Objective To explore the feasibility of the three-port laparoscopic surgery through single umbilical incision with urological desease. Methods Thirty-two patients (10 males and 22 females) were taken the laparoscopic surgery using three ports through single incision. Including varicocele 7 cases, simple kidney cyst 12 cases, double kidney cyst 1 case, polycystic kidney 1 case, left adrenal tumor 3 cases, right adrenal tumor 1 cases, left upper ureteral calculi 1 cases, giant hydronephrosis 1 case and atrophic kidney 4 cases. The surgery procedures were including make a 1.0-3.0 cm long incision in the navel, followed by inserting three 10 mm or 5 mm trocars in the incision for observation and operation. Conventional laparoscopic techniques were used to complete the urological surgery. Results The operation time of varicoeele ligation was 10--20 rain, mean 15 min, no intraoperative bleeding. The operation time of renal cysts was 30-53 min, mean 40 rain, no intraoperative bleeding. The operation time of resection of adrenal tumor was 57--120 min, mean 68 rain, intraoperative bleeding was 20-60 ml, mean 30 ml. The operation time of ureterolithotomy was 86 min, intraoperative bleeding was 50 ml. The operation time of nephrectomy was 45-135 min, mean 65 min, intraoperative bleeding was 90-150 ml, mean 110 ml. Length of stay 3-8 days, average 5.5 days.With average follow-up time 2 months, all cases were fully recovered without complication and no visible scar in the abdominal region. Conclusion The laparoscopic surgery using three ports through single incision is safe and effective in selected urological surgery.

Objective:To explore the patient-ventilator interaction of neurally adjusted ventilatory assist (NAVA) in patients with severe neurological diseases.Methods:A prospective study was conducted. Sixteen severe neurological patients with tracheotomy admitted to neurosurgery intensive care unit (NSICU) of Yijishan Hospital of the First Affiliated Hospital of Wannan Medical College from September 2019 to February 2020 were enrolled. According to the random number table method, they were treated with pressure support ventilation (PSV) mode followed by NAVA mode or NAVA mode followed by PSV mode mechanical ventilation. Each mode was ventilated for 24 hours. The number of auto-triggering, ineffective trigger, double trigger, inspiratory trigger delay, premature cycling, late cycling, and patient-ventilator asynchronous time (inspiratory trigger delay time, premature cycling time, and late cycling time) within 1 minute were recorded every 8 hours for 3 minutes. The average number of asynchronies per minute, asynchrony index (AI), total AI, asynchrony time, arterial blood gas analysis, and coefficient variation (CV%) of respiratory mechanics parameters of each asynchrony type between the two modes were compared.Results:There were significant decrease in the number or AI of auto-triggering, ineffective trigger, inspiratory trigger delay, premature cycling, and late cycling with NAVA mode ventilation compared with PSV mode ventilation [auto-triggering times (times/min): 0.00 (0.00, 0.00) vs. 0.00 (0.00, 0.58), auto-triggering AI: 0.00 (0.00, 0.00) vs. 0.00 (0.00, 0.02), ineffective trigger times (times/min): 0.00 (0.00, 0.33) vs. 1.00 (0.33, 2.17), ineffective trigger AI: 0.00 (0.00, 0.02) vs. 0.05 (0.02, 0.09), inspiratory trigger delay times (times/min): 0.00 (0.00, 0.58) vs. 0.67 (0.33, 1.58), inspiratory trigger delay AI: 0.00 (0.00, 0.02) vs. 0.05 (0.02, 0.09), premature cycling times (times/min): 0.00 (0.00, 0.33) vs. 0.33 (0.08, 1.00), premature cycling AI: 0.00 (0.00, 0.01) vs. 0.02 (0.00, 0.05), late cycling times (times/min): 0.00 (0.00, 0.00) vs. 1.17 (0.00, 4.83), late cycling AI: 0.00 (0.00, 0.00) vs. 0.07 (0.00, 0.25), all P < 0.05]. But there was significant increase in the number or AI of double trigger with NAVA mode ventilation as compared with PSV mode ventilation [times (times/min): 1.00 (0.33, 2.00) vs. 0.00 (0.00, 0.00), AI: 0.04 (0.02, 0.11) vs. 0.00 (0.00, 0.00), both P < 0.05]. Total AI and incidence of total AI > 0.1 showed significant decrease during NAVA mode ventilation as compared with PSV mode ventilation [total AI: 0.08 (0.04, 0.14) vs. 0.22 (0.18, 0.46), incidence of total AI > 0.1: 37.50% (6/16) vs. 93.75% (15/16), both P < 0.01]. There was no significant difference in asynchronous time or arterial blood gas analysis between the two modes. There were significant increases in variances of peak airway pressure (Ppeak) and expiratory tidal volume (VTe) during NAVA mode ventilation as compared with PSV mode ventilation [Ppeak coefficient of variation (CV%): 11.25 (7.12, 15.17)% vs. 0.00 (0.00, 2.82)%, VTe CV%: (8.93±5.53)% vs. (4.71±2.61)%, both P < 0.05]. Conclusions:Compared with PSV mode, NAVA mode can reduce the occurrence of patient-ventilator asynchronous events, reduce the AI and the occurrence of serious patient-ventilator asynchronous events, so as to improve the patient-ventilator interaction. NAVA and PSV modes can achieve the same gas exchange effect. At the same time, NAVA mode has potential advantages in avoiding insufficient or excessive ventilation support, diaphragm protection and prevention of ventilator-induced lung injury.

