Table of Content

Volume 22 Issue 9
26 September 2017

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Application and progress of physiologically-based oral absorption model in clinical development of generic drugs

LILi, YANG Jinbo

2017, 22(9):  961-965. 

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Demonstration of in vitro in vivo correlation (IVIVC) could identify key factors of pharmaceutical characteristics affecting drug efficacy, quality, stability, and safety. Compared with compartmental model-based deconvolution method, physiologically-based oral absorption model could better establish IVIVC by separating kinetics of permeability, metabolism, and transportation. Currently, physiologically-based oral absorption model has been extensively employed by big pharmaceutical companies in US and Europe to develop new formulation and support clinical bioequivalence (BE) trials. It is one of the major tools to simplify development of generic drugs and to evaluate the quality of generic drug application utilized by Food and Drug Administrator (FDA) in US. Regarding the regulatory need of Abbrevitive New Drug Application (ANDA) and generic drug consistency evaluation in China, we reviewed the application progress, investigation strategy, challenges, and regulatory utility of physiologically-based oral absorption model to support generic drug development in China.

Effects and mechanism of total saponins of Achyranthes on acute gouty arthritis in rats

NA Sha, DUAN Chenfangyuan, WANG Lu, LV Lei, CHEN Guangliang

2017, 22(9):  966-971. 

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AIM: To study the preventive effect and mechanism of total saponins of Achyranthes (TSA) on acute gouty arthritis (AGA) in rats. METHODS: Male SD rats were randomly divided into the normal group, model group, TSA high, medium and low dose group (200, 60, 20 mg·kg-1·d-1) and indomethacin group (5 mg·kg-1·d-1).All groups received oral administration, 2 times a day, for 5 consecutive days.Uric acid sodium solution was injected into the rat ankle joint cavity on the third day except the normal group to determine the degree of rat joint swelling. The rats were sacrificed at 48 hours after the injection to detect the IL-1β, IL-18 and IL-6 levels in rat joint swelling leaching solution, and ankle pathology was performed thereafter. The expression of IL-1β protein in the ankle joint of rats was detected by immunohistochemistry. The levels of NALP3 (NACHT, LRR and PYD domains-containing protein 3) and inflammatory related proteins were detected by Western blot. RESULTS: Compared with the normal group, the rats in the model group were significantly swollen, less active. Synovial tissue hyperplasia and inflammatory cell infiltration were observed in synovial joints, the expression of IL-1β protein increased.The levels of IL-1β, IL-18 and IL-6 in synovial fluid, and the NALP3, ASC, pro-caspase-1 and cleaved caspase-1 in synovial tissue were increased significantly. The above indexes in the high and middle dose group and the indomethacin group were improved to different degree. CONCLUSION: TSA has an obvious preventive and therapeutic effect on AGA, and the mechanism may be related with suppressing the NALP3 inflammasome activation and inhibiting the cytokines production.

Change and significance of Ero1α expression on endoplasmic reticulum stress induced by hypoxia/reoxygenation in rat cardiomycytes

LIU Yue, LIU Yuanyuan, ZHANG Ni, CAO Shilu, ZHANG Xiaojing, LAI Lina

2017, 22(9):  972-977. 

