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

Adult ; Critical Illness ; Extracorporeal Membrane Oxygenation ; methods ; Female ; Humans ; Myocarditis ; therapy

ObjectiveTo investigate the significance of hearing screening combined with gene screening for neonates with high-risk of hearing impairment.MethodsNeonates admitted to the Neonatal Department of Guangdong Women and Children Hospital between July 2013 and June 2014 were enrolled in this study. They were divided into high-risk group (with high-risk for hearing impairment) (n=3 129), and control group (n=5 106). Neonate hearing screening was carried out using otoacoustic emission and automated auditory brainstem response. Blood samples were collected using a standard protocol for detecting the mutations of four common deafness genes, includingGJB2,GJB3,SLC26A4 and mitochondrial 12s rRNA.Chi-square test was used to compare the differences of the pass rate of hearing screening and positive rate of gene mutations between the two groups.ResultsThe rates of failure on otoacoustic emission, automated auditory brainstem response or both in the high-risk group were 11.92% (373/3 129), 10.32% (323/3 129) and 4.83% (151/3 129), respectively, higher than those in the control group [5.03%(257/5 106), 6.56%(335/5 106) and 2.02% (103/5 106)] (χ2=130.265, 37.354 and 51.196, allP=0.000). In the high-risk group, the overall positive rate of gene mutations was 5.63% (176/3 129), and theGJB2 andSLC26A4 gene mutation rates were 3.04% (95/3 129) and 2.40% (75/3 129)], all higher than the control group [3.15% (161/5 106), 2.04% (104/5 106) and 1.06% (54/5106)] (χ2=30.301, 8.216 and 22.517, allP<0.01). But the mitochondria 12S rRNA gene andGJB3 gene mutation rates were the same in high-risk group and control group [0.19% (6/3 129) vs 0.06% (3/5 106); 0.03% (1/3 129) vs 0.00%(0/5 106), bothP>0.05]. The rates of failure on otoacoustic emission and automated auditory brainstem response of the neonates with deafness gene mutations were 9.50% (32/337) and 10.39% (35/337), respectively, higher than the neonates without [1.14% (90/7 898) and 1.29% (102/7 898)] (χ2=154.621 and 163.399, both P=0.000).ConclusionCombined hearing screening is of clinical significance for neonates with high-risk of hearing impairment.

Objective To generate a prokaryotic expression system of Salmonella paratyphi A nmpC gene that encoding an outer membrane protein(OMP),and to determine immunogenicity and immonuprotection of the recombinant expressed product rNmpC and carrying and expression frequencies of the nmpC genes in isolates of S.paratyphi A.Methods A nmpC gene clone was obtained from a clinical S.paratyphi A strain JH01 by PCR and T-A cloning method,and then a prokaryotic expression system of the gene clone was generated.SDS-PAGE and Bio-Rad Agarose Image Pattern Analysis System were applied to examine the expression and yield of rNmpC.Antigenicity and immunoreactivity of rNmpC were determined by immunodiffusion test,Western blot assay and micro-Widal's test.The carrying and expression rates of nmpC genes in 98 S.paratyphi A isolates were detected by PCR and ELISA.By a mouse infection model,the immunoprotective effect of rNmpC against the lethal challenge of S.paratyphi A was determined.Results All the cloned nmpC genes had 100% nucleotide and putative amino acid sequence identities compared to the reported sequencing data.The expression yield of rNmpC was approximately 30% of the total bacterial proteins.rNmpC could efficiently induce rabbits to produce specific antibody and present positive Western hybridization signals with S.paratyphi A antiserum.All the tested S.paratyphi A strains have nmpC gene as well as express NmpC protein,but no nmpC gene could be detectable in S.typhi,S paratyphi B and S paratyphi C.Immunization with 100 μg and 200 μg rNmpC contributed 41.7%(5/12) and 66.7%(8/12) immunoprotective rates in mice,respectively.The sera from rNmpC immunized mice and survival mice in the NmpC is an unique OMP antigen of S.paratyphi A with conserved sequence,extensive distribution and natural expression.This OMP can be used as one the candidate antigens for developing multiple-valence genetic engineering vaccine of S.paratyphi A based on its fine immunogenicity and certain immunoprotection.

Electrophoresis, Gel, Two-Dimensional ; methods ; Humans ; Proteomics ; methods ; Urinalysis ; methods

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 analyze the clinical characteristics, short-term and long-term outcome, overall survival and prognosis of nasal-type,natural killer T-cell lymphoma(NK/TCL) patients. Methods Clinical data of 45 patients with nasal NK/T cell lymphoma from Jan 2001 to Dec 2008 were analyzed retrospectively. Results The complete remission rate was 53.3% (24/45)and the partial remission rate was 17. 8% (8/45), the overall response rate was 71.1% (32/45). At a median follow-up of 15 months, the 1-year,3-year and 5-year survival rates were 68. 3% ,57. 1% ,and 43. 7% respectively. Multivariate analysis showed that B symptoms was independent prognostic factors of NK/TCL( P = 0. 001 ). Conclusions NK/TCL showed specific characteristics, and the long-term survival rate is still poor. Investigation of optional treatment is needed.

