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Clinical effect of atorvastatin combined with lopidogrel in patients with transient ischemic attack

Drug Evaluation Research.2017;40(3):361-364. doi:10.7501/j.issn.1674-6376.2017.03.014

Objective To investigate the clinical effect of atorvastatin combined with lopidogrel in patients with transient ischemic attack.Methods Totally 92 cases of patients with transient ischemic attack in Xingyuan Hospital of Yulin City from January 2013 to August 2015 were divided into observation group and control group,46 cases in each group.Patients in observation group were treated with atorvastatin combined with lopidogrel,and patients in control group were treated with lopidogrel.The differences in short term effect,long-term effect,and adverse reaction between two groups were compared.Results The total effective rate of observation group was significantly higher than that of control group (P ＜ 0.05);After treatment,the levels of hs-CPR,Lp-PLA2TC,TG,and LDL,the recurrence rate of transient ischemic attack and the incidence of cerebral infarction of the observation group were significantly lower than that of the control group and before treatment (P ＜ 0.05),but the differences in PLT,PT,and APTT between two groups before and after treatment were not significant.Conclusion The clinical effect of atorvastatin combined with lopidogrel in patients with transient ischemic attack were remarkable,and the incidence of adverse events do not increase.

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Cerebral protection of dexmedetomidine in patients with heart valve replacement under CPB

Yaping ZHU ; Yimin SONG ; Leijun SONG ; Jinju WEI

Drug Evaluation Research.2017;40(3):356-360. doi:10.7501/j.issn.1674-6376.2017.03.013

Objective To investigate the cerebral protection of dexmedetomidine in patients with heart valve replacement under CPB.Methods Totally 80 cases of patients with heart valve replacement under CPB in Seventh people's hospital of Zhengzhou city from January 2015 to December 2015 were selected and divided into observation group and control group,40 cases in each group.Patients in observation group were treated with dexmedetomidine before anesthetic induction and during the operation,and patients in control group were treated with same dose of saline solution.The arterio-venous oxygen content difference (Da-jvO2),jugular venous oxygen saturation (SjvO2),cerebral oxygen extraction rate (CERO2),serum myelin basic protein (MBP),serum neuron-specific enolase (NSE),and S1003 protein content before anesthetic induction (T0) and when the ascending aorta open (T1),After 10 min of CPB (T2) and postoperative 6 h (T3) were compared between two groups,and occurring rates of MMSE and POCD were also compared.Results SjvO2 values of two groups at T1 were significant higher than T0 (P ＜ 0.05),Da-jvO2,and CERO2 were significant lower than T0 (P ＜ 0.05),SjvO2 values of observation group at T1 and T2 were significant higher than those of control group and Da-jvO2 and CERO2 were significant lower than those of control group (P ＜ 0.05);At T2 and T3,MBP levels of observation group and control group were significant higher than T0 (P ＜ 0.05),and those in observation group were significant lower than control group (P ＜ 0.05);At T1,T2,and T3 of observation group and control group were significant higher than T0 (P ＜0.05),and NSE levels of observation group at T1,T2,T3 were significant lower than those of control group (P ＜ 0.05),S-100β levels of observation group at T2 and T3 were significant lower than those of control group (P ＜ 0.05).After 7 d,MMSE score of observation group was significant higher than that of control group and POCD occurring rate was lower (P ＜ 0.05).Conclusion Dexmedetornidine can improve cerebral ischemia hypoxia state and reduce brain damage in patients with heart valve replacement under CPB.

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Determination of eight heavy metal elements in iron dextran by inductively coupled plasma optical emission spectrometry and correction of spectral interference

Chao MA ; Simeng FANG ; Nan MI ; Kexin ZANG ; Mujun SU

Drug Evaluation Research.2017;40(3):335-340. doi:10.7501/j.issn.1674-6376.2017.03.009

Objective To establish a method for the determination of eight heavy metal elements (Pb,Cd,As,Hg,Co,V,Se,and Mo) in iron dextran by inductively coupled plasma optical emission spectrometry (ICP-OES).Methods Through detection wavelength selection,optimization of instrument parameters and applying interference element correction (IEC) method to correction of spectral interference,the eight heavy metal elements were analyzed by ICP-OES.Results The elements recoveries were from 88.7％ to 101.3％ by correction of spectral interference with IEC method.The accuracy of the method was good.The linearities of the detected elements were good,and the correlation coefficients were all greater than 0.999.The detection limits were from 0.12 to 7.26 ng/rnL.The quantization limits were from 0.40 to 23.96 ng/mL.The precision of the method was good (RSD＜3.5％,n=6).Conclusion The results of the spectral interference correction by IEC method are greatly superior to the results of conventional method.The established method is accurate,sensitive,and rapid,which can be applied to the determination of contents of eight heavy metal elements in iron dextran.

