Objective:To ensure the authenticity, scientific and reliability of medical devices clinical trials results.Methods: The drug clinical research institute office set up full-time secondary quality control team, clarified the responsibility, made application form, problem check and track list, subjects’ identity registration form. Using computer network to make 19 medical equipment quality control of clinical trials.Results: Assure the rights and safety of subjects, the validity, accuracy and completeness of clinical trial data and clinical trial results.Conclusion: The drug clinical research institute office, full-time secondary quality control team made strict clinical trial project for the whole process of quality control and ensure the true, scientific and reliable results.

OBJECTIVE To evaluate the influence of three high-level chemical disinfectants for sterilization on cauterization of dental instruments.METHODS The measuring methods for disinfectants on cauterization of metal instruments,and usage indications for disinfectants followed Technical Standard for Disinfection published in 2002 by the Ministry of Health.Fourteen kinds of small instruments(grouped by 4 different metal materials) were analyzed on receipt and after sterilization by three high-level disinfectants(2% glutaraldehyde,chlorine dioxide, and symclosene),using cauterization rate.RESULTS Three high-level disinfectants had different cauterization rates,the cauterization rate was affected by concentration of disinfectant,sterilizing time,and morphology of instruments.The cauterization of chlorine dioxide was the strongest,followed by symclosene(trichloroisocyanuric acid),and then 2% glutaraldehyde.CONCLUSIONS In clinical sterilization,different materials of small instruments need proper disinfectants,concentration and sterilizing time for decreasing their cauterization.

Objective To improve understanding of molybdenum target mammographic findings of hydatid cyst of the breast.Methods The data of mammographic findings of 7 cases with hydatid cysts confirmed by operation and pathology were collected and analyzed retrospectively. The related literatures were reviewed.Results Among 7 cases of hydatial cysts, multiple cyst in one, singular cyst in 6, one of them was rupture caused by trauma. Mammography showed a circluar or elliptical dense shadow, the density was homogeneous with well defined margen, measured 4～8 cm in maximum diameter, 3 cases appeared typical shell-like calcification.Conclusion In combination with clinical and endemical data, molybdenum target mammography can be used in diagnosing hydatid cyst of the breast.

Objective To investigate the role of regulatory B cells (Breg)in children with newly diagnosed immune thrombocytopenia (ITP).Methods A total of 35 newly diagnosed ITP children admitted to the Pediatric De-partment,the First Affiliated Hospital of Zhengzhou University from January to December 201 4 were recruited in this study,and another 20 gender -and age -matched healthy children from the Department of Medical Examination Center of the same Hospital were recruited as controls during the same period.Peripheral blood samples (3 mL from each chil-dren)were collected from all the newly diagnosed ITP children and the normal controls.Breg cells were tested by Flow Cytometry,and the expression levels of interleukin -1 0 (IL -1 0)and transforming growth factor -β1 (TGF -β1 ) mRNA were measured by real time fluorescence quantitative polymerase chain reaction.Meanwhile,the correlation be-tween Breg cells and the expression levels of IL -1 0,TGF -β1 mRNA were analyzed by Pearson correlation.Results The percentages of Breg cells in the peripheral blood of the newly diagnosed ITP children [(2.37 ±0.67)%]were sig-nificantly lower than those of the normal controls [(4.92 ±1 .32)%],and there was a significant difference (t =-7.47,P =0.000);the expression levels of IL -1 0 mRNA in the newly diagnosed ITP children(0.202 ±0.059) were significantly decreased compared with those of the normal controls(0.41 5 ±0.21 2),and there was a significant difference(t =-5.1 75,P =0.000);while the expression levels of TGF -β1 mRNA in the newly diagnosed ITP chil-dren(1 .587 ±0.823)were significantly increased than those in the normal controls(0.61 9 ±0.322),and there was a significant difference(t =4.081 ,P =0.001 ).There was a significant positive correlation between Breg cells and the ex-pression levels of IL -1 0 mRNA(rs =0.828,P <0.05),but no correlation between Breg cells and expression level of TGF -β1 mRNA was found (rs =0.527,P =0.1 1 7).Conclusions The decrease expressions of Breg cells can be found in the newly diagnosed ITP children,and the abnormal expression of Breg cells may play a key role in the immu-nological pathogenesis of the newly diagnosed ITP children.

