OBJECTIVE:To guarantee the quality of the clinical drug trial and to ensure the interests of the subjects.ME- THODS:The basic principles,procedures and methods of ISO9001quality management standards were applied in the whole construction of clinical drug trial institution.RESULTS&CONCLUSION:The construction of clinical drug trial institution based on the ISO9001quality management standards was in conformity with the principle of Good Clinical Practice,which was helpful for the guarantee of the quality of clinical drug trial and the interests the subjects.

Objective To discus the diagnosis,favorabl management and diagnosis of pilocytastrocytoma.Methods Provided by the information from CT,MRI and operation,we try to discus and confirm the characteristics of this tumor.Results Pilocytastrocytoma commonly occurs in 20 years old or younger.The most frequent location involve by tumor were cerebellum.The most common presenting sympton was increased intracranial pressure,and then cerebellum symptoms such as incoordination.Final diagnosis made depending on mainly pathology.We found the relationship between prognosis and the extent of surgical removal.Conclusions Pilocytastrocytoma usually occur in children and adolescent.The most common site of these tumors are the cerebellum.And the more complete extent of surgical removal,the better prognosis.So it was called as "benign" tumors.If pilocyticastrocytoma were subtotally excised,the addition of postoperative irradiati could significantly prolong survival.

Objective To investigate the effects of acupuncture on gene expression profile of neurotrophin and its receptors in cerebral cortex of neonatal rats after cerebral hypoxic-isehemic injury,and to explore the molecu- lar mechanism of acupuncture in treatment of neonatal hypoxic-ischemic encephalopathy.Methods The model of cerebral hypoxic-ischemic injury was established with 10 neonatal Sprague-Dawley(SD)rats,who were subjected to acupuncture once daily for 14 days.The animals were sacrificed on the next day of the last acupuncture and their brain cortex was sampled for examination of gene expression,using GEArray Q series neurotrophin and receptors gene array.Results After 14 days of acupuncture,it was found that 48 genes(50% of total genes on the microarray) were expressed differently between the two groups,of which 40 genes(83.3% of differently expressed genes),such as those of the brain-derived neurotrophic factor(BDNF),ciliary neurotrophic factor(CNTF),ciliary neurotrophic factor receptor(CNTFR),basic fibroblast growth factor(bFGF)and fibroblast growth factor receptor type 1 (FGFR1)were up-regulated,and 8 genes(16.7% of differently expressed genes),such as genes of neuregulin-1 (Nrg1),neuregulin-4(Nrg4)and tyrosine kinase C(TrkC)were down-regulated.Conclusion Acupuncture can regulate the expression of various genes of neurotrophin and receptors in cerebral cortex of neonatal rats after cerebral hypoxic-ischemic injury,which might be the mechanism of acupuncture facilitating the recovery of the rats from hy- poxic-ischemic encephalopathy.

Objective To make follow-up s tudy and e valuation of benign stricture of upper gastrointestinal tract (UGIT) with interv entional procedure. Methods There were 85 cases of benign stric ture of UGIT with interventional procedu re. There were 35 cases with pneumatic dilation (group A), 25 cases with permane nt (group B) placement, and 25 cases with temporary (group C) placement of expan dable metallic stent, respectively. All cases were completed under fluoroscopy. 35 cases of group A had 67 times dilations (mean 1.9 times). Fifteen partial co vered and 10 uncovered expandable metallic stents were permanently placed in the 25 ca ses of group B. 25 partial covered expandable metallic stents were temporari ly p laced in the 25 cases of group C, and the stents were drawn out via gastroscopy 3-7 days later. All stents placement and drawing were technically successful. T he most strictured diameters of UGIT were 0.7-8.5 mm before dilations and 5.1- 200 mm after dilations. Dysphagia scores of all cases were from grade 2 to 4 b efo re dilations, and from grade 0 to 1 after dilations. Follow-up time of all case s was from 6 months to 36 months (mean 19.1 months). Results Complications in group A included chest pain (n=10), reflux (n=8), and bleeding (n =3). Seven (20%) in 35 cases of group A had dysphagia relapse during follow-up over 6 months; 32 (91%) in 35 cases of group A had dysphagia relapse during follow-up over 12 mon t hs; 19(95%) in 20 cases of group A had dysphagia relapse during follow-up over 36 months. Complications in group B included chest pain (n=10), reflux (n =15), bleeding (n=3), and stent migration (n=4). Five (20%) in 25 case s of group B had dysp hagia relapse during follow-up over 6 months; 3(25%) in 12 cases of group B had dysphagia relapse during follow-up over 12 months; 3(60%) in 5 cases of gro up B had dysphagia relapse during follow-up over 36 months. Complications in group C included chest pain (n=10), reflux (n=3), and bleeding (n=4). 3( 12%) in 25 cases of group C had dysphagia relapse during follow-up over 6 months, 2(13.3%) in 1 5 cases of group C had dysphagia relapse during follow-up over 12 months; 1(12.5 % ) in 8 cases of group C had dysphagia relapse during follow-up over 36 months. ConclusionThe effective treatment method of benign stricture of UGIT with inte rventional procedure in short-term therapeutic efficiency were graded pneumatic dilation and temporary placement of partial covered expandable metallic stent. T emporary placement of partial covered expandable metallic stent was the first me thod of choice in the treatment of benign stricture of UGIT in terms of mid and long-term therapeutic efficiency.

