With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).
ObjectiveTo explore the feasibility to use pain scale and arterial oxygen partial pressure(PaO2)as screening internal fixation indications for patients with multiple rib fractures.
MethodsClinical data of 48 patients with multiple rib fractures who were admitted to Shanghai Pudong Hospital from September 2010 to February 2013 were retrospectively analyzed. Visual analogue scale (VAS) was used for pain assessment. Twenty-four patients whose VAS was greater than or equal to 6 and PaO2 was less than 60 mm Hg 3 days after injury were chosen as the experimental group, including 16 males and 8 females with their age of 49.29±15.73 years. Another 24 patients whose VAS was less than or equal to 5 and PaO2 was greater than 60 mm Hg 3 days after injury were chosen as the control group, including 19 males and 5 females with their age of 48.63±13.49 years. Patients in both groups received rib internal fixation with steel plates. Three days and 1 week after surgery respectively, VAS and PaO2 were compared between the 2 groups.
ResultsIn the experimental group, VAS 3 days after surgery was significantly lower than preoperative VAS (4.09±0.93 vs. 8.21±1.18, P < 0.05), and VAS 1 week after surgery was significantly lower than preoperative VAS (3.20±0.98 vs. 8.21±1.18, P < 0.05). In the control group, there was no statistical difference between VAS 3 days after surgery and preoperative VAS (P > 0.05), and there was no statistical difference between VAS 1 week after surgery and preoperative VAS (P > 0.05). Three days after surgery, PaO2 of the experimental group was significantly higher than preoperative PaO2 (61.00±3.47 mm Hg vs. 53.00±3.97 mm Hg, P < 0.05). There was no statistical difference between PaO2 3 days after surgery and preoperative PaO2 in the control group (66.71±5.15 mm Hg vs. 66.00±5.00 mm Hg, P > 0.05). Three days after surgery, pneumonia occurred in 4 patients in the experimental group and 2 patients in the control group (χ2=0.762, P > 0.05). Three days after surgery, pain scale reduction of the experimental group was significantly higher than that of the control group (4.13±1.45 vs. 0.00±0.42, P < 0.05). One week after surgery, pain scale reduction of the experimental group was significantly higher than that of the control group (5.04±1.23 vs. 0.08±0.28, P < 0.05). Three days after surgery, PaO2 increase of the experimental group was significantly higher than that of the control group (7.42±3.59 mm Hg vs. 0.21±0.98 mmHg, P < 0.05).
ConclusionIt's reasonable and feasible to use pain scale greater than or equal to 6 and PaO2 less than 60 mm Hg as internal fixation indications for patients with multiple rib fractures.
ObjectiveTo systemically review the efficacy and safety of Schwann cells (SCs) or activated Schwann cells (ASCs) transplantation in the treatment of traumatic spinal-cord injury (TSCI) in rats models.
MethodsRandomized controlled trials (RCTs) about the effects of SCs and ASCs transplantation for TSCI in rats were searched in PubMed, EMbase, The Cochrane Library (Issue 12, 2014), CBM, CNKI, WanFang Data and VIP from inception to December 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software.
ResultsA total of 14 RCTs involving 510 rats were included. The results of meta-analysis showed that:compared with the control group, the Basso, Beattie and Bresnahan (BBB) scores in the SCs or ASCs transplantation group were superior in 4 weeks (SMD=2.31, 95%CI 1.48 to 3.13, P<0.000 01), 8 weeks (SMD=3.93, 95%CI 3.06 to 4.81, P<0.000 01) and 12 weeks (SMD=6.15, 95%CI 4.30 to 8.00, P<0.000 01) after surgery. The BBB scores in the SCs or ASCs transplantation combined with other therapies group were also better in 4 weeks (SMD=1.06, 95%CI 0.44 to 1.68, P=0.000 8), 8 weeks (SMD=2.26, 95%CI 1.57 to 2.96, P<0.000 01) and 12 weeks (SMD=1.49, 95%CI 0.72 to 2.25, P<0.000 01) after surgery. Compared with the SCs group, the BBB score in the ASCs transplantation group were superior in 4 weeks (SMD=4.31, 95%CI 3.50 to 5.13, P<0.000 01) and 12 weeks (SMD=5.44, 95%CI 3.99 to 6.89, P<0.000 01) after surgery. No significant difference was found in mortality between the transplantation group and the control group.
ConclusionCurrent evidence indicates that SCs and ASCs can promote the recovery of motor function in the rats with TSCI. More functional recoveries can be obtained in ASCs transplantation compared with SCs transplantation. Due to limited quality of the included studies, the above conclusion should be verified by conducting more large-scale, high quality RCTs.
