The construction of clinical research management system in public hospitals is an important platform for China's clinical research workers to achieve new products conversion and application.At present,China have basically realized the informatization of clinical trial management process and scientific research project,improved the efficiency and quality of scientific research management,but there is still a large distance from the requirements of digital management platform.The core problem is that there is no unified standard for clinical data collection,disjointed management of the whole process,and backward communication and collaboration mode.The establishment of a standardized disease database has become an effective means to achieve standardized clinical data,and it is the basis for opening up the clogging point of the whole process management and realizing multi-department data sharing.

Objective: To investigate the sleep-related deglutition in patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) and its correlation with sleep stage and cortical arousals. Methods: From December 2015 to September 2017, simultaneous polysomnography and pharyngeal pressure monitoring were performed in 23 adult patients with OSAHS, Mann-Whitney U test were employed to analyze the following parameters: (1) the relationship between arousal and deglutition; (2) the effect of sleep stage on deglutition; (3) The relationship between the frequency of deglutition and the severity of OSAHS. Results: The subjects in this study aged (43±12) years, and the mean apnea-hypopnea index (AHI) was (49.2±27.7) times/hour. A total of 1 382 deglutition were recorded during sleep, with a median of 9.2[5.8, 13.8]times/person. There was a positive correlation between deglutition frequency and AHI(r=0.570, P=0.005) and negatively correlated with oxygen saturation (r=-0.639, P=0.001). The majority of the deglutition (73.7%) occurred after the respiratory event and in association with respiratory arousal. Deglutition occurred more in Non-rapid eye movement sleep stage 1 (N1) than N2, N3 and REM sleep (Z=-3.680, P<0.001; Z=-2.746, P=0.006; Z=- 3.490, P<0.001). Conclusions The occurrence of deglutition in patients with OSAHS is associated with cortical arousals. Deglutition frequency increased with the severity of apnea and affected by sleep staging.

OBJECTIVE We hypothesized that unstable ventilatory control(high loop gain, LG) could predict the short-term efficacy of positive airway pressure therapy in patients with obstructive sleep apnea(OSA). METHODS 42 adult patients with OSA, M/F=39/3, were studied. The stability of the ventilatory control system(LG) was quantified by fitting a simplified mathematical model to the spontaneous ventilatory pattern obtained via polysomnography. LG, pulmonary function test results, and other PSG parameters were analyzed in patients who had post-treatment AHI≥10 events/hr(non-responders) using auto-positive airway pressure therapy. RESULTS The subjects aged(40±8) years, apnea-hypopnea index(AHI) were 68.2[42.9,81.0]events/hr). Nine patients(34.6％) were non-responders. Twenty pat ients(47.6％) had residual AHI＜5 events/hr. Loop gain and pre-treatment mixed apnea index were higher in the non-responders versus responders(0.74 [0.62, 0.82] vs 0.49[0.37, 0.77], P =0.035) and(11.0[4.3, 22.9] vs 2.0[0.2, 5.3], P =0.004). In the 26 patients with LG＞0.6, nine(34.9％) had posttreatment 5 events/hr≤AHI＜10 events/hr. And all of the non-responders had LG(n=9, 34.9％). The difference was signif icant between the LG＞0.6 a nd LG＜0.6 group(P =0.007). CONCLUSION Loop gain and mixed apnea index was higher in patients with residual AHI＞10 events/hr after short-term auto-PAP therapy. Ventilatory control stability evaluation might have predictive value for PAP treatment efficacy in OSA patients.

BACKGROUND: Previous studies have shown that the complex of polyethylene glycol diacrylate and chitosan is biodegradable, has the anti-inflammation effect and can promote wound healing, with good biocompatibility.However, the composite material is brittle, and thus, it is necessary to develop a mechanical support material due to the anatomy of the nasal cavity.OBJECTIVE: To study the cytocompatibility of a novel degradable absorbable nasal packing material made of polyethylene glycol diacrylate composite hydrogel.METHODS: In our experiment, the composite hydrogel was formed by the combination of different ratios of polyethyleneglycol diacrylate, chitosan and polyvinyl alcohol using photo-crosslinking method. According to the international standard of medical devices, we used direct and indirect international standard experimental methods to evaluate the cytotoxicity of the materials. (1) Direct contact method: the polyethylene glycol acrylate composite hydrogel and mouse fibroblasts L929 were co-cultured for 24 hours to observe the morphological changes of cells. (2) Indirect extraction: mouse fibroblasts L929 were cultured in polyethylene glycol diacrylate composite hydrogel extracts (100, 50 μL) and RPMI1640 medium (100 μL), respectively, for 3 days to observe the proliferation and cytotoxicity by cell counting kit-8 assay.RESULTS AND CONCLUSION: (1) Direct contact method: the cells around the material formed a flat structure with fusiform or stellated protrudes. The material was confirmed to have good biocompatibility depending upon the presence of adherent cell growth, full and strong refraction, and the overall growth trend. (2) Indirect extraction method: with the increase of time, the number of cells in the hydrogel extract group increased, the relative proliferation rate of cells increased gradually, and the cytotoxicity was 0 to 1. To conclude, these experimental findings indicate that the polyethylene glycol acrylate composite hydrogel material has good cytocompatibility.

