Table of Content

Volume 15 Issue 1
26 January 2010

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Pharmacometrics in pediatric drug development and rational dosage

SHI Jun, Jeffrey S .Barrett

2010, 15(1):  1-10. 

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This article provides a comprehensive overview of key issues related to pediatric drug development and rational dosing guidance in pediatrics with an emphasis on how pharmacometrics can improve the efficiency and productivity of pediatric trials. The pharmacokinetics (PK) and pharmacodynamics (PD) of drugs are often different between adult and pediatric populationns which necessitate specific studies in children.The aims of this review are to discuss a number of recent methodological developments of modeling and simulation that facilitate the evaluation of drugs in pediatrics.Specific focus has been placed on addressing the key issues of PK/PD scaling, sparse sampling, colinearity, covariate evaluation, dose optimization for trial design and label, modeling strategies and validation approaches.The features and potent ial advantages of Bayesian hierarchical model, physiology-based PK models, and K-PD models are also presented.

Evaluation on the release discipline of baicalin and its three solid preparations using a drug dissolution simulating system

ZHU Cheng-cheng, LI Zi-qiang, LIU Zhi-dong, GAO Guo-yi, HAJI Juma, SHU Le-xin, HE Xin

2010, 15(1):  11-20. 

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AIM: To study the release features of the baicalin crude drug s and three baicalin so lid preparations such as ordinary tablets, sustained-release tablets and solid lipid nanoparticles by using a continuously dynamic drug dissolution simulating system (DDSS), and to provide a new technology and a new method for the study of devising drug preparations.METHODS: The DDSS method and the oar method were used to study their release features of three different baicalin solid preparations, respectively.Furthermore, the high performance liquid chromatography method was used to determine the contents of baicalin.The data were fitted by SPSS software, and the dissolution parameters such as T50, Td, m were extracted from the fittinge quations, and the correlation between the two systems were estimated.RESULTS: The release equations of the ordinary tablets and the sustained-release tablets of baicalin, in the two diffe rent systems, were Weibull and Higuchi equations, respectively.When the correlation of the release results of the baicalin tablets and the sustained-release tablets in the two different dissolution systems were evaluated, respectively, their corresponding correlational values were 0.975 and 0.9995, which were greater than the critical values (r4, 0.01 =0.917).It means they have a goo d correlation.The release features of the crude drug s and the solid lipid nanoparticles of baicalin on DDSS fit to Weibull equations. CONCLUSION: The DDSS simulates a drug release course which is continuously dynamic and close to the gastrointestinal tract environment. The release feature result s of DDSS and the oar methods embodied to Chinese Pharmacopoeia (edited in 2005) correlated well, which illustrated the reasonableness of the simulating systems to assess the release features of solid preparations.It provides a new technology plat form to the study of devising drug preparations.

Analysis study on the transmigration ingredient of blood serum of Sinisan Freeze-dry Powder

LI Yue-feng, LI Ting-li

2010, 15(1):  21-26. 

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AIM: To study the transmigration ingredient of blood serum of Sinisan Freeze-dry Powder in order to determine that Sinisan enhances the sleep function with drug effect material base. METHODS: The HPLC method was used to do gradient elution, and the transmig ration ingredient of blood serum of Sinisan Freezedry Pow der was determined.The chromatograph condition: Hypersil C18 column (4.6 mm×250 mm, 5 μm), speed of flow 1.0 mL/min, column warm 30 ℃, flowing A is acetonit rile ;flowing B is 0.05 % phosphorus acid water, the flow ingA gradient elution (10 %-90 % aceto nitrile), the analysis time is 150 min.RESULTS: 14 kinds of transmig rationing redient sappeared in blood serum after seven days successive medication with Sinisan Freeze-dry Powder.CONCLUSION: The specificity and characteristic of the blood serum HPLC fingerprint mark in Sinisan are good, which can be used in the transmig ration ingredient of blood serum of Sinisan Freeze-dry Powder.

Bioanalytical method and pharmacokinetics of Bacillus subtilis fibrinolytic enzyme in rhesus monkeys

CAI Yong-ming, CHEN Zheng-min, SUN Chao-yuan, LIU Chang-xiao

2010, 15(1):  27-31. 

