Chinese Journal of Clinical Pharmacology and Therapeutics

Effects of magnesium lithospermate B on the expression of heme oxygenase-1 in HEK293T cells

REN Xian, HOU Rui-ying, QU Jian, SHEN Jie, ZHOU Hong-hao, LIU Zhao-qian

2011, 16(5): 481-487.

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AIM: To further confirm the effects of magnesium lithospermate B (LAB) on the expression of heme oxygenase-1 (HO-1) in HEK293T cells induced by high glucose.METHODS: The intracellular reactive oxygen species in cells was determined by flow cytometry .The expression levels of HO-1 mRNA and HO-1 protein in HEK293T cells treated with high glucose and LAB were determined by quantitative reverse transcription polymerase chain reaction (QRT-PCR) and western blotting.RESULTS: Flow cytometry showed that the ROS concentration was increased markedly in HEK293T cells induced by high glucose and H₂O₂ and LAB inhibited the ROS generation of HEK293T cells. The expression levels of HO-1 mRNA and protein were increased significantly in HEK293T cells treated with high glucose and reached the peak value at 24 h.Compared with high glucose group,the expression levels of HO-1 mRNA and protein were obviously enhanced after cells were treated with 10,50,100 mol/L LAB.CONCLUSION: LAB not only can directly clear up the excess ROS in cells under oxidative stress, but also it play a antioxidant role via an increase of downstream gene HO-1 expression.

Change of p-CREB in the protection effect of agitating gamma-hydroxybutyric acid receptor on focal cerebral ischemia-reperfusion injury in rats

YANG Qi-xia, QIN Hao, GU Shu-ling

2011, 16(5): 488-491.

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AIM: To investigate the change of p-CREB in the protection effect of agitating gamma-hydroxybutyric acid receptor on focal cerebral ischemia-reperfusion injury in rats.METHODS: The Sprague-Dawley rats were randomly divided into five groups: sham operation group(Sham), ischemia-reperfusion group(I/R), NCS-356 160,320,640 μg/kg group.The middle cerebral artery occlusion (MCAO) model referring to Longa's method with modifications was adopted. These groups were administered NCS-356 in right lateral cerebral ventricle. Behavioral consequence of MCAO rats was studied 2 h after ischemia reperfusion. After 24 h of ischemia reperfusion, rats' ischemic cortex were used to measure the phosphorylation cAMP reactive protein binding element (p-CREB) by immunohistochemical method.RESULTS: The ethology score in rats of I/R group was 3.2±0.7,compared with the Sham group, it was increased statistically (n=8, P<0.01) The neurological function score in NCS 640 group was obviously lower than that in I/R group (n=8,P<0.05). The p-CREB gray scale value in I/R group was 96.3±6.0 ,which was higher than that in Sham group(n=8,P<0.01). The p-CREB gray scale value in NCS 640 group and NCS 320 group was obviously lower than that in I/R group(n=8,P<0.01).CONCLUSION: Activating GHBR has protective effects on focal cerebral ischemia-reperfusion injury in rats.The expresstion of p-CREB is reduced in the protection effect of agitating gamma-hydroxybutyric acid receptor on focal cerebral ischemia-reperfusion injury in rats.

Ezetimibe inhibiting intracellular lipid accumulation through caveolin-1 in rat vascular smooth muscle cells

TUO Qin-hui, YUAN Hao-yu, GUO Yan, YU Wei-xia , LIAO Duan-fang

2011, 16(5): 492-495.

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AIM: To determine the effects of ezetimibe on intracellular lipid accumulation and related mechanism in rat vascular smooth muscle cells (VSMCs).METHODS: VSMCs taken from rat aorta were respectively treated with different concentration of ezetimibe(0, 3, 10, 30 μmol/L)for 24 hours or treated with 30 μmol/L of ezetimibe for different time (0, 6, 12, 24, 48 hours). The concentration of total cholesterol and free cholesterol were detected by high performance liquid chromatography. The expression of caveolin-1 were detected by western blotting.RESULTS: The contents of intracellular total cholesterol (TC) and free cholesterol (FC) were significantly decreased with a peak at 30 μmol/L for 24 h in lipid-loaded cells by ezetimibe in a dose- and time-dependent manner.The level of caveolin-1 protein was elevated 70% by ezetimibe.CONCLUSION: Ezetimibe inhibits cholesterol:methy-β-cyclodextrin (Chol:MβCD)-induced cholesterol accumulation in cultured VSMC through modulating caveolin-1 .

