1.Clinical effect of Kudiezi injection on renal function based on propensity score.
Zhao-kang ZHANG ; Wei YANG ; Huan LIU ; Xian-bin ZENG ; Yan ZHUANG ; Yan-ming XIE
China Journal of Chinese Materia Medica 2015;40(13):2661-2667
To explore the effect of Kudiezi injection on renal function in the real world, in order to provide the basis for the clinical medication safety. Patient aged between 18-80 were selected from 18 large hospitals information system (HIS) databases established by clinical research institute for basic traditional Chinese medicine of China academy of Chinese medical sciences. The patients who were treated with Kudiezi injection (24 225 cases) were defined as the exposed group, whereas those who were not treated with Kudiezi injection (14,191 cases) were defined as the non-exposed group. The propensity score method was used to balance the confounding factors. Classic logistic regression, GBM weighted propensity score logistic regression, GBM propensity score weighted logistic regression with covariate and sensitivity analysis were adopted to study the effect of Kudiezi injection on renal function. The results showed no significant difference in the possibility in abnormality in serum creatinine (Scr) (P = 0.940, 0.679, 0.834) and urea nitrogen (BUN) (P = 0, 0.045, 0.164) between both groups. Therefore, the existing data indicated no damage of Kudiezi injection on renal function. Because this study is a retrospective study based on the real world, there may be unknown confounding factors and potential bias. Therefore, further studies shall be conducted to monitor whether Kudiezi injection causes damage on renal function, in order to ensure the clinical medication safety.
Blood Urea Nitrogen
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Drugs, Chinese Herbal
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adverse effects
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Hospital Information Systems
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Humans
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Injections
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Kidney
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drug effects
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physiology
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Kidney Function Tests
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Logistic Models
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Propensity Score
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Retrospective Studies
2.Protective effects of trimetazidine against vascular endothelial cell injury induced by oxidation
Shenghu HE ; Fengdi YAN ; Jing ZHAN ; Jianfeng YAN ; Bin YUAN ; Shu CHEN ; Yong XIE
Journal of Geriatric Cardiology 2008;5(4):248-251
To explore the protective effects of trimetazidine on vascular endothelial cells injury induced by hydrogen peroxide (H2O2) and its pharmacological mechanisms of anti-oxidation.Methods Human umbilical vein endothelial cells (HUVECs) were injured by H2O2.Next,the cells were treated with three different concentrations of trimetazidine (1 μmol/L,10 μmol/L,100μmol/L,respectively).The viability of cells was detected by methyl thiazoeyl tetrazolium (MTT) assay.In addition,malondialdehyde (MDA)contents,superoxide dismutase (SOD) and secretion of NO were measured.Results Trimetazidine could enhance the viability of the injured HUVECs induced by oxidation,decrease the level of MDA,enhance the SOD activity,and increase the secretion of nitrogen monoxide.These effects were in a certain dose-dependent manner and the difference was significant among the three concentrations (P<0.05).Conclusions Our results suggest that trimctazidine may protect lipid peroxidation and prevent oxidation-induced cellular dysfunction of HUVECs (J Geriatr Cardiol 2008;5:248-251)
3.Cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy improve survival of patients with peritoneal carcinomato-sis from colorectal cancer:a retrospective case-control study
Chaoqun HUANG ; Yunfeng ZHOU ; Conghua XIE ; Xiaojun YANG ; Fulin CHENG ; Bin XIONG ; Guoliang YANG ; Yan LI
Chinese Journal of Clinical Oncology 2013;(16):979-983
Objective:To evaluate the efficacy and safety of cytoreductive surgery (CRS) in conjunction with hyperthermic intra-peritoneal chemotherapy (HIPEC) for treating patients with peritoneal carcinomatosis (PC) from colorectal cancer (CRC). Methods:A total of 62 CRC patients with complication of PC were divided into the CRS group, namely, Group One (n=29, CRS and systemic adju-vant chemotherapy) and the CRS+HIPEC group, namely, Group Two (n=33, CRS+HIPEC). The primary end point of the study was overall survival (OS) and the secondary end point was serious adverse events (SAE). Results:Patients' clinicopathologic characteris-tics, peritoneal carcinomatosis index, and completeness of cytoreduction therapy were well balanced and comparable between the two groups. The median follow-up was 41.9 mo (6.5 mo to 110.0 mo) in Group One and 32.0 mo (10.5 mo to 95.9 mo) in Group Two. The median OS was 8.5 mo (95%CI:4.9 mo to 12.1 mo) in Group One and 14.5 mo (95%CI:11.9 mo to 17.1 mo) in Group Two (P=0.007). Within 30 days after the surgery, SAE occurred in 3 of the 29 patients in Group One, and 9 of the 33 patients in Group Two (P=0.126). Multivariate analysis revealed that HIPEC, CC0-1 score, and chemotherapy over six cycles were the independent factors for OS improvement. Conclusion:The CRS+HIPEC method improves the OS of patients with PC from CRC, suggesting an acceptable safety.