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AIM: To characterize the pharmacokinetic proper ties of a Bacillus subtilis fibrinoly tic enzyme (BSFE) following intravenous infusion in rhesus monkeys.METHODS: Six mon-keys received sing leintraveno us infusion doses of BSFE at 2.5 mg/kg.Serum concentration of BSFE was measured at various time-point s after dosing by ELISA.Pharmacokinetic parameters were calculated with DAS 2.0 software.RESULTS: The concentration-timepro file of BSFE in monkey s was described by a two-compartment model.The mean time to reach peak concentration (tmax) was 0.5 h.The mean peak concentration (Cmax) was(592.3 ±150.9) μg/L.The mean elimination half-life (t1/2β) was (5.78 ±1.19) h. The mean drug clearance from the serum (CL) was (4.42 ±1.19) L·h-1·kg -1.The mean area under the serum concentration-time curve (A UC0 -24.5 h) was (557.1 ±211.1) μg·L-1·h. CONCLUSION: A sandwich ELISA method is sensitive, high specificity and convenient, sui table for the determination of BSFE in serum and its pharmacokinetics studies.

Effects of Kanglaite injection on antitumor and expression of EGFR in Lewis lung carcinoma

PAN Pei, WU yan, WANG Rong, WANG Yu-jie, YUAN Yong-fang

2010, 15(1):  32-35. 

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AIM: To research the effects of Kanglaite (KLT) injection on anti tumor and expression of epidermal growth factor receptor (EGFR) in Lew is lung carcinoma (LLC). METHODS: A to tal of 40 C57BL/6 mice were randomly divided into four groups, including model group, KLT 6.25, 12.5, 25 mL/kg groups.All the mice were injected with 2 ×106 LLC cells at 1st day.A t the next day, mice in the K LT groups were peritoneally injected with KLT for 14 days.And at the 16th day, all the mice were sacrificed and the tumors were harvested.The tumor weight was measured and the tumor grow th inhibition rate was analyzed.The expression of EGFR was detected by westernblot.RESULTS: The growth of LLC was significant ly inhibited by KLT, the changes of tumor appearance and histology were affected and the expression level of EGFR was decreased.CONCLUSION: KLT injection could obviously inhibit the growth of LLC, whose mechanism maybe related to the inhibition of EGFR expression.

Protective effect of TQ0701-2 on cerebral ischemia reperfusion injury in rats

LI Qian, WANG Qiu-juan, GUO Qing-long

2010, 15(1):  36-40. 

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AIM: To investigate the protective effect of a new type nerves protectant TQ0701-2, as the derivate of edaravone free radical scavenger, on cerebral ischemia reperfusion injury rat.METHODS: 120 male SD rats were randomly divided into sham group, model group, edaravone group (3.0 mg/kg) and TQ0701-2 highdose group (6.0 mg/kg), middle-dose (3.0 mg/kg) and low-do segroup (1.5mg/kg).Animals in the latter five groups were subjected to transient focal ischemia by the middle cerebral artery occlusion (MCAO) for 2 h before reperfusion, while the sham group wasn't ischemic.The rats were injected with edaravone or TQ0701-230 min before ischemic and 0 min, 2 h after reperfusion in edarav one and TQ0701-2 groups, sham group and model group were treated with normal saline as well. After 24 h of reperfusion, the infarct ratio, neurological and histological deficient and the changes of pathohistology were evaluated.RESULTS: The infarct ratios and neurological deficit scores in the model group were increased (P <0.01 vs. sham group).The neuro logical deficit scores and infarct ratios in three doses of TQ0701-2 were significantly decreased (P <0.01vs.model group), similar to edaravone, and the protection was enhanced in a dose-dependent manner.Moreover, TQ0701-2 improved neuronal degeneration and necrosis induced by ischemia reperfusion.CONCLUSION: Thesere sults show that the the derivate of edaravone TQ 0701-2 has notable protective effect on cerebral ischemia reperfusion injury in rats.

Inhibitions of articular cartilage cells apoptosis in rats with adjuvant arthritis by Amiloride, a blocker of acid-sensing ion channels

ZHANG Teng-yue, CHEN Fei-hu, WANG Nian, YUAN Feng-lai, HU Wei, WU Fanrong

2010, 15(1):  41-46. 

