Table of Content

Volume 9 Issue 12
26 December 2004

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Signal transduction mechanism of antidepressant action

LIU Yan-Mei, QI Hong, CHEN Hong-Zhuan

2004, 9(12):  1321-1326. 

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The mechanisms of antidepressants are still unclear.There are two classical theories on monoamine neurotransmitter or on neurotransmitter receptors, but both of them can not fully explain the delayed therapeutic action of antidepressants.Recently, many researches have focused on the postreceptor intracellular signal transduction as the mechanism of antidepressant action.G protein is the molecular basis of antidepressants. Neurotransmitter receptors and G protein are the two sectors of their therapeutic action.They will ultimately influence intracellular signal transduction and result in relative effects such as phosphoration, the induction of neurotrophic factors and neurogenesis.This mechanism suggests a reasonable explanation for the clinical delaying of antidepressants and it will do great help for the development of antidepressants.It makes the design of novel, safe and more efficacious antidepressants possible and provides significant information for the elucidation of biology of depression.

Progress of medication in myocardial fibrosis

WU Duo-Jiao, HONG Hua-Shan

2004, 9(12):  1327-1332. 

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Myocardial fibrosis caused by various reasons (such as inflammatory, ischemia, hypertension)can induce the myocardial damage if the process continued. There is very progress in the research of the prevention and cure of myocardial fibrosis in present years.This paper summarizes the detection of myocardial fibrosis in laboratory, and the progress and mechanisms of medication in myocardial fibrosis.

Population pharmacokinetics and its application in new drug development

SHENG Yu-Cheng, ZHENG Qing-Shan

2004, 9(12):  1333-1337. 

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There is an increasing focus on the application of population pharmacokinetics(PPK) in new drug development.The population PK approach can quantitative explore relationships among the pharmacokinetics, pathophysiologic features and concomitant medications. The variability of PK parameters within the population can be estimated and dosages can be appropriately modified, and this approach can increase the evaluation of safety and efficacy for the new drug.This article reviews the approach of population pharmacokinetics and its application in new drug develepment.

Progress in dermatotoxicology

CHEN Li, WANG Hui

2004, 9(12):  1338-1342. 

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In this paper, the general conditions in research of dermatotoxicology was described.The some experimental methods were evaluated.The advancement of modern sciences will accelerate the development of dermatotoxicology and make more progresses and new ideas.

Effects of N-n-butyl haloperidol iodide (F2) on Egr-1 mRNA and protein expression after myocardial ischemia-reperfusion

TANG Zhao, SHI Gang-Gang, ZHANG Yan-Mei, YIN Jun, ZHOU Yan-Qiong, HUANG Zhan-Qin, GAO Fen-Fei

2004, 9(12):  1343-1348. 

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AIM: To investigate the effects of N-nbutyl haloperidol iodide (F₂) on Egr-1 mRNA and protein expression in the model of rats with myocardial ischemiareperfusion. METHODS: The myocardial ischemiareperfusion injury animal model was established by occluding rat's left anterior descending branch of coronary artery for 60min and later opening the ligation to reperfusion for 180 min in vivo.F₂ were administered by intravenous injection before the onset of ischemia for 5 min.The changes of hemodynamics were recorded during the experiment, and then the ischemia tissue was extract.The inflammation was observed by tissue section.The Egr-1 gene transcription and protein expression were detected by RT-PCR and Western-blot, respectively.RESULTS: F₂ reduced the levels of Egr-1 mRNA and protein, relieve inflammation and ameliorate the hemodynamics of ischemia-reperfusion injured myocardium.CONCLUSION: F₂ can relieve inflammatory injury and protect myocardial function in rats with myocardial ischemia-reperfusion, and the mechanism may be related to attenuating the transcription and expression of Egr-1.

Induction effects of C2-ceramide on early apoptosis in rat glioma cell C6

QI Hong, LIU Yang-Mei, WU Xing-Jun, SHI Gui-Ying, CHEN Hong-Zhuan

2004, 9(12):  1349-1352. 

