2.The efficacy and safety of linagliptin in elderly patients with type 2 diabetes: a pooled analysis of eight placebo-controlled clinical trials
Xiaohui GUO ; Zhikai FENG ; Linhua XU
Chinese Journal of Internal Medicine 2017;56(8):588-594
Objective To evaluate the efficacy and safety of dipeptidyl peptidase-4 inhibitor,linagliptin,in subjects aged 60 years or older with type 2 diabetes mellitus (T2DM).Methods Data from eight 24-week,multinational,multicenter,randomized,double-blind,placebo-controlled,parallel-group studies were analyzed.Patients aged 60 years or older with T2DM were received oral linagliptin (5 mg/d) or placebo in combination with mefformin,or metformin plus sulfonylurea.Efficacy was assessed by the changes in glycosylated hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) from baseline to 24 weeks of treatment.Safety endpoint included the frequency and intensity of adverse events.Results A total of 1 421 patients (placebo 429,linagliptin 992) were included in the full analysis set (FAS).Mean ages of the subjects were (67.4 ± 5.6) years in the linagliptin group and (66.7-± 5.6) years in the placebo group.Baseline HbA1c was (8.0 ±0.8) % in the linagliptin group and (8.1 ±0.9) % in the placebo group.At the end of 24-week,placebo-adjusted reduction in HbAlc in subjects with linagliptin was (0.7 ±0.1)% (95% CI 0.6-0.8,P <0.000 1),and placebo-adjusted reduction in FPG in subjects with linagliptin was (0.88 ±0.12) mmol/L(95% CI 0.65-1.11,P <0.000 1).Overall safety and tolerability in the two groups were similar.Adverse events occurred in 57.1% of patients in the placebo group and 61.1% of patients in the linagliptin group,and the incidence of adverse events leading to discontinuation was 3.2% in the placebo group and 3.8% in the linagliptin group.Serious adverse events occurred in 1.6% of patients in the placebo group and 2.8% of patients in the linagliptin group.Investigator-defined hypoglycaemia occurred in 7.3% of patients in the placebo group and 11.9% of patients in the linagliptin group.Among them,most were mild or moderate hypoglycaemia,and severe hypoglycaemia only occurred in 0.2% of patients in the placebo and 0.5% in the linagliptin groups.Overall incidence of hypoglycaemia in linagliptin group was slightly higher than that in placebo group,which might be due to the fact that more patients were taking sulfonylureas in linagliptin group than in placebo group (26.8% linagliptin;18.4% placebo).No difference could be viewed in hypoglycaemia between the two groups in patients without sulfonylureas (1.2% linagliptin,1.1% placebo)Moreover,no severe hypoglycaemia was reported in subjects without sulfonylureas.The incidences of other adverse events were similar in both groups.Conclusion Linagliptin was efficacious in lowering glucose with a safety profile similar to placebo in type 2 diabetic patients aged 60 years or older.
3.The von Clauss method for fibrinogen assay and its influential factors
Feng CHENG ; Dan WANG ; Xiaohui ZHU
Chinese Journal of Laboratory Medicine 2000;0(06):-
Objectives To study the influential factors of the von Clauss method and to promote the method for fibrinogen assay in clinical laboratories in China. MethodsKits of foreign and domestic products were used. Calibration curves for fibrinogen determination were established, and calibration plasma was used for comparison. Effects of pH value, thrombin activity, and temperature on the measurement were studied.Results The reproducibility of the von Clauss method using domestic thrombin and related reagents was excellent, the within day CV being 0.039 1, and the between day CV 0.049 7. The percentage variations of calibration plasma determination, with the foreign fibrinogen assay kits using domestic reagents, were +3.17% , +4.76%, and -6.03%, respectively. Determination of a lyophilized plasma using the two sources reagents showed similar results.Conclusions Thrombin and relevant reagents produced in China could be used as a substitute for kits purchased abroad, which would promote the use of von Clauss method in clinical laboratories of China.
4.The changes of multifocal electroretinography in commotio retinae
Haihua ZHENG ; Feng CHEN ; Xiaohui HAN
Chinese Journal of Ocular Fundus Diseases 2000;0(04):-
Objective To observe the changes of the multifocal electroretinograph (mf-ERG) in commotio retinae. Methods The affected eyes (traumatic group) and the fellow eyes (control group) of 31 patients with unilateral commotio retinae were examined by RETI scan 3.15 system. The responses of 61 retinal regions were recorded, and the average amplitude densities of the N 1 (the first negative) wave and P 1 (the first positive) wave in different regions of retinal were analyzed. Results The average amplitude densities of 1-4 rings in N 1 wave and 1-5 rings in P 1 wave were much lower in traumatic group than those in the control. Conclusions The average amplitude densities of N 1 wave and P 1 wave of mf-ERG in retinal affected regions decreases markedly in eyes with commotio retina; mf-ERG may provide the quantificational and orientational detection for the visual ability of the eyes with commotio retinae.
