Objective:The study aimed to evaluate the effect of systemic-pulmonary shunt(SPS) on the infants with tetralogy of Fallot(TOF) with hypoplasia pulmonary arteries.Methods:Among 949 infants less than three-year-old who underwent surgical intervention between January 2010 and December 2015, 853 infants underwent one-stage primary repair(group Ⅰ), whereas 96 infants underwent SPS(group Ⅱ). Among them, 546 were males and 403 were females. The average age and average weight at operation were 13 months and 9.4 kg, respectively. 20.8% infants had clinical symptoms before operation. Perioperative and follow-up parameters were assessed including age, weight, sex, transcutaneous oxygen saturation(SPO 2), preoperative clinic symptom, ratio of McGoon, NAKATA index, Z score of pulmonary annulus, left ventricular end diastolic diameter(LVEDD). Results:There were 28(3.0%) early postoperative deaths in the whole group. And no significant difference in mortality was found between group Ⅰ(2.9%) and group Ⅱ(3.1%). Compared with group Ⅰ, age and weight were significantly lower in patients in group Ⅱ[(0.95±0.56)years old vs.(1.09±0.59)years old] and[(8.6±1.8)kg vs.(9.5±2.1)kg], respectively. Patients in group Ⅱ had a lower SPO 2(0.75±0.09 vs. 0.85±0.09) and was more prone to appear hypoxic spell(30.2% vs. 19.7%) than patients in group Ⅰ. Patients in group Ⅱ had a more poor development in pulmonary artery. The ratio of McGoon, NAKATA index and Z score of pulmonary annulus in group Ⅱ were significantly less than that in group Ⅰ[1.4±0.3 vs. 1.9±0.5, (124±43)mm 2/m 2 vs.(222±88)mm 2/m 2 and-4.3±2.6 vs.-2.3±2.1], respectively. There was no difference of extubation time bewteen two groups. SPO 2 rose significantly from 0.75 to 0.83 after SPS. And after SPS, the diameter of main pulmonary artery, the ratio of McGoon, NAKATA index and Z score of pulmonary annulus increased significantly from 6.4 mm, 1.42, 126.4 mm 2/m 2 and -4.3 to 9.2 mm, 1.83, 212.6 mm 2/m 2 and -2.4, respectively. Moreover, LVEDD also increased significantly from 21.2 mm to 24.5 mm after SPS. Conclusion:SPS is safe and effective for little infants with anoxic spell and hypoplasia pulmonary arteries. SPS can improve oxygenation significantly and delay the age for radical surgery. SPS also promote the growth of the pulmonary arteries, pulmonary valve annulus and left ventricular, and it facilitates the preservation of pulmonary valve annulus and reduce the rate of transannular patching in a portion of infants.

Objective:To study the characteristics of the genotype and phenotypic in a family with X-linked retinoschisis (XLRS) due to RS1 mutation. Methods:A retrospective clinical study. An XLRS family of 4 generations of 26 people were included in the study. Among them, 8 participants were males and 7 participants were females. Routine ophthalmologic examination was performed on 3 patients in the family including the proband and 12 patients with normal phenotype. Optical coherence tomography was performed in 2 of the 3 patients. Peripheral venous blood was extracted from all participants, whole-genome DNA was extracted, and potential pathogenic genes were screened by Panel sequencing. Conservative analysis, pathogenicity analysis and protein structure prediction were carried out by software tools. The pathogenicity of gene mutations was analyzed according to the American Society of Medical Genetics and Genomics (ACMG) guidelines.Results:The proband was 3 years old. Optical coherence tomography (OCT) examination showed that the retinal core layer in the macular area of both eyes had a cystic change, which was segmented by vertical or oblique bridging tissue. The proband's uncle was 32 years old. OCT examination showed atrophy in the macular area of the left eye. The macular area of the right eye was cystoid, segmented by vertical or oblique bridging tissue. No abnormality was found in the fundus examination of the proband's parents and 10 members of his family. Panel sequencing showed that c.361C>T/ p.Q121X hemizygous mutation was found in the fifth exon of RS1 gene in the proband (Ⅳ3) and 2 patients (Ⅱ1, Ⅲ8). The mother was a heterozygous mutation carrier of the gene, while the father had no mutation. The mutant gene causes premature termination of RS1, a truncated protein encoding 224 amino acids to 120 amino acids. Of the 10 patients with normal fundus examination, 6 participants were normal. The mutation was carried by four people, which were women. Homology analysis of the protein sequence showed that the mutant site was highly conserved in 12 mammals. Three-dimensional structural analysis of RS1 protein showed that the c-terminal amino acid sequence of the mutant protein was more than 50% missing. Analysis of ACMG guidelines indicated that the mutation was pathogenic. Conclusion:The RS1 mutation site c.361C>T/p.Q121X is a new mutation site of XLRS.

