Table of Content

Volume 16 Issue 1
26 January 2011

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Consideration on the ethical and GCP issues of clinical trials in third countries of bureau of European Medicines Agency

GAO Chen-yan, LI Jin-ju, ZHANG Rong

2011, 16(1):  1-4. 

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The European Medicines Agency (EMA) is a decentralised body of the European Union. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The EMA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure).    In 2009 the EMA established a Working Group on third country clinical trials on medicinal products for human use. Reflection Paper on ethical and Good Clinical Practice (GCP) aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA responds to the challenges arising from the increasing globalisation of clinical research. The workshop held on 6-7 September 2010 was part of the consultation process.

Effects of three kinds of tea beverages on intestinal first-pass effect and liver Cyp3a, Cyp2e1 activities in mice

LIN Mei, QI Jin-feng, WANG Yong-hui, LIU Jian-min, HAN Jian

2011, 16(1):  5-12. 

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AIM: To investigate the effect of can packaged commercially available green tea, ice black tea and jasmine tea on intestinal first-pass effect and liver Cytochrome P450 (CYPs) Cyp3a, Cyp2e1 activities in mice.METHODS: SPF grade mice were randomly divided into 6 groups, green tea group, ice black tea group, jasmine tea group mice were getting freely access to green tea, ice black tea, jasmine tea respectively for 7 days. Intestinal first-pass effect was inferred through serum acetaminophen (APAP) levels. Liver/intestinal microsomes were prepared by differential centrifugation, and microsomal protein was quantified by Bradford method. Cyp3a, Cyp2e1 activities and serum APAP concentrations were assayed by spectrophotometry.RESULTS: APAP concentrations in green tea group were significantly higher than those in control group (P<0.01), while the levels were notably lower in ice black tea group than those in control group (P<0.01), the intestinal Cyp3a activities in green tea group and ice black tea group were considerably higher than those in control group (P<0.05 or P<0.01). Compared with control group, liver Cyp3a activities in all tea treated groups were greatly increased than those in control group (P<0.01). Compared with control group, liver Cyp2e1 activities in all tea treated groups were obviously reduced (P<0.01).CONCLUSION: Green tea and iced black tea seem significantly change the intestinal first-pass effect (green tea inhibit the activities of intestinal P-gp but induce intestinal Cyp3a, and ice black tea induce both intestinal P-gp and Cyp3a activities), while jasmine tea has no effect on intestinal first-pass effect. All three kinds of tea can significantly induce liver Cyp3a activities and inhibit liver Cyp2e1 activities. Therefore, intensely or frequently consuming these tea beverages during taking the medicines by which are metabolized or transported CYP3A, CYP2E1 and P-gp probably affect the drugs' clinical efficacy.

Effects of blocking of p38 MAPK on the signal passway of NF-κB in glomerular mesangial cells incubated with high concentration of glucose

NI Lian-song, JIN Jie-na, ZHENG Jing-chen, SHEN Fei-xia

2011, 16(1):  13-17. 

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AIM: To investigate the effects of blocking of p38 MAPK on the signal passway of NF-κB in glomerular mesangial cells incubated with high concentration of glucose.METHODS: Rat mesangial cells(MC) were incubated in media containing 5.5 mmol/L glucose(control group), 25 mmol/L high glucose(HG group), 25 mmol/L glucose +10 μmol/L SB203580(specific inhibitor of p38 MAPK)(SB group). Cell proliferation was assessed by CCK-8. Expressions of proteins of p38 MAPK and phospho- p38 MAPK in cytoplasm and nuceli were detected by phospho-ELISA method. Total NF-κB p65, activated-NF-κB p65(NLS-NF-κB), phspho-NF-κB p65(Ser276-NF-κB) in cytoplasms and nuceli were detected by Phospho-ELISA method, too.RESULTS: Compared with control group, MC in HG group showed a high growth rate, the levels of phospho-p38 MAPK in nucli and cytoplasm were increased in HG group,and the levels of NLS-NF-κB and Ser276-NF-κB in nuceli were also increased in HG group. These changes could be reversed by treatment of SB203580.CONCLUSION: Blocking of p38 MAPK could obviously down-regulate the activities of signal passway of NF-κB of MC, then inhibite the abnormal proliferation of mesangial cells.

Experimental studies of glutathione compound injection on anti-hepatic fibrosis in rats

LUO Sheng-yong,YE Shou-shan, MA Zheng, LI Xin-wei, JIA De-yun, NI Guang-yu

2011, 16(1):  18-21. 

