OBJECTIVE To introduce and discuss the quality management system of medical loaner instrumentation and implantables in the US.METHODS With US national standards and industry guidelines on loaner instrumentation and implantables,and the practical problems we encountered in China on this subject,we will discuss their quality management.RESULTS We should apply whole process quality management to loaner instrumentation and implantables.CONCLUSIONS Zero tolerance quality management in loaner instrumentation and implantables is crucial for medical safety.

Objective: To evaluate the role of mitochondrion-dependent apoptosis in reduction of bupivacaine-induced cardiotoxicity by lipid emulsion in rats. Methods: Forty-five healthy adult male Sprague-Dawley rats, weighing 300-350 g, were divided into 3 groups by a random number table method: sham operation group (Sham group, n=5), bupivacaine group (B group, n=20), and lipid emulsion group (L group, n=20). Cardiac arrest was induced by intravenously injecting 0.4% bupivacaine 30 mg/kg over 20 s to establish the cardiotoxicity model.Twenty percent lipid emulsion was intravenously injected in a dose of 5 ml/kg during resuscitation in group L, and normal saline was intravenously injected in a loading dose of 5 ml/kg during resuscitation in group B, followed by a 3-min infusion of 1 ml·kg^-1·min^-1in two groups.The successful resuscitation and survival rate at 120 min of return of spontaneous circulation (ROSC) were recorded.Systolic blood pressure, heart rate, mean arterial pressure, rate-pressure product (RPP) and ratio of RPP at each time point after recovery of spontaneous heart beat to baseline value (RPPh) were recorded every 10 min after ROSC.The time from administration to cardiac arrest (T₀), time from beginning of cardiopulmonary resuscitation to appearance of the first spontaneous heart beat (T_s) and time from beginning of cardiopulmonary resuscitation to appearance of ROSC (T_r) were recorded.Rats were sacrificed at 120 min of ROSC, and left ventricular tissues were obtained for determination of the expression of Bax, Bcl-2, cleaved caspase-9, cleaved caspase-3, cytochrome C (Cyt c) in cytoplasm and mitochondria (by Western blot) and expression of Bax and Bcl-2 mRNA (by real-time polymerase chain reaction) and for examination of myocardial ultrastructure. Results: Compared with Sham group, the expression of Bcl-2 protein and mRNA and mitochondrial Cyt c was significantly down-regulated, and the expression of Bax protein and mRNA, cleaved caspase-9, cleaved caspase-3 and cytoplasmic Cyt c was up-regulated in B group (P<0.05). Compared with B group, the rate of successful resuscitation and survival rate were significantly increased, T_r was shortened, systolic blood pressure, heart rate, RPP and RPPh were increased after ROSC, the expression of Bcl-2 protein and mRNA and mitochondrial Cyt c was up-regulated, the expression of Bax protein and mRNA, cleaved caspase-9, cleaved caspase-3 and cytoplasmic Cyt c was down-regulated (P<0.05), no significant change was found in T_o or T_s (P>0.05), and the pathological changes of myocardium were significantly attenuated in L group. Conclusion The mechanism by which lipid emulsion reduces bupivacaine-induced cardiotoxicity may be related to inhibiting mitochondrion-dependent apoptosis in rats.

Objective:To compare the clinical efficacy of percutaneous transhepatic gallbladder drainage (PTGBD) combined with delayed laparoscopic cholecystectomy (LC) with direct LC in the treatment of acute cholecystitis.Methods:A single-center case-control retrospective study was used. Sixty-three patients with acute cholecystitis with onset time ≥ 72 hours during the period from August 1, 2021 to December 10, 2022 in the Department of Hepatobiliary Surgery of the 900TH Hospital of Joint Logistics Support Force were selected. There were 38 males and 25 females, aged (57.3±15.4) years, with an age range of 28-87 years. According to whether PTGBD treatment was performed before LC, they were divided into experimental group ( n=29) and control group ( n=34). Experimental group was treated with PTGBD combined with delayed LC and control group was treated with LC only.The differences in operative time, intra-operative bleeding, intra-operative transit open rate, post-operative hospital days, total hospital days, hospital costs, short-term post-operative complications of LC and post-operative time to exhaustion were compared and analysed between the two groups. Measurement data with normal distribution were expressed as mean±standard deviation ( ± s), and independent sample t-test was used for comparison between groups.Measurement data with skewed distribution were expressed as M( Q1, Q3), and rank sum test was used for comparison between groups; Chi-square test was used to compare the counting data groups. Results:Intraoperative bleeding, total hospital days, hospital costs and postoperative time to exhaustion were 0(0, 50) mL, 13(11, 18) d, 29 015.0 (22 791.6, 39 000.8) yuan and 1(1, 2) d in the experimental group and 50(0, 88) mL, 7(6, 11) d, 16 015.0 (15 832.1, 22 185.1) yuan, 2(1, 3) d, the difference was statistically significant between the two groups( P<0.05). In the experimental group, the operative time, the intraoperative transit open rate, the number of postoperative hospital days, and the incidence of short-term postoperative complications of LC were 80 (55, 115) min, 13.8%, 5 (3, 7) days, 34.5%, respectively, compared with 98(70, 125) min, 20.6%, 5(3, 6) days, 38.2% in the control group, the difference between the two groups was not statistically significant ( P>0.05). Conclusion:The clinical efficacy of PTGBD combined with delayed LC is better than direct line LC, and it is feasible and effective for patients with cholecystitis whose inflammatory indexes have returned to normal and who have high gallbladder tone.

