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Objective:To analyze that if the quality of ethics review is closely related to the protection of human subjects' right and interest. Methods:This article has analyzed all the issues raised by local Ethics Committee in the process of review in recent two years since guideline of ethical review of drug clinical trials was published, summed up the most common problems occurred in protocols and informed consents. Results:Total 94 new drug or medical device clinical trial projects were reviewed by the local ethics committee, among which 29 projects were ap-proved through regular full board meeting, the approval rate in the initial review was 31%. The most common prob-lems in protocols include: the research backgrounds, design, and risk-benefit ratio; Main issues raised on in-formed consent focused on the contents, language and signature terms. Conclusions:The protection of subjects needs more improvement of capability of investigator, sponsor, drug clinical trial institution and the ethics commit-tee.
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Objective The clinical features of elderly patients with severe acute pancreatitis (SAP) were atypical and these patients were often misdiagnosed as having paralytic ileus. The clinical presentations of elderly patients with SAP whose first diagnosis as paralytic ileus were analyzed. Methods 18 patients of elderly SAP who were misdiagnosed as having paralytic ileus were included and the clinical data were compared with 58 elderly patients with SAP. Results Among the misdiagnosis group, the first symptom onset were fleus, abdominal distension, vomiting, constipation, abdominal pain, diarrhea for 5, 4, 3, 3, 2, 1 case, respectively. Among SAP group, the first symptoms onset were 2, 31, 9, 3, 11, 2 cases, respectively. For misdiagnosis group, 13 cases were correctly diagnosed by CT scan, 3 cases by ultrasound and 2 cases by serum amylase test. For SAP group, 32, 15, 11 cases were diagnosed by CT scan, ultrasound and serum amylase, respectively (P < 0.05). 4 and 13 patients died in misdiagnosis and SAP group, respectively; among these 13 patients, 10 were female and 3 were male. Conclusions The elderly patients with paralytic ileus should consider the possibility of SAP, and CT scan was valuable for correct diagnosis.
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Objective To study on the activity of intestinal mucosal mast cells (IMMC) in dextran sulfate sodium ( DSS) induced colitis of rats. Methods Acute colitis was induced by giving 3% DSS orally. Eighteen male rats were randomized into DSS group ( n = 10 ) and normal control group ( n = 8). The rats in DSS control group drank 3% DSS solution from day 1 to day 7; those in normal control group drank water at random. Diarrhea and bloody stool as well as colonic histology were observed. The levels of colonic tissue histamine, tumor necrosis factor-a (TNF-a) and Prostaglandin E2 ( PGE2) determined with fluorimetry and ELISA, and the expression of IMMC in colonic tissue was detected by histochemical stain method. Results Compared with normal control group, the inflammatory symptoms and histologjcal damages of colonic mucosa in DSS group were significantly presented. The level of histamine in colonic tissue was significantly reduced (P