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HPLC method for determination of uric acid in plasma of hyperuricemia model mice

Xuyuan LIU ; Qian SHANG ; Chuan LI ; Peng LIU ; Wei LIU ; Guilong ZHAO ; Zhixing ZHOU ; Haizhi ZHANG

Drug Evaluation Research.2017;40(3):319-323. doi:10.7501/j.issn.1674-6376.2017.03.006

Objective To establish an efficient HPLC method for the determination of uric acid in plasma of hyperuricemia model mice,and the evaluation of uric acid lowering effect of Lesinurad.Methods The Laballiance Series Ⅲ HPLC system was adopted with Kromasil C18 column (100 mm × 4.6 mm,5 μm).The mobile phase consisted of methanol-0.5％ acetic acid (10:90) for isocratic elution with a flow rate of 0.4 mL/min.The detection wavelength was set at 283 nm.The established HPLC method was used to detect the plasma uric acid level of mice at 0.5,1.0,and 2.0 h time points after which being ip injected with 250 and 500 mg/kg uric acid.Lesinurad of 250 and 500 mg/kg was ig given to mice,0.5 h later,mice were ip injected with 500 mg/kg uric acid to establish hyperuricemia model,and 1 h later,the established HPLC method was used to detect the plasma uric acid level of mice.Results There was a good linear relationship between peak area and the concentration of plasma uric acid in the range of 7.5-150 μg/mL (r =0.997).The specificity,repeatability,precision,stability,and recovery of the established HPLC method was in accordance with the guiding rules of biological sample determination.Compared with the endogenous serum uric acid concentration of control group mice,serum uric acid concentration of 250 mg/kg dose group was significantly increased 0.5 h after ip administration with uric acid (P ＜ 0.01),and serum uric acid concentration of 500 mg/kg dose group was significantly increased 0.5,1.0,and 2.0 h after ip administration with uric acid.Compared with model group,the concentration of uric acid in plasma decreased significantly in low dosage group administered with Lesinurad (P ＜ 0.05),while decreased more significantly in high dosage group (P ＜ 0.01).Conclusion This convenient,rapid,and accurate method can be applied to the determination of uric acid in mouse plasma and the evaluation of relative drugs,which provide an efficient analysis way for establishing hyperuricemia model and screening relative drugs.

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Effect and mechanism of Kuntai Capsule on premature ovarian failure in rats

Wenjun XU ; Hui GAO ; Yang LI ; Ce LIANG ; Xinpeng LI ; Sa ZHANG ; Yameng CUI

Drug Evaluation Research.2017;40(3):314-318. doi:10.7501/j.issn.1674-6376.2017.03.005

Objective To explore the effect and mechanism of Kuntai Capsule (KC) on premature ovarian failure in rats.Methods Totally 40 SD female rats were randomly divided into four groups:control group,model group,Kuntai Capsule (KC) group and conjugated estrogens tablets (CET) group.The premature ovarian failure model in rats was made by ig administration of 75 mg/kg tripterygium.After the model was established,rats were continually treated with 0.6 and 0.625 g/kg of KC and CET respectively by ig administration for 36 d.HE staining was used to observe the morphology of ovary and count the number of follicle.The enzyme-linked immunosorbent assay (Elisa) method was used for the detection of follicle stimulating hormone (FSH),luteinizing hormone (LH),serum estradiol (E2),and anti-Mueller tube hormone (AMH) level.The real-time fluorescence quantitative PCR (qRT-PCR) method was used to detect the mRNA expression of vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF).Results Compared with control group,the number of primordial follicles,preantral follicles and antral follicles were significantly reduced,the number of atretic follicles was increased (P ＜ 0.05),E2 and AMH significantly decreased (P ＜ 0.05),FSH and LH levels increased significantly (P ＜ 0.05),and the levels of VEGF and bFGF mRNA in model group were significantly decreased (P ＜ 0.05).Compared with model group,the number of primordial follicles,preantral follicles,and antral follicles were significantly increased,the number of atretic follicles was significantly reduced (P ＜ 0.05),E2 and AMH significantly increased (P ＜ 0.05),FSH and LH levels significantly decreased (P ＜ 0.05),and the levels of VEGF and bFGF mRNA in KC group were significantly increased (P ＜ 0.05).Conclusion By regulating the level of hormone and up-regulating the expression of VEGF and bFGF,KC can repair the damaged ovarian tissue and promote the growth and development of the follicle,so as to inhibit the premature exhaustion of mRNA.

