In recent years, clinical research shows the trend of globalization. Due to characteristics of the huge number and relative concentration of patients, the wide variety of diseases, a high patient enrolment rate, lower trials costs, and so on, China and India become a focus of this trend. However, China and India also have their own advantages in the aspects of diseases, infrastructure, policies, regulations, regulatory environment, language, and culture. The key question to address is: how to increase the shares in the trial market in the future and to enhance the international status of China’s clinical research? Before we answer this question, we must understand the present situations of clinical research resources in China and India. So, we searched the relevant literature at home and abroad by computer and hand to analyze advantages and efficiency of clinical research resources in China and India.
ObjectiveTo investigate the prevalence, severity and consequences of acute kidney injury (AKI) in the patients who underwent total cavopulmonary connection (TCPC).MethodsThe clinical data of TCPC patients in our center from January 1, 2010 to December 31, 2014 were collected and retrospectively analyzed. The patients with renal replacement therapy, missing serum creatinine data before operation or combined with valve procedures were excluded. We identified whether AKI was associated with hospital length of stay, ICU duration, mechanical ventilation duration, hospital acquired infection, and early mortality by univariable and multivariable analyses.ResultsA total of 163 patients were included. AKI occurred in 57% of patients (n=93), mild AKI in 26.4% (n=43), moderate AKI in 12.3% (n=20) and severe AKI in 18.4% (n=30). Compared with the no AKI group, the AKI group had higher hospital acquired infection rate (15.1% vs. 0.0%, P<0.001). AKI was independently associated with hospital length of stay (median, 10 d, 95%CI 3.9-16.0, P=0.001), ICU duration (median, 103.9, 95%CI 48.6-159.2, P<0.001) , but not associated with mechanical ventilation duration (median, 8 h vs. 7 h, P=0.529).ConclusionPostoperative AKI in the patients undergoing TCPC is common. AKI is associated with higher hospital acquired infection rate, longer hospital length of stay and ICU duration, but not associated with mechanical ventilation duration.
Objective To investigate the application of delayed sternal closure (DSC) following arterial switch operation for neonates with transposition of great arteries (D-TGA). Methods We retrospectively analyzed clinical data of 172 neonates underwent arterial switch operation with transposition of great arteries (D-TGA) between June 1st 2009 and December 31st 2015. These neonates were divided into 2 groups including a DSC group (118 patients with 99 males and 19 females) and a non-DSC group (54 patients with 47 males and 7 females). The outcome of the two groups were compared. Results Preoperative mechanical ventilation(P<0.001), emergency surgery (P=0.023) and extracorporeal circulation time (P<0.001) were the risk factors for delayed sternal closure. The incidence of complications of median sternotomy incision in the DSC group was not higher than that in the non-DSC group. The mortality rate in the DSC group was markedly higher than that in the non-DSC group (P<0.001). However, DSC was not a risk factor for the death of the neonates. Conclusion Delayed sternal closure does not increase the incidence of complications of the median sternotomy incision, nor is it a risk factor for the death of the neonates. Reasonable application of delayed sternal closure is helpful for early postoperative recovery of the neonates.
ObjectiveTo further understand the anatomical characteristics and rules of left upper lingual pulmonary artery.MethodsCT data of 120 patients (82 males, 38 females, median age of 65 years ranging 36-78 years) with pulmonary nodules from December 2018 to August 2020 in our hospital were retrospectively analyzed. The anatomic characteristics of the lingual segment of the upper left lung were analyzed by three-dimensional reconstruction. ResultsMediastinal lingual artery appeared in 34 of the 120 patients, accounting for 28.4%. There were 26 patientsof mixed mediastinal/interlobar type, 8 patients of pure mediastinal lingual artery, and 92.3% (24/26) mixed mediastinal/interlobar type blood vessel contained A4b. Fifty-eight (58/120, 48.3%) patients had interlobar type A4+5 type, the rest were two-branches type. And 22 patients of A4 and A5 type accounted for the most two-branches type (22/28, 78.6%). The single-branch type was located at the distal end of A6 in 54 (54/58, 93.1%) patients, originated from the proximal end of A6 in 4 patients, and originated from the basilar artery in 6 patients. The two-branches type was at the distal end of A6 accounting for 50.0% (14/28).ConclusionMediastinal lingual artery is more common than expected, accounting for 28.4%, among which mixed lingual artery is more prevalent, usually located in the first pulmonary trunk, and mostly follows the principle of proximity to supply relevant lung tissues. The location of the interlobar branches in the pulmonary trunk can be at the distal or proximal end of A6, care should be taken to avoid damaging adjacent structures.