ObjectiveTo determine the genotypes of human papillomavirus(HPV) and to estimate their correlations with recurrence of perianal and anal condyloma acuminatum(CA) among men who have sex with men(MSM) in Shanghai.MethodsTissue specimens were obtained from the lesions of perianal or anal CA in 57 MSM.Flow-through hybridization and gene chip were used to determine the genotypes of HPV in these specimens.Follow-up was carried out to observe the recurrence of CA in these patients after CO2 laser treatment.ResultsOf the 57 specimens,56(98.2％) were positive for HPV,and a total of 11 HPV subtypes were identified.The predominant genotypes were HPV 11 (42 cases,75％ ) and HPV 6 (30 cases,53.6％),sequentially followed by HPV 16 (8 cases,14.3％),HPV 18 (4 cases,7.1％),HPV 33 (2 cases,3.6％),HPV 59(2 cases,3.6％),HPV cp8304 (2 cases,3.6％),HPV 31 (1 case,1.8％) and HPV 35 (1 case,1.8％).Of the HPV-positive specimens,64.3％(36/56) harbored low risk HPV types(11 and/or 6),and 35.7 ％ (20/56) harbored high risk HPV types.Among the 20 specimens positive for high risk HPV,17(85％) harbored both low risk- and high risk-HPV genotypes.During the 6-month follow-up after CO2 laser treatment,recurrence was observed in 95％ of patients with high risk HPV and 66.7％ of patients with low risk HPV (P ＜ 0.05).ConclusionsAmong MSM with perianal and anal CA in Shanghai,the predominant genotypes of HPV are low risk types 11 and 6; high risk HPV infection is usually complicated by low risk HPV infection; the recurrence of CA is higher in patients with high risk HPV than in those with low risk HPV.

目的观察神经外科与针刺联合治疗急性脊髓不完全损伤的疗效。方法神经外科治疗组根据指征确定是否进行手术,药物治疗均给予激素、脱水、抗去甲肾上腺素类药物、神经营养药物,高压氧。神经外科与针刺联合治疗组除上述神经外科治疗外,采用针刺治疗,针刺处方:电针刺激夹脊穴,根据不同辨证配合远端取穴。结果神经外科治疗组9例,持续治疗 3—6个月,出院后随访6个月,6例好转,肌力有所改善,最好者可达到肌力IV—IV+级,3例无效,甚至退步,瘫痪进一步加重。神经外科与针刺联合治疗组病人5例,经针刺及电针治疗10—80天时间后,4例临床治愈,1例经针刺治疗好转后,因转入骨科手术治疗腰椎压缩性骨折时脱离针刺治疗。结论神经外科与针刺联合治疗急性脊髓损伤效果好,并能抑制脊髓损伤的进一步恶化。

ObjectiveTo evaluate the assistant effct of electroacupuncture on acute incomplete spinal cord injury treated with routine therapy.Methods9 cases who accepted routine therapy, including operation and medicine, were in control group, while other 7 cases who accepted electroacupuncture other than routine therapy were in treating group.ResultsThere were 2 cases were effective, 4 cases were improved and 3 cases were not improved in control group, while 6 cases were clinical recovery, 1 case was effective in treating group.ConclusionElectroacupuncture can improve the effect of routine therapy on acute incomplete spinal cord injury.

Little is known about the distribution of Rhodococcus equi in the soil environment of native horses in China. One hundred and eight soil samples were collected from native-horse farms in the Hulun Beier grasslands of eastern Mongolia, the Xilin Goler grasslands of southern Mongolia, and Tongliao city in Inner Mongolia of China for investigating the distribution of R. equi in these regions. The isolation rates of R. equi from soil samples from the Hulun Beier and Xilin Goler grasslands ranged from 25.9% to 30.0%. In contrast, isolation rates from soil samples from Tongliao city was as high as 82.3% and the mean number of R. equi in soil samples from Tongliao city was 10 times more than those of samples from the grasslands. The 488 isolates were examined using PCR for the presence of genes that encode virulence-associated 15 000-17 000 antigen protein (VapA) and the 20 000 antigen protein (VapB). All isolates were negative for virulence-associated proteins. Plasmid profiles of these avirulent isolates showed that cryptic plasmids of various sizes were present with an incidence of 13.3% to 21.5%. The results of the present study contrast with those of our recent study, in which we reported that R. equi was absent from Mongolian horses in Ulaanbaatar, Mongolia. It is suggested that the difference between the results of these two studies is due to the mobile pasturing system in Mongolia and nonmobile pasturing system in Inner Mongolia.