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AIM: To investigate the effects of exogenous cell-permeable C2-ceramide on viability and early apoptosis induction in rat glioma cell C6.METHODS: The effects of C2-ceramide on viability of C6 cell after 24 h treatment were assessed by MTT test.The cellular morphology was observed by Olympus inverted reflected light fluorescence observation attachment.The early events of the apoptosis were recorded by flow cytometry analysis with a combination of Annexin V-FITC and propium iodide (PI) which was used for staining cells.RESULTS: C2-ceramide significantly inhibited the cell viability of C6 cells and the IC₅₀ was 2.2×10^-5mol·L^-1.The classical apoptotic morphology change was induced by C2-ceramide, and the early cell apoptosis was induced in a time and concentration-dependent manner.After treated with 2×10^-5mol·L^-1C2-ceramide for 24 h, the average apoptotic death rate of cells was about 49.3 %.CONCLUSION: C2-ceramide can exert obvious cytotoxic effect in C6 cell through inducing typical early apoptosis of C6 cells, and it suggest that the enhancement of the level of ceramide might offer a novel approach to cancer chemotherapy.

Induction effects of antisense phosphorothioate oligodeoxynucleotides of livin mRNA on apoptosis in MCF-7 cells

ZHANG Hua-Dong, YUAN Shou-Jun, CHEN Hui-Peng, TIAN Zeng-Yue, HAN Chang-Ming

2004, 9(12):  1353-1356. 

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AIM: To design antisense phosphorothioate oligodeoxynucleotides (PS-ODNs) which targeted to livin mRNA and investigate the anti-cancer effects and the mechanism in vitro.METHODS: Several antisense PS-ODNs were designed and exposed to MCF-7 breast cancer cells.MTT, RT-PCR, flow cytometry and caspase-3 assay were tested in the experiment.RESULTS: The level of livin mRNA was decreased and the activity of caspase3 was increased by YMZ05 in several PS-ODNs designed.The growth of MCF-7 was inhibited and the cell apoptosis was induced by PS-ODN.CONCLUSION: The inhibition of livin can inhibit the growth of MCF-7 breast cancer cells and induce the apoptosis of it.The livin may become a new potential target of anticancer therapy.

Pharmacokinetics of CPU-0213 in mice and rats after intravenous injection

DU Rong-Hui, GUAN Li, DAI De-Zai, ZHANG Yuan, JI Min

2004, 9(12):  1357-1360. 

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AIM: To establish a method in determination of CPU-0213 in serum of mice and rats and to investigate the pharmacokinetics parameters after a single injection at the dose of 80 mg·kg^-1.METHODS: The concentration of CPU-0213 in serum was assayed by HPLC and the pharmacokinetics parameters were calculated by the program of 3P97.RESULTS: The linearity of CPU-0213 ranged from 0.4 to 200 mg·L^-1(r=0.9998) and the limit of quantity was 35 μg·L^-1.The RSD of intra-day was less than 2.7 %and that of inter-day was less than 6.3 %.The recovery was more than 95.9 %.The disposition was conformed to a two-compartment model. The T_1/2β of CPU-0213 in mice and rats were 83.0±1.8 and 96.6±11.5 min, respectively.CONCLUSION: The study provides a simple, stable and special method for determining of concentrations of CPU-0213 in serum of mice and rats.After intravenously injection of CPU-0213 at a single dose, there is no significantly difference in the pharmacokinetics patterns of CPU-0213 in mice and rats.

Pharmacokinetics of matrine in Beagle dogs by LC-MS

WANG Su-Jun, WANG Guang-Ji, LI Xiao-Tian, MA Ren-Ling, SHENG Long-Sheng, SUN Jian-Guo, XIE Hai-Tang

2004, 9(12):  1361-1364. 

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AIM: To establish LC-MS method in the determination of matrine in plasma of Beagle dogs and to investigate its absolute bioavailability.METHODS: Lichrospher C18 column was used as the analytical column and maintained at 25 ℃, 250 mm×4.6 mm (ID), and 5 μm.The mobile phase was consisted of 10 mmol·L^-1ammonium acetate and methanol (25 ∶75, v ∶v).Flow rate was 1 ml·min^-1.Electrospray ionization (ESI) was carried out.The ESI ion source was set in positive ion polarity mode.The selective ion monitoring (SIM) was set at m z 249.2 for matrine.RESULTS: The linearity of matrine ranged from 2 to 5 000 μg·L^-1(r=0.9975) and the detection limits of it was 0.3 μg·L^-1.The RSD of within day and between day was less than 4.5 %.The recovery of this method was more than 96.6 %.The disposition was conformed to a two-compartment model.The C_max, T_max, T_1/2β, AUC_0→∞ and absolute bioavailability of matrine were 3821±705 μg·L^-1, 0.4±0.1 h, 11.2±2.1 h, 7446±1456 μg·L^-1·h and (60.1±19.0) %, respectively.CONCLUSION: This study provides a highly sensitive, rapid, simple and special method for determining concentrations of matrine in plasma of Beagle dogs.Matrine shows higher absolute bioavailability in Beagle dogs.