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AIM: To investig ate the protective effects of articular cartilage by acid-sensing ion channels (ASICs) blocker A miloride and its mechanisms.METHODS: The rats were randomly divided into normal group, AIA model group, Amiloride (2.5, 5.0, 10.0 mg·kg -1·d-1) group, aspirin (50 mg/kg) group.The AIA model rats were induced by CFA.The secondary inflammat ion of AIA rats was appeared on the tenth day via intradermal injection CFA.The drug groups were given corresponding experimental drugs, the model group and the normal group were administered with the corresponding capacity of sterile water, lasting for eight day s.The right hind paw articular swelling degree was determined with volume meter, the morphological changes of articular cartilage was observed by light microscope.The apoptosis of articular cartilage cells were observed by transmission electron microscope, Tunel method. The typeII collagen (COII) expressions of extracellular matrix of articular cartilage were determined by using immunohistochemistry.The proteoglycan (PG) contents of the cartilaget issue were detected by Alcian blue staining.RESULTS: Amiloride have no conspicuous effect on the hind paw swelling with AIA rats.The pathology ical study showed that the surface of articular cartilage was slick, the layer was lampros and the quantity of chondrocyte was incresaed.Transmission electron micro scope study showed that condensation and crack of nucleus and apoptotic bodies were appeared in articular cartilage cells in model group, and the condensation of heterochromatin, the distention of rough endoplasmic reticulum and the swell of bioblast were relieved in Amiloride groups.The apoptosis cell calculation in the experiment groups were fewerthan those in the model group (P <0.01) by Tunel method.The COII and PG of extracellular matrix of articular cartilage were significantly increased in Amiloride groups by immunohistochemical method and Alcian blue staining.CONCLUSION: ASICs blocker Ami loride may have protective effects on articular cartilage by inhibiting the apoptosis of articular cartilage cells of adjuvant-induced arthritis rats.

Effects of proanthocyanidins from grape seeds on the antioxidation in the resistance to oxidation and NO comtents

WANG Yan-hong, YANG Xiao-lai, WANG Li, CUI Ming-xia, ZAI Jing, WU Yong-jie

2010, 15(1):  47-52. 

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AIM: To investigate the antio xidation of proanthocy anidins from grape seeds (GSPE)on 2, 4, 6-t rinitrobenzene sulfonic acid (TNBS)twice-induced recurrent ulcerative colitiss (UC)in rats and to probe into its underlying mechanism.METHODS: Recurrent colitis model was established in Wistar male rats by rectal administ ration of 80 mg/kg TNBS dissolved in 50 %ethanol, and then the rats were second instilled with 30 mg/kg TNBS into the colon on the 16th day after the first induction UC.Rats were intragastrically administered different doses of GSPE (100, 200, and 400 mg/kg)per day for 7 days after twice-induction of colitis by TNBS. Sulfasalazine (SASP, 500 mg/kg)was used as a positive control drug.Rats were killed after GSPE treatment 7 days.The colon sample was extracted, and the colon weight/length ratio (mg/cm)was assessed.The activities of, myeloperoxidase (MPO), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), inducible nitricoxide synthase (iNOS), and the contents of malony ldialdehy de (MDA)and glutathione (GSH)and NO in se rum were detected by biochemistry method.RESULTS: Compared with the model group, the rat body w eight was decreased, and the colonic weight/length ratio was reduced in GSPE dosage group(P <0.05 or P <0.01);the activities of MPO and iNOS and the contents of MDA,NO in serum were significantly decreased(P <0.05 or P <0.01);but the activit ies of MPO, iNOS and the contents of MDA, NO were decreased (P <0.05 or P <0.01);the activities of SOD, GSH-Px, the contents of GSH in serum were increased(P <0.05 or P <0.01).CONCLUSION: GSPE can alleviate the inflammatory reactions in colitisthrough inhibiting oxygen free reaction, exerting antioxidation effects and decreasing the production of NO.

Comparative study on neuroprotective effects of active componants of several traditional Chinese medicines on H₂O₂-induced PC12 cells injury

HU Tao, LIU Xiao-yan, GUO Hong-bao, WANG Yin-ye

2010, 15(1):  53-58. 

