RESUMO
Items of design and signature from clinical trial drugs were made , the occurrence ratio of every item in 2265 informed consent form ( ICF) from 63 clinical trial drugs in Beijing Youan Hospital affiliated to Capital U-niversity of Medical Sciences were analyzed , and items with lower occurrence ratio were explored .Generally , the design and signature of ICF met the requirement of GCP .However , there were some defects of ICF and antonym of signature .Based on the analysis on the problems , some measures were put forward:formulate relevant standard op-erating procedures , strengthening the management of informed consent , and strengthen the system construction and education training , promote the hospital ethics construction , to protect the rights and interests of the subjects .
RESUMO
[Objective] To observe the clinical effect of digestive ulcer treated with TCM simple somatotype combined with Pantoprazole. [Method] Divide 160 cases into 2 groups;the treatment group 80 cases took TCM simple somatotype combined with Pantoprazole, the control one 80 cases only Pantopra-zole. Both groups had 2 courses, 4w as a course. [Result] Comparing both groups cure effects, the total effective rate was 96.3% for treatment one, and 88.8% for control one, their difference had statistical meaning. [Conclusion] Combination of TCM and WM treating digestive ulcer can improve clinical cure rate and total effective rate, as wel as gastroscope cure rate.