Child ; Child Development ; drug effects ; Endocrine Glands ; drug effects ; growth & development ; physiology ; Hazardous Substances ; poisoning ; Humans ; Nervous System ; drug effects ; Urogenital System ; drug effects

Objective To investigate the relationships between the expressions of intercellular adhesion molecule 1(ICAM-1),heat shock protein 70(HSP70) and acute rejection after pancreas allotransplantation in miniature swine.Methods Ultrasound guided biopsies of the pancreas and histopathologic examination were performed after the miniature swine models of pancreas allotransplantation were established.According to the histological change,the samples were divided into group Ⅰ(no rejection),group Ⅱ(mild acute rejection),group Ⅲ(moderate acute rejection)and group Ⅳ(serious acute rejection).The expressions of ICAM-1 and HSP70 were analyzed with immunohistochemistry and imaging.Results The expressions of ICAM-1 and HSP70 were increased when acute rejection occurred after pancreas allotransplantation in miniature swine.The levels of ICAM-1 and HSP70 were sequentially high when acute rejection was serious.Conclusion ICAM-1 and HSP70 were involved in pancreas allograft rejection and useful for early diagnosis of acute rejection after pancreas transplantation.

Objective To establish a successful model for pancreaticoduodenal allotransplantation with enteric drainage in piglet and surveillance acute rejection by biopsy.Methods We implemented the model same as protocol of clinical pancrease transplantation.40 piglets were divided into donors and recipients randomly.20 times experimental operation were finished. The total pancreas with a short segment of duodenum was transplanted to a recipient by anastomoses of vessels to the recipient iliac vessels and small bowel segment to the jejunum with enteric drainage. During operation, mean arterial pressure(MAP), central venous pressure(CVP)were monitored. The levels of amylase activity in blood were investigated.Doppler color blood flow ultrasonography was used to evaluate blood flow of pancreatic allografts,and ultrasound-guided percutaneous pancreas allograft biopsy and histopathologic examination were performed.Results The successful rate of operation was 90%. Recipient's MAP was decreased after the reopening of inosculated blood vessels.(P

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.
China ; Drug Approval ; legislation & jurisprudence ; Drug Evaluation ; legislation & jurisprudence ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional

DPP-4 inhibitors are new oral hypoglycemic drugs and hot spots developed and launched in recent years, and they pro-vide new choices for the clinical treatment of type 2 diabetes. In China, DPP-4 inhibitors that are approved to use in the treatment of type 2 diabetes are all imported products currently. In the paper, the current intellectual property situation of DPP-4 inhibitors that are developed and approved at home and abroad is researched and analyzed. Reasonable use of the patent information of DPP-4 inhibitors that is about to expire or have failed can provide good guidance for the subsequent development of DPP-4 inhibitors in domestic with promising curative effect and good market prospects, and can generate new patents in order to enhance the market competitiveness.

Objective To study the role of P53 target gene TIGAR on proliferation ,migration and invasion of lung cancer cells . Methods siRNA was introduced to knock down TIGAR in A 549 cells .Proliferation was detected by CCK-8 .The ability of migra-tion and invasion was measured by and ,respectively .was used to evaluate the expression levels of related proteins .Results Knock-down of TIGAR reduced the proliferation rate (P< 0 .05) ,inhibited the ability of migration and invasion ,decreased expression levels of MMP-2 and MM P-9 .Conclusion TIGAR promotes proliferation ,migration and invasiveness of lung cancer cells .

BACKGROUND: Bone sialoprotein (BSP) gene is expressed in human breast cancer cells, in which bone metastasis occurs easily outside the mineralized tissue. Clinical observation shows that the expression level of BSP of breast cancer cells at bone metastasis is higher that at the primary site;therefore, BSP may be closely related to tumor specific bone metastasis.The study on breast cancer bone metastasis can provide new drug target for clinical prevention and treatment.OBJECTIVE: To establish breast cancer cell strains of BSP with stable expression and observe the effect of BSP in the whole process of breast cancer bone metastasis.DESIGN: Controlled experiment.SETTING: College of Biological Sciences and Engineering, South China University of Science and Technology; Medical Experiment Center,Guangzhou General Hospital of Guangzhou Military Area Command of Chinese PLA.MATERIALS: This experiment was conducted in the Medical Experimental Center,Guangzhou General Hospital of Guangzhou Military Area Command of Chinese PLA,betweer November 2003 and March 2004..pIRES2-EGFP vector (5.3 kb) was purchased from BD Biosciences Clontech Inc.; E.Coli.Top10, pB-hBSP plasmid containing the coding region of hbsp, and human breast carcinoma cells, MDA-MB-231BR that was specifically transferred to brain and MDA -MB-231BO that was specifically transferred to bone.METHODS: hbsp gene was subcloned from pB-hBSP vector by PCR. Bg1Ⅱ and Pst Ⅰ restriction enzyme sites were inserted at 5' and 3' ends, orientation cloned to eukaryon expression vector pIRES2-EGFP, and constructed recombinant vector pIRES2-EGFP. The constructed recombinant vector was transfected into MDA-MB-231BR that was specifically transferred to brain and MDA-MB-231BO that was specifically transferred to bone.MAIN OUTCOME MEASURES: Construction of pIRES2-hBSP-EGFP recombinant expression vector; recombinant expression vector pIRES2-hBSP-EGFP transfecting breast cancer cells.Breast cancer strains specific in bone metastasis and brain metastasis were successfully transfected. The fluorescence labeling could be observed under the fluorescence microscope, and BSP had corresponding expression.CONCLUSION: The successful construction and transfection of pIRES2hBSP-EGFP of eukaryon expression vector would lay foundation for further study on the role of BSP in breast cancer metastasizing to bone in vivo or in vitro.

