Table of Content

Volume 15 Issue 5
26 May 2010

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Analysis of metabolomic data: principal component analysis

Jiye Aa

2010, 15(5):  481-489. 

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Metabolomics has been widely applied to life science and showing a promising perspective. Conventional statistic analysis is not applicable to the large, multivariate dataset generated by high-throughput metabolomic tool, while it's of crucial importance to analyze and interpret the dataset. This article reviews the basic methods of principal components analysis(PCA) that is popular in metabolomics study, aiming at strengthening the fundamental knowledge of PCA and standardizing the methods and procedures for data analysis.

Effects of clozapine on the synaptic transmission and extracellular neurotransmitters release in the hippocampus of rabbits

WANG Man, MA Hui, Jibiki Itsuki, Kubota Takashi, Ishikawa Akira, Kawamura Tomomi

2010, 15(5):  490-495. 

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AIM: To observe whether clozapine can alter the synaptic transmission and extracellular neurotransmitters release in the hippocampus of rabbits. METHODS: The stimulating microelectrodes were inserted into the perforant path of hippocampus in 15 rabbits, while the recording microelectrodes and guide cannulas were inserted into homolateral dentate gyrus of the rabbits. After a 10-day recovery period, they were divided into three groups randomly (n=5): contral(C) group, tetanic stimulation (T) group and without tetanic stimulation (N) group. There were 3 sessions (60 mins/session) in the total 180 mins. Every rabbit was given single stimuli at a fixed intensity(monopolar square pulse of 0.2 ms duration, 200-300 μA,30-second stimulus intervals) in dentate gyrus. T and N were intraperitoneally injected with clozapine resolution(20 mg/kg) and C were intraperitoneally injected with blank solvent after 60 min, while C and T were given a titanic stimulation after 120 min. The synaptic responses in dentate gyrus were recorded every 2 min, and the microdialysis samples were collected to examine the extracellular DA and 5-HT levels every 5 min. RESULTS: The response in dentate gyrus: there was clozapine-induced potentiation in group T and N in session 2(P＝0.004), and there was LTP in group T and C in session 3(P＝0.02). The extracellular DA and 5-HT levels: DA levels were increased significantly in group T in session 2 and 3 when compared with session 1(ther was not responding change of DA levels in session 3)(P＜0.01), DA levels were increased significantly in group N after clozapine administration(P＜0.01), while DA levels in group C and the levels of 5-HT in 3 groups were not changed(P＞0.05). CONCLUSION: Clozapine almost affect the excitatory synaptic response and extracellular DA levels in hippocampus simultaneously.

Effects of sodium hydrosulfide on apoptosis in lung injury induced by ischemic and reperfusion in rats

WANG Xing-min, JI Hai-feng, WANG Wan-tie, SHI Lu, JIA Xu-guang

2010, 15(5):  496-501. 

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AIM: To investigate the effect of sodium hydrosulfide (NaHS), the donor of H₂S, on apoptosis during lung ischemia and reperfusion injury (LIRI) in rats. METHODS: Single lung ischemia and reperfusion animal model were used in vivo. A total of 30 Sprague-Dawley(SD) rats were divided at random into 3 groups as follows: sham operation control (Sham) group, lung ischemia-reperfusion(LIR) group, and LIR-sodium hydrosulfide(LIR+NaHS) group. Each group consisted of 10 rats. Under anesthetized, all rats were underwented the procedure of operation as the following: opening the left chest and isolating the hilus of lung, through which a suture was passed. The Sham group didn't endure the pulmonary hila's ligation while the LIR group was subjected to a 30-minute ischemia and 120-minute reperfusion insult. The lung tissues sampled at the end of experiments were assayed for lung/body weight ratio (LW/BW).The tissue slides were also stained by immunohistochemistry (IHC) for bcl-2/bax to detect the expression of bcl-2/bax protein in lung and to analyze the optical density. The cell apoptosis in lung tissue were determined by TUNEL. The histological and ultrastructure changes were observed by light microscope and electron microscope. The injured alveoli rate (IAR) was counted as well. RESULTS: As compared with LIR group, in intima and extima of small pulmonary artery, alveoli, and bronchiole epithelia, the expression of bcl-2 proteins and the ratio of bcl-2/bax were increased, and the expression of bax protein was decreased in LIR+NaHS group. The values of AI, LW/BW and IAR showed significantly lower than that in LIR group (P<0.05). Meanwhile, abnormal changes of the lung tissue in morphologically were markedly lesseed in LIR-NaHS group. CONCLUSION: NaHS produces a notable protective effect on LIRI in rats by up-regulating bcl-2 protein expression, down-regulating bax protein expression in lung tissue and regulating the balance of bcl-2 and bax to decrease apoptosis.