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AIM: To explore the relationship between Ero1α expression and ERS and apoptosis in rat hypoxia/reoxygenation cardiomyocyte model.  METHODS: The H9C2 cardiomyocytes were randomly divided into groups: control group, hypoxia /reoxygenation 1 h, 3 h, 6 h, 12 h group (H/R1 group, H/R3 group, H/R6 group, H/R12 group), 4-PBA+H/R6 group. H9C2 cardiomyocytes of control group were cultured under normal condition till the end of experiment. Cardiomyocytes of H/R group underwent hypoxia for 3 hours followed by reoxygenation for 1 h, 3 h, 6 h, 12 h. 4PBA were given 2 hours before hypoxia in the 4PBA+H/R6 group. Hoechst 33258 staining was used to observe the apoptosis of cells under fluorescence microscope. The protein expression of Ero1α, glucose-regulated proteins 78(Grp78), C/EBP homologous protein (CHOP), caspase-12 were detected by Western blot. RESULTS: Compared with the control group, the expression level of Ero1α protein increased with the time of reoxygenation. The expression of Ero1α increased significantly at 3 h after reoxygenation and reached high point at 6 h(compared with the control group, P<0.01).Grp78 increased significantly after hypoxia and reoxygenation (compared with the control group, P<0.01), reached a peak at 3 h after reoxygenation. The apoptosis rate was also significantly increased, of which the most significant was at reoxygenation 6 h. Take hypoxia 3 h reoxygenation 6 h as the observation point, the expression of Ero1α, GRP78, CHOP and Caspase-12 in H/R6 group was significantly higher than that in control group (P<0.01). After administration of 4PBA, Ero1α, GRP78, CHOP, Caspase-12 protein expression was significantly lower than that in H/R6 group (P<0.05, P<0.01). CONCLUSION: Hypoxia/reoxygenation can induce cardiomyocyte apoptosis and endoplasmic reticulum stress. The expression of Ero1α in cardiomyocytes induced by hypoxia/reoxygenation can be changed. The expression of Ero1α is related to apoptosis.

Effects of silencing NOTCH1 gene by eukaryotic vector in multiple myeloma RPMI 8226 cell line

HUANG Xiaolu, MA Xudong, LU Quanyi

2017, 22(9):  978-983. 

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AIM: To discuss the impact of NOTCH1 shRNA on cell proliferation and apoptosis in multiple myeloma RPMI 8226 cell line. METHODS: Eukaryotic expression vector for human NOTCH1 gene (NOTCH1 shRNA) was synthesized, and eukaryotic expression vector was transfected into RPMI 8226 cells by LipofectamineTM2000. The influence of cell growth by NOTCH1 shRNA was determined by MTT. Cell apoptosis and cell-cycle distribution were measured by Flow cytometry. Western blot was used for the detection of NOTCH1, P21 and P27. ELISA was used for detecting IL-6 secretion affected by NOTCH1 shRNA.RESULTS:NOTCH1 shRNA inhibited cell growth through blocking cell cycle in G0/G1 phase. The NOTCH1 shRNA group's cell growth rate was (49.09±2.31)%, Neg-shRNA group was (91.73±2.67)%, and blank group was (98.10±0.41)%, (P<0.05). The cell phase in G0/G1 with NOTCH1 shRNA group, Neg-shRNA group and blank group was (66.23±3.71)%, (42.27±3.65)%, (40.70±0.92)% respectively (P<0.05). The S phase was (31.03±1.49)%, (56.53±1.76)%, (51.83±1.45)% , respectively (P<0.05). NOTCH1 shRNA induces cell apoptosis in RPMI 8226 cells. The cell apoptotic rate was (46.67±1.31)% in NOTCH1 shRNA group, (1.37±0.63)% in Neg-shRNA group and (0.85±0.43)% in Blank group (P<0.05), respectively. The NOTCH1 protein was reduced and the expression of P27 and P21 protein were increased by transfected NOTCH1 shRNA. NOTCH1 shRNA downregulated IL-6 secretion. OD value of IL-6 secretion was 28.18±3.50, 167.08±7.97 and 185.86±5.61, respectively through three groups (P<0.05). CONCLUSION: NOTCH1 shRNA inhibits cell growth and induces cell apoptosis RPMI 8226 cell line, which may be a new treatment target in multiple myeloma.

HPLC-MS/MS based pharmacokinetic study of alkaloids of sinomenium acutum

XIE Tong, CHENG Xuefang

2017, 22(9):  984-991. 