To broadly understand the new direction of biological evaluation for medical devices, we introduced both domestic and international progress of biological evaluation and focused on illustrating the key points on full life-cycle biological evaluation, toxicological risk evaluation, evaluation endpoints and package material evaluation concern as well as how to use the update vision of ISO 10993-1:2018 scientifically and reasonably in order to provide us better services on performing biological evaluation for medical devices.
Equipment and Supplies

Objective To investigate the applicate effects in the treatment of left coronary artery abnormality originated from pulmonary artery(ALCAPA) with two perfusion methods of Medium-low temperature-full flow and Low-temperature-low flow.Methods From April 2010 to August 2018, 51 children with ALCAPA were treated with direct coronary artery trans-plantation in Beijing Anzhen Hospital.According to the circulated perfusion method, All of cases were divided into two groups:the Medium-low temperature full flow(group A) and Low-temperature low flow(group B); All patients underwent ALCAPA correct operation under general anesthesia by intravenous inhalation and extracorporeal circulation , and the combined cardiac malformations at the same period.Results The whole of 51 children, including 27 males and 24 females, the aweraged age was(29.19 ±19.43)months(8-36 months), the aweraged weight was(11.73 ±9.99)kg(7.4 -35.0 kg).The cardiotho-racic ratio(C/T) was 0.70 ±0.09.In group A, 24 patients, including 13 males and 11 females, the aweraged age 3 -36 (28.64 ±16.30) months, the aweraged weight 7.4-31.0(12.25 ±10.33) kg, and the cardiothoracic ratio(C/T) 0.71 ± 0.07.Group B included 27 patients, including 15 males and 12 females, the aweraged age 5-31(25.85 ±16.60) months, the aweraged weight 6.7-35.0(10.38 ±3.67)kg, and the cardiothoracic ratio(C/T) of 0.69 ±0.06.The postoperative ear-ly death were 5 cases in the whole group, there were 3 cases in group A and 2 cases in group B, all of them were died of low cardiac output syndrome.Extracorporeal membrane oxygenation(ECMO) support for 7 cases of 5 in group A and 2 in group B. There was no statistically significant difference in in-hospital mortality between the two groups(P >0.05).The Intraoperative extracorporeal circulation time, ascending aorta occlusion time, the number and amount of myocardial cold arrest fluid perfu-sion, postoperative extracorporeal circulation assistance time, the incidence of ventricular fibrillation, ICU residence time, and ventilator assistance time were significantly lower in group B than group A, all with statistically significant differences(P<0. 05).A total of 42 cases were followed up after the operation, the follow-up time 17(3-29) months and the left ventricular e-jection fraction increased from 0.53 ±0.15 to 0.66 ±0.14(P<0.05), there was no statistically significant difference between two groups.Conclusion The perfusion modes of Low-temperature-low flow in the correct operation of ALCAPA can effectively shorten the time of aortic occlusion , improve the effect of intraoperative myocardial protection , reduce intraoperative visual field return blood volume, and reduce postoperative low cardiac output.To improve the curative effect of operation.