Preliminary toxicological study of colchicine in rat renal cells NRK

CHEN Xue-mei, LIU Jun, SONG Jin-ping, WANG Tao, SHANG Jing

2011, 16(5): 496-500.

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AIM: To determine whether colchicine causes nephrotoxicity and to investigate the possible toxicity mechanism.METHODS: The rat renal cells NRK were cultured in vitro and MTT assay, cellular morphology observation, lactate dehydrogenase release assay (LDH assay) were used to evaluate the nephrotoxicity that caused by colchicine, the Hoechst 33324/PI double staining and flow cytometry were used to evaluate the possible mechanism of colchicine toxicity.RESULTS: Results showed that colchicine at the concentrations of 0.1-10 μmol/L could inhibit NRK cells viability significantly in a concentration-dependent manner. Besides, the change of cell morphology were observed and the LDH release were significantly increased when cells were treated with 1 μmol/L of colchicine. Moreover, Hoechst 33342/PI double staining and flow cytometry analysis showed that cells were nearly in late apoptosis/necrosis state and they were blocked in G₂/M phase after treatment with 10 μmol/L of clochicine.CONCLUSION: Colchicine at concentration of 0.1-10 μmol/L could cause serious nephrotoxicity. The mechanism of colchicine toxicity in NRK cells might be that colchicine blocked cell division in G₂/M phase, which induces cells apoptosis, thereby, generates cytotoxicity.

Cell research on anaphylactoid reaction induced by pharmaceutical excipients Polysorbate 80

LI Qin, ZHAO Yin, ZHENG Xiao-liang, ZHANG Xin-yue

2011, 16(5): 501-505.

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AIM: To observe the effects of Polysorbate 80 on basophilic cell leukemia RBL-2H3 cell degranulation and discuss the possible mechanism of anaphylactoid reaction.METHODS: RBL-2H3 cells were incubated with Polysorbate 80 for 60 min, and then the morphological changes of cells degranulation were observed by transmission electron microscopy, cell degranulation rate was detected by Alcian blue dye assay, Annexin V binding assay and β-hexosaminidase assay.RESULTS: Different concentrations of Polysorbate 80 can induce the typical morphological changes in RBL-2H3 cell with degranulation.Compared with the control group,the rates of degranulation and histamine release in Polysorbate 80 treated cells were significantly increased and dose-dependent.CONCLUSION: RBL-2H3 cell degranulation,histamine can be induced by single dose Polysorbate 80, and then induced anaphylactoid reaction, which may be one of the possible mechanisms of serious adverse induced by Polysorbate 80 injection for the first administration in clinic.

Effects of study duration and interview duration on allocation proportions randomized by urn model in clinical trial

YU Li-li, BU Xiao-dong, LIU Zhao-ping, LI Xia, XIA Jie-lai

2011, 16(5): 506-509.

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Urn model is a most commonly used randomization method of adaptive design. In this article, given the study time were from 6 to 12 months and the interview time were from 7 to 56 days, urn model was used to calculate the allocation proportions between the two treatments groups through simulation experiments. The outcomes indicated that the effects of study duration and interview duration on randomization results exactly exist, but they were not as serious as we assumed for the differences of effective modulus were not significant. We hope this study can provide some references for the application of RPW rule in practical clinical trials.

Biomarker finding of individual salviol B exposures in healthy subjects

HUANG Ji-han, WANG Kun, XU Ling, HE Ying-chun, LI Lu-jin, YANG Juan, SHENG Yu-cheng, ZHENG Qing-shan

2011, 16(5): 510-516.