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AIM: To investigate the inhibitory action of glutathione compound injection on dimethylnitrosamine-induced hepatic fibrosis in rats.METHODS: The hepatic fibrosis model in rats were established by injection of dimethylnitrosamin.The liver function, levels of hyaluronic acid(HA),hepatic hydroxyproline(HYP) , transforming growth factor β-1(TGFβ-1) and the pathological change were detected.RESULTS: Compared with model group, glutathione compound injection could markedly improve the liver function, significantly decreased the levels of HA, HYP and TGFβ-1, the pathological changes could also be alleviated.CONCLUSION: Glutathione compound injection has protective effect against hepatic fibrosis ,the possible mechanism might be related to decreasing the level of TGFβ-1.

Expression of NF-κB and IκB in rats with adriamycin nephropathy and the role of Dahuangzhechong Wan

CHEN Ji-hong, ZHOU Dong, GAO Kun, HE Wei-ming,WANG Yue-juan, SUN Wei

2011, 16(1):  22-26. 

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AIM: To investigate the expression of NF-κB and IκB in rats with adriamycin nephropathyand the intervention of Dahuangzhechong Wan.METHODS: The rats were injected with 5 mg/kg adriamycin solution from vena caudalis, then the rats were divided into two groups randomly: Adriamycin nephropathy group(n＝30) and Dahuangzhechong Wan(DHZCW) group(n＝15), and the other 8 rats were selected as the control group. On the 7th day, the 14th day, 4 rats from the model group were sacrificed, the renal tissue was reserved for detection. On the 28th day, the rats were all put to death.The changes of the renal tissue ultrastructure were observed. Immunofluorescence, immunohistochemistry and quantitive analysis were used to detect the expression of NF-κB and IκB-α.RESULTS: Compared with the control rats, the expression of NF-κB in model group increased markedly[(2.491±0.551)×10⁶], accompanying with the down-regulation of IκB-α[(0.947±0.631)×10⁶], and the podocyte was injuried. DHZCW could suppress the expression of NF-κB[(1.165±0.374)×10⁶ ], lessen the podocyte lesion.CONCLUSION: DHZCW has the protection effect on podocyte by influencing the expression of NF-κB and IκB.

VEGF165 reduced apoptosis by regulation of CaSR expression in ischemia/reperfusion cardiomyocytes

ZHANG Bin, XU Zhi-hui, TAO Zheng-xian

2011, 16(1):  26-32. 

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AIM: To examine whether anti-apoptotic role of VEGF165 is associated with downregulation of CaSR expression in ischemia/reperfusion cardiomyocytes.METHODS: We incubated primary neonatal rat ventricular cardiomyocytes in ischemia-mimetic solution for 2 h, then re-incubated them in normal culture medium for 24 h to establish a model of simulated ischemia/reperfusion(I/R). Cardiomyocyte apoptosis was detected by terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL). The expression of CaSR mRNA was detected by RT-PCR. In addition, the expressions of Bax and Bcl-2 were analyzed by Western blot.RESULTS: The simulated I/R enhanced the expression of CaSR(I/R group:2.6±0.4;control group:1.0±0.3, P<0.01)and TUNEL-positive cardiomyocytes(I/R group:15.3%±2.5%;control group:2.9%±1.4%,P<0.01). GdCl₃, a specific activator of CaSR, further increased the expression of CaSR (GdCl₃ group:4.5±0.6;I/R group:2.6±0.4, P<0.01)and TUNEL-positive cardiomyocytes(GdCl₃ group:25.4%±2.6%;I/R group:15.3%±2.5%, P<0.01), along with upregulation of Bax (GdCl₃ group:1.93±0.28;I/R group:1.50±0.21, P<0.01)and downregulation of Bcl-2(GdCl₃ group:0.82±0.18;I/R group:1.71±0.30, P<0.01). Treatment of VEGF165 decreased I/R- and GdCl₃-induced CaSR(GdCl₃+ VEGF165 group:1.46±0.37;GdCl₃ group:4.46±0.62, P<0.01), Bax expression (GdCl₃+ VEGF165 group:1.12±0.23;GdCl₃ group:1.93±0.28, P<0.05), TUNEL-positive cardiomyocytes (GdCl₃+VEGF165 group:11.8%±1.9%;GdCl₃ group:25.4%±2.6%, P<0.05)and increased Bcl-2 expression(GdCl₃+ VEGF165 group: 2.56±0.54;GdCl₃ group:0.82±0.18, P<0.05).CONCLUSION: VEGF165 decrease cardiomyocyte apoptosis induced with I/R by inhibiting CaSR and Bax, promoting Bcl-2 expression.

Effects of aerosol imiquimod on the antigen-induced airway inflammation and Foxp3⁺ regulatory T cells

WANG Shan-lin

2011, 16(1):  33-37. 