OBJECTIVETo understand the prevalence and spatial distribution of vitamin A deficiency (VAD) in China among children at ages under six years.

METHODSAbout 8,600 children under 6 years of age in 14 cities and 28 counties of 14 provinces were selected with stratified cluster sampling for survey, including interview with questionnaire for their family information and nutritional status. Blood specimens were collected for measuring serum level of VA with fluorescent spectrophotometry in laboratory.

RESULTSTotally, 8,669 children under 6 (2,877 in urban area and 5,792 in rural area) were surveyed in 14 provinces, with 4,629 males and 4,040 females. Eight cases of night blindness and seven cases of xerophthalmia were found among the children at ages of two to five years. Sixty-one mothers of the children in this group were also found suffering from night blindness. All the cases of night blindness and xerophthalmia both in children and mothers were living in rural areas. Based on their serum levels of VA, 11.7% of the all 1 018 children were diagnosed as VAD, with serum VA concentrations below or equal to 0.70 micro mol/L. Prevalence of VAD was 15.0% and 5.8% in rural (23.3% in the poverty-stricken counties) and urban areas, respectively, and 5.8%, 11.5% and 16.8% in the coastal, inland and remote areas, respectively. The average serum level of VA was 1.20 micro mol/L and 0.99 micro mol/L for urban and rural areas, respectively, with a national average of 1.06 micro mol/L. And, babies under six months of age with an average serum levels of VA < or = 0.70 micro mol/L accounted for 33.4%, and those at ages of four to five years with the same level of VA accounted for 8%. There was significant difference in serum levels of VA between ages, but no significant difference between genders.

CONCLUSIONVAD did exist in children of China, especially in the remote and poverty-stricken rural areas and VA supplementation is urgently needed for the children in these regions.

Child ; Child, Preschool ; China ; epidemiology ; Dietary Supplements ; Female ; Health Surveys ; Humans ; Infant ; Male ; Night Blindness ; complications ; Prevalence ; Rural Health ; statistics & numerical data ; Vitamin A ; administration & dosage ; therapeutic use ; Vitamin A Deficiency ; complications ; epidemiology ; prevention & control ; Xerophthalmia ; complications

Objective To identify risk factors for seroma formation and to explore the related prevention and treatment methods.Methods We collected clinical and pathological data of 92 breast cancer patients undergoing modified radical mastectomy in Hu'nan Provincial People's Hospital,from January to September 2016.Seroma formation was studied in relation to age,tumor size,nodal involvement,the number of lymph nodes removed,flap fixation and external compression dressing.Count date were evaluated by the frequency and percentage,comparison between the groups was analyzed by the chi-square test.Multivariate analysis was performed using Logistic regression analysis.Results Seroma occurred in 45.7％ of patients.Age,tumor size,nodal involvement,the number of lymph nodes removed,flap fixation were risk factors of modified radical mastectomy postoperative seroma.In multivariate logistic regression analysis an association of postoperative seroma formation was noted with the number of lymph nodes removed(OR =1.123,95％ CI:1.036-1.218,P ＜ 0.01),age(OR =1.060,95％ CI:1.006-1.116,P＜0.05),flap fixation(OR=0.363,95％CI:0.135-0.977,P ＜0.05).Conclusion The findings suggest that older patients,with extensive lymph node dissection may more likely to form postoperative seroma,flap fixation can reduce the incidence of seroma.

Objective: To investigate the expression and distribution of FNDC5/Irisin in pancreatic cancer tissues and adjacent tissues, and to analyze its correlation with clinicopathological features. Methods: Collection of archived wax blocks from 64 patients diagnosed with pancreatic cancer after surgical treatment from January 2015 to December 2018 in the Department of Pathology, Affiliated Qingdao Municipal Hospital of Qingdao University, and 30 tissues collected intraoperatively from January 2016 to December 2018 Samples, all collected samples included tumor tissue and corresponding adjacent tissues (>2 cm from the tumor edge). Real-time quantitative PCR (qRT-PCR) and immunohistochemistry were used to detect the expression of FNDC5/Irisin mRNA and its positivity in pancreatic cancer tissues and adjacent tissues, and to analyze its relationship with clinicopathological features of pancreatic cancer. Results: qRT-PCR showed that the expression of FNDC5/Irisin mRNA in pancreatic cancer tissues was higher than that in the corresponding adjacent pancreatic tissues, the difference was statistically significant (P<0.05). The immunohistochemistry results showed that the positivity of FNDC5/Irisin in pancreatic cancer tissues was 59.4%, and the positivity of FNDC5/Irisin in adjacent tissues was 28.1%, and the positivity of FNDC5/Irisin in cancer tissues and adjacent pancreatic tissues was significantly different (P<0.05); the expression level of FNDC5/Irisin was not related with the gender, age, tumor size, degree of differentiation, and tumor stage.(P>0.05), but FNDC5/Irisin expression was associated with liver and lymph node metastasis (P<0.05). Conclusion The positivity of FNDC5/Irisin in pancreatic cancer tissues is significantly higher than that in adjacent pancreatic tissues, and it is correlated with liver and lymph node metastasis in pancreatic cancer.