AIM　To compare the bioactivity and bioavailability of domestic and imported salcaltonin injections in Chinese healthy volunteers. METHOD　Using randomized cross design, to determine the concentrations of calcium and salcaltonin in serum of healthy volunteers after single dose of domestic and imported injections. RESULT　Two preparations reduced concentration of calcium in serum obviously and there was no difference of mean changes of calcium between the two kinds of injections (P>0.05). The main pharmacokinetic parameters are: Cmax: (2.31±0.16) μg*L-1 and (2.44±0.20) μg*L-1；Tmax: (48.75±12.99) min and (52.50±16.31) min；T1/2ke: (92.93±11.86) min and (97.61±11.23) min；Ke: (0.0079±0.0023) min-1 and (0.0084±0.0014) min-1；AUC(0～360 min): (297.70±44.45) μg*min*L-1 and (313.64±46.03) μg*min*L-1 respectively in domestic and imported salcaltonin injections. The relative bioavailability of domestic formulation is 97.6%±25.6%. CONCLUSION　The domestic and imported salcaltonin injections administered produce similar biological response and bioavailability and they are bioequivalent.

0 05). The main pharmacokinetic parameters are: C max : (2 31?0 16) ?g?L -1 and (2 44?0 20) ?g?L -1 ; T max : (48 75?12 99) min and (52 50?16 31) min; T 1/2ke : (92 93?11 86) min and (97 61?11 23) min; K e: (0 0079?0 0023) min -1 and (0 0084?0 0014) min -1 ; AUC (0～360 min) : (297 70?44 45) ?g?min?L -1 and (313 64?46.03) ?g?min?L -1 respectively in domestic and imported salcaltonin injections. The relative bioavailability of domestic formulation is 97 6%?25 6%. CONCLUSION The domestic and imported salcaltonin injections administered produce similar biological response and bioavailability and they are bioequivalent.

Objective To evaluate the prognostic value of blood lactate (Lac) level in sepsis patients with or without diabetes.Methods 106 patients admitted to intensive care unit (ICU) of Zhongshan Hospital Affiliated to Fudan University from April 2015 to November 2016 were enrolled. The patients with age > 18 years and the length of hospital stay > 24 hours were included. Records including blood Lac, serum creatinine (SCr), white blood cell count (WBC), platelet count (PLT), sequential organ failure assessment (SOFA) on the first day of admission; minimum oxygen index (PaO2/FiO2) in 3 days after admission; mechanical ventilation, whether there was a history of diabetes, usage of biguanides, etiology control treatment, usage of continuous renal replacement therapy (CRRT) were collected. According to the level of blood Lac patients were divided into high Lac group (Lac > 2 mmol/L) and low Lac group (Lac ≤ 2 mmol/L);based on their diabetic history, sepsis patients were divided into the diabetes group and non-diabetes group. The survival curve of each group was analyzed by Kaplan-Meier regression analysis, and the factors influencing the prognosis were analyzed by multivariate Cox regression analysis.Results There were 76 males and 30 females sepsis patients, with an average age of (68.1±14.7) years old. In the 51 patients of low Lac group, there were 7 patients who suffered from diabetes. While in the 55 patients of high Lac group, there were 12 patients who suffered from diabetes. Compared with low Lac group, high Lac group had a higher age, higher SOFA score, and a lower proportion of patients who had the treatment of etiology control (allP < 0.05). There was no significant difference of blood Lac in sepsis patients with diabetes and those without diabetes (mmol/L: 3.03±2.73 vs. 2.81±2.40,P > 0.05). Kaplan-Meier survival curve analysis showed that the 90-day survival rate in the high Lac group was significantly lower than that in the low Lac group (56.36% vs. 90.20%,χ2 = 0.697,P = 0.008). The high Lac group without diabetes had lower survival rate, and the 90-day survival rate was significantly lower than that of the low Lac group without diabetes (58.14% vs. 90.90%,χ2 = 7.152,P = 0.007); there was no significant difference in 90-day survival rate between the high Lac group and the low Lac group with diabetes (50.00% vs. 85.71%,χ2 = 0.012,P = 0.914). Multivariate Cox regression analysis showed that blood Lac was an independent risk factor for the prognosis of sepsis patients [odds ratio (OR) = 3.863, 95% confidence interval (95%CI) = 1.237-12.060,P = 0.020]. After stratification according to their diabetic history, the blood Lac was an independent risk factor for the prognosis of sepsis patients without diabetes (OR = 4.816, 95%CI = 1.407-15.824, P = 0.010), but the blood Lac had no effect on the prognosis of sepsis patients with diabetes (OR = 0.000, 95%CI =0.000-1.103,P = 0.270).Conclusions The predictive value of blood Lac on sepsis patients with or without diabetes was different. The blood Lac was related with the prognosis of sepsis patients without diabetes, while further study should be conducted for the prognostic value of blood Lac in sepsis patients with diabetes, and it's possible to increase the cut-off-point of Lac level in these patients.