ObjectiveTo establish an efficient method of isolating and culturing high activity and high purity of Schwann cells, and to identify the cells at the levels of transcription and translation. MethodsThe sciatic nerves harvested from a 4-week-old Sprague Dawley rat were digested in the collagenase I for 15 minutes after dissecting, and then the explants were planted in culture flask directly. The cells were cultured and passaged in vitro, the growth state and morphological changes of the cells were observed under inverted phase contrast microscope. MTT assay was used to test the proliferation of cells and the cells growth curve was drawn. RT-PCR and immunohistochemistry staining were used to detect S100 and glial fibrillary acidic protein (GFAP) at the levels of transcription and translation, respectively. The purity of cells was caculated under microscope. ResultsAfter the digestion of collagenase I, fibroblast-like cells appeared around explants within 24 hours, with slender cell body and weak refraction. After tissues were transferred to another culture flask, a large number of dipolar or tripolar cells were seen after 48 hours, with slender ecphyma, plump cell body, and b refraction, and the cells formed colonies within 72 hours. The cells were covered with the bottom of culture flask within 48-72 hours after passaging at a ratio of 1∶2, and spiral colonies appeared. Cells showed vigorous growth and full cytoplasm after many passages. MTT assay results showed that the cells at passage 3 entered the logarithmic growth phase on the 3rd day, reached the plateau phase on the 7th day with cell proliferation, and the growth curve was “S” shape. RT-PCR results showed that the cells expressed S100 gene and GFAP gene, and immunohistochemistry staining showed that most of the cells were positively stained, indicating that the majority of cells expressing S100 protein and GFAP protein. The purity of Schwann cells was 98.37% ± 0.30%. ConclusionHigh activity and high purity of Schwann cells can be acquired rapidly by single-enzyme digestion and explant-culture method.
Objective To explore the value of extracorporeal membrane oxygenation(ECMO) combined with hypothermia therapy for children patients with refractory cardiac arrest after congenital heart disease surgery. Methods From January 2013 to June 2016, we conducted a prospective study of 23 children (18 males, 5 females at age of 7±11 months) who underwent ECMO for refractory cardiac arrest after congenital heart disease surgery. All patients were randomly divided into two groups: a standard group (11 patients) and a hypothermia group (12 patients). The patients of the standard group received standard therapy (the core body temperature maintaining at 37.0℃) and the hypothermia group received hypothermia therapy (the core body temperature maintaining at 33.0℃). The hospital discharge rate, the rate of weaning from ECMO and the morbidity were compared between the two groups. Results Eleven of 23 patients (47.8%) were weaned from ECMO successfully and 7 of 23 patients (30.4%) discharged from hospital. The hospital discharge rate between the hypothermia group (n=6, 50.0%) and the standard group (n=1, 9.1%) had no statistical difference (χ2=4.537, P=0.069). The rate of weaning from ECMO of the hypothermia group (n=9, 75.0%) was higher than that of the standard group (n=2, 18.2%, χ2=7.425, P=0.006). The morbidity between the two groups had no statistical difference. Conclusion Extracorporeal cardiopulmonary resuscitation can improve the survival rate of the children who suffered from refractory cardiac arrest after congenital heart disease surgery. There is no evidence that ECMO combined with hyperthermia therapy is better than the only ECMO in improving the discharge rate. But ECMO combined with hypothermia therapy has higher rate of weaning from ECMO than that of the only ECMO.
ObjectivesTo systematically review the proportion of Tregs in peripheral blood of patients with ankylosing spondylitis (AS) and its relationship with Treg's diffrent phenotypes.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and VIP databases were electronically searched to collect case-control studies on peripheral Tregs of AS patients from inception to November 31st, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by using Stata 12.0 software.ResultsA total of 61 case-control studies involving 2 466 AS patients and 1 879 controls were included. The results of meta-analysis showed that: the proportion of peripheral Tregs of patients with AS was significantly lower than that of the normal control (SMD=−0.905, 95%CI −1.294 to −0.517, P<0.000 1), and the proportion of Tregs in the disease-active group was significantly lower than that in disease-inactive group (SMD=−0.928, 95%CI −1.431 to −0.425, P<0.000 1). The proportion of CD4+CD25+FOXP3+Tregs and CD4+CD25+CD127low/−Tregs were lower in AS patients than that in control subjects (SMD=−2.547, 95%CI −3.521 to −1.573, P<0.000 1; SMD=−0.709, 95% CI −1.056 to −0.362, P<0.000 1). The proportion of Tregs defined by CD4+CD25low/−FOXP3+ was higher in AS patients (SMD=0.683, 95%CI 0.161 to 1.206, P=0.01). There was no significant difference betweew other phenotypes of Tregs groups.roups.ConclusionsThe reduction of Tregs may be one of the important reasons for the occurrence and development of AS, which may provide a new approach for the diagnosis and treatment of AS.
