copper ions were released profusely from the stainless steel stents Cu-IUD in the first week of soak (25-12 microg/d), and then it became slowly and steady. The release of the copper ions from the titanium nickel shape memory alloy stents Cu-IUD were always slowly and steady in two months (0.5-5 microg/d). It obviously shows that the corrosion on copper surface of stainless steel stents Cu-IUD were more serious than titanium nickel shape memory alloy stents Cu-IUD by using 200 times microscope testing before and after soaking in formulated fluid.

FE modeling and analysis of the locking plate for proximal humerus fracture / 中国医疗器械杂志

The FE model of proximal humeral locking plate was established and analyzed to provide academic support of the proximal humeral locking plate failure. The stress distributions of the locking plate were observed under the situations of the fracture area providing support and without support. In summary, this type of locking plate cannot afford the stress at 120 degrees abduction position under the situation of fracture area provides without support. In order to reduce the probability of locking plate failure, it is recommended that using other type of locking plate instead or avoiding 120 degree abduction of the patient.

The uncertainty of different vickers-hardness test force in medical device testing / 中国医疗器械杂志

Vickers hardness is widely used in the performance testing of the metallic medical devices. It discusses the relationship between different test force and the uncertainty by mathematical simulation and experiment. With the increase of test force its uncertainty becomes smaller at 400 times magnification. If you can, you should try to choose a large test force, in order to improve the accuracy and repeatability. In the actual testing process, it is best not to use the micro vickers hardness test.

Design & development of orthopedics implants failure management system / 中国医疗器械杂志

The orthopedics implants failure management system has been put forward according to the present status. The function of the system and typical failure case reasoning route also have been described. Furthermore, the analysis process has been presented by illustrating a typical failure case analysis.

Comparison of four prognostic models and a new Logistic regression model to predict short-term prognosis of acute-on-chronic hepatitis B liver failure / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Acute-on-chronic hepatitis B liver failure (ACLF-HBV) is a clinically severe disease associated with major life-threatening complications including hepatic encephalopathy and hepatorenal syndrome. The aim of this study was to evaluate the short-term prognostic predictability of the model for end-stage liver disease (MELD), MELD-based indices, and their dynamic changes in patients with ACLF-HBV, and to establish a new model for predicting the prognosis of ACLF-HBV.</p><p><b>METHODS</b>A total of 172 patients with ACLF-HBV who stayed in the hospital for more than 2 weeks were retrospectively recruited. The predictive accuracy of MELD, MELD-based indices, and their dynamic change (D) were compared using the area under the receiver operating characteristic curve method. The associations between mortality and patient characteristics were studied by univariate and multivariate analyses.</p><p><b>RESULTS</b>The 3-month mortality was 43.6%. The largest concordance (c) statistic predicting 3-month mortality was the MELD score at the end of 2 weeks of admission (0.8), followed by the MELD: sodium ratio (MESO) (0.796) and integrated MELD (iMELD) (0.758) scores, DMELD (0.752), DMESO (0.729), and MELD plus sodium (MELD-Na) (0.728) scores. In multivariate Logistic regression analysis, the independent factors predicting prognosis were hepatic encephalopathy (OR = 3.466), serum creatinine, international normalized ratio (INR), and total bilirubin at the end of 2 weeks of admission (OR = 10.302, 6.063, 5.208, respectively), and cholinesterase on admission (OR = 0.255). This regression model had a greater prognostic value (c = 0.85, 95%CI 0.791 - 0.909) compared to the MELD score at the end of 2 weeks of admission (Z = 4.9851, P = 0.0256).</p><p><b>CONCLUSIONS</b>MELD score at the end of 2 weeks of admission is a useful predictor for 3-month mortality in ACLF-HBV patients. Hepatic encephalopathy, serum creatinine, international normalized ratio, and total bilirubin at the end of 2 weeks of admission and cholinesterase on admission are independent predictors of 3-month mortality.</p>

Failure analysis of orthopedic implants / 中国医疗器械杂志

The clinical failure factors of Orthopedic implants which happened recent years have been summarized. The main failure factors are quality of orthopedic implants itself, iatrogenic and patient-derived. The ways to preventive measures have been suggested.

Comparison of domestic and international standards for orthopedic implants / 中国医疗器械杂志

A great deal of comparisons on domestic standards for Orthopedic implants with ISO and ASTM standards have been presented, and some conclusions have been drawn: Domestic standards for orthopedic implants coincide with ISO and ASTM standards in the items of materials, geometry and classification. There are much bigger differences in some key performances of implants such as assembly, fatigue, wear and tear and so on. Some constructive ways have been suggested.