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Effect of Salviae Miltiorrhizae Radix et Rhizoma and Carthami Flos before and after compatibility on activities of CYP1A2, CYP2E1, and CYP3A4 from rat liver microsomes

Xiaoping WANG ; Jiqing BAI ; Jingping HU ; Jin WANG ; Peifeng WEI ; Lina QUAN

Drug Evaluation Research.2017;40(3):300-306. doi:10.7501/j.issn.1674-6376.2017.03.003

Objective To study the influence of Salviae Miltiorrhizae Radix et Rhizome (SMR) and Carthami Flos (CF) before and after compatibility on activitis of cytochrome P 1A2 (CYP1A2),cytochrome P2E1 (CYP2E1),and cytochrome P3A4 (CYP3A4) from rat liver microsomes.Methods Using caffeine,chlorzoxazone,and midazolam as the probe drugs ofCYP1A2,CYP2E1,and CYP3A4,the SD rats were randomized divided into four groups:control group,SMR (1.2 g crude drug/kg) group,CF (0.4 g crude drug/kg) group,and SMR (1.2 g crude drug/kg) + CF (0.4 g crude drug/kg) group.According to the above dose,rats were ig given drugs for 7 d.Rats were injected with caffeine,chlorzoxazone,and midazolam solution in tail vein 30 rain after the last administration,and the blood was collected at different time points.Metronidazole as internal standard,method has been established to determine the levels of caffeine,chlorzoxazone,and midazolam to evaluate the activities of CYP1A2,CYP2E1,and CYP3A4 by HPLC.Results Compared with control group,SMR increased the clearance rates (CL) of caffeine,chlorzoxazone,and midazolam,reduced the AUC,and t1/2 was also show a decreasing trend,but the difference was not significant.In CF group,CL of caffeine and chlorzoxazone was decreased,but the difference is not significant.CL of midazolam significantly decreased (P ＜ 0.01).AUC of chlorzoxazone increased,but the difference was not significant.AUC of caffeine and midazolam increased significantly (P ＜ 0.05 and 0.01).In SMR + CF group,the CL of caffeine and chlorzoxazone decreased significantly (P ＜ 0.05),the AUC of caffeine and chlorzoxazone increased significantly (P ＜ 0.05),and t1/2 also showed a decreasing trend,but the difference is not significant.Conclusion Compatibility of SMR and CF has an inhibitive effect on CYP1A2 and CYP2E1 in rats,and it could be one of the mechanisms ofinteractive synergy.

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Effect of Lycium barbarum polysaccharide on atherosclerosis in mice by up-regulating adiponectin expression

Lei HU ; Ling DONG ; Lei QU ; Libin WANG ; Wenwen WU ; Haifang WANG

Drug Evaluation Research.2017;40(3):292-299. doi:10.7501/j.issn.1674-6376.2017.03.002

Objective To explore the effect of Lycium barbarum polysaccharide (LBP) on adiponectin (APN) expression and the mechanism of lowering blood-lipid and anti-inflammation in atherosclerotic (AS) mice.Methods C57BL/6J mice with normal feed were chosen as control group.Thirty-two ApoE-/-mice with high cholesterol diet were successfully established as AS models,and then the mice were randomly divided into model group and three LBP groups,which were feed with high,medium,and low dose of LBP.After feeding for four weeks,aortic blood and tissues were collected.Blood-lipid,inflammatory factors,endothelin-1 (ET-1),APN,AdipoR1,and AMPK pathway related protein expression were detected.Differentiated 3T3-L1 cells were divided into control group,LBP group,and LBP + BML-275 group.Triglyceride (TG),inflammatory factors,APN,AdipoR1,and AMPK pathway related protein expression was investigated.Results In mice,compared with the control group,typical AS pathomorphologic changes were found in aorta and the levels of TG,total cholesterol (TC),nitric oxide (NO),ET-1,interleukin-6 (IL-6),and tumor necrosis factor (TNF-α) in the model group were significantly increased,while the protein expression of HDL-C,APN,AdipoR1,PPARα,AMPKα,and p-AMPK-α and Acyl-CoA oxidase (ACO) mRNA expression was reduced.Compared with the model group,AS pathomorphologic state was obviously improved in aorta and the amount of TG,TC,NO,ET-1,IL-6,and TNF-α in LBP groups were markedly decreased,while the protein expression of HDL-C,APN,AdipoR1,PPARα,AMPKα,p-AMPKα,and ACO mRNA expression was up-regulated.These changes were all in a dose-dependent manner.In differentiated 3T3-L1 fat cells,compared with control group,LBP enhanced the expression of APN,AdipoR1,PPARα,AMPKα,p-AMPKα,and ACO,but decreased the amount of TG,IL-6,and TNF-α.Compared with LBP group,the levels of TG,IL-6 and TNF-α was notably increased in BML-275 group.Conclusion LBP up-regulates the expression of APN and AdipoR1,activates APN/AMPK pathway,plays a role in lowering blood-lipid and anti-inflammation,and thus relieves AS in mice.