Objective To analyze the clinical outcomes of Ludloff osteotomy and artificial metatarsophalangeal arthroplasty in the patients with severe hallux valgus and metatarsophalangeal joint osteoarthritis.Methods From Apr.2013 to Aug.2015,120 feet with severe hallux valgus were treated by operation in Beijing Friendship Hospital,Capital Medical University.Before operation,measured some angles,such as hallux valgus angle,intermetatarsal angle,proximal articular surficial intrinsic angle and so on in the two groups.And evaluated the patients condition by Maryland scale at the same time.Through the date,we make sure that there was no significant difference between the two groups before operation.According to the order of hospitalization,all patients were randomly divided into experimental group (n =60) and control group (n =60).The cases of experimental group were treated by Ludloff osteotomy and artificial joint replacement.The cases of control group were treated by Ludloff osteotomy and Akin osteotomy.We used the visual analogue scale,the core quality of life scale-36 and Maryland scale to record the date,such as pain,the range of motion and appearance of the metatarsophalangeal joint and the ability of daily life and sports before and after operation.Compared above categorical variables using paired T-test between before and after operation and using T-test between the two groups.Compared the rate of operative complications by Fisher's exact test between the two groups.Results Through the Maryland scale,the total excellent rate of the experimental group (91.7％) was higher than the total excellent rate of the control group (75.0％),with statistically significant (P ＜ 0.05).The operative complication rate of experimental group (1.7％) was lower than the control group (8.3％),but without statistically significant (P ＞0.05).The scores of quality of life of the experimental group after treatment were significantly higher than those of the control group,with statistically significant (P ＜ 0.05).The visual analogue scale pain score (1.61 ± 0.12) of the experimental group was significantly lower than the control group (3.68 ± 0.58),with statistically significant (P ＜ 0.05).Conclusion The clinical outcomes of Ludloff osteotomy and artificial metatarsophalangeal arthroplasty in patients with severe hallux valgus and metatarsophalangeal joint osteoarthritis is better,high safety,less trauma and faster recovery.It is worthy of promotion and use.

Objective To evaluate the effects of arterial pressure continuous output (APCO) derived from stroke volume variation (SVV)-guided fluid management in the patients undergoing supratentorial neoplasms surgery.Methods Sixty-three patients (29 males, 34 females, aged 18-65 years, ASA physical status Ⅰ or Ⅱ) undergoing elective supratentorial neoplasma surgery were randomly divided into control group (group C, CVP-guided fluid management, n=30) and GDT group (group S, SVV-guided fluid management, n=33).Before the induction of general anesthesia, the hydmxyethyl starch Voluven (130/0.4) bolus 3 ml/kg in the two groups was administered followed by infusion of crystalloid at the rate of physical requirement.Hydroxyethyl starch or vasoactive agents were administrated to achieve the goal of CVP≥8 mm Hg or MAP>80% of baseline in group C andto reach the value of SVV≤12% and MAP>70% of baselinein group S.Intraoperativecrystal, intraoperative colloids,total fluid volume, bleeding volume, volume of blood transfusion and urine volume were recorded.The radial artery and venous blood was sampled for blood gas analysis, measurement of lactate concentration and laboratory parameters at 30 min before anesthesia induction (T0), the dura mater cutted (T1), end of operation (T2) and postoperative 24 h (T3).Postoperative complications and the number of patients with complications in postoperative period, the length of ICU stay and postoperative days were assessed.Results Total infused fluid volume [(1 478±312) ml vs (1 183±294) ml] and intraoperative colloids [(775±236) ml vs (487±243) ml] were significantly higher in group S than those in group C (P<0.05).Compared with T0, the lactate concentration were decreased significantly in two groups at T1 and T2.The lactate concentration in group S was significantly lower than group C at T2 [(0.91±0.25) mmol/L vs (1.31±0.46) mmol/L](P<0.05).There was no significant difference of postoperative complications, the length of ICU stay and postoperative days between two groups.Conclusion Fluid management guided by SVV during supratentorial neoplasms surgery reduces lactate levels.

Abstract?AIM: To analyze the clinical effects of partial rectus muscle transportation procedure for paralytic strabismus due to single rectus muscle paralysis.?METHODS:The conditions of 22 patients (25 eyes) who underwent partial rectus muscle transportation procedure for paralytic strabismus due to single rectus muscle paralysis were retrospectively reviewed. The following data were analyzed:1 ) the angle of deviation of primary position; 2 ) the presence of diploma in the primary position;3) the presence of compensatory head posture;4) the motility of the affected eye.All of the patients attended 6mo postoperative follow-up examinations.?RESULTS: According to the results of examinations before and during operation, different operations were performed:2 eyes were treated with partial rectus muscle transportation, 20 eyes were treated with recession of antagonistic muscle of paralytic rectus muscle combined with partial rectus muscle transportation, 3 eyes were treated with recession of antagonistic muscle, partial rectus muscle transportation and recession of yoke muscle.Twenty patients were orthotropia in the primary position, the diploma and abnormal head posture were eliminated. Two patients with binocular lateral rectus muscles paralysis were in mild undercorrection which were resolved by wearing 8△and 10△prisms respectively. The procedure improved strabismus of 25 eyes from 100.23△ ± 42.61△ preoperatively to 0.82△ ± 2.67△postoperatively ( t=10.797,P<0.001).Ocular movement was improved from -4.52 ±0.51 preoperatively to -2.68 ± 0.63 postoperatively (t=-19.468, P<0.001).? CONCLUSION: Partial rectus muscle transportation procedure for paralytic strabismus due to single rectus muscle paralysis can effectively correct the primary position in paralytic strabismus, eliminate the presence of diploma in primary position and abnormal head posture, and improve the ocular motility, which provides content clinical effects.