OBJECTIVE To evaluate the value of Epworth sleepiness scale(ESS) combined with home-based portable monitoring(PM) in the diagnosis of patients with obstructive sleep apnea syndrome(OSAS). METHODS Adult OSAS patients who visited Beijing Tongren Hospital and complained of snoring were included in this study. The overnight polysomnography(PSG) and the ESS were completed at the sleep center and the portable multi-channel monitoring was completed within one week. Subjects were divided into two groups according to their apnea hypopnea index(AHI) of PSG: simple snoring or mild OSAS group(AHI<15/h) and moderate-severe group(AHI≥15/h). The ESS score, respiratory disturbance index(RDI) of PM and other parameters were compared and the correlation of AHI with ESS scores, RDI were analyzed. The sensitivity and specificity of ESS score≥9 points, RDI≥15/h in the diagnosis of moderate-severe OSAS were calculated. RESULTS A total of 51 subjects were included in this study with 42 males(82.4％) and 9 females(17.6％). Mean age was(43.8±10.8) years, and the mean body mass index was(27.9±4.5)kg/m2; ESS scored 1-24 points and mean(8.6±5.0) points, 18 cases with ESS score ≥9 points; AHI ranged between 2.5 and 99.8/h with a mean of(37.4±29.8)/h. There were 19(37.3％) and 32(62.7％) patients in snoring-mild group and moderate-severe group, respectively. There was significant difference for ESS scores between the two groups(9.9±5.1 vs 6.6±4.2 points, P<0.05),RDI in moderate-severe OSAS group was significantly higher than that in snoring-mild group[(49.4±23.1)/h vs (6.8±4.5)/h, P<0.001)]. There was a positive correlation between the ESS score and PSG derived AHI(r =0.435, P =0.002); the PM derived RDI were significantly correlated with PSG derived AHI in snoring-mild group(r =0.706, P=0.001), moderate-severe group(r =0.873, P=0.000) and patients with ESS score ≥9 points(r =0.967, P=0.000). At a PSG threshold AHI=15/h, the sensitivity and specificity for ESS score ≥9 points were 45.2％ and 78.9％; the PM derived RDI≥15/h had a sensitivity and specificity of 84.4％ and 84.2％, respectively; the sensitivity and specificity for each individual screening tool along with the combination of ESS and PM were 100.0％ and 100.0％. CONCLUSION ESS combined with PM diagnostic method is a valuable measure for the diagnosis of moderate and severe OSAS patients.

Objective: To evaluate the auditory efficacy of Bonebridge implantation in patients with bilateral congenital malformation of external and middle ear. Methods: Eleven cases (6 males and 5 females) had unilateral Bonebridge implantation. The age ranged from 8 to 26 and the average age was 16.9. Seven to ten days after operation, the first fitting was undergone. In acoustic sound field, the average auditory thresholds were respectively measured for unaided ears and Bonebridge implanted ears by pure tone auditory (PTA, 0.25, 0.5, 1, 2 and 4 kHz). For the group over 12-year-old, MSTM was applied to evaluate speech discrimination score (SDS). For the other cases, MLNT was used as the test material. The auditory efficacy post Bonebridge implantation would be analyzed and evaluated by comparing the differences between unaided ears and Bonebridge implanted ears. Results: The bone conduction audibility threshold after Bonebridge implantation was as well as the preoperative. The auditory threshold with Bonebridge aided was improved to 25-35 dB HL, when compared to that of the unaided ears in the sound field. The SDS in the group over 12-year-old was improved about 50%; the efficacy was slightly limited for the other two cases (both less than 12 years old). Statistical analysis showed that there were significant differences between unaided ears and Bonebridge implanted ears in the sound field and SDS(P<0.05). Conclusions The auditory efficacy of Bonebridge is significant and noticeable in patients with bilateral congenital malformation of external and middle ear. Bonebridge provides a new and effective way for patient with congenital malformation of external and middle ear to reconstruct hearing.