Exploratory clinical study of antitussive effects of total alkaloid agent extracted from Papaver somniferum L.in patients with acute tracheitis and bronchitis

ZHU Jia, JIANG Meng, ZOU Jian-Dong, XU Li-Hua, XIONG Ning-Ning

2004, 9(12):  1365-1368. 

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AIM: To evaluate the antitussive effects of total alkaloid agent extracted from Papaver somniferum L.on acute tracheitis and bronchitis of which the syndrome is counterflow ascent of lung qi according to traditional Chinese medicine (TCM).METHODS: Random principle, double blind method, control group applied with placebo and add-on design were adopted in all trials. 89 patients with acute tracheitis and bronchitis whose syndrome is counterflow ascent of lung qi according to TCM took part in the trial.Among them 45 were in the treatment group treated with total alkaloid agent extracted from Papaver somniferum L.and 44 were in the control group treated with placebo.RESULTS: The rate of obvious coughing in treatment group and control group were 75.56 % and 77.27 %(P=0.8487), respectively.The cough alleviation time were 19.55±18.57 h and 25.27±19.60 h(P=0.1993), respectively.The cough disappear rate of the third day were 33.33 % and 36.36 %(P=0.7642) respectively. The average mark value drcreased were 3.53 and 4.16(P=0.2786), respectively.CONCLUSION: The total alkaloid agent extracted from Papaver somniferum L.has no significant antitussive effect on moderate and severe cough on the ground that the patients with acute tracheitis and bronchitis whose syndrome is counterflow ascent of lung qi according to TCM has been treated with cefaclor sustained release capsules simultaneously.

Effects of acanthopanax senticosus saponins on myocardial ATP sensitive potassium channel

ZHOU Yi, TANG Qi-Zhu, SHI Xi-Teng, WANG Teng

2004, 9(12):  1369-1373. 

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AIM: To investigate the effects of acanthopanax senticosus saponins (ASS) on myocardial mitochondrial ATP sensitive potassium channel (mito K_ATP) and sarcolemmal ATP sensitive potassium channel (sarcol K_ATP) and to discuss the protection mechanisms of ASS on myocardial ischemia.METHODS: Ventricular myocytes of rabbits were isolated by enzymatic dissociation.Laser scanning confocal microscope (multi-photon) was used for observe the effects of ASS on mito K_ATP.The whole-cell patch clamp technique was used for observe the effects of ASS on sarcol K_ATP.RESULTS: There was no obvious variation of mitochondrial fluorescence intensity in control group during 10 min observation.Mitochondrial fluorescence intensity increased significantly in 30 mg·L^-1ASS group, 100 mg·L^-1ASS group and 300 mg·L^-1ASS group after administration.The increments were (14.8±3.56) %, (30.4±4.34) % and (38.4±5.68) %, respectively.3 μmol·L^-1of glibenclamide had no effect on mitochondrial fluorescence intensity, but it could block the effects of ASS on mitochondrial fluorescence intensity. There was no significant differences in the peak of I_K-ATP between the control group, 30 mg·L^-1ASS group, 100 mg·L^-1ASS group, and 300 mg·L^-1ASS group.CONCLUSION: ASS can open mito K_ATP, and it has no effect on sarcol K_ATP.The protection mechanism of ASS onmyocardial ischemia is related to opening mito K_ATP.

Research of nonenzymation glyscation inhibitor on cardiac myocyte apoptosis in diabetic rats with heart failure

FU Li-Juan, WANG Hong-Xin, PANG Dong-Bo, BAO Cui-Fen

2004, 9(12):  1374-1376. 