Objective To investigate diagnostic and treatment strategies of patients with congenital heart diseases and right aortic arch. Methods Clinical data of 27 children who underwent surgical correction for congenital heartdiseases and right aortic arch in Children’s Heart Center of Beijing Children’s Hospital from January 1，2012 to April 1，2013 were retrospectively analyzed. There were 20 male and 7 female patients with their age of 10.96±12.08 months and body weight of 7.70±3.13 kg. All the patients had right aortic arch，including 14 children with tetralogy of Fallot，9 childrenwith ventricular septal defect，1 child with patent ductus arteriosus，1 child with pulmonary artery sling and 2 children with isolated double aortic arch. Thirteen children were found to have a vascular ring including aberrant left subclavian artery and double aortic arch. All the patients received surgical correction for their intracardiac anomalies and concomitant transposition of the left subclavian artery for aberrant left subclavian artery or division of the nondominal arch for double aortic arch. Results Three children died perioperatively including 1 child who was unable to be weaned from cardiopulmonary bypass，1 child without vascular ring who died 7 days postoperatively，and 1 child with double aortic arch who died of acuterespiratory distress syndrome. There was another child who gave up further postoperative treatment. Twenty-three children were followed up for 3-17 months after discharge. Echocardiography showed satisfactory correction of their intracardiac anomalies. All the patients alive recovered well with good pulses in arteries of both arms. Conclusion Careful strategiesare needed for surgical correction of patients with congenital heart diseases and concomitant right aortic arch. Comprehensivepreoperative evaluation including contrast-enhanced CT and magnetic resonance imaging is helpful for clinical decision making in diagnosis and treatment. Clinical outcomes of 1-stage surgical correction of vascular ring and other concomitant intracardiac anomalies are satisfactory with good short-term results.
The aim of the present experimental study is to determine the effects of sinotubular junction diameter on artificial bioprosthesis valves. An experimental study was performed for aortic root models with different sinotubular junction taper under pulsatile flow condition. The sinotubular junction diameters were modified to create four models with different sinotubular junction tapers with 0, 1, 3 and 5 degrees, respectively, using three dimensional printing techniques. After installing the testing bioprosthesis valve on the aortic root models, we conducted experiments of the pulsatile flow testing with different stroke volume in the pulsatile circulation simulation system. The testing condition was set at the pulse frequency of 70 beats/min and the stroke volume of 2–7 L/min. The status of the valves in 10 continuous pulse cycles was tested and the average results were obtained for each stroke volume. The results of testing showed that the mean transvalvular pressure gradients agreed well with the national standard, and all smaller than 10 mm Hg. The sinotubular junction taper had an influence on regurgitation fraction of the artificial bioprosthesis valve. The smaller sinotubular junction taper showed beneficial effect to decrease the regurgitation fraction. In the case of smaller stroke volume, the smaller sinotubular junction taper was beneficial to increase the effective valve orifice area. In the case of larger stroke volume, the larger sinotubular junction taper was beneficial to increase the effective valve orifice area. This study indicates that a doctor should consider the smaller sinotubular junction taper in the case of smaller stroke volume more. In the case of larger stroke volume, the doctor should consider the larger sinotubular junction taper more.
Objective To explore the feasibility of ultrasound diagnosis of diaphragmatic paralysis in patients with ventilation after congenital heart disease surgery. Methods There were 542 patients with congenital heart disease after surgery, difficult to be weaned off the ventilator or suspected diaphragmatic paralysis of the patients, respectively, in the ventilator continous positive pressure breathing (CPAP) mode and completely independent breathing state, whose ultrasound examination of diaphragm function was conducted to determine the presence of diaphragmatic paralysis in our hospital between January 1, 2013 and April 30, 2016. There were 327 males and 215 females at age of 14±32 months. The results of ultrasound diagnosis between ventilator CPAP mode and completely spontaneous breathing mode were compared. Results Five hundred and forty-two patients underwent ultrasound diaphragmatic examination. The results of bedside ultrasound were completely diagnosed: in completely spontaneous breathing, 82 patients who were diagnosed as diaphragmatic paralysis, including 39 on the right, 25 on the left, 18 on both sides; in CPAP mode, 82 patients who were diagnosed as diaphragmatic paralysis, 38 on the right, left 25, bilateral 19. Using ultrasound in CPAP mode to diagnose diaphragmatic paralysis after congenital heart disease surgery, compared with the completely spontaneous breathing state, the sensitivity was 100.0% and the specificity was 99.9%. Conclusion It is accurate and feasible to diagnose the presence of diaphragmatic paralysis in patients with ventilation after congenital heart disease surgery.