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AIM: To establish a LC-MS/MS method for the study of pharmacokintic characteristics of alkaloids of sinomenium acutum in sprague dawley rat, and lay the foundation for the extensive research and clinical use of sinomenium acutum. METHODS: (1)LC-MS/MS method for the quantification of alkaloids of sinomenium acutum in biological sample was developed. (2)The in vivo time course of sinomenium acutum extracts (10 g crude drug/kg) in rats after a single oral administration was investigated. Pharmacokinetic parameters were calculated from the concentration data determined by LC-MS/MS. RESULTS:The standard curves showed good linearity over the concentration range of sinoacutine (13.8-3 530.0 ng/mL, R²=0.999 9) and magnoflorine (5.8-2 960.0 ng/mL, R²=0.999 8) in rat plasma. The inter-day and intra-day precision and accuracy values of sinoacutine and magnoflorine at three levels of QC samples were less than 15%. Pharmacokinetic study in rats showed that the main parameters for sinoacutine and magnoflorine were Cmax (14.88) and (0.99) μg/mL, Tmax (55.00) and (57.50) min, T1/2 (2.64) and (6.08) h, AUMC(0-t) (369 127.25) and (32 143.44) μg·h·h·mL-1, AUC(0-t) (2 482.76) and (177.77) μg·h·mL-1, MRT(0-t) (2.50) and (3.12) h, respectively. CONCLUSION: A sensitive, specific, and suitable LC-MS/MS method is validated for simultaneously quantifying the concentrations of sinoacutine and magnoflorine in rat plasma. Pharmacokinetic parameters show that the alkaloids of sinomenium acutum in rats conform to the non-compartmental model, and the plasma concentration reaches its peak rapidly, the elimination process is slow with high blood concentration.

Toxicokinetic study of insulin glargine injection in Beagle dogs

2017, 22(9):  992-997. 

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Effects of dexamethasone on the expression of NF-κB and survivin in acute pancreatitis

YANG Feiyun, ZHU Xiuying, ZHANG Jianxin, YANG Yaqin

2017, 22(9):  998-1001. 

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AIM: To explore the effect of dexamethasone on the expression of NF-κB and survivin in pancreas in acute pancreatitis (AP). METHODS: AP animal model were established using caerulein and were divided into the saline group (control group), the AP group and dexamethasone group. The ELISA method was used to detect TNF-α in serum in each group. Real-time Q-PCR and Western blot were used to detect NF-κB, survivin, TNF-α mRNA and protein expression in pancreas in each group. RESULTS: The results of ELISA test showed that dexamethasone could significantly reduce the content of TNF-α in serum compared with the AP group. The results of qPCR and Western blot showed that dexamethasone could significantly reduce the expression of survivin, NF-κB, TNF-α mRNA and protein in pancreas compared with the AP group.CONCLUSION: Through inhibiting the NF-κB activation, dexamethasone could inhibit the expression and anti-apoptotic effect of survivin, promote apoptosis, reduce necrosis of pancreatic acinar cells, and inhibit the synthesis and release of TNF-α.

Effect of fisetin on learning and memory impairment induced by cerebral ischemia reperfusion and HPA axis

ZHU Jiejin, WU Yong, YE Xiaoli, YE Huajin, WANG Gang, FEI Fei

2017, 22(9):  1002-1007. 

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AIM: To investigate the effect of fisetin on learning memorial ability deficit after cerebral ischemia reperfusion and its possible mechanism.  METHODS: Adult male Wistar rats were randomly divided into seven groups: the sham operation, the IR model group, fisetin group（10, 20, 40 mg/kg, p.o.）. The four-vessel occlusion method was used to build rat model of cerebral ischemia reperfusion. All rats were tested for Morris water maze（MWM）. The serum level of corticosterone was detected using the enzyme linked immunosorbent assay. At the end, the expressions of corticotropin releasing hormone (CRH) mRNA and glucocorticoid receptor (GR) mRNA in the hippocampus were analyzed by RT-PCR and semi-quantitative in situ hybridization, respectively. RESULTS:Compared with the sham group, the learning ability of the IR rats decreased significantly (P<0.01), fisetin（20, 40 mg/kg）could improve the ability of learning memory significantly（P<0.05 or P<0.01）. The serum level of corticosterone increased in IR rats, and fisetin（20, 40 mg/kg）could also decline the level of this stress hormone（P<0.05）. At the end, the expression of CRH mRNA in the hippocampus of IR rats was increased and fisetin（40 mg/kg）reversed the expression of this gene（P<0.05）; the GR receptor expressions in the hippocampus was reduced and fisetin（40 mg/kg）reversed these changes in IR rats（P<0.05）.CONCLUSION: Fisetin reverses the learning memory damage after cerebral ischemia reperfusion injury, and the mechanism may be mediated by regulating the function of the hypothalamo-pituitary-adrenal (HPA) axis and the expression.

