《涉及人的生物医学研究伦理审查办法》规定医疗卫生机构未设立伦理委员会的,不得开展涉及人的生物医学研究工作.目前,国内部分医疗卫生机构特别是基层医疗卫生机构仍未建立伦理委员会,部分医疗卫生机构虽建立了伦理委员会,但是审查能力薄弱,无法保证高质量的伦理审查,无法保护受试者,无法实施部分涉及人的生物医学研究;部分高风险项目的审查建议和/或审查结论存在争议,不能被其他伦理委员会/申办方/研究者认可.委托审查是可行的解决途径.结合委托审查的实践,阐述了委托审查的由来、需求、现状、实践、思考及意义.

OBJECTIVE:To study the relation between psychological symptoms and physical parameters in patients with severe acute respiratory syndrome (SARS) at different stages of the disease.METHODS:Physical parameters such as SCL-90, chest CT, T lymphocytes and subset and SaO2 were studied in 29 SARS patients at three different stages (initial stage, serious stage, rehabilitating stage).RESULTS:Patients with SARS showing severe psychological symptoms constituted about 41% (group I) and patients with SARS showing mild psychological symptoms (group II) constituted about 59%. There were no change of the psychological symptoms at the three stages in group I and II (P > 0.05). Statistical differences were found between physical parameters of group I and II in rehabilitating stage.CONCLUSIONS:Severe psychological symptoms such as obsession, depression and anxiety were found in a minority of patients with SARS and the psychological symptoms were not related with the change of physical parameters. The majority of the patients with SARS did not have severe psychological symptoms. Whether or not psychological symptoms were related to their personality needs further study.

1.材料与方法:(1)研究对象:1990年1月至2000年1月住院患者1005例,均经肝组织活检病理证实为慢性肝炎,男性814例,女性191例,年龄5～75岁,平均年龄33岁.病原学诊断:慢性乙型肝炎病毒感染者718例,慢性丙型肝炎病毒感染者36例,两种以上嗜肝病毒感染者251例.所有病例无肝硬化失代偿期的临床表现,并排除血液病合并感染或其他影响外周血细胞的因素.

BACKGROUND:To assess the effect of recombinant human growth hormone (rhGH) therapy to liver cirrhosis patients with hypoproteinemia.METHODS:31 liver cirrhosis patients were treated with rh GH (0.25 IU/kg/day-) and 20 such patients with human albumin (10 g/day) as control all for 10 days. Serum levels of growth hormone (GH), insulin-like growth factor (IGF)-1 and albumin (ALB) were measured by radio-immunoassay before 24h and after 24h and 10 days of rhGH therapy. Serum levels of GH and IGF-1 of 10 age matched healthy subjects were also measured.RESULTS:As compared with healthy subjects, the pretreatment serum GH level of liver cirrhosis patients was high (4.96 +/- 3.97 vs 1.62 +/- 2.26, P <0.05), and the IGF-1 level was markedly lower (36.53 +/- 12.77 vs 56.95 +/- 16.46, P <0.01). After 10 days of rhGH administration, the serum IGF-1 and ALB levels of the treated group increased significantly as compared with the control group (P <0.01).CONCLUSIONS:Exogenous rhGH therapy can overcome the GH resistance of liver cirrhosis patient s and can increase significantly the serum albumin level as compared with the control group who were treated with human albumin only.

OBJECTIVE:To investigate the location and distribution of transfusion transmitted virus (TTV) in the liver and extrahepatic tissues.METHODS:TTV DNA was detected in paraffin-embedded autopsy liver and extrahepatic tissues, including liver, pancreas, kidney, spleen, testicle, and heart from 13 patients with non A-G hepatitis by nested-PCR and in situ hybridization (ISH) techniques.RESULTS:Positive hybridization signals of TTV nucleus acid were observed in 5 liver, 3 kidney, 2 pancreas and spleen tissues, respectively. TTV DNA was detected in one from each two samples of testicle and heart. Positive signal was mainly located in nucleoli of the liver and extrahepatic parenchymal cells. There was not obvious pathological damage in those extrahepatic tissues. The positive rate of PCR approximately corresponded to ISH.CONCLUSIONS:TTV can infect hepatic and extrahepatic tissues and its infection in extrahepatic tissues might be responsible for a state of reinfection and higher prevalence in different population.

1997年底，日本学者报道了一种与肝功能异常有关的DNA病毒，并命名为TT病毒(TTV)[1]。为了解我国病因不明肝炎患者中TTV感染状况，我们采用聚合酶链反应(PCR)和原位杂交的方法检测了血清及肝组织中TTV表达情况，现报道如下。