Protective effects and the mechanisms of DEAAA on focal cerebral ischemia in rats

JI Rui, CHEN Li, WU Yu-lin

2010, 15(5):  502-506. 

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AIM: To study the protective effects of (E)-3-(4-(2-(dimethylamino) ethoxyl)-3-anisyl) acrylic acid(DEAAA) on focal cerebral ischemia of rats. METHODS: Middle cerebral artery occlusion(MCAO) model was used to evaluate the drug's effects. With Ozagrel as a positive control drug, after cerebral ischemia, the effect of different doses of DEAAA on the neurological behaviors, the cerebral water volumes, the cerebral infarction areas, the cerebral biochemistry and the pathologic change of brains were evaluated. RESULTS: DEAAA (30, 18 mg/kg) decreased the cerebral water volumes and the cerebral infarction areas(P<0.05, P<0.01), increased the levels of SOD and LDH, decreased the content of MDA in brain(P<0.05, P<0.01), improved neurological behaviors of the MCAO rats(P<0.05, P<0.01) and improved the pathologic change of brain after cerebral ischemia. CONCLUSION: DEAAA has the protective effects on cerebral ischemia in rats, the mechanisms of DEAAA involved in anti-oxidation, improving energy metabolism and increasing the ability of getting rid of free radicals.

Study of sulphonylureas derivative ligand and its metal complexes on hypoglycemic activity

DONG Shu-hong, XIE Guo-qiang, ZHANG Bao-lei, GAO Ming-tang, WU Yong-jie, ZENG Zheng-zhi

2010, 15(5):  507-510. 

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AIM: To screen the hypoglycemic activity of diferent sulphonylureas derivative ligand and their metal complexes. METHODS: The mice were administered intragastrically, the blood samples were obtained from tail vein. The serum glucose levels were determined by glucose-oxidase-peroxidase (GOD-PAP) method. The hypoglycemic activities were analyzed by the mean of tolbutamide as a positive control drug, and its mechanism and structure-activity relationship between chemical structure and hypoglycemic activity were studied. RESUITS: The results showed that ZnL₂·2H₂O, NdL₃·2H₂O, SmL₃·2H₂O, Zn(HL')₂·2NO₃, Eu(HL')₃·3NO₃, HL and HL' all reduced the blood sugar in normal mice, while EuL₃·2H₂O, Nd(HL')₃·3NO₃ and Sm(HL')₃·3NO₃ had no obvious hypoglycemic activity. CONCLUSION: The hypoglycemic activity of HL is stronger than that of tolbutamide in normal mice at 2 h, indicating that when the first substituent of tosylurea is the alicyclic group (cyclohexyl), its hypoglycemic activity may be higher than the straight-chain lipid group (butyl), and much higher than the heterocyclic group (4-antipyrine).

Pharmacokinetic comparision in absorption of Rhein in SD rats and Beagle dogs

ZHANG Jin-wen, SUN Jian-guo, WANG Guang-ji, XIE Hai-tang, GU Yi, JIA Yuan-wei, ZHENG Chao-nan, LI Lei-shi, LIU Zhi-hong, ZHANG Hai-tao

2010, 15(5):  511-518. 