Effect of antagonist of NR2A-containing N-methyl-D-aspartate receptors on synaptic long-term potentiation in hippocampus in rats with neuropathic pain

WEI Huiming, MA Weiqing, LI Wenfeng, WANG Huiming

2017, 22(9):  1008-1011. 

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AIM: To investigate the effect of antagonist of NR2A-containing N-methyl-D-aspartate (NMDA) receptors on synaptic long-term potentiation (LTP) in the hippocampus in rats with neuropathic pain. METHODS: Twenty-four adult male Wistar rats were randomly divided into four groups (n=6 each ): sham operating group (group S), S+NVP-AAM077 group (group SN), neuropathic pain group (group NP) and NP+NVP-AAM077 group (group NPN). Neuropathic pain was produced by ligation of the right L4 and L5 spinal nerve. The excitatory post-synaptic potential (EPSP) in hippocampal CA1 region was measured at 3 day after the last measurement of pain threshold. The changes in EPSP and LTP of the CA1 stratum radiatum of the rat hippocampus were observed using stereotaxic technology and extracellular recording respectively. RESULTS: The pain threshold was significantly lower in group NP and NPN, and the amplitude of EPSP was significantly higher in group NP and NPN than in group S and SN (P<0.05), but there was no significant difference in the amplitude of EPSP between group NP and NPN. CONCLUSION: The facilitation of LTP induction by neuropathic pain in the CA1 area of the hippocampus may be little relationship with the activation of NR2A-containing NMDA receptors.

Pharmacokinetics and bioavailability of pidotimod in Beagle dog after oral solution and different solid preparations

2017, 22(9):  1012-1016. 

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Two methods for assessing consistency probability in  multiregional clinical trials: a comparison study

BAI Jianling, CHEN Mengkai, YU Hao, ZHAO Yang, CAI Jingjing, HUANG Lihong, JIANG Zhiwei, CHEN Feng

2017, 22(9):  1017-1021. 

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AIM: To evaluate two methods of consistency assessment in multiregional clinical trials so as to provide a references for the design of multiregional clinical trials. METHODS: R software was applied to compute sample size and consistency probability. RESULTS: By method one, when other parameters were set the same, the required sample size of J region was smaller as the observed treatment effect of J region was better. Compared with the power, the sample size was much more affected by consistency probability. As the size proportion of J region was 10%-50%, the consistency probabilities of method two were higher than method one with two or three regions, and directly opposite with five regions. When four regions are included, the consistency probability of method two is higher than that of method one for the fraction of 10.0%-22.4%. The consistency probability of method two was smaller than that of method one for the fraction of 22.4%-50.0%. CONCLUSION: The sample size of method one is mainly influenced by power, consistency probability and the observed treatment effect for J region. The sample size of method two is also influenced by the number of regions. When method two is used, the number of regions cannot be too much.

Pharmacokinetics of rociverine injection in Chinese healthy volunteers

2017, 22(9):  1022-1028. 

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Effects of nucleos(t)ide analogues on renal function in patients with chronic hepatitis B

HUO Na, LU Haiying, WANG Guiqiang, HUANG Mingjie, WU Chihong, LIN Xiaohong

2017, 22(9):  1029-1034. 