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AIM: To compare the protective effects of several traditional Chinese medicines ginsenosides, puerariaiso flavones and ophiopo gonis on H₂O₂-induced PC12 cell injury.METHODS: Cells were treated with vehicle, series concentrations of ginsenosides, puerariaiso flavones or ophiopogonis, then were injured with H₂O₂.The viability of PC12 cells was determined by MTT assay ;SOD level in culture medium was determined by xanthinoxidanse method ;MDA content in medium was measured by modified thiobarbituric acid (TBA) method and NO content in culture medium was determined by Griessme thod.RESULTS: Among these traditional Chine se medicine components, pueraria iso flavones showed the most potent neuroprotective effects, ophiopogonis and ginsenosides showed the almost equal potency. Puerariaiso flavones displayed the most potent effect on the increasing SOD production, ophiopogonis was less effective, and ginsenosides was weakest on this action.Puerariaiso flavones most potently reduced MDA and NO content, ginseno sides showed better effect compared with ophiopogonis.Whereas ophiopogonis failed to reduce NO production.CONCLUSION: Ginsenosides, pueraria is of lavones and ophiopogonis all show signif icant pro tective effect son H2O2-induced PC12 cells injury, and the intensity of this effect may result from their potency on the increase of SOD level and the decrease of lipid peroxidation and NO production.Puerariais of lavones is most potent among three components.

Expression of the NMDA receptor NR2A and NR2B subunits in the spinal cord of acute opioid tolerance rats

DU Jin, HUANG Yu-guang

2010, 15(1):  59-65. 

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AIM: To observe the acute opioid tolerance repeated application of fentanyl in short term and examine the effects of acute Fentany l administration on protein expression of two major NMDA receptors subunits (NR2B and N R2A) in the spinal cord of rats.METHODS: 24 male Sprague-Dawley rats, weighing 200-220 g, were randomly divided into three groups with 8 rats each: Control, Saline and Fentanyl group.Fentanyl was injected subcutaneously four times at 15 min intervals (30μg/kg per injection) in Fentanyl group.Rats in Saline group received saline injections instead of Fentanyl. And noinjections were given to the rats of Control group. The paw withdraw althresh old (PWT) were measured every 30 min with a Von-Frey hair test.When the PWT of Fentanyl group returned to the baseline which had been measured before injection, an injection of morphine (5 mg/kg) was performed to every rat of these 3 groups.Subsequent changes of PWT were still measured every 30 min until the PWT of Fentanyl group re turned to the baseline again.The PWT at each time point were compared with the baseline and the corresponding one of the other two groups.Another 24 male Sprague-Dawleyrats, were randomly divided into three groups with 8 rats each: Control^*, Saline^* and Fentanyl^* group.Fentanyl was administrated as above except no morphine administrated.When the PWT of Fentanyl^* group returned to the baseline, all of the rats were killed.The spinal cord was sampled and the protein levels of NR2B and NR2A subunits were tested with the Western blotting method.RESULTS: Four fentanyl boluses (in group F) elicited an increase followed by an immediate decrease of the PWT and reduction of the analgesic effect of a subsequent morphine administration compared with the other two groups. According to the results of Western blot ting, in spinal cord, the protein level of NR2B subunit of Fentanyl^* group were higher than that of the Control^* and Saline^* group, but there was no difference of the protein level of NR2A subunit between Fentanyl^* group and the other two groups.CONCLUSION: Opioid tolerance could develop rapidly after an acute opioid exposure in rats. The protein levels of NR2B but not NR2A subunit of spinal cord are increased in acute opioid tolerance rats.

Tissue distribution of adriamycin-loaded chitosan nanoparticles surface-modified with glycyrrhizin in mice

LIU Yi-ming, LIN Ai-hua, DENG Shi-gui, WU Zhi-feng, OU Run-mei

2010, 15(1):  66-71. 