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AIM: An in vivo study was conducted to evaluate the pharmacokinetic profile of Rhein (an anthraquinone derivatives isolated from chinese rhubarab) in plasma of SD rats and Beagle dogs. METHODS: Using a rapid and sensitive HPLC-Fluorescence mothod to determine the plasma concentration of rhein after a single i.v. and i.g. administration to SD rats and Beagle dogs at different dosages. A representative plasma concentration vs time profile was illustrated, and the PK parameters and absolute bioavailability were calculated based on these results. RESULTS: After a single i.g. administration and a single i.v. injection of rhein at high, middle and low dosages to rats, there was a good linear relationship between the AUC and dosage (r>0.99). The estimated half life of rhein had some similarities in three different dosage of i.g. administration and i.v. injection. These indicated a linearity pharmacokinetic behavior of rhein in the studied dosage range. The oral bioavailability of rhein in SD rats of high、middle and low dosages were 16.4%,23.8% and 19.4%,respectively. The pharmacokinetic profiles of rhein to six Beagle dogs show that: after a single i.v. administration of 0.4 mg/kg,and i.g. administration of 20 mg/kg, the estimated half life of rhein were (1.77±0.93) h and (3.25±0.80) h,respectively. However, the oral absolute bioavailability of rhein in Beagle dogs was (49.7±7.4)％. Analysis the subject bioavailability data of each Beagle dog (n=6) and each rat in three oral dosage groups (n＝18), showed a statistically significant difference (P＜0.01) between this two groups. CONCLUSION: There are some species differences between dogs and rats in absorption behavior.The absorption in dogs is higher than in rats.

Bioequivalence of rupatadine furmarate capsule and tablet in healthy volunteers

ZHANG Ji-rong, YAO Kai, FU Zhi-min, TAN Hong-yi, TAN Zhi-rong, HUANG Zhi-jun

2010, 15(5):  519-523. 

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AIM: To evaluate the bioequivalence of furmarate rupatadine capsule and tablet(reference drug). METHODS: 10 mg test preparation and reference preparation were given to 20 male healthy volunteers in two-way crossover design for the pharmacokinetic and relative bioavailability study. Plasma concentrations of rupatadine were detected by LC-ESI-MS/MS. RESULTS: The pharmacokinetic parameters of the reference and test preparations were as the followings: C_max(10.2±5.4) and (10.4±4.9) μg/L, t_max(0.79±0.36) and (0.66±0.17) h, AUC_0-24(28±15) and (27±17) μg·L^-1·h, AUC_0-∞(30±17) and (28±19) μg·L^-1·h, t_1/2(7.0±4.4) and (5.6±3.4) h, respectively. The mean relative bioavailability of the test prparation vs reference prparation was (99±23)%. CONCLUSION: The furmarate rupatadine capsule and tablet are bioequivalent.

A mutli-center randomized double-blind controlled trial on the functional difference between Fritillaria unibracteata Hsiao et K.C.Hsia and Fritillaria delavayi Ftanch in relieving acute bronchitis (heat phlegm cough)

DING Hong, YAN Bo-hua, LIU Song-shan, YANG Ren-xu, ZHANG Rui-ming, ZENG Dai-wen, CHEN Yun-feng, LI Ming-quan, ZENG Jie-ping, LI Ji-shu, ZHOU Yi, HUANG Xiao-yan

2010, 15(5):  524-529. 

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AIM: To study the effect of relieving cough and resolving phlegm between different species of Chuan Fritillaria (Fritillaria unibracteata Hsiao et K.C.Hsia and Fritillaria delavayi Ftanch) and identify the most effective ChuanBeiMu in relieving cough and resolving phlegm. METHODS: A total of 216 patients with acute bronchitis (Cough due to Heat Phlegm) were included and randomized into the Fritillaria unibracteata Hsiao et K.C.Hsia group (Superfine powder of Fritillaria unibracteata Hsiao et K.C.Hsia 2g, po, tid.) and Fritillaria delavayi Ftanch group (Superfine powder of Fritillaria delavayi Ftanch 2g, po, tid.). RESULTS: The clinical trial include 210 patients was completed, 106 in Fritillaria unibracteata Hsiao et K.C.Hsia group and 104 in Fritillaria delavayi Ftanch group. From Day 1 to Day 5, the scores of cough the difficult phlegm and the symptom scores of TCM were reduced. The changing of main symptoms in cough and the difficult phlegm were similar between the two groups (P>0.05), The changing of the secondary symptoms in dry throat, yellow urine and dry movement were significant different between the two groups (P<0.05). The total effective rates of Fritillaria unibracteata Hsiao et K.C.Hsia group in relieving cough was 96.3% and the other group was 92.3%. There was no significant different between the two groups (P>0.05). The incidences of adverse effects were similar between the two groups (P>0.05), and no severe adverse effect was observed. CONCLUSION: Either Fritillaria unibracteata Hsiao et K.C.Hsia or Fritillaria delavayi Ftanch can be separately used to treat “heat phlegm cough”. Both of them can release the symptoms of cough, the difficult phlegm, chest tightness, dry throat, yellow urine and dry movement. There is significant different between the two groups in improving dry throat and dry movement, the Fritillaria unibracteata Hsiao et K.C.Hsia may has a better effect than the Fritillaria delavayi Ftanch.