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Introduction to EU's Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products

Huilai XIAO

Drug Evaluation Research.2017;40(3):285-291. doi:10.7501/j.issn.1674-6376.2017.03.001

The European Union released Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinalproducts rev.1 in July 2016.It is noteworthy in the guideline that the test data can be replaced by the literature when the herbal medicine products are applied for registration and according to the scientific strength of the literature,different indications can be approved.This paper introduces the main contents of the guideline and is expected to inspire the research and supervision of Chinese materia medica and phytomedicine in China.

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Validity analysis of pulmicort respulas combined with montelukast in treating children with asthma and its role in pulmonary function and T lymphocyte subset

Huan ZHANG ; Xiuqin ZHANG

Drug Evaluation Research.2017;40(3):377-380. doi:10.7501/j.issn.1674-6376.2017.03.018

Objective To explore the validity of oxygen atomizing inhalation pulmicort respulas combined with montelukast in treating children with asthma and its role in pulmonary function and T lymphocyte subset.Methods Totally 78 cases treated in Huizhou People's Hospital from June,2014 to June,2016 were randomly divided into observation group and control group with each group of 39 cases.The control group on the basis of routine treatment with oxygen atomizing inhalation of pulmicort 1 mg,twice daily,and the observation group based on control group added Montelukast Sodium Chewable Tablets 5 mg,once daily,one week for one course.The clinical effect,pulmonary function,and level of T lymphocyte subset were compared between two groups.Results The total effective rate in the observation group was 94.70％,which was significantly higher than control group (82.05％,P ＜ 0.05).After therapy,the symptom scores of two groups were obviously decreased compared with those before therapy (P ＜ 0.05),and those of the observation group were significantly lower than control group (P ＜ 0.05);The pulmonary function of the two groups were obviously improved (P ＜ 0.05) compared with that before therapy (P ＜ 0.05),and the levels of FEV1,FVC,and FEV1/FVC in observation group were significantly higher than control group (P ＜ 0.05);The level ofT lymphocyte subset in control group showed no statistical difference compared to that before therapy,and the levels of CD4+ and CD4+/CD8+ in observation group were obviously decreased,whereas CD8+ was increased.Conclusion Oxygen atomizing inhalation pulmicort respulas combined with montelukast could effectively increase the clinical effect on children with asthma,improve pulmonary function and positively regulate immune function,which deserves clinical expansion.

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Clinical effects of ganciclovir combined with gangliosides and gamma globulin in treating children with viral encephalitis

Songyi GAO ; Qinghua DANG ; Xiaoqian GAO ; Yan SUN ; Wenjing ZHAO

Drug Evaluation Research.2017;40(3):373-376. doi:10.7501/j.issn.1674-6376.2017.03.017

Objective To compare the clinical effect and safety evaluation of three different dose regimens for treating children with viral encephalitis.Methods Totally 126 cases treated in Xi'an Central Hospital from January 2010 to December 2015 were randomly divided into observation group 1 (ganciclovir combined with gangliosides,42 cases),observation group 2 (ganciclovir combined with gamma globulin,43 cases),and control group (39 cases).The clinical effect and levels of NSE,inflammatory cytokine were compared in the three groups.Results The total effective rate in observation group 1 was 95.24％ and that of observation group 2 was 93.02％,which were significantly higher than that of control group (79.48％).The disappearance time of headache,fever,convulsions,clouding of consciousness,meningeal irritation sign,cerebrospinal fluid abnormalities,and length of stay in observation groups (both 1 and 2)were significantly shorter than those in control group (P ＜ 0.05);After therapy,the levels of NSE in three groups were obviously decreased compared with those before therapy (P ＜ 0.05),and those in observation group were significantly lower than the control group (P ＜ 0.05);the levels of inflammatory cytokine in all three groups were obviously decreased compared with those before therapy (P ＜ 0.05),and that of observation group 1 had no statistical difference with the normal group,whereas that in control group was significantly higher than the normal group (P ＜ 0.05).Conclusion Ganciclovir combined with gangliosides as well as ganciclovir combined with gamma globulin were both effective methods in treating children with viral encephalitis and could decrease levels of inflammatory cytokine.Ganciclovir combined with gangliosides could effectively repair nerve damage,which deserves clinical expansion.

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