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 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 investigate the effects of Pantoprazole on the expression of TFF1 in stress-induced gastric mucosal lesions in rats, and the mechanism thereof. Methods: Fifty-six rats were randomly divided into seven groups, normal group, model groups (3 groups) and model therapy groups (3 groups). The rat model of water immersion- restraint stress (WRS) was established in model groups, model group1(the immediately after establishing models), model group 2 (4 h after establishing models) and model group 3(8 h after establishing models). The model therapy groups were divided into model therapy group 1 (immediately after establishing models), model therapy group 2 (4 h after establishing models), and model therapy group 3 (8 h after establishing models). The ulcer index (UI) and histological changes were observed after WRS in rats. The expression of TFF1 was detected by immunohistochemistry. Results: After WRS, the gastric mucosa was widely damaged in rats. UI were increased and the expression of TFF1 was decreased in model groups. After intervention with Pantoprazole, UI was lower in model therapy group than those in model groups (model group 1 vs model therapy group 1,69.13±1.97 vs 23.38±1.30, P ＜ 0.01; model group 2 vs model therapy group 2, 57.50±8.81 vs 10.38±3.02, P ＜ 0.01; model group 3 vs model therapy group 3, 43.50±6.76 vs 5.88±1.25, P ＜ 0.01). The staining scores of TFF1 were increased (model group 1 vs model therapy group 1, 0.55±0.11 vs 0.92±O.15, P＜ 0.01; model group 2 vs model therapy group 2, 0.76±0.24 vs 1.36±0.21, P＜ 0.01; model group 3 vs model therapy group 3, 1.12±0.16 vs 1.65±0.11, P ＜ 0.01). Conclusion: TFF1 may participate in the protection of gastric mucosa and promote ulcer recovery. Pantoprazole may participate in the defense of gastric mucosa through mediating the up-regulation of TFFI expression.

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 observe the efficacy of high-energy red light combined with human-like collagen dressing in treatment of facial corticosteroid addictive dermatitis.Methods Eighty-three patients with facial corticosteroid addictive dermatitis were divided into treatment group (42 cases) and control group (41 cases) by random digits table method.All patients in 2 groups were treated with ebastine 10 mg,once a day,and vitamin E cream,twice a day.At the same time,the patients in control group were given human-like collagen dressing,once a day in the first week,then 3 times/week.On the basis of control treatment,the patients in treatment group were irradiated with high-energy red light 10 min in face,2-3 times/week.The treatment of both groups lasted for 12 weeks.The symptoms,skin lesions and untoward reaction were observed after treatment of 4,8 and 12 weeks.Results After treatment of 4 weeks,there was no statistical difference in the effective rate between 2 groups (P ＞ 0.05).After treatment of 8 and 12 weeks,the effective rates in treatment group were significantly higher than those in control group [83.3％(35/42) vs.58.5％ (24/41),90.5％ (38/42) vs.65.9％ (27/41)],there were statistical differences (P ＜ 0.05).No untoward reaction was found in 2 groups.Conclusion High-energy red light combined with human-like collagen dressing is effective and safe in treatment of facial corticosteroid addictive dermatitis.

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 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 evaluate the effect of oral roxithromyein on lung function in chronic obstructive pulmonary disease (COPD) and analyse the probable mechanism. Methods Fifty patients with COPD were divided randomly into treatment group (25 eases) and control group (25 eases). The control group was treated with base therapy, and the treatment group was treated with oral roxithromycin beside base therapy, 0.15 g, twice one day for one year. Then the changes of peripheral blood neutrophil and lung function was observed before and after treatment, and the times of acute exacerbation were statistically analyzed.Results There was significant difference in the changes of peripheral blood neutrophil in treatment group (P<0.05). The ratio of forced expiratory volume in one second and forced vital capacity (FEV_1/FVC),FEV_1% pred, peak expiratory flow, maximal vital volume had no obvious change in treatment group (P>0.05), but had obvious decrease in control group (P<0.05 ). There was significant difference in the changes of lung function in two groups(P<0.05 ). The times of acute exacerbation were 10(40%) in treatment group and 19 (76%) in control group, and the times of need to be in hospital were 6 (24%) and 13 (52%)respectively. There were significant difference (P<0.05). Conclusion Long-term oral roxithromyein can protect the lung function of COPD patients, the probable mechanism is that roxithromyein inhibit the neutrophil's function.