LC-MS determination of terazosin in human plasma and application

WANG Zhen-shan, LI Ling, DENG Xiao-lan, LI Hui, YU Min, YAN Jin, CHEN Ben-mei, YANG Guo-ping, OU-YANG Dong-sheng

2010, 15(5):  530-534. 

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AIM: To develop an LC-MS method to determin the concentration of terazosin in human plasma and its application. METHODS: Shimadzu 2010 LC-MS and Thermo Hypersil-Hypurity C₁₈(150 mm×2.1 mm, 5 μm) were used in the experiment. The column temperature was set at 40 ℃. 20 mmol/L ammonium acetate-methanol-acetonitrile(65∶20∶15, V/V/V) was used as mobile phase and the flow rate was 0.25 mL/min. Ion mass spectral(m/z) of 388, 384 were selected to quantify terazosin, prazosin (internal standard), respectively. The plasma sample were alkalinizedwith 3 mol/L sodium hydroxide buffer and extracted with dichloromethane. The sample room temperature was set at 5 ℃ and the injection volume was 5 μL. RESULTS: Terazosin was linear range from 0.25-50 ng/mL respectively, the limitation of terazosin was about 0.25 ng/mL. The extraction recoveries from plasma was more than 70%, method recovery was 96.0%-97.6%, the intraday and interday precisions were less than 15%. The method was high sensitivity, stability and specificity and has already been used for pharmacokinetics study of terazosin in human successfully. CONCLUSION: The method is simple, accurate, repetitive for the determination of terazosin in human plasma and suitable for bioavailability and bioequivalence study of terazosin.

Pharmacokinetics of faropenem sodium granules in Chinese healthy volunteers

ZHAO Ping-ge, SONG Jun-ying, SU Meng-xiang, Di Bin, ZHANG Yin-di, SHEN Jian-ping

2010, 15(5):  535-540. 

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AIM: To establish an LC-MS-MS method for determination of faropenem in human plasma and investigate the pharmacokinetics of faropenem sodium granules in Chinese healthy volunteers. METHODS: 10 Healthy volunteers (5 male, 5 female) were given a 100 mg dose of faropenem sodium granules.The single dose and multiple dose experiment were carried out. Blood samples were collected from elbow vein, and trichloroacetic acid was used as protein precipitation agents. The analyte were detected by HPLC tandem triple stage quadrupole MS detector. RESULTS: Faropenem had a good linear range of 5.02-6528 ng/mL, with a limit of detection 2 ng/mL. The average recovery was more than 90%. The average RSD was within 10% for intra-batch and inter-batch precision. The major pharmacokinetic parameters of single dose administration were as follows: C_max (2322±1345) ng/mL; t_max (0.78±0.32) h; t_1/2(0.98±0.34) h; MRT(1.8±0.4) h;AUC_0-8(3953±1906) ng·mL^-1·h;AUC_0-∞(3980±1936) ng·mL^-1·h, and multiple dose administration as follows: C_ssmax (2870±1178) ng/mL; C_ssmin (72±55) ng/mL;C_ssav(658±439) ng/mL;t_max(0.80±0.20) h;t_1/2(0.91±0.16) h;AUC_ss(5263±3513)ng·mL^-1·h. CONCLUSION: The LC-MS-MS method is convenient, fast, sensitive and accurate. It is suit for determination of faropenem in human plasma. For the main pharmacokinetic parameters, there is no significant difference of between single dose and multiple doses, which indicates that there is not accumulation phenomenon.

Bioavailability of a new antiarrhythmic agent in Beagle dogs by LC-MS/MS

FAN Fang-tian, ZHU Xiao-guang, LI Jian-chun, GAO Shu

2010, 15(5):  541-546. 