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AIM: To observe the effects of aerosol imiquimod on the antigen-induced airway inflammation and Foxp3⁺ regulatory T cells.METHODS: Thirty-two female BALB/c mice were randomly divided into four groups: control, asthma model, imiquimod and glucocorticoid treatment groups. Asthma was induced by OVA administration in the asthma model, imiquimod and glucocorticoid treatment groups. Imiquimod and dexamethasone were administered to immunized mice before antigen challenge. After 48 hrs of the last challenge, the mice were killed and bronchial alveolar lavage fluid (BALF) was collected to count the number of eosinophil and to measure the levels of IL-5 and IL-10. The lung tissues of inferior lobe of the left lung were obtained for the observation of lung pathological change. The spleen CD₄⁺T cells were isolated and collected. The proportion of CD₂₅⁺Foxp3⁺T cells in the CD₄⁺T cells were determined with flow cytometry.RESULTS: (1)Imiquimod attenuated the airway inflammation of asthmatic mice. (2)In imiquimod and dexamethasone treatment groups eosinophil counts increased by OVA was decreased in BALF of mice. (3)In BALF of imiquimod treatment mice, the level of IL-5 increased by OVA was decreased and IL-10 decreased by OVA was increased.(4)The number and proportion of CD₄⁺CD₂₅⁺ Foxp3⁺T cells were higher in control and treatment groups than that in the asthmatic group.CONCLUSION: Imiquimod aerosol inhalation may inhibit antigen-induced airway inflammation and the number and proportion of CD₄⁺CD₂₅⁺Foxp3⁺T cells.

Effects of di (2-ethylhexyl) phthalate on the prostaglandin E-2 levels and cyclooxygenase-2 mRNA expression of testicular tissue in adult rats

ZHANG Hao-chuan,CHEN Cong-de,BAO Xiao-zhou,CHEN Xiao-ming

2011, 16(1):  38-41. 

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AIM: To explore the effects on prostaglandin E-2 and cyclooxygenase-2 mRNA expression of testicular spermatogenic cells in adult rats exposed to di (2-ethylhexyl) phthalate (DEHP). METHODS: 40 male Sprague-Dauley rats were divided into four groups in random: normal control group and 3 groups exposed to DEHP at the dose of 100,200 or 500 mg/kg bodyweight per day by gavage respectively. One month later,the rats were sacrificed. The expression of testicular prostaglandin E-2 was measured by ELISA. The expression level and location of cyclooxygenase-2 and cyclooxygenase-2 mRNA in testicular tissue were detected by immunohistochemistry and RT-PCR, respectively.RESULTS: The expression levels of prostaglandin E-2 and cyclooxygenase-2 of testicular tissue decreased in 3 groups compared with normal control group,cyclooxygenase-2 was mainly expressed in spermatogonia. CONCLUSION: DEHP can damage spermatogenic cells of adult mice,the down-regulating expression of cyclooxygenase-2 mRNA may be involved in it.

Protective efficacy of Guanxinhuoyu Capsule in rats with acute myocardium ischemia

SONG Ya-juan, WANG Xin, ZHANG Dan-dan, WANG Wei-ming, XU Qing-rui, ZHANG Shu-ming, ZHANG Jun-wei

2011, 16(1):  42-45. 

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AIM: To investigate the effect of Guanxinhuoyu Capsule against hypoxia after injection of isoproterenol and in rats with acute myocardial ischemia induced by pituitary.METHODS: The anti-hypoxia model was established by injection of isoproterenol and the acute myocardium ischemia rat model was established by caudal venous injection of pituitrin.The survival time and the changes of the T wave in lead II ECG and heart rate were observed.RESULTS: Guanxinhuoyu Capsule for low and medium dose groups compare with model group, could significantly prolong the survival time by isoproterenol in mice and significantly lower the percentage change of T wave inhibit slowed heart rate induced by pituitrin in rats, and notably decrease the levels of CK, LDH and AST.CONCLUSION: Guanxinhuoyu Capsule reduces myocardial-oxygen consumption and anti-myocardial ischemia effect in rats with acute myocardium ischemia induced by pituitary.

Biphasic effect of lignanoid decomposition products:enterolactone and enterodiol on osteoblast-like MG63 cells

LI Gao-shun,YE Zhao-ming,YANG Di-sheng

2011, 16(1):  46-50. 