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AIM: To observe the effects of nonenzymation glyscation inhibitor-aminoguanidine on cardiac myocyte apoptosis in diabetic rats with heart failure. METHODS: SD rats were randomly divided into six groups:12-week control group (n=8), 12-week diabetic group which induced by streptozotocin (STZ) (n=8), 12-week AG treated group (n=8), 24-week control group (n=10), 24-week diabetic group (n=10), and 24-week AG treated group (n=10).Heart function and ventricular remodeling parameters were observed at 12 and 24 weeks.The dynamic changes of cardiac myocyte in left venticle of diabetic rats were observed by situ TdT-mediated dUTP nick end labeling (TUNEL) and transmission electron microscope.RESULTS: Abnormal heart function and myocyte apoptosis were observed at 12-week and aggravated at 24-week in diabetic rats.Electron microscopic features of cardiocyte apoptosis were identified in left ventricle.The heart function improved and the number of apoptosis myocytes decreased in AG group.CONCLUSION: Myocyte apoptosis plays an important role in the development of heart failure in diabetic rats.AG can improve the heart function and inhibit myocyte apoptosis.

Effects of recombinant human interleukin-10 (rhIL-10) on proliferation and cytokines production of normal human keratinocytes

CHEN Fei-Hu, CHEN Ming-Zhu, LI Jun, ZHI Qiang

2004, 9(12):  1377-1380. 

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AIM: To investigate the effects of recombinant human interleukin-10 (rhIL-10) on proliferation and cytokines production of serum-free cultured normal human keratinocytes stimulated by PMA and lipopolysaccharides(LPS).METHODS: The influences of rhIL-10 on the proliferation of serum-free cultured normal human keratinocytes were assayed by MTT.Interleukin-1, interleukin-6, and interleukin-8 was detected by Enzymelinked immunosorbent assay (ELISA).RESULTS: The rhIL-10 significantly inhibited the proliferation and the production of IL-1, IL-6 and IL-8 by KC which was activation by PMA LPS with dose-dependent manner.CONCLUSION: The rhIL-10 inhibits the proliferation and cytokines production of serum-free cultured normal human keratinocytes.The anti-psoriatic effects of rhIL-10 may be related to inhibiting hyperplasia of epidermal cells, promoting the formation of granular cells and possessing combined anti-inflammatory and immunomodulatory activity.

Effects of sodium nitroprusside on proliferation inhibition and apoptosis in K562 cell line

ZHOU Yong-Lie, LV Ya-Ping, QIU Lian-Nu, HE Guo-Nong, LIN Hui-Jun, WANG Wen-Song

2004, 9(12):  1381-1387. 

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AIM: To study the effects of nitric oxide donor sodium nitroprusside on proliferation inhibition and apoptosis in K562 human leukemia cell line.METHODS: The different concentration of sodium nitroprusside and K562 cell were cultivated at the different time in vitro.The proliferation inhibition was analyzed by MTT assay and alive cell count.Cell apoptosis was analyzed by cell morphology, DNA agarose gel electrophoresis, DNA content, and Annexin V/PI labeling method.The TDTmediated dUTP nick end labeling (TUNEL) assay was used to quantitate the cell apoptosis in situ.The PFC and the blank were used as controls.RESULTS: NO inhibited K562 cell proliferation within a certain range of treating time and dosage, and a majority of K562 cells were arrested in G₀/G₁ phase.The K562 cells apoptosis was confirmed by type cell morphology, DNA fragment, sub-G₁ phase, TUNEL and Annexin V/PI labeling method with a time and dosage relationship, and the control group had no change like this.CONCLUTION: NO can suppress proliferation of K562 cell line by arresting G₀/G₁ phase and trigger apoptosis of the line.

Effects of different number of tumor cells on xenograft tumor growth and efficacy of anti-tumor agents in mice

ZHANG Bao-Lai, ZANG Kai-Hong, GAO Bei, LI Wen-Guang, GAO Ming-Tang, WU Yong-Jie

2004, 9(12):  1388-1392. 

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AIM: To study the effects of different number of tumor cells on xenograft tumor growth and efficacy of anti-tumor agents inmice.METHODS: Different numbers of tumor cells were injected subcutaneously at the right armpit of the mice.The tumor volume and weight were determined.The efficacies of four anti-tumor agents were evaluated.RESULTS: The more the number of tumor cells implanted, the faster the xenograft tumor growth.The earlier the tumor emerged, the lower the inhibitory rate of antitumor agents showed.CONCLUSION: The number of tumor cells implanted obviously affects the growth of xenograft tumor in mice and lead to misevaluate in efficacy of anti-tumor agents.So the attention should be paid when the efficacies of different antitumor agents are evaluated.