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AIM: To set a linear regression model in selecting 1-4 point blood concentrations as biomarkers for predicting AUC_{0-24 h} and Cmax in individual therapy.METHODS: The blood concentrations of salviol B were determined by HPLC-UA and the data within 7 h were used to set model. The reliability and stability of the model was evaluated with the absolute prediction error (APE) by Jackknife method and plotting.RESULTS: A limited sampling model was set with 1-4 point concentrations by the regression model with plotting. One point for prediction of AUC_{0-24 h} showed 15% APE 29.6% in subjects, but two, three or four points could obtain better prediction with less than 15% APE in all subjects. There were the same results in the prediction of C_max in the subjects.CONCLUSION: Two-four point blood concentrations of salviol B can be taken as biomarkers to predict the AUC_{0-24 h} and C_max for individual therapy.

Exact method of sample size calculation and statistical inference in single-arm clinical trials with objective performance criteria

CHENG Qi, LIU Yu-xiu, CHEN Lin, LIU Li-xia

2011, 16(5): 517-522.

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AIM: To explore the exact method of sample size estimation and statistical inference in single-arm clinical trials with Objective Performance Criteria (OPC) based on binomial distribution principle.METHODS: This article will systematically and comprehensively discuss the exact method of sample size calculation, confidence interval estimation and hypothesis testing which the single-arm clinical trial method involves in.RESULTS: With the starting point of OPC at 75% by an interval of 1% increasing and the starting point of expected event rate at 76% by an interval of 1% increasing, corresponding exact sample sizes are calculated. And two sets of results under the condition of β of 0.20 and α of 0.05 (one sided and two sided) are tabulated respectively. The exact calculating formulas of confidence interval estimation and hypothesis testing are provided.CONCLUSION: Systematic methodology support is provided for OPC method in single-arm clinical trials in calculating sample size, estimating confidence interval and hypothesis testing.

Effects of Lipo-prostaglandin E₁ on diabetic peripheral neuropathy:A meta-analysis

LIU Lin , HUO Mo-fei , SUN Rui-hua

2011, 16(5): 523-529.

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AIM: To evaluate the efficacy and safety of Lipo-prostaglandin E₁ on treating diabetic peripheral neuropathy(DPN) Lipo-prostaglandin E₁.METHODS: The electronic databases OVID-LWW,CNKI and Wanfang were searched to collect randomized controlled trials(RCT) by interventions of Lipo prostaglandin E₁ for the treatment of DPN. The methodological quality of the trials were evaluated and the valid data for Meta-analysis were extracted.RESULTS: 11 RCT and 978 patients were included. Test group was treated combined with common integrated Lipo prostaglandin E₁,or combined treatment on the basis of combined therapy plus B vitamins. Meta analysis showed that the prostaglandin E₁ group of patients with DPN is better than the control group in improving nerve conduction velocity. After treatment, the WMD of the median nerve motor conduction velocity (MCV) and common peroneal nerve MCV and their 95% CI were 4.39(2.86, 5.91) and 3.38(2.21,4.54). The median nerve sensory nerves conduction velocity (SCV) sensitivity analysis of the WMD and 95% CI were 3.55(1.86,5.24).CONCLUSION: Lipo-prostaglandin E₁ can improve nerve conduction velocity in patients with DPN. However, due to the low quality of research literature, more scientific and standardized, high quality, large sample, long-term follow-up of the RCT are still needed.

Acupuncture for migraine: a systematic review and meta-analysis of randomized controlled trials

GAO Xiao-mei, WANG Bo-song, SONG Yan-yan, QI Hong, RONG Zheng-xing, WANG Hao

2011, 16(5): 530-537.

