Objective To assess the efficacy,comfort and tolerability of high-flow nasal cannula oxygen therapy in patients with acute respiratory failure (ARF).Methods The literature of RCTs concerning high-flow nasal cannula (HFNC) versus usual oxygen care (UOC) in ARF patients was searched using the national and international electronic databases.All relevant studies were screened according to inclusion and exclusion criteria,and then the included studies were evaluated,and finally,the extracted data were analyzed using Rev Man 5.3 software provided by the Cochrane Collaboration.Results eleven RCTs were included in 3 170 patients,of those 1 550 patients were in HFNC group,while 1 620 patients were in UOC group.There was no statistical difference in mortality among in HFNC and UOC group (OR =0.92,95％ CI:0.70-1.2,P =0.53),neither was the incidence of nosocomial infection (OR =0.85,95％ CI:0.63-1.15,P =0.3).The incidence of endotracheal intubation was lower in HFNC group than in UOC group.The comfort and tolerablity was greater in HFNC group than that in UOC group.Conclusions No difference in mortality or nosocomial infection was detected in patients with ARF treated with HFNC compared with UOC.However,HFNC seem well tolerated by patients and showed a lower rate of endotracheal intubation.

Objective To study the effect of repairment of articular cartilage defects in non weight-bearing area of rabbit with bone marrow-derived mesenchymal stem cells (BMSCs) seeded on human acellular amniotic membrane (HAAM).Methods From July 2012 to March 2013,bone marrow-derived mesenchymal stem cells were isolated and purified from rabbit in vitro.The cells were seeded on human acellular anniotic membrane at the concentration of 1.63 × l05/cm2.From 7 days to 8 days after cultured,the complexes of BMSC and HAAM were examined under electronmicroscope,light microscope and by HE stain.Full thickness empty defects measuring 4 mm in diameter by 3 mm depth were prepared in femoral intercondylar fossa of 24 rabbits.The rabbits were randomized into two groups:group A and group B with 12 each group.The defects of right knees were served as control and the left as experimental group.BMSCs/HAAM composite was cultured and then transplanted into the defect of left knee joint in group A as group BMSCs/HAAM and HAAM into group B as group HAAM.These rabbits were killed at 4 and 12 weeks after surgery in each group and the newly cartilage samples were evaluated grossly,histologically are graded.Results In the 4th and 12th week after the operation,the regenerated tissue were white,soft and smooth.Chondrocytes were found in the tissue In the 12th week,the morphology,distribution and arrangement of the regenerated tissues were similar to normal cartilage in the knees with HAAM-BMSCs transplantation.The regenerated tissues grew to be integrated with the surrounding normal cartilage with obscure boundary between them.Chondrocytes were found in all layer of the tissue,surrounding normal cartilage with obscure boundary between them.In the HAAM transplantation,the rough surface of regenerated tissue sunk obviously and the fibmblasts in all layer were found.While there were no regenerated tissue in the control side.Conclusion BMSCs seeded on HAAM could repair the articular cartilage defects of femoral intercondylar fossa from rabbits.

