Objective To observe the effects of bolus volume on pharyngeal and upper esophageal sphincter pressures and durations in healthy volunteers by using high-resolution manometry (HRM).Methods Twentyfour health subjects were recruited and asked to swallow three volumes of bolus (3 ml,5 ml and 10 ml) in the neutral head position.Pressure and duration measurements were acquired by utilizing a high-resolution solid-state manometer,with an emphasis on the hypopharynx and upper esophageal sphincter (UES).Variables including UES residual pressure,UES relaxation duration,maximum hypopharygeal pressure and hypopharyngeal pressure duration were analyzed across bolus volumes and consistencies by using three-way repeated measures analysis of variance (ANOVA) to investigate influence of bolus volume.Results UES residual pressure [-1.71 mmHg(3 ml thick liquid)vs.-4.68 mmHg(10 ml thick liquid)],UES relaxation duration[590.45 ms(3 ml thick liquid) vs.702.49 ms (10 ml thick liquid)],maximum hypopharygeal pressure [169.91 mmHg (3 ml thick liquid) vs.204.42 mmHg (10 ml thick liquid)] and hypopharyngeal pressure duration(P ＜0.05) varied significantly across bolus volumes when swallowing water or thick liquid.The UES relaxation duration,UES residual pressure and maximum hypopharyngeal pressure had a direct positive relationship with bolus volume.There was significant differences with regard to UES relaxation duration [685.75 ms(3 ml paste)vs.772.27 ms (10 ml paste)] but not to UES residual pressure (P ＞ 0.05) and maximum hypopharyngeal pressure (P ＞ 0.05) across bolus volume when swallowing paste.Conclusions Difference in hypopharyngeal pressure and duration,UES residual pressure and duration were detected across varying bolus volumes.Consideration of these variables is paramount in understanding normal and pathological swallowing.

Objective To establish a method for reducing the dose to the eye lens of interventional staff,and provide the data basis for improving radiological protection measures.Methods One piece of interventional equipment coupled with conventional auxiliary protective devices and two types of common neural interventional procedures were selected to monitor 46 and 35 procedures before and after the device modification.The doses to the eye lens of staff were measured with direct-reading dosimeters for analysis of dose trends.Results After modification of the devices,the average dose to the left eye lens decreased from (9.71 ±10.86) to (3.23 ±5.59) μSv for the first operator,from (9.51 ± 12.34) to (0.68 ± 0.78) μSv for the second in cerebral angiography;whereas the dose decreased from (14.83 ± 19.13) to (4.17±4.59) for the first operator and from (14.12±21.76) to (1.23 ±1.57)μSv for the second in embolization procedure,respectively.The left eye lens doses measured before and after the modification showed significant difference (U =-2.760,-2.467,-1.967,-2.655,P ＜0.05).Conclusions The modification of the auxiliary radiological protective devices may effectively reduce the dose to the eye lens dose.This method was shown to be feasible for the improvement of radiological protection of interventional staff.

Objective To compare three different internal fixations using dual plates in treatment of type C distal humerus fractures.Methods A total of 59 patients with type C distal humerus fractures fixed with dual plates between January 2004 and December 2008 were enrolled in the study,including 34 patients managed by perpendicular dual plate internal fixation (Group A),14 patients by dorsal dual plate internal fixation (Group B),and 11 patients by parallel dual plate internal fixation (Group C).Functional outcomes of injured elbow joints were assessed using Mayo elbow performance score (MEPS).Fisher' s exact probability,chi-square test and variance analysis were used to compare the perioperative variables among groups.Results The patients were followed up for average 28 months (range,12-55 months),which showed that all fractures were smoothly healed with satisfactory curative effects in each group.There were no significant differences with respect to functional outcomes among three groups.The patients with surgery difficulty in Group C were more than those in other two groups.Besides,an additional intercondylar screw was always required in Groups A and B,but rarely in Group C.Conclusions All internal fixations with three dual plates are effective in management of type C distal humeral fractures.The location of plates is determined by experiences of orthopedic surgeons and specific fracture type.