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AIM: To summarize the effects of nucleoside (acid) drugs on renal function in accepting antiviral therapy chronic hepatitis B patients.  METHODS: Clinical data of 176 cases of chronic hepatitis B patients treated with nucleoside (acid) antiviral therapy (28 cases in ADV+LAM treatment group, 20 cases in ADV+ETV group, 21 cases in LAM group, 26 cases in ADV group, 81 cases in group ETV) were recorded, estimated glomerular filtration rate (eGFR) was calculated. The Kruskal-Wallis test or Mann-Whitney test or chi square difference test were used for comparative analysis of differences.RESULTS:The eGFR of the patients in ADV+LAM treatment group, ADV+ETV group, LAM group, ADV group and ETV group were (78.9±13.8),（80.2±15.8）,（78.8±12.9）,（74.6±14.6）,（79.5±13.1） mL·min-1·1.73 m-2, respectively, P>0.05; the number of cases with eGFR less than 80 mL·min-1·1.73 m-2 were  14(50%), 12(60%), 10(47.6%), 20(69.2%), 47（58.0%）, respectively, P＞0.05. Serum phosphorus levels were （0.95±0.14）,（0.92±0.11）,（1.02±0.13）,（0.92±0.16）,（0.97±0.14）mmol/L, respectively, P>0.05； the number of cases with a decreased serum phosphorus level were 15(53.6%), 13（65%）, 6（28.6%）, 13（50%）, 39（48.1%）, respectively; Furthermore, there were statistically significant differences between LAM group and ADV+ETV group (χ2=5.466 9, P=0.019 4). CONCLUSION: Long-term antiviral therapy of nucleoside (acid) drugs may affect renal function, in which the effect of ADV is the most obvious, ETV is the second, and LAM is the mildest. The monitoring of eGFR and serum phosphorus level is more sensitive to reveal the damage of kidney.

Effects of rosuvastatin on hypertension with carotid atherosclerosis and its influence on peripheral macrophage polarization

ZHENG Xiao, HU Xiaosheng

2017, 22(9):  1035-1039. 

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AIM: To observe the effect of rosuvastatin on carotid atherosclerosis in patients with hypertension and its effect on macrophage polarization.  METHODS: 100 hypertensive patients with carotid atherosclerosis were randomly divided into Control group and Observation group, each of 50 cases. Control group was given amlodipine besylate 2.5 mg QD. On the basis of Control group, Observation group was given rosuvastatin 10 mg QD. The course of treatment was 6 months.The changes of total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C) and high density lipoprotein cholesterol (HDL-C) were detected by biochemical analyzer, high sensitivity C reactive protein (hsCRP) by radioimmunoassay, multiple carotid intima-media thickness (CIMT) by Doppler ultrasound, macrophage polarization by flow cytometry. RESULTS:After treatment, the levels of TC, TG, LDL-C, hsCRP and CIMT in Observation group were significantly lower than those in Control group, while the level of HDL-C was significantly higher than that of Control group, the difference was statistically significant (P<0.05). The expression of M1 markers (CD64, CD11c and CD40) on the surface of macrophages in Observation group, was significantly lower than that in Control group, while the M2 markers (CD206, CD14 and CD23) were significantly higher than those in Control group, and the difference was statistically significant (P<0.05).CONCLUSION:Rosuvastatin can improve dyslipidemia, inflammation and CIMT in patients with hypertension with carotid atherosclerosis, its mechanism may be related to the regulation of macrophage polarization.

Effects of huperzine A combined with escitalopram on clinical efficacy and cognitive function in depression patients

MO Yali, XIA Yong, LIU Yi, TAO Yunhai, JIN Man

2017, 22(9):  1040-1044. 