Effects of naftopidil's ramification-BWYJ on vascular activities and it's vasodilative mechanism

WANG Hui-Jiu, HUANG Xie-Nan, JIANG Qing-Song, WU Qin, SUN An-Sheng, SHI Jing-Shan

2004, 9(12):  1393-1397. 

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AIM: To investigate the effects of BWYJ (naftopidil's ramification) on the vascular activities in rabbits and to explore its vasodilative mechanisms. METHODS: The isotonic contractions of the thoracic aorta strips in rabbits were recorded, and the effects of BWYJ on the concentration-response curves of noradrenaline (NA), high potassium and 5-hydroxytryptamine (5-HT) was observed.The procedure of Ca²⁺ free-Ca²⁺ addition was designed to indirectly observe the effects of BWYJ on intracellular free Ca²⁺ ([Ca²⁺]_i).RESULTS: BWYJ shifted the concentration-response curves of NA and 5-HT to right in parallel, the maximum responses were unchanged, and the pA2 values were 7.61 and 6.56, respectively.But it did not affect the concentration-response curve of high potassium.In Ca²⁺-free medium, BWYJ 10^-7, 3×10^-7, 10^-6 and 10^-5mol·L^-1concentration-dependently inhibited the transient contraction induced by NA and the long-lasting contraction induced by addition of Ca²⁺.But BWYJ 10^-5mol·L^-1did not inhibit the contraction induced by caffeine.CONCLUSION: BWYJ may be an α-adrenergic receptor blocker and a 5-HT receptor blocker simultaneously.The vasodilative mechanism of BWYJ may be related to its inhibiting effects on the Ca²⁺-influx and Ca²⁺-release mediated by α-adrenergic and 5-HT receptors.

Allergenicity change of hydrolyzed cow's milk by proteases

TANG Ning, LIU Bao-Lin, WANG Fu-Yuan, ZHOU Zhu-Cheng, WANG Chan, ZHANG Fang-Li

2004, 9(12):  1398-1402. 

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AIM: To evaluate the allergenicity change of hydrolyzed cow's milk by proteases.METHODS: The range of molecular weight of different formulas was determined by fast protein liquid chromatogram (FPLC) after hydrolyzing the infant milk powder with pepsin, trypsin and self-prepared pancreatin (SPP), and the sensitivity of hydrolysis of formulas milk to protein antigen was assayed by active, passive cutaneous anaphylaxis in mice and the changes of sensitized intestinal permeability in mice were observed.RESULTS: Molecular weights reduced after the hydrolyzation of milk protein with hydrolases and the most effectively degradation reaction was taken by the hydrolyzation with SPP (MW <1 000, 92 %;1 000-10 000, 8 %).The vascular permeability induced by the challenge of the milk protein antigen in mice reduced in the cases of the hydrolysate of pepsin, trypsin and SPP.The inhibition ratio of immediate-type cutaneous hypersensitivity reactions were as follows:51 %(pepsin), 83 % (trypsin)and 86 % (SPP), the inhibition ratio of homogeneous passive cutaneous anaphylaxis were as follows:29 %(pepsin), 70 %(trypsin) and 82 % (SPP), and the inhibition ratio of heterogeneous passive cutaneous anaphylaxis were as follows: 34 %(pepsin), 70 % (trypsin)and 82 % (SPP).Furthermore, hydrolysis of SPP reduced the vascular permeability induced by the small intestine anaphylaxis and the inhibition ratio was 27 %.CONCLUSION: The allergenicity of milk protein reduces after the hydrolysis with SPP.

Effects of saponin of Litchi on decreasing blood glucose and controlling blood lipid in hyperlipemia-fatty liver rats fed by ligh-sugar-fat

GUO Jie-Wen, LIAO Hui-Fang, PAN Jing-Qiang, YE Bi-Bo, JIAN Xiao-Bing, WEI Dan-Lei, DAI Lian-Yi

2004, 9(12):  1403-1407. 

