Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.
China ; Clinical Trials as Topic ; standards ; Drug Evaluation ; Drug Therapy ; standards ; trends ; Drugs, Chinese Herbal ; standards ; therapeutic use ; Humans ; Quality Control ; Research

Objective To understand the water quality of centralized water supply in Shanghai and provide the scientific data for further improvement of the health inspection and management of centralized water supply. Methods The management situation of centralized water supply, the water quality of water source, product water and tap water were investigated by using the methods in Analytical Methods for Water and Sanitary Standard for Drinking Water Quality (2001) in Shanghai in 2006. Results The current situation of management of 165 units of centralized water supply including 19 self-supply water plants in Shanghai was satisfactory. The analysis of drinking water showed that COD and total coliform in source water exceeded the standard limit remarkably(the eligible rates were 63.93% and 22.95% respectively), the eligible rates of COD, turbidity and manganese in product water and tap water were 25.45%, 18.18%, 27.88% and 18.06%, 13.89%, 11.81% respectively. Conclusion The results of the present investigation show that in Shanghai the main problems about the water quality are water source contamination by organic pollutants and the undeveloped water treatment.

Objective:To detect the expression of cyclin B 1 in human ameloblastoma(AB). Methods:Expression of cyclin B1 was detected in 73 cases of AB (32 primary, 33 recurrent and 8 malignant cases), 19 of odontogenic keratocyst (OKC) and 7 of normal oral mucosa by streptovidin-biotin method. Results:The ratio of positive nuclear expression of cyclin B 1 in normal oral mucosa, OKC and AB was 28.6%(2/7), 36.8%(7/19) and 63.0%(46/73) respectively (P

Objective To explore the clinical effect of application of mechanical insufflation-exsufflation (MI-E) for airway mucus clearance in patients with artificial airway.Methods 72 patients were divided into the observation group (36 cases) and the control group (36 cases)according to admission order by random number table.All subjects were given with individual treatment and nursing,while the control group was given with the application of rock sputum ejection machine twice per day,the observation group was given with application of both cough assist and rock sputum ejection machine for sputum excretion.The clinical effect of airway mucus clearance after 5 days' treatment was compared between two groups.Results Compared with the control group,oxygenation index after 5 days' treatment in the observation group increased [(48.16±9.57) kPa vs.(37.99±14.67) kPa,t=-3.48,P＜0.01],clinical pulmonary infection score [(3.39±0.77) scores vs.(5.33±1.47) scores] and procalcitonin level [0.10 (0.07,0.27) μg/L vs.0.43 (0.12,0.79) μg/L] were lower (t=-7.02,Z=-3.28,P＜0.01),the mean sputum amount was bigger [(3.64±0.43) ml vs.(2.31 ±0.44) ml] (t=-4.84,P＜0.01),and the mean interval of suction was longer [(97.81 ±7.28) min vs.(82.00±8.88) min](t=-3.08,P＜0.05).Conclusions MI-E can clear the airway secretion effectively so as to improve oxygenation and the inflammatory markers.And MI-E is a simple,noninvasive and safe technique.

This review focus on the progress of the treatment of obstructive sleep apnea-hypopnea syndrome by using positive airway pressure and upper airway multilevel surgeries. OSAHS is a disease caused by multiple etiologies. We should consider upper airway anatomical abnormalities and the severity of OSAHS before reasonable treatment plans were formulated. "PAP-surgery-PAP" is the classic procedure for treating moderate OSAHS and severe OSAHS. Preoperative use of PAP could reduce the hypoxic condition of patients and decrease surgical risk. Surgery can effectively reduce the optimal PAP pressure value, and increase the tolerance of patient. Postoperative use of PAP can improve surgical efficacy, shorten patient recovery time. However, the influence of different surgical methods on optimal PAP pressure value is lacking in large samples. More related studies need to be per formed in the future.
Continuous Positive Airway Pressure ; Humans ; Respiratory System ; surgery ; Sleep Apnea, Obstructive ; surgery ; therapy ; Treatment Outcome

Objective:To isolate the genes induced by Ty21a. Methods: Prepare the intestinal cells of Balb/C mouse with and without Ty21a immunization, extract the polyA+ RNA, synthesize the dscDNA by using reverse transcription-PCR,get the differentially expressed genes by suppression subtractive hybridization(SSH).Results:Seven genes were novel genes revealed by GenBank searching whose expression were probably induced by Ty21a were isolated by SSH and cDNA microarray. The full length cDNA sequence of three genes are now obtaining through RACE-PCR. Conclusion: SSH is an effective method for isolating the differentiatlly expressed genes; High throughput cDNA microanay is a credibility method to profile changes in gene expression; Ty21a can induce the expression of some new genes related to immune.