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AIM: To observe the effects of enterodiol and enterolactone on osteoblastic MG63 cells.METHODS: The effects of enterodiol and enterolactone on the proliferation of MG63 cells were observed by MTT. The effects of enterodiol and enterolactone on the activity of MG63 cells were tested by alkaline phosphatase(ALP)test. The effects of enterodiol and enterolactone on transcriptional level of a ALP,osteocalcin, and collagenⅠof MG63 cells were measured by RT-PCR.RESULTS: The cell viability of MG63 cells significantly was increased when treated with 0.01 mg/mL enterolactone or enterodiol.The viability of MG63 cells was gradually weakened with the increase of concentration.Similar to their effects on the cell viability of MG63 cells, enterolactone or enterodiol increased the ALP activity of MG63 cells at low concentration and decreased the ALP activity at high concentration. Enterolactone or enterodiol can increase the transcriptional level of ALP, collagenⅠ,and osteocalcin in MG63 cells.CONCLUSION: The osteoblast cells viability is increased at low concentration treated with enterolactone and enterodiol, but that is decreased at high concentration.Enterolactone and enterodiol have biphasic effect on MG63 cells.

Classified and integrated pharmacokinetic study of multipe effective components contained in Gegen-Qinlian decoction

ZHANG Qi-yun, XU Liang-hui, LI Bing-tao, LUO Hui, TANG Xi-lan, XU Guo-liang

2011, 16(1):  51-56. 

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AIM: This study was designed to develop and validate a classified and integrated pharmacokinetic approach to assessing the holistic pharmacokinetic properties of traditional Chinese compound recipes using Gegen-Qinlian decoction (GQD) as a model medicine.METHODS: 11 effective constituents were determined by Triple Quadrupole LC-ESI-MS/MS method after intragastric administration of 20 mL/kg dosage of GQD. An approach of self-defined weighting coefficient has been created to the holistic pharmacokinetic profiles of flavonoids and alkaloids in GQD. The classified and integrated synthetic concentrations were obtained, and then the pharmacokinetic parameters of flavonoids and alkaloids were calculated from non-compartmental model analysis.RESULTS: Based on the self-defined AUC weighting coefficients integration approach, the holistic pharmacokinetic profiles of both flavonoids and alkaloids were obtained and consistent with regularity of drug disposition in the body. The holistic t_1/2 and AUC_0-∝ of flavonoids were 6.08 h, 30.00 mg·h·L^-1 and those of alkaloids were 28.86 h, 1.07 mg·h·L^-1, respectively.CONCLUSION: A classified and integrated pharmacokinetic approach to describing the holistic pharmacokinetic properties has been successfully developed and validated using GQD as a model traditional Chinese compound recipe. This study would be useful for guiding the holistic pharmacokinetic study in consistence with the intrinsic theory and characteristics of traditional Chinese compound recipe.

Association of TNF-α gene -308G/A polymorphism with essential hypertension in Han racial origin in Hunan

PENG Cui-ying, ZHOU Cui-lan, HE Qing-zhi

2011, 16(1):  57-60. 

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AIM: To investigate the association TNF-α gene -308G/A polymorphism with essential hypertension(EH).METHODS: Polymerase chain reaction and Restriction fragment length polymorphism (PCR-RFLP) was used to screen the TNF-α -308G/A polymorphism and the distribution feature of genotypic frequency in 246 EH patients and 208 healthy people.The association of polymorphism and EH hereditary susceptibility was analysed.RESULTS: In the EH group, the frequencies of GG, GA and AA genotypes were 85.0%, 11.8% and 3.2% ,respectively. The frequencies of G and A allele were 90.9% and 9.1%,respectively. In the control group, the frequencies of GG, GA and AA genotypes were 89.4%, 10.6% and 0, respectively. The frequencies of G and A allele were 94.7% and 5.3%,respectively.Compared with the control group, the frequencies of GA , AA genotypes (P=0.028) and A allele were higher in the EH group.Compared with -308GG homozygotes,patients with the -308A allele had a 1.729-fold greater risk of developing EH, (95% confidence interval, 1.056 to 2.831). The differences were statistical significance (P=0.030).CONCLUSION: The TNF-a -308G/A polymorphism is positively associated with EH in Han racial origin in Hunan. The allele A may be a susceptibility gene of EH.

Clinical research of rhubarb combining with early enteral nutrition on severe acute pancreatitis

WU Xiao-li,TAO Li-ping,HUANG Qing-ke,CHEN Xiao-wei,YU Zhen

2011, 16(1):  61-66. 