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AIM: To establish a high performance liquid chromatography coupled with electrospray ionization mass/mass spectrometry( LC-MS/MS) method for determination of 1-(2,3-dihydro-6-propoxychromen-4-ylideneamino)-3-(3-(4-methylpiperazin-1-yl)propyl)imidazolidine-2,4-dione (to call “HY11018”) and investigate its pharmacokinetic and absolute bioavailability in Beagle dogs. METHODS: Eight Beagle dogs were given HY11018 of normal saline solution via i.g. and i.v. gtt by crossover design with the dose of 14.8 mg/kg. LC-MS/MS was used to determine plasma concentration of HY11018 . The pharmacokinetic pagameters was calculated by DAS2.1 and the absolute bioavailability was computed with AUC_(0-t). RESULTS: The method was linear over the range of 8—8000 μg/L (r=0.9995); the lower limit of quantitation (LLOQ) was evaluated to 8 μg/L; the extraction recovery of HY11018 in Beagle dog plasma was more than 90%; intra- and inter-batch precision expressed as RSD was less than 15%. All results accorded with FDA criteria for bio-sample analysis. After i.g. and i.v. gtt administration of 14.8 mg/kg HY11018, physiological disposition of the drug corresponded to two and three compartment models respectively. The absolute bioavailability was 70.5%. CONCLUSION: The convenient sensitive and specific methoddescribed in this study was applied well to the pharmacokinetics of HY11018 in Beagle dogs. HY11018 was quickly absorbed with high absolute bioavailability. The characteristic of physiological disposition of HY11018 can be describe as the “drug like” property, accordingly, it may be a new drug that can be developed.

Therapeutic efficacy of bacterial lysates and montelukast treatment in children with intermittent asthma

GAO Yuan, QIAN Xu-bo, YU Chen-yi, XUAN Miao-yan, LIN Zhen-lang

2010, 15(5):  547-550. 

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AIM: To determine the therapeutic efficacy of bacterial lysates (Broncho-Vaxom) plus montelukast treatment in children with bronchial asthma. METHODS: With parental approval, 173 children with intermittent asthma were randomized to receive montelukast plus bacterial lysates treatment as experimental group or receive montelukast treatment as a control group. The episodes of respiratory tract infection and asthma exacerbation, T lymphocyte subsets, immunoglobulin and the adverse events were recorded in the following 12 months. RESULTS: A total of 156 patients (76 in the experimental group, 80 in the control group) were completed in the study. Compared with control group, The frequencies of asthma exacerbation and respiratory tract infection,duration of fever, cough and antibiotics usage in experimental patients with bronchial asthma were significantly reduced (P＜0.05), and the levels of CD₃⁺%, CD₄⁺%, CD₄⁺/CD₈⁺, serum IgA and salivary slgA were obvious increased in the experimental group (P＜0.01).There were no significant differences in the level of CD₈⁺%, serum IgM and serum IgG between two groups(P＞0.05). No serious adverse events was reported in both groups (χ²=0.939, P＞0.05). CONCLUSION: The results of this study suggest that treatment with bacterial lysates and montelukast may be effective and safe in children withintermittent asthma.

Clinical analgesic effect of lappaconitine in 56 patients after cholecystectomy

WANG Jing-quan

2010, 15(5):  551-554. 

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AIM: To study the analgesic effect of lappaconitine in patients after cholecystecystectomy. METHODS: Fifty-six patients aging 20-65 were randomly divided into two groups (28 patients per group). Lappaconitine group received lappaconitine 40 mg and Fentanyl group fentanyl 0.4 mg. RESULTS: Compared with Lappaconitine group, the pain scaling of patients who received lappaconitine were similar to fentanyl (P>0.05),but there were significant differences on the side-effects such as itch of skin, nausea and vomiting between two groups (P＜0.01). CONCLUSION: Compared with Lappaconitine group, the pain feel ofthe patients who received fentanyl were equal, but the side effects such as itch of skin, nausea and vomiting in Lappaconitine group were less.

A clinical trial comparing the efficacy and safety of Cilnidipine capsules versus Cilnidipine tablets in patients with mild and moderate primary hypertension

XU Lin-yong, ZHANG Wei, YANG Tian-lun, SUN Zhen-qiu

2010, 15(5):  555-560. 