Lamivudine and entecavir significantly improved the prognosis of early-to-mid stage hepatitis B related acute on chronic liver failure / 中华实验和临床病毒学杂志

<p><b>OBJECTIVE</b>To clinically study the antiviral effects of lamivudine and entecavir on patients with early-to-mid stage Hepatitis B related acute on chronic liver failure (HBV-ACLF). METHODS; A prospective, randomized, open and parallel controlled clinical trial was designed to observe the antiviral effects of nucleoside analogues on patients with early-to-mid stage HBV-ACLF. Three groups were set for controlled study, i. e. basic treatment group, lamivudine plus basic treatment group and entecavir plus basic treatment group.</p><p><b>RESULTS</b>One month after treatment, the improvement rates of lamivudine group and entecavir group were 58.85% and 59.15% respectively, significantly higher than that of basic treatment group which was 34.84% (Chi(2) = 9.8323, P = 0.043). By the end of six months, the cumulative survival rates of patients with the antiviral treatments, i.e., lamivudine, entecavir, were 65.8%, 60.1%, significantly higher than that (42%) without the antiviral treatment (P = 0.045, P = 0.04 respectively). The cumulative survival rate in patients with a MELD score < 30 was higher than that with a MELD score over 30 (Chi(2) = 3.920, P = 0.048). For the patients with pretreatment HBV DNA > or = 10(7), the cumulative survival rate in patients with entecavir treatments group was higher than that of patients in basic treatment group (Chi(2) = 5. 014 P= 0.025). According to the Ordinal Regression analysis, antiviral therapy by using either lamivudine or entecavia could significantly increase the improvement rate of patients with early-to-mid stage HBV-ACLF. But severe complications, including hepatorenal syndrome, electrolyte imbalance and hepatic encephalopathy, medical history of liver cirrhosis, and pretreatment HBV DNA > or = 10(7) had significant impacts on prognosis of this group patients.</p><p><b>CONCLUSIONS</b>Antiviral therapy by using either lamivudine or entecavia could significantly increase the survival rate of patients with early-to-mid stage HBV-ACLF.</p>

Research Progress on Trehalose Synthase / 微生物学通报

Trehalose is a naturally occurring non-reducing disaccharide. This sugar has been known as a protector of biomembrane and macromolecules. And it has been widely used in foods, medicines, cosmetics. Trehalose synthase (TreS) is an intramolecular transglycosylase. It can catalyze the conversion of maltose into trehalose in one step. As the simple protocol and cheap substrate, it is very prospect in the industrial production. Here we have discussed the properties, catalytic mechanism and gene-engineering of TreS, and also proposed some solutions to its present research problems.

Biological evaluation within a risk management process / 中国医疗器械杂志

Bio-evaluation within the medical device quality/risk management system is a risk analyzing and assessing process. On the basis of data from characterization of materials, scientific literatures, application history, bio-toxicology testing and so on, weighing the benefit and the risk, bio-evaluation does a conclusion to "take" or "quit" the product design. There is no "zero risk" though "no toxicity" always is the most desirable conclusion in a testing report. The application history data is the most comprehensive among the information available, since no testing system can "clone" the human body. In addition, the capital cost has to be taken into account when bringing the sophisticated testing technologies into the evaluating system. Investigating the #G95-1 of FDA CDRH and the changes of ISO 10993-1, the trend to integrate bio-evaluation into a quality/risk management process can be figured out.

Secreted Expression of M annanase Gene in Pichia pastoris and Anylysis of Enzymic Properties / 中国生物工程杂志

A PCR method was used to amplify the sequence encoding the mature peptide of?-mannanase of Bacillus subtilis. The gene was inserted into the Pichia pastoris vector pPIC9K, downstream of?-factor signal peptide sequence. The resultant recombinant plasmid pPIC9K-MAN was lineared by BglII digestion and introduced into the host Pichia pastoris GS115 by PEG method. After screen, the recombinant P. pastoris strain MAN22 was obtained and fermented in large scale 5L fermenter. The recombinant mannanase activity could reach to 1102IU/ml. The properties of the recombinant mannanase were characterized.

Effects of huanglian jiedu decoction on leptin and resistin in insulin resistive rats / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To study effects of Huanglian Jiedu Decoction (HJD) on lipid metabolism, leptin and resistin in insulin resistive rats.</p><p><b>METHODS</b>Type 2 diabetes mellitus (DM2) rat model was induced by intravenous injection with a low dose of streptozotocin and high fat and high caloric diet, and randomized into four groups: the model control group, the HJD group, the berberine group and the aspirin group. Meanwhile 16 normal rats were assigned as the normal control group. The body weight was observed before and after treatment, total cholesterol (TC), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C), apolipoprotein A1 and B (apoA1, apoB), free fatty acid (FFA), insulin (INS) in serum, skeletal muscle triglyceride (mTG) in skeletal muscle, and oral glucose tolerance test (OGTT) and fasting blood glucose (FBG) were detected after 10 weeks of treatment, at the same time, serum levels of leptin and resistin were determined using ELLISA.</p><p><b>RESULTS</b>The levels of TC, TG, apoB, FBG, FFA, mTG, leptin and resistin were obviously lowered, the levels of HDL-C and apoA1 significantly raised, glucose tolerance improved and body weight reduced in insulin resistive rats, as compared with the model control (P<0.05, P<0.01).</p><p><b>CONCLUSION</b>The effects of HJD in lowering lipids, as well as reducing leptin and resistin might be closely correlated with its effects in ameliorating insulin resistance.</p>