This article elaborated on the importance of collecting archives of drug clinical trails. Taking the drug clinical trial archives into account, the first value is the effort of clinical researchers. Sec-ond, the archives of drug clinical trials are the requirement to obtaining the evaluation before the new drug projects are approved. Third, the archives are the important evidence as getting professional certification from relevant drug research organizations and governmental officials. Making good drug clinical archive man-agement depends on the system and relevant regulations. A system should clarify the responsibilities of the collectors and managers for the archival materials. It also should make clear what are needs for collection, the rule of project numbering, and the rule of transferring. A good system also establishes the functionalities of monitoring and controlling. Last, the article pointed out the usual problem appeared in archive manage-ment of drug clinical trials.

This paper discussed the deviation of the intellectual property strategy applied in hospitals. The deviation, which is reflected on excessive enthusiasm and over-evaluation on research publication on the one hand, and negligence and insufficiency in the protection of whereas relevant patents and technique (commercial) secrets on the other hand. This deviation in the management can impede the hospital development in the long run. Measures should be taken to tackle this problem, which includesis, increasing the awareness, building up stimulation system, improving hospital cultural atmosphere, and training specialized administrators.

Animal models of endometriosis with traditional Chinese medicine (TCM) symptoms, not only provided a useful experimental method for TCM syndrome differentiation of endometriosis, also verified the pathogenesis of TCM of endometriosis, which offered the theoretical support for the clinic. This article discussed the establishment, result examination, existing limit, and solutions of animal models of endometriosis with TCM symptoms.

Objective To evaluate the clinical efficacy and safety between Alprostadil regular therapy in the patients with ischemic stroke. Methods We searched the electronic databases (WANFANG DATA,CNKI,and OVID) in order to obtain the randomized controlled trial (RCT)with interventions of lipo-prostaglandin E1 from January 1,2003 to March 1,2011. The methodological quality of the trials was assessed using four standards:random allocation program,allocation concealment,blind and quit.A meta-analysis of included clinical trials was performed with Revman 5.0 software. Results 13 trials were included and the data were divided into 3 groups by different outcomes,the effective rate(12 trials),the neurological deficit score(CCS,6 trials) and the daily life score (4 trials). Meta-analysis showed that after treatment,there were differences in neurological deficit (OR:-4.76,95％ CI:8.46,-1.06)and daily life(OR:0.95,95％ CI:-1.52,-0.38) between lipo-PGE1 treatment group and regular treatment group.The effective rate were higher in lipo-PGE1 treatment group than in regular treatment group (OR:3.75,95％ CI:2.45,5.75).The improvement in the overall symptoms of ischemic stroke after lipo-PGE1 therapy was better than regular treatment.In the occurrence of adverse reactions,18 cases appeared in lipo-PGEl treatment group(among which 11 cases were vascular stimulating reactions after injection),1 case in regular treatment group. Conclusions Lipo-prostaglandin E1 is an effective drug for ischemic stroke in view of its improvements in cure rate,neurological deficit and activities of daily life.

It is imperative to apply information technology in the area of management of clinical research so as to ensure the quality of clinical trials and to improve management efficiency.In this study,the based analysis method was the quality function deployment (QFD).This methodology is used to analysis the clinical trials management information system on a hospital directly under the Ministry of Health.It ensured user participation,lay a solid foundation for software engineers on system design.

Objectives The aim of the study was to establish a mouse model of endometriosis , and to observe the effects of endometriosis on the reproductive ability in the mice .Methods The mouse models of endometriosis was estab-lished by subcutaneous and intraperitoneal injection of heterogenous endometrium .The pregnancy rate and live embryo number in the experimental , sham operation and blank groups were observed and compared , and the effects of endometrio-sis on reproductive ability of the mice were evaluated .Results Two weeks after the establishment of the mouse model of endometriosis , there were lesions in the peritoneal cavity and subcutaneous tissue of the mice .Compared the pregnancy rates among the model group , sham operation group and blank group , the differences were statistically significant ( P<0.05).Compared the live embryo number in the three groups , there were also significant differences (P<0.05).Con-clusions A mouse model of endometriosis is successfully established , and it demonstrates that endometriosis may affect the reproductive ability of mice .