4.Safety and efficacy of Tirofiban in patients with acute coronary syndrome
Bin YUAN ; Shenghu HE ; Jing ZHANG ; Jianfeng YAN ; Shu CHEN ; Yong XIE
Chinese Journal of General Practitioners 2009;8(5):334-337
A total of 159 patients with acute coronary syndrome(ACS)were enrolled from December 2006 to June 2008 and divided into the percutaneous coronary intervention(PCI)group and the internal medicine treatment group.The participants in the two groups were further assigned to the Tirofiban or the placebo control group.The change in electrocardiograph within 48 hours,major adverse cardiac events (MACE)during hospital stay and 30 days' follow-up,and bleeding were compared between the sub-groups.As a result,in comparison with the placebo control groups,the Tirofiban sub-groups showed significant improvement in electrocardiography(P<0.01).In the internal medicine treatment group,the rate of MACE during 30 days' follow-up was significantly decreased in patients treated with Tirofiban(P<0.05),although no significant difference in bleeding rate was found.Our data suggest that Tirofiban may be safe and effective in the treatment of ACS.
5.Experimental study of suspicious sensitization component screening on Huachansu injection.
Ying XIAO ; Yu-Bin ZHAO ; Yan-Ming XIE
China Journal of Chinese Materia Medica 2012;37(18):2824-2827
OBJECTIVETo explore a new experimental method for screening of allergens in post-market traditional Chinese medicine injections by confirming allergens in Huachansu injection.
METHODFirst of all, the serum of patients allergic to Huachansu injection were collected, at the same time, the dubious allergen was conjugated to bovine serum albumin (BSA) by EDC coupling procedure to form complete antigen (BNP-BSA), which makes it possible to reproduce the allergic reaction of Huachansu injection in vitro. The histamine liberation ratio, the level of TNF-alpha and Histamine released from RBL-2H3 mast cell were detected; the above data were compared with those obtained in vivo.
RESULTThe difference of the histamine liberation ratio, the levels of TNF-alpha and histamine of the resibufogenin-BSA group, group of patients allergic to Huachansu injection were not significant compared with those of normal control group. However, there were significant difference in those data among the cinobufagin-BSA group, the blank control and normal control group (P<0.05).
CONCLUSIONThe allergen in the serum collected from patients allergic to Huachansu injection is resibufogenin.
Allergens ; adverse effects ; immunology ; Amphibian Venoms ; adverse effects ; immunology ; Animals ; Anura ; Bufanolides ; adverse effects ; immunology ; Drug Hypersensitivity ; immunology ; Histamine Release ; Humans ; Mast Cells ; immunology ; Medicine, Chinese Traditional
6.Design of a noninvasive ventilator's turbine.
Ya-Xu ZHOU ; Zhao-Yan HU ; Min ZHAN ; Bin GE ; Hai-Ming XIE
Chinese Journal of Medical Instrumentation 2008;32(2):97-82
The design principles of a noninvasive ventilator's turbine are studied and discussed in this paper. The design is completed from its several aspects and in combination of related theories, using SolidWorks tools. Abundant experimental results prove that this design's technical specifications meet all the requirements.
Equipment Design
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Respiration, Artificial
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instrumentation
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methods
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Ventilators, Mechanical
7.Systematic review of efficacy and safety of shenmai injection for chronic heart failure.
Hong-Dong CHEN ; Yan-Ming XIE ; Lian-Xin WANG ; Jiu-Bin WU
China Journal of Chinese Materia Medica 2014;39(18):3650-3661
The paper is to evaluate the efficacy and safety of Shenmai injection for chronic heart failure, retrieving the Pubmed, CBM, CNKI, Wanfang database and VIP database to comprehensively collect all types research report of Shenmai injection for chronic heart failure (CHF). Particularly wishing to point out, randomized controlled trials are include for the evaluation of effectiveness, which are statistically analyzed and evaluated by Rev-Man 5. 2. The current studies show that the improvement rate of NYHA classification of cardiac function of CHF patients and their related indexes figure such as LVEF, SV, CO, BNP, 6 min walking test value are all improved by the combination of Shenmai injection and foundation treatment. However, HR is almost no improvement. Meanwhile, serious ADR/AE of Shenmai injection for CHF isn't appear.
