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

Animals ; Female ; Gonads ; physiopathology ; Hypothermia ; chemically induced ; physiopathology ; Male ; Rats ; Rats, Wistar ; Sex Factors ; Soman ; adverse effects ; pharmacology

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

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.

The bFGF plays an important role in embryonic development of tendons and ligaments and in the healing of injuried tendons and ligaments. The eukaryotic expression plasmid of rat basic fibroblast growth factor (bFGF) gene was constructed in order to further investigate the bFGF function in molecular regulatory mechanism in the repair of tendons and ligaments and to provide the foundation for the clinical application. The cDNA fragments of bFGF were cloned from the skin of rats by RT-PCR, and recombinated to the pMD18-T vector. The cDNA encoding bFGF was cloned from the pMD18-T vector by RT-PCR, digested with restriction enzyme EcoR I Pst I and bound to eukaryotic expression plasmid pIRES2-EGFP to construct eukaryotic expression plasmid pIRES2-EGFP-bFGF. The pIRES2-EGFP-bFGF was transfected into the tenocytes by lipid-mediated ransfection technique. MTT test was used to detect the biological activity of bFGF in supernatants after the transfection. The expression of type I and III collagen genes was detected by using RT-PCR. It was verified that the pIRES2-EGFP-bFGF was successfully constructed, and its transfection into tenocytes could significantly enhance the biological activity of bFGF, and increase the expression of type I and III collagen mRNA, suggesting that pIRES2-EGFP-mediated bFGF gene therapy was beneficial to the repair of tendons and ligaments.

Probability of causation (PC) was used to facilitate the adjudication of compensation claims for cancers diagnosed following exposure to ionizing radiation. In this article, the excess cancer risk assessment models used for PC calculation are reviewed. Cancer risk transfer models between different populations, dependence of cancer risk on dose and dose rate, modification by epidemiological risk factors and application of PC are also discussed in brief.

Objective To make clinical doctors better understanding of anaplastic large cell lymphoma(ALCL) and reduce the misdiagnosis of ALCL at an earlier stage.Methods Retrospective analysis of clinical features in 31 children with ALCL from Sep.2002 to Jan.2008,who had been misdiagnosed as other diseases at first and latterly been confirmed as ALCL by pathological study.The reasons for mis-diagnosis and the symptoms of the disease were analyzed and reviewed.Results ALCL clinical misdiagnosis rate reached to 91.2%.The reasons for misdiagnosis were:1.The fact that extra-nodal involvement present in earlier stage,which caused ALCL to have diversified clinical symptoms,and the initial symptoms were diverse.2.ALCL cells produce multiple cytokines such as IL-6,IL-9,IL-4,and others.They might make patients have symptoms like inflammation.3.The morphology of ALCL was quite variable.4.The clinical doctors and pathologists did not have frofound understandings of ALCL.5.Inapropriate usage of steroid before diagnosis was mode.Conclusions Clinical doctors should be aware of the diversity of ALCL clinical symptoms and use steroid carefully,while pathologists should pay attention to morphological varieties of ALCL and choose appropriate immunohistiochemical stain markers to avoid misdiagnose.Pathologic diagnosis should be made by more than 2 oncology centers.