OBJECTIVE:To introduce the experience of application and report for accreditation of drug clinical trial institution qualification of our hospital,to provide a reference for other hospitals. METHODS:From the building of institution,drug clinical trial ethics committee,clinical trials of listed drugs,simulated qualification accreditation,and other aspects,the experience and key points of application and report for accreditation of drug clinical trial qualification of our hospital were summed up. RESULTS& CONCLUSIONS:Priority should be given to staffing(particularly the leaders of the institution),the installation of software and hardware (for system development,training,institution office and specialized department),and the building of ethics committee. Departments should share work experience of clinical trials of listed drugs and set up a self-inspection group to simulate qualifica-tion accreditation. Work procedures and methods of qualification accreditation should be clearly understood,the requirements of Good Clinical Practice,the standards for qualification accreditation,should be known well;Good Clinical Practice should be seri-ously implemented and the subjects’rights and interests should be protected,which will contribute to the successful completion of application and report for qualification accreditation.

[Objective]To search for a good way for complex total hip arthroplasty(THA) and hip reconstruction.[Method]From February 1995 to June 2007,THA was done 95 hips in 86 patients with good preoperative preparation,full evaluatibn and complete simulation the details occurring at operation.[Result]Eighty one patients were followed up from 6 months to 10 years(average 3.5 years).All patients were measured by Harris score.The preoperative Harris score in the patients ranged from 35 to 50(average 42.1).The postperative score ranged from 70 to 90(average 82.3).Leg length discrepancy ranged from 1 to 12 cm preoperative.(average 4 cm),but from 0 to 5 cm postperative(average 1.5 cm).Two with serious leg length discrepancy,one is 6 cm,the other is 12 cm,after the operation,one is 2 cm,the other is 5 cm.Two had poor incision healing,upper femur split occurred in 3,one with hip prothesis dislocate,nerve injury happened in 2 and two had venous embolism.[Conclusion]Anatomic structure in complex total hip arthroplasty changes so much that it is hard to rebuild and replace a normal hip anatomic structure.Excellent clinical outcome can be achieved with full preparation and evaluation before operation and careful management at opertation.

Objective To investigate the effect of using massage by finger pressing to prevent the enteroparalysis which caused by continue atropine injection. Methods Divided 60 patients with severe organophosphorus poisoning into experimental group and control group randomly, there were 30 cases in each group.Routine nursing cares were used in the control group, the massage by finger pressing was added in the experimental group.Compared the correlative indexes such as the time of first defecation, the times of defecation, the number of patients with enteroparalysis, the time of cholinesterase reactivation between the two groups. Results By the statistic test, all the indexes which have mentioned above had significant differences between 2 groups,P

Objective To study the influence on primipara's second stage of labor with the methods of Changqiang-pressing and Vaginal-pressing. Methods 180 primipara in the second stage of labor were randomly divided into 3 groups of 60 each, in which Changqiang-pressing, Vaginal-pressing and general guidance (the control group) were used respectively. The duration of uterine contraction and second stage of labor, vaginal bleeding amount in 2 hours after delivery, mode of delivery, perineal injury and birth case would be evaluated. Results The results in both Changqiang-pressing group and Vaginal-pressing group were statistically significant when compared with the control group, but there was no significant difference between Changqiang-pressing group and Vaginal-pressing group. Conclusions Using Changqiang-pressing and Vaginal-pressing can promote the progress of the second stage of labor for primipara, reduce the rate of cesarean section and neonatal asphyxia, and improve the quality of obstetric department.

OBJECTIVE: To analyze the impact of extraction and nonextraction in soft tissue profile repair. METHODS: Databases of CNKI, Wanfang, VIP Chinese Periodical Database, CBM, Medline (ovid) and Science direct had been searched for studies of soft tissue profile after orthodontic treatment with and without extractions published in recent decade, with orthodontics, corrective, tooth extraction, soft tissue profile as key words. Hand searching was also done to obtain any further information about the studies. Meta analysis was used to comprehensively quantitatively analyze the upper (lower) lip with esthetic plane and soft tissue plane before and after extraction and nonextraction treatment. According to homogeneity test, fixed effect model and random effect model were adopted to calculate weighted mean difference (WMD) and 95% confidence interval (95% Cl).Revman 5.0 was used for data management. RESULTS: Five studies with 356 patients were included. Homogeneity test showed that lower lip-esthetic line and lower lip-soft tissue line Ⅰ~2 < 50%, without heterogeneity, so fixed effect model was adopted. Upper lip-esthetic line and upper lip-soft tissue line were more than 50%, indicating heterogeneity, so random effect model was adopted. Result of meta-analysis showed that, the WMD value and 95% Cl of lower lip-esthetic line, lower lip-soft tissue line, and upper lip-soft tissue line has statistically significance. CONCLUSION: The extraction treatment significantly decreased the distance of lower lip-esthetic line, lower lip-soft tissue line, and upper lip-soft tissue line.

Objective To investigate the effect of massaging Changqiang acupuncture point during the second labor course of primiparas. Methods 124 primiparas were randomized into the observation group(63 cases)and the control group (61 cases). In the observation group, after entering the second stage of labor, Changqiang point was massaged upwards by using index finger and middle finger, and at the same time primiparas were guided to hold breath to coordinate with uterine contraction to make effort to the anus point which was massaged. While the control group were directed with routine way of correctly using abdominal pressure during process of uterine contraction in the second stage of labor. Results The lasting time of uterine contraction was significantly longer in the observation group than in the control group, the time of second stage of labor was shorter, and the amount of postpartum hemorrhage in the observation group was less than those in the control group. Conclusions Application of massaging Changqiang acupuncture point could prolonge the time of uterine contraction, advance the progress of second stage of labor, and decreased the amount of postpartum hemorrhage.