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AIM: To research the effects of rhubarb combining with early enteral nutrition on severe acute pancreatitis(SAP).METHODS: 64 patients with SAP were randomly received one of the three therapies below: 20 patients were treated with total parenteral nutrition(TPN), 23 patients were treated with early enteral nutrition(EEN), and 21 patients were treated with rhubarb combining with early enteral nutrition(REN). The hospitalization cost, length of stay, mortality, recovery time of intestinal function and score of APACHEⅡgrade were observed. The positive rate of plasma procalcitonin(PCT), the levels of C-reactive protein(CRP), pre-albumin, the percentage of CD₃,CD₄,CD₈,CD₄/CD₈ ratio and IgG, IgA, IgM were detected and compared.RESULTS: There was no patient died in REN group, but 1 in EEN group and 2 in TPN group.The recovery time of intestinal function in REN group was (2.6±0.7) days, the length of stay was (24±4) days ,the hospitalization cost was (5.5±0.7) thousands yuan, which were obviously shorter than those in the other groups(TPN group,P<0.01;EEN group,P<0.05). After two-week therapy, the score of APACHEⅡgrade in REN group was decreased from 11.8±2.4 to 3.1±1.0(P<0.01),which was lower than that in the TPN and EEN group(TPN group, P<0.01;EEN group, P<0.05).In addition,the level of CRP and the positive rate of PCT in REN group was respectively decreased(P<0.01),which were both lower than those in the other groups( EEN group,P<0.05; TPN group,P<0.01).The level of plasma pre-albumin in REN after two-week therapy was higher than before[(315±21) mg/L vs (121±9) mg/L,P<0.01],which was also higher than that in TPN group(P<0.01). After two-week treatment in REN group, the percentages of CD₃, CD₄ and CD₄/CD₈,IgG,IgA,IgM were increased, while the percentage of CD₈ was decreased, which were all of significant differences with those in EEN and TPN group(TPN,P<0.01;EEN,P<0.05).Besides,CD₄/CD₈ after two-week treatment in REN group was significantly higher than that in EEN and TPN group(TPN,P<0.01;EEN,P<0.05).CONCLUSION: REN is effective for severe acute pancreatitis. It is worthy of recommend because it can promote the recovery of the intestinal function, improve patients' nutritional and immune status, decrease the inflammatory reaction, shorten the length of stay and decrease the hospitalization cost. It is better than TPN and EEN therapy for SAP.

A comparative study of efficacy on the quality of life between duloxetine and amitriptyline in treating patients with depression

WANG Ji-hui, WU Xiao-li, WEI Qin-ling, HAN Zi-li

2011, 16(1):  67-71. 

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AIM: To study the efficacy on the quality of life between duloxetine and amitriptyline in treating patients with depression.METHODS: 57 patients were randomized to either duloxetine group( research group, n=30) or amitriptyline group (control group, n=27) for a 6-week period treatment. All patients were assessed with Short-Form-36 Health Survey (SF-36), Hamilton Depression Scale (HAMD, 24-items), Hamilton Anxiety Scale (HAMA) and the Treatment Emergent Symptom Scale (TESS) before treatment and at the ends of the 1st, 2nd, 4th and 6th week treatment.RESULTS: The response rates in duloxetine and amitriptyline group were 86.67%(26/30)and 85.19%(23/27)respectively at the sixth weekend, the remission rates were 46.67%(14/30)and 44.44%(12/27),which showed no statistical difference between the two groups ( P>0.05). Incidences of adverse reactions in amitriptyline group was significantly higher than that in duloxetine group(77.78％ vs 36.67％, P<0.05). At the sixth weekend, all the factor scores of SF-36 in duloxetine group were significantly higher than those in control group (P<0.05). The improvement of the most factor scores of SF-36 after 6-week treatment was positively correlated with the decrease rates of total score of HAMD and HAMA, and negatively correlated with the total score of TESS (P<0.05).CONCLUSION: Duloxetine is better than amitriptyline in the improvement of quality of life in depression patients. The quality of life in depression patients is closely correlated to their depression, anxiety symptom and treatment emergent side effects.

Effects of parecoxib sodium premedication on pulmonary function in patients with rectal cancer undergoing laparoscopic eradication

ZHENG Xian-he,JIANG Zong-ming,ZHANG Chang-feng,HU Shuang-yan,CHEN Zhong-hua,CHEN Nian-ping

2011, 16(1):  71-75. 