Objective To investigate the prevalence of nonalcoholic fatty liver disease and the risk factors in Jingyuan county of Ningxia Autonomous Region.Methods The population proportionate sampling method was applied to enroll a representative sample of 10 639 adults in Jingyuan county and the study was conducted using questionnaires and physical examinations.A total of 10 553 people were included in the analysis after excluding those with missing data.High-resolution ultrasound was used to examine the liver and fasting blood was collected in the morning for measurement of blood glucose,blood lipid,and uric acid.The participants were divided into two groups of those with and without nonalcoholic fatty liver disease;the difference in blood biochemical indexes between fatty liver and non-fatty liver groups was compared,and the logistic regression model was used to explore the risk factors affecting the prevalence of fatty liver.Results The prevalence of nonalcoholic fatty liver disease was 7.60％.The prevalence of thyroid nodules was higher in men than in women (8.60％ vs.6.82％,x2=1 1.772,P=0.001).The prevalence rate of fatty liver increased with age (x2=57.336,P＜0.001),the prevalence rates among ≥18 years-＜29 years,≥30 years-＜39 years,≥40years-＜49 years,≥50 years-＜59 years,≥60 years-＜69 years,and above 70 years were 2.92％,6.50％,8.81％,9.59％,8.08％,and 4.77％ respectively.The detection rate of overweight,obesity,abdominal obesity,impaired fasting glucose,impaired glucose tolerance,diabetes,hypertension,hyperuricemia,and dyslipidemia were higher in nonalcoholic fatty liver disease group than in the normal group (P＜0.05).Logistic regression analysis showed that nonalcoholic fatty liver disease group had a higher risk for overweight,obesity,abdominal obesity,impaired fasting glucose,impaired glucose tolerance,diabetes,hypertension,hyperurcemia,and dyslipidemia (OR=5.41,12.45,2.99,1.85,2.05,3.30,1.41,2.23,and 1.98).Conclusion The incidence of nonalcoholic fatty liver in Jingyuan county of Ningxia Autonomous Region was higher.The groups of overweight,obesity,abdominal obesity,impaired fasting glucose,impaired glucose tolerance,diabetes,hypertension,hyperuricemia,and dyslipidemia were high risk factors for nonalcoholic fatty liver disease.

Objective To investigate the prevalences of the obesity and hypertension in southern mountain regions of Ningxia. Methods A cross-sectional study was conducted among a representative sample of 10 639 adults using questionnaires, physical examinations, and blood pressure measurement in southern mountain areas with a population proportionate sampling method. Results The prevalences of overweight,obesity,central obesity,high percentage of body fat,and hypertension were 33.53%,10.71%,19.50%,27.69%,and 31.57% respectively, which were 30.31%,9.62%,16.70%,24.90%,and 27.61% after age-adjustment in rural areas of Ningxia,and increased with aging(Ptrend<0.05). The prevalences of overweight,obesity,and hypertension were higher in males than those in females(P<0.05),and that of central obesity was higher in females than in males(P=0.003).The prevalences of hypertension in subjects with overweight, obesity, central obesity, high percentage of body fat were 38. 14%, 53.75%,52.69%,and 48.90%,respectively. Body mass index,waist circumference,and percentage of body fat were positively correlated with systolic and diastolic blood pressure(P<0.05). The multivariable logistic model revealed that the risk of hypertension in different types of obesity increased about 1.5 times. Conclusion There is high prevalence of obesity and hypertension among the adults in southern mountain areas of Ningxia. The prevalence of hypertension in obesity,central obesity,and high percentage of body fat is closed to or more than half of the population investigated.

