OBJECTIVE:To explore the method for the scientific and standard management of clinical trial drugs. METHODS:By theory analysis and empirical analysis,the management model of clinical trial drugs in our hospital was introduced in terms of software and hardware construction of clinical trial pharmacy,the formulation of drug management system and standard operation procedure,regular quality control and drug information management platform construction,etc. RESULTS:In the experience of our hospital,it could safeguard the safety of drug use in subjects and scientificity and preciseness of drug clinical trial results through the concentrated administration trial drugs by full-time pharmacists according to national laws and regulations,management system and standard operation procedure,and regular quality control inspection by quality control group. CONCLUSIONS:Drug clinical trial institute strictly abide the requirements of Good Clinical Practice,strengthen the management of trial drugs and im-prove information management continuously,which is of important significance to construct standardized,detailed and high-effi-ciency centralized management system of clinical trial drugs.

Objective:To investigate the types of cervical epithelial cells and the Human Papillomavirus (HPV) infection subtypes of 7 646 women specimens in Anhui province, and provide evidence for cervical cancer prevention.Methods:Thinprep cytologic test (TCT) and flow fluorescence hybridization technique were used to detect cervical epithelial lesions and HPV subtypes.Results:The total positive rate for TCT was 20.25%, and the positive rate was the highest in ≥ 60 age group (28.41%), followed by 10 to ≤ 19 age group (26.32%). The atypical squamous cells-undetermined significance (ASC-US), cannot exclude high-grade squamous intraepithelial lesion (ASC-H) and HSIL positive rates were the highest in the ≥60 age group, and the low-grade squamous intraepithelial lesions (LSIL) positive rate was highest in the 10-19 age group. The proportion of patients with 40-49 age group was the highest, and that of ≥60 age group was the highest. The single infection rate of different cervical epithelial cell lesions was higher than that of multiple infection rates. As the deepening degree of the lesion, the high-risk single infection rate of HPV showed a increasing trend from ASCUS, LSIL, ASC-H to high-grade squamous intraepithelial lesions (HSIL); The common subtypes of HPV infection in negative for intraepithelial lesion or malignancy (NILM) are 52, 16, 58, 53 and 6. The common subtypes of ASCUS are 52, 16, 53, 58 and 51. The common subtypes of ASC-H are 18, 58 and16. LSIL common subtypes are 16, 52, 56, 58, 53 and 66, HSIL common subtypes are16, 58, 33, 52 and 59 type.Conclusions:The high risk and single genotypes of infection were dominant in different cervical epithelial cell lesions in Anhui. Women who aged ≥60 should pay attention and regularly undergo HPV testing and cervical cancer screening. The HPV infection subtypes of different cervical epithelial cell lesions are different, and the common subtypes are HPV52, 16, 58, 53, among which types 16, 58 and 33 are common infection subtypes detected in different lesions.