Objective:To observe the effects of auricular point sticking on pain and anxiety during the latent period of the first stage of labor in primiparas. Methods:Primiparas meeting eligibility criteria were recruited.The participants were randomized into an auricular point group,a placebo group,and a control group.The control group received daily care.The auricular point group received 120 min of auricular point sticking therapy.The placebo group received the same auricular plasters as the auricular point group but without pressing.Participants'pain,anxiety,and uterine contractions were measured at enrollment and 30,60,and 120 min of interventions. Results:Data from 78 participants were analyzed in this study.After uterine contraction was adjusted as a covariate,there was no significant difference among groups in the baseline anxiety,baseline pain,and anxiety at 30-min intervention(P>0.05),and no significant difference between the placebo group and the control group in each indicator at each time point(P>0.05).The anxiety scores of the auricular point group at 60 min and 120 min were lower than those of the placebo group and the control group(P<0.05).The pain in the auricular point group was less than that in the placebo group and the control group at 30,60,and 120 min of interventions(P<0.05). Conclusion:Auricular point sticking therapy can relieve anxiety and pain in women during the latent period of labor.Moreover,the effect is fast-acting.It can be used as a safe and effective complementary therapy.

Objective To analyze the drug resistance of Helicobacter pylori (H.pylori) in nodular gastritis in children and to further explore the rational use of antibiotics for drug-resistant H.pylori strains. Methods A total of 473 children with upper gastrointestinal symptoms undergoing gastroscopy from January 2013 to June 2014 in our hospital were enrolled. Two pieces of gastric antral mucosa in children with nodular gastritis were collected for H.pylori rapid urease test and H.pylori culture. The resistance of H.pylori to amoxicillin, clarithromycin, metronidazole, moxilfoxacin and levolfoxacin was detected by agar dilution method and E-test. Results In 473 cases of nodular gastritis, 258 cases were H.pylori culture-positive. The resistance rate of H. pylori isolates to amoxicillin, clarithromycin, metronidazole, moxilfoxacin, levolfoxacin was 6.2%, 34.9%, 49.2%, 8.9%and 5.0%, respectively. Dual resistance to clarithromycin and metronidazole was 23.3%. Moreover, 405 cases had a family history of H.pylori infection. Conclusions Nodular gastritis is a special sign of H.pylori infection in children. H.pylori infection has obvious familial aggregation. The low resistance rate of H.pylori to amoxicillin in children with nodular gastritis indicates that amoxicillin can be used as the main drug for eradication of H.pylori. Meanwhile, clarithromycin should be applied according to the drug sensitive test due to high resistance rate of H.pylori to clarithromycin.

Objective To investigate the application effect of nasal gastrointestinal double lumen catheter tube placement with air insufflation in mechanically ventilated patients with intra-abdominal hypertension.Methods A total of 20 patients with intra-abdominal hypertension were randomly divided into control group and observation group (n=10 in each group).Patients in control group received indwelling nasogastric tube for decompression and indwelling nasal intestine tube by air insufflation for enteral nutrition support .Patients in observation group received the dual lumen gastrointestinal tube for decompression and enteral nutrition support.The time required for catheterization,changes in intra-abdominal pressure before and after air insufflation,catheter success rate at one attempt,pain scores of patients to catheter operation, duration of decompression,enteral nutrition start time and the duration of mechanical ventilation were compared between two groups.Results The time required for catheterization,catheter air insufflation volume in observation group were significantly lower than those in control group (P <0.01);pain scores of patients to catheter operation were significantly lower in observation group than those in control group (P <0.01);There was no significantly difference in once catheter success rate,changes in intra-abdominal pressure before and after catheterization,abdominal high pressure relief time ,enteral feeding start time, and duration of mechanical ventilation between the two groups (P >0.05 ).Conclusions The technique of air insufflation has higher success rate for Indwelling nasal intestine tube in mechanically ventilated patients with intra-abdominal hypertension,and this method is safe and reliable,dual lumen gastrointestinal tube can improve patients'comfort,shorter catheterization time and reduce catheter air insufflation volume.

0.05), respectively; the costs were 640.50yuan and 1 151.21yuan, respectively; the cost-effectiveness ratios were 7.01 and 12.28, respectively; the incremental cost-effectiveness ratio of Group B versus Group A was 220.1. CONCLUSION: The sequential therapy of levofloxacin is preferable in the treatment of lower respiratory infection.