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AIM: To investigate the effects of saponin of Litchi seed (SL) and roglitazone on decreasing blood glucose, Lipid and amelioration hepatic, nephritic function in hyperlipemia-fatty liver rats fed by high-sugarfat.METHODS: The animal model with hyperlipemiafatty liver was prepared in rats by feeding on high caloric diet (abounded of sugar and fat) for 10 weeks.After 6 weeks treatment, the effects of SL, roglitazone and gliclazide (intragastrointestinally administered, qd for 4 weeks) on fasting blood glucose (FBG), 2-hour blood glucose (2hBG) after oral glucose tolerance test (OGTT), serum contents of fasting glucose(FSG), total cholesterol(TC), triacylglycerol (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), blood urea nitrogen (BUN), creatine (Cr) and serum activities of alanine aminotransferase (ALT), and aspartate aminotransferase (AST) and hepatic histopathology were observed by microscope.RESULTS: After administration of SL and roglitazone, the serum concentrations of fasting blood glucose (FSG) and 2-hour blood glucose (2hBG) after oral glucose tolerance test (OGTT) significantly decreased (P <0.05);the impaired glucose tolerance (IGT) improved;the level of TG, TC, and LDL-C decreased (P <0.05);the content of HDL-C augmented (P <0.05);the concentrations of BUN and Cr, activities of ALT and AST decreased (P <0.05);and the fatty degeneration of hepatocytes improved (P <0.01). CONCLUSION: SL and roglitazone can control hyperinsulinemia, enhance insulin sensitivity, reduce level of blood glucose, regulate components and contents of blood lipid, and improve both of function in liver and kidney.

Increased expression of tumor-associated antigen after interleukin 6(IL-6) mediated transfection in breast cancer cells

Chen Fang-Zheng, Jiang Xian-Peng, Duan Jin-Ao, Chen Miao, Jonathan FH, Robert LE, Jiang Xi-Ling, Li Xin-Yan

2004, 9(12):  1408-1410. 

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AIM: To investigate the effects of interleukin 6(IL-6) on the expression of breast cancer antigen (CA15-3) and carcinoembryonic antigen (CEA) in the breast cancer cells.METHODS: 1176 bp cDNA that contained the IL-6 protein encoding sequence was inserted into the Pci-neo mammalian expression vector, which contains a neomycin resistance selective marker.The vector was introduced into MCF-7 breast cancer cells by lipofection.Secretion of IL-6 in the culture media was measured by ELISA and the concentrations of CA15-3, CEA and CA125 in the culture media were quantitated by micropartical enzyme immunoassay (MEIA).RESULTS: The secretion of IL-6 (338.5±22.6 pg·10^-6 cells) in MCF-7 cells that contained the exogenous IL-6 gene significantly higher than that in the control parental MCF-7cells (25.4±4.6 pg·10^-6 cells) or the MCF-7 cells which only contained the Pci-neo mammalian expression vector (19.6±3.0 pg·10^-6 cells, P <0.01).After three days of incubation, the level of CA15-3 in the MCF-7 cells which contained the exogenous IL-6 gene (14.9±2.3 pg·10^-6 cells) was higher than that in the parental MCF-7 cells (6.6±1.5 pg·10^-6 cells) or the MCF-7 cells which only contained the Pci-neo vector (3.4±0.07 pg·10^-6 cells, P <0.05).The CA125 in the MCF-7 cells (38.8±5.1 pg·10^-6 cells) which contained the exogenous IL-6 gene significantly higher than that in the parental MCF-7 cells (10.0±1.6 pg·10^-6 cells) or the MCF-7 cells which only contained the Pcineo vector (14.6±2.2 pg·10^-6 cells, P <0.01 or P < 0.05).But the transfer of the exogenous IL-6 gene had not significantly increased the concentration of CEA in the culture medium compared to that in the control MCF-7 cells (P>0.05).CONCLUSION: IL-6 can induce the expression of tumor associated antigen and improve the antigenicity of tumor cells.And it suggest that IL-6maybe result in an increased immunological response.

Bioequivalance of single oral administration of finasteride tablet and capsule in healthy volunteers

ZHAO Ya-Nan, QIU Fu-Rong, WANG Wei-Jia, SUN Hua, DAI Min, YANG Qing-Qing, MAO Guo-Guang

2004, 9(12):  1411-1414. 