Drug Combinations
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Drugs, Chinese Herbal
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administration & dosage
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adverse effects
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therapeutic use
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Heart Failure
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drug therapy
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Humans
8.Protective effect of mailuoning injection on cerebral ischemia/reperfusion injury in rats and its mechanism.
Xiao-Bin PANG ; Xin-Mei XIE ; Hai-Yan WANG ; Bao-Quan WANG
China Journal of Chinese Materia Medica 2014;39(4):721-725
OBJECTIVETo discuss the protective effect of Mailuoning injection on ischemia/reperfusion (I/R) injury in rats and its mechanism.
METHODHealthy male adult Sprague-Dawley (SD) rats were randomly divided into the sham operation group, the model group, the edaravone (3 mg x kg(-1)) control group, and Mailuoning high, middle and low-dose groups (4, 2, 1 mL x kg(-1)), with 10 rats in each group, and administered with drugs through tail intravenous injection. The middle cerebral artery occlusion (MCAO) was adopted to establish the rat ischemia/reperfusion model. After the ischemia for 2 h and reperfusion for 24 h, the pathological changes in neurovascular units (NVU) of brain tissues at the ischemia side was observed by HE staining. The expressions of glialfibrillary acidic protein (GFAP) and ionized calcium-binding adaptor molecule 1 (Ibal) were detected by the immunohistochemical method. The expressions of tumor necrosis factor-alpha (TNF-alpha), interleukin 1beta (IL-1beta), vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1) were detected by the western blotting technique.
RESULTMailuoning injection could significantly improve the pathological changes in cortical penumbra brain tissue UVN of (I/R) rats, reduce the number of GFAP and Ibal positive cells, and significantly decrease the expressions of TNF-alpha, IL-1beta, VCAM-1 and ICAM-1 of brain tissues of I/R rats.
CONCLUSIONMailuoning injection shows an obvious protective effect on UVN of I/R rats. Its mechanism may involve the inhibition of the activation of astrocyte and microglia and the secretion and expression of various inflammatory factors.
Animals ; Brain ; drug effects ; metabolism ; Brain Ischemia ; surgery ; Drugs, Chinese Herbal ; administration & dosage ; Humans ; Infarction, Middle Cerebral Artery ; genetics ; metabolism ; Intercellular Adhesion Molecule-1 ; genetics ; metabolism ; Male ; Protective Agents ; administration & dosage ; Rats ; Rats, Sprague-Dawley ; Reperfusion Injury ; genetics ; metabolism ; prevention & control ; Tumor Necrosis Factor-alpha ; genetics ; metabolism ; Vascular Cell Adhesion Molecule-1 ; genetics ; metabolism
9.Effect of fluoride on expression of mRNA and protein of Wnt3a and β-catenin in osteoblast of rats
Xi-shan, CHEN ; Yan-ni, YU ; Wei, YI ; Liang-bin, WAN ; Ying, XIE
Chinese Journal of Endemiology 2013;(2):140-145
Objective To explore the effect of excessive fluoride on expression of mRNA and protein of Wnt3a and β-catenin in rats' osteoblasts and its correlation with pathogenic mechanism of fluorosis.Methods Thirty-six healthy SD rats,weighting 100-120 g and according to body mass,were randomly divided into three groups(twelve in each group).The rats of control were fed wich tap water(fluoride < 1 mg/L) and the experimental rats were exposed to NaF(low-fluoride group:5 mg/L,high-fluoride group:50 mg/L) added to the drinking water to establish the chronic fluorosis model.After fed for eight morth,all rats were killed and metaphysic of femoral was collected.Rat dental fluorosis was observed and bone fluorine was detected by ashing-fluorin ion selective electrode method.The content of bone alkaline phosphatase (BALP) and tartrate-resistant acid phosphatase 5b(TRACP 5b) in rats' serum was detected by enzyme-linked immunosorbent assay (ELISA).The morphologic changes of the bone were observed by microscopy.The expression of mRNA and protein of Wnt3a and β-catenin in osteoblasts of rats was analyzed with gray scale by hybridization in situ and immunohistochemistry methods,respectively.Results Detection rate of dental fluorosis,fluoride contents of urine and bone were significantly increased [control group:0.0%,(1.26 + 0.17)mg/L,(305.58 ± 91.26)mg/kg; low-fluoride group:66.7%,(2.06 ± 0.64)mg/L,(632.33 ±123.21)mg/kg; high-fluoride group:91.7%,(7.69 ± 1.96)mg/L,(1088.75 ± 156.16) mg/kg] in the rats treated with