Objective To establish the methods for measuring the dose to occupational staff's eye lens in interventional procedures with direct-reading dosimeters,and to realize the real-time monitoring of eye lens dose and warning for high dose rate,thus providing the scientific basis of the staff radiological protection in interventional procedures.Methods Direct-reading dosimeters were calibrated with personal dose equivalent HP (3).The eye lens doses for occupational staff in different kinds of interventional procedures were measured by the devices with both single-and double X-ray tubes.The data obtained fromthe direct-reading dosimeters was compared to those obtained from TLDs.Results Direct-reading dosimeters showed good linear fitting with the calibration of HP (3),and the coefficients of variation were lower than 5％.The average eye lens HP (3) for the main operator in coronary arteriography and stent implantation in brain obtained by direct-reading dosimeters were 12.0 and 24.5 μSv,respectively,whereas those obtained by TLDs were 11.9 and 22.7 μSv,respectively.The direct-reading dosimeters gave similar t~nds as TLDs do so.The direct-reading dosimeters were able to provide eye lens HP (3) in each individual interventional procedure,and to monitor the real-time dose rate as well.Conclusions The calibration of HP (3) and the data gained by direct-reading dosimeters are reliable.Therefore,the methods for real-time measurement of eye lens dose for occupational staff in interventional procedures are successfully established.

Objective:To evaluatte the high risk factors of stent occlusion in patients with acute iliofemoral vein thrombosis and Cockett syndrome.Methods:The clinical data of 178 patients of Cockett syndrome and acute lower extremity deep vein thrombosis from Jan 2014 to Dec 2016 was analyzed retrospectively. All patients underwent catheter directed thrombolysis or percutaneous mechanical thrombectomy combined with stent placement. The patency rate of stent was followed up by color Doppler ultrasound. Patients were divided into study group (stent occlusion) and control group (stent patency).Results:The stent patency rate at 6 months was 83.7%, body mass index ( OR=1.245, 95% CI: 1.097-1.413), time of thrombosis more than 2 weeks ( OR=3.899, 95% CI: 1.147-13.257), low thrombus clearance ( OR=0.238, 95% CI: 0.117-0.486) was the high risk factor of short-term stent occlusion. Stent patency rate at 3 years was 75.3%, body mass index( OR=1.225, 95% CI: 1.076-1.394), thrombosis history more than 2 weeks( OR=11.777, 95% CI: 2.576-53.832), malignant tumor( OR=4.444, 95% CI: 1.153-17.127) , compression therapy( OR=0.332, 95% CI: 0.113-0.977), low thrombus clearance( OR=0.184, 95% CI: 0.089-0.381), long stents( OR=8.427, 95% CI: 2.329-30.488) was the high risk factor for mid-term stent occlusion. Conclusions:Obesity, the duration of thrombus longer than 2 weeks and low thrombus clearance are the high risk factors of early stent occlusion, while malignant tumor, irregular compression therapy and long stents may lead to lower medium and long term patency rate of the stent.

Objective To investigate the effect and the potential mechanisms of low molecular polysaccharide from agaricus blazei (LMPAB) on H2O2-induced oxidative injury in hippocampal neuronal cells of rats.Methods Hippocampal neuronal cells were isolated from SD rats (24 h) and grew in culture.Cultured cells were divided into normal control group (added the same amount of nutrient solution), model control group (added 500 μmol·L-1H2O2 solution) and LMPAB high, medium, low dose groups (added 20,10,5 mg·L-1 LMPAB solution, respectively, then added 500 μmol·L-1 H2O2 solution each).The hippocampal neuron cell activity was detected with MTT method.The hippocampus neuron mitochondrial membrane potential (MMP) was detected by flow cytometry.According to the reagent instruction methods, malondialdehyde (MDA), catalase (CAT), superoxide dismutase (SOD) and glutathione peroxidase (GSH-PX) activities were detected.Results The activities of cell, CAT, SOD, GSH-PX and MMP in normal control group and the LMPAB high dose group were significantly higher than those of model control group (P<0.01);The content of MDA in normal control group and LMPAB high dose group was significantly lower than that of model control group (P<0.01).Conclusion The protective effect of LMPAB on hippocampal neurons with H2O2-induced injury may be related with the mechanism of enhancing the neuronal antioxidative capacity.