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AIM: To precisely assess the efficacy of acupuncture in migraine therapy, and analyze the reasons of different conclusions between domestic and foreign clinical trails.METHODS: Pubmed, Cochrane Library, and Chinese Biomedical Literature Database (CMB) were searched to obtain the randomized controlled trials (RCTs) of acupuncture for the treatment of migraine. Data were synthesized using RevMan 5.0 software provided by the Cochrane Collaboration.RESULTS: Twelve high-quality RCTs comparing verum acupuncture with sham acupuncture were included in the meta-analysis. The results showed that at the end of treatment the responder rate of verum and sham acupuncture were 49.5% and 43.3%, respectively. Acupuncture treatment could significantly reduced the severity of migraine by increasing responder rate (OR=1.28, 95%CI: 1.02-1.61, P=0.03). The responder rate of verum and sham acupuncture at the end of follow-up were 47.7% and 38.5%, respectively, but the difference between them was not significant (OR=1.33, 95%CI: 0.70-2.51, P=0.39). In subgroup analysis, RCTs in China showed significantly amelioration of migraine by acupuncture either at the end of treatment or follow-up (P<0.05), while RCTs in abroad showed no significant difference between two groups at the end of treatment or follow-up (P>0.05).CONCLUSION: The meta-analysis suggested that acupuncture was effective in the treatment of migraine but the effectiveness was not maintained after the withdrawal of acupuncture therapy. Since the conclusions of RCTs conducted in China and abroad are quite different, more full-scale RCTs following the principles of traditional Chinese medicine are recommended to further warrant the effectiveness of acupuncture.

Clinical analysis of therapeutic drug monitoring and drug dosage for ICU patients treated with teicoplanin

LI Hao, WANG Xue, DONG Hai-yan, DONG Ya-lin, TIAN Gang

2011, 16(5): 538-544.

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AIM: To study the necessity of TDM and a reasonable dose of teicoplanin.METHODS: The clinical data of 20 patients who were suffered with severe infection and treated with teicoplanin were retrospectively analyzed.According to the MID, patients were divided into two groups: group1 (MID=533.33 mg/d, n=10), group2 (MID<533.33 mg/d, n=10).The C_min of teicoplanin was measured by HPLC.RESULTS: The C_min of teicoplanin was closely related to initial dose, Pearson correlation was 0.685 and the correlation was significant at the 0.01 level (2-tailed). The C_min and the therapeutic effect of patients who were accepted the initial load dose of teicoplanin was higher and better than the patients who weren't accepted the initial load dose (P<0.01).There was no statistically difference in two groups with the frequency of side-effect.CONCLUSION: The findings suggest that a regular initial load dose of teicoplanin make it possible to rapidly attain an optimal trough concentration and acquire a good therapeutic effect.It is necessary for ICU patient who is treated with teicoplanin to regulate dose by the result of TDM to avoid the side-effect.

Effects of regular consumption of RRR-α-tocopherol on the activity of P-gp in vivo

ZHANG Song-bo, DUAN Juan, ZHOU Hong-hao

2011, 16(5): 545-548.

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AIM: To investigate the effect of regular consumption of RRR-α-tocopherol on the activity of P-gp in vivo.METHODS: In a two-stage doubly periodic cross-over study, 12 healthy volunteers, who were randomly divided into two groups, ingested RRR-α-tocopherol 600 mg each day or placebo (control) for 14 d. On day 15, a single 100 mg dose of talinolol was administered by all the volunteers and 5 mL peripheral vein blood of each one was taken at 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h. Plasma concentrations of talinolol were determined by HPLC after centrifugation and blood plasma separation. The difference of pharmacokinetic parameters of every groups were compared and analyzed.RESULTS: Co-administration of RRR-α-tocopherol obviously decreased the area under the curve AUC_(0-24h) of talinolol [(2104±670) ng·h·mL^-1 vs (2914±1061) ng·h·mL^-1], P<0.05, and significantly decreased C_max of talinolol [(249±69) ng/mL vs (406±214) ng/mL], P<0.05.CONCLUSION: Regular consumption of RRR-α-tocopherol 600 mg each day for 14 d, significantly induces the activity of P-gp.

Simultaneous determination of 10 amino acids in serum by reversed phase high performance liquid chromatography with pre-column phenylisothiocyanate derivatization

YANG Zhi, YANG Li-long, ZHU Wen-bing, CAO Jing, HE Zhou-kang

2011, 16(5): 549-552.