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AIM: To study the distribution characteristics and liver targeting trend of adriamycin-loaded chitosan nanoparticles surfacemodified with glycyrrhizin (GL-ADM-NPs) in mice.METHODS: The GL-ADM-NPs, adriamy cin-loaded chitosan nanoparticles (ADMNPs), and free adriamycin solution (F-ADM) were intravenously administered to mice, respectively.The LC/MS/MS method was used to determine the concentrations of Adriamycin in mice plasma, heart, liver, spleen, lung and kidney. The targeting efficiency was evaluated by targeting parameters (Re and Ce).RESULTS: Compared with F-ADM, ADM-NPs obviously increased the adriamycin concentration in the liver, Re and Ce were 3.54 and 2.2, respectively. After modified with glycyrrhizin on the nanoparticle surface, G L-ADM-NPs showed a higher targeting efficiency in the liver.The Re and Ce were 5.83 and 3.42, respectively.The levels of GL-ADM-N Ps in the heart and kidney tissues were sig nificantly decreased. The AUC were 43.06 % and 62.58 % of the values of F-ADM. CONCLUSION: GL-ADM-NPs changes the tissue distribution of ADM, has the liver targeting effect, and might decrease the side effects of ADM.It will be a promising carrier to deliver ADM to liver.

Paclitaxel in treating non-small cell lung cancer: A systematic review

LI Yan-hong, ZHU Huai-jun

2010, 15(1):  74-81. 

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AIM: To assess the clinical efficacy and safety of paclitaxel in treating non-small cell lung cancer.METHODS: The Wanfang database was searched. The randomized control studies on paclitaxel treating non-small cell lung cancer were brought into the research.RESULTS: A total of 25 randomized control studies with 2160 cases of small cell lung cancer were brought into the research.The Meta analysis showed that the response rate of taxol treatment prescription was higher than that of control group[O R=1.12, 95 %CI(1.03, 1.23)] ;The incidence rate of leukopenia at grade Ⅲ and above was higher [OR =1.35, 95 %CI (1.05, 1.74)] than that of control group ;The incidence rate of induced thrombocytopenia at degree Ⅲ and above was decreased compared with control group [O R=0.37, 95 %CI(0.24, 0.58)] ;The incidence rate of induced digestive tract react ions at degre ; There were no significant differences of 1-year survival between treatment group and control group after chemotherapy [O R =1.15, 95 %CI (0.94, 1.40)].CONCLUSION: There is a certain therapeutic effect of paclitaxel in treating non-small cell lung cancer.Since there is a possible existence of bias in this systematic review of research, the results will affect the strength of the argument and more high-quality randomized double-blind controltrials were look forward.

Association of adiponectin allele -11377 (C/G)polymorphism with type 2 diabetes and rosiglitazone response in Chinese patients

SUN Hong, WANG Shao-ming, ZHUANG Jie, LIU Hai-ling, ZHOU Hong-hao, LIU Zhao-qian

2010, 15(1):  82-88. 

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AIM: To evaluate the impact of adiponectin allele C-11377G genetic polymorphisms on efficacy of rosiglitazone in Chinese patients with type 2 diabetes (T2D).METHODS: Patients with T2D (n =255) and 120 heal thy volunteers were enrolled to identify-11377C/Ggenotypes by polymerase chain reaction restricti on fragment length polymorphism assay.Forty-two T2D patients with different-11377C/G genotypes received orally rosig litazone as asingle-dose therapy (4 mg day-1 p.o.) for 12 weeks.The serum triglyceride, fasting plasma glucose (FPG), postprandial plasma glucose (PPG), glycated hemoglobin(HbAlc), fasting serum insulin(FINS), postprandial serum insulin(PINS), total cholesterol(TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), homeostasis model assessment for insulin resistance (HOMA-IR), and adiponectin concent ration were determined before and after rosiglitazonet reatment. RESULTS: Compared with the health control group, the allele frequency of-11377(C/G) and the genotypic frequency were increased in T2D group(P <0.05), and as the Gallele gene increased, the adiponectin level was significantly decreased, and the level s of FINS and HOMA-IR were significantly increased in T2D patient s(P < 0.05).After treated with rosiglitazone, the degree of the decrease of the FPG (P <0.01),PPG (P <0.05)and HOMA-IR (P<0.05)levels in the CC genotype was significanthigher than that in the othergenotypes.However, the degree of the increase of the serum adiponect in concentration(P<0.01)in the CC genotype was sig nificantly higher than that in the other genotypes.CONCLUSION: These data suggest that the adiponectin allele-11377C/G polymorphisms sig nificantly associated with the pathogenesis of T2D, insulin resistance, and the the rapeuticefficacy of rosiglitazone in Chinese patients with T2D.