5.Subgenotyping analysis of pathogenic Cryptococcus gattii isolates from China
Xiaobo FENG ; Zhirong YAO ; Bo LING ; Xiaohui LI ; Daming REN
Chinese Journal of Dermatology 2009;42(2):138-140
Objective To assess the subgenotypes of pathogenic Cryptococcus gattii isolates from China and to elucidate the epidemiological links between these domestic isolates and those from other parts of the world. Methods DNA was extracted from 9 clinical isolates of Ctyptococcus gattii from China. The partially variable regions of the three unlinked loci, namely IGS1, PLB1 and GEF1, were amplified and sequenced, and the bioinformation at these loci was obtained from GenBank for multi-locus sequences alignment and phylogenetic analysis. Results Of these 9 clinical isolates, 8 were genotype VG Ⅰ and mating type α with the same sequences at the tested regions as the reference strain WM276, which was a representative isolate of an independent subgenotype; 1 was of genotype VG Ⅱ and mating type α, which was the first report in China, with the tested sequences consistent with those of the referrence strain R272. Sequencing and phylogenetic analysis of GEF1 gene, which was located at mating type locus, successfully identified the genotypes and mating types of all the Cryptococcus gattii isolates involved here. Conclusions Multi-locus sequence analysis shows that causative Cryptococcus gattii isolates of genotype VG Ⅰ in China carry similar sequences at the tested loci in IGS1, PLB1 and GEF1 genes, to a widely distributed subgenotype in the world, and the sequences of the first VG Ⅱ genotype isolate from China resemble the less virulent subgenotype VG Ⅱ b found in Vancouver islands.
6.Effect of tanshinone ⅡA on the expression of P-selectin and ICAM-1 after cerebral ischemic reperfusion injury in rats
Hao LI ; Kaixiang LIU ; Junlin FENG ; Jingzi JIANG ; Xiaohui LIN
Journal of Chinese Physician 2008;10(4):444-447
Objective To study the effect of tanshinone ⅡA on the expression of P-selectin and ICAM-1 after cerebral ischemia reperfusion (I/R)injury in rats. Methods Rats were randomly divided into 4 groups: Sham operated group, I/R group, low dose Tan ⅡA treated group and high dose Tan ⅡA treated group. The focal middle cerebral artery occlusion (MCAO) model was made by suture-occluded method. Rats were pretreated with Tan ⅡA, ig for 3d,respectively before MCAO. After 90min MCAO following 24 hours of reperfusion, the expression of P-selectin and ICAM-1 was detected with using immunohistochemistry method. Result Compared with sham operated group, the expression of P-selectin and ICAM-1 increased after reperfusion for 24 hours in the ischemic territory(all P<0.01).Compared with I/R group, the expression of P-selectin and ICAM-1 decreased in a dose dependent manner in low and high dose Tan ⅡA treated group(P<0.01).Compared with that of I/R group, cerebral infarction volume was decreased in a dose dependent manner in low dose Tan ⅡA treated group and high dose Tan ⅡA treated group(all P<0.01).The change of ischemic impairment in low or high dose Tan ⅡA treated group was less than that in IR group, and the change of ischemic impairment in high dose Tan ⅡA treated group was less than that in low dose Tan ⅡA treated group. Conclusion Tan ⅡA may reduce cerebral ischemia-reperfusion inflammation injure by decreasing the expression of p-selectin and ICAM-1.Tan ⅡA plays protective effect on cerebral ischemia injury, especially when high dose of Tan ⅡA(30mg/kg)was used.
7.PCR-RFLP versus PCR fingerprinting method in the genotyping of Cryptococcus neoformans
Xiaobo FENG ; Zhirong YAO ; Xiaohui LI ; Daming REN
Chinese Journal of Dermatology 2008;41(4):226-229
Objective To evaluate the efficiency of PCR-restriction fragment length polymorphism (PCR-RFLP)aiming at the structure gene g6341,versus PCR fingerprinting analysis in the genotyping of Cryptococcus neoformans MethodsEight reference strains and 68 clinical and environmental isolates of C.neoformans were genotyped by PCR-RFLP and PCR fingerprinfing.In PCR fingerprinting,the minisatel lite-specific core sequence of wild-type phage M13 was used as a single primer.The structure gene g6341 was selected for PCR-RFLP analysis by sequence alignments of multiple genes,a pair of pnmers were developed based on the conserved region of g6341 gene.PCR products were digested with the appropriate restriction endonucleases,and RFLP profiles were analyzed.Partial sequence analysis of g6341 gene was performed for different genotypes of C.Neoformans.Phylogenetic analysis was done to study the relatedness between these genotypes.Results As sequence homology analysis showed,g6341 gene was suitable for RFLP analysis.In the case of enotyping of 76 C. Neoformans strains,the results obtained from PCR-RFLP were consistent with those from PCR fingerprinting.Sequence analysis of g6341 gene revealed a homology of 84%-97%among the eight genotypes as well as a consistency of 99%-100%within a same genotype.In the phylogenetic tree,genotypes VNⅠ,VNⅡ,VNⅢand VNⅣ belonged to one cluster,and genotypes VGⅠ,VGⅡ,VGⅢ and VGⅣ to another cluster.Conclusions PCR-RFLP analysis aiming at the structure gene g6341 is a useful tool to genotype C.neoformans.Sequence analysis of g6341 gene can disclose the relatedness among different molecular types of C.neoformans.