Objective To evaluate the value of Epworth sleepiness scale ( ESS) in evaluating the severity of obstructive sleep apnea hypopnea syndrome ( OSAHS) . Methods A total of 340 cases with suspected OSAHS were enrolled. The ESS scores and polysomnography ( PSG) monitoring data were analyzed. According to the PSG monitoring results the patients were classified into non-OSAHS, mild, moderate and severe OSAHS groups. The average ESS scores and the ratio of patients whose ESS score was ≥9 were compared among the four groups. The diagnostic value of ESS score was evaluated by ROC curve. The correlation of ESS scores with age, apnea hypopnea index ( AHI) , the lowest SpO2( LSpO2 ) and microarousal index was analyzed. Results The ESS scores had an ascending tendency as the severity of OSAHS was increased but only in the severe OSAHS cases the difference was significant statistically compared with the other three groups ( P lt; 0. 05) . The mean ESS scores in the four groups were 9. 96 ± 4. 81,10. 21 ±5. 48, 11. 48 ±5. 28 and 13. 52 ±5. 84, respectively. There was no statistical significance while comparing the ratio of patients whose ESS scores were ≥9 among the four groups. The analysis of ROC curve showed the area under the ROC curve ( AUC) was lesser( 0. 601) and a best cutoff could not be obtained. When ESS score ≥9 was made as the cutoff in screening OSAHS patients the sensitivity was 70. 0% and the misdiagnosis rate was 63. 21% . The ESS scores had positive correlation with the apnea hypopnea index ( AHI)( r =0. 240, P lt; 0. 01) and negative correlation with LSpO2 ( r = - 0. 198, P lt;0. 01) . The ESSscores had no correlation with age or the microarousal index ( P gt; 0. 05) . Conclusions The ESS score has some significance in screening severe OSAHS patients but can not exactly reflect the severity of OSAHS patients among Chinese population, suggesting ESS score has limited value in the evaluation of OSAHS severity. The ESS score ≥9 as a cutoff is not a reliable parameter to estimate the severity of OSAHS. A more effective scoring system need to be established for better screening of OSAHS patients.
ObjectiveTo study the preservation effect of true bone ceramics (TBC) prepared by high-temperature calcination of bovine bone on alveolar ridge of canine extraction socket.MethodsSix healthy Beagle dogs (aged 1.5-2 years) were selected to extract the second and fourth premolars of both mandibles and the second premolars of the maxilla. The left extraction socket was implanted with TBC as the experimental group, and the right side was implanted with the calcined bovine bone (CBB) as the control group, to observe the alveolar ridge preservation effect. Three dogs were euthanized after general observation at 1 and 6 months after operation respectively. After separating the maxilla and mandible, cone beam CT (CBCT) was performed to measure the average gray value of the graft site and the adjacent reference area (the area between the roots of the adjacent third premolar) and calculate the gray scale ratio between the bone graft site and the reference area. Histological observation was made on the bone graft site to evaluate the new bone formation.ResultsGeneral observation showed that the wounds of both groups were basically healed at 2 weeks after operation, and the bone graft materials were not exposed. The wounds healed well at 1 and 6 months after operation without swelling. The results of CBCT showed that the residual material was found in both groups at 1 month after operation, and no significant residual material was found in both groups at 6 months after operation, and the alveolar ridge height of the bone graft area was not significantly reduced. There was no significant difference in the bone mineral density between the experimental group and the control group. The gray scale ratios of the experimental group at 1 month and 6 months after operation were 0.97±0.14 and 0.93±0.06, respectively, and were 0.99±0.16 and 0.94±0.05 in control group, showing no significant difference between the two groups (t=?1.030, P=0.333; t=?0.770, P=0.466). HE staining observation showed that a large number of bone graft materials did not degrade and new bone formed around the grafts in both groups at 1 month after operation; the bone graft materials were absorbed and a large number of new bones were formed in both groups at 6 months after operation.ConclusionTBC can maintain bone mineral density and have good osteoconductivity in the alveolar ridge site preservation experiment of dogs, and can be used for alveolar ridge site preservation.