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AIM: To establish a reversed-phase high performance liquid chromatographic method for simultaneous determination of 10 amino acids in serum.METHODS: The sample was mixed with norleucine as the internal standard,then derivatized with phenylisothiocyanate(PITC)and analyzed on a Venusil-AA column at 40 ℃,using gradient elution with detection at 254 nm.RESULTS: The correlation coefficients between the ratios of peak area of amino acid to that of the internal standard and the amino acid concentrations were all above 0.99 in the linear range 15.6-250 μmol/L.The recoveries of amino acids added were 96.3％-103.4％,with-in and between day precision were less than 4.8%.The method was applied to analyze free amino acids in infants plasma and good results were obtained.CONCLUSION: The method is simple, stable, the separation of amino acids is satisfactory.It can be used for determination of amino acids in human plasma.

Effect of silencing CTLA4 with siRNA on the Th1/Th2 cytokines in peripheral blood of chronic hepatitis B patient

YU Yong-sheng, WU Hao, TANG Zheng-hao, ZANG Guo-qing

2011, 16(5): 553-557.

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AIM: To explore the inhibition of expression for cytotoxic T-lymphocyte antigen 4(CTLA-4) in peripheral blood lymphocytes in patients with CHB by chemically synthesized small interfering RNA (siRNA) and the secretion of IFN-γ, IL-2, IL-4, then to analyze the T cellular immune activation by the interference of CTLA-4 gene.METHODS: CTLA-4 of peripheral blood lymphocytes in patients with CHB was detected to observe the correlation with the HBV-DNA; according to human CTAL-4 gene sequence, CTAL-4 siRNA and the negative control (siRNA-co) were designed, synthesized, and then they were transfected into peripheral blood lymphocytes separated from CHB patients by electroporation. The expression of CTLA-4 mRNA was detected by real-time Q-PCR, the CTAL-4 protein was measured by Western Blot and the secretion of IFN-γ,IL-2 and IL-4 were assayed by enzyme-linked immunosorbent assay (ELISA).RESULTS: CTLA-4 of peripheral blood lymphocytes in patients with CHB was correlated to HBV-DNA (P＜0.05); after CTLA-4 were transfected into peripheral blood lymphocytes separated from CHB patients, the expression of CTLA-4 mRNA, CTAL-4 protein were suppressed and the production of IFN-γ, IL-2 were enhanced, compared with the negative control group (P＜0.01), while IL-4 concentrations did not show any significant differences (P＞0.05).CONCLUSION: CTLA-4 of peripheral blood lymphocytes in patients with CHB might contribute to the persistent infection of HBV. Inhibiting the expression of CTLA-4 mRNA in peripheral blood lymphocytes in patients with CHB could up-regulate the secretion of Th1-type cytokines IFN-γ, IL-2 except Th2-type cytokines IL-4. It suggested that inhibiting CTAL-4 is helpful to activating T cellular immunity of patients with CHB.

Compare study of clinical features in polymyositis and dermatomyositis

XUAN Dan, SHENG Jun, LI Zhi , MAO Tong-jun, XU Liang , LU Jin-ming

2011, 16(5): 558-562.

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AIM: To study the difference of clinical charactertics between polymyositis and dermatomyositis patients.METHODS: 11 cases of polymyositis and 21 cases of dermatomyositis were included in this study.Their muscle strength, serum creatine phosphokinase (CPK) levels, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), hospitalization times, the quadriceps muscle MRI and high-resolution lung CT (HRCT) were compared.RESULTS: There were no statistic differences among muscle strength, ESR, CRP, hospitalization times, hoarseness and dysphagia in the two groups(P>0.05).The level of CPK in polymyositis patients was significantly higher than that in dermatomyositis patients [(3032±2973)vs(390±947) U/L(P=0.015)]. But the rate of incidence of interstitial pneumoniin in dermatomyositis patients was significantly higher than that in polymyositis patients (P=0.021),and the therapy effect of glucocorticoids in polymyositis patients was significantly better than that in dermatomyositis patients (P=0.013). 4 deaths were all dermatomyositis patients,3 cases died with interstitial pneumoniin developed respiratory failure and 1 cases died with rhabdomyolysis developed acute renal failure.CONCLUSION: The level of CPK in dermatomyositis patients is higher than polymyositis patients, but more complicated that in by interstitial pneumoniin and poor prognosis.