Objective To evaluate the influence of antiplatelet therapy prior to intravenous thrombolysis (IVT) on acute ischemic stroke (AIS) patients receiving IVT with recombinant tissue type plasminogen activator (rt-PA).Methods Researches about the safety of pre-existing antiplatelet treatment on AIS patients undergoing rt-PA IVT published before 31st December 2013 were retrieved based on internet databases.A meta-analysis of included clinical trials was performed by RevMan 5.2 and Stata 12.0 software.Simultaneously,funnel plot and Egger's test were used to evaluate the publication bias.Results A total of 10 papers were included.Eight researches based meta-analysis showed that pre-existing antiplatelet therapy increased the risk of symptomatic intracranial hemorrhage (SICH ; OR =1.67,95％ CI 1.44-1.93,P ＜ 0.01),6 researches based analysis suggested pre-existing antiplatelet therapy increased the risk of any intracranial hemorrhage (ICH ; OR =1.23,95％ CI 1.04-1.47,P ＜ 0.05) and 3 trials based analysis indicated the functional independence of patients receiving antiplatelet treatment was a bit worse than control group (OR =0.86,95％ CI0.80-0.93,P ＜0.01).Funnel plots and Egger' s test showed that there was no significant publication bias (P ＞ 0.05).Conclusions Antiplatelet therapy might increase the risk of post thrombolysis SICH and ICH,and their 3-month function independence is not so satisfied as those who had no antiplatelet agents before IVT.However,this review has limitations and the above results should be validated in future large prospective clinical studies.

Objective To describe and analyze the clinical characters of patients with FRG from 7 Chinese families.Then analyze and identify their mutations in SGLT2 gene,and explore the association of genotype and phenotype.Methods Quantitative test for 24-hour urine glucose and other laboratory tests were carried out among 7 probands (14 patients in all) and their family members from 7 pedigrees (totaling 23 subjects).All coding regions,including intron-exon boundaries,were analyzed using PCR followed by direct sequence analysis.Results Five novel mutations in SLC5A2 gene were identified in this investigation,including four missense mutations (A Serine to Glycine at position 335 (c.1003A＞G,p.S335G),a Glutamine to Arginine at position 448 (c.1343A ＞ G,p.Q448R),an alanine to proline at position 474 (p.A474P,c.1420G ＞ C) and a glycine to aspartic acid at position 580 (c.1739G ＞ A,p.G580D) and a deletion in intron 7 (c.886(-10_-31)del).By the minigene studies using the pSPL3 plasmids,we confirmed the deletion c.886(-10_-31)del as a splicing mutation.In this study,the mutation c.886(-10_-31)del accounted for about 43％ of the total alleles (12/28).These patients with compound heterozygous or homozygous mutations manifested middle degree or severe glycosuria (Quantitative test for 24-hour urine glucose:10.56-50.68 g/1.73 m2),however those with heterozygous variants presented with mild to moderate glycosuria (Quantitative test for 24-hour urine glucose ≤ 2.45 g/1.73 m2).This fits co-dominant inheritance pattern.Conclusions Five novel mutations which may be related to FRG are found in this study,and c.886(-10-31) del may be a high frequency mutation in Chinese patients.

BACKGROUND:Stem cels from the apical papila are a new kind of mesenchymal stem cels, and whether it can
be used in root regeneration is the key to the present study. OBJECTIVE:To culture rat stem cels from the apical papila and periodontal ligament stem celsin vitro, and to compare the biology behaviors of these two kinds of cels, thereby providing experimental basis for the application of stem cels from the apical papila in root regeneration. METHODS:The apical papila, as wel as the periodontal ligament tissues from the healthy mandibular teeth of young rats were digested and cultured. Immunophenotypes of stem cels from the apical papila and periodontal ligament stem cels were detected by immunofluorescence technique. Then, cel growth curves were determined by MTT method and mineralized nodule formation was observed by alizarin red staining. RESULTS AND CONCLUSION:Stem cels from the apical papila and periodontal ligament stem cels were both positive for STRO-1. Stem cels from the apical papila were positive for CD90 and weakly positive for CD146. Periodontal ligament stem cels were positive for CD146 and weakly positive for CD90. The absorbance values of stem cels from the apical papila and periodontal ligament stem cels increased with the increasing of time and became stable at 8 days. Since the 4th day, the proliferation capacity of stem cels from the apical papila was significantly stronger than that of periodontal ligament stem cels (P < 0.05). Both of stem cels are visible to have mineralized nodule formation. Compared with the periodontal ligament stem cels, stem cels from the apical papila were stained obviously deeper and had more mineralized nodules. These results show that stem cels from the apical papila have stronger proliferation capacity and mineralization ability than periodontal ligament stem cels. Cite this article:Zhao L, Yu L, Yuan P, Zhou CM, Wu PL.Stem cels from the apical papila versus periodontal ligament stem cels: biological behaviors. Zhongguo Zuzhi Gongcheng Yanjiu. 2016;20(1):113-117.