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AIM: To investigate the effect of parecoxib sodium premedication on pulmonary function in patients with rectal cancer undergoing laparoscopic eradication.METHODS: Sixty ASA Ⅱ or Ⅱpatients with rectal cancer, aged 48-67 year and weighing 52-68 kg undergoing laparoscopic eradication were randomly divided into 2 groups (n=30 each):control group(group C) and parecoxib sodium group(group P) . General anesthesia combined epidural blockade were performed in all eligible patients. Parecoxib sodium 40 mg (diluted to 5 mL with normal saline)was injected via vein route before anesthesia induction in group P, while in group C normal saline 5 mL was intravenously administered. Serum IL-6,IL-10 and TNF-α were assayed and arterial blood gas analysis were measured in the following time points: pre-induction(T₀),1 h after pneumoperitoneum(T₁),termination of pneumoperitoneum(T₂), postoperative 4 h(T₃)and 24 h(T₄). Respiratory index (RI) and PaO₂/FiO₂ were calculated.RESULTS: Compared with the baseline values at T₀, serum TNF-α and IL-6 concentrations at T_1-4 and serum IL-10 concentration at T_1-3 were significantly increased in group C, while in group P serum TNF-α and IL-6 concentrations at T_1-3 and serum IL-10 concentration at T_1-4 were significantly increased (P＜0.05). RI was significantly increased and PaO₂/FiO₂ was significantly descended at T_1-2 in two groups (P＜0.05). Serum TNF-α and IL-6 concentrations at T_1-4 and RI at T_1-2 were significantly lower while serum IL-10 concentration at T_1-4 and PaO₂/FiO₂ at T_1-2 were significantly higher in group P than those in group C (P＜0.05).CONCLUSION: Parecoxib sodium premedication can effectively protect the pulmonary function in patients with rectal cancer undergoing laparoscopic eradication by attenuating systemic inflammatory response .

Relationship between serum concentration and clinical efficacy of aripiprazole in the treatment of patients with schizophrenia

LI Jian-hua, ZHONG Hua, SHEN Wei-min, SUN Ju-shui, CHEN Hai-zhi, FAN Zhen-guo, LU Gui-hua

2011, 16(1):  76-81. 

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AIM: To explore the relationship between serum concentration and clinical efficacy of aripiprazole in the treatment of patients with schizophrenia,and the suitable therapeutic window of aripiprazole.METHODS: Prospective study method was adopted.The dosages of aripiprazole were unfixed for eight weeks.The trough serum concentrations were determined by high performance liquid chromatography (HPLC).The clinical efficacy was evaluated with the Positive and Negative Syndrome Scale ( PANSS) and the Clinical Global Impression-Severity of Illnes (CGI-SI), side effects were done with the Treatment Emergent Symptom Scale(TESS).The optimized cutoff value of serum concentration was procured by the receiver operator curve (ROC), and the therapeutic window of aripiprazole was evaluated combining quartering interval.The correlation among serum concentration and dosage, therapeutic effect and side effect of aripiprazole were analyzed.RESULTS: 80 subjects were participated in the study, 47 cases were effective, 29 cases were ineffective, 4 cases were lost. The total side effect incidence rate was 32.5%.The trough serum concentration was significantly positive correlated with dosages, the decreasing ratios of PANSS scores and TESS scores,respectively, and the trough serum concentration was significantly negative correlated with CGI-SI scores.There was no significant correlation between dosages and therapeutic effect.The lowest effective trough serum concentration was 363 μg/L, the trough serum concentration threshold occurring side effects was 540 μg/L, the quartering interval of trough serum concentration in the effective group was 348-623 μg/L.The efficacy of aripiprazole was best and its side effects were mildest when serum aripiprazole levels were in the range of 350-540 μg/L.CONCLUSION: The serum concentration of aripiprazole in the treatment of patients with schizophrenia is correlated with clinical efficacy. The suitable therapeutic window for patients treated with aripiprazole is 350-540 μg/L.

Efficacy analysis of Mycobacterium phlei combined with benzathine penicillin in the treatment of early syphilis

WANG Jun, LIU Wei-bei, CI Chao, CHANG Xiao-li,WANG Li,HANG Shou-yun,JI Bi-hua

2011, 16(1):  82-84. 

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AIM: To investigate the effects of Mycobacterium Phlei combined with benzathine penicillin in the treatment of early syphilis.METHODS: Eighty cases of early syphilis were divided into treatment group (Mycobacterium phlei combined with Benzathine penicillin) and control group (benzathine penicillin alone), all the patients were observed for 6 months.RESULTS: The geometric mean titers of rapid plasma reagin test (RPR) in the treatment group at the 3th and 6th months were lower than those in the control group (P<0.05). The RPR negative conversion rate was 40% after 6 months in treatment group, while 21.2% in the control group, the difference was significant (P<0.05).CONCLUSION: Mycobacterium Phlei can enhance the efficacy of benzathine penicillin in the treatment of early syphilis.

Clinical curative effect observation of ambrette capsule combined with tripterygium glycosides tablet on diabetic nephropathy of IV stage

SHEN Shui-juan, HU Zuo-xiang, WANG Shi-ming, LI Qing-hua

2011, 16(1):  85-88. 