Objectives To evaluate the effect of a Chinese traditional medicine , Huoxue Xiaoyi Fang , on the embryo development after in vitro fertilization ( IVF ) in mouse models of endometriosis .Methods To observe the quantity of oocytes including the average number of superovulation , fertility rate, 2-cell and 4-cell embryo cleavage rates at different stages in vitro fertilization, and morulation rate among the traditional Chinese medicine group (TCM group), endometriosis model group ( EM model group ) and sham-operated group .To explore the influence of endometriosis and the effect of Huoxue Xiaoyi Fang on the quantity of oocytes and embryonic development after IVF in the mouse models of endometriosis.Results All the average number of superovulation , fertility rate, 2-cell and 4-cell embryo cleavage rates in the three groups showed significant differences (P<0.05), and the average number of superovulation was in an order of sham operated group >TCM group>model group .There were no significant differences in the morulation rates in the three groups (P>0.05).There were significant differences among the IVF rates of the three groups (P<0.05), and to be in an order of sham operated group >TCM group>model group .There were significant differences in the final morulation rate among the three groups (P<0.05).Conclusions Endometriosis may influence the quality of embryonic development of EM model mice, including reduced average number of superovulation , fertility rate, and embryo cleavage rate .The Chinese traditional medicine Huoxue Xiaoyi Fang can improve the the quantity of embryonic development after IVF .

Objective The purpose of this study was to evaluate the written project approval Indexes System of Capital Medical Ddevelopment Research Foundation.We analyzed the approval results of application projects and proposed measures to improve the index system.Methods We evaluated its reliability with Cronbach's alpha coefficient,split-half reliability; validity was evaluated with contract validity and content validity,discrimination was studies according to discretion grouping law,and feasibility was studied with the percentage-of-completion method.Results ① Reliability:Cronbach's alpha coefficient of factor and total scores'and split-half reliability were all over 0.80.②Contract validity:the standard factor loading coefficients of the index system were over 0.70 (range:0.57～0.86),indicating path performed well.All factor loading coefficients were statistical significant (T-values were 30.49～54.25,all were over 1.96).Fit Indexes (RMSEA =0.065、NNFI =0.99、IFI =0.99、CFI =0.99、GFI =0.95、AGFI =0.93、X2 =1028.21、X2/DF =11.82) indicated the system's goodness of fit was good.③ Content validity:Scale-level CVI,S-CVI was 0.97 and Interrater agreement was 0.93,over 0.90,which indicated that indexes system's whole Content validity performed well.Except for the item Academic thought item-level CVI being 0.57 all items' item-level CVI were 1.00.④Discrimination:Discrimination index of every primary index,secondary index and total score ranged from 0.51 to 0.76 (all were over 0.40),meaning that discrimination performed extremely well.Conclusion The indexes system's reliability,contract validity,content validity and discrimination conformed to the actual application projects appraisal results.

Objective To structure a preliminary indicators system for evaluating the projects of Hospital in finished phase.Methods With Delphi method,collect the experts' opinion of the importance of every item.With AHP (Analytic hierarchy process) method,calculate the weight coefficient of every item.Results The positivity of the experts was fine; The authority coefficient of two rounds were 0.859 and 0.833,the consultation results are reliable; The coordination coefficient of two rounds were 0.254 and 0.553,according to the significance test,p values were less than 0.05,indicating that the results were desirable.According to the score of every item,we got the weight index of every items based on the AHP method.Finally we structure the indicators system including 3 primary indicators and 10 secondary indicators.Conclusion The preliminary results of this study provide a reference for the performance evaluation of projects in finished phase of China-Japan Friendship Hospital.

ObjectiveTo explore the application of the Structure Equation Model on validity assessment of the evaluation indicator system,we studied Medical Capital Development Fund projects in 2007 to evaluate their construct validity.MethodsPart of the evaluation results (1200 items) were divided into two parts randomly.PART1 was used for Exploratory Factor Analysis (EFA) to explore the Indicator System' structure,and formed model F1.Confirmatory Factor Analysis (CFA) was used to assess the construct validity of model F1.With considerations of Modification Index(MI) and reality,F1 was modified into F3.At last,we take PART2 as the sample to confirm F3.ResultThe results of model F3 fit indices showed a better fit.All the path coefficients,estimated load factors and other parameters were statistically significant.ConclusionStructural Equation Model is professional,reliable and satisfactory for the evaluation of indicator system's contract validity.