AIM: To investigate the role of nitric oxide synthase (NOS), soluble guanylyl cyclase (sGC) and protein kinase C (PKC) signaling in tumor necrosis factor-? (TNF-?)-induced cardioprotection against hypoxia/reoxygenation (H/R) injury. METHODS: Neonatal rat ventricular myocytes were pretreated with TNF-? or sodium nitroprusside (SNP) or L-arginine (L-Arg), respectively, for 12 h and then subjected to continuous hypoxia for 12 h, followed by reoxygenation for 6 h. The manganese superoxide dismutase (Mn-SOD) activity of the cells was measured after H/R. Myocyte injury was determined by the release of lactic dehydrogenase (LDH). RESULTS: TNF-? (10~5 (U/L)) significantly increased the Mn-SOD activity and decreased release of LDH from ventricular myocytes. The cardioprotection against H/R injury was induced by the pretreatment with SNP (5 ?mol/L) or L-Arg (5 mmol/L), which was blocked by ODQ (10 ?mol/L), the specific sGC inhibitor, and Chel (5 ?mol/L), the specific PKC inhibitor. Pretreatment with L-NAME (100 ?mol/L), ODQ, Chel, antoxidant 2-MPG (400 ?mol/L) or tyrosine kinase inhibitor genistein (50 ?mol/L) attenuated the increased Mn-SOD activity and reduced LDH level induced by TNF-?. CONCLUSION: The results suggest that NO may play a role in TNF-?-induced cardioprotection, which is mediated by sGC and PKC. [

BACKGROUND:The periodontal ligament stem cels can promote periodontal tissue regeneration, providing a new way for the treatment of periodontitis. OBJECTIVE:To observe the inflammatory microenvironment effects on the biological properties of periodontal ligament stem cels. METHODS: Periodontal ligament stem cels from healthy controls and patients with periodontitis were primarily cultured by tissue digestion method, purified using limited dilution method, and identified through detection of CD146 and STRO-1. Then, passage 3 cels were taken and denoted as normal control and inflammation groups folowed by osteogenic induction. RESULTS AND CONCLUSION:Purified cels from two sources both expressed STRO-1 and CD146. Periodontal ligament stem cels in the inflammation group showed higher multiplication capacity, but the osteogenesis ability was lower compared with the normal control group. The expressions of Runx2 mRNA and Osterix mRNA were dropped significantly after the stimulus of tumor necrosis factor-α (P < 0.05), but the interleukin-1β and interleukin-6 did not have a significant impact. Tumor necrosis factor-α at 0.1 and 1 μg/L had no significant effects on the expression of Runx2 mRNA, but the expression of Runx2 mRNA was decreased significantly after treatment with 10 μg/L tumor necrosis factor-α (P< 0.05). It is confirmed that the molecular signaling mechanism inside the periodontal ligament stem cels is changed under inflammatory microenvironment, so that the differentiation capacity of cels from the inflammatory sources is lowered. Moreover, tumor necrosis factor-α is one of the key factors and its optimalconcentration is 10 μg/L.

OBJECTIVE:To ensure the stability of electronic data capture(EDC)system in drug clinical trials and to improve the quality of drug clinical trials. METHODS:The quality control system for EDC system was established and introduced from the formulation of quality control process,establishment of data standard,trial project management,daily management,trial project design,system operation,system function,etc. RESULTS & CONCLUSIONS:Data standard have been achieved through estab-lishing EDC quality control system by our hospital based on attributable,legible,contemporaneous,original and accurate principle. The management of trial project and daily management are conducted through data registration,staff training,the formulation of da-ta management plan,fault emergency treatment,database backup;multiple verification of support data,data lock and export,trial report autogeneration and other functions have been realized by formulating related standard operation instruction,program file,op-eration manual and quality record. Those aspects improve facticity,accuracy and integrality of data in clinical trials,and lay a foun-dation for further data mining.