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AIM: To assess the comparative efficacy and safety of the Cilnidipine capsules versus Cilnidipine tablets in patients with mild and moderate primary hypertension. METHODS: 240 patients were enrolled from 3 Chinese study centers for a randomized, double-blind, parallel-group, active-controlled, 8-week clinical trial. Patients were randomly assigned to receive daily dose of Cilnidipine capsules or Cilnidipine tablets 5 after two weeks wash out periods.The efficacy and safety were assessed. RESULTS: The study demonstrated similar reductions at week 8 in both DBP and SBP for both groups. For the primary efficacy analysis of sitting diastolic pressure, there was a mean reduction from baseline of 11.5 mm Hg and 11.3 mm Hg for the Cilnidipine capsules and Cilnidipine tablets groups, respectively (P=0.82). The mean reduction from baseline in sitting systolic presure was 14.1 mm Hg and 16.1 mm Hg for the Cilnidipine capsules and Cilnidipine tablets groups, respectively (P=0.50). At the end of the treatment peroid,the total effective rate of Cilnidipine capsules and Cilnidipine tablets groups was 77.2％ and 77.9% respectively (P=0.90). For the safety／tolerance,there were 22 and 20 incidences of adverse events regarded relatively with cilnidipine capsules and tables respectively.Most of them were palpitation and dizziness.No statistical difference existed between the two groups with respect to adverse events. Both the two treatment groups were associated with a significantly decrease of heart rate (P=0.0009, P=0.0043). CONCLUSION: Cilnidipine capsules are an effective and well-tolerated antihypertensive for patients with mild to moderate hypertension.

Effects of Felodipine on left ventricular remodeling and dispersion of QT interval

LI Zhen, WANG Yan-e, WANG Jiao, ZHU Hao, LIU Jun

2010, 15(5):  561-564. 

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AIM: To evaluate the effects of felodipine on left ventricular and electrical remodeling by measuring left ventricular mass index (LVMI) and dispersion of corrected QT interval (QTcd). METHODS: 25 patients with class 1 or 2 primary systemic hypertension were treated with felodipine sustained-release tablets 5-10 mg per day for 3 months after 2 weeks introduction period. Twelve leads ECG and cardiac ultrasound examination were performed before and after treatment to obtain QTcd and LVMI. The control group included 25 normal persons matched in age and sex with study group. RESULTS: After treatment, the patients' systolic and diastolic blood pressure were significantly reduced [(151±6/97±3) mm Hg vs (136±7/85±7) mm Hg,P<0.01] with the total effectiveness of 96.0%. Compared with control group, the QTcd and LVMI before treatment were significantly higher [QTcd(38±7) ms vs (58±18) ms, LVMI (89±14) g/m² vs (132±12) g/m², both P<0.05]. Compared with pretreatment, the QTcd and LVMI after treatment were significantly lowered [(44±16) ms, (109±13) g/m², P<0.05]. A significant correlation between the change of QTcd and LVMI was observed by linear correlation analysis (r=0.52, P<0.05). CONCLUSION: Patients with hypertension, even in class 1 or 2, may have significant left ventricular structural and electrical remodeling. The aims of anti-hypertension treatment are not only to control blood pressure, but also modify and reverse the remodeling of heart. Felodipine can effectively control the blood pressure, and reverse the heart remodeling by reducing the LVMI and QTcd.

Clinical evaluation of ginkgo leaf capsule combined with comprehensive rehabilitation training in treating chronic schizophrenia

ZHAO Feng-rong, ZHAO Feng-wen, SUN Lian-jun

2010, 15(5):  565-568. 

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AIM: To evaluate the therapeutic effects of treating chronic schizophrenia with ginkgo leaf capsule combined with comprehensive rehabilitation training. METHODS: 110 chronic schizophrenia patients who had been treated with systemic antipsychotic for more than 12 weeks with unsatisfactory therapeutic effects and a long history of hospitalization were enrolled in this study. Ginkgo leaf capsule combined with comprehensive rehabilitation training was applied for 12 weeks and the therapeutic effects were evaluated. The positive and negative syndrome scale (PANSS) and treatment emergent symptom scale(TESS) for the side effects that needed to be treated during treating were used to evaluate the therapeutic effects and side effects. RESULTS: The treatment of ginkgo leaf capsule combined with comprehensive rehabilitation training was effective for the chronic schizophrenia patients with a long history of hospitalization, the total clinical effective rate was 96.36% and the cure rate together with the apparent rate was 67.27%, which were significantly better. CONCLUSION: Ginkgo leaf capsule improves the therapeutic effects of antipsychotic in the treatment of chronic schizophrenia and reduces the side effects, so it is a safe and effective drug for treating the chronic schizophrenia patients with a long history of hospitalization.