Objective To explore the value of evaluating rat liver fibrosis using contrast enhanced sonography.Methods Carbon tetrachloride was used to induce liver fibrosis.Under the mode of pulse-inversion harmonic imaging,ultrasound contrast agent was bolus iniected through tail vein,hepatic artery arrival time(HAAT),portal vein arrival time(PVAT),hepatic vein arrival time(HVAT)was recorded,and their relationship with immunohistochemical results were analyzed.Results There was no statistical difference of HAAT,PVAT between two groups among S0-S4 stage.HVAT was shorter in S3 and S4 stage than in S0-S2 stage(P＜0.05).HVAT was negative correlated with the percentage of immunohistochemical positive area of C-Ⅳ,LN,the correlation coefficients were-0.680 and -0.639 respectively.Conclusions Contrast enhanced sonography is useful for the diagnosing liver fibrosis.

Objective To discuss the influence of parturition balloon on the labor course of primi-paras. Methods We divided 160 primiparas into the observation group and the control group with 80 cases in each group.We gave the observation group parturition balloon intervention with the help of midwife. Nursing measures in the control group were the same as those of the observation group except for the appli-cation of parturition balloon. We observed and compared the psychological status,pain;labor course,dehvery manner and postpartum hemorrhage between the two groups. Results The patients in the observation group got alleviation of psychological condition and pain.The rate of caesarean operation rate,postpartum hemorrhage and time cost of labor course were shortened,which were statistically different from those of the control group(P < 0.01 ). Conclusions Nursing intervention with parturition balloon for primiparas could alleviate pain of the patients, shorten time cost of labor course,improve rate of natural parturition and de-crease caesarean operation rate.It is a service model for delivery worthy of application.

Objective To evaluate the diagnostic value of tracking movement of normal patellar using volume scan on sensation 320 CT. Method Data of dynamic scans of 30 knees was collected using the motor function of 320 CT and retrospectively analyzed. The data of movement of the patellorfemoral joint was obtained during flexion (from 0° to 120°) within 10-sec by 320 CT from all volunteers. The 3D coordinate of the center of patella was recorded to investigate the dispose relation of patellofemoral joint.Result With the knee angle changed from 0° to 90°, the patella moved rapidly along the Y-axis direction ( sagittal plane) down about (53.87 ± 0. 45 ) mm, and then entered the plateau phase with little change.When the knee flexion reached 10°-30° ,the patellar movement along the X-axis reached the largest range of (2. 31 ±0. 52)-(3.36 ± 0. 43 ) mm, and subsequently moved to the opposite lateral direction with the maximum about (8. 53 ± 0. 44 ) mm at 120°. In the Z axis, the track initially showed plateau, and then presented a rapidly downward trend after 30°. The patellar tracking is like an outward arc during the whole knee flexion. Conclusion The motor functional imaging of 320 CT can pinpoint the patelar tracking in a fast, painless way.

Objective To investigate the difference among neonatal rat models of hypoxia-ischemia induced white matter injury of brain by three different methods and to provide theory basis on choosing the proper animal model for deep study on white matter injury of premature infants.Methods Three different hypoxia-ischemia methods were applied to induce brain white matter injury model of Wistar rats of postnatal 3rd day which were left carotid artery ligation followed by 6％ oxygen for 30 minutes and for 4 hours respectively,and bilateral carotid artery ligation followed by 8％ oxygen for 30 minutes.Compared brain pathological results of rats in different groups,changes in white matter of brain by glial fibrillary acidic protein (GFAP) and myelin basic protein (MBP) immunostaining,and changes in time of opening eyes and eyes appearance.Results Left carotid artery ligation followed by 6％ oxygen for 30 minutes resulted in sparse and vague periventricular white matter without necrotic lesions,and the degree of GFAP intensity [(5 021.63 ± 358.92) OD] increase and MBP intensity [(18 488.63 ± 1 822.62) OD] decrease were lowest (P ＜ 0.000 1),as well as the delay of opening time of the left eye.Left carotid artery ligation followed by 6％ oxygen for 4 hours resulted in necrotic lesions of periventricular white matter,with the degree of GFAP intensity [(6 069.13 ± 458.61) OD] and MBP intensity [(15 003.38 ± 1 559.11) OD],and also the delay of opening time of the left eye.Bilateral carotid artery ligation followed by 8％ oxygen for 30 minutes caused cystic necrosis of bilateral periventricular white matters,and the degree of GFAP intensity [(6 194.50 ±432.69) OD] increase and MBP intensity [(10 119.35 ± 735.16) OD] decrease of the left side were highest(P ＜ 0.000 1),as well as the delay of opening time and cataract in both eyes.Conclusion Left carotid artery ligation followed by 6％ oxygen for 30 minutes is more suitable for investigating mild brain white matter injury.Left carotid artery ligation followed by 6％ oxygen for 4 hours and bilateral carotid artery ligation followed by 8％ oxygen for 30 minutes are more proper for the investigation of severe periventricular leukemacia cases.