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AIM: To study the bioequivalance of finasteride tablet and capsule in 24 healthy volunteers. METHODS: A reversed-phase high performance liquid chromatography (RP-HPLC) method was established for the determination of the finasteride concentrations in human plasma after a single oral dose administration of 15 mg finasteride tablet and capsule and control finasteride tablet (control group) to 24 healthy volunteers in an open randomized crossover design.RESULTS: The main pharmacokinetic parameters of finasteride tablet group, capsule group and finasteride tablet group were as follows:T1 2 ke were 4.38±0.90, 4.29±0.78 and 4.32±0.86 h;T_max were 3.04±0.88, 2.98±0.89 and 2.59±0.86 h;C_max were 117.57±19.15, 118.59±20.23 and 124.53±19.77 μg·L^-1;AUC0-18 were 897.57±185.03, 871.57±139.25 and 837.59±149.05 μg·h·L^-1;AUC_0-∞ were 970.04±211.83, 931.51±151.07 and 896.41±164.92 μg·h·L^-1, respectively. CONCLUSION: The finasteride tablet and capsule and the control finasteride tablet are bioequivalent.

Comparison of effects of moxonidion and clonidine on decreasing blood pressure in spontaneous hypertensive rats

ZHANG Wei, ZHU Wei-Zhong, HUANG Jing-Hua

2004, 9(12):  1415-1419. 

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AIM: To compare the peculiarity of effects between moxonidine and clonidine on decreasing blood pressure in spontaneous hypertensive rats (SHR). METHODS: Arterial blood pressure and heat rate were directly determined by a catheter on the carotid artery or indirectly determined by a tail-cuff method in conscious and anesthetized SHR after once or repeatedly oral administration, respectively.RESULTS: Moxonidine showed a dose-dependent effect on reducing blood pressure and heat rate after once large dose oral administration in conscious SHR.The effect on decreasing blood pressure and heart rate after oral administration of 10 mg·kg^-1moxonidine was equal to the effects after oral administration of 1 mg·kg^-1clonidine.The rate of reducing blood pressure by moxonidine was equal to that by clonidine, and the decreasing in heart rate was little and short after repeatedly small dose oral administration of moxonidine.Moxonidine exerted a dose-dependent effect on reducing blood pressure after small dose oral administration in anesthetized SHR.There was no significant difference between moxonidine and clonidine in reducing rate of blood pressure after same dose administration (P>0.05).CONCLUSION: The effects of 10mg·kg^-1moxonidine on reduced blood pressure and heart rate in SHR is equal to the effects of 1mg·kg^-1clonidine after once large dose oral administration.There is no significant difference between the moxonidine and clonidine of the same dose in reducing blood pressure after repeatedly small dose oral administration in SHR.

Experimental studies on analgesic and anti-inflammation effects of aspirinniacinamide-zinc complex (WUY)

PU Qi-Song, LEI Jun, ZHANG Xiang

2004, 9(12):  1420-1423. 

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AIM: To study the analgesia and anti-inflammation effects of aspirin-niacinamide-zinc complex (WUY).METHODS: In this study, the mice ear swelling, vascular permeability increasing and rats'paw edema were adopted to evaluate the anti-inflammable effects of WUY.And the analgesic effects of WUY were tested by writhing reaction and hot-plate method.RESULTS: In high and low dose groups of WUY, the degrees of ear swelling were 3.3 and 2.8 mg·kg^-1) prolonged incubation period of hot-plate reaction and showed marked inhibition effects on writhing induced by acetic acid in mice.CONCLUSION: The analgesic and antiinflammable effects of WUY are stronger than that of ASP.

Efficacy and safety of lizhi soft capsule in treatment of patients with benign prostatic hyperplasia

ZHANG Fa-Rong

2004, 9(12):  1424-1427. 