8.Comparison of the outcomes of central venous catheters inserted from the left side and right side: a prospective randomized controlled study
Bilong FENG ; Xiaohui TAN ; Li TONG ; Bei WANG ; Sujun ZHOU
Chinese Journal of Clinical Nutrition 2010;18(2):87-90
Objective To compare the effectiveness and safety of central venous catheters inserted from the left side and right side during peripheral inserted central catheterizations (PICC). Methods Totally 458 adult patients undergoing PICC between May 2007 and May 2008 were enrolled in this study and divided randomly into right-sided group (n = 228)and left-slded group (n = 230). Chest X-ray was performed immediately after catheterization to identify the initial tip locations. Other parameters were evaluated during follow-up. Results The rate of difficult insertion was significantly lower in right-sided group than in left-sided group (14.9% vs 24. 8% , P =0.003). The rate of tip projection angle >40°was also significantly lower in right-sided group (2.2% vs 23.4% ,P = 0. 000). The rate of tips reaching the central veins was not significantly different between two groups (54.4%vs 53.0% , P = 0. 538). Compared with right-sided catheters, the tip positions in the left-sided group was significantly less frequently located in the inferior segment of superior vena cave in the central tip locations (6. 6% vs 21.0% , P =0. 001)and more commonly positioned in the nominate vein in non-central tip locations (66. 7% vs 48.1% , P = 0. 008). In addition, the catheter detaining time (P = 0. 617), incidence of local phlebitis after puncture (P = 0. 561), catheter obstruction rate (P = 0. 774), and catheter-related infection rate (P = 0. 854)showed no significant differences between two groups. The incidence of swollen limb was significantly lower inright-sided group than in left-sided group (4. 4% vs 8.3%, P = 0. 043). Conclusions Right-sided catheters provide better outcomes than left-sided catheters. PICC through the right elbow veins should be preferred in clinical practices.
9.Development of B→O blood conversion device control system
Xiaohui LIANG ; Ying HUANG ; Feng GONG ; Ying HAN ; Yangpei ZHANG
Chinese Journal of Tissue Engineering Research 2009;13(22):4381-4384
B→O blood conversion has very important meanings in the blood transfusion during the period of peace and war.In the leader of Professor Zhang Yangpei,from Academy of Military Medical Sciences,B→O blood conversion has been achieved by using gene engineering.They obtained the great breakthrough in the domain of blood type conversion.In order to realize standardization and automatization,it is necessary to develop a device applying to B→O blood conversion.This device automatically accomplishes the process of B→O blood conversion,shortens the time of B→O blood conversion to quarter than the time by manual operation,and ensures the standardization and obturation.In the condition of one-off pipeline,this device meets the clinical demands for blood,and lays a foundation for clinical expansion of B→O blood conversion.This paper presented the control system of B→O blood conversion device,including design of software and hardware.This device provides a safe and efficient tool for B→O blood conversion.
10.Effect of basic fibroblast growth factor on endogenous neural stem cell in rat cerebral cortex with global cerebral ischemia-reperfusion.
Mingxin REN ; Xiaohui DENG ; Yiwei GUO ; Fengjin ZHENG ; Zhibo FENG
Journal of Biomedical Engineering 2014;31(4):846-849
The present paper is aimedto investigate the effect of basic fibroblast growth factor (bFGF) on proliferation, migration and differentiation of endogenous neural stem cell in rat cerebral cortex with global brain ischemia-reperfusion. A global brain ischemia-reperfusion model was established. Immunohistochemistry was used to observe the pathological changes and the expression of BrdU and Nestin in cerebral cortex. RT-PCR was used to measure the NSE mRNA in brain tissue. The results of measurements indicated that in sham operation group, there was no positive cell in cerebral cortex, and the content of NSE mRNA did not change. In the operation group, the expression of BrdU and Nestin increased significantly at the end of the 3rd day, and peaked on the 7th day. NSE mRNA expression did not significantly increase. In bFGF group, compared with sham operation group and model group, the number of BrdU-positive and Nestin-positive cells increased significantly at each time point (P<0. 05), and peaked at the end of the 11th day, and the content of NSE mRNA increased significantly (P<0. 05). This research demonstrated that the proliferation of endogenous neural stem cells in situ could be induced by global cerebral ischemia and reperfu- sion, and could be promoted and extended by bFGF. In additiion, bFGF might promote endogenous neural stem cells differentiated into neurons.
Animals
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Brain Ischemia
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pathology
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Cell Differentiation
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Cell Movement
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Cell Proliferation
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Cerebral Cortex
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cytology
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metabolism
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pathology
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Fibroblast Growth Factor 2
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pharmacology
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Nestin
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metabolism
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Neural Stem Cells
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drug effects
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Rats
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Reperfusion Injury