Study on metabolic risk of first-episode acute schizophrenia patients treated with aripiprazole

WU Xiao-li, WEN Fei, ZHONG Zhi-yong, HAN Zi-li

2011, 16(5): 563-567.

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AIM: To study the metabolic risk of first-episode acute schizophrenia patients treated with aripiprazole.METHODS: 31 first-episode acute patients with schizophrenic were enrolled into case group and 44 healthy subjects were enrolled into controle group,all cases accepted treatment with oral aripiprazole.At the baseline and at the end, all patients were checked or tested for weight,waist circumference, waist-to-hipratio(WHR), TC, TG,high density lipoprotein(HDL),low density lipoprotein(LDL),apolipoprotein A1( Apo-Al),apolipoprotein B (Apo-B100), lipoprotein a(LPa),fasting blood glucose(FBS),fasting insulin (INS)and c-peptide(C-P),respectively.The BMI and insulin resistance index (HOMA-IR) were calculated.All indexes were compared and analysed between the case group and controle group,pre and post treatment in the case group.RESULTS: The INS,C-P and HOMA-IR in the case group were significantly higher than those in the control group,there was no significant difference(P<0.05). After treatment,the body weight, BMI,waist circumference, WHR in the case group were increased significantly,there was no significant difference(P<0.05). Copmared with the control group, the TG,INS,C-P,HOMA-IR were significantly increased after treatment in the case group, while aPOA1 was decreased,there is no significant difference(P<0.05).CONCLUSION: There may be some inborn metabolic abnormality in schizophrenia patients themselves.The effects of aripiprazole on glucose and lipid metabolism of first-episode acute schizophrenia are smaller.

Significance of anti-cyclic citrullinated peptides antibodies in patients of systemic lupus erythematosus with arthritis

MAO Tong-jun, XU Guo-fei, SHENG Jun, LI Zhi, XUAN Dan, ZHANG Jun, LU Jin-ming, XU Liang

2011, 16(5): 568-573.

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AIM: To detect the level of anti-cyclic citrullinated peptides(anti-CCP) antibodies in systemic lupus erythematosus(SLE) patients with arthritis,and explore the relationship of anti-CCP antibodies with erosive arthritis in SLE patients.METHODS: The levels of anti-CCP antibodies in 141 case patients with SLE were detected by ELISA.The dependablity between anti-CCP antibodies and clinical features as well as laboratory parameters in these SLE patients were analyzed.RESULTS: The positive rate of anti-CCP in SLE patients was 20.6%(29/141). The positive rate of anti-CCP in SLE patients with arthritis was 26.7%(20/75),which in SLE patients without arthritis was 13.6%(9/66),there was no significant difference(P=0.056). But the level of in anti-CCP in SLE patients with arthritis(16 RU/mL) was higher than that in SLE patients without arthritis(12 RU/mL,P=0.004) .In anti-CCP antibodies positive SLE patients,the level in arthritis patients (304.5 RU/mL)was higher than that in without arthritis patients(30.0 RU/mL) (P=0.001).There were 6 SLE patients with erosive arthritis in all subjects and high level anti-CCP antibodies(459 RU/mL) were detected in 5 patients.CONCLUSION: Anti-CCP antibodies can be found in 20.6% of patients with SLE, the patients who had high level of anti-CCP antibodies might initiate erosive arthritis. Anti-CCP antibodies is important to identify SLE patients with arthritis.

Efficacy study of Escitalopram together with atypical antipsychotic in treating depression symptoms accompanied with acute schizophrenia

JIANG Chang-wang, SHI Jian-fei , ZHU Ya-ping, TAO Yun-hai

2011, 16(5): 574-578.