In order to improve the reliability of cardiac pacemaker contact-less power supply technology, this paper proposes a novel application of wireless feedback voltage stabilizing technology to adjust heart disease patients with inner power supply filter circuit output voltage and current control method, to keep the output voltage stability, and to ensure that the super capacitor and cardiac pacemaker to get a stable power supply. To implement the real-time accurate voltage control with considering the primary and secondary side inductance coupling coefficient changes, the change of the external power supply voltage and load, it is necessary to test thee real-time and accurate output voltage and current value after rectifying filtering. Therefore, based on the chaotic control theory, we adopted method of phase diagram on the basis of the quick observation after rectifying filtering, so that the method of voltage and current could improve the detection time of the circuit. The phase diagram of proposed control method can be divided into 8 segments, and we got 7 zero-extreme points. When these zero-extreme points are detected, according to extreme points of the zero instantaneous values, the corresponding average values of voltage and current were obtained. Simulation and experimental results showed that using the above method can shorten the response time to less than switch devices 1/2 switching cycles, thus validating the effectiveness and feasibility of the proposed detection algorithm.
Algorithms ; Electric Power Supplies ; Feedback ; Humans ; Nonlinear Dynamics ; Pacemaker, Artificial ; Wireless Technology

[Abstract ] Objective Liver cirrhosis modeling with carbon tetrachloride (CCL4) may be influenced by many factors, such as drug concentration and dosing methods.In this article, we explored the influences of different concentrations and different dosing methods and time of CCL4 on the induction of liver cirrhosis in rats. Methods We constructed rat models of liver cirrhosis with different con-centrations of CCL4(30%and 50%), using different dosing methods (subcutaneous injection, intraperitoneal injection, and intragastric administration) , and for different lengths of dosing time (8 wk, 10 wk, and 12 wk) .We collected blood and liver tissues from the rats at different time points for HE and MTC staining, biochemical and histomorphological scores based on the Scoring Model for Liver Cirrho-sis Disease (SLCD, expressed by R) and the Laennec Fibrosis Scoring System (LFSS, expressed by L), and analysis of the results by 3 ×2 ×3 factorial experiment design. Results The R value was lower in the intraperitoneal injection than in the subcutaneous injection and intragastric administration groups, and so was it in the 50% than in the 30%CCL4 group, decreasing with the extending of dosing time, with statistically significant differences in the main effects ( P<0.05) as well as a remarkable correlation among drug concentrations, dosing methods, and dosing time (P<0.05).The L value was higher in the intraperitoneal injection than in the subcutaneous injection and intra-gastric administration groups, and so was it in the 50% than in the 30% CCL4 group and in the 12 wk than in the 10 wk and 8 wk groups, with statistically significant differences in the main effects ( P<0.05) but no remarkable correlation among drug concentrations, dosing methods, and dosing time ( P>0.05) .The death rate showed an increasing trend in the intraperitoneal injection, subcutaneous injection and intragastric administration of 30% CCL4 (25.33%, 37.78%, and 38.37%) and 50% CCL4 (42.97%, 47.85%, and 51.88%), higher in the 50%than in the 30%CCL4 .However, no significant differences were found in the survival curves among differ-ent dosing methods or between different drug concentrations (P>0.05). Conclusion Intraperitoneal injection was better than subcu-taneous injection and intragastric administration of CCL4 in inducing liver cirrhosis, and the three dosing methods all showed progressively improved efficiency of modeling with the increase of drug concentration and dosing time.

Immunogenicity for medical devices of animal origin is the key and difficult point during immune safety evaluation for these devices. This paper firstly investigated the effect of collagen sponge of animal origin on mouse splenic lymphocyte transformation and proliferation, and then analyzed the influence factors on the MTT method and CFSE method. The results showed that collagen sponge extract cannot significantly induce transformation and proliferation of mouse splenic lymphocyte in vitro.
Animals ; Cells, Cultured ; Collagen ; pharmacology ; Lymphocyte Activation ; drug effects ; Mice ; Porifera ; chemistry ; Spleen ; cytology

To discuss IC50 application in cytotoxicity tests of medical devices, we firstly investigated the vibrating condition and endpoint of MTT method specified in ISO 10993-5: 2009. Furthermore, we demonstrated the application of IC50 in the result evaluation of MTT method. The experimental results show that usage of IC50 in quantitative evaluation of MTT method is feasible.
Equipment and Supplies ; adverse effects ; standards ; Inhibitory Concentration 50 ; Toxicity Tests ; methods