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AIM: To observe the curative effect of ambrette capsule combined with tripterygium glycosides tablet on diabetic nephropathy.METHODS: 135 patients with diabetic nephropathy were randomly divided into combined group which was treated with traditional therapy including control blood glucose and control blood pressure with angiotensin Ⅱ receptor antagonist (ARB) and ambrette capsule 5 pieces three times a day by oral administration combined with tripterygium glycosides tablet 1 mg per day and per kilogram, ambrette group which was treated with traditional therapy and ambrette capsule 5 pieces three times a day and control group which was treated with traditional therapy .The 24 h urine protein quantitation, blood albumin, renal function, hepatic function, blood fat and blood routine were respectively detected and compared before treatment and after treatment for two, four, eight and twelve weeks.RESULTS: After 4 weeks treatment, combined group had significantly decreased the urine protein quantitation (P<0.01), but ambrette group had significantly decreased until 8 weeks treatment(P<0.01), there was no statistical significance in control group after 12 weeks treatment(P＞0.05). After 12 weeks treatment, there was significant difference in the urine protein quantitation among ambrette group, combined group and control group respectively (P<0.05 and P<0.01). There was no statistical significance on the other indexes(P＞0.05).CONCLUSION: Ambrette capsule or tripterygium glycosides tablet can decrease urine protein and postpone progress of renal function, but combined group had better curative effect and can shorten course of treatment.

Effects of acute hypervolemic hemodilution with 6%HES 200/0.5 on hemorrheology with diabetes mellitus-2types

ZHOU Chun-lian, ZHOU Gang,CHEN Lin-yang

2011, 16(1):  88-92. 

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AIM: To investigate the effects of acute hypervolemic (AHH)with 6%Hetastarch 200/0.5 on hemorrheology in patients with diabetes mellitus-2types. METHODS: Twenty ASAⅠ-Ⅱpatients with diabetes mellitus-2types were randomly divided into 2 groups(n=10 each). Group H:received with sodium lactate liquid 500 mL at 15 mL·kg^-1·h^-1, followed with HES 200/0.5 500 mL at the same speed. Group R: performed with sodium lactate liquid 1000 mL at the same speed. After anesthesia induction, blood sample were obstained before and after AHH for measurement of whole blood viscosity at low or high shear rate,plasma viscosity,hematocrit(Hct), RBC aggregation anddeformation index. MAP, HR and SpO₂ were recorded, volume of blood and fluid transfusion were recorded. RESULTS: MAP and HR were stable during AHH period. Compared with group R,WBV at low or high shear rates, RBC aggregation index were significantly decreased, while RBC deformation index were significantly increased after AHH in group H(P＜0.01). CONCLUSION: 6%HES 200/0.5 is better than sodium lactate liquid in improving intraoperative and sluggish blood flow.

Effect of Ulinastation on intra-abdominal hypertension and intestinal mucosa barrier in older patients with severe acute pancreatitis

MA Jing, GU Pei-yu,YU Zhui

2011, 16(1):  93-97. 

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AIM: To study the effect of Ulinastation(UTI) on intra-abdominal hypertension(IAP) and intestinal mucosa barrier in older patients with severe acute pancreatitis.METHODS: To divide 48 older patients with severe acute pancreatitis into treatment group(n=24) and contral group(n=24) randomly, including continuous blood purification(CBP).Both treatment group and control group were given conventional therapy,and ulinastatin was added to the treatment group. The changes of intra-abdominal pressure, IL-6,DAO, IgA were observed and compared in 24 and 48 hours.RESULTS: The level of IAP before treatment was (17.45±1.87)mm Hg, which was positively associated with the level of IL-6(P＜0.01). The intra-abdominal pressure,IL-6, DAO level were decreased and IgA was increased significantly in both groups after treatment(P＜0.01). Compared with the control group, there were no significant difference between these results and those of control group before treatment,but significantly the intra-abdominal pressure,IL-6, DAO level were decreased and IgA was increased significantly at 48 hours and IL-6 was decreased at 24 hours after treatment(P＜0.01). CONCLUSION: The conventional therapy plus ulinastatin for older patients with acute acute pancreatitis can improve intra-abdominal hypertension and shelter the function of intestinal mucosa by anti-inflammatory effect.

Artesunate united Primaquine in the treatment of delay or reconnection malaria

SUN Wei-hua,Afel TRAORE

2011, 16(1):  98-100. 