Objective To evaluate the effectiveness of treating depressive patients with somatic symptoms with combined TCM and western medicine.Methods 69 patients were randomly divided into 2 groups:a combined therapy group (treated with Yangyin-Qinggan decoction and paroxetine) and mono-therapy (treated with paroxetine alone as an active control),The depressive and somatic symptoms were assessed before (0 week),during (2 weeks and 4 weeks) and at the end point (8 weeks) of the treatment.Results ①Both therapies alleviated the depressive symptoms:HAMD assessed among patients receiving combined therapy are listed as:(0 week:19.29±2.38),(2 weeks:17.38 ± 2.37),(4 weeks:15.27 ± 2.15),(8 weeks:13.35 ± 2.09) ;combined therapy started to ease the depressive symptoms after 2 weeks of treatment (2 week compared with 0weeks),similar improvements could also be noticed after 4 weeks of treatment 4 weeks with 2 weeks:P＜0.05)and at the end of this research (after 8 weeks of treatment:8 weeks with 4 weeks:P＜0.05).HAMD for mono-therapy are as:(0 week:18.69±3.03),(2 weeks:16.63±3.09),(4 weeks:15.20±2.95),(8 weeks:14.60±2.72) ; mono-therapy started to alleviate the depressive symptoms also,after 2 weeks of treatment (2 weeks compared with 0 week:P＜0.05),yet only slight improvements could be seen after 4 weeks (4 weeks with 2 weeks:P＞0.05) and 8 weeks of the treatment (8 weeks with 4 weeks:P＞0.05).The combined therapy turned to be more effective in alleviating depressive symptoms at the end point of the treatment (P＜0.05).②In terms of improving the somatic symptoms,the Somatization Symptom Scale (SSS) among patients with combined therapy were as follows:(0 week:48.74±4.07),(2 weeks:46.74±4.16),(4 weeks:43.74±3.77),(8 weeks:41.18 ± 3.50) ; Combined therapy was witnessed to start to ease those symptoms after 2 weeks o f treatment (2week compared with 0 weeks,P＜0.05),similar patterns were found again,after 4 weeks (4 weeks with 2 weeks:P＜0.05) and 8 weeks of the treatment (8 weeks with 4 weeks:P＜0.05).Mono-therapy was found to ease the somatic symptoms in a less-effective way,yet no difference was found between any two SSS after 2 weeks,4weeks or 8 weeks of treatment (P＞0.05,respectively).Combined therapy was better at improving the somatic symptoms (P＜ 0.01).Conclusion Combined therapy proved to be more effective in both relieving depression and somatic symptoms.

To explore the clinical characteristic and intervention strategies for pregnancy complicated with heart failure. The clinical data of 67 pregnant women with heart failure during January 1998 to December 2010 were collected and analyzed.The rate of heart failure in pregnancy with heart diseases was 31％ (67/216).The causes of pregnancy complicated with heart failure were peripartum cardiomyopathy ( n =33,49％ ) and hypertensive disorder complicating with pregnancy heart disease( n =28,42％ ).Heart failure in pregnancy appeared at an average of (36.0 ± 2.7 ) weeks.The average terminating time of pregnant women with heart failure was ( 36.5 ± 2.1 ) weeks.Cesarean section was the main safe choice of delivery for pregnant women with heart failure.The average weight of newborns for pregnant women with heart failure was(2517 ±541 )g.The rate of neonatal asphyxia was 22％ (11/50).Strengthening routine antenatal examination and treating pregnant complications timely can prevent and reduce the incidence of heart failure.

Objective To evaluate the clinical significance of plasma ionized calcium (ICa) and total calcium (TCa) measurement in diagnosis of tumor-associated hypercalcemia. Methods The heparin lithium anticoagulated plasma were collected and measured with ion selective electrode (ISE) and orthocresolphthalein complexone (OCPC) method for ICa and TCa in 77 patients with malignant tumor (tumor group) and 44 healthy controls (control group). Meanwhile,plasma albumin and pH value were measured to correct TCa (cTCa) and ICa(nICa). The results were analyzed. Results The levels of cTCa,ICa and nICa in tumor group were significantly higher than those in control group(P＜ 0.01 ) ,but there was no significant difference of TCa between two groups (P ＞ 0.05 ). cTCa ＞ 2.70 mmol/L, nICa ＞ 1.35 mmol/L as the hypercalcemia eritical value, the positive rate of nICa and cTCa were 18.18% (14/77) and 6.49% (5/77)respectively,the difference was significant (P = 0.023). Conclusion Determination of ICa may be more clinical meaningful than TCa for tumor-associated hypercalcemia.