Objective:To investigate the expression of fibroblast growth factor 7 (FGF7) and related inflammatory factors in the serum of patients with acute exacerbation of chronic obstructive pulmonary disease (COPD).Methods:A case control study was conducted. The patients with AECOPD admitted to the First Affiliated Hospital of Xinjiang Medical University from November 2016 to January 2020 were enrolled. The patients were divided into mild group [forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio (FEV1/FVC) < 0.70, FEV1 percentage in predicted value (FEV1%) ≥ 80%], moderate group (FEV1/FVC < 0.70, 50% ≤ FEV1% < 80%), and severe group (FEV1/FVC < 0.70, 30% ≤ FEV1% < 50%) based on their lung function test results, with 20 patients in each group, and 20 patients with normal pulmonary function who underwent elective non-thoracic surgery such as gastrointestinal surgery and orthopedics surgery in the same period were selected as controls. The demographic data, FEV1/FVC, FEV1%, FVC, maximum mid-expiratory flow percentage in predicted value (MMEF%), 6-minute walking test (6MWT), and St George Respiratory Questionnaire (SGRQ) score were recorded respectively. Serum levels of FGF7, interleukins (IL-6, IL-1β) and tumor necrosis factor-α (TNF-α) were determined by enzyme linked immunosorbent assay (ELISA). Pearson correlation was used to analyze the correlation between TNF-α and lung function.Results:Compared with the normal pulmonary function group, the levels of FEV1/FVC, FEV1%, MMEF% and 6MWT in the mild, moderate and severe groups were significantly decreased, and the SGRQ scores were increased, the indicators continued to deteriorate with the aggravation of the disease, the statistical differences were found between severe group and normal pulmonary function group [FEV1/FVC: 0.39±0.09 vs. 0.81±0.04, FEV1%: (38.80±6.28)% vs. (109.58±13.80)%, MMEF%: (0.34±0.14)% vs. (2.69±0.99)%, 6MWT (m): 279.00±41.61 vs. 402.85±53.97, SGRQ scores: 34.95±6.71 vs. 2.60±2.06, all P < 0.05]. Compared with the normal pulmonary function group, the levels of FGF7 in the mild, moderate and severe groups were significantly lowered (ng/L: 6.31±2.65, 6.10±1.39, 6.64±1.77 vs. 8.29±3.51, all P < 0.05), but no significant difference was found among the mild, moderate and severe groups (all P > 0.05). Compared with the normal pulmonary function group, IL-6 and TNF-α levels were significantly increased in the mild, moderate and severe groups, and TNF-α increased with the aggravation of the disease, the statistical difference was found between severe group and normal pulmonary function group (ng/L: 7.42±2.28 vs. 3.83±0.92, P < 0.05). There was no significant difference in IL-1β level between the normal pulmonary function group and the mild, moderate, severe groups. Correlation analysis showed that TNF-α was negatively correlated with FEV1/FVC and FEV1% ( r values were -0.350 and -0.527, respectively, both P < 0.01). Conclusion:In AECOPD patients, serum FGF7 was decreased, while IL-6 and TNF-α were increased; however, with the aggravation of the disease, there was no significant change in the level of FGF7 in the peripheral blood, but the TNF-α level might be increased, accompanied by severe damage of small airway function.

Objective This study aims to investigate the diagnosis and treatment of external root resorption of adjacent teeth caused by impacted teeth via cone-beam computed tomography (CBCT). Methods A total of 19 teeth from 15 patients with uncertain external root resorption caused by an adjacent impacted tooth were examined from January 2011 to December 2011. All teeth with uncertain external root resorption were scanned by CBCT. Three dimensions reconstruction were the con-ducted to determine the location and extent of resorption. Results In all cases, CBCT identified the accurate location and extent of external root resorption caused by adjacent impacted teeth. Furthermore, the technique provided impacted teeth location in three dimensions, including the relation between the impacted teeth and surrounding vital structures. Conclusion CBCT can provide direct and accurate images of the location and extent of external root resorption, as well as the location of the adja-cent impacted teeth in three dimensions. Therefore, the proposed technique provides reliable information for clinical diagnosis and treatment.

With the encouragement of policies and the rapid development of the biopharmaceutical industry,the number of software as medical device(SaMD)registration applications in Shanghai has continued to increase in recent years,and this paper summarizes the GMP nonconformities found in the field inspection of SaMD in Shanghai from 2020 to 2023,and the results show that nearly 70%of the problems were found in the software development process.Through in-depth analysis,this paper proposes the corresponding countermeasures for the problems found in the five most common stages such as software requirements,software design,software testing,software defect management and software configuration management,combined with the characteristics of software development.These suggested measures have certain reference significance for medical device software development and quality control personnel,and technical reviewer and inspectors.

OBJECTIVEThis study aims to investigate the diagnosis and treatment of external root resorption of adjacent teeth caused by impacted teeth via cone-beam computed tomography (CBCT).

METHODSA total of 19 teeth from 15 patients with uncertain external root resorption caused by an adjacent impacted tooth were examined from January 2011 to December 2011. All teeth with uncertain external root resorption were scanned by CBCT. Three dimensions reconstruction were the conducted to determine the location and extent of resorption.