The judgment of the type of arrhythmia is the key to the prevention and diagnosis of early cardiovascular disease. Therefore, electrocardiogram (ECG) analysis has been widely used as an important basis for doctors to diagnose. However, due to the large differences in ECG signal morphology among different patients and the unbalanced distribution of categories, the existing automatic detection algorithms for arrhythmias have certain difficulties in the identification process. This paper designs a variable scale fusion network model for automatic recognition of heart rhythm types. In this study, a variable-scale fusion network model was proposed for automatic identification of heart rhythm types. The improved ECG generation network (EGAN) module was used to solve the imbalance of ECG data, and the ECG signal was reproduced in two dimensions in the form of gray recurrence plot (GRP) and spectrogram. Combined with the branching structure of the model, the automatic classification of variable-length heart beats was realized. The results of the study were verified by the Massachusetts institute of technology and Beth Israel hospital (MIT-BIH) arrhythmia database, which distinguished eight heart rhythm types. The average accuracy rate reached 99.36%, and the sensitivity and specificity were 96.11% and 99.84%, respectively. In conclusion, it is expected that this method can be used for clinical auxiliary diagnosis and smart wearable devices in the future.
Objective To study the characteristics of pulmonary impact injury under closure and open states of glottis. Methods One hundred and eight rabbits were randomly divided into two groups (54 each group). Open state of glottis group(open group): impact injuries with opened glottis; closure state of glottis group (closed group): impact injuries with closed glottis. Parameters were set up with various combinations of driven pressures and compress percentage and the model of rabbit blunt chest trauma were established. Pathological changes were examined and abbreviated injury scale (AIS), water containing and mortality were recorded. Results Two and four rabbits died in open group and closed group respectively under the condition of 30% for compress percentage and 8 250 mmHg for driven pressures. In most cases, AIS values of closed group were significantly higher than that of open group (Plt;0.05). AIS values were positively related to driven pressures and compress percentage (r=0.9313, 0.7847; Plt;0.01, 0.01). Quantities of contained water in lung of closed group were significantly higher than that of open group(t=2.28,Plt;0.01). Conclusion The severity of injury, the increased mortality and earlier occurrence of traumatic acute lung injury were the characteristics of pulmonary impact injury under the closure states of glottis.
Objective To evaluate the reliability and validity of IBS-QOL scale in irritable bowel syndrome (IBS) patients. Methods IBS-QOL scale was applied to survey the quality of life of 123 IBS patients. The split-half and internal consistency method were used to evaluate the reliability, and with the construct method to evaluate the validity. Results The split-half reliability was 0.86. Cronbach’s α-coefficient of all domains was between 0.71 and 0.89 except body image and food avoidance; In the correlation analysis, the correlations between items and its subscale structure were above 0.60 (except interference with activity), but there were no correlations between items and other subscale structure. Eight components from factorial analysis were in accordance with theoretical structure.The cumulative contribution rate was 72.7%. Conclusions The reliability and validity of IBS-QOL scale are acceptable. It might be useful for us to assess the QOL of IBS patients in China.
In clinical, manually scoring by technician is the major method for sleep arousal detection. This method is time-consuming and subjective. This study aimed to achieve an end-to-end sleep-arousal events detection by constructing a convolutional neural network based on multi-scale convolutional layers and self-attention mechanism, and using 1 min single-channel electroencephalogram (EEG) signals as its input. Compared with the performance of the baseline model, the results of the proposed method showed that the mean area under the precision-recall curve and area under the receiver operating characteristic were both improved by 7%. Furthermore, we also compared the effects of single modality and multi-modality on the performance of the proposed model. The results revealed the power of single-channel EEG signals in automatic sleep arousal detection. However, the simple combination of multi-modality signals may be counterproductive to the improvement of model performance. Finally, we also explored the scalability of the proposed model and transferred the model into the automated sleep staging task in the same dataset. The average accuracy of 73% also suggested the power of the proposed method in task transferring. This study provides a potential solution for the development of portable sleep monitoring and paves a way for the automatic sleep data analysis using the transfer learning method.
Objective To observe the serumlevel of neuron-specific enolase( NSE) in patients with pulmonary encephalopathy and its changes after treatment with mechanical ventilation. Methods Twentyone patients with pulmonary encephalopathy were enrolled. Glasgow coma scale( GCS) , serumNSE level, and arterial blood gas were evaluated at three time-points: before mechanical ventilation, after 12 hours mechanical ventilation, and the moment of consciousness. Results 18 patients recovered consciousness, and 3 patients remained in persistent coma and died. GCS and arterial blood gas improved obviously after 12 hours mechanical ventilation. Meanwhile, the serumNSE concentration decreased significantly after 12 hours mechanical ventilation [ ( 24. 54 ±6. 65) μg/L] and at the moment of consciousness [ ( 14. 19 ±2. 91) μg/L] compared with before mechanical ventilation( P lt; 0. 05, P lt; 0. 01) . Conclusion Dynamic measurment of serumNSE may be a useful biomarker for assessing the severity of cerebral injury and predicting prognosis.