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AIM: To approach the clinical therapeutic effects of artesunate united Primaquine in the treatment of delay or recrudescence malaria.METHODS: 82 patients were randomly divided into two groups.Patients of the treatment group(n=41)were given an initial dose of 2.4 mg/kg artesunate i.v., 12 h later,a second dose of 1.2 mg/kg artesunate was given in the same way.For the succeeding 6 days,a daily dose of 1.2 mg/kg artesunate was given in the same manner to each patient in the treatment group;and each of the patients were given Primaquine tables 22.5 mg/d, p.o..The control group(n=41)were given an initial dose of 20 mg of quinimax i.v.,12 h later,a second dose of 10 mg/kg quinimax was given in the same way.Thereafter,10 mg/kg of quinimax was given q.12.h.In the same manner until the patients could take medicines by mouth.Quinimax tablets in a dose of 10 mg/kg were then given q.8.h. The course of treatment was 7 d.RESULTS: After 7 and 28 d,the cure rates in the treatment and control group were 97.5％, 95.1％;97.5%,90.2%,respectively.The changes in the treatment and control group were similar(P>0.05). The defervescence time was 28.0 and 51.6 h,and the clearing time of haemoplasmodium was 30.4 and 59.5 h in the treatment and control group,respectively;the differences was significant(P<0.01).CONCLUSION: Artesunate united Primaquine was found to act more quickly in the treatment of pernicious delay or recrudescence malaria,low recurrence rate,with only mild side effects.It is also effective in the treatment of malaria caused by quinine-resistant strains of malaria parasites.It should be the drug of first choice in the treatment of malaria that quinine fails to effect a cure.

Effects of bisoprolol with different drug administration time on the renin-angiotension-aldosterone system of non-dippers hypertension

LIU Hua-qiang,YAN Mei-xing,WANG Shao-hua,SUN Xiao-lei

2011, 16(1):  101-104. 

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AIM: To explore effect of renin-angiotension-aldosterone system induced by bisoprolol with different time drug administration in patients with non-dipper hypertension.METHODS: The patients were randomly divided into two parallel groups. All patients were treated with bisoprolol. The first group were received bisoprolol at eight o'clock once-daily between 2.5 mg and 10 mg. The second group were received bisoprolol at twenty o'clock once-daily between 2.5 mg and 10 mg. The concentration of rennin,angiotension and aldosterone after 8 weeks' treatment were detected and evaluated.RESULTS: The concentration of rennin,angiotension and aldosterone after treatment were lower than before treatment in two groups(P<0.05). And there was no significant difference between two groups on the concentration of renin (P>0.05), but a significant difference on angiotension and aldosterone(P<0.05).CONCLUSION: Two methods of treatment can decrease the concentration of rennin,angiotension and aldosterone, but the non-dippers hypertension taked drug at eight o'clock has a signifcant effect on angiotension and aldosterone.

Polymorphism of CYP2D6 and the influence to the drug metabolism

HAN Lu, LIU Jie

2011, 16(1):  105-110. 

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CYP2D6 is a member of cytochrome P450 gene family - a group of enzymes that is responsible for phase I metabolism and elimination of numerous endogenous substrates and a diverse array of drugs. It is now thought to be involved in the metabolism of up to 25% of the drugs that are in common use in the clinic, despite its low hepatic content (about 2 %). Among the drug-metabolizing cytochrome P450s, CYP2D6 is the only non-inducible enzyme and is highly polymorphic, which results in a large contribution of genetic variation to its inter-individual variation in enzyme activity and is an enzyme of great historical importance for pharmacogenetics. Here we summarize the polymorphism of CYP2D6 gene and their influence to drug metabolism.

Application and prospects of 5-HT receptor antagonists in the prevention and treatment of pulmonary hypertension

XIAO Xiong, HOU Ying, LI Xiao-qiang

2011, 16(1):  111-115. 

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Pulmonary hypertension is a group of clinical pathophysiological syndrome characterized by increased pulmonary vascular resistance due to multiple etiologies and pathogenesis. The main clinical manifestations are right ventricular dysfunction with poor prognosis, and patient of severe right heart failure can even cause death. This article reviews the relationship between the 5-HT and pulmonary hypertension, and the 5-HT receptor antagonists' effects on the prevention and treatment of pulmonary hypertension. The article also prospects that 5-HT receptor antagonists may be a kind of very promising new drugs in the treatment of pulmonary hypertension.

Effects of Gemfibrozil on several commonly used oral hypoglycemic agents

DAN Hai-Li, YI Fei

2011, 16(1):  116-120. 

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Drug interactions, particularly the studies of interaction between pharmacokinetics become a hot spot in recent years.Gemfibrozil is a lipid-lowering drugs commonly used in clinical, and there are many opportunities hyperlipidemia be in diabetes clinical situation, so whether there are interactions between gemfibrozil and oral agents should also be the concern of clinicians.We review the effect of Gemfibrozil to the pharmacokinetics and pharmacodynamics of several commonly used oral hypoglycemic drug, and to analyze its mechanism. Gemfibrozil inhibited CYP2C and significant effect the pharmacokinetics and pharmacodynamics of oral hypoglycemic drug, so monitoring the blood glucose concentrations in time or adjust the dosage of oral hypoglycemic agents when they are combined in clinical is necessary.