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AIM: To study the efficacy and safety of Escitalopram together with atypical antipsychotic in treating depression symptoms accompanied with acute schizophrenia.METHODS: 71 acute schizophrenia patients with depression were randomly assigned into two groups: the study group and the control group. Escitalopram, together with atypical antipsychotic, were given to patients in the study group; while only atypical antipsychotic were given to patients in the control group. The study period was 8 weeks. At the end of week 1, 2, 4, 8, BPRS, HAMD (as indicator of treatment effect) and TESS (as indicator of adverse effect) were assessed for all patients. The scores of BPRS and HAMD were analyzed using statistics package between the study group and the control group. The dosages of atypical antipsychotic, based on converted dosage of haloperidol, were compared between the two groups also.RESULTS: This study completed 68 observations. HAMD scores in the study group decreased starting from week 1, and were lower than those in the control group from week 2(the differences were significant), while HAMD scores in the control group did not decrease until week 4. At the end of week 2,4,8, BPRS scores in the study group decreased and were lower than those in the control group significantly . At the end of week 8, The recovery rate of study group (42.8%) was significantly higher than that of the control group(15.1%). 65.7% patients in the study group ameliorated while 51.5% patients did in the control group, the difference was not significantly. The average dosages (the peak dosage, the dosage during 8 weeks, and the dosage for week 8) in study group were significantly less than the control. The TESS scores in the study group were significantly less than the control at the week 2, 4, 8.CONCLUSION: Escitalopram together with atypical antipsychotic is able to cure the depression symptoms accompanied with schizophrenia rapidly and effectively. It is safe (with less adverse effect) also. Therefore, Escitalopram can be used as a cooperative medicine in the treatment of schizophrenia with depression symptoms.

Research approaches of CYP450s' induction/inhibition and their application on drug development

BU Ming-hua, ZHANG Ying , LIU Jian-xun , LIU Dong-chun

2011, 16(5): 579-585.

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Cytochrome P450 (CYP450) is the most important enzyme family in liver which plays a crucial role in metabolism of the exogenous and endogenous substances. The change of CYP450s on activity or content is closely related with the effectiveness and safety of their substrate drugs through altering drugs' effective doses or response time. Therefore, it is an indispensable research during drug development to understand the potential induction or inhibition effects on CYP450 enzyme. This paper reviewed methodology development of degree evaluation, phenotype analysis and mechanistic investigation of CYP450 enzyme induction/inhibition, as well as their application mainly on natural products.

Design idea and methodology for the II and III clinical trial of the new drugs in view of effectiveness and ethics

BI Jing-feng, CHEN Su-hong, WEI Zhen-man

2011, 16(5): 586-589.

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For clinical trials, efficacy evaluation of new drugs might not be reliable if it is based on positive drugs for comparison. Furthermore, the clinical trial itself might encounter general ethical problems. When proposing clinical trials for new drugs, placebo drugs should be chosen for comparison during Phase II. In view of research objective and disease situation, patients with mild conditions should be chosen for clinical trials. On the basis of effectiveness of the new drugs, second stage of Phase II and Phase III can be arranged. Add-on research methodology can be adopted in the second stage of Phase II to adequately extend indication. Phase III clinical trials can choose placebo or suitable positive drugs for comparison. This will ensure the effectiveness of the new drugs as well as meet the ethical requirements.

Recent progress of aldose reductase in non-diabetic disease

DENG Xiao-lan, LI Hui, JING Xian, TIAN Ying-ying, LV Pei-yu, OUYANG Dong-sheng

2011, 16(5): 590-594.

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Aldose reductase belongs to aldo-keto reductase superfamily, which catalyzes the rate limiting step of the polyol pathwany. To date, emerging reports have suggested that aldose reductase mediates intracellular signal transduction pathways that triggered by cytokines, growth factors and oxidative stress. Then aldose reductase is involved in various of pathological processes of diseases. This paper summarized the role of aldose reductase in the non-diabetic diseases.

Progression of no-reflow prevention and treatment in percutaneous coronary intervention

LI Xiao-qian, KE Yong-sheng

2011, 16(5): 595-600.

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As percutaneous coronary intervention is widely used in clinic, more and more acute ST-segment elevation myocardial infarction patients undergo direct PCI. However, no-reflow phenomenon seriously affects the prognosis of patients during emergent PCI. The possible mechanisms and therapies of no-reflow phenomenon will be introduced briefly in this review.

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