RESULTSIn all cases, CBCT identified the accurate location and extent of external root resorption caused by adjacent impacted teeth. Furthermore, the technique provided impacted teeth location in three dimensions, including the relation between the impacted teeth and surrounding vital structures.

CONCLUSIONCBCT can provide direct and accurate images of the location and extent of external root resorption, as well as the location of the adjacent impacted teeth in three dimensions. Therefore, the proposed technique provides reliable information for clinical diagnosis and treatment.

Objective:To investigate the clinical effect of flow-through anterolateral thigh perforator flap with fascia lata for repairing dorsal wounds of the hand and foot with extensor tendon defects.Methods:A retrospective case series study was conducted to analyze the clinical date of 14 patients with hand and foot wounds associated with extensor tendon defects admitted to Ruihua Affiliated Hospital of Soochow University from January 2015 to December 2019. There were 13 males and 1 female，aged 10-57 years［（39.2±13.4）years］. The wounds were all single with the area of 10 cm×4 cm to 23 cm×12 cm，including 8 wounds on the back of the hand and 6 wounds on the back of the foot. There was 1 patient accompanied with 1 tendon defect，10 with 4 tendon defects and 3 with 5 tendon defects，with the length of tendon defects ranging from 2.0 to 6.0 cm［（3.8±1.4）cm］. The dimension of flaps ranged from 12 cm×5 cm to 23 cm×13 cm，with the fascia lata from 11 cm×5 cm to 20 cm×7 cm. The deficient extensor tendons were repaired with the fascia lata and vascular pedicles were anastomosed by flow-though. A bilobed flap was harvested in 3 patients and a single flap in 11 patients. Donor sites were sutured directly. The survival of the flap and healing of the donor area were detected after operation. The extremity revascularization and shape and sensation recovery of the flap were measured at the last follow-up. The upper extremity functional evaluation standard set up by Hand Surgery Society of the Chinese Medical Association and Maryland foot functional score were used to evaluate the hand and foot function before operation and at the cast follow-up，respectively. The donor site complications and performance of tendon release or flap thinning in the second stage were recorded.Results:All patients were followed up for 8-30 months［（15.3±6.2）months］. All flaps survived successfully，with wounds and thigh donor areas healed by first intension. No significant effect of revascularization was observed on recipient sites，and acceptable cosmetic outcomes and sensation recovery of the flap were achieved at the final follow-up. For patients with dorsal wounds of the hand，the extensor function recovered in different degrees，and the flexion activities of the fingers were not limited. The total active movement was 180°-250°［（226.3±21.7）°］at the last follow-up，compared to preoperative 110°-170°［（145.6±13.2）°］（ P<0.01）. According to the upper extremity functional evaluation standard，the function was excellent in 4 patients，good in 2 and fair in 2. For patients with wounds of the foot，the flexion and extension function was good，with no obvious deformity of toes，and the Maryland foot functional score ranged from 60 to 92 points［（76.0±12.7）points］at the last follow-up，significantly improved from preoperative 18-45 points［（27.4±7.8）points］（ P<0.01），including excellent results in 2 patients，good in 3 and fair in 1. Only linear scars were left in the thigh donor area，and there was no discomfort such as scar contracture or pain. Four patients underwent skin flap thinning at 4-8 months after operation and none underwent a tenolysis. Conclusion:Repair of dorsal wounds with extensor tendon defects of the hand and foot by flow-through anterolateral thigh perforator flap with fascia lata can reduce interference to recipient sites and repair wounds and extensor tendons simultaneously，which can obtain good flexion and extension function and minor damage to the donor area.