Objective:To explore the prognostic effect and safety of neurally adjusted ventilatory assist (NAVA) mode on the patients with severe neurological cerebrovascular disease undergoing mechanical ventilation.Methods:A prospective study was conducted. Fifty-four patients with cerebrovascular disease undergoing mechanical ventilation admitted to the neurosurgery intensive care unit (NSICU) of the First Affiliated Hospital of Wannan Medical College (Yijishan Hospital) from December 2020 to May 2022 were enrolled. They were divided into NAVA group and pressure support ventilation (PSV) group by computer random number generator with 27 patients in each group. The ventilation time of the two groups was ≥72 hours. The general basic data of the two groups were recorded. The time without mechanical ventilation 28 days after enrollment, total length of mechanical ventilation, survival rate of 90 days after enrollment, length of NSICU stay, total length of hospital stay, NSICU mortality, in-hospital mortality, Glasgow outcome score (GOS), complications related to mechanical ventilation, and changes of respiratory mechanics indexes, arterial blood gases, vital signs, and diaphragm function indexes were observed.Results:The time without mechanical ventilation 28 days after enrollment in the NAVA group was significantly longer than that in the PSV group [days: 22 (15, 26) vs. 6 (0, 23), P < 0.05]. However, there were no significant differences in the total length of mechanical ventilation, 90-day survival rate, length of NSICU stay, total length of hospital stay, NSICU mortality, in-hospital mortality, GOS score, and incidence of mechanical ventilator-related complications between the two groups. In terms of respiratory mechanics parameters, the expiratory tidal volume (VTe) on 3 days after mechanical ventilation of patients in the NAVA group was significantly lower than that on 1 day and 2 days, and significantly lower than that in the PSV group [mL: 411.0 (385.2, 492.6) vs. 489.0 (451.8, 529.4), P < 0.01]. Minute ventilation (MV) at 2 days and 3 days in the NAVA group was significantly higher than that at 1 day, and significantly higher than that in the PSV group at 2 days [L/min: 9.8 (8.4, 10.9) vs. 7.8 (6.5, 9.8), P < 0.01], while there was no significant change of MV in the PSV group. At 1 day, peak airway pressure (Ppeak) and mean airway pressure (Pmean) in the NAVA group were significantly lower than those in the PSV group [Ppeak (cmH 2O, 1 cmH 2O≈0.098 kPa): 14.0 (12.2, 17.0) vs. 16.6 (15.0, 17.4), Pmean (cmH 2O): 7.0 (6.2, 7.9) vs. 8.0 (7.0, 8.2), both P < 0.05]. However, there was no significant difference in the Ppeak or Pmean at 2 days and 3 days between the two groups. In terms of arterial blood gas, there was no significant difference in pH value between the two groups, but with the extension of mechanical ventilation time, the pH value at 3 days of the two groups was significantly higher than that at 1 day. Arterial partial pressure of oxygen (PaO 2) at 1 day in the NAVA group was significantly lower than that in the PSV group [mmHg (1 mmHg≈0.133 kPa): 122.01±37.77 vs. 144.10±40.39, P < 0.05], but there was no significant difference in PaO 2 at 2 days and 3 days between the two groups. There was no significant difference in arterial partial pressure of carbon dioxide (PaCO 2) or oxygenation index (PaO 2/FiO 2) between the two groups. In terms of vital signs, the respiratory rate (RR) at 1, 2, and 3 days of the NAVA group was significantly higher than that of the PSV group [times/min: 19.2 (16.0, 25.2) vs. 15.0 (14.4, 17.0) at 1 day, 21.4 (16.4, 26.0) vs. 15.8 (14.0, 18.6) at 2 days, 20.6 (17.0, 23.0) vs. 16.7 (15.0, 19.0) at 3 days, all P < 0.01]. In terms of diaphragm function, end-inspiratory diaphragm thickness (DTei) at 3 days in the NAVA group was significantly higher than that in the PSV group [cm: 0.26 (0.22, 0.29) vs. 0.22 (0.19, 0.26), P < 0.05]. There was no significant difference in end-expiratory diaphragm thickness (DTee) between the two groups. The diaphragm thickening fraction (DTF) at 2 days and 3 days in the NAVA group was significantly higher than that in the PSV group [(35.18±12.09)% vs. (26.88±8.33)% at 2 days, (35.54±13.40)% vs. (24.39±9.16)% at 3 days, both P < 0.05]. Conclusions:NAVA mode can be applied in patients with neuro-severe cerebrovascular disease, which can prolong the time without mechanical ventilation support and make patients obtain better lung protective ventilation. At the same time, it has certain advantages in avoiding ventilator-associated diaphragm dysfunction and improving diaphragm function.

OBJECTIVE To systematically review the background of bioequivalence assessment of nasal sprays and nasal aerosols and the guiding considerations for the bioequivalence assessment of these complex drug-device combination products by regulatory authorities in the United States, the European Union(EU) and China. METHODS This article provided detailed explanations on the innovative weight of evidence assessment approach adopted by the US Food and Drug Administration(FDA), and the statistical rationale, methods and considerations for the bioequivalence assessment of nasal sprays and nasal aerosols. Using the calculation methods described in the draft guidance for budesonide inhalation suspension and the draft guidance for fluticasone nasal spray propionate issued by FDA, the statistical parameters of two-sided and one-sided population bioequivalence calculation were realized through R language programming, and pseudo-code for the population bioequivalence (PBE) calculation programs was provided. This article also presented a comprehensive review of published guidelines and summaries review principles of the EU and China for nasal sprays and nasal aerosols equivalence assessment. RESULTS & CONCLUSION Nasal sprays/nasal aerosols is the focus of innovative and generic drug development in recent years. This paper provided valuable considerations references for the research and development, quality control and bioequivalence evaluation of generic preparations of nasal sprays/nasal aerosols.