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AIM: To evaluate the effect of huperzine A combined with escitalopram on clinical efficacy and cognitive function in depression patients.  METHODS: Sixty patients with depression were randomly divided into study group which accepted treatment of huperzine A combined with escitalopram and control group that were given escitalopram only (n=30). All patients in both groups accepted treatment for 8 weeks. The 17-item Hamilton Depression Rating Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA) were assessed as indicators of efficacy; Wisconsin Card Sorting Test (WCST) and Wechsler Memory Scale-Revised  of China(WMS-RC) were used for assessment of cognitive function, Treatment Emergent Symptom Scale (TESS) was used to assess the adverse reactions before treatment and 8 weeks after treatment．RESULTS:（1）The total efficacy rate (90.0%) and recovery rate (50.0%) in study group was higher than that in control group (86.7%, 46.7%), but the difference was not statistically significant (P>0.05). The HAMD-17 and HAMA scores in both groups after treatment were significantly lower than that before treatment (P<0.05), however, the HAMD-17 and HAMA scores between the two groups were similar (P>0.05).（2）For study group, total trials, preservative errors and random errors of WCST after treatment were significantly lower than those before treatment (P<0.05) while the total trials after treatment in control group were significantly lower than that before treatment (P<0.05). The WMS-RC score of long-term, short-term and immediate memory, and memory quotient in two groups were significantly higher than that before treatment in both groups (P<0.05). After treatment, the random errors of WCST in study group were significantly lower than those in control group. WMS-RC score of long-term memory, short-term memory and memory quotient in study group were significantly higher than that of control group (P<0.05).（3）No significant difference of adverse reactions were found between two groups (P>0.05). CONCLUSION:A combination of huperzine A and escitalopram in the treatment of depression has high efficacy and safety similar to escitalopram monotherapy. It also can significantly improve cognitive function which is superior to monotherapy.

Effects of different doses of metformin on bone metabolism and bone mineral density in elderly male patients with type 2 diabetes

SHI Dejun, LIU Yi

2017, 22(9):  1045-1049. 

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AIM: To observe the effect of different doses of metformin on bone metabolism and bone mineral density in elderly male patients with type 2 diabetes.  METHODS: 102 untreated elderly male patients with type 2 diabetes were randomly divided into 3 groups. 3 groups were given low doses of metformin group (1 g/d, n=34), medium doses of metformin group (1.5 g/d, n=34) and high doses of metformin group (2 g/d, n=34). Phase of treatment lasted for 3 months. The levels of bone mineral density (BMD) of lumbar L2-4 and the femoral neck, serum bone specific alkaline phosphatase (BAP), blood gla protein (BGP), Tartrate Resistant Acid Phosphatase (TRACP), osteoprotegrin (OPG), fasting blood glucose (FBG) and hemoglobin A1C (HbA1C) were measured before treatment, 1 month and 3 months after administration. RESULTS:The levels of FBP and HbA1C in 3 groups were decreased significantly after treatment (P<0.05), but there was not significant difference among 3 groups (P>0.05). The indicators of bone metabolism TRACP and OPG in 3 groups reflected no significant change before and after treatment (P>0.05); BGP and BAP which reflected indicators of bone turnover and formation were increased after treatment, there was significant difference among 3 groups (P<0.05). The levels of BGP and BAP in the medium doses and the high doses of metformin groups was higher than counterpart in low doses of metformin group (P<0.05), there were significant differences among groups. But the levels of BGP and BAP in the medium and high doses of metformin group were not obvious difference over the same period (P>0.05). After 12 weeks of treatment, the levels of BMD in 3 groups were increased, there was statistical significance among groups (P<0.05). The levels of BMD in the medium doses and the high doses of metformin groups was higher than counterpart in low doses of metformin group (P<0.05), there were significant differences among groups. But the levels of BMD in the medium and high doses of metformin group were not obvious difference over the same period (P>0.05). CONCLUSION:Metformin not only can regulate the levels of blood glucose in elderly male with type 2 diabetes, but also improve the BMD of patients. This effect may depend on promoting bone formation, and curative effects have a certain dose of relevance.

Treatment for 56 cases of recurrent oral ulcer associated with helicobacter pylori based on riple therapy

FAN Meijun, WANG Jinling, MA Kai, KONG Xiuling

2017, 22(9):  1050-1055. 