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AIM: To compare the efficacy and safety of the lizhi soft capsule and the qianliekang capsule in the treatment of patients with benign prostatic hyperplasia. METHODS: The lizhi soft capsule was observed in the randomized, double blind and double-dummy clinical trial.101 patients with benign prostatic hyperplasia were radomly divided into two groups:50 patients were administered the lizhi soft capsule (trail group), while 51 patients were administered the qianliekang capsule (control group).Drugs were orally administered with the same duration in the two groups.Scores of symptoms were recorded before and after the treatment in all of the patients. Curative effects were evaluated with the different grades such as conspicuous, remission, middle, weak and inefficacy.RESULTS: The scores of symptoms significantly decreased after the treatment in the two groups (P < 0.05).There was no significant difference in curative effects between two groups (P>0.05).No serious side effects were found in the two groups.CONCLUSION: Both the lizhi soft capsule and the qianliekang capsule have the same efficacy and safety in the treatment of benign prostatic hyperplasia.

Effects of fluoxetine on changes of energy in patients with depression

XU Song-Quan, HE Xu-Dong, PAN Da-Jin, YING Yi-Fei, ZHU Gui-Dong, WANG Jing

2004, 9(12):  1428-1431. 

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AIM: To investigate the effects of fluoxetine on the changes of depression-related disturbances in energy.METHODS: 55 patients with depression were randomly assigned to two groups:fluoxetine group (n=29) treated with 20 mg·d^-1 fluoxetine, po, qd, and amitriptyline group (n=26) treated with 150 mg·d^-1 amitriptyline, po, bid.Two groups were observed for 6 weeks.According to the Hamilton Rating Scale for Depression (H AMD) retardation factor score, these patients were categorized as low (score <8) or high (score>or=8) levels of retardation at baseline.HAMD retardation factor score (total of items 1:depressed mood, 7:work and activity, 8:retardation, 13:somatic general symptoms and 14:urogenital symptoms) andHopkins Symptom Checklist 58 (HSCL-58) energy-related items (including item 14:feeling low in energy or slowed down, 32:feeling no interest in things, 55:absorption in the difficulty) was used as the primary measure of the improvement of energy.RESULTS: 6 weeks after treatment, HAMD total scores, retardation factor score and SCL-58 energe-related items scores decreased more significantly in fluoxetine group than that in amitriptylined group (P <0.05) after 1-2 weeks treatment.No significant difference of efficacy was found between high and low level of retardation in fluoxetine group, but the efficacy of high levels of retardation was less than that of low levels (P <0.05) in amitriptyline group.Compared to amitriptyline-treated subgroup, the efficacy level of fluoxetine-treated high levels of retardation subgroup was higher (P <0.05). CONCLUSION: Fluoxetine can significantly improve the depression-related disturbances in energy, and it is more suitable for the patients with the higher levels of HAMD retardation factor score.

Comparison of change of body temperature in mice induced by intravenously and intramuscularly injection of different dosage of rhIFNα2a

WANG Wei-Bo, LI Wen-Guang, LU Li, WU Yong-Jie, GAO Ming-Tang

2004, 9(12):  1432-1435. 

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AIM: To study the effects of body temperature changes inmice induced by intravenously and intramuscularly injection of different dosage of rhIFNα2a. METHODS: The body temperature in mice was measured at 30 minute before and at different time after rhIFNα2a injection and the concentration of IFN in serum was measured by ELISA method.RESULTS: Intravenous injection of rhIFNα2a induced remarkably higher and longer fever than intramuscular injection.And the fever increase was inhibited by indomethacin.CONCLUSION: Intramuscular injection of rhIFNα2a shows fewer side effects than intravenous injection.Fever change sensitive to rhIFNα2a can be inhibited by using non-steroid anti-inflammatory drugs.

Design discipline and example of informed consent form for clinical trial

LIU Fang, XIONG Ning-Ning, WANG Xiu-Qin, JIANG Meng, ZOU Jian-Dong, FU Wei-Min, GAO Wei-Min, XUA Jung

2004, 9(12):  1436-1440. 

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Informed consent form is composed of two parts-informing understanding and consent signature.The design of an informed consent form should comply with regulations of full disclosure, adequate comprehension and voluntary choice.And sometimes audiovisual aids which were used for helping subjects to understand the purpose, process, risks and benefits of research were needed.For clinical study of screening collection of biological specimens, two separate informed consents were needed for the subjects, one is consent for collection and analysis of biological specimens, the other is consent for taking part in trial after satisfied results was obtained and according with inclusion criteria.This article introduces the regulations of designing an informed consent form which included basis of design, principles of design, format, content, provision of print, and example of an informed consent form.