BACKGROUND:In order to solve the problems of poly-l-lactic acid (PLLA) stents, such as poor support, acidic metabolites, we researched a novel biogradable stent-PLLA/amorphous calcium plosphate (ACP).
OBJECTIVE: To discuss the safety and histocompatibility of the novel biogradable stent-PLLA/ACP stent implanted in the coronary artery in a porcine model.
METHODS:Sixteen novel biogradable stents were randomly implanted into the coronary arteries, left anterior descending branch, left circumflex artery or right coronary artery of sixteen healthy Tibet miniature pigs. The blood routine and blood biochemistry were measured pre-operation and at 1 month after operation. The coronary blood vessels where the stent was implanted were examined by hematoxylin-eosin staining at 1 and 6 months after operation.
RESULTS AND CONCLUSION: Compared with pre-operation, the post-operation indicators of the blood routine and blood biochemistry were of no significant difference. Coronary angiography revealed coronary artery patency and no thrombosis, the vascular stent segments exhibited clear boundaries with the surrounding tissue, with no tissue adhesion, necrosis, and adherence abnormalities. The results of hematoxylin-eosin staining showed that there was no significant difference in vascular injury integral between 1 month after operation and 6 months after operation. However, 6 months after operation, the scores of the inflammation were lower (P < 0.05), and the scores of the endothelialization were increased (P < 0.05). There was no myocardial infarction and inflammatory cellinfiltration around the stent. These results suggest that the novel biodegradable stent has good safety and histocompatibility.

Objective To investigate the clinical treatment and outcomes of severe community-acquired pneumonia (CAP) complicated with mediastinal emphysema after renal transplantation. Methods Clinical data of9 patients with severe CAP complicated with mediastinal emphysema after renal transplantation were retrospectively analyzed. The acute physiology and chronic health evaluationⅡ(APACHEⅡ) and oxygenation index were recorded when the patients were admitted to the intensive care unit (ICU). The complications of mediastinal emphysema and corresponding treatment were observed. The treatment course during the ICU, mortality rate in ICU, ICU stay time and hospital stay time were recorded. All patients underwent pathogenic examinations. Results The APACHEⅡ score of9 patients with severe CAP complicated with mediastinal emphysema after renal transplantation was 14 (8-21) scores and the oxygenation index was 150 (133-189) mmHg. Among 9 patients, 3 cases were infected by bacteria alone, 3 cases were infected by bacterial infection combined with viral infection, 1 case was infected by mycobacterium tuberculosis complicated with other bacterial infection and 1 case was viral infection. No pathogenic evidence was detected in the remaining 1 patient. Mediastinal emphysema complicated with subcutaneous emphysema occurred in 7 cases and pneumothorax occurred in 6 cases. Treatment methods included anti-infection, modified immunosuppressive program, mediastinal drainage, thoracic closed drainage, subcutaneous incision and extracorporeal membrane oxygenation (ECMO) treatment. Six patients received invasive mechanical ventilation (IMV), 2 received non-invasive positive pressure ventilation (NIV) and 1 received high-flow nasal oxygen cannula (HFNC). Among 9 patients, the mortality rate in ICU was 6/9, the remaining 3 patients were recovered and discharged, the ICU stay time was 26 (17-40) d, and the total hospital stay time was 27-61 d. Conclusions Mediastinal emphysema is a serious complication of patients presenting with severe CAP after renal transplantation with a high mortality rate. For these patients, imaging evaluation, timely drainage and full sedation should be strengthened, and ECMO treatment should be delivered when necessary.

Objective: To investigate IMRT planning process using the combined application of failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by reference to the report of Task Group 100 of the AAPM, and stablish and optimize the quality. Methods: A multidisciplinary team detailed the process mapping of IMRT planning using Eclipse TPS. The team evaluated the potential failure modes (FMs) of every process step. The evaluation was divided into two groups according to whether quality management (QM) was considered. For every FM, occurrence (O), severity (S) and detectability (D) by consensus were evaluated, and the product of O, S and D yielded the risk priority number (RPN), which permitted the ranking of the FMs. Finally, FTA was used to determine the root factors contributing to the riskiest failure modes. Results: The IMRT plan process consisted of 10 major sub-processes and 33 steps, which amounted to 47 failure modes. For the group without quality management, the RPN of FMs was between 13.2-271.8, 27 of which had RPN≥80, and 18 FMs had S≥8. For the group with quality management, the RPN of FMs was between 11.2-158.4, 11 of which had RPN≥80. The difference of RPN between the two groups was statistically significant (RPN of the group without QM=101.17±66.34, RPN of the group with QM=59.54±35.64, t=8.501, P<0.05). Finally, FTA was used to determine the root factors contributing to the FMs, i. e., prescription dose definition and importing images. Conclusions The FMEA and FTA methods are operable and practical, which can systematically and comprehensively analyze the potential failures and risks existing in the process of IMRT plan. And the FMEA and FTA can contribute to establish and optimize the quality management program in radiotherapy.

Objective:To summarize the relevant evidence of environmental management for preventing delirium in ICU patients, so as to provide references for delirium management in ICU patients.Methods:Evidence-based questions were constructed according to the PIPOST model, and relevant clinical decisions, guidelines, expert consensus, systematic reviews and evidence summaries published by various guideline websites, evidence-based databases and comprehensive databases at home and abroad were systematically searched according to the evidence resource "6S" model. The search period was from the establishment of databases to September 3, 2022. Two researchers independently conducted literature quality evaluation using corresponding literature quality evaluation tools. The Joanna Briggs Institute (JBI) Evidence Pre-grading and Evidence Recommendation Grading System (2014 Edition) was used to grade and recommend included evidence.Results:A total of 30 articles were included, including 5 guidelines, 2 expert consensus, 1 clinical recommended practice, 4 evidence summaries and 18 systematic reviews. A total of 36 best evidences were summarized from 5 aspects, including environment optimization, sleep promotion, cognitive stimulation, positioning and orientation function, and safety protection.Conclusions:Medical staff should manage the ICU environment based on evidence-based evidence to prevent or reduce the occurrence of delirium in patients.