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AIM: To study the treatment for 56 cases recurrent oral ulcer (ROU) associated with helicobacter pylori (HP) based on the triple therapy so as to provide a new reference and idea for prevention and treatment of ROU patients in hope of improving the clinical curative effect.  METHODS: One-hundred cases of ROU associated with HP were selected and randomly divided into observation group (56 cases) and control group (44 cases). The observation group was administered with the triple therapy combined with Kangfuxin liquid. While the control group was given single Kangfuxin liquid. Both groups received 7 d continuous treatment. The clinical curative effect, pain index, HS-CRP, ulcer healing time, adverse drug reaction, recurrence rate and eradication rate of HP within six months of two groups were compared. RESULTS: At the end of treatment, the cure rate of the observation group was 91.07% and total effective rate was 100%, and those of the control group were 65.91% and 86.36%, respectively. The differences were statistically significant (P<0.01). Compared with before treatment, pain index and HS-CRP of the two groups showed significant difference after treatment (P<0.01); and the observation group showed more significant difference than that of control group (P<0.05 or 0.01). Compared with the control group, ulcer surface healing time of the observation group showed significant difference (P<0.05). The two groups presented no drug-related death. And liver and kidney function were tested normal. The main adverse reactions were slightly dry mouth, nausea and poor appetite which showed no statistically significant difference (P>0.05), and patients tolerated the reaction without drug withdrawal. Comparison of eradication rate of HP and recurrence rate within six months was statistically significant (P<0.01). CONCLUSION: ROU is associated with HP; Kangfuxin liquid combined with the triple therapy to treat HP associated with ROU are effective, which can improve the symptoms and the HP removing rate, and reduce recurrence rate with no adverse reaction. It is referential for clinical application.

Effect of gexiazhuyu decoction on blood coagulable status and life quality of patients with liver cancer

HE Yangbiao, YUAN Chunying, SHI Guojun

2017, 22(9):  1056-1061. 

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 AIM: To analyze the effect of gexiazhuyu decoction on blood coagulable status and life quality of patients with liver cancer, so as to provide evidence for its clinical application.  METHODS: 105 patients with liver cancer were divided into two groups: the control group (n=52) and the observation group (n=53). All the patients were given surgery,while the patients of the observation group were given gexiazhuyu decoction at the same time. A follow-up of three to five years was completed, and the recurrence rate, survival rate and life quality score of patients were record. Peripheral blood was extracted to detect liver function, hemorheology, vascular endothelial growth factor (VEGF) and intercellular adhesive molecular-1 (ICAM-1). RESULTS: There was no significant difference in postoperative survival curve and survival rate between groups (P>0.05), while the recurrence rate of the observation group in five years after treatment was lower than that of the control group, the QOL-LC score and self assessment score of the observation group were both higher than those of the control group, and the difference had statistical significance (P<0.05). There was no significant difference in liver function indexes and blood clotting indexes between groups before treatment (P>0.05). After treatment, the aspartate amino transferase (AST), alanine aminotransferase (ALT), whole blood high shear viscosity, low shear rates, red cell assembling index, plasma fibrinogen (Fb), VEGF and ICAM-1 of patients were decreased, and the levels of the observation group were lower; the plasma prothrombin time of patients was increased, and the levels of the observation group was higher; all the difference between groups had statistical significance (P<0.05). CONCLUSION: Gexiazhuyu decoction can remit the blood coagulable states, which is benefit to prevent relapse and improve life quality.

Effects of remifentanil on intraocular pressure during laparoscopic surgery in the steep trendelenburg position 

YU Liang, ZHOU Dachun, LIU Yang, GAO Bin

2017, 22(9):  1062-1066. 