Objective To analyse the necessity of colposcopic directed biopsy to vaginal intraepithelial neoplasia (VAIN) before hysterectomy due to early stage cervical cancer (stage Ⅰ) or high grade cervical intraepithelial neoplasia (CIN). Methods A total of 669 patients who underwent a hysterectomy due to early stage cervical cancer (stage Ⅰ) and CINⅢin Beijing Obstetrics and Gynecology Hospital, Capital Medical University,from January 1, 2009 to December 31, 2013 and followed up, 99 patients with VAIN were enrolled. The clinical data and following up the prognosis were prospectively analyzed retrospectively. Results The occurrence rate of VAIN before and after hysterectomy due to cervical dysplasia was 14.8%(99/669), the occurrence rate and the grade of VAIN showed that significantly increased from CINⅢto cervical cancer stageⅠ(P<0.05);Only 15 patients enrolled had undergone vaginal wall biopsy by colposcopy pre-hysterectomy, including 11 patients who were diagnosed with VAINⅡ-Ⅲand underwent vagina extended resection during the hysterectomy. The 5 year recurrence rate of vaginal stump VAIN after hysterectomy was 12.1%(12/99) and the progression rate was 4.0%(4/99), the recurrent rate was 2.0%(2/99). Conclusions For all the patients who are planning to undergo hysterectomy due to stageⅠcervical cancer and CINⅢ, routine upper side of the vagina wall colposcopic-directed biopsy pre-hysterectomy is strongly recommended. All the patients after hysterectomy due to cervical dysplasia should be followed up regularly within 3 years after hysterectomy.

Objective To establish methods of measuring the eye lens dose to interventional staff,to obtain relevant dose data and to provide a scientific basis for reducing eye lens dose.Methods Two kinds of dosimeters,thermoluminescent dosimeter (TLD) and optically stimulated luminescence dosimeter (OSLD),were selected to measure the personal dose equivalent HP (3) to eye lens of occupational staff in several kinds of interventional procedures,including cardiovascular interventional procedures,cerebrovascular interventional procedures etc.Five types of Digital Subtraction Angiography (DSA) equipment were chosen in the study,including single tube equipment and double tube equipment.Results The eye lens dose HP (3) to interventional staff varied significantly with different interventional procedures.The lowest dose is shown in the coronary angiography procedure,while the highest dose shown in the cerebral stenting procedure.For the same type of interventional procedure,the eye lens dose to the primary interventionist was the highest.For same interventionist,the dose to the left eye was obviously higher than that to the right eye.In addition,the measured results of OSLD were apparently higher than that of TLD.Conclusions Both TLD and OSLD could be used to measure eye lens dose,and the ways of calibrating TLD to evaluate personal dose equivalent HP (3) were feasible.The reason of significant difference between the measured results of TLD and OSLD needs further research.

Objective To find out the resistant situation and drug of Mycobacteria patients in Sichuan and offer foundation for clinical.Methods Two hundred randomized clinical isolates of Mycobacterium were determined by Roche drug sensitivity and minimum inhibitory concentration (MIC) method.Results Of the 200 clinical isolates,192 stains were Mycobacterium tuberculosis(MTB) (96.0％),8 strains (4.0％) were non-tuberculosis mycobacterium(NTM).Of the 192 MTB strains,108( 57.3％ ) sensitive strains and 84 (43.7％)stains were resistant to one or more than one drugs.Among these 84 resistant strains 23 were multi-drug resistant ( MDR,12.0％ ),4 were extensively drug resistant( XDR,2.1％ ).The anti-TB drug resistance rates were:SM(16.7％),INH(20.8％),RFP(17.2％),EMB(10.9％),PI(16.1％),LFX(8.8％),AMK ( 16.7％ ),CPM ( 6.2％ ),PTA ( 33.3％ ),respectively.Conclusion The resistance rate of tuberculosis keeps at a high level in Sichuan,especially the resistance rate of multiple (≥4) drug,we should oar attention.

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.
Benchmarking ; Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards ; Quality Control