fluoride,the difference between groups was statistically significant(χ2 =21.6; F =36.57,467.02; all P <0.05).The contents of BALP and TRACP-5b in rats' serum were significantly different between groups(F =89.57,7.68; all P < 0.05).Compared with control group[(16.24 + 1.57)U/L],the contents of BALP in rats' serum of the low-fluoride and high-fluoride groups[(31.47 ± 5.30) and (54.61 ± 2.27)U/L] were increased gradually(all P <0.05).Compared with the low-fluoride group,the value in the high-fluoride group decreased significantly (P < 0.05).The contents of TRACP-5b in rats' serum of low-fluoride group[(3.45 ± 1.85)U/L] were elevated significantly(all P < 0.05) compared with the control group[(1.26 ± 0.23)U/L] and the high-fluoride group[(2.74 ± 1.85)U/L].The bone cortices were thickened and the bone trabecula was broadened,arranged closely together in chronic fluorosis rats with significant difference compared with the control group.In the low-fluoride and high-fluoride groups,the expression levels of Wnt3a and β-catenin mRNA (low-fluoride group:132.87 ± 5.72 and 132.57 ± 9.56; highfluoride group:135.60 ± 6.64 and 137.87 ± 9.16) were markedly elevated with significant difference,respectively (F =12.47,5.96; all P < 0.05) compared with those in control groups(119.86 ± 5.04 and 120.58 ± 7.84) by hybridization in situ(P < 0.05),but there was no statistical significance (P > 0.05) of the level of Wnt3a and β-catenin mRNA between low-fluoride and high-fluoride groups.In the low-fluoride and high-fluoride groups,the protein expression of Wnt3a and β-catenin (low-fluoride group:137.50 ± 4.32 and 140.85 + 3.54; high-fluoride group:142.65 ± 11.84 and 152.52 ± 4.64) were markedly elevated with significant difference,respectively (F =10.07,53.82; all P < 0.05) compared with those in control group (124.01 ± 2.63 and 126.75 ± 4.65) by immunohistochemistry(all P< 0.05),Wnt3a protein production in the low-fluoride group was increased without statistical significance compared with the high-fluoride group (P > 0.05).But the protein production of β-catenin in the lowfluoride group was elevated with significant difference compared with the high-fluoride group(P < 0.05).The mRNA and protein production of Wnt3a were positively correlated with the mRNA and protein production of β-catenin (r =0.731,0.658; all P < 0.05).Conclusions Rat bone tissue lesions caused by excessive fluoride may be associated with an increased expression of Wnt3a and β-catenin mRNA and protein in osteoblasts.In chronic fluorosis,fluoride stimulates the overexpression of Wnt3a and β-catenin in the Wnt signal transduction pathway,enhances bone osteogenesis and causes skeletal fluorosis.
10.Analysis suspected allergic factors to shenqi fuzheng injection based on prescription sequence analysis and nested case control study.
Qing-Hua AI ; Xian-Bin ZENG ; Yan-Ming XIE ; Wei YANG
China Journal of Chinese Materia Medica 2014;39(18):3563-3566
This study based on twenty 3A grade hospital information system (HIS) database in China, adopt toprescription sequence analysis (PSA) with nested case control study (NCCS) to analysis mainly suspected allergy factor of Shenqi Fuzheng injection (Shenqi Fuzheng). Study design according to start to stop using Shenqi Fuzheng whether using dexamethasone injection will crowd divided into cases group and control group, each case matched 4 controls were selected, two groups according to the ratio of the age and sex matched well. Square test, Fisher exact test, single factor and multiple factor logistic regression were used to analyze data Condition on admission, allergic history, dosage and drug combinations were taken into account in cases of suspected allergic reactions. After analysis in two subgroups we found that the single dose (P = 0.000 2) and the combined use of matrine (P < 0.000 1, OR = 14.312, confidence interval [8.184, 25.029]) had significant effects on the suspected allergic reaction. Study on the existing HIS data and the study method based on screening suspected risk factors for allergic reaction. This study can provide guidance for Shenqi Fuzheng injection safety using in clinical practice, and it can also provides new method for the clinical safety reevaluation of post-marketing Chinese medicine injection.
Case-Control Studies
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Drugs, Chinese Herbal
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adverse effects
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Female
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Humans
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Male