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AIM: To observe the effects of remifentanil on intraocular pressure (IOP)undergoing laparoscopic gynecological surgery.  METHODS: Ninety patients of ASA physical status ⅠorⅡ, were randomly allocated to 5 groups (n=18 each): low dose fentanyl group (group F1), high dose fentanyl group (group F2), low dose remifentanil group (group R1), medium dose remifentanil group (group R2) and high dose remifentanil group (group R3) . Upon pneumoperitoneum, Group F1, F2 received fentanil 2 or 4 mcg/kg intravenous bolus while Group R1, R2, R3 received intravenous loading dose of 1  mcg/kg followed by continuous infusions of remifentanil of 0.1, 0.2, or 0.4 μg·kg-1·min-1 till the end of the surgery. IOP, MAP, HR were recorded before (T0), 10 min(T1), 30 min(T2), 60 min(T3) and 90 min(T4) after onset of pneumoperitoneum and at 10 min(T5) after the end of pneumoperitoneum. Time to extubation after discontinue of anesthesia, incidence of intraocular hypertension (IOP>21 mm Hg), hypertension (SBP>140 mm Hg), hypotension(SBP<90 mm Hg), sinus tachycardia(HR>100 beat/min), sinus bradycardia (HR<60 beat/min) were recorded.RESULTS:Compared with T0 , IOP at T1-T5 in group F1, F2, R1, MAP at T1-T4 in group F1 and T1-T5 in group R1 were significantly increased while HR at T1-T5 in group F2、R3 were significantly lower (P'<0.01). Compared with group R2 and R3, IOP at T1-T4 in group F1, F2, R1, MAP and HR at T1-T5 in group F1, R1 were significantly increased (P'<0.01). The incidence of intraocular hypertension of group F1 , F2 and R1 was significantly higher than that of group R2 and R3（P''<0.005）. The incidence of hypertension and sinus tachycardia of group F1 and R1 were significantly higher than that of group F2, R2 and R3(P''<0.005).The incidence of sinus bradycardia of group R3 and extubation time of group F2 was significantly higher than that in the other 4 groups（P''<0.005,P<0.05）.CONCLUSION:Infusion of 0.2 μg·kg-1·min-1 of remifentanil can alleviate intraocular pressure elevation in patients undergoing gynecological laparoscopic surgery without worsen hemodynamic stability or delay the emergence of anesthesia.

Pharmaceutical care for a patient misdiagnosed as Staphylococcus intermedius pulmonary infection

LI Nan，HUANG Haitao，YONG Xiaolan

2017, 22(9):  1067-1071. 

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AIM: To provide reference for clinical rational use of drugs, clinical pharmacists carried out pharmaceutical care for a patient misdiagnosed as methicillin-resistant Staphylococcus intermedius pulmonary infection.  METHODS: Pharmaceutical consultation and care on the patient with sputum culture and drug sensitivity test of methicillin-resistant Staphylococcus intermedius came into effects by analyzing and estimating the presence and degree of infection, the possible pathogens, the antimicrobial resistance, the empirical therapy, the goal-directed therapy, the monitoring of adverse drug reactions and the guidance to the patient. RESULTS: The results of multiple cultures suggested that the possible pathogen was multi-drug-resistant Acinetobacter baumannii. The symptoms and laboratory parameters of the patient were improved after dosage regimen of antimicrobial, and meanwhile no adverse drug reactions occurred. CONCLUSION: Clinical pharmacists participating in pharmaceutical care should not only have a solid knowledge of pharmaceutical knowledge professionally, but also should grasp the methods of relevant clinical diagnosis and the analysis abilities of laboratory testing results. This can provide better guidance to the clinical treatments.

Changes and functions of hepatic macrophages in viral hepatitis C infection

2017, 22(9):  1072-1076. 

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A preliminary study on the ethical risk assessment of human bioequivalence trial

QIAN Wei, ZHENG Linhai, YANG Di, YE Fangqin, YANG Jin

2017, 22(9):  1077-1080. 

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Bioequivalence (BE) trail is an important index to evaluate the quality of the preparation. Due to a large number of listed drug efficacy and safety of data accumulation, the ethical risk is often ignored by the sponsor and ethics committee. This article lists specific cases to assess the additional ethical risks to health subjects in a human bioequivalence trial, including examining the drug brochure, racial differences, and the differences of adverse reactions between healthy and indications in hope of offering reference for controlling ethical risk in human equivalence trial.