[ABSTRACT]OBJECTIVETo explore the method on reconstruction of long and special tracheal defects which can mostly match with natural airway: pedicle rib cartilage with cilia endothelial wall.METHODS8 experimental model of rabbits were trained with cervical double belt blood supply fascia embedding and autologous costal cartilage and nasal septum mucos in the first period, then followed by transplantation in the second period. After the operation, we would assess the physiology, breathing and histopathology index of the rabbits, etc. After the animal experiment, we tried to apply the method to an appropriate clinical case.RESULTS8 cases of experimental rabbits dead after the second period operation with the average survival time of 21.9 days and caused by asphyxia. Histopathological results: rib cartilage and trachea ring up of cartilage cells and fibers have high similarity in histology; cartilage of all cases under the cultivation of the pedicle fascial package has not been absorbed; all cases' nasal septum mucosa in the body and blood supply to differentiation under fascia nutrition. Then we applied the method on a clinical case.CONCLUSIONTrachea ring rib cartilage had a higher similarity to the tracheal cartilage on the histology and biological characteristics that can be used as the preparation of artificial trachea shaping material or cell culture to tissue engineering materials. Package of rib cartilage pedicle fascial can provide adequate blood supply to make up for a free training rib cartilage defect to its absorption. Nasal septum mucosa of pressure in the body and blood supply of the fascia nutrition can simulate the trachea ciliated epithelium, which can play its biological characteristics similar to the inner wall of the trachea.

[ABSTRACT]OBJECTIVETo compare the differences of aerodynamic characteristics of pharyngeal cavity between normal subjects and OSAHS patients, and to study the nasal obstruction in the pathogenesis of the OSAHS.METHODSA total of 60 normal subjects and 60 OSAHS patients were enrolled in this study. Numerical simulation was performed to calculate the airflow dynamic indexes of three sections of pharyngeal cavity. Correlation analysis of the nasal resistance and negative pressure were studied.RESULTSThe average pharyngeal negative pressure and airflow velocity in OSAHS patients were significantly increased than that in normal subjects. The total nasal airway resistance significantly correlated with the average negative pressure of pharyngeal cavity. CONCLUSIONAirflow dynamic indexes of OSAHS patients had significant different pharyngeal aerodynamic characteristics from normal subjects. The increased average negative pressure in pharynx might contribute to the severity of pharyngeal collapse for OSAHS patients. Higher total nasal resistance might play a role in the pathophysiological mechanisms of OSAHS.

[ABSTRACT]OBJECTIVETo compare the aerodynamic differences before and after nasal cavity ventilation expansion techniques in patients with OSAHS. METHODSA total of 30 adult patients with OSAHS were included in this study. Pre-operative upper airway CT of each subject was acquired. Each subject underwent surgery. Postoperative upper airway CT was obtained at least 3 months later. By means of CFD simulation method, numerical simulation was performed to calculate the airflow dynamic indexes of the upper airway. The pre-and post-operative aerodynamic characteristics were compared. RESULTSAfter operation, post-operative negative pressure nephogram of the nasal cavity indicated more smooth variation of pressure gradient, post-operative velocity nephogram of nasal cavity indicated slower airflow velocity. Proper values of flow field indicated the volume of nasal cavity increased significantly (t=4.025,P<0.01), the total nasal airway resistance decreased significantly (t=-2.065,P<0.01). The total negative pressure of the upper airway decreased significantly (t=-2.659,P<0.01) after operation. However, the proper values of flow field increased in 5 patients. CONCLUSIONNasal cavity ventilation expansion effectively increase the volumes of nasal cavity, improve the nasal ventilation, and reduce the air flow velocity of both nasal cavity and pharynx in OSAHS patients, those reduce the pharyngeal negative pressure and the pharyngeal collapse. However, for patients with its narrowest segment at the velopharyngeal level, operation cannot do anything or even aggravate the pharyngeal collapse. Operation should be performed individually.

[ABSTRACT]OBJECTIVETo evaluate the curative effect of endoscopic sinus surgery from the viewpoint of biomechanics analysis.METHODSWe select one case undergoing nasal endoscopic surgery for chronic sinusitis patients, after half year follow-up and collect preoperative and postoperative spiral CT data to build a numerical model of nasal cavity and paranasal sinuses with computer numerical simulation (CFD) research methods, to explore nasal airflow distribution and flow field characteristics of value changes before and after the operation. Patients undergo subjective assessments: nasal obstruction of VAS score, olfactory VAS score, SNOT-20, objective assessment: Lund Kennedy score, Lund Mackay score, saccharin test time and acquisition clinical efficacy data to verify the credibility of the analysis method is feasible and the results. RESULTSThe nasal resistance after endoscopic sinus surgery in nasal cavity and paranasal sinuses numerical simulation decreased, middle meatus of nose and nasal air flow velocity decreased, the pressure change slightly;nasal threshold region, middle turbinate head end section in maxillary sinus ostium section, after nearly sieve horizontal cross-section average velocity decreased, nasal airflow for the mucosa of the shear stress reduced. The volume of the nasal cavity and the area of the mucosa was increased, the volume ratio was decreased, the subjective and subjective assessment of the patients was improved, and the objective assessment was lighten.CONCLUSIONAerodynamic rules are presented through the calculation of numerical simulation of fluid mechanics which is invisible before. Better understanding of changes in the nasal airflow distribution and the changes of flow field characteristics can be useful to establish nasal endoscopic surgery in numerical analysis of offshore platform,which provides a new research tool for the understanding of the pathophysiology of chronic sinusitis by endoscopic sinus surgery.