Clinical study of protective effects and function regulations of piperazine ferulate tablet on traumatic vascular endothelial cells in type 2 diabetes mellitus

JIN Yan, QIU Hui, LAN Xiao-chun, HUO Xiao-jing

2010, 15(1):  89-92. 

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AIM: To invest igate the therapeutic protective effects and function regulations of conventional antidiabe tictreatment plus piperazine ferulate tablet on trauma ticvascular endothelial cells in type 2 diabetes mellitus.METHODS: 80 patients were randomly divided into the treating group (n =37)and the control group (n=43).Conventional antidiabetictreatment plus piperazine ferulate was given to the treating group, and the control group was treated with convent ional antidiabetic treatment plus vitamin Cevery day, and all the patients were treated with 4 weeks.The levels of fast in gblood glucose (FBG), glycosylated hemoglobin alC(HbalC), circulating endothelial cell(CEC), serum lipid peroxide(LPO), endothelin(ET)、nitricoxide (NO), tissue-plasminogen activator (t-PA)were determined during the therapeutic period.RESULTS: After 4 weeks of treatment, the levels of serum CEC, LPO and ET were lower in the treating group than those in the control group (P <0.01).while the levels of NO and t-PA were higher in the treating group than those in the control group (P <0.01), there was significant difference between the two groups(P <0.01).CONCLUSION: Combination of conventional antidiabet ictreatment and piperazine ferulate can pro tect vascular endo thelial cells and regulate their functione from the damage in type 2 diabetes mellitus.

Magnesium sulphate alleviated remifentanil induced postoperative hyperalgesia

GU Wei, GU Xiao-ping, ZHANG Xiao-kun, ZHANG Jing, MA Zheng-liang

2010, 15(1):  93-97. 

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AIM: To evaluate the effect of magnesium sulphate (a NMDA-recepter antagonist) on remifentanil-induced postoperative hyperalgesia. METHODS: Seventy-five patients undergoing scoliosis surgery (ASA I-II, aged 10-25 years) were randomly assigned to three groups (n = 25): Group S(intraoperative remifentanil at 0.05μg· kg ^-1·min^-1) ;Group R (intraoperative remifentanil at 0.4μg·kg^-1·min^-1) ;Group M (intraoperative remifentanil at 0.4μg·kg^-1 ·min^-1, accompany with induction dose of 40 mg/kg magnesium sulphate, followed by an intraoperative infusion of 20 mg·kg ^-1·h^-1 till the end of surgery). Patient controlled intravenous analgesia (PCA) was performed with fentanyl after operation. Cumulative injected volume of the PCA and pain scores were recorded during 48 postoperative hours.RESULTS: During 36h and 48h postoperative fentanyl consumption was less in Group Sthan that of Group R (P <0.05).During 24 h, 36 h and 48 h postoperative fentanyl consumption was less in Group M than that of Group R (P <0.01).There were no significant differences in pain scores in the three groups.CONCLUSION: Intraoperative infusion of remifentanil at 0.4μg·kg^-1·min^-1 triggers postoperative secondary hyperalgesia.Perioperative magnesium sulphate supplementation could alleviate the hyperalgesia induced by remifentanil.

Observation of therapeutic effect of mizolastine and total glucosides of paeony capsule on chronic idiopathic urticaria

WANG Jun, MA Xiao-ling, LIU Wei-bei, CI Chao, CHANG Xiao-li, JI Bi-hua

2010, 15(1):  98-101. 

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AIM: To observe the therapeutic effect of mizolastine combined with total glucosides of paeony (TGP) capsule on chronic idiopathic urticaria.METHODS: According to treatment sequence, 120 cases of chronic idiopathic urticariapatients were divided into two groups, the treatment group were given mizolastine and TGP, the control group only given mizolastine. RESULTS: The effective rates of the treatment group and the control group were 88 % and 87 %, respectively. There was no sig nificant difference between the two groups ;After 3 months, the relapse rates of the treatment group and the control group were 43.27 % and 71.20 %, respectively. There was significant difference between the two groups (P <0.01). CONCLUSION: Mizolastine combined with TGP capsule may be effective for the treatment and preventing the relapse of chronic idiopathic urticaria.