Objective:To investigate the clinical effect of multiple-perforator extra-large anterolateral thigh flap (ALT) for repairing the circular wound of foot and ankle.Methods:Data of 13 cases with the circular wound of foot and ankle repaired by foot and ankle surgery in Ruihua Affiliated Hospital of Soochow University from October 2011 to June 2018 were retrospectively analyzed. The perforator was located by color Doppler ultrasound before the operation, and the flap was designed according to the size of the wound. Both the perforator vessel and lateral femoral cutaneous nerve entering the flap should be carefully protected. When all perforating branches in the flap come from the same vascular trunk, two or more perforating branches are carried to cover the wound directly; when the branches come from the different trunks, the turbocharging technique was used to ensure that there are two or more perforators to nourish the flap. All the donor areas were closed primarily. The sensory of flaps were elevated by the British Medical Research Council (BMRC) sensory function assessment standard, and the motor function was elevated by the American Orthopedic Foot and Ankle Society (AOFAS) ankle and hindfoot function scoring system.Results:A total of 13 patients were enrolled in this study, including 8 males and 5 females.The age ranged from 21 to 65 years, with an average of 39 years. The wound area was 21.0 cm×6.0 cm to 35.0 cm×18.0 cm with exposure of bone and tendon. 12 cases were repaired with multiple-perforator extra-large anterolateral thigh flap ( ALT) harvested from one thigh, and 1 case was repaired with the combined bilateral ALT flap due to the huge wound. The size of flap was 21.0 cm × 7.0 cm to 35.0 cm×10.0 cm. During the procedure, 14 flaps were successfully harvested, 9 flaps were supplied by two perforators, 4 by three perforators, and 1 by four skin perforators. Each flap had an average of 2.4 perforators. Among them, there were 5 flaps with the common source perforators while the other 9 flaps whose perforators came from different sources. All flaps in this group finally survived. One flap suffered the venous crisis 24 hours after the operation and survived after removing the thrombus and re-anastomosing the vessel again. The stitches were removed 2 to 3 weeks after operation when the wound had healed. All wounds in the donor area healed primarily. 9 flaps underwent flap thinning and plastic surgery 6 to 10 months after the operation. Follow-up for 6 to 18 months showed the color and texture of the flap was close to the recipient area, and the sensation of the flap elevated by BMRC sensory function assessment standard was S2-S3. According to the AOFAS ankle and hindfoot scoring system, the function of the recipient area was 72-98 points, with an average of 92 points. Only linear scars were left in the donor area.Conclusions:Because of the advantages of rich blood supply, strong anti-infection ability, and less damage to the donor area, it is an ideal method to repair the circular wound of the foot and ankle with multiple-perforator extra-large anterolateral thigh flap.

Objective:To investigate the clinical effect of multiple-perforator extra-large anterolateral thigh flap (ALT) for repairing the circular wound of foot and ankle.Methods:Data of 13 cases with the circular wound of foot and ankle repaired by foot and ankle surgery in Ruihua Affiliated Hospital of Soochow University from October 2011 to June 2018 were retrospectively analyzed. The perforator was located by color Doppler ultrasound before the operation, and the flap was designed according to the size of the wound. Both the perforator vessel and lateral femoral cutaneous nerve entering the flap should be carefully protected. When all perforating branches in the flap come from the same vascular trunk, two or more perforating branches are carried to cover the wound directly; when the branches come from the different trunks, the turbocharging technique was used to ensure that there are two or more perforators to nourish the flap. All the donor areas were closed primarily. The sensory of flaps were elevated by the British Medical Research Council (BMRC) sensory function assessment standard, and the motor function was elevated by the American Orthopedic Foot and Ankle Society (AOFAS) ankle and hindfoot function scoring system.Results:A total of 13 patients were enrolled in this study, including 8 males and 5 females.The age ranged from 21 to 65 years, with an average of 39 years. The wound area was 21.0 cm×6.0 cm to 35.0 cm×18.0 cm with exposure of bone and tendon. 12 cases were repaired with multiple-perforator extra-large anterolateral thigh flap ( ALT) harvested from one thigh, and 1 case was repaired with the combined bilateral ALT flap due to the huge wound. The size of flap was 21.0 cm × 7.0 cm to 35.0 cm×10.0 cm. During the procedure, 14 flaps were successfully harvested, 9 flaps were supplied by two perforators, 4 by three perforators, and 1 by four skin perforators. Each flap had an average of 2.4 perforators. Among them, there were 5 flaps with the common source perforators while the other 9 flaps whose perforators came from different sources. All flaps in this group finally survived. One flap suffered the venous crisis 24 hours after the operation and survived after removing the thrombus and re-anastomosing the vessel again. The stitches were removed 2 to 3 weeks after operation when the wound had healed. All wounds in the donor area healed primarily. 9 flaps underwent flap thinning and plastic surgery 6 to 10 months after the operation. Follow-up for 6 to 18 months showed the color and texture of the flap was close to the recipient area, and the sensation of the flap elevated by BMRC sensory function assessment standard was S2-S3. According to the AOFAS ankle and hindfoot scoring system, the function of the recipient area was 72-98 points, with an average of 92 points. Only linear scars were left in the donor area.Conclusions:Because of the advantages of rich blood supply, strong anti-infection ability, and less damage to the donor area, it is an ideal method to repair the circular wound of the foot and ankle with multiple-perforator extra-large anterolateral thigh flap.