Advances on the study of the pharmacological effects of artemisinin and its derivatives

LI Bin, ZHOU Hong

2010, 15(5):  572-576. 

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Artemisinin is a sesquiterpene lactone compounds, their derivatives include mainly dihydroartemisinin, artesunate, artemether and Artemisia ether. These drugs are now mainly used for clinical treatment of malaria. With the pharmacological action of artemisinin and its derivatives have been further studied, except antimalarial effects, researchers have found their anti-inflammatory, anti-sepsis, antitumor, radiosensitization, antimicrobial sensitivity, anti-fibrosis effects in recent years. Here, we collect and review the most newly pharmacological effects of artemisinin and its derivatives all over the world in past years.

Immunity and strategy to recombinant adeno-associated virus vector

LU Chao, WAN Jiang-bo, TANG Ming-qing, XIAO Wei-dong, XU Rui-an

2010, 15(5):  577-583. 

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Recombinant adeno-associated viral vectors (rAAV) have been demonstrated as a significant promising viral vector for human gene therapy based on its high safety and good targeting activity in preclinical tests and clinical trials, and there are 71 clinical trials have dong or been doing. Part of them have gain an excellent success in the mant with Hemophilia, retinal disease, Parkinson's disease, cystic fibrosis, cancer et al. With the success in clinical trials, people process a series extensive and deeply research with the immunity induced by rAAV and the responding strategy respond to. In this review we systematically analyze the immunity caused by capsid and transgene product. Apart from this, some strategies, partly based on our work, to eliminate the immunity caused by capsid such as change the capsid, administration route, and eliminate the expression of endo-capsid are reviewed as well.

How to make data and safety monitoring plans in clinical trials

LU Fang, GAO Rui, TANG Xu-dong, WENG Wei-liang, ZI Ming-jie, LI Rui, LI Bo

2010, 15(5):  584-587. 

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The purpose of data and safety monitoring is to ensure the safety of subject and the validity, integrity and accuracy of the data in clinical trials. Data and safety monitoring plans (DSMP), approved by Institutional Review Board (IRB), is indispensable in clinical trials. DSMP consists of protocol outline, trial management, data management and analysis, quality assurance, regulations, safety, efficacy, DSMP execution, data and safety monitoring board plan (If desired). The following aspects should be taken into account when making data and safety monitoring plans: e.g. study risk, study phase, trial design, disease/syndrome of the study, study population, study intervention, endpoints/outcome variables, et al. The monitoring degree depends on the risks, size and complexity of the trials.

Advancement on the therapy of type 2 diabetes by targeting β-cell mass

LIU Jun, ZHANG Lu-yong

2010, 15(5):  588-595. 

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Type 2 diabetes is characterized by progressive β-cell dysfunction and a reduction in β-cell mass. If the β-cell mass is already below the threshold for maintaining normoglycemia, the expansion of β-cell mass is the only option for achieving normoglycemia without the use of additional glucose lowering agents. Therefore, the ultimate goal of therapies on type 2 diabetes is preserving, regenerating or replacing the β-cell mass. In this review, we address the mechanisms involved in β-cell dysfunction and β-cell loss, and provide a rationale for pharmacological intervention for the preservation and/or expansion of β-cell mass in type 2 diabetes.

Progress in study on relationship of Keap1 with oxidative stress

LIU Fang, DU Zhi-ying, WANG Ying-xiong

2010, 15(5):  596-600. 

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Exogenous chemical insults can cause severe damage to the redox homeostasis of biomolecules and lead to oxidative stress reaction. In order to consult these toxicant reaction, eukaryotic cells have evolved complex defense mechanisms to cope with toxicant-induced oxidative stress. One of the most important cellular defense mechanisms against oxidative stress is mediated by the transcription factor Nrf2 and its parter Keap1. This article reviewed the clone, expression, location, structure and function of Keap1 and highlight the importance of Keap1 as a molecular target for disease prevention.