Psychological crisis intervention to improve the quality of life of patients with advanced breast cancer

ZHAO Wen-ying, WU Wan-chun

2010, 15(1):  101-105. 

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AIM: To improve the impact of psychological crisis intervention on the quality of life for patient s with advanced breast cancer.METHODS: 108 cases with advanced breast cancer were randomly divided into psycho logical crisis intervention group (65 cases) and control group (43 cases).A psychological cri sis intervention, a self-rating depression scale (SDS), a self-rating anxiety scale (SAS) and a SF-36 Scale (that i s health survey summary table, the Mos36 item shore form health survey, SF-36) evaluation were used to analyze compared with control group.RESULTS: After the interventionin psychological crisis intervention group, the scores of SDS and SAS were significantly lower than those before the intervention (both P <0.01), the 8 areas of SF-36 score were significantly increased (P <0.01) ;There were nosignificant differences in control group between the scores of SDS and SAS before and after treatment (all P >0.05).Except for 2 areas of physiological functions of the body and outside pain in SF-36 score, there were nosignificant differences before and after treatment (P >0.05). CONCLUSION: Psychological intervention cansignificantly improve the psycho logical state of patients with advanced breast cancer, thereby improve the quality of life in patients with advanced breast cancer.

Quality control of large scale clinical trials

MA Li-yuan, WANG Wen

2010, 15(1):  106-109. 

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In the recent 2 decades, the clinical medical mode has been changed greatly.The experience-based medical mode is gradually replaced by evidence-based modeie evidencebased medicine.Large scale clinical trials provide robust evidence for clinical practice and quality control is critical for the success of one trial.We discuss six facets on this subject, including protocol design, staff training, manual formulating, organization, data management and monitoring.The objective of quality control is to ensure the study conducted according to the protocol, the results are reliable and protect the human rights of participants.

Progression of sulodexide and clinical application

WANG Ya-min

2010, 15(1):  109-115. 

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Sulodexide is a new type of natural glycosaminogly cans, contains two main components to different synergistic action principle, with anticoagulation, thrombolysis, ant i-cardiovascular disease, reducing blood lipid, protecting the kidneys and other role, In recent years, in the treatment of cardio vascular disease, peripheral artery disease, post-phlebitis syndrome, complications of diabetes, especially diabetic nephropathy, etc.The clinical application attracted attention, this article on its chemical composition, pharmacokinetics, biological activity,quality control, mechanism and pharmacology, clinical research and applications, and recent research are reviewed.To be compared with similar drugs heparin, sulode xide to special due to be taken orally, the bioavailability of high, fewer side effects, and with heparin no role of the decomposition of fat can be considered more widely applied.Currently only the imported products, domestic manufacturers are in research and development stage, Ibelieve that in the near future will be made to sulodexide in china.

Advancement of the relationship ERCC1 and platinum resistance in digestive system malignant tumors

LI Xiao-qiu, HU Bing

2010, 15(1):  116-120. 

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Due to the high incidence and mortality of digestivesy stem malignant tumor, so it is of great significance to make further research for digestive tract tumor.Platinum drugs, one of the traditional drugs which is used for the chemo therapy for digestive system tumor, which has been extensively applied to the chemotherapy for malignant tumor.However, the resistance to the drug s exerts a serious influence on its curative effect.At present, it is believed that the nucleotide excision repair (NER) constitutes one of the most important mechanisms which results in the resistance to platinum drugs, mainly because it causes the twi sting of DNA helix by removing large numbers of platinum compounds. The nucleotide excision repair cross complementation group 1(ERCC1) plays an important role in the process of N ER.The different expression of ERCC1 in peripheral blood and tumor tissue of patients with digestive sysem tumor has a close connect ion with therapeutic effect of the platinum-containing chemotherapy.This article aims to provide an overview of the relation between the ERCC1 research development and the curative effect of cisplatin chemotherapy for digestive system tumor.