Objective To evaluate the predictive factors for failure of non-invasive positive pressure ventilation (NIPPV) in immunosuppressed patients with acute respiratory failure (ARF). Methods The clinical data of 118 immuno-deficient patients treated with NIPPV in the respiratory and intensive care unit (RICU) of the First Affiliated Hospital of Xinjiang Medical University from January 2012 to August 2017 were retrospectively analyzed. The patients were divided into a non-endotracheal intubation (ETI) group (n = 62) and ETI group (n = 56) according to whether ETI was performed during the hospitalization period or not. Each observed indicator was analyzed by univariate analysis, and factors leading to failure of NIPPV were further analyzed by Logistic regression. Receiver operating characteristic (ROC) curve was plotted to evaluate the predictive value of risk factors for failure of NIPPV in immunosuppressed patients with ARF. Results The non-intubation rate for NIPPV in immunosuppressed patients was 50.8% (60/118). Compared with the non-ETI group, the body temperature, pH value in the ETI group were significantly increased, the partial pressure of arterial carbon dioxide (PaCO2) was significantly decreased, the ratio of oxygenation index (PaO2/FiO2) < 100 mmHg (1 mmHg = 0.133 kPa), acute physiology and chronic health evaluation Ⅱ(APACHE Ⅱ) score ≥ 20, and the number of cases requiring catecholamine were significantly increased, the mortality was significantly increased. Multivariate Logistic regression analysis showed that the APACHE Ⅱ score ≥ 20 [odds ratio (OR) = 15.274, 95% confidence internal (95%CI) = 2.175-107.252, χ2= 7.516, 1 = 0.006], PaO2/FiO2< 100 mmHg (OR = 0.075, 95%CI = 0.014-0.408, χ2= 8.968, 1 = 0.003), and need for catecholamine (OR = 35.736, 95%CI = 6.974-183.124, χ2= 18.400, 1 < 0.001) were independent risk factors for failure of NIPPV. ROC curve analysis showed that the APACHE Ⅱ score ≥ 20 and PaO2/FiO2< 100 mmHg could predict failure of NIPPV, the area under ROC curve (AUC) of the APACHE Ⅱ score ≥ 20 was 0.787, the sensitivity was 83.93%, the specificity was 69.35%, the positive predict value (PPV) was 71.21%, the negative predict value (NPV) was 82.69%, the positive likelihood ratio (PLR) was 2.74, the negative likelihood ratio (NLR) was 0.23, and Youden index was 0.53; the AUC of PaO2/FiO2< 100 mmHg was 0.757, the sensitivity was 80.65%, the specificity was 66.07%, the PPV was 68.18%, the NPV was 78.85%, the PLR was 2.38, the NLR was 0.29, and Youden index was 0.47. Conclusions 50.8% of immunocompromised and ARF patients treated with NIPPV did not require ETI, which is independent of the etiology of ARF. APACHE Ⅱ score ≥ 20, PaO2/FiO2<100 mmHg, and the need for catecholamine are predictive factors for failure of NIPPV in immunocompromised patients.